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Sample records for cluster randomized trial

  1. A systematic review of the usage of flow diagram in cluster randomized trials

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    Kostić M.

    2014-01-01

    Full Text Available Flow diagram represent an integral part of consolidated standards of reporting trials (CONSORT. Its use in reporting cluster randomization trials is highly recommended. The aim of this article is to present frequency of the use of flow diagram in cluster randomized trials in accordance with standards of reporting. The team has researched Medline database and singled-out 474 studies with cluster randomization for analysis. The studies were reviewed to identify the use of graphic representation, compliance with standards of reporting and the date when study was published. Depending from its duration, studies were divided on completed, and those still ongoing. Usage of CONSORT is recorded in 145 (31% literature units. Frequency of flow diagram was statistically much higher in studies which were in compliance with standards (86,2%, in comparison to those which did not use CONSORT guidelines (71,4%, as well as in completed studies (81,2% in comparison to pilot project studies (54,3%. Number of cluster randomized trials gathered through MEDLINE's search of key words 'cluster randomized trial [ti]' and 'cluster randomised trial [ti]', as well as the use of CONSORT in the reports of cluster randomized trials, are showing linear growth over time (p<0,001. Frequency of flow diagram is higher in the reports of cluster randomized trials that were done in accordance with the standards of reporting.

  2. The Design of Cluster Randomized Trials with Random Cross-Classifications

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    Moerbeek, Mirjam; Safarkhani, Maryam

    2018-01-01

    Data from cluster randomized trials do not always have a pure hierarchical structure. For instance, students are nested within schools that may be crossed by neighborhoods, and soldiers are nested within army units that may be crossed by mental health-care professionals. It is important that the random cross-classification is taken into account…

  3. Person mobility in the design and analysis of cluster-randomized cohort prevention trials.

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    Vuchinich, Sam; Flay, Brian R; Aber, Lawrence; Bickman, Leonard

    2012-06-01

    Person mobility is an inescapable fact of life for most cluster-randomized (e.g., schools, hospitals, clinic, cities, state) cohort prevention trials. Mobility rates are an important substantive consideration in estimating the effects of an intervention. In cluster-randomized trials, mobility rates are often correlated with ethnicity, poverty and other variables associated with disparity. This raises the possibility that estimated intervention effects may generalize to only the least mobile segments of a population and, thus, create a threat to external validity. Such mobility can also create threats to the internal validity of conclusions from randomized trials. Researchers must decide how to deal with persons who leave study clusters during a trial (dropouts), persons and clusters that do not comply with an assigned intervention, and persons who enter clusters during a trial (late entrants), in addition to the persons who remain for the duration of a trial (stayers). Statistical techniques alone cannot solve the key issues of internal and external validity raised by the phenomenon of person mobility. This commentary presents a systematic, Campbellian-type analysis of person mobility in cluster-randomized cohort prevention trials. It describes four approaches for dealing with dropouts, late entrants and stayers with respect to data collection, analysis and generalizability. The questions at issue are: 1) From whom should data be collected at each wave of data collection? 2) Which cases should be included in the analyses of an intervention effect? and 3) To what populations can trial results be generalized? The conclusions lead to recommendations for the design and analysis of future cluster-randomized cohort prevention trials.

  4. Comparing cluster-level dynamic treatment regimens using sequential, multiple assignment, randomized trials: Regression estimation and sample size considerations.

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    NeCamp, Timothy; Kilbourne, Amy; Almirall, Daniel

    2017-08-01

    Cluster-level dynamic treatment regimens can be used to guide sequential treatment decision-making at the cluster level in order to improve outcomes at the individual or patient-level. In a cluster-level dynamic treatment regimen, the treatment is potentially adapted and re-adapted over time based on changes in the cluster that could be impacted by prior intervention, including aggregate measures of the individuals or patients that compose it. Cluster-randomized sequential multiple assignment randomized trials can be used to answer multiple open questions preventing scientists from developing high-quality cluster-level dynamic treatment regimens. In a cluster-randomized sequential multiple assignment randomized trial, sequential randomizations occur at the cluster level and outcomes are observed at the individual level. This manuscript makes two contributions to the design and analysis of cluster-randomized sequential multiple assignment randomized trials. First, a weighted least squares regression approach is proposed for comparing the mean of a patient-level outcome between the cluster-level dynamic treatment regimens embedded in a sequential multiple assignment randomized trial. The regression approach facilitates the use of baseline covariates which is often critical in the analysis of cluster-level trials. Second, sample size calculators are derived for two common cluster-randomized sequential multiple assignment randomized trial designs for use when the primary aim is a between-dynamic treatment regimen comparison of the mean of a continuous patient-level outcome. The methods are motivated by the Adaptive Implementation of Effective Programs Trial which is, to our knowledge, the first-ever cluster-randomized sequential multiple assignment randomized trial in psychiatry.

  5. Evaluation of cluster-randomized trials on maternal and child health research in developing countries

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    Handlos, Line Neerup; Chakraborty, Hrishikesh; Sen, Pranab Kumar

    2009-01-01

    To summarize and evaluate all publications including cluster-randomized trials used for maternal and child health research in developing countries during the last 10 years. METHODS: All cluster-randomized trials published between 1998 and 2008 were reviewed, and those that met our criteria...... for inclusion were evaluated further. The criteria for inclusion were that the trial should have been conducted in maternal and child health care in a developing country and that the conclusions should have been made on an individual level. Methods of accounting for clustering in design and analysis were......, and the trials generally improved in quality. CONCLUSIONS: Shortcomings exist in the sample-size calculations and in the analysis of cluster-randomized trials conducted during maternal and child health research in developing countries. Even though there has been improvement over time, further progress in the way...

  6. Impact of a cancer clinical trials web site on discussions about trial participation: a cluster randomized trial.

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    Dear, R F; Barratt, A L; Askie, L M; Butow, P N; McGeechan, K; Crossing, S; Currow, D C; Tattersall, M H N

    2012-07-01

    Cancer patients want access to reliable information about currently recruiting clinical trials. Oncologists and their patients were randomly assigned to access a consumer-friendly cancer clinical trials web site [Australian Cancer Trials (ACT), www.australiancancertrials.gov.au] or to usual care in a cluster randomized controlled trial. The primary outcome, measured from audio recordings of oncologist-patient consultations, was the proportion of patients with whom participation in any clinical trial was discussed. Analysis was by intention-to-treat accounting for clustering and stratification. Thirty medical oncologists and 493 patients were recruited. Overall, 46% of consultations in the intervention group compared with 34% in the control group contained a discussion about clinical trials (P=0.08). The mean consultation length in both groups was 29 min (P=0.69). The proportion consenting to a trial was 10% in both groups (P=0.65). Patients' knowledge about randomized trials was lower in the intervention than the control group (mean score 3.0 versus 3.3, P=0.03) but decisional conflict scores were similar (mean score 42 versus 43, P=0.83). Good communication between patients and physicians is essential. Within this context, a web site such as Australian Cancer Trials may be an important tool to encourage discussion about clinical trial participation.

  7. Selection bias and subject refusal in a cluster-randomized controlled trial

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    Rochelle Yang

    2017-07-01

    Full Text Available Abstract Background Selection bias and non-participation bias are major methodological concerns which impact external validity. Cluster-randomized controlled trials are especially prone to selection bias as it is impractical to blind clusters to their allocation into intervention or control. This study assessed the impact of selection bias in a large cluster-randomized controlled trial. Methods The Improved Cardiovascular Risk Reduction to Enhance Rural Primary Care (ICARE study examined the impact of a remote pharmacist-led intervention in twelve medical offices. To assess eligibility, a standardized form containing patient demographics and medical information was completed for each screened patient. Eligible patients were approached by the study coordinator for recruitment. Both the study coordinator and the patient were aware of the site’s allocation prior to consent. Patients who consented or declined to participate were compared across control and intervention arms for differing characteristics. Statistical significance was determined using a two-tailed, equal variance t-test and a chi-square test with adjusted Bonferroni p-values. Results were adjusted for random cluster variation. Results There were 2749 completed screening forms returned to research staff with 461 subjects who had either consented or declined participation. Patients with poorly controlled diabetes were found to be significantly more likely to decline participation in intervention sites compared to those in control sites. A higher mean diastolic blood pressure was seen in patients with uncontrolled hypertension who declined in the control sites compared to those who declined in the intervention sites. However, these findings were no longer significant after adjustment for random variation among the sites. After this adjustment, females were now found to be significantly more likely to consent than males (odds ratio = 1.41; 95% confidence interval = 1.03, 1

  8. Improving Language Comprehension in Preschool Children with Language Difficulties: A Cluster Randomized Trial

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    Hagen, Åste M.; Melby-Lervåg, Monica; Lervåg, Arne

    2017-01-01

    Background: Children with language comprehension difficulties are at risk of educational and social problems, which in turn impede employment prospects in adulthood. However, few randomized trials have examined how such problems can be ameliorated during the preschool years. Methods: We conducted a cluster randomized trial in 148 preschool…

  9. Complementary feeding: a Global Network cluster randomized controlled trial

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    Pasha Omrana

    2011-01-01

    Full Text Available Abstract Background Inadequate and inappropriate complementary feeding are major factors contributing to excess morbidity and mortality in young children in low resource settings. Animal source foods in particular are cited as essential to achieve micronutrient requirements. The efficacy of the recommendation for regular meat consumption, however, has not been systematically evaluated. Methods/Design A cluster randomized efficacy trial was designed to test the hypothesis that 12 months of daily intake of beef added as a complementary food would result in greater linear growth velocity than a micronutrient fortified equi-caloric rice-soy cereal supplement. The study is being conducted in 4 sites of the Global Network for Women's and Children's Health Research located in Guatemala, Pakistan, Democratic Republic of the Congo (DRC and Zambia in communities with toddler stunting rates of at least 20%. Five clusters per country were randomized to each of the food arms, with 30 infants in each cluster. The daily meat or cereal supplement was delivered to the home by community coordinators, starting when the infants were 6 months of age and continuing through 18 months. All participating mothers received nutrition education messages to enhance complementary feeding practices delivered by study coordinators and through posters at the local health center. Outcome measures, obtained at 6, 9, 12, and 18 months by a separate assessment team, included anthropometry; dietary variety and diversity scores; biomarkers of iron, zinc and Vitamin B12 status (18 months; neurocognitive development (12 and 18 months; and incidence of infectious morbidity throughout the trial. The trial was supervised by a trial steering committee, and an independent data monitoring committee provided oversight for the safety and conduct of the trial. Discussion Findings from this trial will test the efficacy of daily intake of meat commencing at age 6 months and, if beneficial, will

  10. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

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    Chaudhry Shazia H

    2009-07-01

    Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An

  11. Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

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    Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

    2017-08-01

    Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28

  12. Universal Prevention for Anxiety and Depressive Symptoms in Children: A Meta-analysis of Randomized and Cluster-Randomized Trials.

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    Ahlen, Johan; Lenhard, Fabian; Ghaderi, Ata

    2015-12-01

    Although under-diagnosed, anxiety and depression are among the most prevalent psychiatric disorders in children and adolescents, leading to severe impairment, increased risk of future psychiatric problems, and a high economic burden to society. Universal prevention may be a potent way to address these widespread problems. There are several benefits to universal relative to targeted interventions because there is limited knowledge as to how to screen for anxiety and depression in the general population. Earlier meta-analyses of the prevention of depression and anxiety symptoms among children suffer from methodological inadequacies such as combining universal, selective, and indicated interventions in the same analyses, and comparing cluster-randomized trials with randomized trials without any correction for clustering effects. The present meta-analysis attempted to determine the effectiveness of universal interventions to prevent anxiety and depressive symptoms after correcting for clustering effects. A systematic search of randomized studies in PsychINFO, Cochrane Library, and Google Scholar resulted in 30 eligible studies meeting inclusion criteria, namely peer-reviewed, randomized or cluster-randomized trials of universal interventions for anxiety and depressive symptoms in school-aged children. Sixty-three percent of the studies reported outcome data regarding anxiety and 87 % reported outcome data regarding depression. Seventy percent of the studies used randomization at the cluster level. There were small but significant effects regarding anxiety (.13) and depressive (.11) symptoms as measured at immediate posttest. At follow-up, which ranged from 3 to 48 months, effects were significantly larger than zero regarding depressive (.07) but not anxiety (.11) symptoms. There was no significant moderation effect of the following pre-selected variables: the primary aim of the intervention (anxiety or depression), deliverer of the intervention, gender distribution

  13. Standardized Effect Size Measures for Mediation Analysis in Cluster-Randomized Trials

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    Stapleton, Laura M.; Pituch, Keenan A.; Dion, Eric

    2015-01-01

    This article presents 3 standardized effect size measures to use when sharing results of an analysis of mediation of treatment effects for cluster-randomized trials. The authors discuss 3 examples of mediation analysis (upper-level mediation, cross-level mediation, and cross-level mediation with a contextual effect) with demonstration of the…

  14. Re-estimating sample size in cluster randomized trials with active recruitment within clusters

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    van Schie, Sander; Moerbeek, Mirjam

    2014-01-01

    Often only a limited number of clusters can be obtained in cluster randomised trials, although many potential participants can be recruited within each cluster. Thus, active recruitment is feasible within the clusters. To obtain an efficient sample size in a cluster randomised trial, the cluster

  15. Relative efficiency and sample size for cluster randomized trials with variable cluster sizes.

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    You, Zhiying; Williams, O Dale; Aban, Inmaculada; Kabagambe, Edmond Kato; Tiwari, Hemant K; Cutter, Gary

    2011-02-01

    The statistical power of cluster randomized trials depends on two sample size components, the number of clusters per group and the numbers of individuals within clusters (cluster size). Variable cluster sizes are common and this variation alone may have significant impact on study power. Previous approaches have taken this into account by either adjusting total sample size using a designated design effect or adjusting the number of clusters according to an assessment of the relative efficiency of unequal versus equal cluster sizes. This article defines a relative efficiency of unequal versus equal cluster sizes using noncentrality parameters, investigates properties of this measure, and proposes an approach for adjusting the required sample size accordingly. We focus on comparing two groups with normally distributed outcomes using t-test, and use the noncentrality parameter to define the relative efficiency of unequal versus equal cluster sizes and show that statistical power depends only on this parameter for a given number of clusters. We calculate the sample size required for an unequal cluster sizes trial to have the same power as one with equal cluster sizes. Relative efficiency based on the noncentrality parameter is straightforward to calculate and easy to interpret. It connects the required mean cluster size directly to the required sample size with equal cluster sizes. Consequently, our approach first determines the sample size requirements with equal cluster sizes for a pre-specified study power and then calculates the required mean cluster size while keeping the number of clusters unchanged. Our approach allows adjustment in mean cluster size alone or simultaneous adjustment in mean cluster size and number of clusters, and is a flexible alternative to and a useful complement to existing methods. Comparison indicated that we have defined a relative efficiency that is greater than the relative efficiency in the literature under some conditions. Our measure

  16. A pilot cluster randomized controlled trial of structured goal-setting following stroke.

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    Taylor, William J; Brown, Melanie; William, Levack; McPherson, Kathryn M; Reed, Kirk; Dean, Sarah G; Weatherall, Mark

    2012-04-01

    To determine the feasibility, the cluster design effect and the variance and minimal clinical importance difference in the primary outcome in a pilot study of a structured approach to goal-setting. A cluster randomized controlled trial. Inpatient rehabilitation facilities. People who were admitted to inpatient rehabilitation following stroke who had sufficient cognition to engage in structured goal-setting and complete the primary outcome measure. Structured goal elicitation using the Canadian Occupational Performance Measure. Quality of life at 12 weeks using the Schedule for Individualised Quality of Life (SEIQOL-DW), Functional Independence Measure, Short Form 36 and Patient Perception of Rehabilitation (measuring satisfaction with rehabilitation). Assessors were blinded to the intervention. Four rehabilitation services and 41 patients were randomized. We found high values of the intraclass correlation for the outcome measures (ranging from 0.03 to 0.40) and high variance of the SEIQOL-DW (SD 19.6) in relation to the minimally importance difference of 2.1, leading to impractically large sample size requirements for a cluster randomized design. A cluster randomized design is not a practical means of avoiding contamination effects in studies of inpatient rehabilitation goal-setting. Other techniques for coping with contamination effects are necessary.

  17. A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation

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    Acosta, Joie D.; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S.

    2016-01-01

    Restorative practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this article describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI)…

  18. Implementation of client versus care-provider strategies to improve external cephalic version rates: a cluster randomized controlled trial

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    Vlemmix, Floortje; Rosman, Ageeth N.; Rijnders, Marlies E.; Beuckens, Antje; Opmeer, Brent C.; Mol, Ben W. J.; Kok, Marjolein; Fleuren, Margot A. H.

    2015-01-01

    To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version. Cluster randomized controlled trial. Twenty-five clusters; hospitals and their referring midwifery practices randomly selected in the Netherlands. Singleton breech

  19. Implementation of client versus care-provider strategies to improve external cephalic version rates: a cluster randomized controlled trial

    NARCIS (Netherlands)

    Vlemmix, F.; Rosman, A.N.; Rijnders, M.E.; Beuckens, A.; Opmeer, B.C.; Mol, B.W.J.; Kok, M.; Fleuren, M.A.H.

    2015-01-01

    Onjective: To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version. Design: Cluster randomized controlled trial.Setting: Twenty-five clusters; hospitals and their referring midwifery practices randomly selected in the

  20. Handling missing data in cluster randomized trials: A demonstration of multiple imputation with PAN through SAS

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    Jiangxiu Zhou

    2014-09-01

    Full Text Available The purpose of this study is to demonstrate a way of dealing with missing data in clustered randomized trials by doing multiple imputation (MI with the PAN package in R through SAS. The procedure for doing MI with PAN through SAS is demonstrated in detail in order for researchers to be able to use this procedure with their own data. An illustration of the technique with empirical data was also included. In this illustration thePAN results were compared with pairwise deletion and three types of MI: (1 Normal Model (NM-MI ignoring the cluster structure; (2 NM-MI with dummy-coded cluster variables (fixed cluster structure; and (3 a hybrid NM-MI which imputes half the time ignoring the cluster structure, and the other half including the dummy-coded cluster variables. The empirical analysis showed that using PAN and the other strategies produced comparable parameter estimates. However, the dummy-coded MI overestimated the intraclass correlation, whereas MI ignoring the cluster structure and the hybrid MI underestimated the intraclass correlation. When compared with PAN, the p-value and standard error for the treatment effect were higher with dummy-coded MI, and lower with MI ignoring the clusterstructure, the hybrid MI approach, and pairwise deletion. Previous studies have shown that NM-MI is not appropriate for handling missing data in clustered randomized trials. This approach, in addition to the pairwise deletion approach, leads to a biased intraclass correlation and faultystatistical conclusions. Imputation in clustered randomized trials should be performed with PAN. We have demonstrated an easy way for using PAN through SAS.

  1. The Effectiveness of Healthy Start Home Visit Program: Cluster Randomized Controlled Trial

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    Leung, Cynthia; Tsang, Sandra; Heung, Kitty

    2015-01-01

    Purpose: The study reported the effectiveness of a home visit program for disadvantaged Chinese parents with preschool children, using cluster randomized controlled trial design. Method: Participants included 191 parents and their children from 24 preschools, with 84 dyads (12 preschools) in the intervention group and 107 dyads (12 preschools) in…

  2. Can group-based reassuring information alter low back pain behavior? A cluster-randomized controlled trial

    DEFF Research Database (Denmark)

    Frederiksen, Pernille; Indahl, Aage; Andersen, Lars L

    2017-01-01

    -randomized controlled trial. METHODS: Publically employed workers (n = 505) from 11 Danish municipality centers were randomized at center-level (cluster) to either intervention (two 1-hour group-based talks at the workplace) or control. The talks provided reassuring information together with a simple non...

  3. Structuring communication relationships for interprofessional teamwork (SCRIPT: a cluster randomized controlled trial

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    Kenaszchuk Chris

    2007-09-01

    Full Text Available Abstract Background Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. Objectives The objective is to evaluate the effects of a four-component, hospital-based staff communication protocol designed to promote collaborative communication between healthcare professionals and enhance patient-centred care. Methods The study is a multi-centre mixed-methods cluster randomized controlled trial involving twenty clinical teaching teams (CTTs in general internal medicine (GIM divisions of five Toronto tertiary-care hospitals. CTTs will be randomly assigned either to receive an intervention designed to improve interprofessional collaborative communication, or to continue usual communication practices. Non-participant naturalistic observation, shadowing, and semi-structured, qualitative interviews were conducted to explore existing patterns of interprofessional collaboration in the CTTs, and to support intervention development. Interviews and shadowing will continue during intervention delivery in order to document interactions between the intervention settings and adopters, and changes in interprofessional communication. The primary outcome is the rate of unplanned hospital readmission. Secondary outcomes are length of stay (LOS; adherence to evidence-based prescription drug therapy; patients' satisfaction with care; self-report surveys of CTT staff perceptions of interprofessional collaboration; and frequency of calls to paging devices. Outcomes will be compared on an intention-to-treat basis using adjustment methods appropriate for data from a cluster randomized design. Discussion Pre-intervention qualitative analysis revealed that a

  4. Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

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    Johnson, Anna M; Jones, Sara B; Duncan, Pamela W; Bushnell, Cheryl D; Coleman, Sylvia W; Mettam, Laurie H; Kucharska-Newton, Anna M; Sissine, Mysha E; Rosamond, Wayne D

    2018-01-26

    Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in "real-world" clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers' increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study. The COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7-14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies. We successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board

  5. A simple sample size formula for analysis of covariance in cluster randomized trials.

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    Teerenstra, S.; Eldridge, S.; Graff, M.J.; Hoop, E. de; Borm, G.F.

    2012-01-01

    For cluster randomized trials with a continuous outcome, the sample size is often calculated as if an analysis of the outcomes at the end of the treatment period (follow-up scores) would be performed. However, often a baseline measurement of the outcome is available or feasible to obtain. An

  6. Does clinical equipoise apply to cluster randomized trials in health research?

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    2011-01-01

    This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, Weijer and colleagues set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the third of the questions posed, namely, does clinical equipoise apply to CRTs in health research? The ethical principle of beneficence is the moral obligation not to harm needlessly and, when possible, to promote the welfare of research subjects. Two related ethical problems have been discussed in the CRT literature. First, are control groups that receive only usual care unduly disadvantaged? Second, when accumulating data suggests the superiority of one intervention in a trial, is there an ethical obligation to act? In individually randomized trials involving patients, similar questions are addressed by the concept of clinical equipoise, that is, the ethical requirement that, at the start of a trial, there be a state of honest, professional disagreement in the community of expert practitioners as to the preferred treatment. Since CRTs may not involve physician-researchers and patient-subjects, the applicability of clinical equipoise to CRTs is uncertain. Here we argue that clinical equipoise may be usefully grounded in a trust relationship between the state and research subjects, and, as a result, clinical equipoise is applicable to CRTs. Clinical equipoise is used to argue that control groups receiving only usual care are not disadvantaged so long as the evidence supporting the experimental and control interventions is such that experts would disagree as to which is preferred. Further, while data accumulating during the course of a CRT may favor one intervention over another, clinical equipoise supports continuing the trial until the results are likely to be broadly convincing, often coinciding with the planned completion of the trial

  7. How large are the consequences of covariate imbalance in cluster randomized trials: a simulation study with a continuous outcome and a binary covariate at the cluster level.

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    Moerbeek, Mirjam; van Schie, Sander

    2016-07-11

    The number of clusters in a cluster randomized trial is often low. It is therefore likely random assignment of clusters to treatment conditions results in covariate imbalance. There are no studies that quantify the consequences of covariate imbalance in cluster randomized trials on parameter and standard error bias and on power to detect treatment effects. The consequences of covariance imbalance in unadjusted and adjusted linear mixed models are investigated by means of a simulation study. The factors in this study are the degree of imbalance, the covariate effect size, the cluster size and the intraclass correlation coefficient. The covariate is binary and measured at the cluster level; the outcome is continuous and measured at the individual level. The results show covariate imbalance results in negligible parameter bias and small standard error bias in adjusted linear mixed models. Ignoring the possibility of covariate imbalance while calculating the sample size at the cluster level may result in a loss in power of at most 25 % in the adjusted linear mixed model. The results are more severe for the unadjusted linear mixed model: parameter biases up to 100 % and standard error biases up to 200 % may be observed. Power levels based on the unadjusted linear mixed model are often too low. The consequences are most severe for large clusters and/or small intraclass correlation coefficients since then the required number of clusters to achieve a desired power level is smallest. The possibility of covariate imbalance should be taken into account while calculating the sample size of a cluster randomized trial. Otherwise more sophisticated methods to randomize clusters to treatments should be used, such as stratification or balance algorithms. All relevant covariates should be carefully identified, be actually measured and included in the statistical model to avoid severe levels of parameter and standard error bias and insufficient power levels.

  8. Recruitment to Online Therapies for Depression: Pilot Cluster Randomized Controlled Trial

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    Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

    2013-01-01

    Background Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. Objective To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues....

  9. Cluster-randomized xylitol toothpaste trial for early childhood caries prevention

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    Chi, Donald L.; Tut, Ohnmar K.; Milgrom, Peter

    2013-01-01

    Purpose We assessed the efficacy of supervised toothbrushing with xylitol toothpaste to prevent early childhood caries (ECC) and to reduce mutans streptococci (MS). Methods In this cluster-randomized efficacy trial, 4 Head Start classrooms in the Marshall Islands were randomly assigned to supervised toothbrushing with 1,400ppm/31% fluoride-xylitol (Epic Dental, Provo, UT) or 1,450ppm fluoride-sorbitol toothpaste (Colgate-Palmolive, New York, NY) (N=196 children, ages 4–5 yrs). We hypothesized no difference in efficacy between the two types of toothpaste. The primary outcome was primary molar d2-3mfs increment after 6 mos. A single examiner was blinded to classroom assignments. Two classrooms were assigned to the fluoride-xylitol group (85 children) and 2 classrooms to the fluoride-sorbitol group (83 children). The child-level analyses accounted for clustering. Results There was no difference between the two groups in baseline or end-of-trial mean d2-3mfs. The mean d2-3mfs increment was greater in the fluoride-xylitol group compared to the fluoride-sorbitol group (2.5 and 1.4 d2-3mfs, respectively), but the difference was not significant (95% CI:−0.17, 2.37;P=0.07). No adverse effects were reported. Conclusion After 6 mos, brushing with a low strength xylitol/fluoride toothpaste is no more efficacious in reducing ECC than a fluoride only toothpaste in a high caries risk child population. PMID:24709430

  10. Cluster-randomized xylitol toothpaste trial for early childhood caries prevention.

    Science.gov (United States)

    Chi, Donald L; Tut, Ohnmar; Milgrom, Peter

    2014-01-01

    The purpose of this study was to assess the efficacy of supervised tooth-brushing with xylitol toothpaste to prevent early childhood caries (ECC) and reduce mutans streptococci. In this cluster-randomized efficacy trial, 196 four- to five-year-old children in four Head Start classrooms in the Marshall Islands were randomly assigned to supervised toothbrushing with 1,400 ppm/31 percent fluoride xylitol or 1,450 ppm fluoride sorbitol toothpaste. We hypothesized that there would be no difference in efficacy between the two types of toothpaste. The primary outcome was the surface-level primary molar caries increment (d(2-3)mfs) after six months. A single examiner was blinded to classroom assignments. Two classrooms were assigned to the fluoride-xylitol group (85 children), and two classrooms were assigned to the fluoride-sorbitol group (83 children). The child-level analyses accounted for clustering. There was no difference between the two groups in baseline or end-of-trial mean d(2-3)mfs. The mean d(2-3)mfs increment was greater in the fluoride-xylitol group compared to the fluoride-sorbitol group (2.5 and 1.4 d(2-3)mfs, respectively), but the difference was not significant (95% confidence interval: -0.17, 2.37; P=.07). No adverse effects were reported. After six months, brushing with a low-strength xylitol/fluoride tooth-paste is no more efficacious in reducing ECC than a fluoride-only toothpaste in a high caries-risk child population.

  11. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records

    NARCIS (Netherlands)

    Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C

    BACKGROUND AND PURPOSE: The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using

  12. Structuring communication relationships for interprofessional teamwork (SCRIPT): a cluster randomized controlled trial

    OpenAIRE

    Zwarenstein, Merrick; Reeves, Scott; Russell, Ann; Kenaszchuk, Chris; Conn, Lesley Gotlib; Miller, Karen-Lee; Lingard, Lorelei; Thorpe, Kevin E

    2007-01-01

    Abstract Background Despite a burgeoning interest in using interprofessional approaches to promote effective collaboration in health care, systematic reviews find scant evidence of benefit. This protocol describes the first cluster randomized controlled trial (RCT) to design and evaluate an intervention intended to improve interprofessional collaborative communication and patient-centred care. Objectives The objective is to evaluate the effects of a four-component, hospital-based staff commun...

  13. Making birthing safe for Pakistan women: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Khan Muhammad

    2012-07-01

    Full Text Available Abstract Background Two out of three neonatal deaths occur in just 10 countries and Pakistan stands third among them. Maternal mortality is also high with most deaths occurring during labor, birth, and first few hours after birth. Enhanced access and utilization of skilled delivery and emergency obstetric care is the demonstrated strategy in reducing maternal and neonatal mortality. This trial aims to compare reduction in neonate mortality and utilization of available safe birthing and Emergency Obstetric and Neonatal Care services among pregnant mothers receiving ‘structured birth planning’, and/or ‘transport facilitation’ compared to routine care. Methods A pragmatic cluster randomized trial, with qualitative and economic studies, will be conducted in Jhang, Chiniot and Khanewal districts of Punjab, Pakistan, from February 2011 to May 2013. At least 29,295 pregnancies will be registered in the three arms, seven clusters per arm; 1 structured birth planning and travel facilitation, 2 structured birth planning, and 3 control arm. Trial will be conducted through the Lady Health Worker program. Main outcomes are difference in neonatal mortality and service utilization; maternal mortality being the secondary outcome. Cluster level analysis will be done according to intention-to-treat. Discussion A nationwide network of about 100,000 lady health workers is already involved in antenatal and postnatal care of pregnant women. They also act as “gatekeepers” for the child birthing services. This gate keeping role mainly includes counseling and referral for skill birth attendance and travel arrangements for emergency obstetric care (if required. The review of current arrangements and practices show that the care delivery process needs enhancement to include adequate information provision as well as informed “decision” making and planned “action” by the pregnant women. The proposed three-year research is to develop, through national

  14. Sample size adjustments for varying cluster sizes in cluster randomized trials with binary outcomes analyzed with second-order PQL mixed logistic regression.

    Science.gov (United States)

    Candel, Math J J M; Van Breukelen, Gerard J P

    2010-06-30

    Adjustments of sample size formulas are given for varying cluster sizes in cluster randomized trials with a binary outcome when testing the treatment effect with mixed effects logistic regression using second-order penalized quasi-likelihood estimation (PQL). Starting from first-order marginal quasi-likelihood (MQL) estimation of the treatment effect, the asymptotic relative efficiency of unequal versus equal cluster sizes is derived. A Monte Carlo simulation study shows this asymptotic relative efficiency to be rather accurate for realistic sample sizes, when employing second-order PQL. An approximate, simpler formula is presented to estimate the efficiency loss due to varying cluster sizes when planning a trial. In many cases sampling 14 per cent more clusters is sufficient to repair the efficiency loss due to varying cluster sizes. Since current closed-form formulas for sample size calculation are based on first-order MQL, planning a trial also requires a conversion factor to obtain the variance of the second-order PQL estimator. In a second Monte Carlo study, this conversion factor turned out to be 1.25 at most. (c) 2010 John Wiley & Sons, Ltd.

  15. Fit 5 Kids TV reduction program for Latino preschoolers: A cluster randomized controlled trial

    Science.gov (United States)

    Reducing Latino preschoolers' TV viewing is needed to reduce their risk of obesity and other chronic diseases. This study's objective was to evaluate the Fit 5 Kids (F5K) TV reduction program's impact on Latino preschooler's TV viewing. The study design was a cluster randomized controlled trial (RCT...

  16. A cluster randomized controlled trial testing the effectiveness of Houvast: A strengths-based intervention for homeless young adults

    NARCIS (Netherlands)

    Krabbenborg, M.A.M.; Boersma, S.N.; Veld, W.M. van der; Hulst, B. van; Vollebergh, W.A.M.; Wolf, J.R.L.M.

    2017-01-01

    Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed

  17. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh

    OpenAIRE

    George, Christine Marie; van Geen, Alexander; Slavkovich, Vesna; Singha, Ashit; Levy, Diane; Islam, Tariqul; Ahmed, Kazi Matin; Moon-Howard, Joyce; Tarozzi, Alessandro; Liu, Xinhua; Factor-Litvak, Pam; Graziano, Joseph

    2012-01-01

    Abstract Objective To reduce arsenic (As) exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs) testing and provide As education compared to sending representatives from outside communities to conduct these tasks. Methods We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs...

  18. Comparison of population-averaged and cluster-specific models for the analysis of cluster randomized trials with missing binary outcomes: a simulation study

    Directory of Open Access Journals (Sweden)

    Ma Jinhui

    2013-01-01

    Full Text Available Abstracts Background The objective of this simulation study is to compare the accuracy and efficiency of population-averaged (i.e. generalized estimating equations (GEE and cluster-specific (i.e. random-effects logistic regression (RELR models for analyzing data from cluster randomized trials (CRTs with missing binary responses. Methods In this simulation study, clustered responses were generated from a beta-binomial distribution. The number of clusters per trial arm, the number of subjects per cluster, intra-cluster correlation coefficient, and the percentage of missing data were allowed to vary. Under the assumption of covariate dependent missingness, missing outcomes were handled by complete case analysis, standard multiple imputation (MI and within-cluster MI strategies. Data were analyzed using GEE and RELR. Performance of the methods was assessed using standardized bias, empirical standard error, root mean squared error (RMSE, and coverage probability. Results GEE performs well on all four measures — provided the downward bias of the standard error (when the number of clusters per arm is small is adjusted appropriately — under the following scenarios: complete case analysis for CRTs with a small amount of missing data; standard MI for CRTs with variance inflation factor (VIF 50. RELR performs well only when a small amount of data was missing, and complete case analysis was applied. Conclusion GEE performs well as long as appropriate missing data strategies are adopted based on the design of CRTs and the percentage of missing data. In contrast, RELR does not perform well when either standard or within-cluster MI strategy is applied prior to the analysis.

  19. Engineering practice variation through provider agreement: a cluster-randomized feasibility trial.

    Science.gov (United States)

    McCarren, Madeline; Twedt, Elaine L; Mansuri, Faizmohamed M; Nelson, Philip R; Peek, Brian T

    2014-01-01

    Minimal-risk randomized trials that can be embedded in practice could facilitate learning health-care systems. A cluster-randomized design was proposed to compare treatment strategies by assigning clusters (eg, providers) to "favor" a particular drug, with providers retaining autonomy for specific patients. Patient informed consent might be waived, broadening inclusion. However, it is not known if providers will adhere to the assignment or whether institutional review boards will waive consent. We evaluated the feasibility of this trial design. Agreeable providers were randomized to "favor" either hydrochlorothiazide or chlorthalidone when starting patients on thiazide-type therapy for hypertension. The assignment applied when the provider had already decided to start a thiazide, and providers could deviate from the strategy as needed. Prescriptions were aggregated to produce a provider strategy-adherence rate. All four institutional review boards waived documentation of patient consent. Providers (n=18) followed their assigned strategy for most of their new thiazide prescriptions (n=138 patients). In the "favor hydrochlorothiazide" group, there was 99% adherence to that strategy. In the "favor chlorthalidone" group, chlorthalidone comprised 77% of new thiazide starts, up from 1% in the pre-study period. When the assigned strategy was followed, dosing in the recommended range was 48% for hydrochlorothiazide (25-50 mg/day) and 100% for chlorthalidone (12.5-25.0 mg/day). Providers were motivated to participate by a desire to contribute to a comparative effectiveness study. A study promotional mug, provider information letter, and interactions with the site investigator were identified as most helpful in reminding providers of their study drug strategy. Providers prescribed according to an assigned drug-choice strategy most of the time for the purpose of a comparative effectiveness study. This simple design could facilitate research participation and behavior change

  20. Cluster randomized trial in the general practice research database: 2. Secondary prevention after first stroke (eCRT study: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Dregan Alex

    2012-10-01

    Full Text Available Abstract Background The purpose of this research is to develop and evaluate methods for conducting pragmatic cluster randomized trials in a primary care electronic database. The proposal describes one application, in a less frequent chronic condition of public health importance, secondary prevention of stroke. A related protocol in antibiotic prescribing was reported previously. Methods/Design The study aims to implement a cluster randomized trial (CRT using the electronic patient records of the General Practice Research Database (GPRD as a sampling frame and data source. The specific objective of the trial is to evaluate the effectiveness of a computer-delivered intervention at enhancing the delivery of stroke secondary prevention in primary care. GPRD family practices will be allocated to the intervention or usual care. The intervention promotes the use of electronic prompts to support adherence with the recommendations of the UK Intercollegiate Stroke Working Party and NICE guidelines for the secondary prevention of stroke in primary care. Primary outcome measure will be the difference in systolic blood pressure between intervention and control trial arms at 12-month follow-up. Secondary outcomes will be differences in serum cholesterol, prescribing of antihypertensive drugs, statins, and antiplatelet therapy. The intervention will continue for 12 months. Information on the utilization of the decision-support tools will also be analyzed. Discussion The CRT will investigate the effectiveness of using a computer-delivered intervention to reduce the risk of stroke recurrence following a first stroke event. The study will provide methodological guidance on the implementation of CRTs in electronic databases in primary care. Trial registration Current Controlled Trials ISRCTN35701810

  1. A Cluster Randomized Controlled Trial Testing the Effectiveness of Houvast: A Strengths-Based Intervention for Homeless Young Adults

    Science.gov (United States)

    Krabbenborg, Manon A. M.; Boersma, Sandra N.; van der Veld, William M.; van Hulst, Bente; Vollebergh, Wilma A. M.; Wolf, Judith R. L. M.

    2017-01-01

    Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended.…

  2. Design and protocol of the weight loss lottery- a cluster randomized trial.

    Science.gov (United States)

    van der Swaluw, Koen; Lambooij, Mattijs S; Mathijssen, Jolanda J P; Schipper, Maarten; Zeelenberg, Marcel; Polder, Johan J; Prast, Henriëtte M

    2016-07-01

    People often intend to exercise but find it difficult to attend their gyms on a regular basis. At times, people seek and accept deadlines with consequences to realize their own goals (i.e. commitment devices). The aim of our cluster randomized controlled trial is to test whether a lottery-based commitment device can promote regular gym attendance. The winners of the lottery always get feedback on the outcome but can only claim their prize if they attended their gyms on a regular basis. In this paper we present the design and baseline characteristics of a three-arm trial which is performed with 163 overweight participants in six in-company fitness centers in the Netherlands. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. A comparison of confidence interval methods for the intraclass correlation coefficient in community-based cluster randomization trials with a binary outcome.

    Science.gov (United States)

    Braschel, Melissa C; Svec, Ivana; Darlington, Gerarda A; Donner, Allan

    2016-04-01

    Many investigators rely on previously published point estimates of the intraclass correlation coefficient rather than on their associated confidence intervals to determine the required size of a newly planned cluster randomized trial. Although confidence interval methods for the intraclass correlation coefficient that can be applied to community-based trials have been developed for a continuous outcome variable, fewer methods exist for a binary outcome variable. The aim of this study is to evaluate confidence interval methods for the intraclass correlation coefficient applied to binary outcomes in community intervention trials enrolling a small number of large clusters. Existing methods for confidence interval construction are examined and compared to a new ad hoc approach based on dividing clusters into a large number of smaller sub-clusters and subsequently applying existing methods to the resulting data. Monte Carlo simulation is used to assess the width and coverage of confidence intervals for the intraclass correlation coefficient based on Smith's large sample approximation of the standard error of the one-way analysis of variance estimator, an inverted modified Wald test for the Fleiss-Cuzick estimator, and intervals constructed using a bootstrap-t applied to a variance-stabilizing transformation of the intraclass correlation coefficient estimate. In addition, a new approach is applied in which clusters are randomly divided into a large number of smaller sub-clusters with the same methods applied to these data (with the exception of the bootstrap-t interval, which assumes large cluster sizes). These methods are also applied to a cluster randomized trial on adolescent tobacco use for illustration. When applied to a binary outcome variable in a small number of large clusters, existing confidence interval methods for the intraclass correlation coefficient provide poor coverage. However, confidence intervals constructed using the new approach combined with Smith

  4. The effectiveness of xylitol in a school-based cluster-randomized clinical trial.

    Science.gov (United States)

    Lee, Wonik; Spiekerman, Charles; Heima, Masahiro; Eggertsson, Hafsteinn; Ferretti, Gerald; Milgrom, Peter; Nelson, Suchitra

    2015-01-01

    The purpose of this double-blind, cluster-randomized clinical trial was to examine the effects of xylitol gummy bear snacks on dental caries progression in primary and permanent teeth of inner-city school children. A total of 562 children aged 5-6 years were recruited from five elementary schools in East Cleveland, Ohio. Children were randomized by classroom to receive xylitol (7.8 g/day) or placebo (inulin fiber 20 g/day) gummy bears. Gummy bears were given three times per day for the 9-month kindergarten year within a supervised school environment. Children in both groups also received oral health education, toothbrush and fluoridated toothpaste, topical fluoride varnish treatment and dental sealants. The numbers of new decayed, missing, and filled surfaces for primary teeth (dmfs) and permanent teeth (DMFS) from baseline to the middle of 2nd grade (exit exam) were compared between the treatment (xylitol/placebo) groups using an optimally-weighted permutation test for cluster-randomized data. The mean new d(3-6)mfs at the exit exam was 5.0 ± 7.6 and 4.0 ± 6.5 for the xylitol and placebo group, respectively. Similarly, the mean new D(3-6)MFS was 0.38 ± 0.88 and 0.48 ± 1.39 for the xylitol and placebo group, respectively. The adjusted mean difference between the two groups was not statistically significant: new d(3-6)mfs: mean 0.4, 95% CI -0.25, 0.8), and new D(3-6)MFS: mean 0.16, 95% CI -0.16, 0.43. Xylitol consumption did not have additional benefit beyond other preventive measures. Caries progression in the permanent teeth of both groups was minimal, suggesting that other simultaneous prevention modalities may have masked the possible beneficial effects of xylitol in this trial. © 2014 S. Karger AG, Basel.

  5. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use: a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Kleinjan, M.; Overbeek, G.; Vermulst, A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2014-01-01

    Aim: To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design: Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting: General population of 11-15-year-old

  6. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use : A randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, Monique; Kleinjan, Marloes; Overbeek, Geertjan; Vermulst, Ad; Monshouwer, Karin; Lammers, Jeroen; Vollebergh, Wilma A M; Engels, Rutger C M E

    2014-01-01

    Aim: To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design: Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting: General population of 11-15-year-old

  7. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use: a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Kleinjan, M.; Overbeek, G.J.; Vermulst, A.A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2014-01-01

    Aim To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting General population of 11-15-year-old adolescents

  8. Exergaming and older adult cognition: a cluster randomized clinical trial.

    Science.gov (United States)

    Anderson-Hanley, Cay; Arciero, Paul J; Brickman, Adam M; Nimon, Joseph P; Okuma, Naoko; Westen, Sarah C; Merz, Molly E; Pence, Brandt D; Woods, Jeffrey A; Kramer, Arthur F; Zimmerman, Earl A

    2012-02-01

    Dementia cases may reach 100 million by 2050. Interventions are sought to curb or prevent cognitive decline. Exercise yields cognitive benefits, but few older adults exercise. Virtual reality-enhanced exercise or "exergames" may elicit greater participation. To test the following hypotheses: (1) stationary cycling with virtual reality tours ("cybercycle") will enhance executive function and clinical status more than traditional exercise; (2) exercise effort will explain improvement; and (3) brain-derived neurotrophic growth factor (BDNF) will increase. Multi-site cluster randomized clinical trial (RCT) of the impact of 3 months of cybercycling versus traditional exercise, on cognitive function in older adults. Data were collected in 2008-2010; analyses were conducted in 2010-2011. 102 older adults from eight retirement communities enrolled; 79 were randomized and 63 completed. A recumbent stationary ergometer was utilized; virtual reality tours and competitors were enabled on the cybercycle. Executive function (Color Trails Difference, Stroop C, Digits Backward); clinical status (mild cognitive impairment; MCI); exercise effort/fitness; and plasma BDNF. Intent-to-treat analyses, controlling for age, education, and cluster randomization, revealed a significant group X time interaction for composite executive function (p=0.002). Cybercycling yielded a medium effect over traditional exercise (d=0.50). Cybercyclists had a 23% relative risk reduction in clinical progression to MCI. Exercise effort and fitness were comparable, suggesting another underlying mechanism. A significant group X time interaction for BDNF (p=0.05) indicated enhanced neuroplasticity among cybercyclists. Cybercycling older adults achieved better cognitive function than traditional exercisers, for the same effort, suggesting that simultaneous cognitive and physical exercise has greater potential for preventing cognitive decline. This study is registered at Clinicaltrials.gov NCT01167400. Copyright

  9. Can cannabis use be prevented by targeting personality risk in schools? Twenty?four?month outcome of the adventure trial on cannabis use: a cluster?randomized controlled trial

    OpenAIRE

    Mahu, Ioan T.; Doucet, Christine; O'Leary?Barrett, Maeve; Conrod, Patricia J.

    2015-01-01

    Aims To examine the effectiveness of a personality?targeted intervention program (Adventure trial) delivered by trained teachers to high?risk (HR) high?school students on reducing marijuana use and frequency of use. Design A cluster?randomized controlled trial. Setting Secondary schools in London, UK. Participants Twenty?one secondary schools were randomized to intervention (n?=?12) or control (n?=?9) conditions, encompassing a total of 1038 HR students in the ninth grade [mean (standard devi...

  10. Relative efficiency of unequal versus equal cluster sizes in cluster randomized trials using generalized estimating equation models.

    Science.gov (United States)

    Liu, Jingxia; Colditz, Graham A

    2018-05-01

    There is growing interest in conducting cluster randomized trials (CRTs). For simplicity in sample size calculation, the cluster sizes are assumed to be identical across all clusters. However, equal cluster sizes are not guaranteed in practice. Therefore, the relative efficiency (RE) of unequal versus equal cluster sizes has been investigated when testing the treatment effect. One of the most important approaches to analyze a set of correlated data is the generalized estimating equation (GEE) proposed by Liang and Zeger, in which the "working correlation structure" is introduced and the association pattern depends on a vector of association parameters denoted by ρ. In this paper, we utilize GEE models to test the treatment effect in a two-group comparison for continuous, binary, or count data in CRTs. The variances of the estimator of the treatment effect are derived for the different types of outcome. RE is defined as the ratio of variance of the estimator of the treatment effect for equal to unequal cluster sizes. We discuss a commonly used structure in CRTs-exchangeable, and derive the simpler formula of RE with continuous, binary, and count outcomes. Finally, REs are investigated for several scenarios of cluster size distributions through simulation studies. We propose an adjusted sample size due to efficiency loss. Additionally, we also propose an optimal sample size estimation based on the GEE models under a fixed budget for known and unknown association parameter (ρ) in the working correlation structure within the cluster. © 2018 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  11. Effect of village-wide use of long-lasting insecticidal nets on visceral Leishmaniasis vectors in India and Nepal: a cluster randomized trial.

    Science.gov (United States)

    Picado, Albert; Das, Murari L; Kumar, Vijay; Kesari, Shreekant; Dinesh, Diwakar S; Roy, Lalita; Rijal, Suman; Das, Pradeep; Rowland, Mark; Sundar, Shyam; Coosemans, Marc; Boelaert, Marleen; Davies, Clive R

    2010-01-26

    Visceral leishmaniasis (VL) control in the Indian subcontinent is currently based on case detection and treatment, and on vector control using indoor residual spraying (IRS). The use of long-lasting insecticidal nets (LN) has been postulated as an alternative or complement to IRS. Here we tested the impact of comprehensive distribution of LN on the density of Phlebotomus argentipes in VL-endemic villages. A cluster-randomized controlled trial with household P. argentipes density as outcome was designed. Twelve clusters from an ongoing LN clinical trial--three intervention and three control clusters in both India and Nepal--were selected on the basis of accessibility and VL incidence. Ten houses per cluster selected on the basis of high pre-intervention P. argentipes density were monitored monthly for 12 months after distribution of LN using CDC light traps (LT) and mouth aspiration methods. Ten cattle sheds per cluster were also monitored by aspiration. A random effect linear regression model showed that the cluster-wide distribution of LNs significantly reduced the P. argentipes density/house by 24.9% (95% CI 1.80%-42.5%) as measured by means of LTs. The ongoing clinical trial, designed to measure the impact of LNs on VL incidence, will confirm whether LNs should be adopted as a control strategy in the regional VL elimination programs. The entomological evidence described here provides some evidence that LNs could be usefully deployed as part of the VL control program. ClinicalTrials.gov CT-2005-015374.

  12. Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Ai May Tan

    2016-08-01

    Full Text Available Abstract Background Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. Methods A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each. Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day and physical activity level (duration: minutes/week, measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Results Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p < .0005 and the difference in adjusted mean load-bearing MVPA was 55.6 min/week (95 % CI = 54.5 to 56.6, p < .0005. Six months post intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p < .0005 and 50.9 min/week (95 % CI =49.3 to 52.6, p < .0005

  13. Efficacy of a workplace osteoporosis prevention intervention: a cluster randomized trial.

    Science.gov (United States)

    Tan, Ai May; LaMontagne, Anthony D; English, Dallas R; Howard, Peter

    2016-08-24

    Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore. A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines. Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began. Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016 (retrospectively registered).

  14. A Cluster-Randomized Trial of Restorative Practices: An Illustration to Spur High-Quality Research and Evaluation.

    Science.gov (United States)

    Acosta, Joie D; Chinman, Matthew; Ebener, Patricia; Phillips, Andrea; Xenakis, Lea; Malone, Patrick S

    2016-01-01

    Restorative Practices in schools lack rigorous evaluation studies. As an example of rigorous school-based research, this paper describes the first randomized control trial of restorative practices to date, the Study of Restorative Practices. It is a 5-year, cluster-randomized controlled trial (RCT) of the Restorative Practices Intervention (RPI) in 14 middle schools in Maine to assess whether RPI impacts both positive developmental outcomes and problem behaviors and whether the effects persist during the transition from middle to high school. The two-year RPI intervention began in the 2014-2015 school year. The study's rationale and theoretical concerns are discussed along with methodological concerns including teacher professional development. The theoretical rationale and description of the methods from this study may be useful to others conducting rigorous research and evaluation in this area.

  15. Disseminating quality improvement: study protocol for a large cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    French Michael T

    2011-04-01

    with outcome data will be included in the analysis, following the intent-to-treat principle. Organizational covariates in the analysis include program size, management score, and state. Discussion The study offers seven recommendations for conducting a large-scale cluster-randomized trial: provide valuable services, have aims that are clear and important, seek powerful allies, understand the recruiting challenge, cultivate commitment, address turnover, and encourage rigor and flexibility. Trial Registration ClinicalTrials. govNCT00934141

  16. Citywide cluster randomized trial to restore blighted vacant land and its effects on violence, crime, and fear

    Science.gov (United States)

    Charles C. Branas; Eugenia South; Michelle C. Kondo; Bernadette C. Hohl; Philippe Bourgois; Douglas J. Wiebe; John M. MacDonald

    2018-01-01

    Vacant and blighted urban land is a widespread and potentially risky environmental condition encountered by millions of people on a daily basis. About 15% of the land in US cities is deemed vacant or abandoned, an area roughly the size of Switzerland. In a citywide cluster randomized controlled trial, we investigated the effects of standardized, reproducible...

  17. Effects of Mindfulness-Based Stress Reduction on the Mental Health of Clinical Clerkship Students: A Cluster-Randomized Controlled Trial

    NARCIS (Netherlands)

    Dijk, I. van; Lucassen, P.L.B.J.; Akkermans, R.P.; Engelen, B.G.M. van; Weel, C. van; Speckens, A.E.M.

    2017-01-01

    PURPOSE: To examine the effect of mindfulness-based stress reduction training (MBSR) on the mental health of medical students during clinical clerkships. METHOD: Between February 2011 and May 2014, the authors conducted a cluster-randomized controlled trial of clerkships as usual (CAU) and

  18. Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

    Science.gov (United States)

    Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

    2017-11-09

    Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs

  19. Effectiveness of a multifaceted implementation strategy on physicians' referral behavior to an evidence-based psychosocial intervention in dementia: a cluster randomized controlled trial

    NARCIS (Netherlands)

    Dopp, C.M.E.; Graff, M.J.L.; Teerenstra, S.; Nijhuis-Van der Sanden, M.W.; Olde Rikkert, M.G.M.; Vernooij-Dassen, M.J.F.J.

    2013-01-01

    BACKGROUND: To evaluate the effectiveness of a multifaceted implementation strategy on physicians' referral rate to and knowledge on the community occupational therapy in dementia program (COTiD program). METHODS: A cluster randomized controlled trial with 28 experimental and 17 control clusters was

  20. Measurement Error Correction Formula for Cluster-Level Group Differences in Cluster Randomized and Observational Studies

    Science.gov (United States)

    Cho, Sun-Joo; Preacher, Kristopher J.

    2016-01-01

    Multilevel modeling (MLM) is frequently used to detect cluster-level group differences in cluster randomized trial and observational studies. Group differences on the outcomes (posttest scores) are detected by controlling for the covariate (pretest scores) as a proxy variable for unobserved factors that predict future attributes. The pretest and…

  1. Protocol for Work place adjusted Intelligent physical exercise reducing Musculoskeletal pain in Shoulder and neck (VIMS: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Feveile Helene

    2010-08-01

    Full Text Available Abstract Background Neck and shoulder complaints are common among employees in sedentary occupations characterized by intensive computer use. Specific strength training is a promising type of physical exercise for relieving neck and shoulder pain in office workers. However, the optimal combination of frequency and exercise duration, as well as the importance of exercise supervision, is unknown. The VIMS study investigates in a cluster randomized controlled design the effectiveness of different time wise combinations of specific strength training with identical accumulated volume, and the relevance of training supervision for safe and effective training. Methods/design A cluster randomized controlled trial of 20 weeks duration where employed office workers are randomized to 1 × 60 min, 3 × 20 min, 9 × 7 min per week of specific strength training with training supervision, to 3 × 20 min per week of specific strength training with a minimal amount of training supervision, or to a reference group without training. A questionnaire will be sent to 2000 employees in jobs characterized by intensive computer work. Employees with cardiovascular disease, trauma, hypertension, or serious chronic disease will be excluded. The main outcome measure is pain in the neck and shoulders at week 20. Trial Registration The trial is registered at ClinicalTrials.gov, number NCT01027390.

  2. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  3. Effectiveness of a selective intervention program targeting personality risk factors for alcohol misuse among young adolescents: results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Lammers, J.; Goossens, F.; Conrod, P.; Engels, R.C.M.E.; Wiers, R.W.H.J.; Kleinjan, M.

    2015-01-01

    Aim The effectiveness of Preventure was tested on drinking behaviour of young adolescents in secondary education in the Netherlands. Design A cluster randomized controlled trial was carried out, with participants assigned randomly to a two-session coping skills intervention or a control

  4. A combined community- and facility-based approach to improve pregnancy outcomes in low-resource settings: a Global Network cluster randomized trial.

    Science.gov (United States)

    Pasha, Omrana; McClure, Elizabeth M; Wright, Linda L; Saleem, Sarah; Goudar, Shivaprasad S; Chomba, Elwyn; Patel, Archana; Esamai, Fabian; Garces, Ana; Althabe, Fernando; Kodkany, Bhala; Mabeya, Hillary; Manasyan, Albert; Carlo, Waldemar A; Derman, Richard J; Hibberd, Patricia L; Liechty, Edward K; Krebs, Nancy; Hambidge, K Michael; Buekens, Pierre; Moore, Janet; Jobe, Alan H; Koso-Thomas, Marion; Wallace, Dennis D; Stalls, Suzanne; Goldenberg, Robert L

    2013-10-03

    Fetal and neonatal mortality rates in low-income countries are at least 10-fold greater than in high-income countries. These differences have been related to poor access to and poor quality of obstetric and neonatal care. This trial tested the hypothesis that teams of health care providers, administrators and local residents can address the problem of limited access to quality obstetric and neonatal care and lead to a reduction in perinatal mortality in intervention compared to control locations. In seven geographic areas in five low-income and one middle-income country, most with high perinatal mortality rates and substantial numbers of home deliveries, we performed a cluster randomized non-masked trial of a package of interventions that included community mobilization focusing on birth planning and hospital transport, community birth attendant training in problem recognition, and facility staff training in the management of obstetric and neonatal emergencies. The primary outcome was perinatal mortality at ≥28 weeks gestation or birth weight ≥1000 g. Despite extensive effort in all sites in each of the three intervention areas, no differences emerged in the primary or any secondary outcome between the intervention and control clusters. In both groups, the mean perinatal mortality was 40.1/1,000 births (P = 0.9996). Neither were there differences between the two groups in outcomes in the last six months of the project, in the year following intervention cessation, nor in the clusters that best implemented the intervention. This cluster randomized comprehensive, large-scale, multi-sector intervention did not result in detectable impact on the proposed outcomes. While this does not negate the importance of these interventions, we expect that achieving improvement in pregnancy outcomes in these settings will require substantially more obstetric and neonatal care infrastructure than was available at the sites during this trial, and without them provider training

  5. Preventing knee injuries in adolescent female football players – design of a cluster randomized controlled trial [NCT00894595

    Directory of Open Access Journals (Sweden)

    Waldén Markus

    2009-06-01

    Full Text Available Abstract Background Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. Methods In this cluster randomized trial 516 teams (309 clusters in eight regional football districts in Sweden with female players aged 13–17 years were randomized into an intervention group (260 teams or a control group (256 teams. The teams in the intervention group were instructed to do a structured warm-up program at two training sessions per week throughout the 2009 competitive season (April to October and those in the control group were informed to train and play as usual. Sixty-eight sports physical therapists are assigned to the clubs to assist both groups in data collection and to examine the players' acute knee injuries during the study period. Three different forms are used in the trial: (1 baseline player data form collected at the start of the trial, (2 computer-based registration form collected every month, on which one of the coaches/team leaders documents individual player exposure, and (3 injury report form on which the study therapists report acute knee injuries resulting in time loss from training or match play. The primary outcome is the incidence of ACL injury and the secondary outcomes are the incidence of any acute knee injury (except contusion and incidence of severe knee injury (defined as injury resulting in absence of more than 4 weeks. Outcome measures are assessed after the end of the 2009 season. Discussion Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to

  6. Testing a workplace physical activity intervention: a cluster randomized controlled trial.

    Science.gov (United States)

    McEachan, Rosemary R C; Lawton, Rebecca J; Jackson, Cath; Conner, Mark; Meads, David M; West, Robert M

    2011-04-11

    Increased physical activity levels benefit both an individuals' health and productivity at work. The purpose of the current study was to explore the impact and cost-effectiveness of a workplace physical activity intervention designed to increase physical activity levels. A total of 1260 participants from 44 UK worksites (based within 5 organizations) were recruited to a cluster randomized controlled trial with worksites randomly allocated to an intervention or control condition. Measurement of physical activity and other variables occurred at baseline, and at 0 months, 3 months and 9 months post-intervention. Health outcomes were measured during a 30 minute health check conducted in worksites at baseline and 9 months post intervention. The intervention consisted of a 3 month tool-kit of activities targeting components of the Theory of Planned Behavior, delivered in-house by nominated facilitators. Self-reported physical activity (measured using the IPAQ short-form) and health outcomes were assessed. Multilevel modelling found no significant effect of the intervention on MET minutes of activity (from the IPAQ) at any of the follow-up time points controlling for baseline activity. However, the intervention did significantly reduce systolic blood pressure (B=-1.79 mm/Hg) and resting heart rate (B=-2.08 beats) and significantly increased body mass index (B=.18 units) compared to control. The intervention was found not to be cost-effective, however the substantial variability round this estimate suggested that further research is warranted. The current study found mixed support for this worksite physical activity intervention. The paper discusses some of the tensions involved in conducting rigorous evaluations of large-scale randomized controlled trials in real-world settings. © 2011 McEachan et al; licensee BioMed Central Ltd.

  7. Preventing knee injuries in adolescent female football players - design of a cluster randomized controlled trial [NCT00894595].

    Science.gov (United States)

    Hägglund, Martin; Waldén, Markus; Atroshi, Isam

    2009-06-23

    Knee injuries in football are common regardless of age, gender or playing level, but adolescent females seem to have the highest risk. The consequences after severe knee injury, for example anterior cruciate ligament (ACL) injury, are well-known, but less is known about knee injury prevention. We have designed a cluster randomized controlled trial (RCT) to evaluate the effect of a warm-up program aimed at preventing acute knee injury in adolescent female football. In this cluster randomized trial 516 teams (309 clusters) in eight regional football districts in Sweden with female players aged 13-17 years were randomized into an intervention group (260 teams) or a control group (256 teams). The teams in the intervention group were instructed to do a structured warm-up program at two training sessions per week throughout the 2009 competitive season (April to October) and those in the control group were informed to train and play as usual. Sixty-eight sports physical therapists are assigned to the clubs to assist both groups in data collection and to examine the players' acute knee injuries during the study period. Three different forms are used in the trial: (1) baseline player data form collected at the start of the trial, (2) computer-based registration form collected every month, on which one of the coaches/team leaders documents individual player exposure, and (3) injury report form on which the study therapists report acute knee injuries resulting in time loss from training or match play. The primary outcome is the incidence of ACL injury and the secondary outcomes are the incidence of any acute knee injury (except contusion) and incidence of severe knee injury (defined as injury resulting in absence of more than 4 weeks). Outcome measures are assessed after the end of the 2009 season. Prevention of knee injury is beneficial for players, clubs, insurance companies, and society. If the warm-up program is proven to be effective in reducing the incidence of knee

  8. Analyzing indirect effects in cluster randomized trials. The effect of estimation method, number of groups and group sizes on accuracy and power.

    Directory of Open Access Journals (Sweden)

    Joop eHox

    2014-02-01

    Full Text Available Cluster randomized trials assess the effect of an intervention that is carried out at the group or cluster level. Ajzen’s theory of planned behaviour is often used to model the effect of the intervention as an indirect effect mediated in turn by attitude, norms and behavioural intention. Structural equation modelling (SEM is the technique of choice to estimate indirect effects and their significance. However, this is a large sample technique, and its application in a cluster randomized trial assumes a relatively large number of clusters. In practice, the number of clusters in these studies tends to be relatively small, e.g. much less than fifty. This study uses simulation methods to find the lowest number of clusters needed when multilevel SEM is used to estimate the indirect effect. Maximum likelihood estimation is compared to Bayesian analysis, with the central quality criteria being accuracy of the point estimate and the confidence interval. We also investigate the power of the test for the indirect effect. We conclude that Bayes estimation works well with much smaller cluster level sample sizes such as 20 cases than maximum likelihood estimation; although the bias is larger the coverage is much better. When only 5 to 10 clusters are available per treatment condition even with Bayesian estimation problems occur.

  9. A cluster-randomized, placebo-controlled, maternal vitamin A or beta-carotene supplementation trial in Bangladesh: design and methods.

    Science.gov (United States)

    Labrique, Alain B; Christian, Parul; Klemm, Rolf D W; Rashid, Mahbubur; Shamim, Abu Ahmed; Massie, Allan; Schulze, Kerry; Hackman, Andre; West, Keith P

    2011-04-21

    We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE)), beta-carotene (42 mg, or ~7000 ug RE) or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and infectious morbidity, infant infectious morbidity

  10. A cluster-randomized, placebo-controlled, maternal vitamin a or beta-carotene supplementation trial in bangladesh: design and methods

    Directory of Open Access Journals (Sweden)

    Schulze Kerry

    2011-04-01

    Full Text Available Abstract Background We present the design, methods and population characteristics of a large community trial that assessed the efficacy of a weekly supplement containing vitamin A or beta-carotene, at recommended dietary levels, in reducing maternal mortality from early gestation through 12 weeks postpartum. We identify challenges faced and report solutions in implementing an intervention trial under low-resource, rural conditions, including the importance of population choice in promoting generalizability, maintaining rigorous data quality control to reduce inter- and intra- worker variation, and optimizing efficiencies in information and resources flow from and to the field. Methods This trial was a double-masked, cluster-randomized, dual intervention, placebo-controlled trial in a contiguous rural area of ~435 sq km with a population of ~650,000 in Gaibandha and Rangpur Districts of Northwestern Bangladesh. Approximately 120,000 married women of reproductive age underwent 5-weekly home surveillance, of whom ~60,000 were detected as pregnant, enrolled into the trial and gave birth to ~44,000 live-born infants. Upon enrollment, at ~ 9 weeks' gestation, pregnant women received a weekly oral supplement containing vitamin A (7000 ug retinol equivalents (RE, beta-carotene (42 mg, or ~7000 ug RE or a placebo through 12 weeks postpartum, according to prior randomized allocation of their cluster of residence. Systems described include enlistment and 5-weekly home surveillance for pregnancy based on menstrual history and urine testing, weekly supervised supplementation, periodic risk factor interviews, maternal and infant vital outcome monitoring, birth defect surveillance and clinical/biochemical substudies. Results The primary outcome was pregnancy-related mortality assessed for 3 months following parturition. Secondary outcomes included fetal loss due to miscarriage or stillbirth, infant mortality under three months of age, maternal obstetric and

  11. Cost-Effectiveness of a Long-Term Internet-Delivered Worksite Health Promotion Programme on Physical Activity and Nutrition: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Robroek, Suzan J. W.; Polinder, Suzanne; Bredt, Folef J.; Burdorf, Alex

    2012-01-01

    This study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the unit of randomization. The intervention was compared with a…

  12. A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Adang Eddy

    2011-03-01

    Full Text Available Abstract Background Even effective interventions for people with dementia and their caregivers require specific implementation efforts. A pilot study showed that the highly effective community occupational therapy in dementia (COTiD program was not implemented optimally due to various barriers. To decrease these barriers and make implementation of the program more effective a combined implementation (CI strategy was developed. In our study we will compare the effectiveness of this CI strategy with the usual educational (ED strategy. Methods In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service, have been allocated randomly to either the intervention group (CI strategy or the control group (ED strategy. The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program. Discussion Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes. Clinical trials registration NCT01117285

  13. Effectiveness of a multifaceted implementation strategy on physicians? referral behavior to an evidence-based psychosocial intervention in dementia: a cluster randomized controlled trial

    OpenAIRE

    D?pp, Carola ME; Graff, Maud JL; Teerenstra, Steven; Nijhuis-van der Sanden, Maria WG; Olde Rikkert, Marcel GM; Vernooij-Dassen, Myrra JFJ

    2013-01-01

    BACKGROUND: To evaluate the effectiveness of a multifaceted implementation strategy on physicians' referral rate to and knowledge on the community occupational therapy in dementia program (COTiD program). METHODS: A cluster randomized controlled trial with 28 experimental and 17 control clusters was conducted. Cluster included a minimum of one physician, one manager, and two occupational therapists. In the control group physicians and managers received no interventions and occupational therap...

  14. Walking Away from Type 2 diabetes: a cluster randomized controlled trial.

    Science.gov (United States)

    Yates, T; Edwardson, C L; Henson, J; Gray, L J; Ashra, N B; Troughton, J; Khunti, K; Davies, M J

    2017-05-01

    This study aimed to investigate whether an established behavioural intervention, Walking Away from Type 2 Diabetes, is effective at promoting and sustaining increased walking activity when delivered within primary care. Cluster randomized controlled trial involving 10 general practices recruited from Leicestershire, UK, in 2009-2010. Eight hundred and eight (36% female) individuals with a high risk of Type 2 diabetes mellitus, identified through a validated risk score, were included. Participants in five practices were randomized to Walking Away from Type 2 Diabetes, a pragmatic 3-h group-based structured education programme incorporating pedometer use with annual follow-on refresher sessions. The primary outcome was accelerometer assessed ambulatory activity (steps/day) at 12 months. Longer term maintenance was assessed at 24 and 36 months. Results were analysed using generalized estimating equation models, accounting for clustering. Complete accelerometer data for the primary outcome were available for 571 (71%) participants. Increases in ambulatory activity of 411 steps/day [95% confidence interval (CI): 117, 704] and self-reported vigorous-intensity physical activity of 218 metabolic equivalent min/week (95% CI: 6, 425) at 12 months were observed in the intervention group compared with control; differences between groups were not sustained at 36 months. No differences between groups were observed for markers of cardiometabolic health. Replacing missing data with multiple imputation did not affect the results. A pragmatic low-resource group-based structured education programme with pedometer use resulted in modest increases in ambulatory activity compared with control conditions after 12 months when implemented within a primary care setting to those at high risk of Type 2 diabetes mellitus; however, the results were not maintained over 36 months. © 2016 Diabetes UK.

  15. Review of Recent Methodological Developments in Group-Randomized Trials: Part 2-Analysis.

    Science.gov (United States)

    Turner, Elizabeth L; Prague, Melanie; Gallis, John A; Li, Fan; Murray, David M

    2017-07-01

    In 2004, Murray et al. reviewed methodological developments in the design and analysis of group-randomized trials (GRTs). We have updated that review with developments in analysis of the past 13 years, with a companion article to focus on developments in design. We discuss developments in the topics of the earlier review (e.g., methods for parallel-arm GRTs, individually randomized group-treatment trials, and missing data) and in new topics, including methods to account for multiple-level clustering and alternative estimation methods (e.g., augmented generalized estimating equations, targeted maximum likelihood, and quadratic inference functions). In addition, we describe developments in analysis of alternative group designs (including stepped-wedge GRTs, network-randomized trials, and pseudocluster randomized trials), which require clustering to be accounted for in their design and analysis.

  16. Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial

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    Mash Bob

    2012-12-01

    Full Text Available Abstract Background Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Methods Trial design: Pragmatic cluster randomized controlled trial Participants: Type 2 diabetic patients attending 45 public sector community health centres in Cape Town Interventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. Objective: To evaluate the effectiveness of the group diabetes education programme Outcomes: Primary outcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. Secondary outcomes: self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of life Randomisation: Computer generated random numbers Blinding: Patients, health promoters and research assistants could not be blinded to the health centre’s allocation Numbers randomized: Seventeen health centres (34 in total will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. Discussion The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can

  17. Geographic analysis of vaccine uptake in a cluster-randomized controlled trial in Hue, Vietnam.

    Science.gov (United States)

    Ali, Mohammad; Thiem, Vu Dinh; Park, Jin-Kyung; Ochiai, Rion Leon; Canh, Do Gia; Danovaro-Holliday, M Carolina; Kaljee, Linda M; Clemens, John D; Acosta, Camilo J

    2007-09-01

    This paper identifies spatial patterns and predictors of vaccine uptake in a cluster-randomized controlled trial in Hue, Vietnam. Data for this study result from the integration of demographic surveillance, vaccine record, and geographic data of the study area. A multi-level cross-classified (non-hierarchical) model was used for analyzing the non-nested nature of individual's ecological data. Vaccine uptake was unevenly distributed in space and there was spatial variability among predictors of vaccine uptake. Vaccine uptake was higher among students with younger, male, or not literate family heads. Students from households with higher per-capita income were less likely to participate in the trial. Residency south of the river or further from a hospital/polyclinic was associated with higher vaccine uptake. Younger students were more likely to be vaccinated than older students in high- or low-risk areas, but not in the entire study area. The findings are important for the management of vaccine campaigns during a trial and for interpretation of disease patterns during vaccine-efficacy evaluation.

  18. Snoezelen, structured reminiscence therapy and 10-minutes activation in long term care residents with dementia (WISDE: study protocol of a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Becker Christiane

    2010-01-01

    Full Text Available Abstract Background People with dementia are often inapproachable due to symptoms of their illness. Therefore nurses should establish relationships with dementia patients via their remaining resources and facilitate communication. In order to achieve this, different targeted non-pharmacological interventions are recommended and practiced. However there is no sufficient evidence about the efficacy of most of these interventions. A number of publications highlight the urgent need for methodological sound studies so that more robust conclusions may be drawn. Methods/Design The trial is designed as a cluster randomized controlled trial with 20 nursing homes in Saxony and Saxony-Anhalt (Germany as the units of randomization. Nursing homes will be randomly allocated into 4 study groups consisting of 5 clusters and 90 residents: snoezelen, structured reminiscence therapy, 10-minutes activation or unstructured verbal communication (control group. The purpose is to determine whether the interventions are effective to reduce apathy in long-term care residents with dementia (N = 360 as the main outcome measure. Assessments will be done at baseline, 3, 6 and 12 months after beginning of the interventions. Discussion This trial will particularly contribute to the evidence on efficacy of non-pharmacological interventions in dementia care. Trial Registration ClinicalTrials.gov NCT00653731

  19. Involving patients in setting priorities for healthcare improvement: a cluster randomized trial.

    Science.gov (United States)

    Boivin, Antoine; Lehoux, Pascale; Lacombe, Réal; Burgers, Jako; Grol, Richard

    2014-02-20

    Patients are increasingly seen as active partners in healthcare. While patient involvement in individual clinical decisions has been extensively studied, no trial has assessed how patients can effectively be involved in collective healthcare decisions affecting the population. The goal of this study was to test the impact of involving patients in setting healthcare improvement priorities for chronic care at the community level. Cluster randomized controlled trial. Local communities were randomized in intervention (priority setting with patient involvement) and control sites (no patient involvement). Communities in a canadian region were required to set priorities for improving chronic disease management in primary care, from a list of 37 validated quality indicators. Patients were consulted in writing, before participating in face-to-face deliberation with professionals. Professionals established priorities among themselves, without patient involvement. A total of 172 individuals from six communities participated in the study, including 83 chronic disease patients, and 89 health professionals. The primary outcome was the level of agreement between patients' and professionals' priorities. Secondary outcomes included professionals' intention to use the selected quality indicators, and the costs of patient involvement. Priorities established with patients were more aligned with core generic components of the Medical Home and Chronic Care Model, including: access to primary care, self-care support, patient participation in clinical decisions, and partnership with community organizations (p Priorities established by professionals alone placed more emphasis on the technical quality of single disease management. The involvement intervention fostered mutual influence between patients and professionals, which resulted in a 41% increase in agreement on common priorities (95%CI: +12% to +58%, p priorities. Patient involvement can change priorities driving healthcare

  20. A cluster randomized trial of strategies to increase uptake amongst young women invited for their first cervical screen: The STRATEGIC trial.

    Science.gov (United States)

    Kitchener, H; Gittins, M; Cruickshank, M; Moseley, C; Fletcher, S; Albrow, R; Gray, A; Brabin, L; Torgerson, D; Crosbie, E J; Sargent, A; Roberts, C

    2018-06-01

    Objectives To measure the feasibility and effectiveness of interventions to increase cervical screening uptake amongst young women. Methods A two-phase cluster randomized trial conducted in general practices in the NHS Cervical Screening Programme. In Phase 1, women in practices randomized to intervention due for their first invitation to cervical screening received a pre-invitation leaflet and, separately, access to online booking. In Phase 2, non-attenders at six months were randomized to one of: vaginal self-sample kits sent unrequested or offered; timed appointments; nurse navigator; or the choice between nurse navigator or self-sample kits. Primary outcome was uplift in intervention vs. control practices, at 3 and 12 months post invitation. Results Phase 1 randomized 20,879 women. Neither pre-invitation leaflet nor online booking increased screening uptake by three months (18.8% pre-invitation leaflet vs. 19.2% control and 17.8% online booking vs. 17.2% control). Uptake was higher amongst human papillomavirus vaccinees at three months (OR 2.07, 95% CI 1.69-2.53, p < 0.001). Phase 2 randomized 10,126 non-attenders, with 32-34 clusters for each intervention and 100 clusters as controls. Sending self-sample kits increased uptake at 12 months (OR 1.51, 95% CI 1.20-1.91, p = 0.001), as did timed appointments (OR 1.41, 95% CI 1.14-1.74, p = 0.001). The offer of a nurse navigator, a self-sample kits on request, and choice between timed appointments and nurse navigator were ineffective. Conclusions Amongst non-attenders, self-sample kits sent and timed appointments achieved an uplift in screening over the short term; longer term impact is less certain. Prior human papillomavirus vaccination was associated with increased screening uptake.

  1. Effectiveness of the universal prevention program 'Healthy School and Drugs': Study protocol of a randomized clustered trial

    Directory of Open Access Journals (Sweden)

    Malmberg Monique

    2010-09-01

    Full Text Available Abstract Background Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a quasi-experimental design before, many program changes were made afterwards. The present study, therefore, aims to test the effects of this widely used, renewed universal prevention program. Methods/Design A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands. The trial has three conditions; two intervention conditions (i.e., e-learning and integral and a control condition. The e-learning condition consists of three digital learning modules (i.e., about alcohol, tobacco, and marijuana that are sequentially offered over the course of three school years (i.e., grade 1, grade 2, and grade 3. The integral condition consists of parental participation in a parental meeting on substance use, regulation of substance use, and monitoring and counseling of students' substance use at school, over and above the three digital modules. The control condition is characterized as business as usual. Participating schools were randomly assigned to either an intervention or control condition. Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements (8, 20, and 32 months after baseline. Outcome variables included in the questionnaire are the percentage of binge drinking (more than five drinks per occasion, the average weekly number of drinks, and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana. Discussion This study protocol describes the design of a randomized clustered trial that evaluates the

  2. Reducing Tobacco Use among Low Socio-Economic Status Youth in Delhi, India: Outcomes from Project ACTIVITY, a Cluster Randomized Trial

    Science.gov (United States)

    Harrell, Melissa B.; Arora, Monika; Bassi, Shalini; Gupta, Vinay K.; Perry, Cheryl L.; Reddy, K. Srinath

    2016-01-01

    To test the efficacy of an intervention to reduce tobacco use among youth (10-19 years old) in slum communities in Delhi, India. This community-based cluster-randomized trial included 14 slums composed of purposely built resettlement colonies and adjacent inhabitant-built Jhuggi Jhopris. Youth in the intervention received a 2 year…

  3. Cluster-Randomized Controlled Trial Evaluating the Effectiveness of Computer-Assisted Intervention Delivered by Educators for Children with Speech Sound Disorders

    Science.gov (United States)

    McLeod, Sharynne; Baker, Elise; McCormack, Jane; Wren, Yvonne; Roulstone, Sue; Crowe, Kathryn; Masso, Sarah; White, Paul; Howland, Charlotte

    2017-01-01

    Purpose: The aim was to evaluate the effectiveness of computer-assisted input-based intervention for children with speech sound disorders (SSD). Method: The Sound Start Study was a cluster-randomized controlled trial. Seventy-nine early childhood centers were invited to participate, 45 were recruited, and 1,205 parents and educators of 4- and…

  4. Remedial after-school support classes offered in rural Gambia (The SCORE trial): study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Boone, Peter; Camara, Alpha; Eble, Alex; Elbourne, Diana; Fernandes, Samory; Frost, Chris; Jayanty, Chitra; Lenin, Maitri; Silva, Ana Filipa

    2015-12-16

    Low education levels are endemic in much of the developing world, particularly in rural areas where traditional government-provided public services often have difficulty reaching beneficiaries. Providing trained para-teachers to teach regular after-school remedial education classes has been shown to improve literacy and numeracy in children of primary school age residing in such areas in India. This trial investigates whether such an intervention can also be effective in a West African setting with similarly low learning levels and difficult geographic access. cluster-randomized controlled trial. Clusters: villages or groups of villages with 15-300 households and at least 15 eligible children in the Lower River and North Bank Regions of The Gambia. children born between 1 September 2007 and 31 August 2009 planning to enter the first grade, for the first time, in the 2015-2016 school year in eligible villages. We anticipate enrolling approximately 150 clusters of villages with approximately 6000 children as participants. a program providing remedial after-school lessons, focusing on literacy and numeracy, 5 to 6 days a week for 3 years to eligible children, based on the intervention evaluated in the Support To Rural India's Public Education System (STRIPES) trial (PLoS ONE 8(7):e65775). both the intervention and control groups will receive small bundles of useful materials during annual data collection as recompense for their time. If the education intervention is shown to be cost-effective at raising learning levels, it is expected that the control group villages will receive the intervention for several years after the trial results are available. the primary outcome of the trial is a composite mathematics and language test score. Secondary outcomes include school attendance, enrollment, performance on nationally administered exams, parents' spending on education, spillover learning to siblings and family members, and school-related time use of parents and

  5. Effect of Reassuring Information About Musculoskeletal and Mental Health Complaints at the Workplace: A Cluster Randomized Trial of the atWork Intervention.

    Science.gov (United States)

    Johnsen, Tone Langjordet; Eriksen, Hege Randi; Baste, Valborg; Indahl, Aage; Odeen, Magnus; Tveito, Torill Helene

    2018-05-21

    Purpose The purpose of this study was to investigate the possible difference between the Modified atWork intervention (MAW) and the Original atWork intervention (OAW) on sick leave and other health related outcomes. atWork is a group intervention using the workplace as an arena for distribution of evidence-based knowledge about musculoskeletal and mental health complaints. Methods A cluster randomized controlled trial with 93 kindergartens, comprising a total of 1011 employees, was conducted. Kindergartens were stratified by county and size and randomly allocated to MAW (45 clusters, 324 respondents) or OAW (48 clusters, 313 respondents). The randomization and intervention allocation processes were concealed. There was no blinding to group allocation. Primary outcome was register data on sick leave at cluster level. Secondary outcomes were health complaints, job satisfaction, social support, coping, and beliefs about musculoskeletal and mental health complaints, measured at the individual level. Results The MAW group reduced sick leave by 5.7% during the intervention year, while the OAW group had a 7.5% increase. Overall, the changes were not statistically significant, and no difference was detected between groups, based on 45 and 47 kindergartens. Compared to the OAW group, the MAW group had a smaller reduction for two of the statements concerning faulty beliefs about back pain, but believed less in the hereditary nature of depression. Conclusions The MAW did not have a different effect on sick leave at cluster level compared to the OAW. Trial registration https://Clinicaltrials.gov/ : NCT02396797. Registered March 23th, 2015.

  6. Outcomes of a pilot hand hygiene randomized cluster trial to reduce communicable infections among US office-based employees.

    Science.gov (United States)

    Stedman-Smith, Maggie; DuBois, Cathy L Z; Grey, Scott F; Kingsbury, Diana M; Shakya, Sunita; Scofield, Jennifer; Slenkovich, Ken

    2015-04-01

    To determine the effectiveness of an office-based multimodal hand hygiene improvement intervention in reducing self-reported communicable infections and work-related absence. A randomized cluster trial including an electronic training video, hand sanitizer, and educational posters (n = 131, intervention; n = 193, control). Primary outcomes include (1) self-reported acute respiratory infections (ARIs)/influenza-like illness (ILI) and/or gastrointestinal (GI) infections during the prior 30 days; and (2) related lost work days. Incidence rate ratios calculated using generalized linear mixed models with a Poisson distribution, adjusted for confounders and random cluster effects. A 31% relative reduction in self-reported combined ARI-ILI/GI infections (incidence rate ratio: 0.69; 95% confidence interval, 0.49 to 0.98). A 21% nonsignificant relative reduction in lost work days. An office-based multimodal hand hygiene improvement intervention demonstrated a substantive reduction in self-reported combined ARI-ILI/GI infections.

  7. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    NARCIS (Netherlands)

    Pradhan, M.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.

    2013-01-01

    Background This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program

  8. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group

    NARCIS (Netherlands)

    Pradhan, M.P.; Brinkman, S.A.; Beatty, A.; Maika, A.; Satriawan, E.; de Ree, J.; Hasan, A.

    2013-01-01

    Background: This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program

  9. A cluster randomized controlled trial of a brief tobacco cessation intervention for low-income communities in India: study protocol.

    Science.gov (United States)

    Sarkar, Bidyut K; Shahab, Lion; Arora, Monika; Lorencatto, Fabiana; Reddy, K Srinath; West, Robert

    2014-03-01

    India has 275 million adult tobacco users and tobacco use is estimated to contribute to more than a million deaths in the country each year. There is an urgent need to develop and evaluate affordable, practicable and scalable interventions to promote cessation of tobacco use. Because tobacco use is so harmful, an increase of as little as 1 percentage point in long-term quit success rates can have an important public health impact. This protocol paper describes the rationale and methods of a large randomized controlled trial which aims to evaluate the effectiveness of a brief scalable smoking cessation intervention delivered by trained health professionals as an outreach programme in poor urban communities in India. This is a pragmatic, two-arm, community-based cluster randomized controlled trial focused on tobacco users in low-income communities. The treatment arm is a brief intervention comprising brief advice including training in craving control using simple yogic breathing exercises (BA-YBA) and the control arm is very brief advice (VBA). Of a total of 32 clusters, 16 will be allocated to the intervention arm and 16 to the control arm. Each cluster will have 31 participants, making a total of 992 participants. The primary outcome measure will follow the Russell Standard: self-report of sustained abstinence for at least 6 months following the intervention confirmed at the final follow-up by salivary cotinine. This trial will inform national and international policy on delivery of scalable and affordable brief outreach interventions to promote tobacco use cessation in low resource settings where tobacco users have limited access to physicians and medications. © 2014 Society for the Study of Addiction.

  10. Effect of Financial Incentives on Breastfeeding: A Cluster Randomized Clinical Trial.

    Science.gov (United States)

    Relton, Clare; Strong, Mark; Thomas, Kate J; Whelan, Barbara; Walters, Stephen J; Burrows, Julia; Scott, Elaine; Viksveen, Petter; Johnson, Maxine; Baston, Helen; Fox-Rushby, Julia; Anokye, Nana; Umney, Darren; Renfrew, Mary J

    2018-02-05

    Although breastfeeding has a positive effect on an infant's health and development, the prevalence is low in many communities. The effect of financial incentives to improve breastfeeding prevalence is unknown. To assess the effect of an area-level financial incentive for breastfeeding on breastfeeding prevalence at 6 to 8 weeks post partum. The Nourishing Start for Health (NOSH) trial, a cluster randomized trial with 6 to 8 weeks follow-up, was conducted between April 1, 2015, and March 31, 2016, in 92 electoral ward areas in England with baseline breastfeeding prevalence at 6 to 8 weeks post partum less than 40%. A total of 10 010 mother-infant dyads resident in the 92 study electoral ward areas where the infant's estimated or actual birth date fell between February 18, 2015, and February 17, 2016, were included. Areas were randomized to the incentive plus usual care (n = 46) (5398 mother-infant dyads) or to usual care alone (n = 46) (4612 mother-infant dyads). Usual care was delivered by clinicians (mainly midwives, health visitors) in a variety of maternity, neonatal, and infant feeding services, all of which were implementing the UNICEF UK Baby Friendly Initiative standards. Shopping vouchers worth £40 (US$50) were offered to mothers 5 times based on infant age (2 days, 10 days, 6-8 weeks, 3 months, 6 months), conditional on the infant receiving any breast milk. The primary outcome was electoral ward area-level 6- to 8-week breastfeeding period prevalence, as assessed by clinicians at the routine 6- to 8-week postnatal check visit. Secondary outcomes were area-level period prevalence for breastfeeding initiation and for exclusive breastfeeding at 6 to 8 weeks. In the intervention (5398 mother-infant dyads) and control (4612 mother-infant dyads) group, the median (interquartile range) percentage of women aged 16 to 44 years was 36.2% (3.0%) and 37.4% (3.6%) years, respectively. After adjusting for baseline breastfeeding prevalence and local government

  11. An innovative telemedicine knowledge translation program to improve quality of care in intensive care units: protocol for a cluster randomized pragmatic trial

    Directory of Open Access Journals (Sweden)

    Pinto Ruxandra

    2009-02-01

    Full Text Available Abstract Background There are challenges to timely adoption of, and ongoing adherence to, evidence-based practices known to improve patient care in the intensive care unit (ICU. Quality improvement initiatives using a collaborative network approach may increase the use of such practices. Our objective is to evaluate the effectiveness of a novel knowledge translation program for increasing the proportion of patients who appropriately receive the following six evidence-based care practices: venous thromboembolism prophylaxis; ventilator-associated pneumonia prevention; spontaneous breathing trials; catheter-related bloodstream infection prevention; decubitus ulcer prevention; and early enteral nutrition. Methods and design We will conduct a pragmatic cluster randomized active control trial in 15 community ICUs and one academic ICU in Ontario, Canada. The intervention is a multifaceted videoconferenced educational and problem-solving forum to organize knowledge translation strategies, including comparative audit and feedback, educational sessions from content experts, and dissemination of algorithms. Fifteen individual ICUs (clusters will be randomized to receive quality improvement interventions targeting one of the best practices during each of six study phases. Each phase lasts four months during the first study year and three months during the second. At the end of each study phase, ICUs are assigned to an intervention for a best practice not yet received according to a random schedule. The primary analysis will use patient-level process-of-care data to measure the intervention's effect on rates of adoption and adherence of each best practice in the targeted ICU clusters versus controls. Discussion This study design evaluates a new system for knowledge translation and quality improvement across six common ICU problems. All participating ICUs receive quality improvement initiatives during every study phase, improving buy-in. This study design

  12. The effectiveness of a construction worksite prevention program on work ability, health, and sick leave: Results from a cluster randomized controlled trial

    NARCIS (Netherlands)

    Oude Hengel, K.M.; Blatter, B.M.; Molen, H.F. van der; Bongers, P.M.; Beek, A.J. van der

    2013-01-01

    Objective This study aimed to investigate the effectiveness of a prevention program on work ability, health, and sick leave targeted at construction worksites. Methods A total of 15 departments (N=297 workers) from 6 construction companies participated in this cluster randomized controlled trial and

  13. A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population

    Directory of Open Access Journals (Sweden)

    Gardini Andrea

    2007-11-01

    Full Text Available Abstract Background The hospital treatment of heart failure frequently does not follow published guidelines, potentially contributing to the high morbidity, mortality and economic cost of this disorder. Consequently the development of clinical pathways has the potential to reduce the current variability in care, enhance guideline adherence, and improve outcomes for patients. Despite enthusiasm and diffusion, the widespread acceptance of clinical pathways remain questionable because very little prospective controlled data demonstrated their effectiveness. The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was designed in order to conduct a rigorous evaluation of clinical pathways in hospital treatment of acute heart failure. The primary objective of the trial was to evaluate the effectiveness of the implementation of clinical pathways for hospital treatment of heart failure in Italian hospitals. Methods/design Two-arm, cluster-randomized trial. 14 community hospitals were randomized either to arm 1 (clinical pathway: appropriate use of practice guidelines and supplies of drugs and ancillary services, new organization and procedures, patient education, etc. or to arm 2 (no intervention, usual care. 424 patients sample (212 in each group, 80% of power at the 5% significance level (two-sided. The primary outcome measure is in-hospital mortality. We will also analyze the impact of the clinical pathways comparing the length and the appropriateness of the stay, the rate of unscheduled readmissions, the customers' satisfaction and the costs treating the patients with the pathways and with the current practice along all the observation period. The quality of the care will be assessed by monitoring the use of diagnostic and therapeutic procedures during hospital stay and by measuring key quality indicators at discharge. Discussion This paper examines the design of the evaluation of a complex

  14. Reporting non-adherence in cluster randomised trials: A systematic review.

    Science.gov (United States)

    Agbla, Schadrac C; DiazOrdaz, Karla

    2018-06-01

    Treatment non-adherence in randomised trials refers to situations where some participants do not receive their allocated treatment as intended. For cluster randomised trials, where the unit of randomisation is a group of participants, non-adherence may occur at the cluster or individual level. When non-adherence occurs, randomisation no longer guarantees that the relationship between treatment receipt and outcome is unconfounded, and the power to detect the treatment effects in intention-to-treat analysis may be reduced. Thus, recording adherence and estimating the causal treatment effect adequately are of interest for clinical trials. To assess the extent of reporting of non-adherence issues in published cluster trials and to establish which methods are currently being used for addressing non-adherence, if any, and whether clustering is accounted for in these. We systematically reviewed 132 cluster trials published in English in 2011 previously identified through a search in PubMed. One-hundred and twenty three cluster trials were included in this systematic review. Non-adherence was reported in 56 cluster trials. Among these, 19 reported a treatment efficacy estimate: per protocol in 15 and as treated in 4. No study discussed the assumptions made by these methods, their plausibility or the sensitivity of the results to deviations from these assumptions. The year of publication of the cluster trials included in this review (2011) could be considered a limitation of this study; however, no new guidelines regarding the reporting and the handling of non-adherence for cluster trials have been published since. In addition, a single reviewer undertook the data extraction. To mitigate this, a second reviewer conducted a validation of the extraction process on 15 randomly selected reports. Agreement was satisfactory (93%). Despite the recommendations of the Consolidated Standards of Reporting Trials statement extension to cluster randomised trials, treatment adherence is

  15. A Clustered Randomized Controlled Trial of the Positive Prevention PLUS Adolescent Pregnancy Prevention Program.

    Science.gov (United States)

    LaChausse, Robert G

    2016-09-01

    To determine the impact of Positive Prevention PLUS, a school-based adolescent pregnancy prevention program on delaying sexual intercourse, birth control use, and pregnancy. I randomly assigned a diverse sample of ninth grade students in 21 suburban public high schools in California into treatment (n = 2483) and control (n = 1784) groups that participated in a clustered randomized controlled trial. Between October 2013 and May 2014, participants completed baseline and 6-month follow-up surveys regarding sexual behavior and pregnancy. Participants in the treatment group were offered Positive Prevention PLUS, an 11-lesson adolescent pregnancy prevention program. The program had statistically significant impacts on delaying sexual intercourse and increasing the use of birth control. However, I detected no program effect on pregnancy rates at 6-month follow-up. The Positive Prevention PLUS program demonstrated positive impacts on adolescent sexual behavior. This suggests that programs that focus on having students practice risk reduction skills may delay sexual activity and increase birth control use.

  16. Cost-effectiveness of a long-term Internet-delivered worksite health promotion programme on physical activity and nutrition: A cluster randomized controlled trial

    NARCIS (Netherlands)

    S.J.W. Robroek (Suzan); S. Polinder (Suzanne); F.J. Bredt (Folef); A. Burdorf (Alex)

    2012-01-01

    textabstractThis study aims to evaluate the cost-effectiveness of a long-term workplace health promotion programme on physical activity (PA) and nutrition. In total, 924 participants enrolled in a 2-year cluster randomized controlled trial, with departments (n = 74) within companies (n = 6) as the

  17. Exploring the transparency mechanism and evaluating the effect of public reporting on prescription: a protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Du, Xin; Wang, Dan; Wang, Xuan; Yang, Shiru; Zhang, Xinping

    2015-03-21

    The public reporting of health outcomes has become one of the most popular topics and is accepted as a quality improvement method in the healthcare field. However, little research has been conducted on the transparency mechanism, and results are mixed with regard to the evaluation of the effect of public reporting on quality improvement. The objectives of this trial are to investigate the transparency mechanism and to evaluate the effect of public reporting on prescription at the level of individual participants. This study involves a cluster randomized controlled trial conducted in 20 primary-care facilities (clusters). Eligible clusters are those facilities with excellent hospital information systems and that have agreed to participate in the trial. The 20 clusters are matched into 10 pairs according to Technique for Order Preference by Similarity to Ideal Solution score. As the unit of randomization, each pair of facilities is assigned at random to a control or an intervention group through coin flipping. Prescribed ranking information is publicly reported in the intervention group. The public materials include the posters of individuals and of facilities, the ranking lists of general practitioners, and brochures of patients, which are updated monthly. The intervention began on 13th November 2013 and lasted for one year. Specifically, participants are surveyed at five points in time (baseline, quarterly following the intervention) through questionnaires, interviews, and observations. These participants include an average of 600 patients, 300 general practitioners, 15 directors, and 6 health bureau administrators. The primary outcomes are the transparency mechanism model and the changes in medicine-prescribe. Subsequently, the modifications in the transparency mechanism constructs are evaluated. The outcomes are measured at the individual participant level, and the professional who analyzes the data is blind to the randomization status. This study protocol

  18. Effect of Behavior Modification on Outcome in Early- to Moderate-Stage Chronic Kidney Disease: A Cluster-Randomized Trial.

    Science.gov (United States)

    Yamagata, Kunihiro; Makino, Hirofumi; Iseki, Kunitoshi; Ito, Sadayoshi; Kimura, Kenjiro; Kusano, Eiji; Shibata, Takanori; Tomita, Kimio; Narita, Ichiei; Nishino, Tomoya; Fujigaki, Yoshihide; Mitarai, Tetsuya; Watanabe, Tsuyoshi; Wada, Takashi; Nakamura, Teiji; Matsuo, Seiichi

    2016-01-01

    Owing to recent changes in our understanding of the underlying cause of chronic kidney disease (CKD), the importance of lifestyle modification for preventing the progression of kidney dysfunction and complications has become obvious. In addition, effective cooperation between general physicians (GPs) and nephrologists is essential to ensure a better care system for CKD treatment. In this cluster-randomized study, we studied the effect of behavior modification on the outcome of early- to moderate-stage CKD. Stratified open cluster-randomized trial. A total of 489 GPs belonging to 49 local medical associations (clusters) in Japan. A total of 2,379 patients (1,195 in group A (standard intervention) and 1,184 in group B (advanced intervention)) aged between 40 and 74 years, who had CKD and were under consultation with GPs. All patients were managed in accordance with the current CKD guidelines. The group B clusters received three additional interventions: patients received both educational intervention for lifestyle modification and a CKD status letter, attempting to prevent their withdrawal from treatment, and the group B GPs received data sheets to facilitate reducing the gap between target and practice. The primary outcome measures were 1) the non-adherence rate of accepting continuous medical follow-up of the patients, 2) the collaboration rate between GPs and nephrologists, and 3) the progression of CKD. The rate of discontinuous clinical visits was significantly lower in group B (16.2% in group A vs. 11.5% in group B, p = 0.01). Significantly higher referral and co-treatment rates were observed in group B (pbehavior modification of CKD patients, namely, significantly lower discontinuous clinical visits, and behavior modification of both GPs and nephrologists, namely significantly higher referral and co-treatment rates, resulting in the retardation of CKD progression, especially in patients with proteinuric Stage 3 CKD. The University Hospital Medical Information

  19. The Effects of Therapist Competence in Assigning Homework in Cognitive Therapy with Cluster C Personality Disorders: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Ryum, Truls; Stiles, Tore C.; Svartberg, Martin; McCullough, Leigh

    2010-01-01

    Therapist competence in assigning homework was used to predict mid- and posttreatment outcome for patients with Cluster C personality disorders in cognitive therapy (CT). Twenty-five patients that underwent 40 sessions of CT were taken from a randomized controlled trial (Svartberg, Stiles, & Seltzer, 2004). Therapist competence in assigning…

  20. Strategies to enhance venous thromboprophylaxis in hospitalized medical patients (SENTRY: a pilot cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Pai Menaka

    2013-01-01

    Full Text Available Abstract Background Venous thromboembolism (VTE is a common preventable cause of mortality in hospitalized medical patients. Despite rigorous randomized trials generating strong recommendations for anticoagulant use to prevent VTE, nearly 40% of medical patients receive inappropriate thromboprophylaxis. Knowledge-translation strategies are needed to bridge this gap. Methods We conducted a 16-week pilot cluster randomized controlled trial (RCT to determine the proportion of medical patients that were appropriately managed for thromboprophylaxis (according to the American College of Chest Physician guidelines within 24 hours of admission, through the use of a multicomponent knowledge-translation intervention. Our primary goal was to determine the feasibility of conducting this study on a larger scale. The intervention comprised clinician education, a paper-based VTE risk assessment algorithm, printed physicians’ orders, and audit and feedback sessions. Medical wards at six hospitals (representing clusters in Ontario, Canada were included; three were randomized to the multicomponent intervention and three to usual care (i.e., no active strategies for thromboprophylaxis in place. Blinding was not used. Results A total of 2,611 patients (1,154 in the intervention and 1,457 in the control group were eligible and included in the analysis. This multicomponent intervention did not lead to a significant difference in appropriate VTE prophylaxis rates between intervention and control hospitals (appropriate management rate odds ratio = 0.80; 95% confidence interval: 0.50, 1.28; p = 0.36; intra-class correlation coefficient: 0.022, and thus was not considered feasible. Major barriers to effective knowledge translation were poor attendance by clinical staff at education and feedback sessions, difficulty locating preprinted orders, and lack of involvement by clinical and administrative leaders. We identified several factors that may increase uptake of a VTE

  1. Mobile phone intervention reduces perinatal mortality in zanzibar: secondary outcomes of a cluster randomized controlled trial.

    Science.gov (United States)

    Lund, Stine; Rasch, Vibeke; Hemed, Maryam; Boas, Ida Marie; Said, Azzah; Said, Khadija; Makundu, Mkoko Hassan; Nielsen, Birgitte Bruun

    2014-03-26

    Mobile phones are increasingly used in health systems in developing countries and innovative technical solutions have great potential to overcome barriers of access to reproductive and child health care. However, despite widespread support for the use of mobile health technologies, evidence for its role in health care is sparse. We aimed to evaluate the association between a mobile phone intervention and perinatal mortality in a resource-limited setting. This study was a pragmatic, cluster-randomized, controlled trial with primary health care facilities in Zanzibar as the unit of randomization. At their first antenatal care visit, 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary health care facilities were included in this study and followed until 42 days after delivery. Twenty-four primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text message and voucher component. Secondary outcome measures included stillbirth, perinatal mortality, and death of a child within 42 days after birth as a proxy of neonatal mortality. Within the first 42 days of life, 2482 children were born alive, 54 were stillborn, and 36 died. The overall perinatal mortality rate in the study was 27 per 1000 total births. The rate was lower in the intervention clusters, 19 per 1000 births, than in the control clusters, 36 per 1000 births. The intervention was associated with a significant reduction in perinatal mortality with an odds ratio (OR) of 0.50 (95% CI 0.27-0.93). Other secondary outcomes showed an insignificant reduction in stillbirth (OR 0.65, 95% CI 0.34-1.24) and an insignificant reduction in death within the first 42 days of life (OR 0.79, 95% CI 0.36-1.74). Mobile phone applications may contribute to improved health of the newborn and should be considered by policy makers in resource-limited settings. ClinicalTrials

  2. Implementation of client versus care-provider strategies to improve external cephalic version rates: a cluster randomized controlled trial.

    Science.gov (United States)

    Vlemmix, Floortje; Rosman, Ageeth N; Rijnders, Marlies E; Beuckens, Antje; Opmeer, Brent C; Mol, Ben W J; Kok, Marjolein; Fleuren, Margot A H

    2015-05-01

    To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version. Cluster randomized controlled trial. Twenty-five clusters; hospitals and their referring midwifery practices randomly selected in the Netherlands. Singleton breech presentation from 32 weeks of gestation onwards. We randomized clusters to a client strategy (written information leaflets and decision aid), a care-provider strategy (1-day counseling course focused on knowledge and counseling skills), a combined client and care-provider strategy and care-as-usual strategy. We performed an intention-to-treat analysis. Rate of external cephalic version in various strategies. Secondary outcomes were the percentage of women counseled and opting for a version attempt. The overall implementation rate of external cephalic version was 72% (1169 of 1613 eligible clients) with a range between clusters of 8-95%. Neither the client strategy (OR 0.8, 95% CI 0.4-1.5) nor the care-provider strategy (OR 1.2, 95% CI 0.6-2.3) showed significant improvements. Results were comparable when we limited the analysis to those women who were actually offered intervention (OR 0.6, 95% CI 0.3-1.4 and OR 2.0, 95% CI 0.7-4.5). Neither a client nor a care-provider strategy improved the external cephalic version implementation rate for breech presentation, neither with regard to the number of version attempts offered nor the number of women accepting the procedure. © 2015 Nordic Federation of Societies of Obstetrics and Gynecology.

  3. E-learning or educational leaflet: does it make a difference in oral health promotion? A clustered randomized trial.

    Science.gov (United States)

    Al Bardaweel, Susan; Dashash, Mayssoon

    2018-05-10

    The early recognition of technology together with great ability to use computers and smart systems have promoted researchers to investigate the possibilities of utilizing technology for improving health care in children. The aim of this study was to compare between the traditional educational leaflets and E-applications in improving oral health knowledge, oral hygiene and gingival health in schoolchildren of Damascus city, Syria. A clustered randomized controlled trial at two public primary schools was performed. About 220 schoolchildren aged 10-11 years were included in this study and grouped into two clusters. Children in Leaflet cluster received oral health education through leaflets, while children in E-learning cluster received oral health education through an E-learning program. A questionnaire was designed to register information related to oral health knowledge and to record Plaque and Gingival indices. Questionnaire administration and clinical assessment were undertaken at baseline, 6 and at 12 weeks of oral health education. Data was analysed using one way repeated measures ANOVA, post hoc Bonferroni test and independent samples t-test. Leaflet cluster (107 participants) had statistically significant better oral health knowledge than E-learning cluster (104 participants) at 6 weeks (P E-learning cluster:100 participants). The mean knowledge gain compared to baseline was higher in Leaflet cluster than in E-learning cluster. A significant reduction in the PI means at 6 weeks and 12 weeks was observed in both clusters (P E-learning cluster at 6 weeks (P E-learning cluster at 6 weeks (P < 0.05) and 12 weeks (P < 0.05). Traditional educational leaflets are an effective tool in the improvement of both oral health knowledge as well as clinical indices of oral hygiene and care among Syrian children. Leaflets can be used in school-based oral health education for a positive outcome. Australian New Zealand Clinical Trials Registry ( ACTRN

  4. Optimizing polypharmacy among elderly hospital patients with chronic diseases--study protocol of the cluster randomized controlled POLITE-RCT trial.

    Science.gov (United States)

    Löffler, Christin; Drewelow, Eva; Paschka, Susanne D; Frankenstein, Martina; Eger, Julia; Jatsch, Lisa; Reisinger, Emil C; Hallauer, Johannes F; Drewelow, Bernd; Heidorn, Karen; Schröder, Helmut; Wollny, Anja; Kundt, Günther; Schmidt, Christian; Altiner, Attila

    2014-10-06

    Treatment of patients with multimorbidity is challenging. A rational reduction of long-term drugs can lead to decreased mortality, less acute hospital treatment, and a reduction of costs. Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence. The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients. The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based, patient-centered medication review prior to the patient's discharge from hospital. The POLITE-RCT trial is a cluster randomized controlled trial. Two major secondary health care providers of Mecklenburg-Western Pomerania, Germany, take part in the study. Clusters are wards of both medical centers. All wards where patients with chronic diseases and multimorbidity are regularly treated will be included. Patients aged 65+ years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively. Cluster-randomization takes place after a six-month baseline data collection period. Patients of the control group receive care as usual. The independent two main primary outcomes are (1) health-related quality of life (EQ-5D) and (2) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group. The secondary outcomes are appropriateness of prescribed medication (PRISCUS list, Beers Criteria, MAI), patient satisfaction (TSQM), patient empowerment (PEF-FB-9), patient autonomy (IADL), falls, re-hospitalization, and death. The points of measurement are at admission to (T0) and discharge from hospital (T1) as well as 6 and 12 months after discharge from the hospital (T2 and T3). In 42 wards, 1,626 patients will be recruited. In case of positive

  5. Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care: Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial

    NARCIS (Netherlands)

    van Leeuwen, K.M.; Bosmans, J.E.; Jansen, A.P.D.; Hoogendijk, E.O.; Muntinga, M.E.; van Hout, H.P.J.; Nijpels, G.; van der Horst, H.E.; van Tulder, M.W.

    2015-01-01

    Objectives To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. Design Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. Setting

  6. Cost-Effectiveness of a Chronic Care Model for Frail Older Adults in Primary Care : Economic Evaluation Alongside a Stepped-Wedge Cluster-Randomized Trial

    NARCIS (Netherlands)

    van Leeuwen, Karen M; Bosmans, Judith E; Jansen, Aaltje P D; Hoogendijk, Emiel O; Muntinga, Maaike E; van Hout, Hein P J; Nijpels, Giel; van der Horst, Henriette E; van Tulder, Maurits W

    2015-01-01

    OBJECTIVES: To evaluate the cost-effectiveness of the Geriatric Care Model (GCM), an integrated care model for frail older adults based on the Chronic Care Model, with that of usual care. DESIGN: Economic evaluation alongside a 24-month stepped-wedge cluster-randomized controlled trial. SETTING:

  7. Patients’ general satisfaction with telephone counseling by pharmacists and effects on satisfaction with information and beliefs about medicines: results from a cluster randomized trial.

    NARCIS (Netherlands)

    Kooy, M.J.; Geffen, E.C.G. van; Heerdink, E.R.; Dijk, L. van; Bouvy, M.L.

    2015-01-01

    Objective: Assess effects of pharmacists’ counseling by telephone on patients’ satisfaction with counseling, satisfaction with information and beliefs about medicines for newly prescribed medicines. Methods: A cluster randomized trial in Dutch community pharmacies. Patients ≥18 years were included

  8. Patients' general satisfaction with telephone counseling by pharmacists and effects on satisfaction with information and beliefs about medicines : Results from a cluster randomized trial

    NARCIS (Netherlands)

    Kooy, Marcel Jan; Van Geffen, Erica C G; Heerdink, Eibert R.; Van Dijk, Liset; Bouvy, Marcel L.

    2015-01-01

    Assess effects of pharmacists' counseling by telephone on patients' satisfaction with counseling, satisfaction with information and beliefs about medicines for newly prescribed medicines. Methods: A cluster randomized trial in Dutch community pharmacies. Patients ≥18 years were included when

  9. Point-of-care cluster randomized trial in stroke secondary prevention using electronic health records.

    Science.gov (United States)

    Dregan, Alex; van Staa, Tjeerd P; McDermott, Lisa; McCann, Gerard; Ashworth, Mark; Charlton, Judith; Wolfe, Charles D A; Rudd, Anthony; Yardley, Lucy; Gulliford, Martin C; Trial Steering Committee

    2014-07-01

    The aim of this study was to evaluate whether the remote introduction of electronic decision support tools into family practices improves risk factor control after first stroke. This study also aimed to develop methods to implement cluster randomized trials in stroke using electronic health records. Family practices were recruited from the UK Clinical Practice Research Datalink and allocated to intervention and control trial arms by minimization. Remotely installed, electronic decision support tools promoted intensified secondary prevention for 12 months with last measure of systolic blood pressure as the primary outcome. Outcome data from electronic health records were analyzed using marginal models. There were 106 Clinical Practice Research Datalink family practices allocated (intervention, 53; control, 53), with 11 391 (control, 5516; intervention, 5875) participants with acute stroke ever diagnosed. Participants at trial practices had similar characteristics as 47,887 patients with stroke at nontrial practices. During the intervention period, blood pressure values were recorded in the electronic health records for 90% and cholesterol values for 84% of participants. After intervention, the latest mean systolic blood pressure was 131.7 (SD, 16.8) mm Hg in the control trial arm and 131.4 (16.7) mm Hg in the intervention trial arm, and adjusted mean difference was -0.56 mm Hg (95% confidence interval, -1.38 to 0.26; P=0.183). The financial cost of the trial was approximately US $22 per participant, or US $2400 per family practice allocated. Large pragmatic intervention studies may be implemented at low cost by using electronic health records. The intervention used in this trial was not found to be effective, and further research is needed to develop more effective intervention strategies. http://www.controlled-trials.com. Current Controlled Trials identifier: ISRCTN35701810. © 2014 American Heart Association, Inc.

  10. Effectiveness of a group diabetes education programme in underserved communities in South Africa: pragmatic cluster randomized control trial.

    Science.gov (United States)

    Mash, Bob; Levitt, Naomi; Steyn, Krisela; Zwarenstein, Merrick; Rollnick, Stephen

    2012-12-24

    Diabetes is an important contributor to the burden of disease in South Africa and prevalence rates as high as 33% have been recorded in Cape Town. Previous studies show that quality of care and health outcomes are poor. The development of an effective education programme should impact on self-care, lifestyle change and adherence to medication; and lead to better control of diabetes, fewer complications and better quality of life. Pragmatic cluster randomized controlled trialParticipants: Type 2 diabetic patients attending 45 public sector community health centres in Cape TownInterventions: The intervention group will receive 4 sessions of group diabetes education delivered by a health promotion officer in a guiding style. The control group will receive usual care which consists of ad hoc advice during consultations and occasional educational talks in the waiting room. To evaluate the effectiveness of the group diabetes education programmeOutcomes: diabetes self-care activities, 5% weight loss, 1% reduction in HbA1c. self-efficacy, locus of control, mean blood pressure, mean weight loss, mean waist circumference, mean HbA1c, mean total cholesterol, quality of lifeRandomisation: Computer generated random numbersBlinding: Patients, health promoters and research assistants could not be blinded to the health centre's allocationNumbers randomized: Seventeen health centres (34 in total) will be randomly assigned to either control or intervention groups. A sample size of 1360 patients in 34 clusters of 40 patients will give a power of 80% to detect the primary outcomes with 5% precision. Altogether 720 patients were recruited in the intervention arm and 850 in the control arm giving a total of 1570. The study will inform policy makers and managers of the district health system, particularly in low to middle income countries, if this programme can be implemented more widely. Pan African Clinical Trial Registry PACTR201205000380384.

  11. Effects of improved sanitation on diarrheal reduction for children under five in Idiofa, DR Congo: a cluster randomized trial.

    Science.gov (United States)

    Cha, Seungman; Lee, JaeEun; Seo, DongSik; Park, Byoung Mann; Mansiangi, Paul; Bernard, Kabore; Mulakub-Yazho, Guy Jerome Nkay; Famasulu, Honore Minka

    2017-09-19

    The lack of safe water and sanitation contributes to the rampancy of diarrhea in many developing countries. This study describes the design of a cluster-randomized trial in Idiofa, the Democratic Republic of the Congo, seeking evidence of the impact of improved sanitation on diarrhea for children under four. Of the 276 quartiers, 18 quartiers were randomly allocated to the intervention or control arm. Seven hundred and-twenty households were sampled and the youngest under-four child in each household was registered for this study. The primary endpoint of the study is diarrheal incidence, prevalence and duration in children under five. Material subsidies will be provided only to the households who complete pit digging plus superstructure and roof construction, regardless of their income level. This study employs a Sanitation Calendar so that the mother of each household can record the diarrheal episodes of her under-four child on a daily basis. The diary enables examination of the effect of the sanitation intervention on diarrhea duration and also resolves the limitation of the small number of clusters in the trial. In addition, the project will be monitored through the 'Sanitation Map', on which all households in the study area, including both the control and intervention arms, are registered. To avoid information bias or courtesy bias, photos will be taken of the latrine during the household visit, and a supervisor will determine well-equipped latrine uptake based on the photos. This reduces the possibility of recall bias and under- or over-estimation of diarrhea, which was the main limitation of previous studies. The study was approved by the Institutional Review Board of the School of Public Health, Kinshasa University (ESP/CE/040/15; April 13, 2015) and registered as an International Standard Randomized Controlled Trial (ISRCTN: 10,419,317) on March 13, 2015.

  12. Effect of an educational toolkit on quality of care: a pragmatic cluster randomized trial.

    Science.gov (United States)

    Shah, Baiju R; Bhattacharyya, Onil; Yu, Catherine H Y; Mamdani, Muhammad M; Parsons, Janet A; Straus, Sharon E; Zwarenstein, Merrick

    2014-02-01

    Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes. All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population. The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions. http://www.ClinicalTrials.gov NCT01411865 and NCT01026688.

  13. Text Clustering Algorithm Based on Random Cluster Core

    Directory of Open Access Journals (Sweden)

    Huang Long-Jun

    2016-01-01

    Full Text Available Nowadays clustering has become a popular text mining algorithm, but the huge data can put forward higher requirements for the accuracy and performance of text mining. In view of the performance bottleneck of traditional text clustering algorithm, this paper proposes a text clustering algorithm with random features. This is a kind of clustering algorithm based on text density, at the same time using the neighboring heuristic rules, the concept of random cluster is introduced, which effectively reduces the complexity of the distance calculation.

  14. Restrictive vs Liberal Blood Transfusion for Acute Upper Gastrointestinal Bleeding: Rationale and Protocol for a Cluster Randomized Feasibility Trial

    Science.gov (United States)

    Jairath, Vipul; Kahan, Brennan C.; Gray, Alasdair; Doré, Caroline J.; Mora, Ana; Dyer, Claire; Stokes, Elizabeth A.; Llewelyn, Charlotte; Bailey, Adam A.; Dallal, Helen; Everett, Simon M.; James, Martin W.; Stanley, Adrian J.; Church, Nicholas; Darwent, Melanie; Greenaway, John; Le Jeune, Ivan; Reckless, Ian; Campbell, Helen E.; Meredith, Sarah; Palmer, Kelvin R.; Logan, Richard F.A.; Travis, Simon P.L.; Walsh, Timothy S.; Murphy, Michael F.

    2013-01-01

    Acute upper gastrointestinal bleeding (AUGIB) is the commonest reason for hospitalization with hemorrhage in the UK and the leading indication for transfusion of red blood cells (RBCs). Observational studies suggest an association between more liberal RBC transfusion and adverse patient outcomes, and a recent randomised trial reported increased further bleeding and mortality with a liberal transfusion policy. TRIGGER (Transfusion in Gastrointestinal Bleeding) is a pragmatic, cluster randomized trial which aims to evaluate the feasibility and safety of implementing a restrictive versus liberal RBC transfusion policy in adult patients admitted with AUGIB. The trial will take place in 6 UK hospitals, and each centre will be randomly allocated to a transfusion policy. Clinicians throughout each hospital will manage all eligible patients according to the transfusion policy for the 6-month trial recruitment period. In the restrictive centers, patients become eligible for RBC transfusion when their hemoglobin is bleeding, mortality, thromboembolic events, and infections. Quality of life will be measured using the EuroQol EQ-5D at day 28, and the costs associated with hospitalization for AUGIB in the UK will be estimated. Consent will be sought from participants or their representatives according to patient capacity for use of routine hospital data and day 28 follow up. The study has ethical approval for conduct in England and Scotland. Results will be analysed according to a pre-defined statistical analysis plan and disseminated in peer reviewed publications to relevant stakeholders. The results of this study will inform the feasibility and design of a phase III randomized trial. PMID:23706959

  15. PRagmatic trial Of Video Education in Nursing homes: The design and rationale for a pragmatic cluster randomized trial in the nursing home setting.

    Science.gov (United States)

    Mor, Vincent; Volandes, Angelo E; Gutman, Roee; Gatsonis, Constantine; Mitchell, Susan L

    2017-04-01

    Background/Aims Nursing homes are complex healthcare systems serving an increasingly sick population. Nursing homes must engage patients in advance care planning, but do so inconsistently. Video decision support tools improved advance care planning in small randomized controlled trials. Pragmatic trials are increasingly employed in health services research, although not commonly in the nursing home setting to which they are well-suited. This report presents the design and rationale for a pragmatic cluster randomized controlled trial that evaluated the "real world" application of an Advance Care Planning Video Program in two large US nursing home healthcare systems. Methods PRagmatic trial Of Video Education in Nursing homes was conducted in 360 nursing homes (N = 119 intervention/N = 241 control) owned by two healthcare systems. Over an 18-month implementation period, intervention facilities were instructed to offer the Advance Care Planning Video Program to all patients. Control facilities employed usual advance care planning practices. Patient characteristics and outcomes were ascertained from Medicare Claims, Minimum Data Set assessments, and facility electronic medical record data. Intervention adherence was measured using a Video Status Report embedded into electronic medical record systems. The primary outcome was the number of hospitalizations/person-day alive among long-stay patients with advanced dementia or cardiopulmonary disease. The rationale for the approaches to facility randomization and recruitment, intervention implementation, population selection, data acquisition, regulatory issues, and statistical analyses are discussed. Results The large number of well-characterized candidate facilities enabled several unique design features including stratification on historical hospitalization rates, randomization prior to recruitment, and 2:1 control to intervention facilities ratio. Strong endorsement from corporate leadership made randomization

  16. Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.

    Science.gov (United States)

    Forster, Anne; Young, John; Chapman, Katie; Nixon, Jane; Patel, Anita; Holloway, Ivana; Mellish, Kirste; Anwar, Shamaila; Breen, Rachel; Knapp, Martin; Murray, Jenni; Farrin, Amanda

    2015-08-01

    We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke. A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months. Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups. This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice. URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305. © 2015 Bradford Teaching Hospitals NHS Foundation Trust.

  17. Structured patient handoff on an internal medicine ward: A cluster randomized control trial.

    Science.gov (United States)

    Tam, Penny; Nijjar, Aman P; Fok, Mark; Little, Chris; Shingina, Alexandra; Bittman, Jesse; Raghavan, Rashmi; Khan, Nadia A

    2018-01-01

    The effect of a multi-faceted handoff strategy in a high volume internal medicine inpatient setting on process and patient outcomes has not been clearly established. We set out to determine if a multi-faceted handoff intervention consisting of education, standardized handoff procedures, including fixed time and location for face-to-face handoff would result in improved rates of handoff compared with usual practice. We also evaluated resident satisfaction, health resource utilization and clinical outcomes. This was a cluster randomized controlled trial in a large academic tertiary care center with 18 inpatient internal medicine ward teams from January-April 2013. We randomized nine inpatient teams to an intervention where they received an education session standardizing who and how to handoff patients, with practice and feedback from facilitators. The control group of 9 teams continued usual non-standardized handoffs. The primary process outcome was the rate of patients handed over per 1000 patient nights. Other process outcomes included perceptions of inadequate handoff by overnight physicians, resource utilization overnight and hospital length of stay. Clinical outcomes included medical errors, frequency of patients requiring higher level of care overnight, and in-hospital mortality. The intervention group demonstrated a significant increase in the rate of patients handed over to the overnight physician (62.90/1000 person-nights vs. 46.86/1000 person-nights, p = 0.002). There was no significant difference in other process outcomes except resource utilization was increased in the intervention group (26.35/1000 person-days vs. 17.57/1000 person-days, p-value = 0.01). There was no significant difference between groups in medical errors (4.8% vs. 4.1%), need for higher level of care or in hospital mortality. Limitations include a dependence of accurate record keeping by the overnight physician, the possibility of cross-contamination in the handoff process, analysis at

  18. Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people : Results of a cluster randomized trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J.; MacNeil-Vroomen, Janet L.; van Rijn, Marjon; Buurman, Bianca M.; de Rooij, Sophia E.; van Charente, Eric P. Moll; Bosmans, Judith E.

    2017-01-01

    Objective To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. Methods We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year

  19. Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people: Results of a cluster randomized trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J.; MacNeil-Vroomen, Janet L.; van Rijn, Marjon; Buurman, Bianca M.; de Rooij, Sophia E.; Moll van Charante, Eric P.; Bosmans, Judith E.

    2017-01-01

    Objective To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. Methods We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year

  20. Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people : Results of a cluster randomized trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J; MacNeil-Vroomen, Janet L; van Rijn, Marjon; Buurman, Bianca M; de Rooij, Sophia E; Moll van Charante, Eric P; Bosmans, Judith E

    2017-01-01

    OBJECTIVE: To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. METHODS: We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year

  1. COSMOS--improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial.

    Science.gov (United States)

    Husebo, Bettina S; Flo, Elisabeth; Aarsland, Dag; Selbaek, Geir; Testad, Ingelin; Gulla, Christine; Aasmul, Irene; Ballard, Clive

    2015-09-15

    Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial. COSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality. Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover

  2. The Long-Term Effectiveness of a Selective, Personality-Targeted Prevention Program in Reducing Alcohol Use and Related Harms: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Newton, Nicola C.; Conrod, Patricia J.; Slade, Tim; Carragher, Natacha; Champion, Katrina E.; Barrett, Emma L.; Kelly, Erin V.; Nair, Natasha K.; Stapinski, Lexine; Teesson, Maree

    2016-01-01

    Background: This study investigated the long-term effectiveness of Preventure, a selective personality-targeted prevention program, in reducing the uptake of alcohol, harmful use of alcohol, and alcohol-related harms over a 3-year period. Methods: A cluster randomized controlled trial was conducted to assess the effectiveness of Preventure.…

  3. The implementation of the serial trial intervention for pain and challenging behaviour in advanced dementia patients (STA OP!: a clustered randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Francke Anneke L

    2011-03-01

    Full Text Available Abstract Background Pain (physical discomfort and challenging behaviour are highly prevalent in nursing home residents with dementia: at any given time 45-80% of nursing home residents are in pain and up to 80% have challenging behaviour. In the USA Christine Kovach developed the serial trial intervention (STI and established that this protocol leads to less discomfort and fewer behavioural symptoms in moderate to severe dementia patients. The present study will provide insight into the effects of implementation of the Dutch version of the STI-protocol (STA OP! in comparison with a control intervention, not only on behavioural symptoms, but also on pain, depression, and quality of life. This article outlines the study protocol. Methods/Design The study is a cluster randomized controlled trial in 168 older people (aged >65 years with mild or moderate dementia living in nursing homes. The clusters, Dutch nursing homes, are randomly assigned to either the intervention condition (training and implementation of the STA OP!-protocol or the control condition (general training focusing on challenging behaviour and pain, but without the step-wise approach. Measurements take place at baseline, after 3 months (end of the STA OP! training period and after 6 months. Primary outcome measures are symptoms of challenging behaviour (measured with the Cohen-Mansfield Agitation Inventory (CMAI and the Neuropsychiatric Inventory-Nursing Home version (NPI-NH, and pain (measure with the Dutch version of the Pain Assessment Checklist for Seniors (PACSLAC-D and the Minimum Data Set of the Resident Assessment Instrument (MDS-RAI pain scale. Secondary outcome measures include symptoms of depression (Cornell and MDS-RAI depression scale, Quality of Live (Qualidem, changes in prescriptions of analgesics and psychotropic drugs, and the use of non-pharmacological comfort interventions (e.g. snoezelen, reminiscence therapy. Discussion The transfer from the American design to

  4. Evaluation of a self-management patient education program for patients with chronic heart failure undergoing inpatient cardiac rehabilitation: study protocol of a cluster randomized controlled trial.

    Science.gov (United States)

    Meng, Karin; Musekamp, Gunda; Seekatz, Bettina; Glatz, Johannes; Karger, Gabriele; Kiwus, Ulrich; Knoglinger, Ernst; Schubmann, Rainer; Westphal, Ronja; Faller, Hermann

    2013-08-23

    Chronic heart failure requires a complex treatment regimen on a life-long basis. Therefore, self-care/self-management is an essential part of successful treatment and comprehensive patient education is warranted. However, specific information on program features and educational strategies enhancing treatment success is lacking. This trial aims to evaluate a patient-oriented and theory-based self-management educational group program as compared to usual care education during inpatient cardiac rehabilitation in Germany. The study is a multicenter cluster randomized controlled trial in four cardiac rehabilitation clinics. Clusters are patient education groups that comprise HF patients recruited within 2 weeks after commencement of inpatient cardiac rehabilitation. Cluster randomization was chosen for pragmatic reasons, i.e. to ensure a sufficient number of eligible patients to build large-enough educational groups and to prevent contamination by interaction of patients from different treatment allocations during rehabilitation. Rehabilitants with chronic systolic heart failure (n = 540) will be consecutively recruited for the study at the beginning of inpatient rehabilitation. Data will be assessed at admission, at discharge and after 6 and 12 months using patient questionnaires. In the intervention condition, patients receive the new patient-oriented self-management educational program, whereas in the control condition, patients receive a short lecture-based educational program (usual care). The primary outcome is patients' self-reported self-management competence. Secondary outcomes include behavioral determinants and self-management health behavior (symptom monitoring, physical activity, medication adherence), health-related quality of life, and treatment satisfaction. Treatment effects will be evaluated separately for each follow-up time point using multilevel regression analysis, and adjusting for baseline values. This study evaluates the effectiveness of a

  5. Impact of an automated email notification system for results of tests pending at discharge: a cluster-randomized controlled trial.

    Science.gov (United States)

    Dalal, Anuj K; Roy, Christopher L; Poon, Eric G; Williams, Deborah H; Nolido, Nyryan; Yoon, Cathy; Budris, Jonas; Gandhi, Tejal; Bates, David W; Schnipper, Jeffrey L

    2014-01-01

    Physician awareness of the results of tests pending at discharge (TPADs) is poor. We developed an automated system that notifies responsible physicians of TPAD results via secure, network email. We sought to evaluate the impact of this system on self-reported awareness of TPAD results by responsible physicians, a necessary intermediary step to improve management of TPAD results. We conducted a cluster-randomized controlled trial at a major hospital affiliated with an integrated healthcare delivery network in Boston, Massachusetts. Adult patients with TPADs who were discharged from inpatient general medicine and cardiology services were assigned to the intervention or usual care arm if their inpatient attending physician and primary care physician (PCP) were both randomized to the same study arm. Patients of physicians randomized to discordant study arms were excluded. We surveyed these physicians 72 h after all TPAD results were finalized. The primary outcome was awareness of TPAD results by attending physicians. Secondary outcomes included awareness of TPAD results by PCPs, awareness of actionable TPAD results, and provider satisfaction. We analyzed data on 441 patients. We sent 441 surveys to attending physicians and 353 surveys to PCPs and received 275 and 152 responses from 83 different attending physicians and 112 different PCPs, respectively (attending physician survey response rate of 63%). Intervention attending physicians and PCPs were significantly more aware of TPAD results (76% vs 38%, adjusted/clustered OR 6.30 (95% CI 3.02 to 13.16), pemail notification represents a promising strategy for managing TPAD results, potentially mitigating an unresolved patient safety concern. ClinicalTrials.gov (NCT01153451).

  6. Community resource centres to improve the health of women and children in Mumbai slums: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Shah More, Neena; Das, Sushmita; Bapat, Ujwala; Rajguru, Mahesh; Alcock, Glyn; Joshi, Wasundhara; Pantvaidya, Shanti; Osrin, David

    2013-05-08

    The trial addresses the general question of whether community resource centers run by a non-government organization improve the health of women and children in slums. The resource centers will be run by the Society for Nutrition, Education and Health Action, and the trial will evaluate their effects on a series of public health indicators. Each resource center will be located in a vulnerable Mumbai slum area and will serve as a base for salaried community workers, supervised by officers and coordinators, to organize the collection and dissemination of health information, provision of services, home visits to identify and counsel families at risk, referral of individuals and families to appropriate services and support for their access, meetings of community members and providers, and events and campaigns on health issues. A cluster randomized controlled trial in which 20 urban slum areas with resource centers are compared with 20 control areas. Each cluster will contain approximately 600 households and randomized allocation will be in three blocked phases, of 12, 12 and 16 clusters. Any resident of an intervention cluster will be able to participate in the intervention, but the resource centers will target women and children, particularly women of reproductive age and children under 5.The outcomes will be assessed through a household census after 2 years of resource center operations. The primary outcomes are unmet need for family planning in women aged 15 to 49 years, proportion of children under 5 years of age not fully immunized for their ages, and proportion of children under 5 years of age with weight for height less than 2 standard deviations below the median for age and sex. Secondary outcomes describe adolescent pregnancies, home deliveries, receipt of conditional cash transfers for institutional delivery, other childhood anthropometric indices, use of public sector health and nutrition services, indices of infant and young child feeding, and consultation

  7. Evaluation of a self-management patient education program for patients with fibromyalgia syndrome: study protocol of a cluster randomized controlled trial.

    Science.gov (United States)

    Musekamp, Gunda; Gerlich, Christian; Ehlebracht-König, Inge; Faller, Hermann; Reusch, Andrea

    2016-02-03

    Fibromyalgia syndrome (FMS) is a complex chronic condition that makes high demands on patients' self-management skills. Thus, patient education is considered an important component of multimodal therapy, although evidence regarding its effectiveness is scarce. The main objective of this study is to assess the effectiveness of an advanced self-management patient education program for patients with FMS as compared to usual care in the context of inpatient rehabilitation. We conducted a multicenter cluster randomized controlled trial in 3 rehabilitation clinics. Clusters are groups of patients with FMS consecutively recruited within one week after admission. Patients of the intervention group receive the advanced multidisciplinary self-management patient education program (considering new knowledge on FMS, with a focus on transfer into everyday life), whereas patients in the control group receive standard patient education programs including information on FMS and coping with pain. A total of 566 patients are assessed at admission, at discharge and after 6 and 12 months, using patient reported questionnaires. Primary outcomes are patients' disease- and treatment-specific knowledge at discharge and self-management skills after 6 months. Secondary outcomes include satisfaction, attitudes and coping competences, health-promoting behavior, psychological distress, health impairment and participation. Treatment effects between groups are evaluated using multilevel regression analysis adjusting for baseline values. The study evaluates the effectiveness of a self-management patient education program for patients with FMS in the context of inpatient rehabilitation in a cluster randomized trial. Study results will show whether self-management patient education is beneficial for this group of patients. German Clinical Trials Register, DRKS00008782 , Registered 8 July 2015.

  8. Enhancing a sustainable healthy working life: design of a clustered randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Koolhaas Wendy

    2010-08-01

    Full Text Available Abstract Background To improve a sustainable healthy working life, we have developed the intervention 'Staying healthy at work', which endeavours to enhance work participation of employees aged 45 years and older by increasing their problem-solving capacity and stimulating their awareness of their role and responsibility towards a healthy working life. This research study aims to evaluate the process and the effectiveness of the intervention compared with care as usual. Methods/design The study is a cluster-randomized controlled trial design (randomized at the supervisor level, with a 1-year follow-up. Workers aged 45 years and older have been enrolled in the study. Workers in the intervention group are receiving the intervention 'Staying healthy at work'. The main focus of the intervention is to promote a healthy working life of ageing workers by: (1 changing workers awareness and behaviour, by emphasizing their own decisive role in attaining goals; (2 improving the supervisors' ability to support workers in taking the necessary action, by means of enhancing knowledge and competence; and (3 enhancing the use of the human resource professionals and the occupational health tools available within the organization. The supervisors in the intervention group have been trained how to present themselves as a source of support for the worker. Workers in the control group are receiving care as usual; supervisors in the control group have not participated in the training. Measurements have been taken at baseline and will be followed up at 3, 6 and 12 months. The primary outcome measures are vitality, work ability and productivity. The secondary outcomes measures include fatigue, job strain, work attitude, self-efficacy and work engagement. A process evaluation will be conducted at both the supervisor and the worker levels, and satisfaction with the content of the intervention will be assessed. Discussion The intervention 'Staying healthy at work' has the

  9. Knowledge Translation Interventions to Improve the Timing of Dialysis Initiation: Protocol for a Cluster Randomized Trial.

    Science.gov (United States)

    Chau, Elaine M T; Manns, Braden J; Garg, Amit X; Sood, Manish M; Kim, S Joseph; Naimark, David; Nesrallah, Gihad E; Soroka, Steven D; Beaulieu, Monica; Dixon, Stephanie; Alam, Ahsan; Tangri, Navdeep

    2016-01-01

    Early initiation of chronic dialysis (starting dialysis with higher vs lower kidney function) has risen rapidly in the past 2 decades in Canada and internationally, despite absence of established health benefits and higher costs. In 2014, a Canadian guideline on the timing of dialysis initiation, recommending an intent-to-defer approach, was published. The objective of this study is to evaluate the efficacy and safety of a knowledge translation intervention to promote the intent-to-defer approach in clinical practice. This study is a multicenter, 2-arm parallel, cluster randomized trial. The study involves 55 advanced chronic kidney disease clinics across Canada. Patients older than 18 years who are managed by nephrologists for more than 3 months, and initiate dialysis in the follow-up period are included in the study. Outcomes will be measured at the patient-level and enumerated within a cluster. Data on characteristics of each dialysis start will be determined by linkages with the Canadian Organ Replacement Register. Primary outcomes include the proportion of patients who start dialysis early with an estimated glomerular filtration rate greater than 10.5 mL/min/1.73 m 2 and start dialysis in hospital as inpatients or in an emergency room setting. Secondary outcomes include the rate of change in early dialysis starts; rates of hospitalizations, deaths, and cost of predialysis care (wherever available); quarterly proportion of new starts; and acceptability of the knowledge translation materials. We randomized 55 multidisciplinary chronic disease clinics (clusters) in Canada to receive either an active knowledge translation intervention or no intervention for the uptake of the guideline on the timing of dialysis initiation. The active knowledge translation intervention consists of audit and feedback as well as patient- and provider-directed educational tools delivered at a comprehensive in-person medical detailing visit. Control clinics are only exposed to guideline

  10. Peer Coaches to Improve Diabetes Outcomes in Rural Alabama: A Cluster Randomized Trial.

    Science.gov (United States)

    Safford, Monika M; Andreae, Susan; Cherrington, Andrea L; Martin, Michelle Y; Halanych, Jewell; Lewis, Marquita; Patel, Ashruta; Johnson, Ethel; Clark, Debra; Gamboa, Christopher; Richman, Joshua S

    2015-08-01

    It is unclear whether peer coaching is effective in minority populations living with diabetes in hard-to-reach, under-resourced areas such as the rural South. We examined the effect of an innovative peer-coaching intervention plus brief education vs brief education alone on diabetes outcomes. This was a community-engaged, cluster-randomized, controlled trial with primary care practices and their surrounding communities serving as clusters. The trial enrolled 424 participants, with 360 completing baseline and follow-up data collection (84.9% retention). The primary outcomes were change in glycated hemoglobin (HbA1c), systolic blood pressure (BP), low density lipoprotein cholesterol (LDL-C), body mass index (BMI), and quality of life, with diabetes distress and patient activation as secondary outcomes. Peer coaches were trained for 2 days in community settings; the training emphasized motivational interviewing skills, diabetes basics, and goal setting. All participants received a 1-hour diabetes education class and a personalized diabetes report card at baseline. Intervention arm participants were also paired with peer coaches; the protocol called for telephone interactions weekly for the first 8 weeks, then monthly for a total of 10 months. Due to real-world constraints, follow-up was protracted, and intervention effects varied over time. The analysis that included the 68% of participants followed up by 15 months showed only a significant increase in patient activation in the intervention group. The analysis that included all participants who eventually completed follow-up revealed that intervention arm participants had significant differences in changes in systolic BP (P = .047), BMI (P = .02), quality of life (P = .003), diabetes distress (P = .004), and patient activation (P = .03), but not in HbA1c (P = .14) or LDL-C (P = .97). Telephone-delivered peer coaching holds promise to improve health for individuals with diabetes living in under-resourced areas. © 2015

  11. Pain management in cancer center inpatients: a cluster randomized trial to evaluate a systematic integrated approach—The Edinburgh Pain Assessment and Management Tool

    OpenAIRE

    Fallon, M; Walker, J; Colvin, L; Rodriguez, A; Murray, G; Sharpe, M

    2018-01-01

    Purpose Pain is suboptimally managed in patients with cancer. We aimed to compare the effect of a policy of adding a clinician-delivered bedside pain assessment and management tool (Edinburgh Pain Assessment and management Tool [EPAT]) to usual care (UC) versus UC alone on pain outcomes. Patients and Methods In a two-arm, parallel group, cluster randomized (1:1) trial, we observed pain outcomes in 19 cancer centers in the United Kingdom and then randomly assigned the centers to eithe...

  12. Enhancing Executive Functions Among Dutch Elementary School Children Using the Train Your Mind Program: Protocol for a Cluster Randomized Trial.

    Science.gov (United States)

    Bervoets, Joachim; Jonkman, Lisa M; Mulkens, Sandra; de Vries, Hein; Kok, Gerjo

    2018-06-07

    Executive functions are higher cognitive control functions, which are essential to physical and psychological well-being, academic performance, and healthy social relationships. Executive functions can be trained, albeit without broad transfer, to this date. Broad transfer entails the translation of improved cognitive functions to daily life (behaviors). The intervention Train your Mind was designed to train executive functions among elementary school children aged 9 to 11 years, and obtain broad transfer in terms of enhanced physical activity, healthy eating, and socioemotional regulation. This paper aims to describe the cluster randomized trial to test the effectiveness of the Train your Mind intervention. Train your Mind was integrated into the existing school curriculum for 8 months (25 weeks excluding holidays). The effectiveness of the intervention was tested in a cluster randomized trial comprising 13 schools, 34 groups (school classes), and 800 children, using a battery of 6 computer tasks at pre- and postmeasurement. Each of the 3 core executive functions was measured by 2 tasks (Flanker and Go/No-Go; N-Back and Running Span; Attention Switching Task and Dots/Triangles). Moreover, we administered questionnaires that measure emotion-regulation, cognitive errors, physical activity, dietary habits, and the psycho-social determinants of diet and physical activity. Body mass index was also measured. Multilevel analyses will account for clustering at the school and group levels, and randomization took place at the school level. Results are currently being analyzed. The main purpose of this study is to test Train your Mind's effectiveness in enhancing executive functions. Second, we investigate whether increased executive functions lead to improved physical activity and healthy eating. If found effective, executive function training could easily be integrated into school curricula everywhere, and as such, boost health, academic performance, and emotion

  13. Protocol for work place adjusted intelligent physical exercise reducing musculoskeletal pain in shoulder and neck (VIMS): a cluster randomized controlled trial

    DEFF Research Database (Denmark)

    Andersen, Lars L.; Zebis, Mette K.; Pedersen, Mogens Theisen

    2010-01-01

    of training supervision for safe and effective training. METHODS/DESIGN: A cluster randomized controlled trial of 20 weeks duration where employed office workers are randomized to 1 x 60 min, 3 x 20 min, 9 x 7 min per week of specific strength training with training supervision, to 3 x 20 min per week...... of specific strength training with a minimal amount of training supervision, or to a reference group without training. A questionnaire will be sent to 2000 employees in jobs characterized by intensive computer work. Employees with cardiovascular disease, trauma, hypertension, or serious chronic disease...

  14. Electronic laboratory system reduces errors in National Tuberculosis Program: a cluster randomized controlled trial.

    Science.gov (United States)

    Blaya, J A; Shin, S S; Yale, G; Suarez, C; Asencios, L; Contreras, C; Rodriguez, P; Kim, J; Cegielski, P; Fraser, H S F

    2010-08-01

    To evaluate the impact of the e-Chasqui laboratory information system in reducing reporting errors compared to the current paper system. Cluster randomized controlled trial in 76 health centers (HCs) between 2004 and 2008. Baseline data were collected every 4 months for 12 months. HCs were then randomly assigned to intervention (e-Chasqui) or control (paper). Further data were collected for the same months the following year. Comparisons were made between intervention and control HCs, and before and after the intervention. Intervention HCs had respectively 82% and 87% fewer errors in reporting results for drug susceptibility tests (2.1% vs. 11.9%, P = 0.001, OR 0.17, 95%CI 0.09-0.31) and cultures (2.0% vs. 15.1%, P Chasqui users sent on average three electronic error reports per week to the laboratories. e-Chasqui reduced the number of missing laboratory results at point-of-care health centers. Clinical users confirmed viewing electronic results not available on paper. Reporting errors to the laboratory using e-Chasqui promoted continuous quality improvement. The e-Chasqui laboratory information system is an important part of laboratory infrastructure improvements to support multidrug-resistant tuberculosis care in Peru.

  15. Effect of providing free glasses on children's educational outcomes in China: cluster randomized controlled trial.

    Science.gov (United States)

    Ma, Xiaochen; Zhou, Zhongqiang; Yi, Hongmei; Pang, Xiaopeng; Shi, Yaojiang; Chen, Qianyun; Meltzer, Mirjam E; le Cessie, Saskia; He, Mingguang; Rozelle, Scott; Liu, Yizhi; Congdon, Nathan

    2014-09-23

    To assess the effect of provision of free glasses on academic performance in rural Chinese children with myopia. Cluster randomized, investigator masked, controlled trial. 252 primary schools in two prefectures in western China, 2012-13. 3177 of 19,934 children in fourth and fifth grades (mean age 10.5 years) with visual acuity 6/12 with glasses. 3052 (96.0%) completed the study. Children were randomized by school (84 schools per arm) to one of three interventions at the beginning of the school year: prescription for glasses only (control group), vouchers for free glasses at a local facility, or free glasses provided in class. Spectacle wear at endline examination and end of year score on a specially designed mathematics test, adjusted for baseline score and expressed in standard deviations. Among 3177 eligible children, 1036 (32.6%) were randomized to control, 988 (31.1%) to vouchers, and 1153 (36.3%) to free glasses in class. All eligible children would benefit from glasses, but only 15% wore them at baseline. At closeout glasses wear was 41% (observed) and 68% (self reported) in the free glasses group, and 26% (observed) and 37% (self reported) in the controls. Effect on test score was 0.11 SD (95% confidence interval 0.01 to 0.21) when the free glasses group was compared with the control group. The adjusted effect of providing free glasses (0.10, 0.002 to 0.19) was greater than parental education (0.03, -0.04 to 0.09) or family wealth (0.01, -0.06 to 0.08). This difference between groups was significant, but was smaller than the prespecified 0.20 SD difference that the study was powered to detect. The provision of free glasses to Chinese children with myopia improves children's performance on mathematics testing to a statistically significant degree, despite imperfect compliance, although the observed difference between groups was smaller than the study was originally designed to detect. Myopia is common and rarely corrected in this setting.Trial Registration

  16. Changing cluster composition in cluster randomised controlled trials: design and analysis considerations

    Science.gov (United States)

    2014-01-01

    Background There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. Methods We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Results Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Conclusions Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations

  17. EHLS at School: school-age follow-up of the Early Home Learning Study cluster randomized controlled trial.

    Science.gov (United States)

    Westrupp, Elizabeth M; Bennett, Clair; Cullinane, Meabh; Hackworth, Naomi J; Berthelsen, Donna; Reilly, Sheena; Mensah, Fiona K; Gold, Lisa; Bennetts, Shannon K; Levickis, Penny; Nicholson, Jan M

    2018-05-02

    Targeted interventions during early childhood can assist families in providing strong foundations that promote children's health and wellbeing across the life course. There is growing recognition that longer follow-up times are necessary to assess intervention outcomes, as effects may change as children develop. The Early Home Learning Study, or 'EHLS', comprised two cluster randomized controlled superiority trials of a brief parenting intervention, smalltalk, aimed at supporting parents to strengthen the early childhood home learning environment of infants (6-12 months) or toddlers (12-36 months). Results showed sustained improvements in parent-child interactions and the home environment at the 32 week follow-up for the toddler but not the infant trial. The current study will therefore follow up the EHLS toddler cohort to primary school age, with the aim of addressing a gap in literature concerning long-term effects of early childhood interventions focused on improving school readiness and later developmental outcomes. 'EHLS at School' is a school-aged follow-up study of the toddler cluster randomized controlled trial (n = 1226). Data will be collected by parent-, child- and teacher-report questionnaires, recorded observations of parent-child interactions, and direct child assessment when children are aged 7.5 years old. Data linkage will provide additional data on child health and academic functioning at ages 5, 8 and 10 years. Child outcomes will be compared for families allocated to standard/usual care (control) versus those allocated to the smalltalk program (group program only or group program with additional home coaching). Findings from The Early Home Learning Study provided evidence of the benefits of the smalltalk intervention delivered via facilitated playgroups for parents of toddlers. The EHLS at School Study aims to examine the long-term outcomes of this initiative to determine whether improvements in the quality of the parent

  18. Cluster randomization and political philosophy.

    Science.gov (United States)

    Chwang, Eric

    2012-11-01

    In this paper, I will argue that, while the ethical issues raised by cluster randomization can be challenging, they are not new. My thesis divides neatly into two parts. In the first, easier part I argue that many of the ethical challenges posed by cluster randomized human subjects research are clearly present in other types of human subjects research, and so are not novel. In the second, more difficult part I discuss the thorniest ethical challenge for cluster randomized research--cases where consent is genuinely impractical to obtain. I argue that once again these cases require no new analytic insight; instead, we should look to political philosophy for guidance. In other words, the most serious ethical problem that arises in cluster randomized research also arises in political philosophy. © 2011 Blackwell Publishing Ltd.

  19. Effect of a Nutrition Supplement and Physical Activity Program on Pneumonia and Walking Capacity in Chilean Older People: A Factorial Cluster Randomized Trial

    Science.gov (United States)

    Dangour, Alan D.; Albala, Cecilia; Allen, Elizabeth; Grundy, Emily; Walker, Damian G.; Aedo, Cristian; Sanchez, Hugo; Fletcher, Olivia; Elbourne, Diana; Uauy, Ricardo

    2011-01-01

    Background Ageing is associated with increased risk of poor health and functional decline. Uncertainties about the health-related benefits of nutrition and physical activity for older people have precluded their widespread implementation. We investigated the effectiveness and cost-effectiveness of a national nutritional supplementation program and/or a physical activity intervention among older people in Chile. Methods and Findings We conducted a cluster randomized factorial trial among low to middle socioeconomic status adults aged 65–67.9 years living in Santiago, Chile. We randomized 28 clusters (health centers) into the study and recruited 2,799 individuals in 2005 (∼100 per cluster). The interventions were a daily micronutrient-rich nutritional supplement, or two 1-hour physical activity classes per week, or both interventions, or neither, for 24 months. The primary outcomes, assessed blind to allocation, were incidence of pneumonia over 24 months, and physical function assessed by walking capacity 24 months after enrolment. Adherence was good for the nutritional supplement (∼75%), and moderate for the physical activity intervention (∼43%). Over 24 months the incidence rate of pneumonia did not differ between intervention and control clusters (32.5 versus 32.6 per 1,000 person years respectively; risk ratio = 1.00; 95% confidence interval 0.61–1.63; p = 0.99). In intention-to-treat analysis, after 24 months there was a significant difference in walking capacity between the intervention and control clusters (mean difference 33.8 meters; 95% confidence interval 13.9–53.8; p = 0.001). The overall cost of the physical activity intervention over 24 months was US$164/participant; equivalent to US$4.84/extra meter walked. The number of falls and fractures was balanced across physical activity intervention arms and no serious adverse events were reported for either intervention. Conclusions Chile's nutritional supplementation program for older

  20. Unequal cluster sizes in stepped-wedge cluster randomised trials: a systematic review.

    Science.gov (United States)

    Kristunas, Caroline; Morris, Tom; Gray, Laura

    2017-11-15

    To investigate the extent to which cluster sizes vary in stepped-wedge cluster randomised trials (SW-CRT) and whether any variability is accounted for during the sample size calculation and analysis of these trials. Any, not limited to healthcare settings. Any taking part in an SW-CRT published up to March 2016. The primary outcome is the variability in cluster sizes, measured by the coefficient of variation (CV) in cluster size. Secondary outcomes include the difference between the cluster sizes assumed during the sample size calculation and those observed during the trial, any reported variability in cluster sizes and whether the methods of sample size calculation and methods of analysis accounted for any variability in cluster sizes. Of the 101 included SW-CRTs, 48% mentioned that the included clusters were known to vary in size, yet only 13% of these accounted for this during the calculation of the sample size. However, 69% of the trials did use a method of analysis appropriate for when clusters vary in size. Full trial reports were available for 53 trials. The CV was calculated for 23 of these: the median CV was 0.41 (IQR: 0.22-0.52). Actual cluster sizes could be compared with those assumed during the sample size calculation for 14 (26%) of the trial reports; the cluster sizes were between 29% and 480% of that which had been assumed. Cluster sizes often vary in SW-CRTs. Reporting of SW-CRTs also remains suboptimal. The effect of unequal cluster sizes on the statistical power of SW-CRTs needs further exploration and methods appropriate to studies with unequal cluster sizes need to be employed. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  1. Effect on postpartum hemorrhage of prophylactic oxytocin (10 IU by injection by community health officers in Ghana: a community-based, cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Cynthia K Stanton

    2013-10-01

    Full Text Available BACKGROUND: Oxytocin (10 IU is the drug of choice for prevention of postpartum hemorrhage (PPH. Its use has generally been restricted to medically trained staff in health facilities. We assessed the effectiveness, safety, and feasibility of PPH prevention using oxytocin injected by peripheral health care providers without midwifery skills at home births. METHODS AND FINDINGS: This community-based, cluster-randomized trial was conducted in four rural districts in Ghana. We randomly allocated 54 community health officers (stratified on district and catchment area distance to a health facility: ≥10 km versus <10 km to intervention (one injection of oxytocin [10 IU] one minute after birth and control (no provision of prophylactic oxytocin arms. Births attended by a community health officer constituted a cluster. Our primary outcome was PPH, using multiple definitions; (PPH-1 blood loss ≥500 mL; (PPH-2 PPH-1 plus women who received early treatment for PPH; and (PPH-3 PPH-2 plus any other women referred to hospital for postpartum bleeding. Unsafe practice is defined as oxytocin use before delivery of the baby. We enrolled 689 and 897 women, respectively, into oxytocin and control arms of the trial from April 2011 to November 2012. In oxytocin and control arms, respectively, PPH-1 rates were 2.6% versus 5.5% (RR: 0.49; 95% CI: 0.27-0.88; PPH-2 rates were 3.8% versus 10.8% (RR: 0.35; 95% CI: 0.18-0.63, and PPH-3 rates were similar to those of PPH-2. Compared to women in control clusters, those in the intervention clusters lost 45.1 mL (17.7-72.6 less blood. There were no cases of oxytocin use before delivery of the baby and no major adverse events requiring notification of the institutional review boards. Limitations include an unblinded trial and imbalanced numbers of participants, favoring controls. CONCLUSION: Maternal health care planners can consider adapting this model to extend the use of oxytocin into peripheral settings including, in some

  2. Web-based consultation between general practitioners and nephrologists: a cluster randomized controlled trial.

    Science.gov (United States)

    van Gelder, Vincent A; Scherpbier-de Haan, Nynke D; van Berkel, Saskia; Akkermans, Reinier P; de Grauw, Inge S; Adang, Eddy M; Assendelft, Pim J; de Grauw, Wim J C; Biermans, Marion C J; Wetzels, Jack F M

    2017-08-01

    Consultation of a nephrologist is important in aligning care for patients with chronic kidney disease (CKD) at the primary-secondary care interface. However, current consultation methods come with practical difficulties that can lead to postponed consultation or patient referral instead. This study aimed to investigate whether a web-based consultation platform, telenephrology, led to a lower referral rate of indicated patients. Furthermore, we assessed consultation rate, quality of care, costs and general practitioner (GPs') experiences with telenephrology. Cluster randomized controlled trial with 47 general practices in the Netherlands was randomized to access to telenephrology or to enhanced usual care. A total of 3004 CKD patients aged 18 years or older who were under primary care were included (intervention group n = 1277, control group n = 1727) and 2693 completed the trial. All practices participated in a CKD management course and were given an overview of their CKD patients. The referral rates amounted to 2.3% (n = 29) in the intervention group and 3.0% (n = 52) in the control group, which was a non-significant difference, OR 0.61; 95% CI 0.31 to 1.23. The intervention group's consultation rate was 6.3% (n = 81) against 5.0% (n = 87) (OR 2.00; 95% CI 0.75-5.33). We found no difference in quality of care or costs. The majority of GPs had a positive opinion about telenephrology. The data in our study do not allow for conclusions on the effect of telenephrology on the rate of patient referrals and provider-to-provider consultations, compared to conventional methods. It was positively evaluated by GPs and was non-inferior in terms of quality of care and costs. © The Author 2017. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  3. Using the 4 Pillars™ Immunization Toolkit to Increase Pneumococcal Immunizations for Older Adults: A Cluster Randomized Trial

    Science.gov (United States)

    Zimmerman, Richard K.; Brown, Anthony E.; Pavlik, Valory N.; Moehling, Krissy K.; Raviotta, Jonathan M.; Lin, Chyongchiou J.; Zhang, Song; Hawk, Mary; Kyle, Shakala; Patel, Suchita; Ahmed, Faruque; Nowalk, Mary Patricia

    2016-01-01

    BACKGROUND Quality improvement in primary care has focused on improving adult immunization. OBJECTIVES Test the effectiveness of a step-by step, evidence-based guide, the 4 Pillars™ Immunization Toolkit, to increase adult pneumococcal vaccination. DESIGN Randomized controlled cluster trial (RCCT) in Year 1 (6/1/2013–5/31/2014) and a pre-post study in Year 2 (6/1/2014–1/31/2015) with data analyzed in 2016. Baseline year was 6/1/2012–5/31/2013. Demographic and vaccination data were derived from de-identified EMR extractions. SETTING 25 primary care practices stratified by city (Houston, Pittsburgh), location (rural, urban, suburban) and type (family medicine, internal medicine), randomized to receive the intervention in Year 1 (n=13) or Year 2 (n=12). PARTICIPANTS A cohort of 18,107 patients ≥65 years at baseline with a mean age of 74.2 years; 60.7% were women, 16.5% were non-white and 15.7% were Hispanic. INTERVENTION The Toolkit, provider education, and one-on-one coaching of practice-based immunization champions. Outcome measures were 23-valent pneumococcal polysaccharide vaccine (PPSV) and pneumococcal conjugate vaccine (PCV) rates and percentage point (PP) changes. RESULTS In the RCCT, all intervention and control groups had significantly higher PPSV vaccination rates with average increases ranging from 6.5–8.7 PP (P<0.01). The intervention was not related to higher likelihood of PPSV vaccination. In the Year 2 pre-post study, the likelihood of PPSV and PCV vaccination was significantly higher in the active intervention sites than the maintenance sites in Pittsburgh, but not in Houston. CONCLUSION In a randomized controlled cluster trial, both intervention and control groups increased PPSV among adults ≥65 years. In a pre-post study, private primary care practices using the 4 Pillars™ Immunization Toolkit significantly improved PPSV and PCV uptake compared with practices that were in the maintenance phase of the study. PMID:27755655

  4. Pressure ulcer multidisciplinary teams via telemedicine: a pragmatic cluster randomized stepped wedge trial in long term care.

    Science.gov (United States)

    Stern, Anita; Mitsakakis, Nicholas; Paulden, Mike; Alibhai, Shabbir; Wong, Josephine; Tomlinson, George; Brooker, Ann-Sylvia; Krahn, Murray; Zwarenstein, Merrick

    2014-02-24

    The study was conducted to determine the clinical and cost effectiveness of enhanced multi-disciplinary teams (EMDTs) vs. 'usual care' for the treatment of pressure ulcers in long term care (LTC) facilities in Ontario, Canada We conducted a multi-method study: a pragmatic cluster randomized stepped-wedge trial, ethnographic observation and in-depth interviews, and an economic evaluation. Long term care facilities (clusters) were randomly allocated to start dates of the intervention. An advance practice nurse (APN) with expertise in skin and wound care visited intervention facilities to educate staff on pressure ulcer prevention and treatment, supported by an off-site hospital based expert multi-disciplinary wound care team via email, telephone, or video link as needed. The primary outcome was rate of reduction in pressure ulcer surface area (cm2/day) measured on before and after standard photographs by an assessor blinded to facility allocation. Secondary outcomes were time to healing, probability of healing, pressure ulcer incidence, pressure ulcer prevalence, wound pain, hospitalization, emergency department visits, utility, and cost. 12 of 15 eligible LTC facilities were randomly selected to participate and randomized to start date of the intervention following the stepped wedge design. 137 residents with a total of 259 pressure ulcers (stage 2 or greater) were recruited over the 17 month study period. No statistically significant differences were found between control and intervention periods on any of the primary or secondary outcomes. The economic evaluation demonstrated a mean reduction in direct care costs of $650 per resident compared to 'usual care'. The qualitative study suggested that onsite support by APN wound specialists was welcomed, and is responsible for reduced costs through discontinuation of expensive non evidence based treatments. Insufficient allocation of nursing home staff time to wound care may explain the lack of impact on healing

  5. Impact of preoperative patient education on the prevention of postoperative complications after major visceral surgery: the cluster randomized controlled PEDUCAT trial.

    Science.gov (United States)

    Klaiber, Ulla; Stephan-Paulsen, Lisa M; Bruckner, Thomas; Müller, Gisela; Auer, Silke; Farrenkopf, Ingrid; Fink, Christine; Dörr-Harim, Colette; Diener, Markus K; Büchler, Markus W; Knebel, Phillip

    2018-05-24

    The prevention of postoperative complications is of prime importance after complex elective abdominal operations. Preoperative patient education may prevent postoperative complications and improve patients' wellbeing, but evidence for its efficacy is poor. The aims of the PEDUCAT trial were (a) to assess the impact of preoperative patient education on postoperative complications and patient-reported outcomes in patients scheduled for elective complex visceral surgery and (b) to evaluate the feasibility of cluster randomization in this setting. Adult patients (age ≥ 18 years) scheduled for elective major visceral surgery were randomly assigned in clusters to attend a preoperative education seminar or to the control group receiving the department's standard care. Outcome measures were the postoperative complications pneumonia, deep vein thrombosis (DVT), pulmonary embolism, burst abdomen, and in-hospital fall, together with patient-reported outcomes (postoperative pain, anxiety and depression, patient satisfaction, quality of life), length of hospital stay (LOS), and postoperative mortality within 30 days after the index operation. Statistical analysis was primarily by intention to treat. In total 244 patients (60 clusters) were finally included (intervention group 138 patients; control group 106 patients). Allocation of hospital wards instead of individual patients facilitated study conduct and reduced confusion about group assignment. In the intervention and control groups respectively, pneumonia occurred in 7.4% versus 8.3% (p = 0.807), pulmonary embolism in 1.6% versus 1.0% (p = 0.707), burst abdomen in 4.2% versus 1.0% (p = 0.165), and in-hospital falls in 0.0% versus 4.2% of patients (p = 0.024). DVT did not occur in any of the patients. Mortality rates (1.4% versus 1.9%, p = 0.790) and LOS (14.2 (+/- 12.0) days versus 16.1 (+/- 15.0) days, p = 0.285) were also similar in the intervention and control groups. Cluster

  6. Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial

    DEFF Research Database (Denmark)

    Beck, Anne Marie; Gøgsig Christensen, Annette; Stenbæk Hansen, Birthe

    2014-01-01

    BACKGROUND: Older adults in nursing home and home-care are a particularly high-risk population for weight loss or poor nutrition. One negative consequence of undernutrition is increased health care costs. Several potentially modifiable nutritional risk factors increase the likelihood of weight loss......-effectiveness of nutritional support among undernourished older adults and none of these have used such a multidisciplinary approach. METHODS: An 11 week cluster randomized trial to assess the cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home...... older adults in home-care and nursing home and contribute to important research. TRIAL REGISTRATION: ClinicalTrials.gov 2013 NCT01873456....

  7. A participatory parent-focused intervention promoting physical activity in preschools: design of a cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    Hoffmann Kristina

    2010-01-01

    Full Text Available Abstract Background With rates of childhood obesity increasing, physical activity (PA promotion especially in young children has assumed greater importance. Given the limited effectiveness of most interventions to date, new approaches are needed. The General Systems theory suggests that involving parents as intervention targets may be effective in fostering healthier life styles in children. We describe the development of a parent-focused participatory intervention and the procedures used to evaluate its effectiveness in increasing daily PA in preschoolers. Methods/Design Thirty-seven South German preschools were identified for this study and agreed to participate. Using a two-armed, controlled cluster-randomized trial design we test a participatory intervention with parents as the primary target group and potential agents of behavioural change. Specifically, the intervention is designed to engage parents in the development, refinement and selection of project ideas to promote PA and in incorporating these ideas into daily routines within the preschool community, consisting of children, teachers and parents. Our study is embedded within an existing state-sponsored programme providing structured gym lessons to preschool children. Thus, child-based PA outcomes from the study arm with the parent-focused intervention and the state-sponsored programme are compared with those from the study arm with the state-sponsored programme alone. The evaluation entails baseline measurements of study outcomes as well as follow-up measurements at 6 and 12 months. Accelerometry measures PA intensity over a period of six days, with the mean over six days used as the primary outcome measure. Secondary outcomes include childrens' BMI, a sum of averaged skin fold thickness measurements across multiple sites, and PA behaviour. Longitudinal multilevel models are used to assess within-subject change and between-group differences in study outcomes, adjusted for covariates

  8. Increasing students' physical activity during school physical education: rationale and protocol for the SELF-FIT cluster randomized controlled trial.

    Science.gov (United States)

    Ha, Amy S; Lonsdale, Chris; Lubans, David R; Ng, Johan Y Y

    2017-07-11

    The Self-determined Exercise and Learning For FITness (SELF-FIT) is a multi-component school-based intervention based on tenets of self-determination theory. SELF-FIT aims to increase students' moderate-to-vigorous physical activity (MVPA) during physical education lessons, and enhance their autonomous motivation towards fitness activities. Using a cluster randomized controlled trial, we aim to examine the effects of the intervention on students' MVPA during school physical education. Secondary 2 students (approximately aged 14 years) from 26 classes in 26 different schools will be recruited. After baseline assessments, students will be randomized into either the experimental group or wait-list control group using a matched-pair randomization. Teachers allocated to the experimental group will attend two half-day workshops and deliver the SELF-FIT intervention for 8 weeks. The main intervention components include training teachers to teach in more need supportive ways, and conducting fitness exercises using a fitness dice with interchangeable faces. Other motivational components, such as playing music during classes, are also included. The primary outcome of the trial is students' MVPA during PE lessons. Secondary outcomes include students' leisure-time MVPA, perceived need support from teachers, need satisfaction, autonomous motivation towards physical education, intention to engage in physical activity, psychological well-being, and health-related fitness (cardiorespiratory and muscular fitness). Quantitative data will be analyzed using multilevel modeling approaches. Focus group interviews will also be conducted to assess students' perceptions of the intervention. The SELF-FIT intervention has been designed to improve students' health and well-being by using high-intensity activities in classes delivered by teachers who have been trained to be autonomy needs supportive. If successful, scalable interventions based on SELF-FIT could be applied in physical

  9. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. Methods/Design This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder

  10. Culturally adaptive storytelling intervention versus didactic intervention to improve hypertension control in Vietnam: a cluster-randomized controlled feasibility trial.

    Science.gov (United States)

    Nguyen, Hoa L; Allison, Jeroan J; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Nguyen, Cuong K; Dang, Diem M; Phan, Ngoc T; Vu, Nguyen C; Nguyen, Quang P; Goldberg, Robert J

    2017-01-01

    Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. Novel, large-scale, effective, and sustainable interventions to control hypertension in Vietnam are needed. We report the results of a cluster-randomized feasibility trial at 3 months follow-up conducted in Hung Yen province, Vietnam, designed to evaluate the feasibility and acceptability of two community-based interventions to improve hypertension control: a "storytelling" intervention, "We Talk about Our Hypertension," and a didactic intervention. The storytelling intervention included stories about strategies for coping with hypertension, with patients speaking in their own words, and didactic content about the importance of healthy lifestyle behaviors including salt reduction and exercise. The didactic intervention included only didactic content. The storytelling intervention was delivered by two DVDs at 3-month intervals; the didactic intervention included only one installment. The trial was conducted in four communes, equally randomized to the two interventions. The mean age of the 160 study patients was 66 years, and 54% were men. Most participants described both interventions as understandable, informative, and motivational. Between baseline and 3 months, mean systolic blood pressure declined by 8.2 mmHg (95% CI 4.1-12.2) in the storytelling group and by 5.5 mmHg (95% CI 1.4-9.5) in the didactic group. The storytelling group also reported a significant increase in hypertension medication adherence. Both interventions were well accepted in several rural communities and were shown to be potentially effective in lowering blood pressure. A large-scale randomized trial is needed to compare the effectiveness of the two interventions in controlling hypertension. ClinicalTrials.gov, NCT02483780.

  11. Effect of a web-based audit and feedback intervention with outreach visits on the clinical performance of multidisciplinary teams: a cluster-randomized trial in cardiac rehabilitation

    NARCIS (Netherlands)

    Gude, Wouter T.; van Engen-Verheul, Mariëtte M.; van der Veer, Sabine N.; Kemps, Hareld M. C.; Jaspers, Monique W. M.; de Keizer, Nicolette F.; Peek, Niels

    2016-01-01

    The objective of this study was to assess the effect of a web-based audit and feedback (A&F) intervention with outreach visits to support decision-making by multidisciplinary teams. We performed a multicentre cluster-randomized trial within the field of comprehensive cardiac rehabilitation (CR) in

  12. Effect of workplace- versus home-based physical exercise on pain in healthcare workers: study protocol for a single blinded cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Kristensen, Anne Zoëga; Jay, Kenneth; Stelter, Reinhard; Lavendt, Ebbe; Aagaard, Per; Andersen, Lars L

    2014-04-07

    The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous investigations have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or conducted as home-based exercise. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase adherence. On the other hand, physical exercise performed during working hours at the workplace may be costly for the employers in terms of time spend. Thus, it seems relevant to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study is intended to investigate the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers. This study was designed as a cluster randomized controlled trial performed at 3 hospitals in Copenhagen, Denmark. Clusters are hospital departments and hospital units. Cluster randomization was chosen to increase adherence and avoid contamination between interventions. Two hundred healthcare workers from 18 departments located at three different hospitals is allocated to 10 weeks of 1) workplace based physical exercise performed during working hours (using kettlebells, elastic bands and exercise balls) for 5 × 10 minutes per week and up to 5 group-based coaching sessions, or 2) home based physical exercise performed during leisure time (using elastic bands and body weight exercises) for 5 × 10 minutes per week. Both intervention groups will also receive ergonomic instructions on patient handling and use of lifting aides etc. Inclusion criteria are female healthcare workers working at a hospital. Average pain intensity (VAS scale 0-10) of the back, neck and shoulder (primary outcome) and physical

  13. Ethical implications of excessive cluster sizes in cluster randomised trials.

    Science.gov (United States)

    Hemming, Karla; Taljaard, Monica; Forbes, Gordon; Eldridge, Sandra M; Weijer, Charles

    2018-02-20

    The cluster randomised trial (CRT) is commonly used in healthcare research. It is the gold-standard study design for evaluating healthcare policy interventions. A key characteristic of this design is that as more participants are included, in a fixed number of clusters, the increase in achievable power will level off. CRTs with cluster sizes that exceed the point of levelling-off will have excessive numbers of participants, even if they do not achieve nominal levels of power. Excessively large cluster sizes may have ethical implications due to exposing trial participants unnecessarily to the burdens of both participating in the trial and the potential risks of harm associated with the intervention. We explore these issues through the use of two case studies. Where data are routinely collected, available at minimum cost and the intervention poses low risk, the ethical implications of excessively large cluster sizes are likely to be low (case study 1). However, to maximise the social benefit of the study, identification of excessive cluster sizes can allow for prespecified and fully powered secondary analyses. In the second case study, while there is no burden through trial participation (because the outcome data are routinely collected and non-identifiable), the intervention might be considered to pose some indirect risk to patients and risks to the healthcare workers. In this case study it is therefore important that the inclusion of excessively large cluster sizes is justifiable on other grounds (perhaps to show sustainability). In any randomised controlled trial, including evaluations of health policy interventions, it is important to minimise the burdens and risks to participants. Funders, researchers and research ethics committees should be aware of the ethical issues of excessively large cluster sizes in cluster trials. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is

  14. Increasing students’ physical activity during school physical education: rationale and protocol for the SELF-FIT cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Amy S. Ha

    2017-07-01

    Full Text Available Abstract Background The Self-determined Exercise and Learning For FITness (SELF-FIT is a multi-component school-based intervention based on tenets of self-determination theory. SELF-FIT aims to increase students’ moderate-to-vigorous physical activity (MVPA during physical education lessons, and enhance their autonomous motivation towards fitness activities. Using a cluster randomized controlled trial, we aim to examine the effects of the intervention on students’ MVPA during school physical education. Methods Secondary 2 students (approximately aged 14 years from 26 classes in 26 different schools will be recruited. After baseline assessments, students will be randomized into either the experimental group or wait-list control group using a matched-pair randomization. Teachers allocated to the experimental group will attend two half-day workshops and deliver the SELF-FIT intervention for 8 weeks. The main intervention components include training teachers to teach in more need supportive ways, and conducting fitness exercises using a fitness dice with interchangeable faces. Other motivational components, such as playing music during classes, are also included. The primary outcome of the trial is students’ MVPA during PE lessons. Secondary outcomes include students’ leisure-time MVPA, perceived need support from teachers, need satisfaction, autonomous motivation towards physical education, intention to engage in physical activity, psychological well-being, and health-related fitness (cardiorespiratory and muscular fitness. Quantitative data will be analyzed using multilevel modeling approaches. Focus group interviews will also be conducted to assess students’ perceptions of the intervention. Discussion The SELF-FIT intervention has been designed to improve students’ health and well-being by using high-intensity activities in classes delivered by teachers who have been trained to be autonomy needs supportive. If successful, scalable

  15. Determinants of Dropout and Nonadherence in a Dementia Prevention Randomized Controlled Trial: The Prevention of Dementia by Intensive Vascular Care Trial

    NARCIS (Netherlands)

    Beishuizen, Cathrien R. L.; Coley, Nicola; Moll van Charante, Eric P.; van Gool, Willem A.; Richard, Edo; Andrieu, Sandrine

    2017-01-01

    To explore and compare sociodemographic, clinical, and neuropsychiatric determinants of dropout and nonadherence in older people participating in an open-label cluster-randomized controlled trial-the Prevention of Dementia by Intensive Vascular care (preDIVA) trial-over 6 years. Secondary analysis.

  16. Determinants of Dropout and Nonadherence in a Dementia Prevention Randomized Controlled Trial: The Prevention of Dementia by Intensive Vascular Care Trial

    NARCIS (Netherlands)

    Beishuizen, C.R.; Coley, N.; Charante, E.P.M. van; Gool, W.A. van; Richard, E.; Andrieu, S.

    2017-01-01

    OBJECTIVES: To explore and compare sociodemographic, clinical, and neuropsychiatric determinants of dropout and nonadherence in older people participating in an open-label cluster-randomized controlled trial-the Prevention of Dementia by Intensive Vascular care (preDIVA) trial-over 6 years. DESIGN:

  17. Cluster-Randomized, Crossover Trial of Head Positioning in Acute Stroke.

    Science.gov (United States)

    Anderson, Craig S; Arima, Hisatomi; Lavados, Pablo; Billot, Laurent; Hackett, Maree L; Olavarría, Verónica V; Muñoz Venturelli, Paula; Brunser, Alejandro; Peng, Bin; Cui, Liying; Song, Lily; Rogers, Kris; Middleton, Sandy; Lim, Joyce Y; Forshaw, Denise; Lightbody, C Elizabeth; Woodward, Mark; Pontes-Neto, Octavio; De Silva, H Asita; Lin, Ruey-Tay; Lee, Tsong-Hai; Pandian, Jeyaraj D; Mead, Gillian E; Robinson, Thompson; Watkins, Caroline

    2017-06-22

    The role of supine positioning after acute stroke in improving cerebral blood flow and the countervailing risk of aspiration pneumonia have led to variation in head positioning in clinical practice. We wanted to determine whether outcomes in patients with acute ischemic stroke could be improved by positioning the patient to be lying flat (i.e., fully supine with the back horizontal and the face upwards) during treatment to increase cerebral perfusion. In a pragmatic, cluster-randomized, crossover trial conducted in nine countries, we assigned 11,093 patients with acute stroke (85% of the strokes were ischemic) to receive care in either a lying-flat position or a sitting-up position with the head elevated to at least 30 degrees, according to the randomization assignment of the hospital to which they were admitted; the designated position was initiated soon after hospital admission and was maintained for 24 hours. The primary outcome was degree of disability at 90 days, as assessed with the use of the modified Rankin scale (scores range from 0 to 6, with higher scores indicating greater disability and a score of 6 indicating death). The median interval between the onset of stroke symptoms and the initiation of the assigned position was 14 hours (interquartile range, 5 to 35). Patients in the lying-flat group were less likely than patients in the sitting-up group to maintain the position for 24 hours (87% vs. 95%, P<0.001). In a proportional-odds model, there was no significant shift in the distribution of 90-day disability outcomes on the global modified Rankin scale between patients in the lying-flat group and patients in the sitting-up group (unadjusted odds ratio for a difference in the distribution of scores on the modified Rankin scale in the lying-flat group, 1.01; 95% confidence interval, 0.92 to 1.10; P=0.84). Mortality within 90 days was 7.3% among the patients in the lying-flat group and 7.4% among the patients in the sitting-up group (P=0.83). There were

  18. Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Costello Anthony

    2011-06-01

    Full Text Available Abstract Background Neonatal mortality remains high in rural Nepal. Previous work suggests that local women's groups can effect significant improvement through community mobilisation. The possibility of identification and management of newborn infections by community-based workers has also arisen. Methods/Design The objective of this trial is to evaluate the effects on newborn health of two community-based interventions involving Female Community Health Volunteers. MIRA Dhanusha community groups: a participatory intervention with women's groups. MIRA Dhanusha sepsis management: training of community volunteers in the recognition and management of neonatal sepsis. The study design is a cluster randomized controlled trial involving 60 village development committee clusters allocated 1:1 to two interventions in a factorial design. MIRA Dhanusha community groups: Female Community Health Volunteers (FCHVs are supported in convening monthly women's groups. Nine groups per cluster (270 in total work through two action research cycles in which they (i identify local issues around maternity, newborn health and nutrition, (ii prioritise key problems, (iii develop strategies to address them, (iv implement the strategies, and (v evaluate their success. Cycle 1 focuses on maternal and newborn health and cycle 2 on nutrition in pregnancy and infancy and associated postpartum care practices. MIRA Dhanusha sepsis management: FCHVs are trained to care for vulnerable newborn infants. They (i identify local births, (ii identify low birth weight infants, (iii identify possible newborn infection, (iv manage the process of treatment with oral antibiotics and referral to a health facility to receive parenteral gentamicin, and (v follow up infants and support families. Primary outcome: neonatal mortality rates. Secondary outcomes: MIRA Dhanusha community group: stillbirth, infant and under-two mortality rates, care practices and health care seeking behaviour, maternal

  19. Cost-effectiveness of intensive multifactorial treatment compared with routine care for individuals with screen-detected Type 2 diabetes : analysis of the ADDITION-UK cluster-randomized controlled trial

    NARCIS (Netherlands)

    Tao, L.; Wilson, E. C. F.; Wareham, N. J.; Sandbaek, A.; Rutten, G. E. H. M.; Lauritzen, T.; Khunti, K.; Davies, M. J.; Borch-Johnsen, K.; Griffin, S. J.; Simmons, R. K.

    Aims To examine the short- and long-term cost-effectiveness of intensive multifactorial treatment compared with routine care among people with screen-detected Type 2 diabetes. Methods Cost-utility analysis in ADDITION-UK, a cluster-randomized controlled trial of early intensive treatment in people

  20. Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial.

    Science.gov (United States)

    Allison, Jeroan J; Nguyen, Hoa L; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Phan, Ngoc T; Vu, Nguyen C; Kim, Minjin; Goldberg, Robert J

    2016-01-14

    Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. At present, the major risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam; inasmuch, the burden of CVD will continue to increase in this country unless effective prevention and control measures are put in place. A national survey in 2008 found that the prevalence of hypertension (HTN) was approximately 25 % among Vietnamese adults and it increased with advancing age. Therefore, novel, large-scale, and sustainable interventions for public health education to promote engagement in the process of detecting and treating HTN in Vietnam are urgently needed. A feasibility randomized trial will be conducted in Hung Yen province, Vietnam to evaluate the feasibility and acceptability of a novel community-based intervention using the "storytelling" method to enhance the control of HTN in adults residing in four rural communities. The intervention will center on stories about living with HTN, with patients speaking in their own words. The stories will be obtained from particularly eloquent patients, or "video stars," identified during Story Development Groups. The study will involve two phases: (i) developing a HTN intervention using the storytelling method, which is designed to empower patients to facilitate changes in their lifestyle practices, and (ii) conducting a feasibility cluster-randomized trial to investigate the feasibility, acceptability, and potential efficacy of the intervention compared with usual care in HTN control among rural residents. The trial will be conducted at four communes, and within each commune, 25 individuals 50 years or older with HTN will be enrolled in the trial resulting in a total sample size of 100 patients. This feasibility trial will provide the necessary groundwork for a subsequent large-scale, fully powered, cluster-randomized controlled trial to test the efficacy of our novel

  1. Propensity score to detect baseline imbalance in cluster randomized trials: the role of the c-statistic.

    Science.gov (United States)

    Leyrat, Clémence; Caille, Agnès; Foucher, Yohann; Giraudeau, Bruno

    2016-01-22

    Despite randomization, baseline imbalance and confounding bias may occur in cluster randomized trials (CRTs). Covariate imbalance may jeopardize the validity of statistical inferences if they occur on prognostic factors. Thus, the diagnosis of a such imbalance is essential to adjust statistical analysis if required. We developed a tool based on the c-statistic of the propensity score (PS) model to detect global baseline covariate imbalance in CRTs and assess the risk of confounding bias. We performed a simulation study to assess the performance of the proposed tool and applied this method to analyze the data from 2 published CRTs. The proposed method had good performance for large sample sizes (n =500 per arm) and when the number of unbalanced covariates was not too small as compared with the total number of baseline covariates (≥40% of unbalanced covariates). We also provide a strategy for pre selection of the covariates needed to be included in the PS model to enhance imbalance detection. The proposed tool could be useful in deciding whether covariate adjustment is required before performing statistical analyses of CRTs.

  2. Single-cluster dynamics for the random-cluster model

    NARCIS (Netherlands)

    Deng, Y.; Qian, X.; Blöte, H.W.J.

    2009-01-01

    We formulate a single-cluster Monte Carlo algorithm for the simulation of the random-cluster model. This algorithm is a generalization of the Wolff single-cluster method for the q-state Potts model to noninteger values q>1. Its results for static quantities are in a satisfactory agreement with those

  3. Resistance training program for fatigue management in the workplace: exercise protocol in a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hélio Gustavo Santos

    2016-12-01

    Full Text Available Abstract Background Fatigue is a multifactorial condition that leads to disease and loss in production, and it affects a large number of workers worldwide. This study aims to demonstrate a resistance exercise protocol that individuals will perform during the work schedule, and to evaluate the effectiveness of this exercises program for fatigue control. Methods/Design This is a cluster randomized controlled trial with two arms and is assessor blinded. A total of 352 workers of both sexes, aged 18–65 years, from a medium-sized dairy plant were enrolled in this study. Participants will be recruited from 13 production sectors according to the eligibility criteria and will be randomized by clusters to either the Progressive Resistance Exercise (PRE intervention group or the Compensatory Workplace Exercise (CWE comparative group. A resistance exercise program will be implemented for both groups. The groups will receive instructions on self-management, breaks, adjustments to workstations, and the benefits of physical exercise. The PRE group will perform resistance exercises with gradual loads in an exercise room, and the CWE group will perform exercise at their workstations using elastic bands. The exercise sessions will be held 3 times a week for 20 min. The primary outcome measures will be symptoms of physical and mental fatigue, and muscular fatigue based on a one-repetition maximum (1RM. The secondary outcome measures will be level of physical activity, musculoskeletal symptoms, physical condition, perceived exposure, and productivity. The workers will be assessed at baseline and after a 4-month program. A linear mixed model will be applied on an intention-to-treat basis. Discussion This intervention is expected to reduce symptoms of fatigue in the workers. The exercise program is indicating in the workplace, although there are few studies describing the effects of exercise on the control of fatigue in the workplace. Emphasis will be placed on

  4. National Cluster-Randomized Trial of Duty-Hour Flexibility in Surgical Training.

    Science.gov (United States)

    Bilimoria, Karl Y; Chung, Jeanette W; Hedges, Larry V; Dahlke, Allison R; Love, Remi; Cohen, Mark E; Hoyt, David B; Yang, Anthony D; Tarpley, John L; Mellinger, John D; Mahvi, David M; Kelz, Rachel R; Ko, Clifford Y; Odell, David D; Stulberg, Jonah J; Lewis, Frank R

    2016-02-25

    Concerns persist regarding the effect of current surgical resident duty-hour policies on patient outcomes, resident education, and resident well-being. We conducted a national, cluster-randomized, pragmatic, noninferiority trial involving 117 general surgery residency programs in the United States (2014-2015 academic year). Programs were randomly assigned to current Accreditation Council for Graduate Medical Education (ACGME) duty-hour policies (standard-policy group) or more flexible policies that waived rules on maximum shift lengths and time off between shifts (flexible-policy group). Outcomes included the 30-day rate of postoperative death or serious complications (primary outcome), other postoperative complications, and resident perceptions and satisfaction regarding their well-being, education, and patient care. In an analysis of data from 138,691 patients, flexible, less-restrictive duty-hour policies were not associated with an increased rate of death or serious complications (9.1% in the flexible-policy group and 9.0% in the standard-policy group, P=0.92; unadjusted odds ratio for the flexible-policy group, 0.96; 92% confidence interval, 0.87 to 1.06; P=0.44; noninferiority criteria satisfied) or of any secondary postoperative outcomes studied. Among 4330 residents, those in programs assigned to flexible policies did not report significantly greater dissatisfaction with overall education quality (11.0% in the flexible-policy group and 10.7% in the standard-policy group, P=0.86) or well-being (14.9% and 12.0%, respectively; P=0.10). Residents under flexible policies were less likely than those under standard policies to perceive negative effects of duty-hour policies on multiple aspects of patient safety, continuity of care, professionalism, and resident education but were more likely to perceive negative effects on personal activities. There were no significant differences between study groups in resident-reported perception of the effect of fatigue on

  5. The Cluster-Randomized BRIGHT Trial: Proactive Case Finding for Community-Dwelling Older Adults

    Science.gov (United States)

    Kerse, Ngaire; McLean, Chris; Moyes, Simon A.; Peri, Kathy; Ng, Terence; Wilkinson-Meyers, Laura; Brown, Paul; Latham, Nancy; Connolly, Martin

    2014-01-01

    PURPOSE People are now living longer, but disability may affect the quality of those additional years of life. We undertook a trial to assess whether case finding reduces disability among older primary care patients. METHODS We conducted a cluster-randomized trial of the Brief Risk Identification Geriatric Health Tool (BRIGHT) among 60 primary care practices in New Zealand, assigning them to an intervention or control group. Intervention practices sent a BRIGHT screening tool to older adults every birthday; those with a score of 3 or higher were referred to regional geriatric services for assessment and, if needed, service provision. Control practices provided usual care. Main outcomes, assessed in blinded fashion, were residential care placement and hospitalization, and secondary outcomes were disability, assessed with Nottingham Extended Activities of Daily Living Scale (NEADL), and quality of life, assessed with the World Health Organization Quality of Life scale, abbreviated version (WHOQOL-BREF). RESULTS All 8,308 community-dwelling patients aged 75 years and older were approached; 3,893 (47%) participated, of whom 3,010 (77%) completed the trial. Their mean age was 80.3 (SD 4.5) years, and 55% were women. Overall, 88% of the intervention group returned a BRIGHT tool; 549 patients were referred. After 36 months, patients in the intervention group were more likely than those in the control group to have been placed in residential care: 8.4% vs 6.2% (hazard ratio = 1.32; 95% CI, 1.04–1.68; P = .02). Intervention patients had smaller declines in mean scores for physical health-related quality of life (1.6 vs 2.9 points, P = .007) and psychological health-related quality of life (1.1 vs 2.4 points, P = .005). Hospitalization, disability, and use of services did not differ between groups, however. CONCLUSIONS Our case-finding strategy was effective in increasing identification of older adults with disability, but there was little evidence of improved outcomes

  6. Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial.

    Science.gov (United States)

    Loeb, Mark; Russell, Margaret L; Manning, Vanessa; Fonseca, Kevin; Earn, David J D; Horsman, Gregory; Chokani, Khami; Vooght, Mark; Babiuk, Lorne; Schwartz, Lisa; Neupane, Binod; Singh, Pardeep; Walter, Stephen D; Pullenayegum, Eleanor

    2016-11-01

    Whether vaccinating children with intranasal live attenuated influenza vaccine (LAIV) is more effective than inactivated influenza vaccine (IIV) in providing both direct protection in vaccinated persons and herd protection in unvaccinated persons is uncertain. Hutterite colonies, where members live in close-knit, small rural communities in which influenza virus infection regularly occurs, offer an opportunity to address this question. To determine whether vaccinating children and adolescents with LAIV provides better community protection than IIV. A cluster randomized blinded trial conducted between October 2012 and May 2015 over 3 influenza seasons. (ClinicalTrials.gov: NCT01653015). 52 Hutterite colonies in Alberta and Saskatchewan, Canada. 1186 Canadian children and adolescents aged 36 months to 15 years who received the study vaccine and 3425 community members who did not. Children were randomly assigned according to community in a blinded manner to receive standard dosing of either trivalent LAIV or trivalent IIV. The primary outcome was reverse transcriptase polymerase chain reaction-confirmed influenza A or B virus in all participants (vaccinated children and persons who did not receive the study vaccine). Mean vaccine coverage among children in the LAIV group was 76.9% versus 72.3% in the IIV group. Influenza virus infection occurred at a rate of 5.3% (295 of 5560 person-years) in the LAIV group versus 5.2% (304 of 5810 person-years) in the IIV group. The hazard ratio comparing LAIV with IIV for influenza A or B virus was 1.03 (95% CI, 0.85 to 1.24). The study was conducted in Hutterite communities, which may limit generalizability. Immunizing children with LAIV does not provide better community protection against influenza than IIV. The Canadian Institutes for Health Research.

  7. Mental health first aid training for high school teachers: a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Jorm Anthony F

    2010-06-01

    Full Text Available Abstract Background Mental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial. Methods The trial was carried out with teachers in South Australian high schools. Teachers at 7 schools received training and those at another 7 were wait-listed for future training. The effects of the training on teachers were evaluated using questionnaires pre- and post-training and at 6 months follow-up. The questionnaires assessed mental health knowledge, stigmatizing attitudes, confidence in providing help to others, help actually provided, school policy and procedures, and teacher mental health. The indirect effects on students were evaluated using questionnaires at pre-training and at follow-up which assessed any mental health help and information received from school staff, and also the mental health of the student. Results The training increased teachers' knowledge, changed beliefs about treatment to be more like those of mental health professionals, reduced some aspects of stigma, and increased confidence in providing help to students and colleagues. There was an indirect effect on students, who reported receiving more mental health information from school staff. Most of the changes found were sustained 6 months after training. However, no effects were found on teachers' individual support towards students with mental health problems or on student mental health. Conclusions Mental Health First Aid training has positive effects on teachers' mental health knowledge, attitudes, confidence and some aspects of their behaviour. Trial registration ACTRN12608000561381

  8. Effect of a nutrition supplement and physical activity program on pneumonia and walking capacity in Chilean older people: a factorial cluster randomized trial.

    Directory of Open Access Journals (Sweden)

    Alan D Dangour

    2011-04-01

    Full Text Available Ageing is associated with increased risk of poor health and functional decline. Uncertainties about the health-related benefits of nutrition and physical activity for older people have precluded their widespread implementation. We investigated the effectiveness and cost-effectiveness of a national nutritional supplementation program and/or a physical activity intervention among older people in Chile.We conducted a cluster randomized factorial trial among low to middle socioeconomic status adults aged 65-67.9 years living in Santiago, Chile. We randomized 28 clusters (health centers into the study and recruited 2,799 individuals in 2005 (~100 per cluster. The interventions were a daily micronutrient-rich nutritional supplement, or two 1-hour physical activity classes per week, or both interventions, or neither, for 24 months. The primary outcomes, assessed blind to allocation, were incidence of pneumonia over 24 months, and physical function assessed by walking capacity 24 months after enrollment. Adherence was good for the nutritional supplement (~75%, and moderate for the physical activity intervention (~43%. Over 24 months the incidence rate of pneumonia did not differ between intervention and control clusters (32.5 versus 32.6 per 1,000 person years respectively; risk ratio = 1.00; 95% confidence interval 0.61-1.63; p = 0.99. In intention-to-treat analysis, after 24 months there was a significant difference in walking capacity between the intervention and control clusters (mean difference 33.8 meters; 95% confidence interval 13.9-53.8; p = 0.001. The overall cost of the physical activity intervention over 24 months was US$164/participant; equivalent to US$4.84/extra meter walked. The number of falls and fractures was balanced across physical activity intervention arms and no serious adverse events were reported for either intervention.Chile's nutritional supplementation program for older people is not effective in reducing the

  9. Effectiveness of a self-management program for dual sensory impaired seniors in aged care settings: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Roets-Merken, Lieve M; Graff, Maud J L; Zuidema, Sytse U; Hermsen, Pieter G J M; Teerenstra, Steven; Kempen, Gertrudis I J M; Vernooij-Dassen, Myrra J F J

    2013-10-07

    Five to 25 percent of residents in aged care settings have a combined hearing and visual sensory impairment. Usual care is generally restricted to single sensory impairment, neglecting the consequences of dual sensory impairment on social participation and autonomy. The aim of this study is to evaluate the effectiveness of a self-management program for seniors who acquired dual sensory impairment at old age. In a cluster randomized, single-blind controlled trial, with aged care settings as the unit of randomization, the effectiveness of a self-management program will be compared to usual care. A minimum of 14 and maximum of 20 settings will be randomized to either the intervention cluster or the control cluster, aiming to include a total of 132 seniors with dual sensory impairment. Each senior will be linked to a licensed practical nurse working at the setting. During a five to six month intervention period, nurses at the intervention clusters will be trained in a self-management program to support and empower seniors to use self-management strategies. In two separate diaries, nurses keep track of the interviews with the seniors and their reflections on their own learning process. Nurses of the control clusters offer care as usual. At senior level, the primary outcome is the social participation of the seniors measured using the Hearing Handicap Questionnaire and the Activity Card Sort, and secondary outcomes are mood, autonomy and quality of life. At nurse level, the outcome is job satisfaction. Effectiveness will be evaluated using linear mixed model analysis. The results of this study will provide evidence for the effectiveness of the Self-Management Program for seniors with dual sensory impairment living in aged care settings. The findings are expected to contribute to the knowledge on the program's potential to enhance social participation and autonomy of the seniors, as well as increasing the job satisfaction of the licensed practical nurses. Furthermore, an

  10. Computer-Based Driving in Dementia Decision Tool With Mail Support: Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Rapoport, Mark J; Zucchero Sarracini, Carla; Kiss, Alex; Lee, Linda; Byszewski, Anna; Seitz, Dallas P; Vrkljan, Brenda; Molnar, Frank; Herrmann, Nathan; Tang-Wai, David F; Frank, Christopher; Henry, Blair; Pimlott, Nicholas; Masellis, Mario; Naglie, Gary

    2018-05-25

    Physicians often find significant challenges in assessing automobile driving in persons with mild cognitive impairment and mild dementia and deciding when to report to transportation administrators. Care must be taken to balance the safety of patients and other road users with potential negative effects of issuing such reports. The aim of this study was to assess whether a computer-based Driving in Dementia Decision Tool (DD-DT) increased appropriate reporting of patients with mild dementia or mild cognitive impairment to transportation administrators. The study used a parallel-group cluster nonblinded randomized controlled trial design to test a multifaceted knowledge translation intervention. The intervention included a computer-based decision support system activated by the physician-user, which provides a recommendation about whether to report patients with mild dementia or mild cognitive impairment to transportation administrators, based on an algorithm derived from earlier work. The intervention also included a mailed educational package and Web-based specialized reporting forms. Specialists and family physicians with expertise in dementia or care of the elderly were stratified by sex and randomized to either use the DD-DT or a control version of the tool that required identical data input as the intervention group, but instead generated a generic reminder about the reporting legislation in Ontario, Canada. The trial ran from September 9, 2014 to January 29, 2016, and the primary outcome was the number of reports made to the transportation administrators concordant with the algorithm. A total of 69 participating physicians were randomized, and 36 of these used the DD-DT; 20 of the 35 randomized to the intervention group used DD-DT with 114 patients, and 16 of the 34 randomized to the control group used it with 103 patients. The proportion of all assessed patients reported to the transportation administrators concordant with recommendation did not differ

  11. Increasing physical activity in young primary school children-it's child's play: A cluster randomised controlled trial

    NARCIS (Netherlands)

    Engelen, L.; Bundy, A.C.; Naughton, G.; Simpson, J.M.; Bauman, A.; Ragen, J.; Baur, L.; Wyver, S.; Tranter, P.; Niehues, A.; Schiller, W.; Perry, G.; Jessup, G.; van der Ploeg, H.P.

    2013-01-01

    Objective: To explore the effects of an innovative school-based intervention for increasing physical activity. Methods: 226 children (5-7. years old) randomly selected from 12 Australian primary schools were recruited to a cluster randomised trial with schools randomly allocated to intervention or

  12. Comparative effectiveness of childhood obesity interventions in pediatric primary care: a cluster-randomized clinical trial.

    Science.gov (United States)

    Taveras, Elsie M; Marshall, Richard; Kleinman, Ken P; Gillman, Matthew W; Hacker, Karen; Horan, Christine M; Smith, Renata L; Price, Sarah; Sharifi, Mona; Rifas-Shiman, Sheryl L; Simon, Steven R

    2015-06-01

    Evidence of effective treatment of childhood obesity in primary care settings is limited. To examine the extent to which computerized clinical decision support (CDS) delivered to pediatric clinicians at the point of care of obese children, with or without individualized family coaching, improved body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) and quality of care. We conducted a cluster-randomized, 3-arm clinical trial. We enrolled 549 children aged 6 to 12 years with a BMI at the 95% percentile or higher from 14 primary care practices in Massachusetts from October 1, 2011, through June 30, 2012. Patients were followed up for 1 year (last follow-up, August 30, 2013). In intent-to-treat analyses, we used linear mixed-effects models to account for clustering by practice and within each person. In 5 practices randomized to CDS, pediatric clinicians received decision support on obesity management, and patients and their families received an intervention for self-guided behavior change. In 5 practices randomized to CDS + coaching, decision support was augmented by individualized family coaching. The remaining 4 practices were randomized to usual care. Smaller age-associated change in BMI and the Healthcare Effectiveness Data and Information Set (HEDIS) performance measures for obesity during the 1-year follow-up. At baseline, mean (SD) patient age and BMI were 9.8 (1.9) years and 25.8 (4.3), respectively. At 1 year, we obtained BMI from 518 children (94.4%) and HEDIS measures from 491 visits (89.4%). The 3 randomization arms had different effects on BMI over time (P = .04). Compared with the usual care arm, BMI increased less in children in the CDS arm during 1 year (-0.51 [95% CI, -0.91 to -0.11]). The CDS + coaching arm had a smaller magnitude of effect (-0.34 [95% CI, -0.75 to 0.07]). We found substantially greater achievement of childhood obesity HEDIS measures in the CDS arm (adjusted odds ratio, 2.28 [95% CI, 1

  13. Nonpharmacologic Pain Management Interventions in German Nursing Homes: A Cluster Randomized Trial.

    Science.gov (United States)

    Kalinowski, Sonja; Budnick, Andrea; Kuhnert, Ronny; Könner, Franziska; Kissel-Kröll, Angela; Kreutz, Reinhold; Dräger, Dagmar

    2015-08-01

    The reported prevalence of pain among nursing home residents (NHRs) is high. Insufficient use of analgesics, the conventional pain management strategy, is often reported. Whether and to what extent nonpharmacologic therapies (NPTs) are used to manage the pain of NHRs in Germany is largely unknown. The aim of this cluster-randomized trial was to assess the NPTs provided and to enhance the application and prescription of NPTs in NHRs on an individual level. There were six nursing homes in the intervention group and six in the control group. There were 239 NHRs, aged ≥65 years, with an average Mini-Mental State Examination score of at least 18 at baseline. Pain management interventions (cluster level) included an online course for physicians and 1-day seminar for nurses. Data on NPT applied by nurses and therapeutic NPT prescribed by physicians were obtained from residents' nursing documentation. Face-to-face interviews with NHRs assessed the NPT received. At baseline, 82.6% of NHR (mean age 83 years) were affected by pain, but less than 1 in 10 received NPT. The intervention did not result in a significant increase in the NPT applied by nurses, but did significantly increase the therapeutic NPT prescribed by physicians. Residents were active in using NPT to self-manage their pain. Given the prevalence of pain in NHRs, there is a clear need to improve pain management in this population. Extended use of NPT offers a promising approach. We recommend that nurses provide residents with education on pain-management techniques to support them in taking a proactive role in managing their pain. Copyright © 2015 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

  14. Impact of a school-based intervention to promote fruit intake: a cluster randomized controlled trial.

    Science.gov (United States)

    Rosário, R; Araújo, A; Padrão, P; Lopes, O; Moreira, A; Abreu, S; Vale, S; Pereira, B; Moreira, P

    2016-07-01

    There is evidence that fruit consumption among school children is below the recommended levels. This study aims to examine the effects of a dietary education intervention program me, held by teachers previously trained in nutrition, on the consumption of fruit as a dessert at lunch and dinner, among children 6-12 years old. This is a randomized trial with the schools as the unit of randomisation. A total of 464 children (239 female, 6-12years) from seven elementary schools participated in this cluster randomized controlled trial. Three schools were allocated to the intervention and four to the control group. For the intervention schools, we delivered professional development training to school teachers (12 sessions of 3 h each). The training provided information about nutrition, healthy eating, the importance of drinking water and healthy cooking activities. After each session, teachers were encouraged to develop classroom activities focused on the learned topics. Sociodemographic was assessed at baseline and anthropometric, dietary intake and physical activity assessments were performed at baseline and at the end of the intervention. Dietary intake was evaluated by a 24-h dietary recall and fruit consumption as a dessert was gathered at lunch and dinner. Intervened children reported a significant higher intake in the consumption of fruit compared to the controlled children at lunch (P = 0.001) and at dinner (P = 0.012), after adjusting for confounders. Our study provides further support for the success of intervention programmes aimed at improving the consumption of fruit as a dessert in children. Copyright © 2016 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

  15. Protocol: Adaptive Implementation of Effective Programs Trial (ADEPT): cluster randomized SMART trial comparing a standard versus enhanced implementation strategy to improve outcomes of a mood disorders program.

    Science.gov (United States)

    Kilbourne, Amy M; Almirall, Daniel; Eisenberg, Daniel; Waxmonsky, Jeanette; Goodrich, David E; Fortney, John C; Kirchner, JoAnn E; Solberg, Leif I; Main, Deborah; Bauer, Mark S; Kyle, Julia; Murphy, Susan A; Nord, Kristina M; Thomas, Marshall R

    2014-09-30

    Despite the availability of psychosocial evidence-based practices (EBPs), treatment and outcomes for persons with mental disorders remain suboptimal. Replicating Effective Programs (REP), an effective implementation strategy, still resulted in less than half of sites using an EBP. The primary aim of this cluster randomized trial is to determine, among sites not initially responding to REP, the effect of adaptive implementation strategies that begin with an External Facilitator (EF) or with an External Facilitator plus an Internal Facilitator (IF) on improved EBP use and patient outcomes in 12 months. This study employs a sequential multiple assignment randomized trial (SMART) design to build an adaptive implementation strategy. The EBP to be implemented is life goals (LG) for patients with mood disorders across 80 community-based outpatient clinics (N = 1,600 patients) from different U.S. regions. Sites not initially responding to REP (defined as implementation costs, and organizational change. This study design will determine whether an off-site EF alone versus the addition of an on-site IF improves EBP uptake and patient outcomes among sites that do not respond initially to REP. It will also examine the value of delaying the provision of EF/IF for sites that continue to not respond despite EF. ClinicalTrials.gov identifier: NCT02151331.

  16. Community-wide intervention and population-level physical activity: a 5-year cluster randomized trial

    Science.gov (United States)

    Kamada, Masamitsu; Kitayuguchi, Jun; Abe, Takafumi; Taguri, Masataka; Inoue, Shigeru; Ishikawa, Yoshiki; Bauman, Adrian; Lee, I-Min; Miyachi, Motohiko; Kawachi, Ichiro

    2018-01-01

    Abstract Background Evidence from a limited number of short-term trials indicates the difficulty in achieving population-level improvements in physical activity (PA) through community-wide interventions (CWIs). We sought to evaluate the effectiveness of a 5-year CWI for promoting PA in middle-aged and older adults using a cluster randomized design. Methods We randomized 12 communities in Unnan, Japan, to either intervention (9) or control (3). Additionally, intervention communities were randomly allocated to three subgroups by different PA types promoted. Randomly sampled residents aged 40–79 years responded to the baseline survey (n = 4414; 74%) and were followed at 1, 3 and 5 years (78–83% response rate). The intervention was a 5-year CWI using social marketing to promote PA. The primary outcome was a change in recommended levels of PA. Results Compared with control communities, adults achieving recommended levels of PA increased in intervention communities [adjusted change difference = 4.6 percentage points (95% confidence interval: 0.4, 8.8)]. The intervention was effective for promoting all types of recommended PAs, i.e. aerobic (walking, 6.4%), flexibility (6.1%) and muscle-strengthening activities (5.7%). However, a bundled approach, which attempted to promote all forms of PAs above simultaneously, was not effective (1.3–3.4%, P ≥ 0.138). Linear dose–response relationships between the CWI awareness and changes in PA were observed (P ≤ 0.02). Pain intensity decreased in shoulder (intervention and control) and lower back (intervention only) but there was little change difference in all musculoskeletal pain outcomes between the groups. Conclusions The 5-year CWI using the focused social marketing strategy increased the population-level of PA. PMID:29228255

  17. Informing resource-poor populations and the delivery of entitled health and social services in rural India: a cluster randomized controlled trial.

    Science.gov (United States)

    Pandey, Priyanka; Sehgal, Ashwini R; Riboud, Michelle; Levine, David; Goyal, Madhav

    2007-10-24

    A lack of awareness about entitled health and social services may contribute to poor delivery of such services in developing countries, especially among individuals of low socioeconomic status. To determine the impact of informing resource-poor rural populations about entitled services. Community-based, cluster randomized controlled trial conducted from May 2004 to May 2005 in 105 randomly selected village clusters in Uttar Pradesh state in India. Households (548 intervention and 497 control) were selected by a systematic sampling design, including both low-caste and mid- to high-caste households. Four to 6 public meetings were held in each intervention village cluster to disseminate information on entitled health services, entitled education services, and village governance requirements. No intervention took place in control village clusters. Visits by nurse midwife; prenatal examinations, tetanus vaccinations, and prenatal supplements received by pregnant women; vaccinations received by infants; excess school fees charged; occurrence of village council meetings; and development work in villages. At baseline, there were no significant differences in self-reported delivery of health and social services. After 1 year, intervention villagers reported better delivery of several services compared with control villagers: in a multivariate analysis, 30% more prenatal examinations (95% confidence interval [CI], 17%-43%; P India about entitled services enhanced the delivery of health and social services among both low- and mid- to high-caste households. Interventions that emphasize educating resource-poor populations about entitled services may improve the delivery of such services. clinicaltrials.gov Identifier: NCT00421291.

  18. Rationale and design of the Study of a Tele-pharmacy Intervention for Chronic diseases to Improve Treatment adherence (STIC2IT): A cluster randomized pragmatic trial

    Science.gov (United States)

    Choudhry, Niteesh K.; Isaac, Thomas; Lauffenburger, Julie C.; Gopalakrishnan, Chandrasekar; Khan, Nazleen F.; Lee, Marianne; Vachon, Amy; Iliadis, Tanya L.; Hollands, Whitney; Doheny, Scott; Elman, Sandra; Kraft, Jacqueline M.; Naseem, Samrah; Gagne, Joshua J.; Jackevicius, Cynthia A.; Fischer, Michael A.; Solomon, Daniel H.; Sequist, Thomas D.

    2016-01-01

    Background Approximately half of patients with chronic cardiometabolic conditions are non-adherent with their prescribed medications. Interventions to improve adherence have been only modestly effective because they often address single barriers to adherence, intervene at single points in time, or are imprecisely targeted to patients who may or may not need adherence assistance. Objective To evaluate the effect of a multi-component, behaviorally-tailored pharmacist-based intervention to improve adherence to medications for diabetes, hypertension, and hyperlipidemia. Trial design The STIC2IT (Study of a Tele-pharmacy Intervention for Chronic diseases To Improve Treatment adherence) trial is a cluster-randomized pragmatic trial testing the impact of a pharmacist-led multi-component intervention that uses behavioral interviewing, text messaging, mailed progress reports and video visits. Targeted patients are those who are non-adherent to glucose-lowering, anti-hypertensive, or statin medications and who also have evidence of poor disease control. The intervention is tailored to patients’ individual health barriers and their level of health activation. We cluster randomized 14 practice sites of a large multi-specialty group practice to receive either the pharmacist-based intervention or usual care. STIC2IT has enrolled 4,076 patients to be followed for 12 months after randomization. The trial’s primary outcome is medication adherence, assessed using pharmacy claims data. Secondary outcomes are disease control and healthcare resource utilization. Conclusion This trial will determine whether a technologically-enabled, behaviorally-targeted pharmacist-based intervention results in improved adherence and disease control. If effective, this strategy could be a scalable method of offering tailored adherence support to those with the greatest clinical need. PMID:27659887

  19. The Impact of Combined Music and Tai Chi on Depressive Symptoms Among Community-Dwelling Older Persons: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Liao, S J; Tan, M P; Chong, M C; Chua, Y P

    2018-05-01

    The effectiveness of pharmacological treatment may be limited in older persons. Several studies using Tai Chi or music therapy separately confirmed positive effects in the reduction of depressive symptoms. We conducted a cluster randomized controlled trial to evaluate the possible synergistic effect of combined music and Tai Chi on depressive symptoms. One hundred and seven older adults with mild to moderate depressive symptoms were recruited from Ya'an city. Fifty-five participants were cluster randomized to combined music and Tai Chi group for three months, while the other fifty-two individuals were randomized to the control group that entailed routine health education delivered monthly by community nurses. The primary outcome of depressive symptoms was measured with the Geriatric Depression Scale (GDS) at baseline and monthly for three months. At three-month follow-up, a statistically significant improvement in depressive symptoms was found in the intervention group compared with control group (F(3,315) = 69.661, P < 0.001). Following adjustments for socio-demographic data, the true effect of intervention on depressive symptoms was significant (F = 41.725, P < 0.01, η p 2 = 0.574). Combined music and Tai Chi reduced depressive symptoms among community-dwelling older persons. This represents an economically viable solution to the management of depression in highly populous developing nations.

  20. Cluster randomized trial to evaluate the impact of team training on surgical outcomes.

    Science.gov (United States)

    Duclos, A; Peix, J L; Piriou, V; Occelli, P; Denis, A; Bourdy, S; Carty, M J; Gawande, A A; Debouck, F; Vacca, C; Lifante, J C; Colin, C

    2016-12-01

    The application of safety principles from the aviation industry to the operating room has offered hope in reducing surgical complications. This study aimed to assess the impact on major surgical complications of adding an aviation-based team training programme after checklist implementation. A prospective parallel-group cluster trial was undertaken between September 2011 and March 2013. Operating room teams from 31 hospitals were assigned randomly to participate in a team training programme focused on major concepts of crew resource management and checklist utilization. The primary outcome measure was the occurrence of any major adverse event, including death, during the hospital stay within the first 30 days after surgery. Using a difference-in-difference approach, the ratio of the odds ratios (ROR) was estimated to compare changes in surgical outcomes between intervention and control hospitals. Some 22 779 patients were enrolled, including 5934 before and 16 845 after team training implementation. The risk of major adverse events fell from 8·8 to 5·5 per cent in 16 intervention hospitals (adjusted odds ratio 0·57, 95 per cent c.i. 0·48 to 0·68; P trends revealed significant improvements among ten institutions, equally distributed across intervention and control hospitals. Surgical outcomes improved substantially, with no difference between trial arms. Successful implementation of an aviation-based team training programme appears to require modification and adaptation of its principles in the context of the the surgical milieu. Registration number: NCT01384474 (http://www.clinicaltrials.gov). © 2016 BJS Society Ltd Published by John Wiley & Sons Ltd.

  1. Group based prenatal care in a low-and high risk population in the Netherlands: a study protocol for a stepped wedge cluster randomized controlled trial.

    Science.gov (United States)

    van Zwicht, Birgit S; Crone, Matty R; van Lith, Jan M M; Rijnders, Marlies E B

    2016-11-15

    CenteringPregnancy (CP) is a multifaceted group based care-model integrated in routine prenatal care, combining health assessment, education, and support. CP has shown some positive results on perinatal outcomes. However, the effects are less obvious when limited to the results of randomized controlled trials: as there are few trials and there is a variation in reported outcomes. Furthermore, former research was mostly conducted in the United States of America and in specific (often high risk) populations. Our study aims to evaluate the effects of CP in the Netherlands in a general population of pregnant women (low and high risk). Furthermore we aim to explore the mechanisms leading to the eventual effects by measuring potential mediating factors. We will perform a stepped wedge cluster randomized controlled trial, in a Western region in the Netherlands. Inclusion criteria are care, women in the intervention period (starting at the randomized time-point) will be offered the choice between individual care or CP. Primary outcomes are maternal and neonatal morbidity, retrieved from a national routine database. Secondary outcomes are health behavior, psychosocial outcomes, satisfaction, health care utilization and process outcomes, collected through self-administered questionnaires, group-evaluations and individual interviews. We will conduct intention-to-treat analyses. Also a per protocol analysis will be performed comparing the three subgroups: control group, CP-participants and non-CP-participants, using multilevel techniques to account for clustering effects. This study contributes to the evidence regarding the effect of CP and gives a first indication of the effect and implementation of CP in both low and high-risk pregnancies in a high-income Western society other than the USA. Also, measuring factors that are hypothesized to mediate the effect of CP will enable to explain the mechanisms that lead to effects on maternal and neonatal outcomes. Dutch Trial

  2. Full impact of laboratory information system requires direct use by clinical staff: cluster randomized controlled trial.

    Science.gov (United States)

    Blaya, Joaquín A; Shin, Sonya; Contreras, Carmen; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Kim, Jihoon; Rodriguez, Pablo; Cegielski, Peter; Fraser, Hamish S F

    2011-01-01

    To evaluate the time to communicate laboratory results to health centers (HCs) between the e-Chasqui web-based information system and the pre-existing paper-based system. Cluster randomized controlled trial in 78 HCs in Peru. In the intervention group, 12 HCs had web access to results via e-Chasqui (point-of-care HCs) and forwarded results to 17 peripheral HCs. In the control group, 22 point-of-care HCs received paper results directly and forwarded them to 27 peripheral HCs. Baseline data were collected for 15 months. Post-randomization data were collected for at least 2 years. Comparisons were made between intervention and control groups, stratified by point-of-care versus peripheral HCs. For point-of-care HCs, the intervention group took less time to receive drug susceptibility tests (DSTs) (median 9 vs 16 days, p60 days to arrive (pChasqui information system had reduced communication times and fewer results with delays of >2 months. Peripheral HCs had no benefits from the system. This suggests that health establishments should have point-of-care access to reap the benefits of electronic laboratory reporting.

  3. Spirometry and regular follow-up do not improve quality of life in children or adolescents with asthma: Cluster randomized controlled trials.

    Science.gov (United States)

    Abramson, Michael J; Schattner, Rosa L; Holton, Christine; Simpson, Pam; Briggs, Nancy; Beilby, Justin; Nelson, Mark R; Wood-Baker, Richard; Thien, Francis; Sulaiman, Nabil D; Colle, Eleonora Del; Wolfe, Rory; Crockett, Alan J; Massie, R John

    2015-10-01

    To determine whether spirometry and regular medical review improved quality of life or other outcomes in children and adolescents with asthma. We conducted two cluster randomized controlled trials. We recruited 238 asthma patients aged between 7 and 17 years from 56 general practices in South Eastern Australia. Participants were randomized to receive an intervention that included spirometry or usual care. The main outcome measure was asthma related quality of life. Baseline characteristics were well matched between the intervention and control groups. Neither trial found any difference in asthma related quality of life between groups. However because of measurement properties, a formal meta-analysis could not be performed. Nor were there any significant effects of the intervention upon asthma attacks, limitation to usual activities, nocturnal cough, bother during physical activity, worry about asthma, or written asthma action plans. The findings do not support more widespread use of spirometry for the management of childhood asthma in general practice, unless it is integrated into a complete management model. © 2014 Wiley Periodicals, Inc.

  4. Effects of a guided web-based smoking cessation program with telephone counseling: a cluster randomized controlled trial.

    Science.gov (United States)

    Mehring, Michael; Haag, Max; Linde, Klaus; Wagenpfeil, Stefan; Schneider, Antonius

    2014-09-24

    Preliminary findings suggest that Web-based interventions may be effective in achieving significant smoking cessation. To date, very few findings are available for primary care patients, and especially for the involvement of general practitioners. Our goal was to examine the short-term effectiveness of a fully automated Web-based coaching program in combination with accompanied telephone counseling in smoking cessation in a primary care setting. The study was an unblinded cluster-randomized trial with an observation period of 12 weeks. Individuals recruited by general practitioners randomized to the intervention group participated in a Web-based coaching program based on education, motivation, exercise guidance, daily short message service (SMS) reminding, weekly feedback through Internet, and active monitoring by general practitioners. All components of the program are fully automated. Participants in the control group received usual care and advice from their practitioner without the Web-based coaching program. The main outcome was the biochemically confirmed smoking status after 12 weeks. We recruited 168 participants (86 intervention group, 82 control group) into the study. For 51 participants from the intervention group and 70 participants from the control group, follow-up data were available both at baseline and 12 weeks. Very few patients (9.8%, 5/51) from the intervention group and from the control group (8.6%, 6/70) successfully managed smoking cessation (OR 0.86, 95% CI 0.25-3.0; P=.816). Similar results were found within the intent-to-treat analysis: 5.8% (5/86) of the intervention group and 7.3% (6/82) of the control group (OR 1.28, 95% CI 0.38-4.36; P=.694). The number of smoked cigarettes per day decreased on average by 9.3 in the intervention group and by 6.6 in the control group (2.7 mean difference; 95% CI -5.33 to -0.58; P=.045). After adjustment for the baseline value, age, gender, and height, this significance decreases (mean difference 2.2; 95

  5. Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    Savolainen-Kopra Carita

    2012-01-01

    Full Text Available Abstract Background Hand hygiene is considered as an important means of infection control. We explored whether guided hand hygiene together with transmission-limiting behaviour reduces infection episodes and lost days of work in a common work environment in an open cluster-randomized 3-arm intervention trial. Methods A total of 21 clusters (683 persons were randomized to implement hand hygiene with soap and water (257 persons, with alcohol-based hand rub (202 persons, or to serve as a control (224 persons. Participants in both intervention arms also received standardized instructions on how to limit the transmission of infections. The intervention period (16 months included the emergence of the 2009 influenza pandemic and the subsequent national hand hygiene campaign influencing also the control arm. Results In the total follow-up period there was a 6.7% reduction of infection episodes in the soap-and water arm (p = 0.04. Before the onset of the anti-pandemic campaign, a statistically significant (p = 0.002 difference in the mean occurrence of infection episodes was observed between the control (6.0 per year and the soap-and-water arm (5.0 per year but not between the control and the alcohol-rub arm (5.6 per year. Neither intervention had a decreasing effect on absence from work. Conclusions We conclude that intensified hand hygiene using water and soap together with behavioural recommendations can reduce the occurrence of self-reported acute illnesses in common work environment. Surprisingly, the occurrence of reported sick leaves also increased in the soap-and water-arm. Trial Registration ClinicalTrials.gov: NCT00981877 Source of funding The Finnish Work Environment Fund and the National Institute for Health and Welfare.

  6. Cluster randomized controlled trial of a consumer behavior intervention to improve healthy food purchases from online canteens.

    Science.gov (United States)

    Delaney, Tessa; Wyse, Rebecca; Yoong, Sze Lin; Sutherland, Rachel; Wiggers, John; Ball, Kylie; Campbell, Karen; Rissel, Chris; Lecathelinais, Christophe; Wolfenden, Luke

    2017-11-01

    Background: School canteens represent an opportune setting in which to deliver public health nutrition strategies because of their wide reach and frequent use by children. Online school-canteen ordering systems, where students order and pay for their lunch online, provide an avenue to improve healthy canteen purchases through the application of consumer-behavior strategies that have an impact on purchasing decisions. Objective: We assessed the efficacy of a consumer-behavior intervention implemented in an online school-canteen ordering system in reducing the energy, saturated fat, sugar, and sodium contents of primary student lunch orders. Design: A cluster-randomized controlled trial was conducted that involved 2714 students (aged 5-12 y) from 10 primary schools in New South Wales, Australia, who were currently using an online canteen ordering system. Schools were randomized in a 1:1 ratio to receive either the intervention (enhanced system) or the control (standard online ordering only). The intervention included consumer-behavior strategies that were integrated into the online ordering system (targeting menu labeling, healthy food availability, placement, and prompting). Results: Mean energy (difference: -567.25 kJ; 95% CI: -697.95, -436.55 kJ; P consumer-behavior intervention using an existing online canteen infrastructure to improve purchasing behavior from primary school canteens. Such an intervention may represent an appealing policy option as part of a broader government strategy to improve child public health nutrition. This trial was registered at www.anzctr.org.au as ACTRN12616000499482. © 2017 American Society for Nutrition.

  7. Home-based versus mobile clinic HIV testing and counseling in rural Lesotho: a cluster-randomized trial.

    Science.gov (United States)

    Labhardt, Niklaus Daniel; Motlomelo, Masetsibi; Cerutti, Bernard; Pfeiffer, Karolin; Kamele, Mashaete; Hobbins, Michael A; Ehmer, Jochen

    2014-12-01

    The success of HIV programs relies on widely accessible HIV testing and counseling (HTC) services at health facilities as well as in the community. Home-based HTC (HB-HTC) is a popular community-based approach to reach persons who do not test at health facilities. Data comparing HB-HTC to other community-based HTC approaches are very limited. This trial compares HB-HTC to mobile clinic HTC (MC-HTC). The trial was powered to test the hypothesis of higher HTC uptake in HB-HTC campaigns than in MC-HTC campaigns. Twelve clusters were randomly allocated to HB-HTC or MC-HTC. The six clusters in the HB-HTC group received 30 1-d multi-disease campaigns (five villages per cluster) that delivered services by going door-to-door, whereas the six clusters in MC-HTC group received campaigns involving community gatherings in the 30 villages with subsequent service provision in mobile clinics. Time allocation and human resources were standardized and equal in both groups. All individuals accessing the campaigns with unknown HIV status or whose last HIV test was >12 wk ago and was negative were eligible. All outcomes were assessed at the individual level. Statistical analysis used multivariable logistic regression. Odds ratios and p-values were adjusted for gender, age, and cluster effect. Out of 3,197 participants from the 12 clusters, 2,563 (80.2%) were eligible (HB-HTC: 1,171; MC-HTC: 1,392). The results for the primary outcomes were as follows. Overall HTC uptake was higher in the HB-HTC group than in the MC-HTC group (92.5% versus 86.7%; adjusted odds ratio [aOR]: 2.06; 95% CI: 1.18-3.60; p = 0. 011). Among adolescents and adults ≥ 12 y, HTC uptake did not differ significantly between the two groups; however, in children versus 58.7%; aOR: 4.91; 95% CI: 2.41-10.0; pindividuals in the HB-HTC and in the MC-HTC arms, respectively, linked to HIV care within 1 mo after testing positive. Findings for secondary outcomes were as follows: HB-HTC reached more first-time testers

  8. Assessing the feasibility of interrupting the transmission of soil-transmitted helminths through mass drug administration: The DeWorm3 cluster randomized trial protocol.

    Science.gov (United States)

    Ásbjörnsdóttir, Kristjana Hrönn; Ajjampur, Sitara S Rao; Anderson, Roy M; Bailey, Robin; Gardiner, Iain; Halliday, Katherine E; Ibikounle, Moudachirou; Kalua, Khumbo; Kang, Gagandeep; Littlewood, D Timothy J; Luty, Adrian J F; Means, Arianna Rubin; Oswald, William; Pullan, Rachel L; Sarkar, Rajiv; Schär, Fabian; Szpiro, Adam; Truscott, James E; Werkman, Marleen; Yard, Elodie; Walson, Judd L

    2018-01-01

    Current control strategies for soil-transmitted helminths (STH) emphasize morbidity control through mass drug administration (MDA) targeting preschool- and school-age children, women of childbearing age and adults in certain high-risk occupations such as agricultural laborers or miners. This strategy is effective at reducing morbidity in those treated but, without massive economic development, it is unlikely it will interrupt transmission. MDA will therefore need to continue indefinitely to maintain benefit. Mathematical models suggest that transmission interruption may be achievable through MDA alone, provided that all age groups are targeted with high coverage. The DeWorm3 Project will test the feasibility of interrupting STH transmission using biannual MDA targeting all age groups. Study sites (population ≥80,000) have been identified in Benin, Malawi and India. Each site will be divided into 40 clusters, to be randomized 1:1 to three years of twice-annual community-wide MDA or standard-of-care MDA, typically annual school-based deworming. Community-wide MDA will be delivered door-to-door, while standard-of-care MDA will be delivered according to national guidelines. The primary outcome is transmission interruption of the STH species present at each site, defined as weighted cluster-level prevalence ≤2% by quantitative polymerase chain reaction (qPCR), 24 months after the final round of MDA. Secondary outcomes include the endline prevalence of STH, overall and by species, and the endline prevalence of STH among children under five as an indicator of incident infections. Secondary analyses will identify cluster-level factors associated with transmission interruption. Prevalence will be assessed using qPCR of stool samples collected from a random sample of cluster residents at baseline, six months after the final round of MDA and 24 months post-MDA. A smaller number of individuals in each cluster will be followed with annual sampling to monitor trends in

  9. Detection of domestic violence by community mental health teams: a multi-center, cluster randomized controlled trial.

    Science.gov (United States)

    Ruijne, Roos E; Howard, Louise M; Trevillion, Kylee; Jongejan, Femke E; Garofalo, Carlo; Bogaerts, Stefan; Mulder, Cornelis L; Kamperman, Astrid M

    2017-08-07

    Domestic Violence and Abuse (DVA) is associated with a range of psychosocial and mental health problems. Having a psychiatric illness increases likelihood of being a victim of DVA. Despite the evidence of a high risk for DVA and the serious effects of violent victimization in psychiatric patients, detection rates are low and responses are inadequate. The aim of the BRAVE (Better Reduction trough Assessment of Violence and Evaluation) study is to improve detection of and response to DVA in psychiatric patients. In this article, we present the protocol of the BRAVE study which follows the SPIRIT guidelines. The BRAVE study is a cluster randomized controlled trial. We will include 24 community mental health teams from Rotterdam and The Hague. Twelve teams will provide care as usual and 12 teams will receive the intervention. The intervention consists of 1) a knowledge and skills training for mental health professionals about DVA, 2) a knowledge and skills training of DVA professionals about mental illness, 3) provision and implementation of a referral pathway between community mental health and DVA services. The follow up period is 12 months. Our primary outcome is the rate of detected cases of recent or any history of DVA in patients per team in 12 months. Detection rates are obtained through a systematic search in electronic patient files. Our secondary aims are to obtain information about the gain and sustainability of knowledge on DVA in mental health professionals, and to obtain insight into the feasibility, sustainability and acceptability of the intervention. Data on our secondary aims will be obtained through structured in depth interviews and a questionnaire on knowledge and attitudes on DVA. This study is the first cluster randomized controlled trial to target both male and female psychiatric patients that experience DVA, using an intervention that involves training of professionals. We expect the rate of detected cases of DVA to increase in the

  10. Random matrix improved subspace clustering

    KAUST Repository

    Couillet, Romain; Kammoun, Abla

    2017-01-01

    This article introduces a spectral method for statistical subspace clustering. The method is built upon standard kernel spectral clustering techniques, however carefully tuned by theoretical understanding arising from random matrix findings. We show

  11. A cluster randomized controlled trial evaluating the efficacy of peer mentors to support South African women living with HIV and their infants.

    Directory of Open Access Journals (Sweden)

    Mary Jane Rotheram-Borus

    Full Text Available We evaluate the effect of clinic-based support by HIV-positive Peer Mentors, in addition to standard clinic care, on maternal and infant well-being among Women Living with HIV (WLH from pregnancy through the infant's first year of life.In a cluster randomized controlled trial in KwaZulu-Natal, South Africa, eight clinics were randomized for pregnant WLH to receive either: a Standard Care condition (SC; 4 clinics; n = 656 WLH; or an Enhanced Intervention (EI; 4 clinics; n = 544 WLH. WLH in the EI were invited to attend four antenatal and four postnatal meetings led by HIV-positive Peer Mentors, in addition to SC. WLH were recruited during pregnancy, and at least two post-birth assessment interviews were completed by 57% of WLH at 1.5, 6 or 12 months. EI's effect was ascertained on 19 measures of maternal and infant well-being using random effects regressions to control for clinic clustering. A binomial test for correlated outcomes evaluated EI's overall efficacy.WLH attended an average of 4.1 sessions (SD = 2.0; 13% did not attend any sessions. Significant overall benefits were found in EI compared to SC using the binomial test. Secondarily, over time, WLH in the EI reported significantly fewer depressive symptoms and fewer underweight infants than WLH in the SC condition. EI WLH were significantly more likely to use one feeding method for six months and exclusively breastfeed their infants for at least 6 months.WLH benefit by support from HIV-positive Peer Mentors, even though EI participation was partial, with incomplete follow-up rates from 6-12 months.ClinicalTrials.gov NCT00972699.

  12. Who is the research subject in cluster randomized trials in health research?

    Directory of Open Access Journals (Sweden)

    Brehaut Jamie C

    2011-07-01

    Full Text Available Abstract This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently. We examine the research ethics literature and international regulations to identify the core features of human research subjects, and then unify these features under a single, comprehensive definition of human research subject. We define a human research subject as any person whose interests may be compromised as a result of interventions in a research study. Individuals are only human research subjects in CRTs if: (1 they are directly intervened upon by investigators; (2 they interact with investigators; (3 they are deliberately intervened upon via a manipulation of their environment that may compromise their interests; or (4 their identifiable private information is used to generate data. Individuals who are indirectly affected by CRT study interventions, including patients of healthcare providers participating in knowledge translation CRTs, are not human research subjects unless at least one of these conditions is met.

  13. The effects of office ergonomic training on musculoskeletal complaints, sickness absence, and psychological well-being: a cluster randomized control trial.

    Science.gov (United States)

    Mahmud, Norashikin; Kenny, Dianna T; Md Zein, Raemy; Hassan, Siti Nurani

    2015-03-01

    This study explored whether musculoskeletal complaints can be reduced by the provision of ergonomics education. A cluster randomized controlled trial study was conducted in which 3 units were randomized to intervention and received training and 3 units were given a leaflet. The effect of intervention on knowledge, workstation practices, musculoskeletal complaints, sickness absence, and psychological well-being were assessed at 6 and 12 months. Although there was no increment of knowledge among workers, significant improvements in workstation practices in the use of monitor, keyboard, and chair were observed. There were significant reductions in neck and upper and lower back complaints among workers but these did not translate into fewer days lost from work. Workers' stress was found to be significantly reduced across the studies. In conclusion, office ergonomics training can be beneficial in reducing musculoskeletal risks and stress among workers. © 2011 APJPH.

  14. The QUIT-PRIMO provider-patient Internet-delivered smoking cessation referral intervention: a cluster-randomized comparative effectiveness trial: study protocol

    Directory of Open Access Journals (Sweden)

    Ford Daniel E

    2010-11-01

    Full Text Available Abstract Background Although screening for tobacco use is increasing with electronic health records and standard protocols, other tobacco-control activities, such as referral of patients to cessation resources, is quite low. In the QUIT-PRIMO study, an online referral portal will allow providers to enter smokers' email addresses into the system. Upon returning home, the smokers will receive automated emails providing education about tobacco cessation and encouragement to use the patient smoking cessation website (with interactive tools, educational resources, motivational email messages, secure messaging with a tobacco treatment specialist, and online support group. Methods The informatics system will be evaluated in a comparative effectiveness trial of 160 community-based primary care practices, cluster-randomized at the practice level. In the QUIT-PRIMO intervention, patients will be provided a paper information-prescription referral and then "e-referred" to the system. In the comparison group, patients will receive only the paper-based information-prescription referral with the website address. Once patients go to the website, they are subsequently randomized within practices to either a standard patient smoking cessation website or an augmented version with access to a tobacco treatment specialist online, motivational emails, and an online support group. We will compare intervention and control practice participation (referral rates and patient participation (proportion referred who go to the website. We will then compare the effectiveness of the standard and augmented patient websites. Discussion Our goal is to evaluate an integrated informatics solution to increase access to web-delivered smoking cessation support. We will analyze the impact of this integrated system in terms of process (provider e-referral and patient login and patient outcomes (six-month smoking cessation. Trial Registration Web-delivered Provider Intervention for

  15. Effects of quality improvement in health facilities and community mobilization through women's groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial.

    Science.gov (United States)

    Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

    2013-09-01

    Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. We evaluated a rural participatory women's group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14,576 and 20,576 births were recorded during baseline (June 2007-September 2008) and intervention (October 2008-December 2010) periods. For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60-1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72-0.97). We did not observe any intervention effects on maternal mortality. Despite implementation problems, a combined community and facility approach using participatory women's groups and quality improvement at health centres reduced newborn mortality in rural Malawi.

  16. Test of a workforce development intervention to expand opioid use disorder treatment pharmacotherapy prescribers: protocol for a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Todd Molfenter

    2017-11-01

    Full Text Available Abstract Background Overdoses due to non-medical use of prescription opioids and other opiates have become the leading cause of accidental deaths in the USA. Buprenorphine and extended-release naltrexone are key evidence-based pharmacotherapies available to addiction treatment providers to address opioid use disorder (OUD and prevent overdose deaths. Treatment organizations’ efforts to provide these pharmacotherapies have, however, been stymied by limited success in recruiting providers (physicians, nurse practitioners, and physician assistants to prescribe these medications. Historically, the addiction treatment field has not attracted physicians, and many barriers to implementing OUD pharmacotherapy exist, ranging from lack of confidence in treating OUD patients to concerns regarding reimbursement. Throughout the USA, the prevalence of OUD far exceeds the capacity of the OUD pharmacotherapy treatment system. Poor access to OUD pharmacotherapy prescribers has become a workforce development need for the addiction treatment field and a significant health issue. Methods This cluster randomized controlled trial (RCT is designed to increase buprenorphine and extended-release naltrexone treatment capacity for OUD. The implementation intervention to be tested is a bundle of OUD pharmacotherapy capacity building practices called the Prescriber Recruitment Bundle (PRB, which was developed and piloted in a previous statewide buprenorphine implementation study. For this cluster RCT, organizational sites will be recruited and then randomized into one of two arms: (1 control, with treatment as usual and access to a website with PRB resources, or (2 intervention, with organizations implementing the PRB using the Network for the Improvement of Addiction Treatment organizational change model over a 24-month intervention period and a 10-month sustainability period. The primary treatment outcomes for each organizational site are self-reported monthly counts of

  17. Mental health first aid training for high school teachers: a cluster randomized trial.

    Science.gov (United States)

    Jorm, Anthony F; Kitchener, Betty A; Sawyer, Michael G; Scales, Helen; Cvetkovski, Stefan

    2010-06-24

    Mental disorders often have their first onset during adolescence. For this reason, high school teachers are in a good position to provide initial assistance to students who are developing mental health problems. To improve the skills of teachers in this area, a Mental Health First Aid training course was modified to be suitable for high school teachers and evaluated in a cluster randomized trial. The trial was carried out with teachers in South Australian high schools. Teachers at 7 schools received training and those at another 7 were wait-listed for future training. The effects of the training on teachers were evaluated using questionnaires pre- and post-training and at 6 months follow-up. The questionnaires assessed mental health knowledge, stigmatizing attitudes, confidence in providing help to others, help actually provided, school policy and procedures, and teacher mental health. The indirect effects on students were evaluated using questionnaires at pre-training and at follow-up which assessed any mental health help and information received from school staff, and also the mental health of the student. The training increased teachers' knowledge, changed beliefs about treatment to be more like those of mental health professionals, reduced some aspects of stigma, and increased confidence in providing help to students and colleagues. There was an indirect effect on students, who reported receiving more mental health information from school staff. Most of the changes found were sustained 6 months after training. However, no effects were found on teachers' individual support towards students with mental health problems or on student mental health. Mental Health First Aid training has positive effects on teachers' mental health knowledge, attitudes, confidence and some aspects of their behaviour. ACTRN12608000561381.

  18. Effect of fortified complementary food supplementation on child growth in rural Bangladesh: a cluster-randomized trial.

    Science.gov (United States)

    Christian, Parul; Shaikh, Saijuddin; Shamim, Abu Ahmed; Mehra, Sucheta; Wu, Lee; Mitra, Maithilee; Ali, Hasmot; Merrill, Rebecca D; Choudhury, Nuzhat; Parveen, Monira; Fuli, Rachel D; Hossain, Md Iqbal; Islam, Md Munirul; Klemm, Rolf; Schulze, Kerry; Labrique, Alain; de Pee, Saskia; Ahmed, Tahmeed; West, Keith P

    2015-12-01

    Growth faltering in the first 2 years of life is high in South Asia where prevalence of stunting is estimated at 40-50%. Although nutrition counselling has shown modest benefits, few intervention trials of food supplementation exist showing improvements in growth and prevention of stunting. A cluster-randomized controlled trial was conducted in rural Bangladesh to test the effect of two local, ready-to-use foods (chickpea and rice-lentil based) and a fortified blended food (wheat-soy-blend++, WSB++) compared with Plumpy'doz, all with nutrition counselling vs nutrition counselling alone (control) on outcomes of linear growth (length and length-for-age z-score, LAZ), stunting (LAZ food groups, provided with one of the allocated supplements daily for a year. Growth deceleration occurred from 6 to 18 months of age but deceleration in LAZ was lower (by 0.02-0.04/month) in the Plumpy'doz (P = 0.02), rice-lentil (food groups relative to the control. In rural Bangladesh, small amounts of daily fortified complementary foods, provided for a year in addition to nutrition counselling, modestly increased linear growth and reduced stunting at 18 months of age. © The Author 2015. Published by Oxford University Press on behalf of the International Epidemiological Association.

  19. Effect of Behavior Modification on Outcome in Early- to Moderate-Stage Chronic Kidney Disease: A Cluster-Randomized Trial.

    Directory of Open Access Journals (Sweden)

    Kunihiro Yamagata

    Full Text Available Owing to recent changes in our understanding of the underlying cause of chronic kidney disease (CKD, the importance of lifestyle modification for preventing the progression of kidney dysfunction and complications has become obvious. In addition, effective cooperation between general physicians (GPs and nephrologists is essential to ensure a better care system for CKD treatment. In this cluster-randomized study, we studied the effect of behavior modification on the outcome of early- to moderate-stage CKD.Stratified open cluster-randomized trial.A total of 489 GPs belonging to 49 local medical associations (clusters in Japan.A total of 2,379 patients (1,195 in group A (standard intervention and 1,184 in group B (advanced intervention aged between 40 and 74 years, who had CKD and were under consultation with GPs.All patients were managed in accordance with the current CKD guidelines. The group B clusters received three additional interventions: patients received both educational intervention for lifestyle modification and a CKD status letter, attempting to prevent their withdrawal from treatment, and the group B GPs received data sheets to facilitate reducing the gap between target and practice.The primary outcome measures were 1 the non-adherence rate of accepting continuous medical follow-up of the patients, 2 the collaboration rate between GPs and nephrologists, and 3 the progression of CKD.The rate of discontinuous clinical visits was significantly lower in group B (16.2% in group A vs. 11.5% in group B, p = 0.01. Significantly higher referral and co-treatment rates were observed in group B (p<0.01. The average eGFR deterioration rate tended to be lower in group B (group A: 2.6±5.8 ml/min/1.73 m2/year, group B: 2.4±5.1 ml/min/1.73 m2/year, p = 0.07. A significant difference in eGFR deterioration rate was observed in subjects with Stage 3 CKD (group A: 2.4±5.9 ml/min/1.73 m2/year, group B: 1.9±4.4 ml/min/1.73 m2/year, p = 0.03.Our care

  20. Psychosocial benefits of workplace physical exercise: cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Andersen, Lars L

    2017-10-10

    While benefits of workplace physical exercise on physical health is well known, little is known about the psychosocial effects of such initiatives. This study evaluates the effect of workplace versus home-based physical exercise on psychosocial factors among healthcare workers. A total of 200 female healthcare workers (Age: 42.0, BMI: 24.1) from 18 departments at three hospitals were cluster-randomized to 10 weeks of: 1) home-based physical exercise (HOME) performed alone during leisure time for 10 min 5 days per week or 2) workplace physical exercise (WORK) performed in groups during working hours for 10 min 5 days per week and up to 5 group-based coaching sessions on motivation for regular physical exercise. Vitality and mental health (SF-36, scale 0-100), psychosocial work environment (COPSOQ, scale 0-100), work- and leisure disability (DASH, 0-100), control- (Bournemouth, scale 0-10) and concern about pain (Pain Catastrophizing Scale, scale 0-10) were assessed at baseline and at 10-week follow-up. Vitality as well as control and concern about pain improved more following WORK than HOME (all p health remained unchanged. Between-group differences at follow-up (WORK vs. HOME) were 7 [95% confidence interval (95% CI) 3 to 10] for vitality, -0.8 [95% CI -1.3 to -0.3] for control of pain and -0.9 [95% CI -1.4 to -0.5] for concern about pain, respectively. Performing physical exercise together with colleagues during working hours was more effective than home-based exercise in improving vitality and concern and control of pain among healthcare workers. These benefits occurred in spite of increased work pace. NCT01921764 at ClinicalTrials.gov . Registered 10 August 2013.

  1. Effectiveness of a cognitive behavioural workbook for changing beliefs about antipsychotic polypharmacy: analysis from a cluster randomized controlled trial.

    Science.gov (United States)

    Thompson, Andrew; Sullivan, Sarah; Barley, Maddi; Moore, Laurence; Rogers, Paul; Sipos, Attila; Harrison, Glynn

    2010-06-01

    Educational workbooks have been used in psychiatry to influence patient but not clinician behaviour. Targeted education interventions to change prescribing practice in other areas of medicine have only looked at changes in prescribing and not attitudes or beliefs related to the prescribing. We aimed to examine whether clinicians' beliefs about a common prescribing issue in psychiatry (antipsychotic polypharmacy prescription) changed alongside behaviour as a result of a complex intervention. Medical and nursing staff were recruited from 19 general adult psychiatry units in the south-west of the UK as part of a cluster randomized controlled trial. A questionnaire was used to assess beliefs on the prescribing of antipsychotic polypharmacy as a secondary outcome before and after completion of a cognitive behavioural 'self-help' style workbook (one part of a complex intervention). A factor analysis suggested three dimensions of the questionnaire that corresponded to predetermined themes. The data were analysed using a random-effects regression model (adjusting for clustering) controlling for possible confounders. There was a significant change in beliefs on both of the factors: antipsychotic polypharmacy (coefficient = -0.89, P change in antipsychotic polypharmacy prescribing (odds ratio 0.43, 95% confidence intervals 0.21-0.90). The workbook appeared to change staff beliefs about antipsychotic polypharmacy, but achieving substantial changes in clinician behaviour may require further exploration of other factors important in complex prescribing issues.

  2. Recruitment to online therapies for depression: pilot cluster randomized controlled trial.

    Science.gov (United States)

    Jones, Ray B; Goldsmith, Lesley; Hewson, Paul; Williams, Christopher J

    2013-03-05

    Raising awareness of online cognitive behavioral therapy (CBT) could benefit many people with depression, but we do not know how purchasing online advertising compares to placing free links from relevant local websites in increasing uptake. To pilot a cluster randomized controlled trial (RCT) comparing purchase of Google AdWords with placing free website links in raising awareness of online CBT resources for depression in order to better understand research design issues. We compared two online interventions with a control without intervention. The pilot RCT had 4 arms, each with 4 British postcode areas: (A) geographically targeted AdWords, (B) adverts placed on local websites by contacting website owners and requesting links be added, (C) both interventions, (D) control. Participants were directed to our research project website linking to two freely available online CBT resource sites (Moodgym and Living Life To The Full (LLTTF)) and two other depression support sites. We used data from (1) AdWords, (2) Google Analytics for our project website and for LLTTF, and (3) research project website. We compared two outcomes: (1) numbers with depression accessing the research project website, and then chose an onward link to one of the two CBT websites, and (2) numbers registering with LLTTF. We documented costs, and explored intervention and assessment methods to make general recommendations to inform researchers aiming to use similar methodologies in future studies. Trying to place local website links appeared much less cost effective than AdWords and although may prove useful for service delivery, was not worth pursuing in the context of the current study design. Our AdWords intervention was effective in recruiting people to the project website but our location targeting "leaked" and was not as geographically specific as claimed. The impact on online CBT was also diluted by offering participants other choices of destinations. Measuring the impact on LLTTF use was

  3. Using Cluster Bootstrapping to Analyze Nested Data with a Few Clusters

    Science.gov (United States)

    Huang, Francis L.

    2018-01-01

    Cluster randomized trials involving participants nested within intact treatment and control groups are commonly performed in various educational, psychological, and biomedical studies. However, recruiting and retaining intact groups present various practical, financial, and logistical challenges to evaluators and often, cluster randomized trials…

  4. Leveraging microfinance to impact HIV and financial behaviors among adolescents and their mothers in West Bengal: a cluster randomized trial.

    Science.gov (United States)

    Spielberg, Freya; Crookston, Benjamin T; Chanani, Sheila; Kim, Jaewhan; Kline, Sean; Gray, Bobbi L

    2013-01-01

    Microfinance can be used to reach women and adolescent girls with HIV prevention education. We report findings from a cluster-randomized control trial among 55 villages in West Bengal to determine the impact of non-formal education on knowledge, attitudes and behaviors for HIV prevention and savings. Multilevel regression models were used to evaluate differences between groups for key outcomes while adjusting for cluster correlation and differences in baseline characteristics. Women and girls who received HIV education showed significant gains in HIV knowledge, awareness that condoms can prevent HIV, self-efficacy for HIV prevention, and confirmed use of clean needles, as compared to the control group. Condom use was rare and did not improve for women. While HIV testing was uncommon, knowledge of HIV-testing resources significantly increased among girls, and trended in the positive direction among women in intervention groups. Conversely, the savings education showed no impact on financial knowledge or behavior change.

  5. Evaluating the impact of continuous quality improvement methods at hospitals in Tanzania: a cluster-randomized trial.

    Science.gov (United States)

    Kamiya, Yusuke; Ishijma, Hisahiro; Hagiwara, Akiko; Takahashi, Shizu; Ngonyani, Henook A M; Samky, Eleuter

    2017-02-01

    To evaluate the impact of implementing continuous quality improvement (CQI) methods on patient's experiences and satisfaction in Tanzania. Cluster-randomized trial, which randomly allocated district-level hospitals into treatment group and control group, was conducted. Sixteen district-level hospitals in Kilimanjaro and Manyara regions of Tanzania. Outpatient exit surveys targeting totally 3292 individuals, 1688 in the treatment and 1604 in the control group, from 3 time-points between September 2011 and September 2012. Implementation of the 5S (Sort, Set, Shine, Standardize, Sustain) approach as a CQI method at outpatient departments over 12 months. Cleanliness, waiting time, patient's experience, patient's satisfaction. The 5S increased cleanliness in the outpatient department, patients' subjective waiting time and overall satisfaction. However, negligible effects were confirmed for patient's experiences on hospital staff behaviours. The 5S as a CQI method is effective in enhancing hospital environment and service delivery; that are subjectively assessed by outpatients even during the short intervention period. Nevertheless, continuous efforts will be needed to connect CQI practices with the further improvement in the delivery of quality health care. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  6. Testing feedback message framing and comparators to address prescribing of high-risk medications in nursing homes: protocol for a pragmatic, factorial, cluster-randomized trial.

    Science.gov (United States)

    Ivers, Noah M; Desveaux, Laura; Presseau, Justin; Reis, Catherine; Witteman, Holly O; Taljaard, Monica K; McCleary, Nicola; Thavorn, Kednapa; Grimshaw, Jeremy M

    2017-07-14

    Audit and feedback (AF) interventions that leverage routine administrative data offer a scalable and relatively low-cost method to improve processes of care. AF interventions are usually designed to highlight discrepancies between desired and actual performance and to encourage recipients to act to address such discrepancies. Comparing to a regional average is a common approach, but more recipients would have a discrepancy if compared to a higher-than-average level of performance. In addition, how recipients perceive and respond to discrepancies may depend on how the feedback itself is framed. We aim to evaluate the effectiveness of different comparators and framing in feedback on high-risk prescribing in nursing homes. This is a pragmatic, 2 × 2 factorial, cluster-randomized controlled trial testing variations in the comparator and framing on the effectiveness of quarterly AF in changing high-risk prescribing in nursing homes in Ontario, Canada. We grouped homes that share physicians into clusters and randomized these clusters into the four experimental conditions. Outcomes will be assessed after 6 months; all primary analyses will be by intention-to-treat. The primary outcome (monthly number of high-risk medications received by each patient) will be analysed using a general linear mixed effects regression model. We will present both four-arm and factorial analyses. With 160 clusters and an average of 350 beds per cluster, assuming no interaction and similar effects for each intervention, we anticipate 90% power to detect an absolute mean difference of 0.3 high-risk medications prescribed. A mixed-methods process evaluation will explore potential mechanisms underlying the observed effects, exploring targeted constructs including intention, self-efficacy, outcome expectations, descriptive norms, and goal prioritization. An economic analysis will examine cost-effectiveness analysis from the perspective of the publicly funded health care system. This protocol

  7. Clustering in surgical trials - database of intracluster correlations

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    Cook Jonathan A

    2012-01-01

    Full Text Available Abstract Background Randomised trials evaluation of surgical interventions are often designed and analysed as if the outcome of individual patients is independent of the surgeon providing the intervention. There is reason to expect outcomes for patients treated by the same surgeon tend to be more similar than those under the care of another surgeon due to previous experience, individual practice, training, and infrastructure. Such a phenomenon is referred to as the clustering effect and potentially impacts on the design and analysis adopted and thereby the required sample size. The aim of this work was to inform trial design by quantifying clustering effects (at both centre and surgeon level for various outcomes using a database of surgical trials. Methods Intracluster correlation coefficients (ICCs were calculated for outcomes from a set of 10 multicentre surgical trials for a range of outcomes and different time points for clustering at both the centre and surgeon level. Results ICCs were calculated for 198 outcomes across the 10 trials at both centre and surgeon cluster levels. The number of cases varied from 138 to 1370 across the trials. The median (range average cluster size was 32 (9 to 51 and 6 (3 to 30 for centre and surgeon levels respectively. ICC estimates varied substantially between outcome type though uncertainty around individual ICC estimates was substantial, which was reflected in generally wide confidence intervals. Conclusions This database of surgical trials provides trialists with valuable information on how to design surgical trials. Our data suggests clustering of outcome is more of an issue than has been previously acknowledged. We anticipate that over time the addition of ICCs from further surgical trial datasets to our database will further inform the design of surgical trials.

  8. Improving mental health among ultra-poor children: Two-year outcomes of a cluster-randomized trial in Burkina Faso.

    Science.gov (United States)

    Ismayilova, Leyla; Karimli, Leyla; Sanson, Jo; Gaveras, Eleni; Nanema, Rachel; Tô-Camier, Alexice; Chaffin, Josh

    2018-07-01

    There is limited evidence about interventions improving child mental health in francophone West Africa. Behavioral mental health interventions alone may have limited effects on children's emotional well-being in families living in abject poverty, especially in low-income countries. This study tests the effects of economic intervention, alone and in combination with a family-focused component, on the mental health of children from ultra-poor households in rural Burkina Faso. The three-arm cluster randomized trial included children in the age range of 10-15 years old (N = 360), from twelve villages in Nord region of Burkina Faso (ClinicalTrial.gov ID: NCT02415933). Villages were randomized (4 villages/120 households per arm) to the waitlist arm, the economic intervention utilizing the Graduation approach (Trickle Up/TU arm), or to the economic strengthening plus family coaching component (TU + arm). Intervention effects were tested using repeated-measures mixed-effects regressions that account for the clustered nature of the data. Children from the TU + arm showed a reduction in depressive symptoms at 12 months (medium effect size Cohen's d = -0.41, p = .001) and 24 months (d = -0.39, p = .025), compared to the control condition and the economic intervention alone (at 12 months d = -0.22, p = .020). Small effect size improvements in self-esteem were detected in the TU + group, compared to the control arm at 12 months (d = 0.21) and to the TU arm at 24 months (d = 0.21). Trauma symptoms significantly reduced in the TU + group at 12 months (Incidence Risk Ratio/IRR = 0.62, 95% CI = 0.41, 0.92, p = .042), compared to the control group. Integrating psychosocial intervention involving all family members with economic empowerment strategies may be an innovative approach for improving emotional well-being among children living in extreme poverty. Copyright © 2018 Elsevier Ltd. All rights reserved.

  9. Cluster Randomized Controlled Trial Evaluation of a Gender Equity and Family Planning Intervention for Married Men and Couples in Rural India.

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    Anita Raj

    Full Text Available Despite ongoing recommendations to increase male engagement and gender-equity (GE counseling in family planning (FP services, few such programs have been implemented and rigorously evaluated. This study evaluates the impact of CHARM, a three-session GE+FP counseling intervention delivered by male health care providers to married men, alone (sessions 1&2 and with their wives (session 3 in India.A two-armed cluster randomized controlled trial was conducted with young married couples (N = 1081 couples recruited from 50 geographic clusters (25 clusters randomized to CHARM and a control condition, respectively in rural Maharashtra, India. Couples were surveyed on demographics, contraceptive behaviors, and intimate partner violence (IPV attitudes and behaviors at baseline and 9 &18-month follow-ups, with pregnancy testing at baseline and 18-month follow-up. Outcome effects on contraceptive use and incident pregnancy, and secondarily, on contraceptive communication and men's IPV attitudes and behaviors, were assessed using logistic generalized linear mixed models. Most men recruited from CHARM communities (91.3% received at least one CHARM intervention session; 52.5% received the couple's session with their wife. Findings document that women from the CHARM condition, relative to controls, were more likely to report contraceptive communication at 9-month follow-up (AOR = 1.77, p = 0.04 and modern contraceptive use at 9 and 18-month follow-ups (AORs = 1.57-1.58, p = 0.05, and they were less likely to report sexual IPV at 18-month follow-up (AOR = 0.48, p = 0.01. Men in the CHARM condition were less likely than those in the control clusters to report attitudes accepting of sexual IPV at 9-month (AOR = 0.64, p = 0.03 and 18-month (AOR = 0.51, p = 0.004 follow-up, and attitudes accepting of physical IPV at 18-month follow-up (AOR = 0.64, p = 0.02. No significant effect on pregnancy was seen.Findings demonstrate that men can be engaged in FP programming in

  10. Group sequential designs for stepped-wedge cluster randomised trials.

    Science.gov (United States)

    Grayling, Michael J; Wason, James Ms; Mander, Adrian P

    2017-10-01

    The stepped-wedge cluster randomised trial design has received substantial attention in recent years. Although various extensions to the original design have been proposed, no guidance is available on the design of stepped-wedge cluster randomised trials with interim analyses. In an individually randomised trial setting, group sequential methods can provide notable efficiency gains and ethical benefits. We address this by discussing how established group sequential methodology can be adapted for stepped-wedge designs. Utilising the error spending approach to group sequential trial design, we detail the assumptions required for the determination of stepped-wedge cluster randomised trials with interim analyses. We consider early stopping for efficacy, futility, or efficacy and futility. We describe first how this can be done for any specified linear mixed model for data analysis. We then focus on one particular commonly utilised model and, using a recently completed stepped-wedge cluster randomised trial, compare the performance of several designs with interim analyses to the classical stepped-wedge design. Finally, the performance of a quantile substitution procedure for dealing with the case of unknown variance is explored. We demonstrate that the incorporation of early stopping in stepped-wedge cluster randomised trial designs could reduce the expected sample size under the null and alternative hypotheses by up to 31% and 22%, respectively, with no cost to the trial's type-I and type-II error rates. The use of restricted error maximum likelihood estimation was found to be more important than quantile substitution for controlling the type-I error rate. The addition of interim analyses into stepped-wedge cluster randomised trials could help guard against time-consuming trials conducted on poor performing treatments and also help expedite the implementation of efficacious treatments. In future, trialists should consider incorporating early stopping of some kind into

  11. Effects of quality improvement in health facilities and community mobilization through women’s groups on maternal, neonatal and perinatal mortality in three districts of Malawi: MaiKhanda, a cluster randomized controlled effectiveness trial

    Science.gov (United States)

    Colbourn, Tim; Nambiar, Bejoy; Bondo, Austin; Makwenda, Charles; Tsetekani, Eric; Makonda-Ridley, Agnes; Msukwa, Martin; Barker, Pierre; Kotagal, Uma; Williams, Cassie; Davies, Ros; Webb, Dale; Flatman, Dorothy; Lewycka, Sonia; Rosato, Mikey; Kachale, Fannie; Mwansambo, Charles; Costello, Anthony

    2016-01-01

    Background Maternal, perinatal and neonatal mortality remains high in low-income countries. We evaluated community and facility-based interventions to reduce deaths in three districts of Malawi. Methods We evaluated a rural participatory women’s group community intervention (CI) and a quality improvement intervention at health centres (FI) via a two-by-two factorial cluster randomized controlled trial. Consenting pregnant women were followed-up to 2 months after birth using key informants. Primary outcomes were maternal, perinatal and neonatal mortality. Clusters were health centre catchment areas assigned using stratified computer-generated randomization. Following exclusions, including non-birthing facilities, 61 clusters were analysed: control (17 clusters, 4912 births), FI (15, 5335), CI (15, 5080) and FI + CI (14, 5249). This trial was registered as International Standard Randomised Controlled Trial [ISRCTN18073903]. Outcomes for 14 576 and 20 576 births were recorded during baseline (June 2007–September 2008) and intervention (October 2008–December 2010) periods. Results For control, FI, CI and FI + CI clusters neonatal mortality rates were 34.0, 28.3, 29.9 and 27.0 neonatal deaths per 1000 live births and perinatal mortality rates were 56.2, 55.1, 48.0 and 48.4 per 1000 births, during the intervention period. Adjusting for clustering and stratification, the neonatal mortality rate was 22% lower in FI + CI than control clusters (OR = 0.78, 95% CI 0.60–1.01), and the perinatal mortality rate was 16% lower in CI clusters (OR = 0.84, 95% CI 0.72–0.97). We did not observe any intervention effects on maternal mortality. Conclusions Despite implementation problems, a combined community and facility approach using participatory women’s groups and quality improvement at health centres reduced newborn mortality in rural Malawi. PMID:24030269

  12. Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

    Science.gov (United States)

    2014-01-01

    Background Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. Methods A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. Results A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. Conclusions Research ethics committees

  13. Improving Care for Patients With or at Risk for Chronic Kidney Disease Using Electronic Medical Record Interventions: A Pragmatic Cluster-Randomized Trial Protocol

    Science.gov (United States)

    Nash, Danielle M.; Ivers, Noah M.; Young, Jacqueline; Jaakkimainen, R. Liisa; Garg, Amit X.; Tu, Karen

    2017-01-01

    Background: Many patients with or at risk for chronic kidney disease (CKD) in the primary care setting are not receiving recommended care. Objective: The objective of this study is to determine whether a multifaceted, low-cost intervention compared with usual care improves the care of patients with or at risk for CKD in the primary care setting. Design: A pragmatic cluster-randomized trial, with an embedded qualitative process evaluation, will be conducted. Setting: The study population comes from the Electronic Medical Record Administrative data Linked Database®, which includes clinical data for more than 140 000 rostered adults cared for by 194 family physicians in 34 clinics across Ontario, Canada. The 34 primary care clinics will be randomized to the intervention or control group. Intervention: The intervention group will receive resources from the “CKD toolkit” to help improve care including practice audit and feedback, printed educational materials for physicians and patients, electronic decision support and reminders, and implementation support. Measurements: Patients with or at risk for CKD within participating clinics will be identified using laboratory data in the electronic medical records. Outcomes will be assessed after dissemination of the CKD tools and after 2 rounds of feedback on performance on quality indicators have been sent to the physicians using information from the electronic medical records. The primary outcome is the proportion of patients aged 50 to 80 years with nondialysis-dependent CKD who are on a statin. Secondary outcomes include process of care measures such as screening tests, CKD recognition, monitoring tests, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker prescriptions, blood pressure targets met, and nephrologist referral. Hierarchical analytic modeling will be performed to account for clustering. Semistructured interviews will be conducted with a random purposeful sample of physicians in the

  14. Does mass azithromycin distribution impact child growth and nutrition in Niger? A cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Abdou Amza

    2014-09-01

    Full Text Available Antibiotic use on animals demonstrates improved growth regardless of whether or not there is clinical evidence of infectious disease. Antibiotics used for trachoma control may play an unintended benefit of improving child growth.In this sub-study of a larger randomized controlled trial, we assess anthropometry of pre-school children in a community-randomized trial of mass oral azithromycin distributions for trachoma in Niger. We measured height, weight, and mid-upper arm circumference (MUAC in 12 communities randomized to receive annual mass azithromycin treatment of everyone versus 12 communities randomized to receive biannual mass azithromycin treatments for children, 3 years after the initial mass treatment. We collected measurements in 1,034 children aged 6-60 months of age.We found no difference in the prevalence of wasting among children in the 12 annually treated communities that received three mass azithromycin distributions compared to the 12 biannually treated communities that received six mass azithromycin distributions (odds ratio = 0.88, 95% confidence interval = 0.53 to 1.49.We were unable to demonstrate a statistically significant difference in stunting, underweight, and low MUAC of pre-school children in communities randomized to annual mass azithromycin treatment or biannual mass azithromycin treatment. The role of antibiotics on child growth and nutrition remains unclear, but larger studies and longitudinal trials may help determine any association.

  15. Resistance training program for fatigue management in the workplace: exercise protocol in a cluster randomized controlled trial.

    Science.gov (United States)

    Santos, Hélio Gustavo; Chiavegato, Luciana Dias; Valentim, Daniela Pereira; da Silva, Patricia Rodrigues; Padula, Rosimeire Simprini

    2016-12-22

    Fatigue is a multifactorial condition that leads to disease and loss in production, and it affects a large number of workers worldwide. This study aims to demonstrate a resistance exercise protocol that individuals will perform during the work schedule, and to evaluate the effectiveness of this exercises program for fatigue control. This is a cluster randomized controlled trial with two arms and is assessor blinded. A total of 352 workers of both sexes, aged 18-65 years, from a medium-sized dairy plant were enrolled in this study. Participants will be recruited from 13 production sectors according to the eligibility criteria and will be randomized by clusters to either the Progressive Resistance Exercise (PRE) intervention group or the Compensatory Workplace Exercise (CWE) comparative group. A resistance exercise program will be implemented for both groups. The groups will receive instructions on self-management, breaks, adjustments to workstations, and the benefits of physical exercise. The PRE group will perform resistance exercises with gradual loads in an exercise room, and the CWE group will perform exercise at their workstations using elastic bands. The exercise sessions will be held 3 times a week for 20 min. The primary outcome measures will be symptoms of physical and mental fatigue, and muscular fatigue based on a one-repetition maximum (1RM). The secondary outcome measures will be level of physical activity, musculoskeletal symptoms, physical condition, perceived exposure, and productivity. The workers will be assessed at baseline and after a 4-month program. A linear mixed model will be applied on an intention-to-treat basis. This intervention is expected to reduce symptoms of fatigue in the workers. The exercise program is indicating in the workplace, although there are few studies describing the effects of exercise on the control of fatigue in the workplace. Emphasis will be placed on adherence to the program, which may result in significant and

  16. The extended Infant Feeding, Activity and Nutrition Trial (InFANT Extend Program: a cluster-randomized controlled trial of an early intervention to prevent childhood obesity

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    Karen J. Campbell

    2016-02-01

    Full Text Available Abstract Background Understanding how we can prevent childhood obesity in scalable and sustainable ways is imperative. Early RCT interventions focused on the first two years of life have shown promise however, differences in Body Mass Index between intervention and control groups diminish once the interventions cease. Innovative and cost-effective strategies seeking to continue to support parents to engender appropriate energy balance behaviours in young children need to be explored. Methods/Design The Infant Feeding Activity and Nutrition Trial (InFANT Extend Program builds on the early outcomes of the Melbourne InFANT Program. This cluster randomized controlled trial will test the efficacy of an extended (33 versus 15 month and enhanced (use of web-based materials, and Facebook® engagement, version of the original Melbourne InFANT Program intervention in a new cohort. Outcomes at 36 months of age will be compared against the control group. Discussion This trial will provide important information regarding capacity and opportunities to maximize early childhood intervention effectiveness over the first three years of life. This study continues to build the evidence base regarding the design of cost-effective, scalable interventions to promote protective energy balance behaviors in early childhood, and in turn, promote improved child weight and health across the life course. Trial registration ACTRN12611000386932 . Registered 13 April 2011.

  17. Dissemination of Evidence-Based Antipsychotic Prescribing Guidelines to Nursing Homes: A Cluster Randomized Trial.

    Science.gov (United States)

    Tjia, Jennifer; Field, Terry; Mazor, Kathleen; Lemay, Celeste A; Kanaan, Abir O; Donovan, Jennifer L; Briesacher, Becky A; Peterson, Daniel; Pandolfi, Michelle; Spenard, Ann; Gurwitz, Jerry H

    2015-07-01

    To evaluate the effectiveness of efforts to translate and disseminate evidence-based guidelines about atypical antipsychotic use to nursing homes (NHs). Three-arm, cluster randomized trial. NHs. NHs in the state of Connecticut. Evidence-based guidelines for atypical antipsychotic prescribing were translated into a toolkit targeting NH stakeholders, and 42 NHs were recruited and randomized to one of three toolkit dissemination strategies: mailed toolkit delivery (minimal intensity); mailed toolkit delivery with quarterly audit and feedback reports about facility-level antipsychotic prescribing (moderate intensity); and in-person toolkit delivery with academic detailing, on-site behavioral management training, and quarterly audit and feedback reports (high intensity). Outcomes were evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Toolkit awareness of 30% (7/23) of leadership of low-intensity NHs, 54% (19/35) of moderate-intensity NHs, and 82% (18/22) of high-intensity NHs reflected adoption and implementation of the intervention. Highest levels of use and knowledge among direct care staff were reported in high-intensity NHs. Antipsychotic prescribing levels declined during the study period, but there were no statistically significant differences between study arms or from secular trends. RE-AIM indicators suggest some success in disseminating the toolkit and differences in reach, adoption, and implementation according to dissemination strategy but no measurable effect on antipsychotic prescribing trends. Further dissemination to external stakeholders such as psychiatry consultants and hospitals may be needed to influence antipsychotic prescribing for NH residents. © 2015, Copyright the Authors Journal compilation © 2015, The American Geriatrics Society.

  18. Effects of integrated chronic care models on hypertension outcomes and spending: a multi-town clustered randomized trial in China.

    Science.gov (United States)

    Zhang, Yuting; Tang, Wenxi; Zhang, Yan; Liu, Lulu; Zhang, Liang

    2017-03-11

    Hypertension affects one billion people globally and is one of the leading risk factors for cardiovascular and renal diseases. However, hypertension management remains poor, especially in rural China. A clustered randomized controlled trial was conducted in six towns in China's Qianjiang county between 7/2012 and 6/2014, including 5462 hypertension patients above 35 years old. Six towns were randomly assigned to three groups: Group 1 had the integrated care model including a multidisciplinary team and continuous care coordination, Group 2 had both the integrated care model and provider-level financial incentives, and the control group had the usual care. Primary outcomes were systolic blood pressure and health-related quality of life measured by SF36; secondary outcomes included hypertension-related hospitalization rate and inpatient spending. Blood pressure was measured sixteen times bimonthly between 12/1/2011 and 6/30/2014, and quality of life was measured on 7/1/2012 and 6/30/2014. Inpatient data between 7/1/2010 and 8/31/2014 were used. This trial is registered at the World Health Organization's International Clinical Trials Registry, number ChiCTR-OOR-14005563. We found that the integrated care model effectively lowered blood pressure by 1.93 mmHg (95% CI 0.063-3.8), improved self-assessed health-related quality of life, and reduced the rate of hypertension-related hospitalization by 0.17 percentage points (95% CI 0.094-0.24). We also found that the provider-level financial contract further lowered blood pressure by 1.76 mmHg (95% CI 0.73-2.79) and reduced rates of hospitalization and inpatient spending, but it also reduced patients' self-assessed health-related quality of life. Integrated care and financial incentives are effective in lowering blood pressure and reducing hospitalization rate, but financial contracts may hurt patient quality of life. This trial was registered at the Chinese Clinical Trial Registry (ChiCTR-OOR-14005563) on November 23, 2014

  19. Effects of integrated chronic care models on hypertension outcomes and spending: a multi-town clustered randomized trial in China

    Directory of Open Access Journals (Sweden)

    Yuting Zhang

    2017-03-01

    Full Text Available Abstract Background Hypertension affects one billion people globally and is one of the leading risk factors for cardiovascular and renal diseases. However, hypertension management remains poor, especially in rural China. Methods A clustered randomized controlled trial was conducted in six towns in China’s Qianjiang county between 7/2012 and 6/2014, including 5462 hypertension patients above 35 years old. Six towns were randomly assigned to three groups: Group 1 had the integrated care model including a multidisciplinary team and continuous care coordination, Group 2 had both the integrated care model and provider-level financial incentives, and the control group had the usual care. Primary outcomes were systolic blood pressure and health-related quality of life measured by SF36; secondary outcomes included hypertension-related hospitalization rate and inpatient spending. Blood pressure was measured sixteen times bimonthly between 12/1/2011 and 6/30/2014, and quality of life was measured on 7/1/2012 and 6/30/2014. Inpatient data between 7/1/2010 and 8/31/2014 were used. This trial is registered at the World Health Organization’s International Clinical Trials Registry, number ChiCTR-OOR-14005563. Results We found that the integrated care model effectively lowered blood pressure by 1.93 mmHg (95% CI 0.063–3.8, improved self-assessed health-related quality of life, and reduced the rate of hypertension-related hospitalization by 0.17 percentage points (95% CI 0.094–0.24. We also found that the provider-level financial contract further lowered blood pressure by 1.76 mmHg (95% CI 0.73–2.79 and reduced rates of hospitalization and inpatient spending, but it also reduced patients’ self-assessed health-related quality of life. Conclusions Integrated care and financial incentives are effective in lowering blood pressure and reducing hospitalization rate, but financial contracts may hurt patient quality of life. This trial was registered at

  20. A cluster-randomized trial of a college health center-based alcohol and sexual violence intervention (GIFTSS): Design, rationale, and baseline sample.

    Science.gov (United States)

    Abebe, Kaleab Z; Jones, Kelley A; Rofey, Dana; McCauley, Heather L; Clark, Duncan B; Dick, Rebecca; Gmelin, Theresa; Talis, Janine; Anderson, Jocelyn; Chugani, Carla; Algarroba, Gabriela; Antonio, Ashley; Bee, Courtney; Edwards, Clare; Lethihet, Nadia; Macak, Justin; Paley, Joshua; Torres, Irving; Van Dusen, Courtney; Miller, Elizabeth

    2018-02-01

    Sexual violence (SV) on college campuses is common, especially alcohol-related SV. This is a 2-arm cluster randomized controlled trial to test a brief intervention to reduce risk for alcohol-related sexual violence (SV) among students receiving care from college health centers (CHCs). Intervention CHC staff are trained to deliver universal SV education to all students seeking care, to facilitate patient and provider comfort in discussing SV and related abusive experiences (including the role of alcohol). Control sites provide participants with information about drinking responsibly. Across 28 participating campuses (12 randomized to intervention and 16 to control), 2292 students seeking care at CHCs complete surveys prior to their appointment (baseline), immediately after (exit), 4months later (T2) and one year later (T3). The primary outcome is change in recognition of SV and sexual risk. Among those reporting SV exposure at baseline, changes in SV victimization, disclosure, and use of SV services are additional outcomes. Intervention effects will be assessed using generalized linear mixed models that account for clustering of repeated observations both within CHCs and within students. Slightly more than half of the participating colleges have undergraduate enrollment of ≥3000 students; two-thirds are public and almost half are urban. Among participants there were relatively more Asian (10 v 1%) and Black/African American (13 v 7%) and fewer White (58 v 74%) participants in the intervention compared to control. This study will offer the first formal assessment for SV prevention in the CHC setting. Clinical Trials #: NCT02355470. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  1. Hand washing with soap and water together with behavioural recommendations prevents infections in common work environment: an open cluster-randomized trial.

    Science.gov (United States)

    Savolainen-Kopra, Carita; Haapakoski, Jaason; Peltola, Piia A; Ziegler, Thedi; Korpela, Terttu; Anttila, Pirjo; Amiryousefi, Ali; Huovinen, Pentti; Huvinen, Markku; Noronen, Heikki; Riikkala, Pia; Roivainen, Merja; Ruutu, Petri; Teirilä, Juha; Vartiainen, Erkki; Hovi, Tapani

    2012-01-16

    Hand hygiene is considered as an important means of infection control. We explored whether guided hand hygiene together with transmission-limiting behaviour reduces infection episodes and lost days of work in a common work environment in an open cluster-randomized 3-arm intervention trial. A total of 21 clusters (683 persons) were randomized to implement hand hygiene with soap and water (257 persons), with alcohol-based hand rub (202 persons), or to serve as a control (224 persons). Participants in both intervention arms also received standardized instructions on how to limit the transmission of infections. The intervention period (16 months) included the emergence of the 2009 influenza pandemic and the subsequent national hand hygiene campaign influencing also the control arm. In the total follow-up period there was a 6.7% reduction of infection episodes in the soap-and water arm (p = 0.04). Before the onset of the anti-pandemic campaign, a statistically significant (p = 0.002) difference in the mean occurrence of infection episodes was observed between the control (6.0 per year) and the soap-and-water arm (5.0 per year) but not between the control and the alcohol-rub arm (5.6 per year). Neither intervention had a decreasing effect on absence from work. We conclude that intensified hand hygiene using water and soap together with behavioural recommendations can reduce the occurrence of self-reported acute illnesses in common work environment. Surprisingly, the occurrence of reported sick leaves also increased in the soap-and water-arm. ClinicalTrials.gov: NCT00981877 The Finnish Work Environment Fund and the National Institute for Health and Welfare.

  2. Random matrix improved subspace clustering

    KAUST Repository

    Couillet, Romain

    2017-03-06

    This article introduces a spectral method for statistical subspace clustering. The method is built upon standard kernel spectral clustering techniques, however carefully tuned by theoretical understanding arising from random matrix findings. We show in particular that our method provides high clustering performance while standard kernel choices provably fail. An application to user grouping based on vector channel observations in the context of massive MIMO wireless communication networks is provided.

  3. Progressive Resistance and Balance Training for Falls Prevention in Long-Term Residential Aged Care: A Cluster Randomized Trial of the Sunbeam Program.

    Science.gov (United States)

    Hewitt, Jennifer; Goodall, Stephen; Clemson, Lindy; Henwood, Timothy; Refshauge, Kathryn

    2018-04-01

    Falls prevention is an international priority, and residents of long-term aged care fall approximately 3 times more often than community dwellers. There is a relative scarcity of published trials in this setting. Our objective was to undertake a randomized controlled trial to test the effect of published best practice exercise in long-term residential aged care. The trial was designed to determine if combined high level balance and moderate intensity progressive resistance training (the Sunbeam Program) is effective in reducing the rate of falls in residents of aged care facilities. A cluster randomized controlled trial of 16 residential aged care facilities and 221 participants was conducted. The broad inclusion criterion was permanent residents of aged care. Exclusions were diagnosed terminal illness, no medical clearance, permanent bed- or wheelchair-bound status, advanced Parkinson's disease, or insufficient cognition to participate in group exercise. Assessments were taken at baseline, after intervention, and at 12 months. Randomization was performed by computer-generated sequence to receive either the Sunbeam program or usual care. A cluster refers to an aged care facility. The program consisted of individually prescribed progressive resistance training plus balance exercise performed in a group setting for 50 hours over a 25-week period, followed by a maintenance period for 6 months. The primary outcome measure was the rate of falls (number of falls and days followed up). Secondary outcomes included physical performance (Short Physical Performance Battery), quality of life (36-item Short-Form Health Survey), functional mobility (University of Alabama Life Space Assessment), fear of falling (Falls Efficacy Scale International), and cognition (Addenbrooke's Cognitive Evaluation-revised). The rate of falls was reduced by 55% in the exercise group (incidence rate ratio = 0.45, 95% confidence interval 0.17-0.74); an improvement was also seen in physical

  4. Childhood asthma clusters and response to therapy in clinical trials.

    Science.gov (United States)

    Chang, Timothy S; Lemanske, Robert F; Mauger, David T; Fitzpatrick, Anne M; Sorkness, Christine A; Szefler, Stanley J; Gangnon, Ronald E; Page, C David; Jackson, Daniel J

    2014-02-01

    Childhood asthma clusters, or subclasses, have been developed by computational methods without evaluation of clinical utility. To replicate and determine whether childhood asthma clusters previously identified computationally in the Severe Asthma Research Program (SARP) are associated with treatment responses in Childhood Asthma Research and Education (CARE) Network clinical trials. A cluster assignment model was determined by using SARP participant data. A total of 611 participants 6 to 18 years old from 3 CARE trials were assigned to SARP pediatric clusters. Primary and secondary outcomes were analyzed by cluster in each trial. CARE participants were assigned to SARP clusters with high accuracy. Baseline characteristics were similar between SARP and CARE children of the same cluster. Treatment response in CARE trials was generally similar across clusters. However, with the caveat of a smaller sample size, children in the early-onset/severe-lung function cluster had best response with fluticasone/salmeterol (64% vs 23% 2.5× fluticasone and 13% fluticasone/montelukast in the Best ADd-on Therapy Giving Effective Responses trial; P = .011) and children in the early-onset/comorbidity cluster had the least clinical efficacy to treatments (eg, -0.076% change in FEV1 in the Characterizing Response to Leukotriene Receptor Antagonist and Inhaled Corticosteroid trial). In this study, we replicated SARP pediatric asthma clusters by using a separate, large clinical trials network. Early-onset/severe-lung function and early-onset/comorbidity clusters were associated with differential and limited response to therapy, respectively. Further prospective study of therapeutic response by cluster could provide new insights into childhood asthma treatment. Copyright © 2013 American Academy of Allergy, Asthma & Immunology. Published by Mosby, Inc. All rights reserved.

  5. Analysis of cost data in a cluster-randomized, controlled trial: comparison of methods

    DEFF Research Database (Denmark)

    Sokolowski, Ineta; Ørnbøl, Eva; Rosendal, Marianne

    studies have used non-valid analysis of skewed data. We propose two different methods to compare mean cost in two groups. Firstly, we use a non-parametric bootstrap method where the re-sampling takes place on two levels in order to take into account the cluster effect. Secondly, we proceed with a log......-transformation of the cost data and apply the normal theory on these data. Again we try to account for the cluster effect. The performance of these two methods is investigated in a simulation study. The advantages and disadvantages of the different approaches are discussed.......  We consider health care data from a cluster-randomized intervention study in primary care to test whether the average health care costs among study patients differ between the two groups. The problems of analysing cost data are that most data are severely skewed. Median instead of mean...

  6. Novel Ordered Stepped-Wedge Cluster Trial Designs for Detecting Ebola Vaccine Efficacy Using a Spatially Structured Mathematical Model.

    Directory of Open Access Journals (Sweden)

    Ibrahim Diakite

    2016-08-01

    Full Text Available During the 2014 Ebola virus disease (EVD outbreak, policy-makers were confronted with difficult decisions on how best to test the efficacy of EVD vaccines. On one hand, many were reluctant to withhold a vaccine that might prevent a fatal disease from study participants randomized to a control arm. On the other, regulatory bodies called for rigorous placebo-controlled trials to permit direct measurement of vaccine efficacy prior to approval of the products. A stepped-wedge cluster study (SWCT was proposed as an alternative to a more traditional randomized controlled vaccine trial to address these concerns. Here, we propose novel "ordered stepped-wedge cluster trial" (OSWCT designs to further mitigate tradeoffs between ethical concerns, logistics, and statistical rigor.We constructed a spatially structured mathematical model of the EVD outbreak in Sierra Leone. We used the output of this model to simulate and compare a series of stepped-wedge cluster vaccine studies. Our model reproduced the observed order of first case occurrence within districts of Sierra Leone. Depending on the infection risk within the trial population and the trial start dates, the statistical power to detect a vaccine efficacy of 90% varied from 14% to 32% for standard SWCT, and from 67% to 91% for OSWCTs for an alpha error of 5%. The model's projection of first case occurrence was robust to changes in disease natural history parameters.Ordering clusters in a step-wedge trial based on the cluster's underlying risk of infection as predicted by a spatial model can increase the statistical power of a SWCT. In the event of another hemorrhagic fever outbreak, implementation of our proposed OSWCT designs could improve statistical power when a step-wedge study is desirable based on either ethical concerns or logistical constraints.

  7. Home-based versus mobile clinic HIV testing and counseling in rural Lesotho: a cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Niklaus Daniel Labhardt

    2014-12-01

    Full Text Available The success of HIV programs relies on widely accessible HIV testing and counseling (HTC services at health facilities as well as in the community. Home-based HTC (HB-HTC is a popular community-based approach to reach persons who do not test at health facilities. Data comparing HB-HTC to other community-based HTC approaches are very limited. This trial compares HB-HTC to mobile clinic HTC (MC-HTC.The trial was powered to test the hypothesis of higher HTC uptake in HB-HTC campaigns than in MC-HTC campaigns. Twelve clusters were randomly allocated to HB-HTC or MC-HTC. The six clusters in the HB-HTC group received 30 1-d multi-disease campaigns (five villages per cluster that delivered services by going door-to-door, whereas the six clusters in MC-HTC group received campaigns involving community gatherings in the 30 villages with subsequent service provision in mobile clinics. Time allocation and human resources were standardized and equal in both groups. All individuals accessing the campaigns with unknown HIV status or whose last HIV test was >12 wk ago and was negative were eligible. All outcomes were assessed at the individual level. Statistical analysis used multivariable logistic regression. Odds ratios and p-values were adjusted for gender, age, and cluster effect. Out of 3,197 participants from the 12 clusters, 2,563 (80.2% were eligible (HB-HTC: 1,171; MC-HTC: 1,392. The results for the primary outcomes were as follows. Overall HTC uptake was higher in the HB-HTC group than in the MC-HTC group (92.5% versus 86.7%; adjusted odds ratio [aOR]: 2.06; 95% CI: 1.18-3.60; p = 0. 011. Among adolescents and adults ≥ 12 y, HTC uptake did not differ significantly between the two groups; however, in children <12 y, HTC uptake was higher in the HB-HTC arm (87.5% versus 58.7%; aOR: 4.91; 95% CI: 2.41-10.0; p<0.001. Out of those who took up HTC, 114 (4.9% tested HIV-positive, 39 (3.6% in the HB-HTC arm and 75 (6.2% in the MC-HTC arm (aOR: 0.64; 95% CI

  8. The effect of financial incentives on top of behavioral support on quit rates in tobacco smoking employees: study protocol of a cluster-randomized trial.

    Science.gov (United States)

    van den Brand, F A; Nagelhout, G E; Winkens, B; Evers, S M A A; Kotz, D; Chavannes, N H; van Schayck, C P

    2016-10-06

    Stimulating successful tobacco cessation among employees has multiple benefits. Employees who quit tobacco are healthier, more productive, less absent from work, and longer employable than employees who continue to use tobacco. Despite the evidence for these benefits of tobacco cessation, a successful method to stimulate employees to quit tobacco is lacking. The aim of this study is to evaluate whether adding a financial incentive to behavioral support (compared with no additional incentive) is effective and cost-effective in increasing abstinence rates in tobacco smoking employees participating in a smoking cessation group training. In this cluster-randomized trial employees in the intervention and control group both participate in a smoking cessation group training consisting of seven weekly counseling sessions of ninety minutes each. In addition to the training, employees in the intervention group receive a voucher as an incentive for being abstinent from smoking at the end of the training (€50), after three months (€50), after six months (€50), and after one year (€200). The control group does not receive any incentive. The primary outcome is carbon monoxide validated 12-month continuous abstinence from smoking (Russel's standard). Additionally, an economic evaluation is performed from a societal and an employer perspective. The present paper describes the methods and design of this cluster-randomized trial in detail. We hypothesize that the financial incentive for abstinence in the form of vouchers increases abstinence rates over and above the group training. The results of this study can provide important recommendations for enhancement of employee tobacco cessation. Dutch Trial Register: NTR5657 . First received 27-01-2016.

  9. Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Adang Eddy

    2009-06-01

    Full Text Available Abstract Background Care for people with dementia and their informal caregivers is a challenging aim in healthcare. There is an urgent need for cost-effective support programs that prevent informal caregivers of people with dementia from becoming overburdened, which might result in a delay or decrease of patient institutionalization. For this reason, we have developed the Systematic Care Program for Dementia (SCPD. The SCPD consists of an assessment of caregiver's sense of competence and suggestions on how to deal with competence deficiencies. The efficiency of the SCPD will be evaluated in our study. Methods and design In our ongoing, cluster, randomized, single-blind, controlled trial, the participants in six mental health services in four regions of the Netherlands have been randomized per service. Professionals of the ambulatory mental health services (psychologists and social psychiatric nurses have been randomly allocated to either the intervention group or the control group. The study population consists of community-dwelling people with dementia and their informal caregivers (patient-caregiver dyads coming into the health service. The dyads have been clustered to the professionals. The primary outcome measure is the patient's admission to a nursing home or home for the elderly at 12 months of follow-up. This measure is the most important variable for estimating cost differences between the intervention group and the control group. The secondary outcome measure is the quality of the patient's and caregiver's lives. Discussion A novelty in the SCPD is the pro-active and systematic approach. The focus on the caregiver's sense of competence is relevant to economical healthcare, since this sense of competence is an important determinant of delay of institutionalization of people with dementia. The SCPD might be able to facilitate this with a relatively small cost investment for caregivers' support, which could result in a major decrease in

  10. The Diabetes Telephone Study: Design and challenges of a pragmatic cluster randomized trial to improve diabetic peripheral neuropathy treatment.

    Science.gov (United States)

    Adams, Alyce S; Bayliss, Elizabeth A; Schmittdiel, Julie A; Altschuler, Andrea; Dyer, Wendy; Neugebauer, Romain; Jaffe, Marc; Young, Joseph D; Kim, Eileen; Grant, Richard W

    2016-06-01

    Challenges to effective pharmacologic management of symptomatic diabetic peripheral neuropathy include the limited effectiveness of available medicines, frequent side effects, and the need for ongoing symptom assessment and treatment titration for maximal effectiveness. We present here the rationale and implementation challenges of the Diabetes Telephone Study, a randomized trial designed to improve medication treatment, titration, and quality of life among patients with symptomatic diabetic peripheral neuropathy. We implemented a pragmatic cluster randomized controlled trial to test the effectiveness of an automated interactive voice response tool designed to provide physicians with real-time patient-reported data about responses to newly prescribed diabetic peripheral neuropathy medicines. A total of 1834 primary care physicians treating patients in the diabetes registry at Kaiser Permanente Northern California were randomized into the intervention or control arm. In September 2014, we began identification and recruitment of patients assigned to physicians in the intervention group who receive three brief interactive calls every 2 months after a medication is prescribed to alleviate diabetic peripheral neuropathy symptoms. These calls provide patients with the opportunity to report on symptoms, side effects, self-titration of medication dose and overall satisfaction with treatment. We plan to compare changes in self-reported quality of life between the intervention group and patients in the control group who receive three non-interactive automated educational phone calls. Successful implementation of this clinical trial required robust stakeholder engagement to help tailor the intervention and to address pragmatic concerns such as provider time constraints. As of 27 October 2015, we had screened 2078 patients, 1447 of whom were eligible for participation. We consented and enrolled 1206 or 83% of those eligible. Among those enrolled, 53% are women and the mean age

  11. Supportive supervision for volunteers to deliver reproductive health education: a cluster randomized trial.

    Science.gov (United States)

    Singh, Debra; Negin, Joel; Orach, Christopher Garimoi; Cumming, Robert

    2016-10-03

    Community Health Volunteers (CHVs) can be effective in improving pregnancy and newborn outcomes through community education. Inadequate supervision of CHVs, whether due to poor planning, irregular visits, or ineffective supervisory methods, is, however, recognized as a weakness in many programs. There has been little research on best practice supervisory or accompaniment models. From March 2014 to February 2015 a proof of concept study was conducted to compare training alone versus training and supportive supervision by paid CHWs (n = 4) on the effectiveness of CHVs (n = 82) to deliver education about pregnancy, newborn care, family planning and hygiene. The pair-matched cluster randomized trial was conducted in eight villages (four intervention and four control) in Budondo sub-county in Jinja, Uganda. Increases in desired behaviors were seen in both the intervention and control arms over the study period. Both arms showed high retention rates of CHVs (95 %). At 1 year follow-up there was a significantly higher prevalence of installed and functioning tippy taps for hand washing (p services. Supportive supervision involves creating a non-threatening, empowering environment in which both the CHV and the supervising CHW learn together and overcome obstacles that might otherwise demotivate the CHV. While the results seem promising for added value with supportive supervision for CHVs undertaking reproductive health activities, further research on a larger scale will be needed to substantiate the effect.

  12. Percolation and epidemics in random clustered networks

    Science.gov (United States)

    Miller, Joel C.

    2009-08-01

    The social networks that infectious diseases spread along are typically clustered. Because of the close relation between percolation and epidemic spread, the behavior of percolation in such networks gives insight into infectious disease dynamics. A number of authors have studied percolation or epidemics in clustered networks, but the networks often contain preferential contacts in high degree nodes. We introduce a class of random clustered networks and a class of random unclustered networks with the same preferential mixing. Percolation in the clustered networks reduces the component sizes and increases the epidemic threshold compared to the unclustered networks.

  13. Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial.

    Science.gov (United States)

    Rodriguez-Cristobal, Juan Jose; Alonso-Villaverde, Carlos; Panisello, Jose Ma; Travé-Mercade, Pere; Rodriguez-Cortés, Francisca; Marsal, Josep Ramon; Peña, Esther

    2017-06-20

    Overweight and obesity are common health problems which increase the risk of developing several serious health conditions. The main difficulty in the management of weight-loss lies in its maintenance, once it is achieved. The aim of this study was to investigate whether a motivational intervention, together with current clinical practice, was more efficient than a traditional intervention, in the treatment of overweight and obesity and whether this intervention reduces cardiovascular risk factors associated with overweight and obesity. Multi-centre cluster randomized trial with a 24-month follow-up included 864 overweight/obese patients randomly assigned. Motivational intervention group (400 patients), delivered by a nurse trained by an expert psychologist, in 32 sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard programmed diet and exercise. The control group (446 patients), received the usual follow-up. Weight reduction was statistically significant in the second year with a mean reduction of 1.0 Kg in the control group and 2.5 Kg in the intervention group (p = 0. 02). While 18.1% of patients in the control group reduced their weight by more than 5%, this percentage rose to 26.9% in the intervention group, which is statistically significant (p = 0.04). Patients in the motivational intervention group had significantly greater improvements in triglycerides and APOB/APOA1ratio. The results highlight the importance of the group motivational interview in the treatment of overweight /obese patients in primary care, and in the improvement of their associated cardiovascular risks factors. ClinicalTrials.gov Identifier: NCT01006213 October 30, 2009.

  14. Mobile phones improve antenatal care attendance in Zanzibar: a cluster randomized controlled trial

    Science.gov (United States)

    2014-01-01

    Background Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems. Antenatal care has the potential to reduce maternal morbidity and improve newborns’ survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining. We evaluated the association between a mobile phone intervention and antenatal care in a resource-limited setting. We aimed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy. Methods This study was an open label pragmatic cluster-randomised controlled trial with primary healthcare facilities in Zanzibar as the unit of randomisation. 2550 pregnant women (1311 interventions and 1239 controls) who attended antenatal care at selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery. 24 primary health care facilities in six districts were randomized to either mobile phone intervention or standard care. The intervention consisted of a mobile phone text-message and voucher component. Primary outcome measure was four or more antenatal care visits during pregnancy. Secondary outcome measures were tetanus vaccination, preventive treatment for malaria, gestational age at last antenatal care visit, and antepartum referral. Results The mobile phone intervention was associated with an increase in antenatal care attendance. In the intervention group 44% of the women received four or more antenatal care visits versus 31% in the control group (OR, 2.39; 95% CI, 1.03-5.55). There was a trend towards improved timing and quality of antenatal care services across all secondary outcome measures although not statistically significant. Conclusions The wired mothers’ mobile phone intervention significantly increased the proportion of women receiving the recommended four antenatal care

  15. School-based strategies for oral health education of adolescents- a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Haleem Abdul

    2012-12-01

    Full Text Available Abstract Background Oral health education (OHE in schools has largely been imparted by dental professionals. Considering the substantial cost of this expert-led approach, the strategies relying on teachers, peer-leaders and learners themselves have also been utilized. However the evidence for comparative effectiveness of these strategies is lacking in the dental literature. The present study was conducted to compare the effectiveness of dentist-led, teacher-led, peer-led and self-learning strategies of oral health education. Methods A two-year cluster randomized controlled trial following a parallel design was conducted. It involved five groups of adolescents aged 10-11 years at the start of the study. The trial involved process as well as four outcome evaluations. The present paper discusses the findings of the study pertaining to the baseline and final outcome evaluation, both comprising of a self-administered questionnaire, a structured interview and clinical oral examination. The data were analyzed using Generalized Estimating Equations. Results All the three educator-led strategies of OHE had statistically higher mean oral health knowledge (OHK, oral health behavior (OHB, oral hygiene status (OHS and combined knowledge, behavior and oral hygiene status (KBS scores than the self-learning and control groups (p Conclusions The dentist-led, teacher-led and peer-led strategies of oral health education are equally effective in improving the oral health knowledge and oral hygiene status of adolescents. The peer-led strategy, however, is almost as effective as the dentist-led strategy and comparatively more effective than the teacher-led and self-learning strategies in improving their oral health behavior. Trail registration SRCTN39391017

  16. The PULSAR Specialist Care protocol: a stepped-wedge cluster randomized control trial of a training intervention for community mental health teams in recovery-oriented practice.

    Science.gov (United States)

    Shawyer, Frances; Enticott, Joanne C; Brophy, Lisa; Bruxner, Annie; Fossey, Ellie; Inder, Brett; Julian, John; Kakuma, Ritsuko; Weller, Penelope; Wilson-Evered, Elisabeth; Edan, Vrinda; Slade, Mike; Meadows, Graham N

    2017-05-08

    Recovery features strongly in Australian mental health policy; however, evidence is limited for the efficacy of recovery-oriented practice at the service level. This paper describes the Principles Unite Local Services Assisting Recovery (PULSAR) Specialist Care trial protocol for a recovery-oriented practice training intervention delivered to specialist mental health services staff. The primary aim is to evaluate whether adult consumers accessing services where staff have received the intervention report superior recovery outcomes compared to adult consumers accessing services where staff have not yet received the intervention. A qualitative sub-study aims to examine staff and consumer views on implementing recovery-oriented practice. A process evaluation sub-study aims to articulate important explanatory variables affecting the interventions rollout and outcomes. The mixed methods design incorporates a two-step stepped-wedge cluster randomized controlled trial (cRCT) examining cross-sectional data from three phases, and nested qualitative and process evaluation sub-studies. Participating specialist mental health care services in Melbourne, Victoria are divided into 14 clusters with half randomly allocated to receive the staff training in year one and half in year two. Research participants are consumers aged 18-75 years who attended the cluster within a previous three-month period either at baseline, 12 (step 1) or 24 months (step 2). In the two nested sub-studies, participation extends to cluster staff. The primary outcome is the Questionnaire about the Process of Recovery collected from 756 consumers (252 each at baseline, step 1, step 2). Secondary and other outcomes measuring well-being, service satisfaction and health economic impact are collected from a subset of 252 consumers (63 at baseline; 126 at step 1; 63 at step 2) via interviews. Interview-based longitudinal data are also collected 12 months apart from 88 consumers with a psychotic disorder

  17. Personalized PageRank Clustering: A graph clustering algorithm based on random walks

    Science.gov (United States)

    A. Tabrizi, Shayan; Shakery, Azadeh; Asadpour, Masoud; Abbasi, Maziar; Tavallaie, Mohammad Ali

    2013-11-01

    Graph clustering has been an essential part in many methods and thus its accuracy has a significant effect on many applications. In addition, exponential growth of real-world graphs such as social networks, biological networks and electrical circuits demands clustering algorithms with nearly-linear time and space complexity. In this paper we propose Personalized PageRank Clustering (PPC) that employs the inherent cluster exploratory property of random walks to reveal the clusters of a given graph. We combine random walks and modularity to precisely and efficiently reveal the clusters of a graph. PPC is a top-down algorithm so it can reveal inherent clusters of a graph more accurately than other nearly-linear approaches that are mainly bottom-up. It also gives a hierarchy of clusters that is useful in many applications. PPC has a linear time and space complexity and has been superior to most of the available clustering algorithms on many datasets. Furthermore, its top-down approach makes it a flexible solution for clustering problems with different requirements.

  18. A hand hygiene intervention to decrease infections among children attending day care centers: design of a cluster randomized controlled trial.

    Science.gov (United States)

    Zomer, Tizza P; Erasmus, Vicki; Vlaar, Nico; van Beeck, Ed F; Tjon-A-Tsien, Aimée; Richardus, Jan Hendrik; Voeten, Hélène A C M

    2013-06-03

    Day care center attendance has been recognized as a risk factor for acquiring gastrointestinal and respiratory infections, which can be prevented with adequate hand hygiene (HH). Based on previous studies on environmental and sociocognitive determinants of caregivers' compliance with HH guidelines in day care centers (DCCs), an intervention has been developed aiming to improve caregivers' and children's HH compliance and decrease infections among children attending DCCs. The aim of this paper is to describe the design of a cluster randomized controlled trial to evaluate the effectiveness of this intervention. The intervention will be evaluated in a two-arm cluster randomized controlled trial among 71 DCCs in the Netherlands. In total, 36 DCCs will receive the intervention consisting of four components: 1) HH products (dispensers and refills for paper towels, soap, alcohol-based hand sanitizer, and hand cream); 2) training to educate about the Dutch national HH guidelines; 3) two team training sessions aimed at goal setting and formulating specific HH improvement activities; and 4) reminders and cues to action (posters/stickers). Intervention DCCs will be compared to 35 control DCCs continuing usual practice. The primary outcome measure will be observed HH compliance of caregivers and children, measured at baseline and one, three, and six months after start of the intervention. The secondary outcome measure will be the incidence of gastrointestinal and respiratory infections in 600 children attending DCCs, monitored over six months by parents using a calendar to mark the days their child has diarrhea and/or a cold. Multilevel logistic regression will be performed to assess the effect of the intervention on HH compliance. Multilevel poisson regression will be performed to assess the incidence of gastrointestinal and respiratory infections in children attending DCCs. This is one of the first DCC intervention studies to assess HH compliance of both caregivers and

  19. Test of a workforce development intervention to expand opioid use disorder treatment pharmacotherapy prescribers: protocol for a cluster randomized trial.

    Science.gov (United States)

    Molfenter, Todd; Knudsen, Hannah K; Brown, Randy; Jacobson, Nora; Horst, Julie; Van Etten, Mark; Kim, Jee-Seon; Haram, Eric; Collier, Elizabeth; Starr, Sanford; Toy, Alexander; Madden, Lynn

    2017-11-15

    Overdoses due to non-medical use of prescription opioids and other opiates have become the leading cause of accidental deaths in the USA. Buprenorphine and extended-release naltrexone are key evidence-based pharmacotherapies available to addiction treatment providers to address opioid use disorder (OUD) and prevent overdose deaths. Treatment organizations' efforts to provide these pharmacotherapies have, however, been stymied by limited success in recruiting providers (physicians, nurse practitioners, and physician assistants) to prescribe these medications. Historically, the addiction treatment field has not attracted physicians, and many barriers to implementing OUD pharmacotherapy exist, ranging from lack of confidence in treating OUD patients to concerns regarding reimbursement. Throughout the USA, the prevalence of OUD far exceeds the capacity of the OUD pharmacotherapy treatment system. Poor access to OUD pharmacotherapy prescribers has become a workforce development need for the addiction treatment field and a significant health issue. This cluster randomized controlled trial (RCT) is designed to increase buprenorphine and extended-release naltrexone treatment capacity for OUD. The implementation intervention to be tested is a bundle of OUD pharmacotherapy capacity building practices called the Prescriber Recruitment Bundle (PRB), which was developed and piloted in a previous statewide buprenorphine implementation study. For this cluster RCT, organizational sites will be recruited and then randomized into one of two arms: (1) control, with treatment as usual and access to a website with PRB resources, or (2) intervention, with organizations implementing the PRB using the Network for the Improvement of Addiction Treatment organizational change model over a 24-month intervention period and a 10-month sustainability period. The primary treatment outcomes for each organizational site are self-reported monthly counts of buprenorphine slots, extended

  20. Effects of Nurse-Led Multifactorial Care to Prevent Disability in Community-Living Older People : Cluster Randomized Trial

    NARCIS (Netherlands)

    Suijker, Jacqueline J.; van Rijn, Marjon; Buurman, Bianca M.; ter Riet, Gerben; van Charante, Eric P. Moll; de Rooij, Sophia E.

    2016-01-01

    Background To evaluate the effects of nurse-led multifactorial care to prevent disability in community-living older people. Methods In a cluster randomized trail, 11 practices (n = 1,209 participants) were randomized to the intervention group, and 13 practices (n = 1,074 participants) were

  1. Control of Phlebotomus argentipes (Diptera: Psychodidae sand fly in Bangladesh: A cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Rajib Chowdhury

    2017-09-01

    Full Text Available A number of studies on visceral leishmaniasis (VL vector control have been conducted during the past decade, sometimes came to very different conclusion. The present study on a large sample investigated different options which are partially unexplored including: (1 indoor residual spraying (IRS with alpha cypermethrin 5WP; (2 long lasting insecticide impregnated bed-net (LLIN; (3 impregnation of local bed-nets with slow release insecticide K-O TAB 1-2-3 (KOTAB; (4 insecticide spraying in potential breeding sites outside of house using chlorpyrifos 20EC (OUT and different combinations of the above.The study was a cluster randomized controlled trial where 3089 houses from 11 villages were divided into 10 sections, each section with 6 clusters and each cluster having approximately 50 houses. Based on vector density (males plus females during baseline survey, the 60 clusters were categorized into 3 groups: (1 high, (2 medium and (3 low. Each group had 20 clusters. From these three groups, 6 clusters (about 300 households were randomly selected for each type of intervention and control arms. Vector density was measured before and 2, 4, 5, 7, 11, 14, 15, 18 and 22 months after intervention using CDC light traps. The impact of interventions was measured by using the difference-in-differences regression model.A total of 17,434 sand flies were collected at baseline and during the surveys conducted over 9 months following the baseline measurements. At baseline, the average P. argentipes density per household was 10.6 (SD = 11.5 in the control arm and 7.3 (SD = 8.46 to 11.5 (SD = 20.2 in intervention arms. The intervention results presented as the range of percent reductions of sand flies (males plus females and rate ratios in 9 measurements over 22 months. Among single type interventions, the effect of IRS with 2 rounds of spraying (applied by the research team ranged from 13% to 75% reduction of P. argentipes density compared to the control arm (rate

  2. Implementing Resistance Training in Secondary Schools: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Kennedy, Sarah G; Smith, Jordan J; Morgan, Philip J; Peralta, Louisa R; Hilland, Toni A; Eather, Narelle; Lonsdale, Chris; Okely, Anthony D; Plotnikoff, Ronald C; Salmon, J O; Dewar, Deborah L; Estabrooks, Paul A; Pollock, Emma; Finn, Tara L; Lubans, David R

    2018-01-01

    Guidelines recommend that young people engage in muscle-strengthening activities on at least 3 d·wk. The purpose of this study was to examine the effect of a school-based intervention focused on resistance training (RT) for adolescents. The "Resistance Training for Teens" intervention was evaluated using a cluster-randomized, controlled trial with 607 adolescents (50.1% girls; 14.1 ± 0.5 yr) from 16 secondary schools. Teachers were trained to deliver the intervention, which included the following: (i) an interactive student seminar; (ii) a structured physical activity program, focused on RT; (iii) lunchtime fitness sessions; and (iv) Web-based smartphone apps. The primary outcome was muscular fitness (MF) and secondary outcomes included body mass index, RT skill competency, flexibility, physical activity, self-efficacy, and motivation. Assessments were conducted at baseline, 6 months (postprogram; primary end point), and 12 months (follow-up). Outcomes were assessed using linear mixed models, with three potential moderators tested using interaction terms (and subgroup analyses where appropriate). For the primary outcome (MF), a group-time effect was observed at 6 months for the upper body (2.0 repetitions; 95% confidence interval (CI), 0.8-3.2), but not the lower body (-1.4 cm; 95% CI, -4.7-1.9). At 6 months, there were intervention effects for RT skill competency and self-efficacy, but no other secondary outcomes. Effects for upper body MF and RT skill competency were sustained at 12 months. Despite overall no effect for body mass index, there was a group-time effect at 12 months among students who were overweight/obese at baseline (-0.55 kg·m; 95% CI, -1.01 to -0.08). The school-based RT intervention resulted in immediate and sustained improvements in upper body MF and RT skill competency, demonstrating an effective and scalable approach to delivering RT within secondary schools.

  3. Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial.

    Science.gov (United States)

    Rockers, Peter C; Zanolini, Arianna; Banda, Bowen; Chipili, Mwaba Moono; Hughes, Robert C; Hamer, Davidson H; Fink, Günther

    2018-04-01

    Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia. We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads) or control (15 clusters, 258 caregiver-child dyads). Caregivers were eligible if they had a child 6 to 12 months old at baseline. In intervention clusters, caregivers were visited twice per month during the first year of the study by child development agents (CDAs) and were invited to attend fortnightly parenting group meetings. Parenting groups selected "head mothers" from their communities who were trained by CDAs to facilitate meetings and deliver a diverse parenting curriculum. The parenting group intervention, originally designed to run for 1 year, was extended, and households were visited for a follow-up assessment at the end of year 2. The control group did not receive any intervention. Intention-to-treat analysis was performed for primary outcomes measured at the year 2 follow-up: stunting and 5 domains of neurocognitive development measured using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III). In order to show Cohen's d estimates, BSID-III composite scores were converted to z-scores by standardizing within the study population. In all, 195/268 children (73%) in the intervention group and 182/258 children (71%) in the control group were assessed at endline after 2 years. The intervention significantly reduced stunting (56/195 versus 72/182; adjusted odds ratio 0.45, 95% CI 0.22 to 0.92; p = 0.028) and had a significant positive impact on language (β 0.14, 95% CI 0.01 to 0.27; p = 0.039). The intervention did not significantly impact cognition (β 0

  4. Two-year impact of community-based health screening and parenting groups on child development in Zambia: Follow-up to a cluster-randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Peter C Rockers

    2018-04-01

    Full Text Available Early childhood interventions have potential to offset the negative impact of early adversity. We evaluated the impact of a community-based parenting group intervention on child development in Zambia.We conducted a non-masked cluster-randomized controlled trial in Southern Province, Zambia. Thirty clusters of villages were matched based on population density and distance from the nearest health center, and randomly assigned to intervention (15 clusters, 268 caregiver-child dyads or control (15 clusters, 258 caregiver-child dyads. Caregivers were eligible if they had a child 6 to 12 months old at baseline. In intervention clusters, caregivers were visited twice per month during the first year of the study by child development agents (CDAs and were invited to attend fortnightly parenting group meetings. Parenting groups selected "head mothers" from their communities who were trained by CDAs to facilitate meetings and deliver a diverse parenting curriculum. The parenting group intervention, originally designed to run for 1 year, was extended, and households were visited for a follow-up assessment at the end of year 2. The control group did not receive any intervention. Intention-to-treat analysis was performed for primary outcomes measured at the year 2 follow-up: stunting and 5 domains of neurocognitive development measured using the Bayley Scales of Infant and Toddler Development-Third Edition (BSID-III. In order to show Cohen's d estimates, BSID-III composite scores were converted to z-scores by standardizing within the study population. In all, 195/268 children (73% in the intervention group and 182/258 children (71% in the control group were assessed at endline after 2 years. The intervention significantly reduced stunting (56/195 versus 72/182; adjusted odds ratio 0.45, 95% CI 0.22 to 0.92; p = 0.028 and had a significant positive impact on language (β 0.14, 95% CI 0.01 to 0.27; p = 0.039. The intervention did not significantly impact

  5. Using the 4 pillars™ practice transformation program to increase adult influenza vaccination and reduce missed opportunities in a randomized cluster trial

    Directory of Open Access Journals (Sweden)

    Chyongchiou J. Lin

    2016-11-01

    Full Text Available Abstract Background An evidence-based, step-by-step guide, the 4 Pillars™ Practice Transformation Program, was the foundation of an intervention to increase adult immunizations in primary care and was tested in a randomized controlled cluster trial. The purpose of this study is to report changes in influenza immunization rates and on factors related to receipt of influenza vaccine. Methods Twenty five primary care practices were recruited in 2013, stratified by city (Houston, Pittsburgh, location (rural, urban, suburban and type (family medicine, internal medicine, and randomized to the intervention (n = 13 or control (n = 12 in Year 1 (2013-14. A follow-up intervention occurred in Year 2 (2014-15. Demographic and vaccination data were derived from de-identified electronic medical record extractions. Results A cohort of 70,549 adults seen in their respective practices (n = 24 with 1 drop out at least once each year was followed. Baseline mean age was 55.1 years, 35 % were men, 21 % were non-white and 35 % were Hispanic. After one year, both intervention and control arms significantly (P < 0.001 increased influenza vaccination, with average increases of 2.7 to 6.5 percentage points. In regression analyses, likelihood of influenza vaccination was significantly higher in sites with lower percentages of patients with missed opportunities (P < 0.001 and, after adjusting for missed opportunities, the intervention further improved vaccination rates in Houston (lower baseline rates but not Pittsburgh (higher baseline rates. In the follow-up intervention, the likelihood of vaccination increased for both intervention sites and those that reduced missed opportunities (P < 0.005. Conclusions Reducing missed opportunities across the practice increases likelihood of influenza vaccination of adults. The 4 Pillars™ Practice Transformation Program provides strategies for reducing missed opportunities to vaccinate adults. Trial

  6. Motivational Interviewing for Workers with Disabling Musculoskeletal Disorders: Results of a Cluster Randomized Control Trial.

    Science.gov (United States)

    Park, Joanne; Esmail, Shaniff; Rayani, Fahreen; Norris, Colleen M; Gross, Douglas P

    2018-06-01

    Purpose Although functional restoration programs appear effective in assisting injured workers to return-to-work (RTW) after a work related musculoskeletal (MSK) disorder, the addition of Motivational Interviewing (MI) to these programs may result in higher RTW. Methods We conducted a cluster randomized controlled trial with claimants attending an occupational rehabilitation facility from November 17, 2014 to June 30, 2015. Six clinicians provided MI in addition to the standard functional restoration program and formed an intervention group. Six clinicians continued to provide the standard functional restoration program based on graded activity, therapeutic exercise, and workplace accommodations. Independent t tests and chi square analysis were used to compare groups. Multivariable logistic regression was used to obtain the odds ratio of claimants' confirmed RTW status at time of program discharge. Results 728 workers' compensation claimants with MSK disorders were entered into 1 of 12 therapist clusters (MI group = 367, control group = 361). Claimants were predominantly employed (72.7%), males (63.2%), with moderate levels of pain and disability (mean pain VAS = 5.0/10 and mean Pain Disability Index = 48/70). Claimants were stratified based on job attachment status. The proportion of successful RTW at program discharge was 12.1% higher for unemployed workers in the intervention group (intervention group 21.6 vs. 9.5% in control, p = 0.03) and 3.0% higher for job attached workers compared to the control group (intervention group 97.1 vs. 94.1% in control, p = 0.10). Adherence to MI was mixed, but RTW was significantly higher among MI-adherent clinicians. The odds ratio for unemployed claimants was 2.64 (0.69-10.14) and 2.50 (0.68-9.14) for employed claimants after adjusting for age, sex, pain intensity, perceived disability, and therapist cluster. Conclusion MI in addition to routine functional restoration is more effective than routine

  7. Impact on Prehospital Delay of a Stroke Preparedness Campaign: A SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial).

    Science.gov (United States)

    Denti, Licia; Caminiti, Caterina; Scoditti, Umberto; Zini, Andrea; Malferrari, Giovanni; Zedde, Maria Luisa; Guidetti, Donata; Baratti, Mario; Vaghi, Luca; Montanari, Enrico; Marcomini, Barbara; Riva, Silvia; Iezzi, Elisa; Castellini, Paola; Olivato, Silvia; Barbi, Filippo; Perticaroli, Eva; Monaco, Daniela; Iafelice, Ilaria; Bigliardi, Guido; Vandelli, Laura; Guareschi, Angelica; Artoni, Andrea; Zanferrari, Carla; Schulz, Peter J

    2017-12-01

    Public campaigns to increase stroke preparedness have been tested in different contexts, showing contradictory results. We evaluated the effectiveness of a stroke campaign, designed specifically for the Italian population in reducing prehospital delay. According to an SW-RCT (Stepped-Wedge Cluster Randomized Controlled Trial) design, the campaign was launched in 4 provinces in the northern part of the region Emilia Romagna at 3-month intervals in randomized sequence. The units of analysis were the patients admitted to hospital, with stroke and transient ischemic attack, over a time period of 15 months, beginning 3 months before the intervention was launched in the first province to allow for baseline data collection. The proportion of early arrivals (within 2 hours of symptom onset) was the primary outcome. Thrombolysis rate and some behavioral end points were the secondary outcomes. Data were analyzed using a fixed-effect model, adjusting for cluster and time trends. We enrolled 1622 patients, 912 exposed and 710 nonexposed to the campaign. The proportion of early access was nonsignificantly lower in exposed patients (354 [38.8%] versus 315 [44.4%]; adjusted odds ratio, 0.81; 95% confidence interval, 0.60-1.08; P =0.15). As for secondary end points, an increase was found for stroke recognition, which approximated but did not reach statistical significance ( P =0.07). Our campaign was not effective in reducing prehospital delay. Even if some limitations of the intervention, mainly in terms of duration, are taken into account, our study demonstrates that new communication strategies should be tested before large-scale implementation. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01881152. © 2017 American Heart Association, Inc.

  8. The effectiveness of educational interventions to enhance the adoption of fee-based arsenic testing in Bangladesh: a cluster randomized controlled trial.

    Science.gov (United States)

    George, Christine Marie; Inauen, Jennifer; Rahman, Sheikh Masudur; Zheng, Yan

    2013-07-01

    Arsenic (As) testing could help 22 million people, using drinking water sources that exceed the Bangladesh As standard, to identify safe sources. A cluster randomized controlled trial was conducted to evaluate the effectiveness of household education and local media in the increasing demand for fee-based As testing. Randomly selected households (N = 452) were divided into three interventions implemented by community workers: 1) fee-based As testing with household education (HE); 2) fee-based As testing with household education and a local media campaign (HELM); and 3) fee-based As testing alone (Control). The fee for the As test was US$ 0.28, higher than the cost of the test (US$ 0.16). Of households with untested wells, 93% in both intervention groups HE and HELM purchased an As test, whereas only 53% in the control group. In conclusion, fee-based As testing with household education is effective in the increasing demand for As testing in rural Bangladesh.

  9. The Impact of a School-Based Hygiene, Water Quality and Sanitation Intervention on Soil-Transmitted Helminth Reinfection: A Cluster-Randomized Trial

    Science.gov (United States)

    Freeman, Matthew C.; Clasen, Thomas; Brooker, Simon J.; Akoko, Daniel O.; Rheingans, Richard

    2013-01-01

    We conducted a cluster-randomized trial to assess the impact of a school-based water treatment, hygiene, and sanitation program on reducing infection with soil-transmitted helminths (STHs) after school-based deworming. We assessed infection with STHs at baseline and then at two follow-up rounds 8 and 10 months after deworming. Forty government primary schools in Nyanza Province, Kenya were randomly selected and assigned to intervention or control arms. The intervention reduced reinfection prevalence (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.31–1.00) and egg count (rate ratio [RR] 0.34, CI 0.15–0.75) of Ascaris lumbricoides. We found no evidence of significant intervention effects on the overall prevalence and intensity of Trichuris trichiura, hookworm, or Schistosoma mansoni reinfection. Provision of school-based sanitation, water quality, and hygiene improvements may reduce reinfection of STHs after school-based deworming, but the magnitude of the effects may be sex- and helminth species-specific. PMID:24019429

  10. Effectiveness and Cost-Effectiveness of Occupation-Based Occupational Therapy Using the Aid for Decision Making in Occupation Choice (ADOC) for Older Residents: Pilot Cluster Randomized Controlled Trial

    Science.gov (United States)

    Nagayama, Hirofumi; Tomori, Kounosuke; Ohno, Kanta; Takahashi, Kayoko; Ogahara, Kakuya; Sawada, Tatsunori; Uezu, Sei; Nagatani, Ryutaro; Yamauchi, Keita

    2016-01-01

    Background Care-home residents are mostly inactive, have little interaction with staff, and are dependent on staff to engage in daily occupations. We recently developed an iPad application called the Aid for Decision-making in Occupation Choice (ADOC) to promote shared decision-making in activities and occupation-based goal setting by choosing from illustrations describing daily activities. This study aimed to evaluate if interventions based on occupation-based goal setting using the ADOC could focus on meaningful activities to improve quality of life and independent activities of daily living, with greater cost-effectiveness than an impairment-based approach as well as to evaluate the feasibility of conducting a large cluster, randomized controlled trial. Method In this single (assessor)-blind pilot cluster randomized controlled trial, the intervention group (ADOC group) received occupational therapy based on occupation-based goal setting using the ADOC, and the interventions were focused on meaningful occupations. The control group underwent an impairment-based approach focused on restoring capacities, without goal setting tools. In both groups, the 20-minute individualized intervention sessions were conducted twice a week for 4 months. Main Outcome Measures Short Form-36 (SF-36) score, SF-6D utility score, quality adjusted life years (QALY), Barthel Index, and total care cost. Results We randomized and analyzed 12 facilities (44 participants, 18.5% drop-out rate), with 6 facilities each allocated to the ADOC (n = 23) and control (n = 21) groups. After the 4-month intervention, the ADOC group had a significantly greater change in the BI score, with improved scores (P = 0.027, 95% CI 0.41 to 6.87, intracluster correlation coefficient = 0.14). No other outcome was significantly different. The incremental cost-effectiveness ratio, calculated using the change in BI score, was $63.1. Conclusion The results suggest that occupational therapy using the ADOC for older

  11. Effectiveness of a virtual intervention for primary healthcare professionals aimed at improving attitudes towards the empowerment of patients with chronic diseases: study protocol for a cluster randomized controlled trial (e-MPODERA project).

    Science.gov (United States)

    González-González, Ana Isabel; Orrego, Carola; Perestelo-Perez, Lilisbeth; Bermejo-Caja, Carlos Jesús; Mora, Nuria; Koatz, Débora; Ballester, Marta; Del Pino, Tasmania; Pérez-Ramos, Jeannet; Toledo-Chavarri, Ana; Robles, Noemí; Pérez-Rivas, Francisco Javier; Ramírez-Puerta, Ana Belén; Canellas-Criado, Yolanda; Del Rey-Granado, Yolanda; Muñoz-Balsa, Marcos José; Becerril-Rojas, Beatriz; Rodríguez-Morales, David; Sánchez-Perruca, Luis; Vázquez, José Ramón; Aguirre, Armando

    2017-10-30

    Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases. This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice. This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases. ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016.

  12. Prevention of low back pain and its consequences among nurses’ aides in elderly care: a stepped-wedge multi-faceted cluster-randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background A high prevalence of low back pain has persisted over the years despite extensive primary prevention initiatives among nurses’ aides. Many single-faceted interventions addressing just one aspect of low back pain have been carried out at workplaces, but with low success rate. This may be due to the multi-factorial origin of low back pain. Participatory ergonomics, cognitive behavioral training and physical training have previously shown promising effects on prevention and rehabilitation of low back pain. Therefore, the main aim of this study is to examine whether a multi-faceted workplace intervention consisting of participatory ergonomics, physical training and cognitive behavioral training can prevent low back pain and its consequences among nurses’ aides. External resources for the participating workplace and a strong commitment from the management and the organization support the intervention. Methods/design To overcome implementation barriers within usual randomized controlled trial designed workplace interventions, this study uses a stepped-wedge cluster-randomized controlled trial design with 4 groups. The intervention is delivered to the groups at random along four successive time periods three months apart. The intervention lasts three months and integrates participatory ergonomics, physical training and cognitive behavioral training tailored to the target group. Local physiotherapists and occupational therapists conduct the intervention after having received standardized training. Primary outcomes are low back pain and its consequences measured monthly by text messages up to three months after initiation of the intervention. Discussion Intervention effectiveness trials for preventing low back pain and its consequences in workplaces with physically demanding work are few, primarily single-faceted, with strict adherence to a traditional randomized controlled trial design that may hamper implementation and compliance, and have mostly been

  13. Headache cessation by an educational intervention in grammar schools: a cluster randomized trial.

    Science.gov (United States)

    Albers, L; Heinen, F; Landgraf, M; Straube, A; Blum, B; Filippopulos, F; Lehmann, S; Mansmann, U; Berger, U; Akboga, Y; von Kries, R

    2015-02-01

    Headache is a common health problem in adolescents. There are a number of risk factors for headache in adolescents that are amenable to intervention. The aim of the study was to assess the effectiveness of a low-level headache prevention programme in the classroom setting to prevent these risk factors. In all, 1674 students in 8th-10th grade at 12 grammar schools in greater Munich, Germany, were cluster randomized into intervention and control groups. A standardized 60-min prevention lesson focusing on preventable risk factors for headache (physical inactivity, coffee consumption, alcohol consumption and smoking) and providing instructions on stress management and neck and shoulder muscle relaxation exercises was given in a classroom setting. Seven months later, students were reassessed. The main outcome parameter was headache cessation. Logistic regression models with random effects for cluster and adjustment for baseline risk factors were calculated. Nine hundred students (intervention group N = 450, control group N = 450) with headache at baseline and complete data for headache and confounders were included in the analysis. Headache cessation was observed in 9.78% of the control group compared with 16.22% in the intervention group (number needed to treat = 16). Accounting for cluster effects and confounders, the probability of headache cessation in the intervention group was 1.77 (95% confidence interval = [1.08; 2.90]) higher than in the control group. The effect was most pronounced in adolescents with tension-type headache: odds ratio = 2.11 (95% confidence interval = [1.15; 3.80]). Our study demonstrates the effectiveness of a one-time, classroom-based headache prevention programme. © 2014 EAN.

  14. Effect on mental health of a participatory intervention to improve psychosocial work environment: a cluster randomized controlled trial among nurses.

    Science.gov (United States)

    Uchiyama, Ayako; Odagiri, Yuko; Ohya, Yumiko; Takamiya, Tomoko; Inoue, Shigeru; Shimomitsu, Teruichi

    2013-01-01

    Improvement of psychosocial work environment has proved to be valuable for workers' mental health. However, limited evidence is available for the effectiveness of participatory interventions. The purpose of this study was to investigate the effect on mental health among nurses of a participatory intervention to improve the psychosocial work environment. A cluster randomized controlled trial was conducted in hospital settings. A total of 434 nurses in 24 units were randomly allocated to 11 intervention units (n=183) and 13 control units (n=218). A participatory program was provided to the intervention units for 6 months. Depressive symptoms as mental health status and psychosocial work environment, assessed by the Job Content Questionnaire, the Effort-Reward Imbalance Questionnaire, and the Quality Work Competence questionnaire, were measured before and immediately after the 6-month intervention by a self-administered questionnaire. No significant intervention effect was observed for mental health status. However, significant intervention effects were observed in psychosocial work environment aspects, such as Coworker Support (pwork environment, but not mental health, among Japanese nurses.

  15. The Study of HIV and Antenatal Care Integration in Pregnancy in Kenya: Design, Methods, and Baseline Results of a Cluster-Randomized Controlled Trial

    Science.gov (United States)

    Turan, Janet M.; Steinfeld, Rachel L.; Onono, Maricianah; Bukusi, Elizabeth A.; Woods, Meghan; Shade, Starley B.; Washington, Sierra; Marima, Reson; Penner, Jeremy; Ackers, Marta L.; Mbori-Ngacha, Dorothy; Cohen, Craig R.

    2012-01-01

    Background Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT), HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC) services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma. Methodology/Principal Findings A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic) or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment). During June 2009– March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines. Conclusions/Significance This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery

  16. Short-term effects of a rights-based sexuality education curriculum for high-school students: a cluster-randomized trial.

    Science.gov (United States)

    Constantine, Norman A; Jerman, Petra; Berglas, Nancy F; Angulo-Olaiz, Francisca; Chou, Chih-Ping; Rohrbach, Louise A

    2015-03-26

    An emerging model for sexuality education is the rights-based approach, which unifies discussions of sexuality, gender norms, and sexual rights to promote the healthy sexual development of adolescents. A rigorous evaluation of a rights-based intervention for a broad population of adolescents in the U.S. has not previously been published. This paper evaluates the immediate effects of the Sexuality Education Initiative (SEI) on hypothesized psychosocial determinants of sexual behavior. A cluster-randomized trial was conducted with ninth-grade students at 10 high schools in Los Angeles. Classrooms at each school were randomized to receive either a rights-based curriculum or basic sex education (control) curriculum. Surveys were completed by 1,750 students (N = 934 intervention, N = 816 control) at pretest and immediate posttest. Multilevel regression models examined the short-term effects of the intervention on nine psychosocial outcomes, which were hypothesized to be mediators of students' sexual behaviors. Compared with students who received the control curriculum, students receiving the rights-based curriculum demonstrated significantly greater knowledge about sexual health and sexual health services, more positive attitudes about sexual relationship rights, greater communication about sex and relationships with parents, and greater self-efficacy to manage risky situations at immediate posttest. There were no significant differences between the two groups for two outcomes, communication with sexual partners and intentions to use condoms. Participation in the rights-based classroom curriculum resulted in positive, statistically significant effects on seven of nine psychosocial outcomes, relative to a basic sex education curriculum. Longer-term effects on students' sexual behaviors will be tested in subsequent analyses. ClinicalTrials.gov NCT02009046.

  17. The Impact of Hotspot-Targeted Interventions on Malaria Transmission in Rachuonyo South District in the Western Kenyan Highlands: A Cluster-Randomized Controlled Trial

    Science.gov (United States)

    Bradley, John; Knight, Philip; Stone, William; Osoti, Victor; Makori, Euniah; Owaga, Chrispin; Odongo, Wycliffe; China, Pauline; Shagari, Shehu; Doumbo, Ogobara K.; Sauerwein, Robert W.; Kariuki, Simon; Drakeley, Chris; Stevenson, Jennifer; Cox, Jonathan

    2016-01-01

    Background Malaria transmission is highly heterogeneous, generating malaria hotspots that can fuel malaria transmission across a wider area. Targeting hotspots may represent an efficacious strategy for reducing malaria transmission. We determined the impact of interventions targeted to serologically defined malaria hotspots on malaria transmission both inside hotspots and in surrounding communities. Methods and Findings Twenty-seven serologically defined malaria hotspots were detected in a survey conducted from 24 June to 31 July 2011 that included 17,503 individuals from 3,213 compounds in a 100-km2 area in Rachuonyo South District, Kenya. In a cluster-randomized trial from 22 March to 15 April 2012, we randomly allocated five clusters to hotspot-targeted interventions with larviciding, distribution of long-lasting insecticide-treated nets, indoor residual spraying, and focal mass drug administration (2,082 individuals in 432 compounds); five control clusters received malaria control following Kenyan national policy (2,468 individuals in 512 compounds). Our primary outcome measure was parasite prevalence in evaluation zones up to 500 m outside hotspots, determined by nested PCR (nPCR) at baseline and 8 wk (16 June–6 July 2012) and 16 wk (21 August–10 September 2012) post-intervention by technicians blinded to the intervention arm. Secondary outcome measures were parasite prevalence inside hotpots, parasite prevalence in the evaluation zone as a function of distance from the hotspot boundary, Anopheles mosquito density, mosquito breeding site productivity, malaria incidence by passive case detection, and the safety and acceptability of the interventions. Intervention coverage exceeded 87% for all interventions. Hotspot-targeted interventions did not result in a change in nPCR parasite prevalence outside hotspot boundaries (p ≥ 0.187). We observed an average reduction in nPCR parasite prevalence of 10.2% (95% CI −1.3 to 21.7%) inside hotspots 8 wk post

  18. Prevention of Gestational Diabetes: Design of a Cluster-Randomized Controlled Trial and One-Year Follow-Up

    Directory of Open Access Journals (Sweden)

    Mansikkamäki Kirsi

    2010-08-01

    Full Text Available Abstract Background Annual prevalence of gestational diabetes mellitus (GDM is 12.5% among Finnish pregnant women. The prevalence is expected to rise with the increasing overweight among women before pregnancy. Physical activity and diet are both known to have favourable effects on insulin resistance and possibly on the risk of GDM. We aimed to investigate, whether GDM can be prevented by counseling on diet, physical activity and gestational weight gain during pregnancy. Methods/Design A cluster-randomized controlled trial was conducted in 14 municipalities in the southern part of Finland. Pairwise randomization was performed in order to take into account socioeconomic differences. Recruited women were at 8-12 weeks' gestation and fulfilled at least one of the following criteria: body mass index ≥ 25 kg/m2, history of earlier gestational glucose intolerance or macrosomic newborn (> 4500 g, age ≥ 40 years, first or second degree relative with history of type 1 or 2 diabetes. Main exclusion criterion was pathological oral glucose tolerance test (OGTT at 8-12 weeks' gestation. The trial included one counseling session on physical activity at 8-12 weeks' gestation and one for diet at 16-18 weeks' gestation, and three to four booster sessions during other routine visits. In the control clinics women received usual care. Information on height, weight gain and other gestational factors was obtained from maternity cards. Physical activity, dietary intake and quality of life were followed by questionnaires during pregnancy and at 1-year postpartum. Blood samples for lipid status, hormones, insulin and OGTT were taken at 8-12 and 26-28 weeks' gestation and 1 year postpartum. Workability and return to work were elicited by a questionnaire at 1- year postpartum. Linkage to the national birth register of years 2007-2009 will provide information on perinatal complications and GDM incidence among the non-participants of the study. Cost

  19. Safety voice for ergonomics (SAVE project: protocol for a workplace cluster-randomized controlled trial to reduce musculoskeletal disorders in masonry apprentices

    Directory of Open Access Journals (Sweden)

    Laurel D. Kincl

    2016-04-01

    Full Text Available Abstract Background Masons have the highest rate of overexertion injuries among all construction trades and rank second for occupational back injuries in the United States. Identified ergonomic solutions are the primary method of reducing exposure to risk factors associated with musculoskeletal disorders. However, many construction workers lack knowledge about these solutions, as well as basic ergonomic principles. Construction apprentices, as they embark on their careers, are greatly in need of ergonomics training to minimize the cumulative exposure that leads to musculoskeletal disorders. Apprentices receive safety training; however, ergonomics training is often limited or non-existent. In addition, apprenticeship programs often lack “soft skills” training on how to appropriately respond to work environments and practices that are unsafe. The SAVE program – SAfety Voice for Ergonomics – strives to integrate evidence-based health and safety training strategies into masonry apprenticeship skills training to teach ergonomics, problem solving, and speaking up to communicate solutions that reduce musculoskeletal injury risk. The central hypothesis is that the combination of ergonomics training and safety voice promotion will be more effective than no training or either ergonomics training alone or safety voice training alone. Methods/design Following the development and pilot testing of the SAVE intervention, SAVE will be evaluated in a cluster-randomized controlled trial at 12 masonry training centers across the U.S. Clusters of apprentices within centers will be assigned at random to one of four intervention groups (n = 24 per group: (1 ergonomics training only, (2 safety voice training only, (3 combined ergonomics and safety voice training, or (4 control group with no additional training intervention. Outcomes assessed at baseline, at the conclusion of training, and then at six and 12 months post training will include

  20. Does routine psychosocial screening improve referral to psychosocial care providers and patient-radiotherapist communication? A cluster randomized controlled trial.

    Science.gov (United States)

    Braeken, Anna P B M; Lechner, Lilian; Eekers, Daniëlle B P; Houben, Ruud M A; van Gils, Francis C J M; Ambergen, Ton; Kempen, Gertrudis I J M

    2013-11-01

    This study tests whether using a screening instrument improves referral to psychosocial care providers (e.g. psychologist) and facilitates patient-radiotherapist communication. A cluster randomized controlled trial was used. Fourteen radiotherapists were randomly allocated to the experimental or control group and 568 of their patients received care in accordance with the group to which their radiotherapist was allocated. Patients in the experimental group were asked to complete a screening instrument before and at the end of the radiation treatment period. All patients were requested to complete questionnaires concerning patient-physician communication after the first consultation and concerning psychosocial care 3 and 12 months post-intervention. Patients who completed the screening instrument were referred to social workers at an earlier stage than patients who did not (Pcommunication. Our results suggest that a simple screening procedure can be valuable for the timely treatment of psychosocial problems in patients. Future efforts should be directed at appropriate timing of screening and enhancing physicians' awareness regarding the importance of identifying, discussing and treating psychosocial problems in cancer patients. Psychosocial screening can be enhanced by effective radiotherapist-patient communication. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  1. The effectiveness of a near-infrared vascular imaging device to support intravenous cannulation in children with dark skin color: a cluster randomized clinical trial.

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    van der Woude, Olga C P; Cuper, Natascha J; Getrouw, Chavalleh; Kalkman, Cor J; de Graaff, Jurgen C

    2013-06-01

    Poor vein visibility can make IV cannulation challenging in children with dark skin color. In the operating room, we studied the effectiveness of a near-infrared vascular imaging device (VascuLuminator) to facilitate IV cannulation in children with dark skin color. In the operating room of a general hospital in Curacao, all consecutive children (0-15 years of age) requiring IV cannulation were included in a pragmatic cluster randomized clinical trial. The VascuLuminator was made available to anesthesiologists at the operating complex in randomized clusters of 1 week. Success at first attempt was 63% (27/43, 95% confidence interval [CI], 47%-77%) in the VascuLuminator group vs 51% (23 of 45 patients, 95% CI, 36%-66%) in the control group (P = 0.27). Median time to successful cannulation was 53 seconds (interquartile range: 34-154) in the VascuLuminator group and 68 seconds (interquartile range: 40-159) in the control group (P = 0.54), and hazard ratio was 1.12 (95% CI, 0.73-1.71). The VascuLuminator has limited value in improving success at first attempt of facilitating IV cannulation in children with dark skin color.

  2. Reducing the use of sugar in public schools: a randomized cluster trial.

    Science.gov (United States)

    Souza, Rita Adriana Gomes de; Mediano, Mauro Felippe Felix; Souza, Amanda de Moura; Sichieri, Rosely

    2013-08-01

    To test the efficacy of nutritional guidelines for school lunch cooks aiming to reduce added sugar in school meals and their own sugar intake. A controlled randomized cluster trial was carried out in twenty public schools in the municipality of Niteroi in Rio de Janeiro, Southeastern Brazil, from March to December 2007. A nutrition educational program was implemented in the schools in question through messages, activities and printed educational materials encouraging reduced levels of added sugar in school meals and in the school lunch cooks' own intake. The reduced availability of added sugar in schools was evaluated using spreadsheets including data on the monthly use of food item supplies. The cooks' individual food intake was evaluated by a Food Frequency Questionnaire. Anthropometric measurements were taken according to standardized techniques and variation in weight was measured throughout the duration of the study. There was a more marked reduction in the intervention schools compared to the control schools (-6.0 kg versus 0.34 kg), but no statistically significant difference (p = 0.21), although the study power was low. Both groups of school lunch cooks showed a reduction in the consumption of sweets and sweetened beverages, but the difference in sugar intake was not statistically significant. Weight loss and a reduction in total energy consumption occurred in both groups, but the difference between them was not statistically significant, and there was no alteration in the percentages of adequacy of macronutrients in relation to energy consumption. The strategy of reducing the use and consumption of sugar by school lunch cooks from public schools could not be proved to be effective.

  3. Results of a lay health education intervention to increase colorectal cancer screening among Filipino Americans: A cluster randomized controlled trial.

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    Cuaresma, Charlene F; Sy, Angela U; Nguyen, Tung T; Ho, Reginald C S; Gildengorin, Ginny L; Tsoh, Janice Y; Jo, Angela M; Tong, Elisa K; Kagawa-Singer, Marjorie; Stewart, Susan L

    2018-04-01

    Filipino colorectal cancer (CRC) screening rates fall below Healthy People 2020 goals. In this study, the authors explore whether a lay health educator (LHE) approach can increase CRC screening among Filipino Americans ages 50 to 75 years in Hawai'i. A cluster randomized controlled trial from 2012 through 2015 compared an intervention, which consisted of LHEs delivering 2 education sessions and 2 telephone follow-up calls on CRC screening plus a CRC brochure versus an attention control, in which 2 lectures and 2 follow-up calls on nutrition and physical activity plus a CRC brochure were provided. The primary outcome was change in self-reported ever receipt of CRC screening at 6 months. Among 304 participants (77% women, 86% had > 10 years of residence in the United States), the proportion of participants who reported ever having received CRC screening increased significantly in the intervention group (from 80% to 89%; P = .0003), but not in the control group (from 73% to 74%; P = .60). After covariate adjustment, there was a significant intervention effect (odds ratio, 1.9; 95% confidence interval, 1.0-3.5). There was no intervention effect on up-to-date screening. This first randomized controlled trial for CRC screening among Hawai'i's Filipinos used an LHE intervention with mixed, but promising, results. Cancer 2018;124:1535-42. © 2018 American Cancer Society. © 2018 American Cancer Society.

  4. Assessment of an enhanced program for depression management in primary care: a cluster randomized controlled trial. The INDI project (Interventions for Depression Improvement

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    Hernández Josep M

    2007-09-01

    Full Text Available Abstract Background Most depressed patients are attended at primary care. However, there are significant shortcomings in the diagnosis, management and outcomes of these patients. The aim of this study is to determine whether the implementation of a structured programme for managing depression will provide better health outcomes than usual management. Methods/Design Design: A cluster-randomized controlled trial involving two groups, one of which is the control group consisting of patients who are treated for depression in the usual way and the other is the intervention group consisting of patients on a structured programme for treating depression. Setting: 20 primary care centres in the province of Tarragona (Spain Sample: 400 patients over 18 years of age who have experienced an episode of major depression (DSM-IV and who need to initiate antidepressant treatment Intervention: A multi-component programme with clinical, educational and organisational procedures that includes training for the health care provider and evidence-based clinical guidelines. It also includes primary care nurses working as care-managers who provide educational and emotional support for the patients and who are responsible for active and systematic clinical monitoring. The programme aims to improve the primary care/specialized level interface. Measurements: The patients will be monitored by telephone interviews. The interviewer will not know which group the patient belongs to (blind trial. These interviews will be given at 0, 3, 6 and 12 months. Main variables: Severity of the depressive symptoms, response rate and remission rate. Analysis: Outcomes will be analyzed on an intent-to-treat basis and the unit of analysis will be the individual patient. This analysis will take into account the effect of study design on potential lack of independence between observations within the same cluster. Discussion The effectiveness of caring for depression in primary care can be

  5. Energy Balance 4 Kids with Play: Results from a Two-Year Cluster-Randomized Trial.

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    Madsen, Kristine; Linchey, Jennifer; Gerstein, Dana; Ross, Michelle; Myers, Esther; Brown, Katie; Crawford, Patricia

    2015-08-01

    Identifying sustainable approaches to improving the physical activity (PA) and nutrition environments in schools is an important public health goal. This study examined the impact of Energy Balance for Kids with Play (EB4K with Play), a school-based intervention developed by the Academy of Nutrition and Dietetics Foundation and Playworks, on students' PA, dietary habits and knowledge, and weight status over 2 years. This cluster-randomized, controlled trial took place in four intervention and two control schools over 2 years (n=879; third- to fifth-grade students). PA (fourth and fifth grades only), dietary knowledge and behaviors, school policies, and BMI z-score were assessed at baseline (fall 2011), midpoint (spring 2012), and endpoint (fall 2012 for accelerometers; spring 2013 for all other outcomes). At endpoint, there were no group differences in change in PA or dietary behaviors, although BMI z-score decreased overall by -0.07 (p=0.05). Students' dietary knowledge significantly increased, as did the amount of vegetables schools served. Post-hoc analyses stratified by grade revealed that, relative to control students, fourth-grade intervention students reduced school-day sedentary time by 15 minutes (p=0.023) and third-grade intervention students reduced BMI z-score by -0.2 (0.05; pchildren's dietary knowledge and may improve weight status and decrease sedentary behaviors among younger children. Future iterations should examine programming specific for different age groups.

  6. Design and methods for a cluster randomized trial of the Sunless Study: A skin cancer prevention intervention promoting sunless tanning among beach visitors

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    Merriam Philip

    2009-02-01

    Full Text Available Abstract Background Skin cancer is the most prevalent yet most preventable cancer in the US. While protecting oneself from ultraviolet radiation (UVR can largely reduce risk, rates of unprotected sun exposure remain high. Because the desire to be tan often outweighs health concerns among sunbathers, very few interventions have been successful at reducing sunbathing behavior. Sunless tanning (self-tanners and spray tans, a method of achieving the suntanned look without UVR exposure, might be an effective supplement to prevention interventions. Methods and Design This cluster randomized trial will examine whether a beach-based intervention that promotes sunless tanning as a substitute for sunbathing and includes sun damage imaging and sun safety recommendations is superior to a questionnaire only control group in reducing sunbathing frequency. Female beach visitors (N = 250 will be recruited from 2 public beaches in eastern Massachusetts. Beach site will be the unit of randomization. Follow-up assessment will occur at the end of the summer (1-month following intervention and 1 year later. The primary outcome is average sunbathing time per week. The study was designed to provide 90% power for detecting a difference of .70 hours between conditions (standard deviation of 2.0 at 1-year with an intra-cluster correlation coefficient of 0.01 and assuming a 25% rate of loss to follow-up. Secondary outcomes include frequency of sunburns, use of sunless tanning products, and sun protection behavior. Discussion Interventions might be improved by promoting behavioral substitutes for sun exposure, such as sunless tanners, that create a tanned look without exposure to UVR. Trial registration NCT00403377

  7. Reconciling research and implementation in micro health insurance experiments in India: study protocol for a randomized controlled trial

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    Doyle Conor

    2011-10-01

    Full Text Available Abstract Background Microinsurance or Community-Based Health Insurance is a promising healthcare financing mechanism, which is increasingly applied to aid rural poor persons in low-income countries. Robust empirical evidence on the causal relations between Community-Based Health Insurance and healthcare utilisation, financial protection and other areas is scarce and necessary. This paper contains a discussion of the research design of three Cluster Randomised Controlled Trials in India to measure the impact of Community-Based Health Insurance on several outcomes. Methods/Design Each trial sets up a Community-Based Health Insurance scheme among a group of micro-finance affiliate families. Villages are grouped into clusters which are congruous with pre-existing social groupings. These clusters are randomly assigned to one of three waves of implementation, ensuring the entire population is offered Community-Based Health Insurance by the end of the experiment. Each wave of treatment is preceded by a round of mixed methods evaluation, with quantitative, qualitative and spatial evidence on impact collected. Improving upon practices in published Cluster Randomised Controlled Trial literature, we detail how research design decisions have ensured that both the households offered insurance and the implementers of the Community-Based Health Insurance scheme operate in an environment replicating a non-experimental implementation. Discussion When a Cluster Randomised Controlled Trial involves randomizing within a community, generating adequate and valid conclusions requires that the research design must be made congruous with social structures within the target population, to ensure that such trials are conducted in an implementing environment which is a suitable analogue to that of a non-experimental implementing environment.

  8. A cluster-randomized controlled trial of strategies to increase adolescents’ physical activity and motivation during physical education lessons: the Motivating Active Learning in Physical Education (MALP trial

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    Rosenkranz Richard R

    2012-10-01

    Full Text Available Abstract Background The physical activity (PA levels of many children and adolescents in Australia are currently insufficient to promote health benefits. Physical education (PE programs aim to promote PA and reach nearly all school-aged children, but PA levels within PE lessons are often low. PE teachers may influence children’s motivation to be physically active in PE lessons, but little is known about teacher strategies that effectively motivate children to participate in PA, and few intervention studies have examined motivational strategies in PE. The purpose of this study was to compare the effect of three motivational strategies, each based on Self-Determination Theory (SDT, on PA levels, and their hypothesized antecedents, during year 8 PE lessons. Methods/design This study employed a cluster-randomized controlled trial design. Following a familiarization session, PA levels and hypothesized PA antecedents were measured during a baseline lesson and a post-intervention or control lesson. Teachers (n = 16 and their classes from five secondary schools in Sydney, Australia were randomly assigned into four blocks and instructed to provide one of four 20-min lesson teaching strategy conditions: (1 explaining the relevance of activities; (2 providing choice from PA options selected by the teacher; (3 providing equipment and free choice of activities; or (4 usual practice. The primary outcomes were lesson time spent in moderate-to-vigorous PA, and motivation towards the lesson. Secondary outcomes were perceptions of teacher behavior, psychological needs satisfaction, and lesson time spent in sedentary behavior. PA and sedentary behavior were measured during baseline and post-intervention lessons with waist-mounted Actigraph GT3X accelerometers. Teacher behavior, psychological needs satisfaction, and motivation were assessed via questionnaires at the end of each lesson. Linear mixed-model analyses will be run on all outcomes, with students nested

  9. Active versus passive adverse event reporting after pediatric chiropractic manual therapy: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Pohlman, Katherine A; Carroll, Linda; Tsuyuki, Ross T; Hartling, Lisa; Vohra, Sunita

    2017-12-01

    Patient safety performance can be assessed with several systems, including passive and active surveillance. Passive surveillance systems provide opportunity for health care personnel to confidentially and voluntarily report incidents, including adverse events, occurring in their work environment. Active surveillance systems systematically monitor patient encounters to seek detailed information about adverse events that occur in work environments; unlike passive surveillance, active surveillance allows for collection of both numerator (number of adverse events) and denominator (number of patients seen) data. Chiropractic manual therapy is commonly used in both adults and children, yet few studies have been done to evaluate the safety of chiropractic manual therapy for children. In an attempt to evaluate this, this study will compare adverse event reporting in passive versus active surveillance systems after chiropractic manual therapy in the pediatric population. This cluster randomized controlled trial aims to enroll 70 physicians of chiropractic (unit of randomization) to either passive or active surveillance system to report adverse events that occur after treatment for 60 consecutive pediatric (13 years of age and younger) patient visits (unit of analysis). A modified enrollment process with a two-phase consent procedure will be implemented to maintain provider blinding and minimize dropouts. The first phase of consent is for the provider to confirm their interest in a trial investigating the safety of chiropractic manual therapy. The second phase ensures that they understand the specific requirements for the group to which they were randomized. Percentages, incidence estimates, and 95% confidence intervals will be used to describe the count of reported adverse events in each group. The primary outcome will be the number and quality of the adverse event reports in the active versus the passive surveillance group. With 80% power and 5% one-sided significance

  10. School playground surfacing and arm fractures in children: a cluster randomized trial comparing sand to wood chip surfaces.

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    Andrew W Howard

    2009-12-01

    Full Text Available The risk of playground injuries, especially fractures, is prevalent in children, and can result in emergency room treatment and hospital admissions. Fall height and surface area are major determinants of playground fall injury risk. The primary objective was to determine if there was a difference in playground upper extremity fracture rates in school playgrounds with wood fibre surfacing versus granite sand surfacing. Secondary objectives were to determine if there were differences in overall playground injury rates or in head injury rates in school playgrounds with wood fibre surfacing compared to school playgrounds with granite sand surfacing.The cluster randomized trial comprised 37 elementary schools in the Toronto District School Board in Toronto, Canada with a total of 15,074 students. Each school received qualified funding for installation of new playground equipment and surfacing. The risk of arm fracture from playground falls onto granitic sand versus onto engineered wood fibre surfaces was compared, with an outcome measure of estimated arm fracture rate per 100,000 student-months. Schools were randomly assigned by computer generated list to receive either a granitic sand or an engineered wood fibre playground surface (Fibar, and were not blinded. Schools were visited to ascertain details of the playground and surface actually installed and to observe the exposure to play and to periodically monitor the depth of the surfacing material. Injury data, including details of circumstance and diagnosis, were collected at each school by a prospective surveillance system with confirmation of injury details through a validated telephone interview with parents and also through collection (with consent of medical reports regarding treated injuries. All schools were recruited together at the beginning of the trial, which is now closed after 2.5 years of injury data collection. Compliant schools included 12 schools randomized to Fibar that installed

  11. The effectiveness of non-pyrethroid insecticide-treated durable wall lining to control malaria in rural Tanzania: study protocol for a two-armed cluster randomized trial

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    George Mtove

    2016-07-01

    Full Text Available Abstract Background Despite considerable reductions in malaria achieved by scaling-up long-lasting insecticidal nets (LLINs and indoor residual spraying (IRS, maintaining sustained community protection remains operationally challenging. Increasing insecticide resistance also threatens to jeopardize the future of both strategies. Non-pyrethroid insecticide­treated wall lining (ITWL may represent an alternate or complementary control method and a potential tool to manage insecticide resistance. To date no study has demonstrated whether ITWL can reduce malaria transmission nor provide additional protection beyond the current best practice of universal coverage (UC of LLINs and prompt case management. Methods/design A two-arm cluster randomized controlled trial will be conducted in rural Tanzania to assess whether non-pyrethroid ITWL and UC of LLINs provide added protection against malaria infection in children, compared to UC of LLINs alone. Stratified randomization based on malaria prevalence will be used to select 22 village clusters per arm. All 44 clusters will receive LLINs and half will also have ITWL installed on interior house walls. Study children, aged 6 months to 11 years old, will be enrolled from each cluster and followed monthly to estimate cumulative incidence of malaria parasitaemia (primary endpoint, time to first malaria episode and prevalence of anaemia before and after intervention. Entomological inoculation rate will be estimated using indoor CDC light traps and outdoor tent traps followed by detection of Anopheles gambiae species, sporozoite infection, insecticide resistance and blood meal source. ITWL bioefficacy and durability will be monitored using WHO cone bioassays and household surveys, respectively. Social and cultural factors influencing community and household ITWL acceptability will be explored through focus-group discussions and in-depth interviews. Cost-effectiveness, compared between study arms, will be

  12. Using the 4 pillars™ practice transformation program to increase adult influenza vaccination and reduce missed opportunities in a randomized cluster trial.

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    Lin, Chyongchiou J; Nowalk, Mary Patricia; Pavlik, Valory N; Brown, Anthony E; Zhang, Song; Raviotta, Jonathan M; Moehling, Krissy K; Hawk, Mary; Ricci, Edmund M; Middleton, Donald B; Patel, Suchita; South-Paul, Jeannette E; Zimmerman, Richard K

    2016-11-03

    An evidence-based, step-by-step guide, the 4 Pillars™ Practice Transformation Program, was the foundation of an intervention to increase adult immunizations in primary care and was tested in a randomized controlled cluster trial. The purpose of this study is to report changes in influenza immunization rates and on factors related to receipt of influenza vaccine. Twenty five primary care practices were recruited in 2013, stratified by city (Houston, Pittsburgh), location (rural, urban, suburban) and type (family medicine, internal medicine), and randomized to the intervention (n = 13) or control (n = 12) in Year 1 (2013-14). A follow-up intervention occurred in Year 2 (2014-15). Demographic and vaccination data were derived from de-identified electronic medical record extractions. A cohort of 70,549 adults seen in their respective practices (n = 24 with 1 drop out) at least once each year was followed. Baseline mean age was 55.1 years, 35 % were men, 21 % were non-white and 35 % were Hispanic. After one year, both intervention and control arms significantly (P < 0.001) increased influenza vaccination, with average increases of 2.7 to 6.5 percentage points. In regression analyses, likelihood of influenza vaccination was significantly higher in sites with lower percentages of patients with missed opportunities (P < 0.001) and, after adjusting for missed opportunities, the intervention further improved vaccination rates in Houston (lower baseline rates) but not Pittsburgh (higher baseline rates). In the follow-up intervention, the likelihood of vaccination increased for both intervention sites and those that reduced missed opportunities (P < 0.005). Reducing missed opportunities across the practice increases likelihood of influenza vaccination of adults. The 4 Pillars™ Practice Transformation Program provides strategies for reducing missed opportunities to vaccinate adults. This study was registered as a clinical trial on 03/20/2013 at

  13. Assessment of community-level effects of intermittent preventive treatment for malaria in schoolchildren in Jinja, Uganda (START-IPT trial): a cluster-randomised trial.

    Science.gov (United States)

    Staedke, Sarah G; Maiteki-Sebuguzi, Catherine; Rehman, Andrea M; Kigozi, Simon P; Gonahasa, Samuel; Okiring, Jaffer; Lindsay, Steve W; Kamya, Moses R; Chandler, Clare I R; Dorsey, Grant; Drakeley, Chris

    2018-06-01

    Intermittent preventive treatment (IPT) is a well established malaria control intervention. Evidence that delivering IPT to schoolchildren could provide community-level benefits is limited. We did a cluster-randomised controlled trial to assess the effect of IPT of primary schoolchildren with dihydroartemisinin-piperaquine (DP) on indicators of malaria transmission in the community, in Jinja, Uganda. We included 84 clusters, each comprising one primary school and the 100 closest available households. The clusters were randomly assigned 1:1 to receive IPT with DP or standard care (control) by restricted randomisation to ensure balance by geography and school type. Children in intervention schools received IPT monthly for up to six rounds (June to December, 2014). We did cross-sectional community surveys in randomly selected households at baseline and in January to April, 2015, during which we measured participants' temperatures and obtained finger-prick blood smears for measurement of parasite prevalence by microscopy. We also did entomological surveys 1 night per month in households from 20 randomly selected IPT and 20 control clusters. The primary trial outcome was parasite prevalence in the final community survey. The primary entomological survey outcome was the annual entomological inoculation rate (aEIR) from July, 2014, to April, 2015. This trial is registered at ClinicalTrials.gov, number NCT02009215. Among 23 280 students registered in the 42 intervention schools, 10 079 (43%) aged 5-20 years were enrolled and received at least one dose of DP. 9286 (92%) of 10 079 received at least one full course of DP (three doses). Community-level parasite prevalence was lower in the intervention clusters than in the control clusters (19% vs 23%, adjusted risk ratio 0·85, 95% CI 0·73-1·00, p=0·05). The aEIR was lower in the intervention group than in the control group, but not significantly so (10·1 vs 15·2 infective bites per person, adjusted incidence rate

  14. A Cluster Randomized Controlled Trial of Nonpharmacological Interventions for Old-Old Subjects with a Clinical Dementia Rating of 0.5: The Kurihara Project

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    Masahiro Nakatsuka

    2015-05-01

    Full Text Available Background: Evidence as to the benefits of nonpharmacological interventions for the boundary state between normal aging and dementia [mild cognitive impairment or a Clinical Dementia Rating (CDR of 0.5] remains weak due to a lack of positive controls. Aims: To directly compare the effects of cognitive interventions (CI, physical activities (PA and a group reminiscence approach (GRA, we conducted a pilot study on the basis of a cluster randomized controlled trial design. Method: A total of 127 participants aged >74 years with a CDR of 0.5 were cluster randomized into three groups for CI, PA and GRA. The intervention lasted 12 weeks and consisted of weekly group sessions and home assignments. Mini-Mental State Examination (MMSE, Trail Making Test part A (TMT-A, word fluency (WF, 6-meter walk time and Quality of Life (QOL Face Scale scores were evaluated as primary outcomes. Results: Methodology-related benefits of CI and PA were found for MMSE scores and walk time, respectively. TMT-A, WF and QOL Face Scale scores improved irrespective of the methodologies used. Conclusions: Our findings suggest that CI and PA may be beneficial to cognitive and physical abilities, respectively. Executive functions and QOL may improve irrespective of the intervention methodologies used.

  15. Gender differences on effectiveness of a school-based physical activity intervention for reducing cardiometabolic risk: a cluster randomized trial.

    Science.gov (United States)

    Martínez-Vizcaíno, Vicente; Sánchez-López, Mairena; Notario-Pacheco, Blanca; Salcedo-Aguilar, Fernando; Solera-Martínez, Montserrat; Franquelo-Morales, Pablo; López-Martínez, Sara; García-Prieto, Jorge C; Arias-Palencia, Natalia; Torrijos-Niño, Coral; Mora-Rodríguez, Ricardo; Rodríguez-Artalejo, Fernando

    2014-12-10

    Studies that have examined the impact of a physical activity intervention on cardiometabolic risk factors have yielded conflicting results. The objective of this study was to assess the impact of a standardized physical activity program on adiposity and cardiometabolic risk factors in schoolchildren. Cluster randomized trial study of 712 schoolchildren, 8-10 years, from 20 public schools in the Province of Cuenca, Spain. The intervention (MOVI-2) consisted of play-based and non-competitive activities. MOVI-2 was conducted during two 90-minute sessions on weekdays and one 150-minute session on Saturday mornings every week between September 2010 and May 2011. We measured changes in adiposity (overweight/obesity prevalence, body mass index [BMI], triceps skinfold thickness [TST], body fat %, fat-free mass, waist circumference) and other cardiometabolic risk factors (LDL-cholesterol, triglycerides/HDL-cholesterol ratio, insulin, C-reactive protein and blood pressure). The analyses used mixed regression models to adjust for baseline covariates under cluster randomization. Among girls, we found a reduction of adiposity in intervention versus control schools, with a decrease in TST (-1.1 mm; 95% confidence interval [CI] -2.3 to -0.7), body fat % (-0.9%; 95% CI -1.3 to -0.4), waist circumference (-2.7 cm; 95% CI -4.5 to -0.9), and an increase in fat-free mass (0.3 kg; 95% CI 0.01 to 0.6). The intervention also led to lower serum LDL-cholesterol and insulin levels. Among boys, a reduction in waist circumference (-1.4 cm; 95% CI -2.6 to -0.1; P = 0.03), and an increase in fat-free mass (0.5 kg; 95% CI 0.2 to 0.9; P = 0.003) was associated with the intervention versus control schools. The prevalence of overweight/obesity or underweight, BMI, and other cardiometabolic risk factors was not modified by the intervention. No important adverse events were registered. An extracurricular intervention of non-competitive physical activity during an academic year, targeting all

  16. Cost-effectiveness of a screening strategy for Q fever among pregnant women in risk areas: a clustered randomized controlled trial

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    Lo-Ten-Foe Jerome R

    2010-11-01

    Full Text Available Abstract Background In The Netherlands the largest human Q fever outbreak ever reported in the literature is currently ongoing with more than 2300 notified cases in 2009. Pregnant women are particularly at risk as Q fever during pregnancy may cause maternal and obstetric complications. Since the majority of infected pregnant women are asymptomatic, a screening strategy might be of great value to reduce Q fever related complications. We designed a trial to assess the (cost-effectiveness of a screening program for Q fever in pregnant women living in risks areas in The Netherlands. Methods/design We will conduct a clustered randomized controlled trial in which primary care midwife centres in Q fever risk areas are randomized to recruit pregnant women for either the control group or the intervention group. In both groups a blood sample is taken around 20 weeks postmenstrual age. In the intervention group, this sample is immediately analyzed by indirect immunofluorescence assay for detection of IgG and IgM antibodies using a sensitive cut-off level of 1:32. In case of an active Q fever infection, antibiotic treatment is recommended and serological follow up is performed. In the control group, serum is frozen for analysis after delivery. The primary endpoint is a maternal (chronic Q fever or reactivation or obstetric complication (low birth weight, preterm delivery or fetal death in Q fever positive women. Secondary aims pertain to the course of infection in pregnant women, diagnostic accuracy of laboratory tests used for screening, histo-pathological abnormalities of the placenta of Q fever positive women, side effects of therapy, and costs. The analysis will be according to the intention-to-screen principle, and cost-effectiveness analysis will be performed by comparing the direct and indirect costs between the intervention and control group. Discussion With this study we aim to provide insight into the balance of risks of undetected and detected Q

  17. Promotion and provision of drinking water in schools for overweight prevention: randomized, controlled cluster trial.

    Science.gov (United States)

    Muckelbauer, Rebecca; Libuda, Lars; Clausen, Kerstin; Toschke, André Michael; Reinehr, Thomas; Kersting, Mathilde

    2009-04-01

    The study tested whether a combined environmental and educational intervention solely promoting water consumption was effective in preventing overweight among children in elementary school. The participants in this randomized, controlled cluster trial were second- and third-graders from 32 elementary schools in socially deprived areas of 2 German cities. Water fountains were installed and teachers presented 4 prepared classroom lessons in the intervention group schools (N = 17) to promote water consumption. Control group schools (N = 15) did not receive any intervention. The prevalence of overweight (defined according to the International Obesity Task Force criteria), BMI SD scores, and beverage consumption (in glasses per day; 1 glass was defined as 200 mL) self-reported in 24-hour recall questionnaires, were determined before (baseline) and after the intervention. In addition, the water flow of the fountains was measured during the intervention period of 1 school year (August 2006 to June 2007). Data on 2950 children (intervention group: N = 1641; control group: N = 1309; age, mean +/- SD: 8.3 +/- 0.7 years) were analyzed. After the intervention, the risk of overweight was reduced by 31% in the intervention group, compared with the control group, with adjustment for baseline prevalence of overweight and clustering according to school. Changes in BMI SD scores did not differ between the intervention group and the control group. Water consumption after the intervention was 1.1 glasses per day greater in the intervention group. No intervention effect on juice and soft drink consumption was found. Daily water flow of the fountains indicated lasting use during the entire intervention period, but to varying extent. Our environmental and educational, school-based intervention proved to be effective in the prevention of overweight among children in elementary school, even in a population from socially deprived areas.

  18. A cluster randomized control field trial of the ABRACADABRA web-based literacy intervention: Replication and extension of basic findings.

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    Noella Angele Piquette

    2014-12-01

    Full Text Available The present paper reports a cluster randomized control trial evaluation of teaching using ABRACADABRA (ABRA, an evidence-based and web-based literacy intervention (http://abralite.concordia.ca with 107 kindergarten and 96 grade 1 children in 24 classes (12 intervention 12 control classes from all 12 elementary schools in one school district in Canada. Children in the intervention condition received 10-12 hours of whole class instruction using ABRA between pre- and post-test. Hierarchical linear modeling of post-test results showed significant gains in letter-sound knowledge for intervention classrooms over control classrooms. In addition, medium effect sizes were evident for three of five outcome measures favoring the intervention: letter-sound knowledge (d = +.66, phonological blending (d = +.52, and word reading (d = +.52, over effect sizes for regular teaching. It is concluded that regular teaching with ABRA technology adds significantly to literacy in the early elementary years.

  19. Development of an e-supported illness management and recovery programme for consumers with severe mental illness using intervention mapping, and design of an early cluster randomized controlled trial.

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    Beentjes, Titus A A; van Gaal, Betsie G I; Goossens, Peter J J; Schoonhoven, Lisette

    2016-01-19

    E-mental health is a promising medium to keep mental health affordable and accessible. For consumers with severe mental illness the evidence of the effectiveness of e-health is limited. A number of difficulties and barriers have to be addressed concerning e-health for consumers with severe mental illness. One possible solution might be to blend e-health with face-to-face delivery of a recovery-oriented treatment, like the Illness Management & Recovery (IMR) programme. This paper describes the development of an e-health application for the IMR programme and the design of an early clustered randomized controlled trial. We developed the e-IMR intervention according to the six-step protocol of Intervention Mapping. Consumers joined the development group to address important and relevant issues for the target group. Decisions during the six-step development process were based on qualitative evaluations of the Illness Management & Recovery programme, structured interviews, discussion in the development group, and literature reviews on qualitative papers concerning consumers with severe mental illness, theoretical models, behavioural change techniques, and telemedicine for consumers with severe mental illness. The aim of the e-IMR intervention is to help consumers with severe mental illness to involve others, manage achieving goals, and prevent relapse. The e-IMR intervention consists of face-to-face delivery of the Illness Management & Recovery programme and an e-health application containing peer-testimonials on videos, follow up on goals and coping strategies, monitoring symptoms, solving problems, and communication opportunities. We designed an early cluster randomized controlled trial that will evaluate the e-IMR intervention. In the control condition the Illness Management & Recovery programme is provided. The main effect-study parameters are: illness management, recovery, psychiatric symptoms severity, self-management, quality of life, and general health. The

  20. The Diabetes Manual trial protocol – a cluster randomized controlled trial of a self-management intervention for type 2 diabetes [ISRCTN06315411

    Directory of Open Access Journals (Sweden)

    Dale Jeremy

    2006-07-01

    Full Text Available Abstract Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months and following an agreed protocol change over 7% (months 13 to 18. Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.

  1. Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects.

    Science.gov (United States)

    Dreyhaupt, Jens; Mayer, Benjamin; Keis, Oliver; Öchsner, Wolfgang; Muche, Rainer

    2017-01-01

    An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention) studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called "cluster randomization"). Compared with studies with individual randomization, studies with cluster randomization normally require (significantly) larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies. Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

  2. Rational and design of a stepped-wedge cluster randomized trial evaluating quality improvement initiative for reducing cardiovascular events among patients with acute coronary syndromes in resource-constrained hospitals in China.

    Science.gov (United States)

    Li, Shenshen; Wu, Yangfeng; Du, Xin; Li, Xian; Patel, Anushka; Peterson, Eric D; Turnbull, Fiona; Lo, Serigne; Billot, Laurent; Laba, Tracey; Gao, Runlin

    2015-03-01

    Acute coronary syndromes (ACSs) are a major cause of morbidity and mortality, yet effective ACS treatments are frequently underused in clinical practice. Randomized trials including the CPACS-2 study suggest that quality improvement initiatives can increase the use of effective treatments, but whether such programs can impact hard clinical outcomes has never been demonstrated in a well-powered randomized controlled trial. The CPACS-3 study is a stepped-wedge cluster-randomized trial conducted in 104 remote level 2 hospitals without PCI facilities in China. All hospitalized ACS patients will be recruited consecutively over a 30-month period to an anticipated total study population of more than 25,000 patients. After a 6-month baseline period, hospitals will be randomized to 1 of 4 groups, and a 6-component quality improvement intervention will be implemented sequentially in each group every 6months. These components include the following: establishment of a quality improvement team, implementation of a clinical pathway, training of physicians and nurses, hospital performance audit and feedback, online technical support, and patient education. All patients will be followed up for 6months postdischarge. The primary outcome will be the incidence of in-hospital major adverse cardiovascular events comprising all-cause mortality, myocardial infarction or reinfarction, and nonfatal stroke. The CPACS-3 study will be the first large randomized trial with sufficient power to assess the effects of a multifaceted quality of care improvement initiative on hard clinical outcomes, in patients with ACS. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. The role of repetition and reinforcement in school-based oral health education-a cluster randomized controlled trial.

    Science.gov (United States)

    Haleem, Abdul; Khan, Muhammad Khalil; Sufia, Shamta; Chaudhry, Saima; Siddiqui, Muhammad Irfanullah; Khan, Ayyaz Ali

    2016-01-04

    Repetition and reinforcement have been shown to play a crucial role in the sustainability of the effect of Oral Health Education (OHE) programs. However, its relevance to school-based OHE imparted by different personnel is not depicted by the existing dental literature. The present study was undertaken to determine the effectiveness of the repeated and reinforced OHE (RR-OHE) compared to one-time OHE intervention and to assess its role in school-based OHE imparted by dentist, teachers and peers. The study was a cluster randomized controlled trial that involved 935 adolescents aged 10-11 years. Twenty four boys' and girls' schools selected at random in two towns of Karachi, Pakistan were randomly assigned to three groups to receive OHE by dentist (DL), teachers (TL) and peer-leaders (PL). The groups received a single OHE session and were evaluated post-intervention and 6 months after. The three groups were then exposed to OHE for 6 months followed by 1 year of no OHE activity. Two further evaluations at 6-month and 12-month intervals were conducted. The data were collected by a self-administered questionnaire preceded by a structured interview and followed by oral examination of participants. The adolescents' oral health knowledge (OHK) in the DL and PL groups increased significantly by a single OHE session compared to their baseline knowledge (p strategy. Although the OHK scores of the DL and PL groups decreased significantly at 12-month evaluation of RR-OHE (p play a key role in school-based OHE irrespective of educators. The trained teachers and peers can play a complementary role in RR-OHE.

  4. Cluster-randomized Studies in Educational Research: Principles and Methodological Aspects

    Directory of Open Access Journals (Sweden)

    Dreyhaupt, Jens

    2017-05-01

    Full Text Available An increasing number of studies are being performed in educational research to evaluate new teaching methods and approaches. These studies could be performed more efficiently and deliver more convincing results if they more strictly applied and complied with recognized standards of scientific studies. Such an approach could substantially increase the quality in particular of prospective, two-arm (intervention studies that aim to compare two different teaching methods. A key standard in such studies is randomization, which can minimize systematic bias in study findings; such bias may result if the two study arms are not structurally equivalent. If possible, educational research studies should also achieve this standard, although this is not yet generally the case. Some difficulties and concerns exist, particularly regarding organizational and methodological aspects. An important point to consider in educational research studies is that usually individuals cannot be randomized, because of the teaching situation, and instead whole groups have to be randomized (so-called “cluster randomization”. Compared with studies with individual randomization, studies with cluster randomization normally require (significantly larger sample sizes and more complex methods for calculating sample size. Furthermore, cluster-randomized studies require more complex methods for statistical analysis. The consequence of the above is that a competent expert with respective special knowledge needs to be involved in all phases of cluster-randomized studies.Studies to evaluate new teaching methods need to make greater use of randomization in order to achieve scientifically convincing results. Therefore, in this article we describe the general principles of cluster randomization and how to implement these principles, and we also outline practical aspects of using cluster randomization in prospective, two-arm comparative educational research studies.

  5. Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Jafar, Tazeen H; Jehan, Imtiaz; de Silva, H Asita; Naheed, Aliya; Gandhi, Mihir; Assam, Pryseley; Finkelstein, Eric A; Quigley, Helena Legido; Bilger, Marcel; Khan, Aamir Hameed; Clemens, John David; Ebrahim, Shah; Turner, Elizabeth L; Kasturiratne, Anuradhani

    2017-06-12

    High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension continues to be a significant public health issue with sub-optimal BP control rates. The goal of the trial is to compare a multicomponent intervention (MCI) to usual care to evaluate the effectiveness and cost-effectiveness of the MCI for lowering BP among adults with hypertension in rural communities in Bangladesh, Pakistan and Sri Lanka. This study is a stratified, cluster randomized controlled trial with a qualitative component for evaluation of processes and stakeholder feedback. The MCI has five components: (1) home health education by government community health workers (CHWs), (2) BP monitoring and stepped-up referral to a trained general practitioner using a checklist, (3) training public and private providers in management of hypertension and using a checklist, (4) designating hypertension triage counter and hypertension care coordinators in government clinics and (5) a financing model to compensate for additional health services and provide subsidies to low income individuals with poorly controlled hypertension. Usual care will comprise existing services in the community without any additional training. The trial will be conducted on 2550 individuals aged ≥40 years with hypertension (with systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, based on the mean of the last two of three measurements from two separate days, or on antihypertensive therapy) in 30 rural communities in Bangladesh, Pakistan and Sri Lanka. The primary outcome is change in systolic BP from baseline to follow-up at 24 months post-randomization. The incremental cost of MCI per CVD disability-adjusted life years averted will be computed. Stakeholders including policy makers, provincial- and district-level coordinators of relevant programmes, physicians, CHWs, key community leaders, hypertensive individuals and family members in the identified clusters will

  6. The study of HIV and antenatal care integration in pregnancy in Kenya: design, methods, and baseline results of a cluster-randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Janet M Turan

    Full Text Available Despite strong evidence for the effectiveness of anti-retroviral therapy for improving the health of women living with HIV and for the prevention of mother-to-child transmission (PMTCT, HIV persists as a major maternal and child health problem in sub-Saharan Africa. In most settings antenatal care (ANC services and HIV treatment services are offered in separate clinics. Integrating these services may result in better uptake of services, reduction of the time to treatment initiation, better adherence, and reduction of stigma.A prospective cluster randomized controlled trial design was used to evaluate the effects of integrating HIV treatment into ANC clinics at government health facilities in rural Kenya. Twelve facilities were randomized to provide either fully integrated services (ANC, PMTCT, and HIV treatment services all delivered in the ANC clinic or non-integrated services (ANC clinics provided ANC and basic PMTCT services and referred clients to a separate HIV clinic for HIV treatment. During June 2009- March 2011, 1,172 HIV-positive pregnant women were enrolled in the study. The main study outcomes are rates of maternal enrollment in HIV care and treatment, infant HIV testing uptake, and HIV-free infant survival. Baseline results revealed that the intervention and control cohorts were similar with respect to socio-demographics, male partner HIV testing, sero-discordance of the couple, obstetric history, baseline CD4 count, and WHO Stage. Challenges faced while conducting this trial at low-resource rural health facilities included frequent staff turnover, stock-outs of essential supplies, transportation challenges, and changes in national guidelines.This is the first randomized trial of ANC and HIV service integration to be conducted in rural Africa. It is expected that the study will provide critical evidence regarding the implementation and effectiveness of this service delivery strategy, with important implications for programs striving

  7. Using Getting To Outcomes to facilitate the use of an evidence-based practice in VA homeless programs: a cluster-randomized trial of an implementation support strategy.

    Science.gov (United States)

    Chinman, Matthew; McCarthy, Sharon; Hannah, Gordon; Byrne, Thomas Hugh; Smelson, David A

    2017-03-09

    Incorporating evidence-based integrated treatment for dual disorders into typical care settings has been challenging, especially among those serving Veterans who are homeless. This paper presents an evaluation of an effort to incorporate an evidence-based, dual disorder treatment called Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking-Veterans Edition (MISSION-Vet) into case management teams serving Veterans who are homeless, using an implementation strategy called Getting To Outcomes (GTO). This Hybrid Type III, cluster-randomized controlled trial assessed the impact of GTO over and above MISSION-Vet Implementation as Usual (IU). Both conditions received standard MISSION-Vet training and manuals. The GTO group received an implementation manual, training, technical assistance, and data feedback. The study occurred in teams at three large VA Medical Centers over 2 years. Within each team, existing sub-teams (case managers and Veterans they serve) were the clusters randomly assigned. The trial assessed MISSION-Vet services delivered and collected via administrative data and implementation barriers and facilitators, via semi-structured interview. No case managers in the IU group initiated MISSION-Vet while 68% in the GTO group did. Seven percent of Veterans with case managers in the GTO group received at least one MISSION-Vet session. Most case managers appreciated the MISSION-Vet materials and felt the GTO planning meetings supported using MISSION-Vet. Case manager interviews also showed that MISSION-Vet could be confusing; there was little involvement from leadership after their initial agreement to participate; the data feedback system had a number of difficulties; and case managers did not have the resources to implement all aspects of MISSION-Vet. This project shows that GTO-like support can help launch new practices but that multiple implementation facilitators are needed for successful execution of a complex evidence

  8. "Together at school"--a school-based intervention program to promote socio-emotional skills and mental health in children: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Björklund, Katja; Liski, Antti; Samposalo, Hanna; Lindblom, Jallu; Hella, Juho; Huhtinen, Heini; Ojala, Tiina; Alasuvanto, Paula; Koskinen, Hanna-Leena; Kiviruusu, Olli; Hemminki, Elina; Punamäki, Raija-Leena; Sund, Reijo; Solantaus, Tytti; Santalahti, Päivi

    2014-10-07

    Schools provide a natural context to promote children's mental health. However, there is a need for more evidence-based, high quality school intervention programs combined with an accurate evaluation of their general effectiveness and effectiveness of specific intervention methods. The aim of this paper is to present a study protocol of a cluster randomized controlled trial evaluating the "Together at School" intervention program. The intervention program is designed to promote social-emotional skills and mental health by utilizing whole-school approach and focuses on classroom curriculum, work environment of school staff, and parent-teacher collaboration methods. The evaluation study examines the effects of the intervention on children's socio-emotional skills and mental health in a cluster randomized controlled trial design with 1) an intervention group and 2) an active control group. Altogether 79 primary school participated at baseline. A multi-informant setting involves the children themselves, their parents, and teachers. The primary outcomes are measured using parent and teacher ratings of children's socio-emotional skills and psychological problems measured by the Strengths and Difficulties Questionnaire and the Multisource Assessment of Social Competence Scale. Secondary outcomes for the children include emotional understanding, altruistic behavior, and executive functions (e.g. working memory, planning, and inhibition). Secondary outcomes for the teachers include ratings of e.g. school environment, teaching style and well-being. Secondary outcomes for both teachers and parents include e.g. emotional self-efficacy, child rearing practices, and teacher-parent collaboration. The data was collected at baseline (autumn 2013), 6 months after baseline, and will be collected also 18 months after baseline from the same participants. This study protocol outlines a trial which aims to add to the current state of intervention programs by presenting and studying a

  9. Specialist mental health consultation for depression in Australian aged care residents with dementia: a cluster randomized trial.

    Science.gov (United States)

    McSweeney, Kate; Jeffreys, Aimee; Griffith, Joanne; Plakiotis, Chris; Kharsas, Renee; O'Connor, Daniel W

    2012-11-01

    This cluster randomized controlled trial sought to determine whether multidisciplinary specialist mental health consultation was more effective than care as usual in treating the depression of aged care residents with dementia. Three hundred and eighty nine aged care residents were screened for dementia and major depression. Forty four were ultimately included in the intervention sample, selected from 20 aged care facilities located in Melbourne, Australia. Facilities were randomly allocated to an intervention condition involving the provision of multidisciplinary specialist consultation regarding the best-practice management of depression in dementia, or to a care as usual condition. Consultations involved individually tailored medical and psychosocial recommendations provided to care staff and general practitioners. All residents participated in a comprehensive pre-intervention diagnostic assessment, including the administration of the Cornell Scale for Depression in Dementia. This assessment was repeated approximately 15 weeks post-intervention by a rater blind to study condition. Multidisciplinary specialist mental health consultation was significantly more effective than care as usual in treating the clinical depression of aged care residents with dementia (p Depression in Dementia score for the intervention group was 9.47, compared with 14.23 for the control group. In addition, 77% of the intervention group no longer met criteria for major depression. The results of this study suggest that the psychosocial and medical management of depressed aged care residents can be improved by increasing access to specialist mental health consultation. Copyright © 2012 John Wiley & Sons, Ltd.

  10. Systematic pain assessment in nursing homes: a cluster-randomized trial using mixed-methods approach.

    Science.gov (United States)

    Mamhidir, Anna-Greta; Sjölund, Britt-Marie; Fläckman, Birgitta; Wimo, Anders; Sköldunger, Anders; Engström, Maria

    2017-02-28

    Chronic pain affects nursing home residents' daily life. Pain assessment is central to adequate pain management. The overall aim was to investigate effects of a pain management intervention on nursing homes residents and to describe staffs' experiences of the intervention. A cluster-randomized trial and a mixed-methods approach. Randomized nursing home assignment to intervention or comparison group. The intervention group after theoretical and practical training sessions, performed systematic pain assessments using predominately observational scales with external and internal facilitators supporting the implementation. No measures were taken in the comparison group; pain management continued as before, but after the study corresponding training was provided. Resident data were collected baseline and at two follow-ups using validated scales and record reviews. Nurse group interviews were carried out twice. Primary outcome measures were wellbeing and proxy-measured pain. Secondary outcome measures were ADL-dependency and pain documentation. Using both non-parametric statistics on residential level and generalized estimating equation (GEE) models to take clustering effects into account, the results revealed non-significant interaction effects for the primary outcome measures, while for ADL-dependency using Katz-ADL there was a significant interaction effect. Comparison group (n = 66 residents) Katz-ADL values showed increased dependency over time, while the intervention group demonstrated no significant change over time (n = 98). In the intervention group, 13/44 residents showed decreased pain scores over the period, 14/44 had no pain score changes ≥ 30% in either direction measured with Doloplus-2. Furthermore, 17/44 residents showed increased pain scores ≥ 30% over time, indicating pain/risk for pain; 8 identified at the first assessment and 9 were new, i.e. developed pain over time. No significant changes in the use of drugs was found in any of

  11. Primary care management for optimized antithrombotic treatment [PICANT]: study protocol for a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Siebenhofer Andrea

    2012-08-01

    Full Text Available Abstract Background Antithrombotic treatment is a continuous therapy that is often performed in general practice and requires careful safety management. The aim of this study is to investigate whether a best-practice model that applies major elements of case management and patient education, can improve antithrombotic management in primary healthcare in terms of reducing major thromboembolic and bleeding events. Methods This 24-month cluster-randomized trial will be performed with 690 adult patients from 46 practices. The trial intervention will be a complex intervention involving general practitioners, healthcare assistants, and patients with an indication for oral anticoagulation. To assess adherence to medication and symptoms in patients, as well as to detect complications early, healthcare assistants will be trained in case management and will use the Coagulation-Monitoring List (Co-MoL to regularly monitor patients. Patients will receive information (leaflets and a video, treatment monitoring via the Co-MoL and be motivated to perform self-management. Patients in the control group will continue to receive treatment as usual from their general practitioners. The primary endpoint is the combined endpoint of all thromboembolic events requiring hospitalization and all major bleeding complications. Secondary endpoints are mortality, hospitalization, strokes, major bleeding and thromboembolic complications, severe treatment interactions, the number of adverse events, quality of anticoagulation, health-related quality of life, and costs. Further secondary objectives will be investigated to explain the mechanism by which the intervention is effective: patients’ assessment of chronic illness care, self-reported adherence to medication, general practitioners’ and healthcare assistants’ knowledge, and patients’ knowledge and satisfaction with shared decision making. Practice recruitment is expected to take place between July and December 2012

  12. A cluster randomized controlled trial of strategies to increase adolescents' physical activity and motivation in physical education: results of the Motivating Active Learning in Physical Education (MALP) trial.

    Science.gov (United States)

    Lonsdale, Chris; Rosenkranz, Richard R; Sanders, Taren; Peralta, Louisa R; Bennie, Andrew; Jackson, Ben; Taylor, Ian M; Lubans, David R

    2013-11-01

    Physical education (PE) programs aim to promote physical activity (PA) and reach most school-aged youth. However, PA levels within PE lessons are often low. In this cluster-randomized controlled trial, we examined the effects of three self-determination theory-based motivational strategies on PA and sedentary behavior, as well as their hypothesized antecedents during PE lessons. Data were collected in Sydney, Australia (October-December 2011). After baseline testing, teachers (n=16) and their classes (n=288 students; M=13.6 years, 50.4% male) were randomly assigned to one of four teaching strategy conditions: (1) explaining relevance; (2) providing choice; (3) complete free choice; or (4) usual practice. Teachers then delivered the assigned strategy. Primary outcomes were accelerometer-assessed PA and student motivation during lessons. Secondary outcomes included sedentary behavior, perceptions of teachers' support and psychological needs satisfaction. The 'free choice' intervention increased PA (pmotivation, but students' autonomy increased during both choice-based interventions (p<.05). Promoting choice can produce short-term increases in PA and decreases in sedentary behavior, as well as increased perceived autonomy during PE lessons. © 2013.

  13. Enhancing evidence-based diabetes and chronic disease control among local health departments: a multi-phase dissemination study with a stepped-wedge cluster randomized trial component.

    Science.gov (United States)

    Parks, Renee G; Tabak, Rachel G; Allen, Peg; Baker, Elizabeth A; Stamatakis, Katherine A; Poehler, Allison R; Yan, Yan; Chin, Marshall H; Harris, Jenine K; Dobbins, Maureen; Brownson, Ross C

    2017-10-18

    The rates of diabetes and prediabetes in the USA are growing, significantly impacting the quality and length of life of those diagnosed and financially burdening society. Premature death and disability can be prevented through implementation of evidence-based programs and policies (EBPPs). Local health departments (LHDs) are uniquely positioned to implement diabetes control EBPPs because of their knowledge of, and focus on, community-level needs, contexts, and resources. There is a significant gap, however, between known diabetes control EBPPs and actual diabetes control activities conducted by LHDs. The purpose of this study is to determine how best to support the use of evidence-based public health for diabetes (and related chronic diseases) control among local-level public health practitioners. This paper describes the methods for a two-phase study with a stepped-wedge cluster randomized trial that will evaluate dissemination strategies to increase the uptake of public health knowledge and EBPPs for diabetes control among LHDs. Phase 1 includes development of measures to assess practitioner views on and organizational supports for evidence-based public health, data collection using a national online survey of LHD chronic disease practitioners, and a needs assessment of factors influencing the uptake of diabetes control EBPPs among LHDs within one state in the USA. Phase 2 involves conducting a stepped-wedge cluster randomized trial to assess effectiveness of dissemination strategies with local-level practitioners at LHDs to enhance capacity and organizational support for evidence-based diabetes prevention and control. Twelve LHDs will be selected and randomly assigned to one of the three groups that cross over from usual practice to receive the intervention (dissemination) strategies at 8-month intervals; the intervention duration for groups ranges from 8 to 24 months. Intervention (dissemination) strategies may include multi-day in-person workshops, electronic

  14. Risk moderation of a parent and student preventive alcohol intervention by adolescent and family factors: a cluster randomized trial.

    Science.gov (United States)

    Verdurmen, Jacqueline E E; Koning, Ina M; Vollebergh, Wilma A M; van den Eijnden, Regina J J M; Engels, Rutger C M E

    2014-03-01

    To examine risk moderation of an alcohol intervention targeting parents and adolescents. A cluster randomized trial including 2937 Dutch early adolescents (m=12.68years, SD=0.51) and their parents randomized over four conditions: parent intervention, student intervention, combined parent-student intervention, and control group. 152 classes of 19 high schools in The Netherlands (2006). Moderators at baseline (adolescent: gender, educational level and externalizing behavior; parent: educational level and heavy alcohol use) were used to examine the differential effects of the interventions on onset of (heavy) weekly drinking at 22-month follow-up. The combined intervention effectively delayed the onset of weekly drinking in the general population of adolescents, and was particularly effective in delaying the onset of heavy weekly drinking in a higher-risk subsample of adolescents (i.e. those attending lower levels of education and reporting higher levels of externalizing behavior). Present and previous results have established the combined intervention to be universally effective in postponing weekly alcohol use among Dutch adolescents, with an added effect on postponing heavy weekly drinking in high risk subgroups. Therefore, implementation of this intervention in the general population of schools in The Netherlands is advised. NTR649. Copyright © 2013 Elsevier Inc. All rights reserved.

  15. Teen Dating Violence Prevention: Cluster-Randomized Trial of Teen Choices, an Online, Stage-Based Program for Healthy, Nonviolent Relationships.

    Science.gov (United States)

    Levesque, Deborah A; Johnson, Janet L; Welch, Carol A; Prochaska, Janice M; Paiva, Andrea L

    2016-07-01

    Teen dating violence is a serious public health problem. A cluster-randomized trial was conducted to assess the efficacy of Teen Choices , a 3-session online program that delivers assessments and individualized guidance matched to dating history, dating violence experiences, and stage of readiness for using healthy relationship skills. For high risk victims of dating violence, the program addresses readiness to keep oneself safe in relationships. Twenty high schools were randomly assigned to the Teen Choices condition ( n =2,000) or a Comparison condition ( n =1,901). Emotional and physical dating violence victimization and perpetration were assessed at 6 and 12 months in the subset of participants (total n =2,605) who reported a past-year history of dating violence at baseline, and/or who dated during the study. The Teen Choices program was associated with significantly reduced odds of all four types of dating violence (adjusted ORs ranging from .45 to .63 at 12 months follow-up). For three of the four violence outcomes, participants with a past-year history of that type of violence benefited significantly more from the intervention than students without a past-year history. The Teen Choices program provides an effective and practicable strategy for intervention for teen dating violence prevention.

  16. Results of a multicenter randomized controlled trial of the clinical effectiveness of schema therapy for personality disorders

    NARCIS (Netherlands)

    Bamelis, L.L.M.; Evers, S.M.A.A.; Spinhoven, P.; Arntz, A.

    2014-01-01

    Objective: The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C, paranoid, histrionic, or narcissistic personality disorder. Method: A multicenter randomized controlled trial, with

  17. Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

    2013-05-22

    The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process

  18. Electronic health record-based patient identification and individualized mailed outreach for primary cardiovascular disease prevention: a cluster randomized trial.

    Science.gov (United States)

    Persell, Stephen D; Lloyd-Jones, Donald M; Friesema, Elisha M; Cooper, Andrew J; Baker, David W

    2013-04-01

    Many individuals at higher risk for cardiovascular disease (CVD) do not receive recommended treatments. Prior interventions using personalized risk information to promote prevention did not test clinic-wide effectiveness. To perform a 9-month cluster-randomized trial, comparing a strategy of electronic health record-based identification of patients with increased CVD risk and individualized mailed outreach to usual care. Patients of participating physicians with a Framingham Risk Score of at least 5 %, low-density lipoprotein (LDL)-cholesterol level above guideline threshold for drug treatment, and not prescribed a lipid-lowering medication were included in the intention-to-treat analysis. Patients of physicians randomized to the intervention group were mailed individualized CVD risk messages that described benefits of using a statin (and controlling hypertension or quitting smoking when relevant). The primary outcome was occurrence of a LDL-cholesterol level, repeated in routine practice, that was at least 30 mg/dl lower than prior. A secondary outcome was lipid-lowering drug prescribing. Clinicaltrials.gov identifier: NCT01286311. Fourteen physicians with 218 patients were randomized to intervention, and 15 physicians with 217 patients to control. The mean patient age was 60.7 years and 77% were male. There was no difference in the primary outcome (11.0 % vs. 11.1 %, OR 0.99, 95 % CI 0.56-1.74, P = 0.96), but intervention group patients were twice as likely to receive a prescription for lipid-lowering medication (11.9 %, vs. 6.0 %, OR 2.13, 95 % CI 1.05-4.32, p = 0.038). In post hoc analysis with extended follow-up to 18 months, the primary outcome occurred more often in the intervention group (22.5 % vs. 16.1 %, OR 1.59, 95 % CI 1.05-2.41, P = 0.029). In this effectiveness trial, individualized mailed CVD risk messages increased the frequency of new lipid-lowering drug prescriptions, but we observed no difference in proportions lowering LDL

  19. Efficacy of iron-supplement bars to reduce anemia in urban Indian women: a cluster-randomized controlled trial.

    Science.gov (United States)

    Mehta, Rajvi; Platt, Alyssa C; Sun, Xizi; Desai, Mukesh; Clements, Dennis; Turner, Elizabeth L

    2017-03-01

    Background: India's high prevalence of iron-deficiency anemia has largely been attributed to the local diet consisting of nonheme iron, which has lower absorption than that of heme iron. Objective: We assessed the efficacy of the consumption of iron-supplement bars in raising hemoglobin concentrations and hematocrit percentages in anemic (hemoglobin concentration Indian women of reproductive age. Design: The Let's be Well Red study was a 90-d, pair-matched, cluster-randomized controlled trial. A total of 361 nonpregnant women (age 18-35 y) were recruited from 10 sites within Mumbai and Navi Mumbai, India. All participants received anemia education and a complete blood count (CBC). Random assignment of anemic participants to intervention and control arms occurred within 5 matched site-pairs. Intervention participants received 1 iron-supplement bar (containing 14 mg Fe)/d for 90 d, whereas control subjects received nothing. CBC tests were given at days 15, 45, and 90. Primary outcomes were 90-d changes from baseline in hemoglobin concentrations and hematocrit percentages. Linear mixed models and generalized estimating equations were used to model continuous and binary outcomes, respectively. Results: Of 179 anemic participants, 136 (76.0%) completed all follow-up assessments (65 intervention and 71 control participants). Baseline characteristics were comparable by arm. Mean hemoglobin and hematocrit increases after 90 d were greater for intervention than for control participants [1.4 g/dL (95% CI: 1.3, 1.6 g/dL) and 2.7% (95% CI: 2.2%, 3.2%), respectively]. The anemia prevalence at 90 d was lower for intervention (29.2%) than for control participants (98.6%) (OR: 0.007; 95% CI: 0.001, 0.04). Conclusions: The daily consumption of an iron-supplement bar leads to increased hemoglobin concentrations and hematocrit percentages and to a lower anemia prevalence in the target population with no reported side effects. This intervention is an attractive option to combat anemia

  20. Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial

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    van Gaalen Johanna L

    2012-11-01

    Full Text Available Abstract Background Internet-based self-management (IBSM support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. Methods/design This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS: dissemination of the IBSM program; intermediate strategy (IS: MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals; and extended strategy (ES: IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions are primarily targeted at general practices, randomisation will occur at practice level. In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations; self-management related outcomes (health education impact, medication adherence, and illness perceptions; and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption

  1. The CAP study, evaluation of integrated universal and selective prevention strategies for youth alcohol misuse: study protocol of a cluster randomized controlled trial

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    Newton Nicola C

    2012-08-01

    Full Text Available Abstract Background Alcohol misuse amongst young people is a serious concern. The need for effective prevention is clear, yet there appear to be few evidenced-based programs that prevent alcohol misuse and none that target both high and low-risk youth. The CAP study addresses this gap by evaluating the efficacy of an integrated approach to alcohol misuse prevention, which combines the effective universal internet-based Climate Schools program with the effective selective personality-targeted Preventure program. This article describes the development and protocol of the CAP study which aims to prevent alcohol misuse and related harms in Australian adolescents. Methods/Design A cluster randomized controlled trial (RCT is being conducted with Year 8 students aged 13 to 14-years-old from 27 secondary schools in New South Wales and Victoria, Australia. Blocked randomisation was used to assign schools to one of four groups; Climate Schools only, Preventure only, CAP (Climate Schools and Preventure, or Control (alcohol, drug and health education as usual. The primary outcomes of the trial will be the uptake and harmful use of alcohol and alcohol related harms. Secondary outcomes will include alcohol and cannabis related knowledge, cannabis related harms, intentions to use, and mental health symptomatology. All participants will complete assessments on five occasions; baseline; immediately post intervention, and at 12, 24 and 36 months post baseline. Discussion This study protocol presents the design and current implementation of a cluster RCT to evaluate the efficacy of the CAP study; an integrated universal and selective approach to prevent alcohol use and related harms among adolescents. Compared to students who receive the stand-alone universal Climate Schools program or alcohol and drug education as usual (Controls, we expect the students who receive the CAP intervention to have significantly less uptake of alcohol use, a reduction in average

  2. The Effect of India's Total Sanitation Campaign on Defecation Behaviors and Child Health in Rural Madhya Pradesh: A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Patil, Sumeet R.; Arnold, Benjamin F.; Salvatore, Alicia L.; Briceno, Bertha; Ganguly, Sandipan; Colford, John M.; Gertler, Paul J.

    2014-01-01

    Background Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). Methods and Findings We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May–July 2009), and revisited households 21 months later (February–April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%–26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%–15%; group means: 73% intervention versus 84% control). However, the intervention

  3. A stepped wedge, cluster-randomized trial of a household UV-disinfection and safe storage drinking water intervention in rural Baja California Sur, Mexico.

    Science.gov (United States)

    Gruber, Joshua S; Reygadas, Fermin; Arnold, Benjamin F; Ray, Isha; Nelson, Kara; Colford, John M

    2013-08-01

    In collaboration with a local non-profit organization, this study evaluated the expansion of a program that promoted and installed Mesita Azul, an ultraviolet-disinfection system designed to treat household drinking water in rural Mexico. We conducted a 15-month, cluster-randomized stepped wedge trial by randomizing the order in which 24 communities (444 households) received the intervention. We measured primary outcomes (water contamination and diarrhea) during seven household visits. The intervention increased the percentage of households with access to treated and safely stored drinking water (23-62%), and reduced the percentage of households with Escherichia coli contaminated drinking water (risk difference (RD): -19% [95% CI: -27%, -14%]). No significant reduction in diarrhea was observed (RD: -0.1% [95% CI: -1.1%, 0.9%]). We conclude that household water quality improvements measured in this study justify future promotion of the Mesita Azul, and that future studies to measure its health impact would be valuable if conducted in populations with higher diarrhea prevalence.

  4. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh.

    Science.gov (United States)

    George, Christine Marie; van Geen, Alexander; Slavkovich, Vesna; Singha, Ashit; Levy, Diane; Islam, Tariqul; Ahmed, Kazi Matin; Moon-Howard, Joyce; Tarozzi, Alessandro; Liu, Xinhua; Factor-Litvak, Pam; Graziano, Joseph

    2012-06-19

    To reduce arsenic (As) exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs) testing and provide As education compared to sending representatives from outside communities to conduct these tasks. We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs testing. In a second set of 10 villages an outside representative performed these tasks. Overall, 53% of respondents using As contaminated wells, relative to the Bangladesh As standard of 50 μg/L, at baseline switched after receiving the intervention. Further, when there was less than 60% arsenic contaminated wells in a village, the classification used by the Bangladeshi and UNICEF, 74% of study households in the community tester villages, and 72% of households in the outside tester villages reported switching to an As safe drinking water source. Switching was more common in the outside-tester (63%) versus community-tester villages (44%). However, after adjusting for the availability of arsenic safe drinking water sources, well switching did not differ significantly by type of As tester (Odds ratio = 0.86[95% confidence interval 0.42-1.77). At follow-up, among those using As contaminated wells who switched to safe wells, average urinary As concentrations significantly decreased. The overall intervention was effective in reducing As exposure provided there were As-safe drinking water sources available. However, there was not a significant difference observed in the ability of the community and outside testers to encourage study households to use As-safe water sources. The findings of this study suggest that As education and WAs testing programs provided by As testers, irrespective of their residence, could be used as an effective, low cost approach to reduce As exposure in many As-affected areas of

  5. The added value of a mobile application of Community Case Management on referral, re-consultation and hospitalization rates of children aged under 5 years in two districts in Northern Malawi: study protocol for a pragmatic, stepped-wedge cluster-randomized controlled trial.

    Science.gov (United States)

    Hardy, Victoria; O'Connor, Yvonne; Heavin, Ciara; Mastellos, Nikolaos; Tran, Tammy; O'Donoghue, John; Fitzpatrick, Annette L; Ide, Nicole; Wu, Tsung-Shu Joseph; Chirambo, Griphin Baxter; Muula, Adamson S; Nyirenda, Moffat; Carlsson, Sven; Andersson, Bo; Thompson, Matthew

    2017-10-11

    There is evidence to suggest that frontline community health workers in Malawi are under-referring children to higher-level facilities. Integrating a digitized version of paper-based methods of Community Case Management (CCM) could strengthen delivery, increasing urgent referral rates and preventing unnecessary re-consultations and hospital admissions. This trial aims to evaluate the added value of the Supporting LIFE electronic Community Case Management Application (SL eCCM App) compared to paper-based CCM on urgent referral, re-consultation and hospitalization rates, in two districts in Northern Malawi. This is a pragmatic, stepped-wedge cluster-randomized trial assessing the added value of the SL eCCM App on urgent referral, re-consultation and hospitalization rates of children aged 2 months and older to up to 5 years, within 7 days of the index visit. One hundred and two health surveillance assistants (HSAs) were stratified into six clusters based on geographical location, and clusters randomized to the timing of crossover to the intervention using simple, computer-generated randomization. Training workshops were conducted prior to the control (paper-CCM) and intervention (paper-CCM + SL eCCM App) in assigned clusters. Neither participants nor study personnel were blinded to allocation. Outcome measures were determined by abstraction of clinical data from patient records 2 weeks after recruitment. A nested qualitative study explored perceptions of adherence to urgent referral recommendations and a cost evaluation determined the financial and time-related costs to caregivers of subsequent health care utilization. The trial was conducted between July 2016 and February 2017. This is the first large-scale trial evaluating the value of adding a mobile application of CCM to the assessment of children aged under 5 years. The trial will generate evidence on the potential use of mobile health for CCM in Malawi, and more widely in other low- and middle

  6. A new mother-child play activity program to decrease parenting stress and improve child cognitive abilities: a cluster randomized controlled trial.

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    Yoshiyuki Tachibana

    Full Text Available BACKGROUND: We propose a new play activity intervention program for mothers and children. Our interdisciplinary program integrates four fields of child-related sciences: neuroscience, preschool pedagogy, developmental psychology, and child and maternal psychiatry. To determine the effect of this intervention on child and mother psychosocial problems related to parenting stress and on the children's cognitive abilities, we performed a cluster randomized controlled trial. METHODOLOGY/PRINCIPAL FINDINGS: Participants were 238 pairs of mothers and typically developing preschool children (ages 4-6 years old from Wakakusa kindergarten in Japan. The pairs were asked to play at home for about 10 min a day, 5 days a week for 3 months. Participants were randomly assigned to the intervention or control group by class unit. The Parenting Stress Index (PSI (for mothers, the Goodenough Draw-a-Man intelligence test (DAM, and the new S-S intelligence test (NS-SIT (for children were administered prior to and 3 months after the intervention period. Pre-post changes in test scores were compared between the groups using a linear mixed-effects model analysis. The primary outcomes were the Total score on the child domain of the PSI (for child psychosocial problems related to parenting stress, Total score on the parent domain of the PSI (for maternal psychosocial problems related to parenting stress, and the score on the DAM (for child cognitive abilities. The results of the PSI suggested that the program may reduce parenting stress. The results of the cognitive tests suggested that the program may improve the children's fluid intelligence, working memory, and processing speed. CONCLUSIONS/SIGNIFICANCE: Our intervention program may ameliorate the children's psychosocial problems related to parenting stress and increase their cognitive abilities. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000002265.

  7. Implementing international osteoarthritis treatment guidelines in primary health care: study protocol for the SAMBA stepped wedge cluster randomized controlled trial.

    Science.gov (United States)

    Østerås, Nina; van Bodegom-Vos, Leti; Dziedzic, Krysia; Moseng, Tuva; Aas, Eline; Andreassen, Øyvor; Mdala, Ibrahim; Natvig, Bård; Røtterud, Jan Harald; Schjervheim, Unni-Berit; Vlieland, Thea Vliet; Hagen, Kåre Birger

    2015-12-02

    Previous research indicates that people with osteoarthritis (OA) are not receiving the recommended and optimal treatment. Based on international treatment recommendations for hip and knee OA and previous research, the SAMBA model for integrated OA care in Norwegian primary health care has been developed. The model includes physiotherapist (PT) led patient OA education sessions and an exercise programme lasting 8-12 weeks. This study aims to assess the effectiveness, feasibility, and costs of a tailored strategy to implement the SAMBA model. A cluster randomized controlled trial with stepped wedge design including an effect, process, and cost evaluation will be conducted in six municipalities (clusters) in Norway. The municipalities will be randomized for time of crossover from current usual care to the implementation of the SAMBA model by a tailored strategy. The tailored strategy includes interactive workshops for general practitioners (GPs) and PTs in primary care covering the SAMBA model for integrated OA care, educational material, educational outreach visits, feedback, and reminder material. Outcomes will be measured at the patient, GP, and PT levels using self-report, semi-structured interviews, and register based data. The primary outcome measure is patient-reported quality of care (OsteoArthritis Quality Indicator questionnaire) at 6-month follow-up. Secondary outcomes include referrals to PT, imaging, and referrals to the orthopaedic surgeon as well as participants' treatment satisfaction, symptoms, physical activity level, body weight, and self-reported and measured lower limb function. The actual exposure to the tailor made implementation strategy and user experiences will be measured in a process evaluation. In the economic evaluation, the difference in costs of usual OA care and the SAMBA model for integrated OA care will be compared with the difference in health outcomes and reported by the incremental cost-effectiveness ratio (ICER). The results

  8. Implementing school nursing strategies to reduce LGBTQ adolescent suicide: a randomized cluster trial study protocol

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    Cathleen E. Willging

    2016-10-01

    Full Text Available Abstract Background Reducing youth suicide in the United States (U.S. is a national public health priority, and lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ youth are at elevated risk. The Centers for Disease Control and Prevention (CDC endorses six evidence-based (EB strategies that center on meeting the needs of LGBTQ youth in schools; however, fewer than 6 % of U.S. schools implement all of them. The proposed intervention model, “RLAS” (Implementing School Nursing Strategies to Reduce LGBTQ Adolescent Suicide, builds on the Exploration, Preparation, Implementation, and Sustainment (EPIS conceptual framework and the Dynamic Adaptation Process (DAP to implement EB strategies in U.S. high schools. The DAP accounts for the multilevel context of school settings and uses Implementation Resource Teams (IRTs to facilitate appropriate expertise, advise on acceptable adaptations, and provide data feedback to make schools implementation ready and prepared to sustain changes. Methods/Design Mixed methods will be used to examine individual, school, and community factors influencing both implementation process and youth outcomes. A cluster randomized controlled trial will assess whether LGBTQ students and their peers in RLAS intervention schools (n = 20 report reductions in suicidality, depression, substance use, bullying, and truancy related to safety concerns compared to those in usual care schools (n = 20. Implementation progress and fidelity for each EB strategy in RLAS intervention schools will be examined using a modified version of the Stages of Implementation Completion checklist. During the implementation and sustainment phases, annual focus groups will be conducted with the 20 IRTs to document their experiences identifying and advancing adaptation supports to facilitate use of EB strategies and their perceptions of the DAP. Discussion The DAP represents a data-informed, collaborative, multiple stakeholder

  9. Balancing Opposing Forces—A Nested Process Evaluation Study Protocol for a Stepped Wedge Designed Cluster Randomized Controlled Trial of an Experience Based Codesign Intervention

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    Victoria Jane Palmer

    2016-10-01

    Full Text Available Background: Process evaluations are essential to understand the contextual, relational, and organizational and system factors of complex interventions. The guidance for developing process evaluations for randomized controlled trials (RCTs has until recently however, been fairly limited. Method/Design: A nested process evaluation (NPE was designed and embedded across all stages of a stepped wedge cluster RCT called the CORE study. The aim of the CORE study is to test the effectiveness of an experience-based codesign methodology for improving psychosocial recovery outcomes for people living with severe mental illness (service users. Process evaluation data collection combines qualitative and quantitative methods with four aims: (1 to describe organizational characteristics, service models, policy contexts, and government reforms and examine the interaction of these with the intervention; (2 to understand how the codesign intervention works, the cluster variability in implementation, and if the intervention is or is not sustained in different settings; (3 to assist in the interpretation of the primary and secondary outcomes and determine if the causal assumptions underpinning the codesign interventions are accurate; and (4 to determine the impact of a purposefully designed engagement model on the broader study retention and knowledge transfer in the trial. Discussion: Process evaluations require prespecified study protocols but finding a balance between their iterative nature and the structure offered by protocol development is an important step forward. Taking this step will advance the role of qualitative research within trials research and enable more focused data collection to occur at strategic points within studies.

  10. Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

    Science.gov (United States)

    Jeemon, Panniyammakal; Narayanan, Gitanjali; Kondal, Dimple; Kahol, Kashvi; Bharadwaj, Ashok; Purty, Anil; Negi, Prakash; Ladhani, Sulaiman; Sanghvi, Jyoti; Singh, Kuldeep; Kapoor, Deksha; Sobti, Nidhi; Lall, Dorothy; Manimunda, Sathyaprakash; Dwivedi, Supriya; Toteja, Gurudyal; Prabhakaran, Dorairaj

    2016-03-15

    Effective task-shifting interventions targeted at reducing the global cardiovascular disease (CVD) epidemic in low and middle-income countries (LMICs) are urgently needed. DISHA is a cluster randomised controlled trial conducted across 10 sites (5 in phase 1 and 5 in phase 2) in India in 120 clusters. At each site, 12 clusters were randomly selected from a district. A cluster is defined as a small village with 250-300 households and well defined geographical boundaries. They were then randomly allocated to intervention and control clusters in a 1:1 allocation sequence. If any of the intervention and control clusters were workers (mainly Anganwadi workers and ASHA workers) and a post intervention survey in a representative sample. The study staff had no information on intervention allocation until the completion of the baseline survey. In order to ensure comparability of data across sites, the DISHA study follows a common protocol and manual of operation with standardized measurement techniques. Our study is the largest community based cluster randomised trial in low and middle-income country settings designed to test the effectiveness of 'task shifting' interventions involving frontline health workers for cardiovascular risk reduction. CTRI/2013/10/004049 . Registered 7 October 2013.

  11. Neuromuscular training reduces lower limb injuries in elite female basketball players. A cluster randomized controlled trial.

    Science.gov (United States)

    Bonato, M; Benis, R; La Torre, A

    2018-04-01

    The study was a two-armed, parallel group, cluster randomized controlled trial in which 15 teams (160 players) were assigned to either an experimental group (EG, 8 teams n = 86), which warmed-up with bodyweight neuromuscular exercises, or a control group (CG, 7 teams, n = 74) that performed standard tactical-technical exercises before training. All injuries during the 2015-2016 regular season were counted. Epidemiologic incidence proportion and incidence rate were also calculated. Countermovement jump (CMJ) and composite Y-Excursion Balance test (YBT) were used to assess lower limb strength and postural control. A total of 111 injuries were recorded. Chi-square test detected statistically significant differences between EG and CG (32 vs 79, P = .006). Significant differences in the injuries sustained in the EG (21 vs 11, P = .024) and CG (52 vs 27, P = .0001) during training and matches, respectively, were observed. Significant differences in post-intervention injuries were observed between in EG and CG during training (21 vs 52, P training into warm-up routines reduced the incidence of serious lower limb injuries in elite female basketball players. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. An Integrated Approach to Control Soil-Transmitted Helminthiasis, Schistosomiasis, Intestinal Protozoa Infection, and Diarrhea: Protocol for a Cluster Randomized Trial.

    Science.gov (United States)

    Raso, Giovanna; Essé, Clémence; Dongo, Kouassi; Ouattara, Mamadou; Zouzou, Fabien; Hürlimann, Eveline; Koffi, Veronique A; Coulibaly, Gaoussou; Mahan, Virginie; Yapi, Richard B; Koné, Siaka; Coulibaly, Jean Tenena; Meïté, Aboulaye; Guéhi-Kabran, Marie-Claire; Bonfoh, Bassirou; N'Goran, Eliézer Kouakou; Utzinger, Jürg

    2018-06-12

    The global strategy to control helminthiases (schistosomiasis and soil-transmitted helminthiasis) emphasizes preventive chemotherapy. However, in the absence of access to clean water, improved sanitation, and adequate hygiene, reinfection after treatment can occur rapidly. Integrated approaches might be necessary to sustain the benefits of preventive chemotherapy and make progress toward interruption of helminthiases transmission. The aim of this study was to assess and quantify the effect of an integrated control package that consists of preventive chemotherapy, community-led total sanitation, and health education on soil-transmitted helminthiasis, schistosomiasis, intestinal protozoa infection, and diarrhea in rural Côte d'Ivoire. In a first step, a community health education program was developed that includes an animated cartoon to promote improved hygiene and health targeting school-aged children, coupled with a health education theater for the entire community. In a second step, a cluster randomized trial was implemented in 56 communities of south-central Côte d'Ivoire with 4 intervention arms: (1) preventive chemotherapy; (2) preventive chemotherapy plus community-led total sanitation; (3) preventive chemotherapy plus health education; and (4) all 3 interventions combined. Before implementation of the aforementioned interventions, a baseline parasitologic, anthropometric, and hygiene-related knowledge, attitudes, practices, and beliefs survey was conducted. These surveys were repeated 18 and 39 months after the baseline cross-sectional survey to determine the effect of different interventions on helminth and intestinal protozoa infection, nutritional indicators, and knowledge, attitudes, practices, and beliefs. Monitoring of diarrhea was done over a 24-month period at 2-week intervals, starting right after the baseline survey. Key results from this cluster randomized trial will shed light on the effect of integrated approaches consisting of preventive

  13. Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients--the INDICA study: a cluster randomized controlled trial.

    Science.gov (United States)

    Ramallo-Fariña, Yolanda; García-Pérez, Lidia; Castilla-Rodríguez, Iván; Perestelo-Pérez, Lilisbeth; Wägner, Ana María; de Pablos-Velasco, Pedro; Domínguez, Armando Carrillo; Cortés, Mauro Boronat; Vallejo-Torres, Laura; Ramírez, Marcos Estupiñán; Martín, Pablo Pedrianes; García-Puente, Ignacio; Salinero-Fort, Miguel Ángel; Serrano-Aguilar, Pedro Guillermo

    2015-04-09

    Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals' decision-making. The Diabetes Intervention study in the Canary Islands (INDICA study) aims to evaluate the effectiveness and cost-effectiveness of educational interventions supported by new technology decision tools for type 2 diabetes patients and primary care professionals in the Canary Islands. The INDICA study is an open, community-based, multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care. The setting is primary care where physicians and nurses are invited to participate. Patients with diabetes diagnosis, 18-65 years of age, and regular users of mobile phone were randomly selected. Patients with severe comorbidities were excluded. The clusters are primary healthcare practices with enough professionals and available places to provide the intervention. The calculated sample size was 2,300 patients. Patients in group 1 are receiving an educational group program of eight sessions every 3 months led by trained nurses and monitored by means of logs and a web-based platform and tailored semi-automated SMS for continuous support. Primary care professionals in group 2 are receiving a short educational program to update their diabetes knowledge, which includes a decision support tool embedded into the electronic clinical record and a monthly feedback report of patients' results. Group 3 is receiving a combination of the interventions for patients and professionals. The primary endpoint is the change in HbA1c in 2 years. Secondary endpoints are cardiovascular risk factors, macrovascular and microvascular diabetes complications, quality of life, psychological outcomes, diabetes knowledge, and healthcare utilization. Data is being collected from interviews, questionnaires, clinical examinations, and records. Generalized linear mixed models with repeated time measurements will be used

  14. Shamba Maisha: Pilot agricultural intervention for food security and HIV health outcomes in Kenya: design, methods, baseline results and process evaluation of a cluster-randomized controlled trial.

    Science.gov (United States)

    Cohen, Craig R; Steinfeld, Rachel L; Weke, Elly; Bukusi, Elizabeth A; Hatcher, Abigail M; Shiboski, Stephen; Rheingans, Richard; Scow, Kate M; Butler, Lisa M; Otieno, Phelgona; Dworkin, Shari L; Weiser, Sheri D

    2015-01-01

    Despite advances in treatment of people living with HIV, morbidity and mortality remains unacceptably high in sub-Saharan Africa, largely due to parallel epidemics of poverty and food insecurity. We conducted a pilot cluster randomized controlled trial (RCT) of a multisectoral agricultural and microfinance intervention (entitled Shamba Maisha) designed to improve food security, household wealth, HIV clinical outcomes and women's empowerment. The intervention was carried out at two HIV clinics in Kenya, one randomized to the intervention arm and one to the control arm. HIV-infected patients >18 years, on antiretroviral therapy, with moderate/severe food insecurity and/or body mass index (BMI) loan (~$150) to purchase the farming commodities, 2) a micro-irrigation pump, seeds, and fertilizer, and 3) trainings in sustainable agricultural practices and financial literacy. Enrollment of 140 participants took four months, and the screening-to-enrollment ratio was similar between arms. We followed participants for 12 months and conducted structured questionnaires. We also conducted a process evaluation with participants and stakeholders 3-5 months after study start and at study end. Baseline results revealed that participants at the two sites were similar in age, gender and marital status. A greater proportion of participants at the intervention site had a low BMI in comparison to participants at the control site (18% vs. 7%, p = 0.054). While median CD4 count was similar between arms, a greater proportion of participants enrolled at the intervention arm had a detectable HIV viral load compared with control participants (49% vs. 28%, respectively, p loans, agricultural challenges due to weather patterns, and a challenging partnership with the microfinance institution. We expect the results from this pilot study to provide useful data on the impacts of livelihood interventions and will help in the design of a definitive cluster RCT. This trial is registered at ClinicalTrials

  15. The role of commitment strength in enhancing safe water consumption: mediation analysis of a cluster-randomized trial.

    Science.gov (United States)

    Inauen, Jennifer; Tobias, Robert; Mosler, Hans-Joachim

    2014-11-01

    The objectives of this study were to investigate the importance of commitment strength in the theory of planned behaviour (TPB) and to test whether behaviour change techniques (BCTs) aimed at increasing commitment strength indeed promote switching to arsenic-safe wells by changing commitment strength. A cluster-randomized controlled trial with four arms was conducted to compare an information-only intervention to information plus one, two, or three commitment-enhancing BCTs. Randomly selected households (N = 340) of Monoharganj, Bangladesh, in seven geographically separate areas, whose members were drinking arsenic-contaminated water at baseline and had access to arsenic-safe wells, participated in this trial. The areas were randomly allocated to the four intervention arms. Water consumption behaviour, variables of the TPB, commitment strength, and socio-demographic characteristics were assessed at baseline and at 3-month follow-up by structured face-to-face interviews. Mediation analysis was used to investigate the mechanisms of behaviour change. Changes in commitment strength significantly increased the explanatory power of the TPB to predict well-switching. Commitment-enhancing BCTs - public self-commitment, implementation intentions, and reminders - increased the behaviour change effects of information by up to 50%. Mediation analyses confirmed that the BCTs indeed increased well-switching by increasing commitment strength. Unexpectedly, however, mediation via changes in behavioural intentions was the strongest mechanism of the intervention effects. Commitment is an important construct to consider in water- and health-related behaviour change and may be for other health behaviours as well. BCTs that alter behavioural intentions and commitment strength proved highly effective at enhancing the behaviour change effects of information alone. Statement of contribution What is already known on this subject? Millions of people drink contaminated water even if they

  16. Cluster Tails for Critical Power-Law Inhomogeneous Random Graphs

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    van der Hofstad, Remco; Kliem, Sandra; van Leeuwaarden, Johan S. H.

    2018-04-01

    Recently, the scaling limit of cluster sizes for critical inhomogeneous random graphs of rank-1 type having finite variance but infinite third moment degrees was obtained in Bhamidi et al. (Ann Probab 40:2299-2361, 2012). It was proved that when the degrees obey a power law with exponent τ \\in (3,4), the sequence of clusters ordered in decreasing size and multiplied through by n^{-(τ -2)/(τ -1)} converges as n→ ∞ to a sequence of decreasing non-degenerate random variables. Here, we study the tails of the limit of the rescaled largest cluster, i.e., the probability that the scaling limit of the largest cluster takes a large value u, as a function of u. This extends a related result of Pittel (J Combin Theory Ser B 82(2):237-269, 2001) for the Erdős-Rényi random graph to the setting of rank-1 inhomogeneous random graphs with infinite third moment degrees. We make use of delicate large deviations and weak convergence arguments.

  17. A cluster-randomized controlled trial of strategies to increase adolescents' physical activity and motivation during physical education lessons: the Motivating Active Learning in Physical Education (MALP) trial.

    Science.gov (United States)

    Rosenkranz, Richard R; Lubans, David R; Peralta, Louisa R; Bennie, Andrew; Sanders, Taren; Lonsdale, Chris

    2012-10-01

    The physical activity (PA) levels of many children and adolescents in Australia are currently insufficient to promote health benefits. Physical education (PE) programs aim to promote PA and reach nearly all school-aged children, but PA levels within PE lessons are often low. PE teachers may influence children's motivation to be physically active in PE lessons, but little is known about teacher strategies that effectively motivate children to participate in PA, and few intervention studies have examined motivational strategies in PE. The purpose of this study was to compare the effect of three motivational strategies, each based on Self-Determination Theory (SDT), on PA levels, and their hypothesized antecedents, during year 8 PE lessons. This study employed a cluster-randomized controlled trial design. Following a familiarization session, PA levels and hypothesized PA antecedents were measured during a baseline lesson and a post-intervention or control lesson. Teachers (n = 16) and their classes from five secondary schools in Sydney, Australia were randomly assigned into four blocks and instructed to provide one of four 20-min lesson teaching strategy conditions: (1) explaining the relevance of activities; (2) providing choice from PA options selected by the teacher; (3) providing equipment and free choice of activities; or (4) usual practice. The primary outcomes were lesson time spent in moderate-to-vigorous PA, and motivation towards the lesson. Secondary outcomes were perceptions of teacher behavior, psychological needs satisfaction, and lesson time spent in sedentary behavior. PA and sedentary behavior were measured during baseline and post-intervention lessons with waist-mounted Actigraph GT3X accelerometers. Teacher behavior, psychological needs satisfaction, and motivation were assessed via questionnaires at the end of each lesson. Linear mixed-model analyses will be run on all outcomes, with students nested within teachers as a random effect. Study

  18. Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial.

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    Jøranson, Nina; Pedersen, Ingeborg; Rokstad, Anne Marie Mork; Ihlebaek, Camilla

    2016-12-01

    The aim of this study was to investigate effects of robot-assisted group activity with Paro on quality of life in older people with dementia. Nursing home residents with severe dementia often experience social withdrawal and lower quality of life, which are suggested to be enhanced by non-pharmacological interventions. A cluster-randomized controlled trial. Ten nursing home units were randomized to robot-assisted intervention or control group (treatment as usual). Data were collected between March 2013-September 2014. 27 participants participated in group activity for 30 minutes twice a week over 12 weeks, 26 participated in the control group. Change in quality of life was assessed by local nurses through the Quality of Life in Late-Stage Dementia scale at baseline, after end of intervention and at 3 months follow-up. The scale and regular psychotropic medication were analysed stratified by dementia severity. Analysis using mixed model, one-way anova and linear regression were performed. An effect was found among participants with severe dementia from baseline to follow-up showing stable quality of life in the intervention group compared with a decrease in the control group. The intervention explained most of the variance in change in the total scale and in the subscales describing Tension and Well-being for the group with severe dementia. The intervention group used significantly less psychotropic medication compared with the control group after end of intervention. Pleasant and engaging activities facilitated by nursing staff, such as group activity with Paro, could improve quality of life in people with severe dementia. The trial is in adherence with the CONSORT statement and is registered at www.clinicaltrials.gov (study ID number: NCT02008630). © 2016 John Wiley & Sons Ltd.

  19. Effectiveness of a clinical practice guideline implementation strategy for patients with anxiety disorders in primary care: cluster randomized trial

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    Tello-Bernabé Eugenia

    2011-12-01

    Full Text Available Abstract Background Anxiety is a common mental health problem seen in primary care. However, its management in clinical practice varies greatly. Clinical practice guidelines (CPGs have the potential to reduce variations and improve the care received by patients by promoting interventions of proven benefit. However, uptake and adherence to their recommendations can be low. Method/design This study involves a community based on cluster randomized trial in primary healthcare centres in the Madrid Region (Spain. The project aims to determine whether the use of implementation strategy (including training session, information, opinion leader, reminders, audit, and feed-back of CPG for patients with anxiety disorders in primary care is more effective than usual diffusion. The number of patients required is 296 (148 in each arm, all older than 18 years and diagnosed with generalized anxiety disorder, panic disorder, and panic attacks by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV. They are chosen by consecutive sampling. The main outcome variable is the change in two or more points into Goldberg anxiety scale at six and twelve months. Secondary outcome variables include quality of life (EuroQol 5D, and degree of compliance with the CPG recommendations on treatment, information, and referrals to mental health services. Main effectiveness will be analyzed by comparing the patients percentage improvement on the Goldberg scale between the intervention group and the control group. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion There is a need to identify effective implementation strategies for CPG for the management of anxiety disorders present in primary care. Ensuring the appropriate uptake of guideline recommendations can reduce clinical variation and improve the care

  20. Protocol for the Osteoporosis Choice trial. A pilot randomized trial of a decision aid in primary care practice

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    Tulledge-Scheitel Sidna M

    2009-12-01

    Full Text Available Abstract Background Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1 preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE for postmenopausal women at risk for osteoporotic fractures; and (2 assess the feasibility and validity (i.e., absence of contamination of patient-level randomization (vs. cluster randomization in pilot trials of decision aid efficacy. Methods/Design This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of STEOPOROSIS CHOICE on five outcomes: (a patient knowledge regarding osteoporosis risk factors and treatment; (b quality of the decision-making process for both the patient and clinician; (c patient and clinician acceptability and satisfaction with the decision aid; (d rate of bisphosphonate use and adherence, and (e trial processes (e.g., ability to recruit participants, collect patient outcomes. To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination. Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months. Discussion This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach -- decision aids -- to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform

  1. Mobile access to virtual randomization for investigator-initiated trials.

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    Deserno, Thomas M; Keszei, András P

    2017-08-01

    Background/aims Randomization is indispensable in clinical trials in order to provide unbiased treatment allocation and a valid statistical inference. Improper handling of allocation lists can be avoided using central systems, for example, human-based services. However, central systems are unaffordable for investigator-initiated trials and might be inaccessible from some places, where study subjects need allocations. We propose mobile access to virtual randomization, where the randomization lists are non-existent and the appropriate allocation is computed on demand. Methods The core of the system architecture is an electronic data capture system or a clinical trial management system, which is extended by an R interface connecting the R server using the Java R Interface. Mobile devices communicate via the representational state transfer web services. Furthermore, a simple web-based setup allows configuring the appropriate statistics by non-statisticians. Our comprehensive R script supports simple randomization, restricted randomization using a random allocation rule, block randomization, and stratified randomization for un-blinded, single-blinded, and double-blinded trials. For each trial, the electronic data capture system or the clinical trial management system stores the randomization parameters and the subject assignments. Results Apps are provided for iOS and Android and subjects are randomized using smartphones. After logging onto the system, the user selects the trial and the subject, and the allocation number and treatment arm are displayed instantaneously and stored in the core system. So far, 156 subjects have been allocated from mobile devices serving five investigator-initiated trials. Conclusion Transforming pre-printed allocation lists into virtual ones ensures the correct conduct of trials and guarantees a strictly sequential processing in all trial sites. Covering 88% of all randomization models that are used in recent trials, virtual randomization

  2. Exploring biological network structure with clustered random networks

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    Bansal Shweta

    2009-12-01

    Full Text Available Abstract Background Complex biological systems are often modeled as networks of interacting units. Networks of biochemical interactions among proteins, epidemiological contacts among hosts, and trophic interactions in ecosystems, to name a few, have provided useful insights into the dynamical processes that shape and traverse these systems. The degrees of nodes (numbers of interactions and the extent of clustering (the tendency for a set of three nodes to be interconnected are two of many well-studied network properties that can fundamentally shape a system. Disentangling the interdependent effects of the various network properties, however, can be difficult. Simple network models can help us quantify the structure of empirical networked systems and understand the impact of various topological properties on dynamics. Results Here we develop and implement a new Markov chain simulation algorithm to generate simple, connected random graphs that have a specified degree sequence and level of clustering, but are random in all other respects. The implementation of the algorithm (ClustRNet: Clustered Random Networks provides the generation of random graphs optimized according to a local or global, and relative or absolute measure of clustering. We compare our algorithm to other similar methods and show that ours more successfully produces desired network characteristics. Finding appropriate null models is crucial in bioinformatics research, and is often difficult, particularly for biological networks. As we demonstrate, the networks generated by ClustRNet can serve as random controls when investigating the impacts of complex network features beyond the byproduct of degree and clustering in empirical networks. Conclusion ClustRNet generates ensembles of graphs of specified edge structure and clustering. These graphs allow for systematic study of the impacts of connectivity and redundancies on network function and dynamics. This process is a key step in

  3. Will Mobile Diabetes Education Teams (MDETs in primary care improve patient care processes and health outcomes? Study protocol for a randomized controlled trial

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    Gucciardi Enza

    2012-09-01

    Full Text Available Abstract Background There is evidence to suggest that delivery of diabetes self-management support by diabetes educators in primary care may improve patient care processes and patient clinical outcomes; however, the evaluation of such a model in primary care is nonexistent in Canada. This article describes the design for the evaluation of the implementation of Mobile Diabetes Education Teams (MDETs in primary care settings in Canada. Methods/design This study will use a non-blinded, cluster-randomized controlled trial stepped wedge design to evaluate the Mobile Diabetes Education Teams' intervention in improving patient clinical and care process outcomes. A total of 1,200 patient charts at participating primary care sites will be reviewed for data extraction. Eligible patients will be those aged ≥18, who have type 2 diabetes and a hemoglobin A1c (HbA1c of ≥8%. Clusters (that is, primary care sites will be randomized to the intervention and control group using a block randomization procedure within practice size as the blocking factor. A stepped wedge design will be used to sequentially roll out the intervention so that all clusters eventually receive the intervention. The time at which each cluster begins the intervention is randomized to one of the four roll out periods (0, 6, 12, and 18 months. Clusters that are randomized into the intervention later will act as the control for those receiving the intervention earlier. The primary outcome measure will be the difference in the proportion of patients who achieve the recommended HbA1c target of ≤7% between intervention and control groups. Qualitative work (in-depth interviews with primary care physicians, MDET educators and patients; and MDET educators’ field notes and debriefing sessions will be undertaken to assess the implementation process and effectiveness of the MDET intervention. Trial registration ClinicalTrials.gov NCT01553266

  4. An educational and physical program to reduce headache, neck/shoulder pain in a working community: a cluster-randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Franco Mongini

    Full Text Available Noninvasive physical management is often prescribed for headache and neck pain. Systematic reviews, however, indicate that the evidence of its efficacy is limited. Our aim was to evaluate the effectiveness of a workplace educational and physical program in reducing headache and neck/shoulder pain.Cluster-randomized controlled trial. All municipal workers of the City of Turin, Italy, were invited to participate. Those who agreed were randomly assigned, according to their departments, to the intervention group (IG or to the control group and were given diaries for the daily recording of pain episodes for 1 month (baseline. Subsequently, only the IG (119 departments, 923 workers began the physical and educational program, whereas the control group (117 departments, 990 workers did not receive any intervention. All participants were again given diaries for the daily recording of pain episodes after 6 months of intervention. The primary outcome was the change in the frequency of headache (expressed as the proportion of subjects with a ≥50% reduction of frequency; responder rate; among the secondary outcomes there were the absolute reduction of the number of days per month with headache and neck/shoulder pain. Differences between the two groups were evaluated using mixed-effect regression models. The IG showed a higher responder rate [risk ratio, 95% confidence interval (CI] for headache (1.58; 1.28 to 1.92 and for neck/shoulder pain (1.53; 1.27 to 1.82, and a larger reduction of the days per month (95% CI with headache (-1.72; -2.40 to -1.04 and with neck/shoulder pain (-2.51; -3.56 to -1.47.The program effectively reduced headache and neck/shoulder pain in a large working community and appears to be easily transferable to primary-care settings. Further trials are needed to investigate the program effectiveness in a clinical setting, for highly selected patients suffering from specific headache types.ClinicalTrials.gov NCT00551980.

  5. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost

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    Scardino Peter T

    2009-03-01

    Full Text Available Abstract Introduction Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients on- and off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization.

  6. Accounting for interactions and complex inter-subject dependency in estimating treatment effect in cluster-randomized trials with missing outcomes.

    Science.gov (United States)

    Prague, Melanie; Wang, Rui; Stephens, Alisa; Tchetgen Tchetgen, Eric; DeGruttola, Victor

    2016-12-01

    Semi-parametric methods are often used for the estimation of intervention effects on correlated outcomes in cluster-randomized trials (CRTs). When outcomes are missing at random (MAR), Inverse Probability Weighted (IPW) methods incorporating baseline covariates can be used to deal with informative missingness. Also, augmented generalized estimating equations (AUG) correct for imbalance in baseline covariates but need to be extended for MAR outcomes. However, in the presence of interactions between treatment and baseline covariates, neither method alone produces consistent estimates for the marginal treatment effect if the model for interaction is not correctly specified. We propose an AUG-IPW estimator that weights by the inverse of the probability of being a complete case and allows different outcome models in each intervention arm. This estimator is doubly robust (DR); it gives correct estimates whether the missing data process or the outcome model is correctly specified. We consider the problem of covariate interference which arises when the outcome of an individual may depend on covariates of other individuals. When interfering covariates are not modeled, the DR property prevents bias as long as covariate interference is not present simultaneously for the outcome and the missingness. An R package is developed implementing the proposed method. An extensive simulation study and an application to a CRT of HIV risk reduction-intervention in South Africa illustrate the method. © 2016, The International Biometric Society.

  7. Factors influencing participation in a vascular disease prevention lifestyle program among participants in a cluster randomized trial.

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    Laws, Rachel A; Fanaian, Mahnaz; Jayasinghe, Upali W; McKenzie, Suzanne; Passey, Megan; Davies, Gawaine Powell; Lyle, David; Harris, Mark F

    2013-05-31

    Previous research suggests that lifestyle intervention for the prevention of diabetes and cardiovascular disease (CVD) are effective, however little is known about factors affecting participation in such programs. This study aims to explore factors influencing levels of participation in a lifestyle modification program conducted as part of a cluster randomized controlled trial of CVD prevention in primary care. This concurrent mixed methods study used data from the intervention arm of a cluster RCT which recruited 30 practices through two rural and three urban primary care organizations. Practices were randomly allocated to intervention (n = 16) and control (n = 14) groups. In each practice up to 160 eligible patients aged between 40 and 64 years old, were invited to participate. Intervention practice staff were trained in lifestyle assessment and counseling and referred high risk patients to a lifestyle modification program (LMP) consisting of two individual and six group sessions over a nine month period. Data included a patient survey, clinical audit, practice survey on capacity for preventive care, referral and attendance records at the LMP and qualitative interviews with Intervention Officers facilitating the LMP. Multi-level logistic regression modelling was used to examine independent predictors of attendance at the LMP, supplemented with qualitative data from interviews with Intervention Officers facilitating the program. A total of 197 individuals were referred to the LMP (63% of those eligible). Over a third of patients (36.5%) referred to the LMP did not attend any sessions, with 59.4% attending at least half of the planned sessions. The only independent predictors of attendance at the program were employment status - not working (OR: 2.39 95% CI 1.15-4.94) and having high psychological distress (OR: 2.17 95% CI: 1.10-4.30). Qualitative data revealed that physical access to the program was a barrier, while GP/practice endorsement of the program and

  8. The Effect of Three-Monthly Albendazole Treatment on Malarial Parasitemia and Allergy: A Household-Based Cluster-Randomized, Double-Blind, Placebo-Controlled Trial

    Science.gov (United States)

    Kaisar, Maria M. M.; May, Linda; Prasetyani, Margaretta A.; Wahyuni, Sitti; Djuardi, Yenny; Ariawan, Iwan; Wibowo, Heri; Lell, Bertrand; Sauerwein, Robert; Brice, Gary T.; Sutanto, Inge; van Lieshout, Lisette; de Craen, Anton J. M.; van Ree, Ronald; Verweij, Jaco J.; Tsonaka, Roula; Houwing-Duistermaat, Jeanine J.; Luty, Adrian J. F.; Sartono, Erliyani; Supali, Taniawati; Yazdanbakhsh, Maria

    2013-01-01

    Background Helminth infections are proposed to have immunomodulatory activities affecting health outcomes either detrimentally or beneficially. We evaluated the effects of albendazole treatment, every three months for 21 months, on STH, malarial parasitemia and allergy. Methods and Findings A household-based cluster-randomized, double-blind, placebo-controlled trial was conducted in an area in Indonesia endemic for STH. Using computer-aided block randomization, 481 households (2022 subjects) and 473 households (1982 subjects) were assigned to receive placebo and albendazole, respectively, every three months. The treatment code was concealed from trial investigators and participants. Malarial parasitemia and malaria-like symptoms were assessed in participants older than four years of age while skin prick test (SPT) to allergens as well as reported symptoms of allergy in children aged 5–15 years. The general impact of treatment on STH prevalence and body mass index (BMI) was evaluated. Primary outcomes were prevalence of malarial parasitemia and SPT to any allergen. Analysis was by intention to treat. At 9 and 21 months post-treatment 80.8% and 80.1% of the study subjects were retained, respectively. The intensive treatment regiment resulted in a reduction in the prevalence of STH by 48% in albendazole and 9% in placebo group. Albendazole treatment led to a transient increase in malarial parasitemia at 6 months post treatment (OR 4.16(1.35–12.80)) and no statistically significant increase in SPT reactivity (OR 1.18(0.74–1.86) at 9 months or 1.37 (0.93–2.01) 21 months). No effect of anthelminthic treatment was found on BMI, reported malaria-like- and allergy symptoms. No adverse effects were reported. Conclusions The study indicates that intensive community treatment of 3 monthly albendazole administration for 21 months over two years leads to a reduction in STH. This degree of reduction appears safe without any increased risk of malaria or allergies. Trial

  9. Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS): a cluster randomized trial targeting system-wide improvement in substance use services.

    Science.gov (United States)

    Knight, Danica K; Belenko, Steven; Wiley, Tisha; Robertson, Angela A; Arrigona, Nancy; Dennis, Michael; Bartkowski, John P; McReynolds, Larkin S; Becan, Jennifer E; Knudsen, Hannah K; Wasserman, Gail A; Rose, Eve; DiClemente, Ralph; Leukefeld, Carl

    2016-04-29

    The purpose of this paper is to describe the Juvenile Justice-Translational Research on Interventions for Adolescents in the Legal System (JJ-TRIALS) study, a cooperative implementation science initiative involving the National Institute on Drug Abuse, six research centers, a coordinating center, and Juvenile Justice Partners representing seven US states. While the pooling of resources across centers enables a robust implementation study design involving 36 juvenile justice agencies and their behavioral health partner agencies, co-producing a study protocol that has potential to advance implementation science, meets the needs of all constituencies (funding agency, researchers, partners, study sites), and can be implemented with fidelity across the cooperative can be challenging. This paper describes (a) the study background and rationale, including the juvenile justice context and best practices for substance use disorders, (b) the selection and use of an implementation science framework to guide study design and inform selection of implementation components, and (c) the specific study design elements, including research questions, implementation interventions, measurement, and analytic plan. The JJ-TRIALS primary study uses a head-to-head cluster randomized trial with a phased rollout to evaluate the differential effectiveness of two conditions (Core and Enhanced) in 36 sites located in seven states. A Core strategy for promoting change is compared to an Enhanced strategy that incorporates all core strategies plus active facilitation. Target outcomes include improvements in evidence-based screening, assessment, and linkage to substance use treatment. Contributions to implementation science are discussed as well as challenges associated with designing and deploying a complex, collaborative project. NCT02672150 .

  10. Reducing communication delays and improving quality of care with a tuberculosis laboratory information system in resource poor environments: a cluster randomized controlled trial.

    Science.gov (United States)

    Blaya, Joaquín A; Shin, Sonya S; Yagui, Martin; Contreras, Carmen; Cegielski, Peter; Yale, Gloria; Suarez, Carmen; Asencios, Luis; Bayona, Jaime; Kim, Jihoon; Fraser, Hamish S F

    2014-01-01

    Lost, delayed or incorrect laboratory results are associated with delays in initiating treatment. Delays in treatment for Multi-Drug Resistant Tuberculosis (MDR-TB) can worsen patient outcomes and increase transmission. The objective of this study was to evaluate the impact of a laboratory information system in reducing delays and the time for MDR-TB patients to culture convert (stop transmitting). 78 primary Health Centers (HCs) in Lima, Peru. Participants lived within the catchment area of participating HCs and had at least one MDR-TB risk factor. The study design was a cluster randomized controlled trial with baseline data. The intervention was the e-Chasqui web-based laboratory information system. Main outcome measures were: times to communicate a result; to start or change a patient's treatment; and for that patient to culture convert. 1671 patients were enrolled. Intervention HCs took significantly less time to receive drug susceptibility test (DST) (median 11 vs. 17 days, Hazard Ratio 0.67 [0.62-0.72]) and culture (5 vs. 8 days, 0.68 [0.65-0.72]) results. The time to treatment was not significantly different, but patients in intervention HCs took 16 days (20%) less time to culture convert (p = 0.047). The eChasqui system reduced the time to communicate results between laboratories and HCs and time to culture conversion. It is now used in over 259 HCs covering 4.1 million people. This is the first randomized controlled trial of a laboratory information system in a developing country for any disease and the only study worldwide to show clinical impact of such a system. ClinicalTrials.gov NCT01201941.

  11. Short stick exercises for fall prevention among older adults: a cluster randomized trial.

    Science.gov (United States)

    Yokoi, Katsushi; Yoshimasu, Kouichi; Takemura, Shigeki; Fukumoto, Jin; Kurasawa, Shigeki; Miyashita, Kazuhisa

    2015-01-01

    To investigate the effects of short stick exercise (SSEs) on fall prevention and improvement of physical function in older adults. A cluster randomized trial was conducted in five residential care facilities. The intervention group (n = 51) practiced SSEs for six months, followed by routine care for six more months. The control group (n = 54) received ordinary care for 12 months. The primary outcome measure was the number of fallers, taking into account the time to first fall using the Kaplan-Meier method. The secondary outcome measures were physical and mental functions. The number of fallers was significantly lower in the intervention group (n = 6) than in the control group (n = 16) during the 12 months. The adjusted hazard ratio for a first fall in the intervention group compared with the control group was 0.15 (CI, 0.03 to 0.74, p = 0.02). The fall-free period was significantly longer in the intervention group than in controls (mean ± SD, 10.1 ± 3.0 versus 9.0 ± 4.1 months, p = 0.027). The functional reach and sit and reach tests were significantly improved at three and six months. The SSEs appeared effective for fall prevention and improvement of physical function in older adults. Implications for Rehabilitation The newly developed short stick exercises appear an effective means of reducing falls among older adults in residential care facilities. The short stick exercises seem to have an immediate effect on improving physical functions. Effects gained by performing the short stick exercises, such as static balance, flexibility and agility may last for six months. The short stick exercises were found to be easy for older adults to practice continuously in residential care facilities.

  12. Effects of the X:IT smoking intervention: a school-based cluster randomized trial.

    Science.gov (United States)

    Andersen, Anette; Krølner, Rikker; Bast, Lotus Sofie; Thygesen, Lau Caspar; Due, Pernille

    2015-12-01

    Uptake of smoking in adolescence is still of major public health concern. Evaluations of school-based programmes for smoking prevention show mixed results. The aim of this study was to examine the effect of X:IT, a multi-component school-based programme to prevent adolescent smoking. Data from a Danish cluster randomized trial included 4041 year-7 students (mean age: 12.5) from 51 intervention and 43 control schools. Outcome measure 'current smoking' was dichotomized into smoking daily, weekly, monthly or more seldom vs do not smoke. Analyses were adjusted for baseline covariates: sex, family socioeconomic position (SEP), best friend's smoking and parental smoking. We performed multilevel, logistic regression analyses of available cases and intention-to-treat (ITT) analyses, replacing missing outcome values by multiple imputation. At baseline, 4.7% and 6.8% of the students at the intervention and the control schools smoked, respectively. After 1 year of the intervention, the prevalence was 7.9% and 10.7%, respectively. At follow-up, 553 students (13.7%) did not answer the question on smoking. Available case analyses: crude odds ratios (OR) for smoking at intervention schools compared with control schools: 0.65 (0.48-0.88) and adjusted: 0.70 (0.47-1.04). ITT analyses: crude OR for smoking at intervention schools compared with control schools: 0.67 (0.50-0.89) and adjusted: 0.61 (0.45-0.82). Students at intervention schools had a lower risk of smoking after a year of intervention in year 7. This multi-component intervention involving educational, parental and context-related intervention components seems to be efficient in lowering or postponing smoking uptake in Danish adolescents. © The Author 2015; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.

  13. Safety voice for ergonomics (SAVE) project: protocol for a workplace cluster-randomized controlled trial to reduce musculoskeletal disorders in masonry apprentices.

    Science.gov (United States)

    Kincl, Laurel D; Anton, Dan; Hess, Jennifer A; Weeks, Douglas L

    2016-04-27

    Masons have the highest rate of overexertion injuries among all construction trades and rank second for occupational back injuries in the United States. Identified ergonomic solutions are the primary method of reducing exposure to risk factors associated with musculoskeletal disorders. However, many construction workers lack knowledge about these solutions, as well as basic ergonomic principles. Construction apprentices, as they embark on their careers, are greatly in need of ergonomics training to minimize the cumulative exposure that leads to musculoskeletal disorders. Apprentices receive safety training; however, ergonomics training is often limited or non-existent. In addition, apprenticeship programs often lack "soft skills" training on how to appropriately respond to work environments and practices that are unsafe. The SAVE program - SAfety Voice for Ergonomics - strives to integrate evidence-based health and safety training strategies into masonry apprenticeship skills training to teach ergonomics, problem solving, and speaking up to communicate solutions that reduce musculoskeletal injury risk. The central hypothesis is that the combination of ergonomics training and safety voice promotion will be more effective than no training or either ergonomics training alone or safety voice training alone. Following the development and pilot testing of the SAVE intervention, SAVE will be evaluated in a cluster-randomized controlled trial at 12 masonry training centers across the U.S. Clusters of apprentices within centers will be assigned at random to one of four intervention groups (n = 24 per group): (1) ergonomics training only, (2) safety voice training only, (3) combined ergonomics and safety voice training, or (4) control group with no additional training intervention. Outcomes assessed at baseline, at the conclusion of training, and then at six and 12 months post training will include: musculoskeletal symptoms, general health perceptions, knowledge of

  14. A community-based cluster randomized controlled trial (cRCT) to evaluate the impact and operational assessment of "safe motherhood and newborn health promotion package": study protocol.

    Science.gov (United States)

    Hoque, Dewan Md Emdadul; Chowdhury, Mohiuddin Ahsanul Kabir; Rahman, Ahmed Ehsanur; Billah, Sk Masum; Bari, Sanwarul; Tahsina, Tazeen; Hasan, Mohammad Mehedi; Islam, Sajia; Islam, Tajul; Mori, Rintaro; Arifeen, Shams El

    2018-05-03

    Despite considerable progress in reduction of both under-five and maternal mortality in recent decades, Bangladesh is still one of the low and middle income countries with high burden of maternal and neonatal mortality. The primary objective of the current study is to measure the impact of a comprehensive package of interventions on maternal and neonatal mortality. In addition, changes in coverage, quality and utilization of maternal and newborn health (MNH) services, social capital, and cost effectiveness of the interventions will be measured. A community-based, cluster randomized controlled trial design will be adopted and implemented in 30 unions of three sub-districts of Chandpur district of Bangladesh. Every union, the lowest administrative unit of the local government with population of around 20,000-30,000, will be considered a cluster. Based on the baseline estimates, 15 clusters will be paired for random assignment as intervention and comparison clusters. The primary outcome measure is neonatal mortality, and secondary outcomes are coverage of key interventions like ANC, PNC, facility and skilled provider delivery. Baseline, midterm and endline household survey will be conducted to assess the key coverage of interventions. Health facility assessment surveys will be conducted periodically to assess facility readiness and utilization of MNH services in the participating health facilities. The current study is expected to provide essential strong evidences on the impact of a comprehensive package of interventions to the Bangladesh government, and other developmental partners. The study results may help in prioritizing, planning, and scaling-up of Safe Motherhood Promotional interventions in other geographical areas of Bangladesh as well as to inform other developing countries of similar settings. NCT03032276 .

  15. The Effect of Improved Water Supply on Diarrhea Prevalence of Children under Five in the Volta Region of Ghana: A Cluster-Randomized Controlled Trial

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    Seungman Cha

    2015-09-01

    Full Text Available Although a number of studies have been conducted to explore the effect of water quality improvement, the majority of them have focused mainly on point-of-use water treatment, and the studies investigating the effect of improved water supply have been based on observational or inadequately randomized trials. We report the results of a matched cluster randomized trial investigating the effect of improved water supply on diarrheal prevalence of children under five living in rural areas of the Volta Region in Ghana. We compared the diarrheal prevalence of 305 children in 10 communities of intervention with 302 children in 10 matched communities with no intervention (October 2012 to February 2014. A modified Poisson regression was used to estimate the prevalence ratio. An intention-to-treat analysis was undertaken. The crude prevalence ratio of diarrhea in the intervention compared with the control communities was 0.85 (95% CI 0.74–0.97 for Krachi West, 0.96 (0.87–1.05 for Krachi East, and 0.91 (0.83–0.98 for both districts. Sanitation was adjusted for in the model to remove the bias due to residual imbalance since it was not balanced even after randomization. The adjusted prevalence ratio was 0.82 (95% CI 0.71–0.96 for Krachi West, 0.95 (0.86–1.04 for Krachi East, and 0.89 (0.82–0.97 for both districts. This study provides a basis for a better approach to water quality interventions.

  16. Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

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    Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena J

    2017-03-21

    A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). 10 Duke University Health System community-based primary care clinics. 537 outpatients with symptomatic hip or knee osteoarthritis. The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. The study involved 1 health care network. Data on provider referrals were not collected. Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically

  17. Depressive symptoms and gestational length among pregnant adolescents: Cluster randomized control trial of CenteringPregnancy® plus group prenatal care.

    Science.gov (United States)

    Felder, Jennifer N; Epel, Elissa; Lewis, Jessica B; Cunningham, Shayna D; Tobin, Jonathan N; Rising, Sharon Schindler; Thomas, Melanie; Ickovics, Jeannette R

    2017-06-01

    Depressive symptoms are associated with preterm birth among adults. Pregnant adolescents have high rates of depressive symptoms and low rates of treatment; however, few interventions have targeted this vulnerable group. Objectives are to: (a) examine impact of CenteringPregnancy® Plus group prenatal care on perinatal depressive symptoms compared to individual prenatal care; and (b) determine effects of depressive symptoms on gestational age and preterm birth among pregnant adolescents. This cluster-randomized controlled trial was conducted in 14 community health centers and hospitals in New York City. Clinical sites were randomized to receive standard individual prenatal care (n = 7) or CenteringPregnancy® Plus group prenatal care (n = 7). Pregnant adolescents (ages 14-21, N = 1,135) completed the Center for Epidemiologic Studies Depression Scale during pregnancy (second and third trimesters) and postpartum (6 and 12 months). Gestational age was obtained from medical records, based on ultrasound dating. Intention to treat analyses were used to examine objectives. Adolescents at clinical sites randomized to CenteringPregnancy® Plus experienced greater reductions in perinatal depressive symptoms compared to those at clinical sites randomized to individual care (p = .003). Increased depressive symptoms from second to third pregnancy trimester were associated with shorter gestational age at delivery and preterm birth (<37 weeks gestation). Third trimester depressive symptoms were also associated with shorter gestational age and preterm birth. All p < .05. Pregnant adolescents should be screened for depressive symptoms prior to third trimester. Group prenatal care may be an effective nonpharmacological option for reducing depressive symptoms among perinatal adolescents. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  18. Solar drinking water disinfection (SODIS to reduce childhood diarrhoea in rural Bolivia: a cluster-randomized, controlled trial.

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    Daniel Mäusezahl

    2009-08-01

    Full Text Available Solar drinking water disinfection (SODIS is a low-cost, point-of-use water purification method that has been disseminated globally. Laboratory studies suggest that SODIS is highly efficacious in inactivating waterborne pathogens. Previous field studies provided limited evidence for its effectiveness in reducing diarrhoea.We conducted a cluster-randomized controlled trial in 22 rural communities in Bolivia to evaluate the effect of SODIS in reducing diarrhoea among children under the age of 5 y. A local nongovernmental organisation conducted a standardised interactive SODIS-promotion campaign in 11 communities targeting households, communities, and primary schools. Mothers completed a daily child health diary for 1 y. Within the intervention arm 225 households (376 children were trained to expose water-filled polyethyleneteraphtalate bottles to sunlight. Eleven communities (200 households, 349 children served as a control. We recorded 166,971 person-days of observation during the trial representing 79.9% and 78.9% of the total possible person-days of child observation in intervention and control arms, respectively. Mean compliance with SODIS was 32.1%. The reported incidence rate of gastrointestinal illness in children in the intervention arm was 3.6 compared to 4.3 episodes/year at risk in the control arm. The relative rate of diarrhoea adjusted for intracluster correlation was 0.81 (95% confidence interval 0.59-1.12. The median length of diarrhoea was 3 d in both groups.Despite an extensive SODIS promotion campaign we found only moderate compliance with the intervention and no strong evidence for a substantive reduction in diarrhoea among children. These results suggest that there is a need for better evidence of how the well-established laboratory efficacy of this home-based water treatment method translates into field effectiveness under various cultural settings and intervention intensities. Further global promotion of SODIS for general use

  19. Evaluation of a specialized oncology nursing supportive care intervention in newly diagnosed breast and colorectal cancer patients following surgery: a cluster randomized trial.

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    Sussman, Jonathan; Bainbridge, Daryl; Whelan, Timothy J; Brazil, Kevin; Parpia, Sameer; Wiernikowski, Jennifer; Schiff, Susan; Rodin, Gary; Sergeant, Myles; Howell, Doris

    2018-05-01

    Better coordination of supportive services during the early phases of cancer care has been proposed to improve the care experience of patients. We conducted a randomized trial to test a community-based nurse-led coordination of care intervention in cancer patients. Surgical practices were cluster randomized to a control group involving usual care practices or a standardized nursing intervention consisting of an in-person supportive care assessment with ongoing support to meet identified needs, including linkage to community services. Newly diagnosed breast and colorectal cancer patients within 7 days of cancer surgery were eligible. The primary outcome was the patient-reported outcome (PRO) of continuity of care (CCCQ) measured at 3 weeks. Secondary outcomes included unmet supportive care needs (SCNS), quality of life (EORTC QLQ-C30), health resource utilization, and level of uncertainty with care trajectory (MUIS) at 3 and/or 8 weeks. A total of 121 breast and 72 colorectal patients were randomized through 28 surgical practices. There was a small improvement in the informational domain of continuity of care (difference 0.29 p = 0.05) and a trend to less emergency room use (15.8 vs 7.1%) (p = 0.07). There were no significant differences between groups on unmet need, quality of life, or uncertainty. We did not find substantial gaps in the PROs measured immediately following surgery for breast and colorectal cancer patients. The results of this study support a more targeted approach based on need and inform future research focused on improving navigation during the initial phases of cancer treatment. ClinicalTrials.gov Identifier: NCT00182234. SONICS-Effectiveness of Specialist Oncology Nursing.

  20. Targeted HIV Screening in Eight Emergency Departments: The DICI-VIH Cluster-Randomized Two-Period Crossover Trial.

    Science.gov (United States)

    Leblanc, Judith; Hejblum, Gilles; Costagliola, Dominique; Durand-Zaleski, Isabelle; Lert, France; de Truchis, Pierre; Verbeke, Geert; Rousseau, Alexandra; Piquet, Hélène; Simon, François; Pateron, Dominique; Simon, Tabassome; Crémieux, Anne-Claude

    2017-10-30

    This study compares the effectiveness and cost-effectiveness of nurse-driven targeted HIV screening alongside physician-directed diagnostic testing (intervention strategy) with diagnostic testing alone (control strategy) in 8 emergency departments. In this cluster-randomized, 2-period, crossover trial, 18- to 64-year-old patients presenting for reasons other than potential exposure to HIV were included. The strategy applied first was randomly assigned. During both periods, diagnostic testing was prescribed by physicians following usual care. During the intervention periods, patients were asked to complete a self-administered questionnaire. According to their answers, the triage nurse suggested performing a rapid test to patients belonging to a high-risk group. The primary outcome was the proportion of new diagnoses among included patients, which further refers to effectiveness. A secondary outcome was the intervention's incremental cost (health care system perspective) per additional diagnosis. During the intervention periods, 74,161 patients were included, 16,468 completed the questionnaire, 4,341 belonged to high-risk groups, and 2,818 were tested by nurses, yielding 13 new diagnoses. Combined with 9 diagnoses confirmed through 97 diagnostic tests, 22 new diagnoses were established. During the control periods, 74,166 patients were included, 92 were tested, and 6 received a new diagnosis. The proportion of new diagnoses among included patients was higher during the intervention than in the control periods (3.0 per 10,000 versus 0.8 per 10,000; difference 2.2 per 10,000, 95% CI 1.3 to 3.6; relative risk 3.7, 95% CI 1.4 to 9.8). The incremental cost was €1,324 per additional new diagnosis. The combined strategy of targeted screening and diagnostic testing was effective. Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

  1. The Effects of a Community-Based Sodium Reduction Program in Rural China - A Cluster-Randomized Trial.

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    Nicole Li

    Full Text Available Average sodium intake and stroke mortality in northern China are both among the highest in the world. An effective, low-cost strategy to reduce sodium intake in this population is urgently needed.We sought to determine the effects of a community-based sodium reduction program on salt consumption in rural northern China.This study was a cluster-randomized trial done over 18 months in 120 townships (one village from each township from five provinces. Sixty control villages were compared to 60 intervention villages that were given access to a reduced-sodium, added-potassium salt substitute in conjunction with a community-based health education program focusing on sodium reduction. The primary outcome was the difference in 24-hour urinary sodium excretion between randomized groups.Among 1,903 people with valid 24-hour urine collections, mean urinary sodium excretion in intervention compared with control villages was reduced by 5.5% (-14mmol/day, 95% confidence interval -26 to -1; p = 0.03, potassium excretion was increased by 16% (+7mmol/day, +4 to +10; p<0.001, and sodium to potassium ratio declined by 15% (-0.9, -1.2 to -0.5; p<0.001. Mean blood pressure differences were -1.1 mm Hg systolic (-3.3 to +1.1; p = 0.33 and -0.7 mm Hg diastolic (-2.2 to +0.8, p = 0.35 and the difference in the proportion with hypertension was -1.3% (-5.1 to 2.5, p = 0.56.There were clear differences in population sodium and potassium intake between villages that were most likely a consequence of increased use of salt substitute. The absence of effects on blood pressure reflects the moderate changes in sodium and potassium intake achieved.Clinicaltrials.gov identifier: NCT01259700.

  2. Integration of family planning services into HIV care and treatment in Kenya: a cluster-randomized trial.

    Science.gov (United States)

    Grossman, Daniel; Onono, Maricianah; Newmann, Sara J; Blat, Cinthia; Bukusi, Elizabeth A; Shade, Starley B; Steinfeld, Rachel L; Cohen, Craig R

    2013-10-01

    To determine whether integrating family planning services into HIV care is associated with increased use of more effective contraceptive methods (sterilization, intrauterine device, implant, injectable or oral contraceptives). Cluster-randomized trial. Eighteen public HIV clinics in Nyanza Province, Kenya. Women aged 18-45 years receiving care at participating HIV clinics; 5682 clinical encounters from baseline period (December 2009-February 2010) and 12,531 encounters from end-line period (July 2011-September 2011, 1 year after site training). Twelve sites were randomized to integrate family planning services into the HIV clinic, whereas six clinics were controls where clients desiring contraception were referred to family planning clinics at the same facility. Increase in use of more effective contraceptive methods between baseline and end-line periods. Pregnancy rates during the follow-up year (October 2010-September 2011) were also compared. Women seen at integrated sites were significantly more likely to use more effective contraceptive methods at the end of the study [increased from 16.7 to 36.6% at integrated sites, compared to increase from 21.1 to 29.8% at controls; odds ratio (OR) 1.81, 95% confidence interval (CI) 1.24-2.63]. Condom use decreased non-significantly at intervention sites compared to controls (OR 0.64, 95% CI 0.35-1.19). No difference was observed in incident pregnancy in the first year after integration comparing intervention to control sites (incidence rate ratio 0.90; 95% CI 0.68-1.20). Integration of family planning services into HIV care clinics increased use of more effective contraceptive methods with a non-significant reduction in condom use. Although no significant reduction in pregnancy incidence was observed during the study, 1 year may be too short a period of observation for this outcome.

  3. A Cluster Randomized-Controlled Trial of a Classroom-Based Drama Workshop Program to Improve Mental Health Outcomes among Immigrant and Refugee Youth in Special Classes

    Science.gov (United States)

    Rousseau, Cécile; Beauregard, Caroline; Daignault, Katherine; Petrakos, Harriet; Thombs, Brett D.; Steele, Russell; Vasiliadis, Helen-Maria; Hechtman, Lily

    2014-01-01

    Objectives The aim of this cluster randomized trial was to evaluate the effectiveness of a school-based theatre intervention program for immigrant and refugee youth in special classes for improving mental health and academic outcomes. The primary hypothesis was that students in the theatre intervention group would report a greater reduction in impairment from symptoms compared to students in the control and tutoring groups. Methods Special classrooms in five multiethnic high schools were randomly assigned to theater intervention (n = 10), tutoring (n = 10) or control status (n = 9), for a total of 477 participants. Students and teachers were non-blinded to group assignment. The primary outcome was impairment from emotional and behavioural symptoms assessed by the Impact Supplement of the Strengths and Difficulties Questionnaire (SDQ) completed by the adolescents. The secondary outcomes were the SDQ global scores (teacher and youth reports), impairment assessed by teachers and school performance. The effect of the interventions was assessed through linear mixed effect models which incorporate the correlation between students in the same class, due to the nature of the randomization of the interventions by classroom. Results The theatre intervention was not associated with a greater reduction in self-reported impairment and symptoms in youth placed in special class because of learning, emotional and behavioural difficulties than a tutoring intervention or a non-active control group. The estimates of the different models show a non-significant decrease in both self-reported and impairment scores in the theatre intervention group for the overall group, but the impairment score decreased significantly for first generation adolescents while it increased for second generation adolescents. Conclusion The difference between the population of immigrant and refugee youth newcomers studied previously and the sample of this trial may explain some of the differences

  4. Objectively Measured Baseline Physical Activity Patterns in Women in the mPED Trial: Cluster Analysis.

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    Fukuoka, Yoshimi; Zhou, Mo; Vittinghoff, Eric; Haskell, William; Goldberg, Ken; Aswani, Anil

    2018-02-01

    Determining patterns of physical activity throughout the day could assist in developing more personalized interventions or physical activity guidelines in general and, in particular, for women who are less likely to be physically active than men. The aims of this report are to identify clusters of women based on accelerometer-measured baseline raw metabolic equivalent of task (MET) values and a normalized version of the METs ≥3 data, and to compare sociodemographic and cardiometabolic risks among these identified clusters. A total of 215 women who were enrolled in the Mobile Phone Based Physical Activity Education (mPED) trial and wore an accelerometer for at least 8 hours per day for the 7 days prior to the randomization visit were analyzed. The k-means clustering method and the Lloyd algorithm were used on the data. We used the elbow method to choose the number of clusters, looking at the percentage of variance explained as a function of the number of clusters. The results of the k-means cluster analyses of raw METs revealed three different clusters. The unengaged group (n=102) had the highest depressive symptoms score compared with the afternoon engaged (n=65) and morning engaged (n=48) groups (overall Pcluster groups using a large national dataset. ClinicalTrials.gov NCT01280812; https://clinicaltrials.gov/ct2/show/NCT01280812 (Archived by WebCite at http://www.webcitation.org/6vVyLzwft). ©Yoshimi Fukuoka, Mo Zhou, Eric Vittinghoff, William Haskell, Ken Goldberg, Anil Aswani. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 01.02.2018.

  5. SPACE for physical activity - a multicomponent intervention study: study design and baseline findings from a cluster randomized controlled trial

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    Kristensen Peter L

    2011-10-01

    Full Text Available Abstract Background The aim of the School site, Play Spot, Active transport, Club fitness and Environment (SPACE Study was to develop, document, and assess a comprehensive intervention in local school districts that promote everyday physical activity (PA among 11-15-year-old adolescents. The study is based on a social ecological framework, and is designed to implement organizational and structural changes in the physical environment. Methods/design The SPACE Study used a cluster randomized controlled study design. Twenty-one eligible schools in the Region of Southern Denmark were matched and randomized in seven pairs according to eight matching variables summarized in an audit tool (crow-fly distance from residence to school for 5-6th graders; area household income; area education level; area ethnicity distribution; school district urbanity; condition and characteristics of school outdoor areas; school health policy; and active transport in the local area. Baseline measurements with accelerometers, questionnaires, diaries, and physical fitness tests were obtained in Spring 2010 in 5-6th grade in 7 intervention and 7 control schools, with follow-up measurements to be taken in Spring 2012 in 7-8th grade. The primary outcome measure is objective average daily physical activity and will be supported by analyses of time spent in moderate to vigorous activity and time spent sedentary. Other secondary outcome measures will be obtained, such as, overweight, physical fitness, active commuting to/from school and physical activity in recess periods. Discussion A total of 1348 adolescents in 5-6th grade in the Region of Southern Denmark participated at baseline (n = 14 schools. The response rate was high in all type of measurements (72.6-97.4%. There were no significant differences between intervention and control groups at baseline according to selected background variables and outcome measures: gender (p = .54, age (p = .17, BMI (p = .59, waist

  6. Study protocol for a multi-component kindergarten-based intervention to promote healthy diets in toddlers: a cluster randomized trial

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    Sissel H. Helland

    2016-03-01

    Full Text Available Abstract Background There is concern about the lack of diversity in children’s diets, particularly low intakes of fruit and vegetables and high intakes of unhealthy processed food. This may be a factor in the rising prevalence of obesity. A reason for the lack of diversity in children’s diets may be food neophobia. This study aimed to promote a healthy and varied diet among toddlers in kindergarten. The primary objectives were to reduce food neophobia in toddlers, and promote healthy feeding practices among kindergarten staff and parents. Secondary objectives were to increase food variety in toddlers’ diets and reduce future overweight and obesity in these children. Methods This is an ongoing, cluster randomized trial. The intervention finished in 2014, but follow-up data collection is not yet complete. Eighteen randomly selected kindergartens located in two counties in Norway with enrolled children born in 2012 participated in the intervention. The kindergartens were matched into pairs based on background information, and randomly assigned to the intervention or control groups. A 9-week multi-component intervention was implemented, with four main elements: 1 kindergarten staff implemented a pedagogical tool (Sapere method in daily sessions to promote willingness to try new food; 2 kindergarten staff prepared and served the toddlers a cooked lunch from a menu corresponding to the pedagogical sessions; 3 kindergarten staff were encouraged to follow 10 meal principles on modeling, responsive feeding, repeated exposure, and enjoyable meals; and 4 parents were encouraged to read information and apply relevant feeding practices at home. The control group continued their usual practices. Preference taste tests were conducted to evaluate behavioral food neophobia, and children’s height and weight were measured. Parents and staff completed questionnaires before and after the intervention. Data have not yet been analyzed. Discussion This study

  7. Impact of a social-emotional and character development program on school-level indicators of academic achievement, absenteeism, and disciplinary outcomes: A matched-pair, cluster randomized, controlled trial.

    Science.gov (United States)

    Snyder, Frank; Flay, Brian; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac; Beets, Michael; Li, Kin-Kit

    2010-01-01

    This paper reports the effects of a comprehensive elementary school-based social-emotional and character education program on school-level achievement, absenteeism, and disciplinary outcomes utilizing a matched-pair, cluster randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools (mean enrollment = 544) and was conducted from the 2002-03 through the 2005-06 academic years. Using school-level archival data, analyses comparing change from baseline (2002) to one-year post trial (2007) revealed that intervention schools scored 9.8% better on the TerraNova (2 nd ed.) test for reading and 8.8% on math; 20.7% better in Hawai'i Content and Performance Standards scores for reading and 51.4% better in math; and that intervention schools reported 15.2% lower absenteeism and fewer suspensions (72.6%) and retentions (72.7%). Overall, effect sizes were moderate to large (range 0.5-1.1) for all of the examined outcomes. Sensitivity analyses using permutation models and random-intercept growth curve models substantiated results. The results provide evidence that a comprehensive school-based program, specifically developed to target student behavior and character, can positively influence school-level achievement, attendance, and disciplinary outcomes concurrently.

  8. Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047

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    Abu-Elyazeed Remon

    2006-05-01

    Full Text Available Abstract Objective To determine the safety and logistic feasibility of a mass immunization strategy outside the local immunization program in the pediatric population of urban squatter settlements in Karachi, Pakistan. Methods A cluster-randomized double blind preventive trial was launched in August 2003 in 60 geographic clusters covering 21,059 children ages 2 to 16 years. After consent was obtained from parents or guardians, eligible children were immunized parenterally at vaccination posts in each cluster with Vi polysaccharide or hepatitis A vaccine. Safety, logistics, and standards were monitored and documented. Results The vaccine coverage of the population was 74% and was higher in those under age 10 years. No life-threatening serious adverse events were reported. Adverse events occurred in less than 1% of all vaccine recipients and the main reactions reported were fever and local pain. The proportion of adverse events in Vi polysaccharide and hepatitis A recipients will not be known until the end of the trial when the code is broken. Throughout the vaccination campaign safe injection practices were maintained and the cold chain was not interrupted. Mass vaccination in slums had good acceptance. Because populations in such areas are highly mobile, settlement conditions could affect coverage. Systemic reactions were uncommon and local reactions were mild and transient. Close community involvement was pivotal for information dissemination and immunization coverage. Conclusion This vaccine strategy described together with other information that will soon be available in the area (cost/effectiveness, vaccine delivery costs, etc will make typhoid fever control become a reality in the near future.

  9. Strengthening the delivery of asthma and chronic obstructive pulmonary disease care at primary health-care facilities: study design of a cluster randomized controlled trial in Pakistan

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    Muhammad Amir Khan

    2015-11-01

    Full Text Available Background: Respiratory diseases, namely asthma and chronic obstructive pulmonary disease (COPD, account for one-fourth of the patients at the primary health-care (PHC facilities in Pakistan. Standard care practices to manage these diseases are necessary to reduce the morbidity and mortality rate associated with non-communicable diseases in developing countries. Objective: To develop and measure the effectiveness of operational guidelines and implementation materials, with sound scientific evidence, for expanding lung health care, especially asthma and COPD through PHC facilities already strengthened for tuberculosis (TB care in Pakistan. Design: A cluster randomized controlled trial with two arms (intervention and control, with qualitative and costing study components, is being conducted in 34 clusters; 17 clusters per arm (428 asthma and 306 COPD patients, in three districts in Pakistan from October 2014 to December 2016. The intervention consists of enhanced case management of asthma and COPD patients through strengthening of PHC facilities. The main outcomes to be measured are asthma and COPD control among the registered cases at 6 months. Cluster- and individual-level analyses will be done according to intention to treat. Residual confounding will be addressed by multivariable logistic and linear regression models for asthma and COPD control, respectively. The trial is registered with ISRCTN registry (ISRCTN 17409338. Conclusions: Currently, only about 20% of the estimated prevalent asthma and COPD cases are being identified and reported through the respective PHC network. Lung health care and prevention has not been effectively integrated into the core PHC package, although a very well-functioning TB program exists at the PHC level. Inclusion of these diseases in the already existent TB program is expected to increase detection rates and care for asthma and COPD.

  10. Screening and treatment of maternal genitourinary tract infections in early pregnancy to prevent preterm birth in rural Sylhet, Bangladesh: a cluster randomized trial.

    Science.gov (United States)

    Lee, Anne C C; Quaiyum, Mohammad A; Mullany, Luke C; Mitra, Dipak K; Labrique, Alain; Ahmed, Parvez; Uddin, Jamal; Rafiqullah, Iftekhar; DasGupta, Sushil; Mahmud, Arif; Koumans, Emilia H; Christian, Parul; Saha, Samir; Baqui, Abdullah H

    2015-12-07

    Approximately half of preterm births are attributable to maternal infections, which are commonly undetected and untreated in low-income settings. Our primary aim is to determine the impact of early pregnancy screening and treatment of maternal genitourinary tract infections on the incidence of preterm live birth in Sylhet, Bangladesh. We will also assess the effect on other adverse pregnancy outcomes, including preterm birth (stillbirth and live birth), late miscarriage, maternal morbidity, and early onset neonatal sepsis. We are conducting a cluster randomized controlled trial that will enroll 10,000 pregnant women in Sylhet district in rural northeastern Bangladesh. Twenty-four clusters, each with ~4000 population (120 pregnant women/year) and served by a community health worker (CHW), are randomized to: 1) the control arm, which provides routine antenatal and postnatal home-based care, or 2) the intervention arm, which includes routine antenatal and postnatal home-based care plus screening and treatment of pregnant women between 13 and 19 weeks of gestation for abnormal vaginal flora (AVF) and urinary tract infection (UTI). CHWs conduct monthly pregnancy surveillance, make 2 antenatal and 4 postnatal home visits for all enrolled pregnant women and newborns, and refer mothers or newborns with symptoms of serious illness to the government sub-district hospital. In the intervention clusters, CHWs perform home-based screening of AVF and UTI. Self-collected vaginal swabs are plated on slides, which are Gram stained and Nugent scored. Women with AVF (Nugent score ≥4) are treated with oral clindamycin, rescreened and retreated, if needed, after 3 weeks. Urine culture is performed and UTI treated with nitrofurantoin. Repeat urine culture is performed after 1 week for test of cure. Gestational age is determined by maternal report of last menstrual period at study enrollment using prospectively completed study calendars, and in a subset by early (pregnancy outcomes

  11. A cluster-based randomized controlled trial promoting community participation in arsenic mitigation efforts in Bangladesh

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    George Christine

    2012-06-01

    Full Text Available Abstract Objective To reduce arsenic (As exposure, we evaluated the effectiveness of training community members to perform water arsenic (WAs testing and provide As education compared to sending representatives from outside communities to conduct these tasks. Methods We conducted a cluster based randomized controlled trial of 20 villages in Singair, Bangladesh. Fifty eligible respondents were randomly selected in each village. In 10 villages, a community member provided As education and WAs testing. In a second set of 10 villages an outside representative performed these tasks. Results Overall, 53% of respondents using As contaminated wells, relative to the Bangladesh As standard of 50 μg/L, at baseline switched after receiving the intervention. Further, when there was less than 60% arsenic contaminated wells in a village, the classification used by the Bangladeshi and UNICEF, 74% of study households in the community tester villages, and 72% of households in the outside tester villages reported switching to an As safe drinking water source . Switching was more common in the outside-tester (63% versus community-tester villages (44%. However, after adjusting for the availability of arsenic safe drinking water sources, well switching did not differ significantly by type of As tester (Odds ratio =0.86[95% confidence interval 0.42-1.77. At follow-up, among those using As contaminated wells who switched to safe wells, average urinary As concentrations significantly decreased. Conclusion The overall intervention was effective in reducing As exposure provided there were As-safe drinking water sources available. However, there was not a significant difference observed in the ability of the community and outside testers to encourage study households to use As-safe water sources. The findings of this study suggest that As education and WAs testing programs provided by As testers, irrespective of their residence, could be used as an effective, low cost

  12. Impact of 4.0% chlorhexidine cleansing of the umbilical cord on mortality and omphalitis among newborns of Sylhet, Bangladesh: design of a community-based cluster randomized trial

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    Ahmed Saifuddin

    2009-10-01

    Full Text Available Abstract Background The World Health Organization recommends dry cord care for newborns but this recommendation may not be optimal in low resource settings where most births take place in an unclean environment and infections account for up to half of neonatal deaths. A previous trial in Nepal indicated that umbilical cord cleansing with 4.0% chlorhexidine could substantially reduce mortality and omphalitis risk, but policy changes await additional community-based data. Methods The Projahnmo Chlorhexidine study was a three-year, cluster-randomized, community-based trial to assess the impact of three cord care regimens on neonatal mortality and omphalitis. Women were recruited mid-pregnancy, received a basic package of maternal and neonatal health promotion messages, and were followed to pregnancy outcome. Newborns were visited at home by local village-based workers whose areas were randomized to either 1 single- or 2 7-day cord cleansing with 4.0% chlorhexidine, or 3 promotion of dry cord care as recommended by WHO. All mothers received basic messages regarding hand-washing, clean cord cutting, and avoidance of harmful home-base applications to the cord. Death within 28 days and omphalitis were the primary outcomes; these were monitored directly through home visits by community health workers on days 1, 3, 6, 9, 15, and 28 after birth. Discussion Due to report in early 2010, the Projahnmo Chlorhexidine Study examines the impact of multiple or single chlorhexidine cleansing of the cord on neonatal mortality and omphalitis among newborns of rural Sylhet District, Bangladesh. The results of this trial will be interpreted in conjunction with a similarly designed trial previously conducted in Nepal, and will have implications for policy guidelines for optimal cord care of newborns in low resource settings in Asia. Trial Registration ClinicalTrials.gov (NCT00434408

  13. eLearning course may shorten the duration of mechanical restraint among psychiatric inpatients: a cluster-randomized trial.

    Science.gov (United States)

    Kontio, Raija; Pitkänen, Anneli; Joffe, Grigori; Katajisto, Jouko; Välimäki, Maritta

    2014-10-01

    The management of psychiatric inpatients exhibiting severely disturbed and aggressive behaviour is an important educational topic. Well structured, IT-based educational programmes (eLearning) often ensure quality and may make training more affordable and accessible. The aim of this study was to explore the impact of an eLearning course for personnel on the rates and duration of seclusion and mechanical restraint among psychiatric inpatients. In a cluster-randomized intervention trial, the nursing personnel on 10 wards were randomly assigned to eLearning (intervention) or training-as-usual (control) groups. The eLearning course comprised six modules with specific topics (legal and ethical issues, behaviour-related factors, therapeutic relationship and self-awareness, teamwork and integrating knowledge with practice) and specific learning methods. The rates (incidents per 1000 occupied bed days) and durations of the coercion incidents were examined before and after the course. A total of 1283 coercion incidents (1143 seclusions [89%] and 140 incidents involving the use of mechanical restraints [11%]) were recorded on the study wards during the data collection period. On the intervention wards, there were no statistically significant changes in the rates of seclusion and mechanical restraint. However, the duration of incidents involving mechanical restraints shortened from 36.0 to 4.0 h (median) (P eLearning course, the duration of incidents involving the use of mechanical restraints decreased. However, more studies are needed to ensure that the content of the course focuses on the most important factors associated with the seclusion-related elements. The eLearning course deserves further development and further studies. The duration of coercion incidents merits attention in future research.

  14. A new mother-child play activity program to decrease parenting stress and improve child cognitive abilities: a cluster randomized controlled trial.

    Science.gov (United States)

    Tachibana, Yoshiyuki; Fukushima, Ai; Saito, Hitomi; Yoneyama, Satoshi; Ushida, Kazuo; Yoneyama, Susumu; Kawashima, Ryuta

    2012-01-01

    We propose a new play activity intervention program for mothers and children. Our interdisciplinary program integrates four fields of child-related sciences: neuroscience, preschool pedagogy, developmental psychology, and child and maternal psychiatry. To determine the effect of this intervention on child and mother psychosocial problems related to parenting stress and on the children's cognitive abilities, we performed a cluster randomized controlled trial. Participants were 238 pairs of mothers and typically developing preschool children (ages 4-6 years old) from Wakakusa kindergarten in Japan. The pairs were asked to play at home for about 10 min a day, 5 days a week for 3 months. Participants were randomly assigned to the intervention or control group by class unit. The Parenting Stress Index (PSI) (for mothers), the Goodenough Draw-a-Man intelligence test (DAM), and the new S-S intelligence test (NS-SIT) (for children) were administered prior to and 3 months after the intervention period. Pre-post changes in test scores were compared between the groups using a linear mixed-effects model analysis. The primary outcomes were the Total score on the child domain of the PSI (for child psychosocial problems related to parenting stress), Total score on the parent domain of the PSI (for maternal psychosocial problems related to parenting stress), and the score on the DAM (for child cognitive abilities). The results of the PSI suggested that the program may reduce parenting stress. The results of the cognitive tests suggested that the program may improve the children's fluid intelligence, working memory, and processing speed. Our intervention program may ameliorate the children's psychosocial problems related to parenting stress and increase their cognitive abilities. UMIN Clinical Trials Registry UMIN000002265.

  15. A cluster randomized control trial to assess the impact of active learning on child activity, attention control, and academic outcomes: The Texas I-CAN trial.

    Science.gov (United States)

    Bartholomew, John B; Jowers, Esbelle M; Errisuriz, Vanessa L; Vaughn, Sharon; Roberts, Gregory

    2017-10-01

    Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity. The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning. This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. A cluster-randomized trial of provider-initiated (opt-out) HIV counseling and testing of tuberculosis patients in South Africa.

    Science.gov (United States)

    Pope, Diana S; Deluca, Andrea N; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammad A; Celentano, David D; Chaisson, Richard E

    2008-06-01

    To determine whether implementation of provider-initiated human immunodeficiency virus (HIV) counseling would increase the proportion of tuberculosis (TB) patients who received HIV counseling and testing. Cluster-randomized trial with clinic as the unit of randomization. Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa. A total of 754 adults (18 years and older) newly registered as TB patients in the 20 study clinics. Implementation of provider-initiated HIV counseling and testing. Percentage of TB patients HIV counseled and tested. SECONDARY: Percentage of patients with HIV test positive, and percentage of those who received cotrimoxazole and who were referred for HIV care. : A total of 754 adults newly registered as TB patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (P = 0.011), and 20.2% (n = 71) versus 6.5% (n = 26) underwent HIV testing (P = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (P = 0.12). The proportion of patients identified as HIV infected in intervention clinics was 8.5% versus 2.5% in control clinics (P = 0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Provider-initiated HIV counseling significantly increased the proportion of adult TB patients who received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated.

  17. Evaluation of an early detection tool for social-emotional and behavioral problems in toddlers: The Brief Infant Toddler Social and Emotional Assessment - A cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Carter Alice S

    2011-06-01

    Full Text Available Abstract Background The prevalence of social-emotional and behavioral problems is estimated to be 8 to 9% among preschool children. Effective early detection tools are needed to promote the provision of adequate care at an early stage. The Brief Infant-Toddler Social and Emotional Assessment (BITSEA was developed for this purpose. This study evaluates the effectiveness of the BITSEA to enhance social-emotional and behavioral health of preschool children. Methods and Design A cluster randomized controlled trial is set up in youth health care centers in the larger Rotterdam area in the Netherlands, to evaluate the BITSEA. The 31 youth health care centers are randomly allocated to either the control group or the intervention group. The intervention group uses the scores on the BITSEA and cut-off points to evaluate a child's social-emotional and behavioral health and to decide whether or not the child should be referred. The control group provides care as usual, which involves administering a questionnaire that structures the conversation between child health professionals and parents. At a one year follow-up measurement the social-emotional and behavioral health of all children included in the study population will be evaluated. Discussion It is hypothesized that better results will be found, in terms of social-emotional and behavioral health in the intervention group, compared to the control group, due to more adequate early detection, referral and more appropriate and timely care. Trial registration Current Controlled Trials NTR2035

  18. The effect of India's total sanitation campaign on defecation behaviors and child health in rural Madhya Pradesh: a cluster randomized controlled trial.

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    Sumeet R Patil

    2014-08-01

    Full Text Available Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs, defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth.We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009, and revisited households 21 months later (February-April 2011 after the program was delivered. The study enrolled a random sample of 5,209 children <5 years old from 3,039 households that had at least one child <24 months at the beginning of the study. A random subsample of 1,150 children <24 months at enrollment were tested for soil transmitted helminth and protozoan infections in stool. The randomization successfully balanced intervention and control groups, and we estimated differences between groups in an intention to treat analysis. The intervention increased percentage of households in a village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention, decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control. However, the intervention did not improve child health

  19. Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

    Science.gov (United States)

    Lopez-Gonzalez, Elena; Herdeiro, Maria T; Piñeiro-Lamas, María; Figueiras, Adolfo

    2015-02-01

    The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs). To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system. A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months. Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55). Pharmacovigilance educational interventions that have proved effective can be

  20. A cluster randomized non-inferiority field trial on the immunogenicity and safety of tetanus toxoid vaccine kept in controlled temperature chain compared to cold chain.

    Science.gov (United States)

    Juan-Giner, Aitana; Domicent, Camille; Langendorf, Céline; Roper, Martha H; Baoundoh, Paul; Fermon, Florence; Gakima, Primitive; Zipursky, Simona; Tamadji, Mbaihol; Grais, Rebecca F

    2014-10-29

    In resource-poor settings, cold chain requirements present barriers for vaccine delivery. We evaluated the immunogenicity and safety of tetanus toxoid (TT) vaccine in "Controlled Temperature Chain" (CTC; up to 40 °C for cold chain (SCC; 2-8 °C). Prior to the study, stability parameters of TT-CTC were shown to meet international requirements. A cluster randomized, non-inferiority trial was conducted in Moïssala district, Chad, December 2012-March 2013. Thirty-four included clusters were randomized to CTC or SCC. Women aged 14-49 years, eligible for TT vaccination and with a history of ≤1 TT dose, received two TT doses 4 weeks apart. Participants were blinded to allocation strategy. Tetanus antibody titers were measured using standard ELISA at inclusion and 4 weeks post-TT2. Primary outcome measures were post-vaccination seroconversion and fold-increase in geometric mean concentrations (GMC). Non-inferiority was by seroconversion difference (TTSCC-TTCTC) 95% of participants; upper 95%CI of the difference was 5.6%. Increases in GMC were over 4-fold; upper 95%CI of GMC ratio was 1.36 in the adjusted analysis. Few adverse events were recorded. This study demonstrates the immunogenicity and safety of TT in CTC at cold chain cannot be maintained. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  1. The effect of India's total sanitation campaign on defecation behaviors and child health in rural Madhya Pradesh: a cluster randomized controlled trial.

    Science.gov (United States)

    Patil, Sumeet R; Arnold, Benjamin F; Salvatore, Alicia L; Briceno, Bertha; Ganguly, Sandipan; Colford, John M; Gertler, Paul J

    2014-08-01

    Poor sanitation is thought to be a major cause of enteric infections among young children. However, there are no previously published randomized trials to measure the health impacts of large-scale sanitation programs. India's Total Sanitation Campaign (TSC) is one such program that seeks to end the practice of open defecation by changing social norms and behaviors, and providing technical support and financial subsidies. The objective of this study was to measure the effect of the TSC implemented with capacity building support from the World Bank's Water and Sanitation Program in Madhya Pradesh on availability of individual household latrines (IHLs), defecation behaviors, and child health (diarrhea, highly credible gastrointestinal illness [HCGI], parasitic infections, anemia, growth). We conducted a cluster-randomized, controlled trial in 80 rural villages. Field staff collected baseline measures of sanitation conditions, behaviors, and child health (May-July 2009), and revisited households 21 months later (February-April 2011) after the program was delivered. The study enrolled a random sample of 5,209 children village with improved sanitation facilities as defined by the WHO/UNICEF Joint Monitoring Programme by an average of 19% (95% CI for difference: 12%-26%; group means: 22% control versus 41% intervention), decreased open defecation among adults by an average of 10% (95% CI for difference: 4%-15%; group means: 73% intervention versus 84% control). However, the intervention did not improve child health measured in terms of multiple health outcomes (diarrhea, HCGI, helminth infections, anemia, growth). Limitations of the study included a relatively short follow-up period following implementation, evidence for contamination in ten of the 40 control villages, and bias possible in self-reported outcomes for diarrhea, HCGI, and open defecation behaviors. The intervention led to modest increases in availability of IHLs and even more modest reductions in open

  2. Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina: study design of a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Niederer Iris

    2009-03-01

    life and signs of hyperactivity (questionnaires, attention and spatial working memory ability (two validated tests. Researchers were blinded to group allocation. Discussion The purpose of this paper is to outline the design of a school-based multicenter cluster randomized, controlled trial aiming to reduce body mass index and to increase aerobic fitness in preschool children in culturally different parts of Switzerland with a high migrant population. Trial Registration Trial Registration: clinicaltrials.gov NCT00674544

  3. Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial.

    Science.gov (United States)

    Mbonye, Anthony K; Magnussen, Pascal; Chandler, Clare I R; Hansen, Kristian S; Lal, Sham; Cundill, Bonnie; Lynch, Caroline A; Clarke, Siân E

    2014-07-29

    An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated through a cluster randomized trial. In this paper, we present detailed design, implementation and evaluation experiences in order to help inform future studies of a complex nature. Three preparatory studies (formative, baseline and willingness-to-pay) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops, and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities. The intervention required careful design with the intention to be acceptable, sustainable and effective. Critical components of intervention were: community sensitization and creating awareness, training of drug shop vendors to diagnose malaria with mRDTs, treat and refer customers to formal health facilities, giving pre-referral rectal artesunate and improved record-keeping. The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT, evaluated against microscopy on a research blood slide. Introducing mRDTs in drug shops may seem simple, but our experience of intervention design, conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other. The main challenges

  4. An interdisciplinary intervention to prevent falls in community-dwelling elderly persons: protocol of a cluster-randomized trial [PreFalls

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    Schuster Tibor

    2011-02-01

    Full Text Available Abstract Background Prevention of falls in the elderly is a public health target in many countries around the world. While a large number of trials have investigated the effectiveness of fall prevention programs, few focussed on interventions embedded in the general practice setting and its related network. In the Prevent Falls (PreFalls trial we aim to investigate the effectiveness of a pre-tested multi-modal intervention compared to usual care in this setting. Methods/Design PreFalls is a controlled multicenter prospective study with cluster-randomized allocation of about 40 general practices to an experimental or a control group. We aim to include 382 community dwelling persons aged 65 and older with an increased risk of falling. All participating general practitioners are trained to systematically assess the risk of falls using a set of validated tests. Patients from intervention practices are invited to participate in a 16-weeks exercise program with focus on fall prevention delivered by specifically trained local physiotherapists. Patients from practices allocated to the control group receive usual care. Main outcome measure is the number of falls per individual in the first 12 months (analysis by negative binomial regression. Secondary outcomes include falls in the second year, the proportion of participants falling in the first and the second year, falls associated with injury, risk of falls, fear of falling, physical activity and quality of life. Discussion Reducing falls in the elderly remains a major challenge. We believe that with its strong focus on a both systematic and realistic fall prevention strategy adapted to primary care setting PreFalls will be a valuable addition to the scientific literature in the field. Trial registration NCT01032252

  5. Effects of Mindfulness-Based Stress Reduction on the Mental Health of Clinical Clerkship Students: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    van Dijk, Inge; Lucassen, Peter L B J; Akkermans, Reinier P; van Engelen, Baziel G M; van Weel, Chris; Speckens, Anne E M

    2017-07-01

    To examine the effect of mindfulness-based stress reduction training (MBSR) on the mental health of medical students during clinical clerkships. Between February 2011 and May 2014, the authors conducted a cluster-randomized controlled trial of clerkships as usual (CAU) and clerkships with additional MBSR in medical students during their first year of clinical clerkships at a Dutch university medical center. MBSR consisted of eight weekly two-hour sessions, comprising didactic teaching, meditation exercises, and group dialogues. Students completed online assessments at baseline and after 3, 7, 12, 15, and 20 months. Outcome measures were psychological distress, positive mental health, life satisfaction, physician empathy, mindfulness skills, and dysfunctional cognitions as measured by validated tools. Of 232 eligible students, 167 students (72%) participated and were randomized by clerkship group into MBSR (n = 83) or CAU (n = 84). The MBSR group reported a small reduction of psychological distress (P = .03, Cohen's d = 0.20) and dysfunctional cognitions (P = .05, Cohen's d = 0.18) and a moderate increase of positive mental health (P = .002, Cohen's d = 0.44), life satisfaction (P = .01, Cohen's d = 0.51), and mindfulness skills (P = .05, Cohen's d = 0.35) compared with CAU during the 20-month follow-up. The authors detected no significant effect on physician empathy (P = .18, Cohen's d = 0.27). MBSR appeared feasible and acceptable to medical clerkship students and resulted in a small to moderate improvement of mental health compared with CAU over the 20-month follow-up.

  6. Strengthening referral of sick children from the private health sector and its impact on referral uptake in Uganda: a cluster randomized controlled trial protocol

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    Esther Buregyeya

    2016-11-01

    Full Text Available Abstract Background Uganda’s under-five mortality is high, currently estimated at 66/1000 live births. Poor referral of sick children that seek care from the private sector is one of the contributory factors. The proposed intervention aims to improve referral and uptake of referral advice for children that seek care from private facilities (registered drug shops/private clinics. Methods/Design A cluster randomized design will be applied to test the intervention in Mukono District, central Uganda. A sample of study clusters will implement the intervention. The intervention will consist of three components: i raising awareness in the community: village health teams will discuss the importance of referral and encourage households to save money, ii training and supervision of providers in the private sector to diagnose, treat and refer sick children, iii regular meetings between the public and private providers (convened by the district health team to discuss the referral system. Twenty clusters will be included in the study, randomized in the ratio of 1:1. A minimum of 319 sick children per cluster and the total number of sick children to be recruited from all clusters will be 8910; adjusting for a 10 % loss to follow up and possible withdrawal of private outlets. Discussion The immediate sustainable impact will be appropriate treatment of sick children. The intervention is likely to impact on private sector practices since the scope of the services they provide will have expanded. The proposed study is also likely to have an impact on families as; i they may appreciate the importance of timely referral on child illness management, ii the cost savings related to reduced morbidity will be used by household to access other social services. The linkage between the private and public sectors will create a potential avenue for delivery of other public health interventions and improved working relations in the two sectors. Further, improved quality of

  7. The impact of providing rapid diagnostic malaria tests on fever management in the private retail sector in Ghana: a cluster randomized trial.

    Science.gov (United States)

    Ansah, Evelyn K; Narh-Bana, Solomon; Affran-Bonful, Harriet; Bart-Plange, Constance; Cundill, Bonnie; Gyapong, Margaret; Whitty, Christopher J M

    2015-03-04

    To examine the impact of providing rapid diagnostic tests for malaria on fever management in private drug retail shops where most poor rural people with fever present, with the aim of reducing current massive overdiagnosis and overtreatment of malaria. Cluster randomized trial of 24 clusters of shops. Dangme West, a poor rural district of Ghana. Shops and their clients, both adults and children. Providing rapid diagnostic tests with realistic training. The primary outcome was the proportion of clients testing negative for malaria by a double-read research blood slide who received an artemisinin combination therapy or other antimalarial. Secondary outcomes were use of antibiotics and antipyretics, and safety. Of 4603 clients, 3424 (74.4%) tested negative by double-read research slides. The proportion of slide-negative clients who received any antimalarial was 590/1854 (32%) in the intervention arm and 1378/1570 (88%) in the control arm (adjusted risk ratio 0.41 (95% CI 0.29 to 0.58), Pretail sector significantly reduced dispensing of antimalarials to patients without malaria, did not reduce prescribing of antimalarials to true malaria cases, and appeared safe. Rapid diagnostic tests should be considered for the informal private drug retail sector.Registration Clinicaltrials.gov NCT01907672. © Ansah et al 2015.

  8. The Cost-Effectiveness of Using PARO, a Therapeutic Robotic Seal, to Reduce Agitation and Medication Use in Dementia: Findings from a Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Mervin, Merehau C; Moyle, Wendy; Jones, Cindy; Murfield, Jenny; Draper, Brian; Beattie, Elizabeth; Shum, David H K; O'Dwyer, Siobhan; Thalib, Lukman

    2018-01-09

    To examine the within-trial costs and cost-effectiveness of using PARO, compared with a plush toy and usual care, for reducing agitation and medication use in people with dementia in long-term care. An economic evaluation, nested within a cluster-randomized controlled trial. Twenty-eight facilities in South-East Queensland, Australia. A total of 415 residents, all aged 60 years or older, with documented diagnoses of dementia. Facilities were randomized to 1 of 3 groups: PARO (individual, nonfacilitated 15-minute sessions, 3 afternoons per week for 10 weeks); plush toy (as per PARO but with artificial intelligence disabled); and usual care. The incremental cost per Cohen-Mansfield Agitation Inventory-Short Form (CMAI-SF) point averted from a provider's perspective. Australian New Zealand Clinical Trials Registry (BLINDED FOR REVIEW). For the within-trial costs, the PARO group was $50.47 more expensive per resident compared with usual care, whereas the plush toy group was $37.26 more expensive than usual care. There were no statistically significant between-group differences in agitation levels after the 10-week intervention. The point estimates of the incremental cost-effectiveness ratios were $13.01 for PARO and $12.85 for plush toy per CMAI-SF point averted relative to usual care. The plush toy used in this study offered marginally greater value for money than PARO in improving agitation. However, these costs are much lower than values estimated for psychosocial group activities and sensory interventions, suggesting that both a plush toy and the PARO are cost-effective psychosocial treatment options for agitation. Copyright © 2017 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  9. The effectiveness of participatory ergonomics to prevent low-back and neck pain - results of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Driessen, M.T.; Proper, K.I.; Anema, J.R.; Knol, D.L.; Bongers, P.M.; Beek, A.J. van der

    2011-01-01

    Objective The aim of this randomized controlled trial (RCT) was to investigate the effectiveness of the Stay@ Work participatory ergonomics (PE) program to prevent low-back and neck pain. Methods A total of 37 departments were randomly allocated to either the intervention (PE) or control group (no

  10. A randomized trial assessing the impact of written information on outpatients' knowledge about and attitude toward randomized clinical trials. The Info Trial Group

    DEFF Research Database (Denmark)

    Kruse, A Y; Kjaergard, L L; Krogsgaard, K

    2000-01-01

    To improve the patient education process in clinical research, three information materials describing general aspects of design and conduct of randomized clinical trials were developed. The materials varied in length, reading ability level, and reader appeal. Their influence on knowledge about...... and attitude toward randomized clinical trials was assessed in a randomized, parallel group, evaluator-blinded trial among 415 outpatients. The patients were randomized to the following groups: control (no intervention), leaflet, brochure, or booklet. Knowledge was assessed by a 17-item multiple......-choice questionnaire and attitude was assessed by a 32-item Likert questionnaire at entry and 2 weeks after the intervention. The interventions and the questionnaires were pilot tested and power calculations were performed. At entry, the mean knowledge score was 7.9 points. At follow-up, the knowledge scores increased...

  11. Evaluating the effectiveness of a tailored multifaceted performance feedback intervention to improve the quality of care: protocol for a cluster randomized trial in intensive care

    Directory of Open Access Journals (Sweden)

    Westert Gert P

    2011-10-01

    Full Text Available Abstract Background Feedback is potentially effective in improving the quality of care. However, merely sending reports is no guarantee that performance data are used as input for systematic quality improvement (QI. Therefore, we developed a multifaceted intervention tailored to prospectively analyzed barriers to using indicators: the Information Feedback on Quality Indicators (InFoQI program. This program aims to promote the use of performance indicator data as input for local systematic QI. We will conduct a study to assess the impact of the InFoQI program on patient outcome and organizational process measures of care, and to gain insight into barriers and success factors that affected the program's impact. The study will be executed in the context of intensive care. This paper presents the study's protocol. Methods/design We will conduct a cluster randomized controlled trial with intensive care units (ICUs in the Netherlands. We will include ICUs that submit indicator data to the Dutch National Intensive Care Evaluation (NICE quality registry and that agree to allocate at least one intensivist and one ICU nurse for implementation of the intervention. Eligible ICUs (clusters will be randomized to receive basic NICE registry feedback (control arm or to participate in the InFoQI program (intervention arm. The InFoQI program consists of comprehensive feedback, establishing a local, multidisciplinary QI team, and educational outreach visits. The primary outcome measures will be length of ICU stay and the proportion of shifts with a bed occupancy rate above 80%. We will also conduct a process evaluation involving ICUs in the intervention arm to investigate their actual exposure to and experiences with the InFoQI program. Discussion The results of this study will inform those involved in providing ICU care on the feasibility of a tailored multifaceted performance feedback intervention and its ability to accelerate systematic and local quality

  12. Missing continuous outcomes under covariate dependent missingness in cluster randomised trials.

    Science.gov (United States)

    Hossain, Anower; Diaz-Ordaz, Karla; Bartlett, Jonathan W

    2017-06-01

    Attrition is a common occurrence in cluster randomised trials which leads to missing outcome data. Two approaches for analysing such trials are cluster-level analysis and individual-level analysis. This paper compares the performance of unadjusted cluster-level analysis, baseline covariate adjusted cluster-level analysis and linear mixed model analysis, under baseline covariate dependent missingness in continuous outcomes, in terms of bias, average estimated standard error and coverage probability. The methods of complete records analysis and multiple imputation are used to handle the missing outcome data. We considered four scenarios, with the missingness mechanism and baseline covariate effect on outcome either the same or different between intervention groups. We show that both unadjusted cluster-level analysis and baseline covariate adjusted cluster-level analysis give unbiased estimates of the intervention effect only if both intervention groups have the same missingness mechanisms and there is no interaction between baseline covariate and intervention group. Linear mixed model and multiple imputation give unbiased estimates under all four considered scenarios, provided that an interaction of intervention and baseline covariate is included in the model when appropriate. Cluster mean imputation has been proposed as a valid approach for handling missing outcomes in cluster randomised trials. We show that cluster mean imputation only gives unbiased estimates when missingness mechanism is the same between the intervention groups and there is no interaction between baseline covariate and intervention group. Multiple imputation shows overcoverage for small number of clusters in each intervention group.

  13. Economic evaluation of neonatal care packages in a cluster-randomized controlled trial in Sylhet, Bangladesh.

    Science.gov (United States)

    LeFevre, Amnesty E; Shillcutt, Samuel D; Waters, Hugh R; Haider, Sabbir; El Arifeen, Shams; Mannan, Ishtiaq; Seraji, Habibur R; Shah, Rasheduzzaman; Darmstadt, Gary L; Wall, Steve N; Williams, Emma K; Black, Robert E; Santosham, Mathuram; Baqui, Abdullah H

    2013-10-01

    To evaluate and compare the cost-effectiveness of two strategies for neonatal care in Sylhet division, Bangladesh. In a cluster-randomized controlled trial, two strategies for neonatal care--known as home care and community care--were compared with existing services. For each study arm, economic costs were estimated from a societal perspective, inclusive of programme costs, provider costs and household out-of-pocket payments on care-seeking. Neonatal mortality in each study arm was determined through household surveys. The incremental cost-effectiveness of each strategy--compared with that of the pre-existing levels of maternal and neonatal care--was then estimated. The levels of uncertainty in our estimates were quantified through probabilistic sensitivity analysis. The incremental programme costs of implementing the home-care package were 2939 (95% confidence interval, CI: 1833-7616) United States dollars (US$) per neonatal death averted and US$ 103.49 (95% CI: 64.72-265.93) per disability-adjusted life year (DALY) averted. The corresponding total societal costs were US$ 2971 (95% CI: 1844-7628) and US$ 104.62 (95% CI: 65.15-266.60), respectively. The home-care package was cost-effective--with 95% certainty--if healthy life years were valued above US$ 214 per DALY averted. In contrast, implementation of the community-care strategy led to no reduction in neonatal mortality and did not appear to be cost-effective. The home-care package represents a highly cost-effective intervention strategy that should be considered for replication and scale-up in Bangladesh and similar settings elsewhere.

  14. Group Music Therapy as a Preventive Intervention for Young People at Risk: Cluster-Randomized Trial.

    Science.gov (United States)

    Gold, Christian; Saarikallio, Suvi; Crooke, Alexander Hew Dale; McFerran, Katrina Skewes

    2017-07-01

    Music forms an important part of the lives and identities of adolescents and may have positive or negative mental health implications. Music therapy can be effective for mental disorders such as depression, but its preventive potential is unknown. The aim of this study was to examine whether group music therapy (GMT) is an effective intervention for young people who may be at risk of developing mental health problems, as indicated via unhealthy music use. The main question was whether GMT can reduce unhealthy uses of music and increase potentials for healthy uses of music, compared to self-directed music listening (SDML). We were also interested in effects of GMT on depressive symptoms, psychosocial well-being, rumination, and reflection. In an exploratory cluster-randomized trial in Australian schools, 100 students with self-reported unhealthy music use were invited to GMT (weekly sessions over 8 weeks) or SDML. Changes in the Healthy-Unhealthy Music Scale (HUMS) and mental health outcomes were measured over 3 months. Both interventions were well accepted. No effects were found between GMT and SDML (all p > 0.05); both groups tended to show small improvements over time. Younger participants benefited more from GMT, and older ones more from SDML (p = 0.018). GMT was associated with similar changes as SDML. Further research is needed to improve the processes of selecting participants for targeted interventions; to determine optimal dosage; and to provide more reliable evidence of effects of music-based interventions for adolescents. © the American Music Therapy Association 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

  15. Psychosocial behaviour management programme for home-dwelling people with dementia: A cluster-randomized controlled trial.

    Science.gov (United States)

    Nakanishi, Miharu; Endo, Kaori; Hirooka, Kayo; Granvik, Eva; Minthon, Lennart; Nägga, Katarina; Nishida, Atsushi

    2018-03-01

    Little is known about the effectiveness of a psychosocial behaviour management programme on home-dwelling people with dementia. We developed a Behaviour Analytics & Support Enhancement (BASE) programme for care managers and professional caregivers of home care services in Japan. We investigated the effects of BASE on challenging behaviour of home-dwelling people with dementia. A cluster-randomized controlled trial was conducted with home care providers from 3 different districts in Tokyo. Each provider recruited persons with dementia aged 65 years or older to receive home care in the BASE programme in August 2016. An online monitoring and assessment system was introduced to the intervention group for repeated measures of challenging behaviour with a total score of the Neuropsychiatric Inventory. Care professionals in both the intervention and control groups evaluated challenging behaviour of persons with dementia at baseline (September 2016) and follow-up (February 2017). A majority of persons with dementia had Alzheimer disease (59.3%). One-hundred and forty-one persons with dementia were included in the intervention group and 142 in the control group. Multilevel modelling revealed a significant reduction in challenging behaviour in the intervention group after 6 months (mean score, 18.3 to 11.2) compared with that of the control group (11.6 to 10.8; P dwelling people with dementia. Future research should examine the long-term effects of behaviour management programmes on behaviour, nursing home placement, and hospital admission of home-dwelling people with dementia. Copyright © 2017 John Wiley & Sons, Ltd.

  16. Reduction of self-perceived discomforts in critically ill patients in French intensive care units: study protocol for a cluster-randomized controlled trial.

    Science.gov (United States)

    Kalfon, Pierre; Mimoz, Olivier; Loundou, Anderson; Geantot, Marie-Agnès; Revel, Nathalie; Villard, Isabelle; Amour, Julien; Azoulay, Elie; Garrouste-Orgeas, Maïté; Martin, Claude; Sharshar, Tarek; Baumstarck, Karine; Auquier, Pascal

    2016-02-16

    It is now well documented that critically ill patients are exposed to stressful conditions and experience discomforts from multiple sources. Improved identification of the discomforts of patients in intensive care units (ICUs) may have implications for managing their care, including consideration of ethical issues, and may assist clinicians in choosing the most appropriate interventions. The primary objective of this study was to assess the effectiveness of a multicomponent program of discomfort reduction in critically ill patients. The secondary objectives were to assess the sustainability of the impact of the program and the potential seasonality effect. We conducted a multicenter, cluster-randomized, controlled, single (patient)-blind study involving 34 French adult ICUs. The experimental intervention was a 6-month period during which the multicomponent program was implemented in the ICU and included the following steps: identification of discomforts, immediate feedback to the healthcare team, and implementation of targeted interventions. The control intervention was a 6-month period during which any program was implemented. The primary endpoint was the monthly overall score of self-reported discomfort from the French questionnaire on discomforts in ICU patients (IPREA). The secondary endpoints were the scores of the discomfort items of IPREA. The sample size was 660 individuals to obtain 80% power to detect a 25% difference in the overall discomfort score of IPREA between the two groups (design effect: 2.9). The results of this cluster-randomized controlled study are expected to confirm that a multicomponent program of discomfort reduction may be a new strategy in the management of care for critically ill patients. ClinicalTrials.gov NCT02442934, registered 11 May 2015.

  17. Improved delivery of cardiovascular care (IDOCC through outreach facilitation: study protocol and implementation details of a cluster randomized controlled trial in primary care

    Directory of Open Access Journals (Sweden)

    Akbari Ayub

    2011-09-01

    Full Text Available Abstract Background There is a need to find innovative approaches for translating best practices for chronic disease care into daily primary care practice routines. Primary care plays a crucial role in the prevention and management of cardiovascular disease. There is, however, a substantive care gap, and many challenges exist in implementing evidence-based care. The Improved Delivery of Cardiovascular Care (IDOCC project is a pragmatic trial designed to improve the delivery of evidence-based care for the prevention and management of cardiovascular disease in primary care practices using practice outreach facilitation. Methods The IDOCC project is a stepped-wedge cluster randomized control trial in which Practice Outreach Facilitators work with primary care practices to improve cardiovascular disease prevention and management for patients at highest risk. Primary care practices in a large health region in Eastern Ontario, Canada, were eligible to participate. The intervention consists of regular monthly meetings with the Practice Outreach Facilitator over a one- to two-year period. Starting with audit and feedback, consensus building, and goal setting, the practices are supported in changing practice behavior by incorporating chronic care model elements. These elements include (a evidence-based decision support for providers, (b delivery system redesign for practices, (c enhanced self-management support tools provided to practices to help them engage patients, and (d increased community resource linkages for practices to enhance referral of patients. The primary outcome is a composite score measured at the level of the patient to represent each practice's adherence to evidence-based guidelines for cardiovascular care. Qualitative analysis of the Practice Outreach Facilitators' written narratives of their ongoing practice interactions will be done. These textual analyses will add further insight into understanding critical factors impacting

  18. What do You Need to Get Male Partners of Pregnant Women Tested for HIV in Resource Limited Settings? The Baby Shower Cluster Randomized Trial.

    Science.gov (United States)

    Ezeanolue, Echezona E; Obiefune, Michael C; Yang, Wei; Ezeanolue, Chinenye O; Pharr, Jennifer; Osuji, Alice; Ogidi, Amaka G; Hunt, Aaron T; Patel, Dina; Ogedegbe, Gbenga; Ehiri, John E

    2017-02-01

    Male partner involvement has the potential to increase uptake of interventions to prevent mother-to-child transmission of HIV (PMTCT). Finding cultural appropriate strategies to promote male partner involvement in PMTCT programs remains an abiding public health challenge. We assessed whether a congregation-based intervention, the Healthy Beginning Initiative (HBI), would lead to increased uptake of HIV testing among male partners of pregnant women during pregnancy. A cluster-randomized controlled trial of forty churches in Southeastern Nigeria randomly assigned to either the HBI (intervention group; IG) or standard of care referral to a health facility (control group; CG) was conducted. Participants in the IG received education and were offered onsite HIV testing. Overall, 2498 male partners enrolled and participated, a participation rate of 88.9%. Results showed that male partners in the IG were 12 times more likely to have had an HIV test compared to male partners of pregnant women in the CG (CG = 37.71% vs. IG = 84.00%; adjusted odds ratio = 11.9; p HIV testing and counseling among male partners of pregnant women.

  19. Efficacy of community-based physiotherapy networks for patients with Parkinson's disease: a cluster-randomised trial.

    Science.gov (United States)

    Munneke, Marten; Nijkrake, Maarten J; Keus, Samyra Hj; Kwakkel, Gert; Berendse, Henk W; Roos, Raymund Ac; Borm, George F; Adang, Eddy M; Overeem, Sebastiaan; Bloem, Bastiaan R

    2010-01-01

    Many patients with Parkinson's disease are treated with physiotherapy. We have developed a community-based professional network (ParkinsonNet) that involves training of a selected number of expert physiotherapists to work according to evidence-based recommendations, and structured referrals to these trained physiotherapists to increase the numbers of patients they treat. We aimed to assess the efficacy of this approach for improving health-care outcomes. Between February, 2005, and August, 2007, we did a cluster-randomised trial with 16 clusters (defined as community hospitals and their catchment area). Clusters were randomly allocated by use of a variance minimisation algorithm to ParkinsonNet care (n=8) or usual care (n=8). Patients were assessed at baseline and at 8, 16, and 24 weeks of follow-up. The primary outcome was a patient preference disability score, the patient-specific index score, at 16 weeks. Health secondary outcomes were functional mobility, mobility-related quality of life, and total societal costs over 24 weeks. Analysis was by intention to treat. This trial is registered, number NCT00330694. We included 699 patients. Baseline characteristics of the patients were comparable between the ParkinsonNet clusters (n=358) and usual-care clusters (n=341). The primary endpoint was similar for patients within the ParkinsonNet clusters (mean 47.7, SD 21.9) and control clusters (48.3, 22.4). Health secondary endpoints were also similar for patients in both study groups. Total costs over 24 weeks were lower in ParkinsonNet clusters compared with usual-care clusters (difference euro727; 95% CI 56-1399). Implementation of ParkinsonNet networks did not change health outcomes for patients living in ParkinsonNet clusters. However, health-care costs were reduced in ParkinsonNet clusters compared with usual-care clusters. ZonMw; Netherlands Organisation for Scientific Research; Dutch Parkinson's Disease Society; National Parkinson Foundation; Stichting Robuust

  20. Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol.

    Science.gov (United States)

    Chavane, Leonardo; Merialdi, Mario; Betrán, Ana Pilar; Requejo-Harris, Jennifer; Bergel, Eduardo; Aleman, Alicia; Colomar, Mercedes; Cafferata, Maria Luisa; Carbonell, Alicia; Crahay, Beatrice; Delvaux, Therese; Geelhoed, Diederike; Gülmezoglu, Metin; Malapende, Celsa Regina; Melo, Armando; Nguyen, My Huong; Osman, Nafissa Bique; Widmer, Mariana; Temmerman, Marleen; Althabe, Fernando

    2014-05-21

    Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher.WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country. This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in

  1. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    Science.gov (United States)

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-10-01

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79–653) [DOSAGE ERROR CORRECTED] . The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  2. Creating a synergy effect: A cluster randomized controlled trial testing the effect of a tailored multimedia intervention on patient outcomes.

    Science.gov (United States)

    Linn, Annemiek J; van Dijk, Liset; van Weert, Julia C M; Gebeyehu, Beniam G; van Bodegraven, Ad A; Smit, Edith G

    2018-03-17

    Improving adherence is a challenge and multiple barriers are likely to explain non-adherence. These barriers differ per patient and over course of the regimen. Hence, personalized interventions tailored to the specific barriers are needed. In a theoretical and evidence-based Tailored Multimedia Intervention, technology (online preparatory assessment, text messaging) was used as an add-on to a tailored counseling session (learned during a communication skills training), with the expectation of synergistic effects. A cluster randomized controlled trial was conducted in six hospitals, eight nurses and 160 chronic patients. Patient satisfaction with communication, beliefs about medication, self-efficacy and medication adherence were assessed at initiation of the treatment and after six months. Intervention effects were found for patient satisfaction with nurses' affective communication and self-efficacy at the initiation of treatment. The effect on self-efficacy remained after six months. By combining tailored counseling with technology, this intervention resulted in positive changes in important prerequisites of medication adherence. Technology can contribute significantly to health care providers' ability to tailor information to the patients' needs. Copyright © 2018. Published by Elsevier B.V.

  3. A Cluster Randomized Controlled Trial to Reduce Childhood Diarrhea Using Hollow Fiber Water Filter and/or Hygiene–Sanitation Educational Interventions

    Science.gov (United States)

    Lindquist, Erik D.; George, C. M.; Perin, Jamie; Neiswender de Calani, Karen J.; Norman, W. Ray; Davis, Thomas P.; Perry, Henry

    2014-01-01

    Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15–0.30) for the filter arm and 0.27 (95% CI = 0.22–0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59–0.86). PMID:24865680

  4. Implementation strategies of internet-based asthma self-management support in usual care. Study protocol for the IMPASSE cluster randomized trial.

    Science.gov (United States)

    van Gaalen, Johanna L; Bakker, Moira J; van Bodegom-Vos, Leti; Snoeck-Stroband, Jiska B; Assendelft, Willem J J; Kaptein, Ad A; van der Meer, Victor; Taube, Christian; Thoonen, Bart P; Sont, Jacob K

    2012-11-21

    Internet-based self-management (IBSM) support cost-effectively improves asthma control, asthma related quality of life, number of symptom-free days, and lung function in patients with mild to moderate persistent asthma. The current challenge is to implement IBSM in clinical practice. This study is a three-arm cluster randomized trial with a cluster pre-randomisation design and 12 months follow-up per practice comparing the following three IBSM implementation strategies: minimum strategy (MS): dissemination of the IBSM program; intermediate strategy (IS): MS + start-up support for professionals (i.e., support in selection of the appropriate population and training of professionals); and extended strategy (ES): IS + additional training and ongoing support for professionals. Because the implementation strategies (interventions) are primarily targeted at general practices, randomisation will occur at practice level.In this study, we aim to evaluate 14 primary care practices per strategy in the Leiden-The Hague region, involving 140 patients per arm. Patients aged 18 to 50 years, with a physician diagnosis of asthma, prescription of inhaled corticosteroids, and/or montelukast for ≥3 months in the previous year are eligible to participate. Primary outcome measures are the proportion of referred patients that participate in IBSM, and the proportion of patients that have clinically relevant improvement in the asthma-related quality of life. The secondary effect measures are clinical outcomes (asthma control, lung function, usage of airway treatment, and presence of exacerbations); self-management related outcomes (health education impact, medication adherence, and illness perceptions); and patient utilities. Process measures are the proportion of practices that participate in IBSM and adherence of professionals to implementation strategies. Cost-effective measurements are medical costs and healthcare consumption. Follow-up is six months per patient. This study

  5. Inference of median difference based on the Box-Cox model in randomized clinical trials.

    Science.gov (United States)

    Maruo, K; Isogawa, N; Gosho, M

    2015-05-10

    In randomized clinical trials, many medical and biological measurements are not normally distributed and are often skewed. The Box-Cox transformation is a powerful procedure for comparing two treatment groups for skewed continuous variables in terms of a statistical test. However, it is difficult to directly estimate and interpret the location difference between the two groups on the original scale of the measurement. We propose a helpful method that infers the difference of the treatment effect on the original scale in a more easily interpretable form. We also provide statistical analysis packages that consistently include an estimate of the treatment effect, covariance adjustments, standard errors, and statistical hypothesis tests. The simulation study that focuses on randomized parallel group clinical trials with two treatment groups indicates that the performance of the proposed method is equivalent to or better than that of the existing non-parametric approaches in terms of the type-I error rate and power. We illustrate our method with cluster of differentiation 4 data in an acquired immune deficiency syndrome clinical trial. Copyright © 2015 John Wiley & Sons, Ltd.

  6. The Comparative Effectiveness of Diabetes Prevention Strategies to Reduce Postpartum Weight Retention in Women With Gestational Diabetes Mellitus: The Gestational Diabetes' Effects on Moms (GEM) Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Ferrara, Assiamira; Hedderson, Monique M; Brown, Susan D; Albright, Cheryl L; Ehrlich, Samantha F; Tsai, Ai-Lin; Caan, Bette J; Sternfeld, Barbara; Gordon, Nancy P; Schmittdiel, Julie A; Gunderson, Erica P; Mevi, Ashley A; Herman, William H; Ching, Jenny; Crites, Yvonne; Quesenberry, Charles P

    2016-01-01

    To compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)-derived lifestyle intervention. This study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered.

  7. Community-based intermittent mass testing and treatment for malaria in an area of high transmission intensity, western Kenya: study design and methodology for a cluster randomized controlled trial.

    Science.gov (United States)

    Samuels, Aaron M; Awino, Nobert; Odongo, Wycliffe; Abong'o, Benard; Gimnig, John; Otieno, Kephas; Shi, Ya Ping; Were, Vincent; Allen, Denise Roth; Were, Florence; Sang, Tony; Obor, David; Williamson, John; Hamel, Mary J; Patrick Kachur, S; Slutsker, Laurence; Lindblade, Kim A; Kariuki, Simon; Desai, Meghna

    2017-06-07

    Most human Plasmodium infections in western Kenya are asymptomatic and are believed to contribute importantly to malaria transmission. Elimination of asymptomatic infections requires active treatment approaches, such as mass testing and treatment (MTaT) or mass drug administration (MDA), as infected persons do not seek care for their infection. Evaluations of community-based approaches that are designed to reduce malaria transmission require careful attention to study design to ensure that important effects can be measured accurately. This manuscript describes the study design and methodology of a cluster-randomized controlled trial to evaluate a MTaT approach for malaria transmission reduction in an area of high malaria transmission. Ten health facilities in western Kenya were purposively selected for inclusion. The communities within 3 km of each health facility were divided into three clusters of approximately equal population size. Two clusters around each health facility were randomly assigned to the control arm, and one to the intervention arm. Three times per year for 2 years, after the long and short rains, and again before the long rains, teams of community health volunteers visited every household within the intervention arm, tested all consenting individuals with malaria rapid diagnostic tests, and treated all positive individuals with an effective anti-malarial. The effect of mass testing and treatment on malaria transmission was measured through population-based longitudinal cohorts, outpatient visits for clinical malaria, periodic population-based cross-sectional surveys, and entomological indices.

  8. Minimal improvement of nurses’ motivational interviewing skills in routine diabetes care one year after training: a cluster randomized trial

    Science.gov (United States)

    2013-01-01

    Background The effectiveness of nurse-led motivational interviewing (MI) in routine diabetes care in general practice is inconclusive. Knowledge about the extent to which nurses apply MI skills and the factors that affect the usage can help to understand the black box of this intervention. The current study compared MI skills of trained versus non-trained general practice nurses in diabetes consultations. The nurses participated in a cluster randomized trial in which a comprehensive program (including MI training) was tested on improving clinical parameters, lifestyle, patients’ readiness to change lifestyle, and quality of life. Methods Fifty-eight general practices were randomly assigned to usual care (35 nurses) or the intervention (30 nurses). The ratings of applying 24 MI skills (primary outcome) were based on five consultation recordings per nurse at baseline and 14 months later. Two judges evaluated independently the MI skills and the consultation characteristics time, amount of nurse communication, amount of lifestyle discussion and patients’ readiness to change. The effect of the training on the MI skills was analysed with a multilevel linear regression by comparing baseline and the one-year follow-up between the interventions with usual care group. The overall effect of the consultation characteristics on the MI skills was studied in a multilevel regression analyses. Results At one year follow up, it was demonstrated that the nurses improved on 2 of the 24 MI skills, namely, “inviting the patient to talk about behaviour change” (mean difference=0.39, p=0.009), and “assessing patient’s confidence in changing their lifestyle” (mean difference=0.28, p=0.037). Consultation time and the amount of lifestyle discussion as well as the patients’ readiness to change health behaviour was associated positively with applying MI skills. Conclusions The maintenance of the MI skills one year after the training program was minimal. The question is whether

  9. A cluster randomized trial of provider-initiated (Opt-out) HIV counseling and testing of tuberculosis patients in South Africa

    Science.gov (United States)

    Pope, Diana S.; DeLuca, Andrea N.; Kali, Paula; Hausler, Harry; Sheard, Carol; Hoosain, Ebrahim; Chaudhary, Mohammed A.; Celentano, David D.; Chaisson, Richard E.

    2008-01-01

    Objective To determine whether implementation of provider-initiated HIV counseling would increase the proportion of tuberculosis patients that received HIV counseling and testing. Design Cluster-randomized trial with clinic as unit of randomization Setting Twenty, medium-sized primary care TB clinics in the Nelson Mandela Metropolitan Municipality, Port Elizabeth, Eastern Cape Province, South Africa Subjects A total of 754 adults (≥ 18 years) newly registered as tuberculosis patients the twenty study clinics Intervention Implementation of provider-initiated HIV counseling and testing. Main outcome measures Percentage of TB patients HIV counseled and tested. Secondary Percentage of patients HIV test positive and percentage of those that received cotrimoxazole and who were referred for HIV care. Results A total of 754 adults newly registered as tuberculosis patients were enrolled. In clinics randomly assigned to implement provider-initiated HIV counseling and testing, 20.7% (73/352) patients were counseled versus 7.7% (31/402) in the control clinics (p = 0.011), and 20.2 % (n = 71) versus 6.5% (n = 26) underwent HIV testing (p = 0.009). Of those patients counseled, 97% in the intervention clinics accepted testing versus 79% in control clinics (p =0.12). The proportion of patients identified as HIV-infected in intervention clinics was 8.5% versus 2.5% in control clinics (p=0.044). Fewer than 40% of patients with a positive HIV test were prescribed cotrimoxazole or referred for HIV care in either study arm. Conclusions Provider-initiated HIV counseling significantly increased the proportion of adult TB patients that received HIV counseling and testing, but the magnitude of the effect was small. Additional interventions to optimize HIV testing for TB patients urgently need to be evaluated. PMID:18520677

  10. An Internet-Based Intervention to Promote Alcohol-Related Attitudinal and Behavioral Change Among Adolescents: Protocol of a Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Ip, Patrick; Chan, Ko-Ling; Chow, Chun-Bong; Lam, Tai-Hing; Ho, Sai-Yin; Wong, Wilfred Hing-Sang; Wong, Margaret Fung-Yee

    2016-06-01

    Underage drinking is a prevalent risk behavior and common public health problem. Research shows that alcohol abuse not only affects the quality of life of drinkers themselves. The problems resulting from underage drinking pose substantial costs to society as well. The proposed study will address underage drinking with the use of an Internet campaign, which is a cost-effective way of tackling the problem. The aims of this study are to test the effectiveness of an online quiz competition in changing adolescents' alcohol-related attitudes and behavior and to explore the feasibility of using Internet viral marketing to reach a significant number of adolescents. The study will constitute a cluster randomized controlled trial for 20 secondary schools (6720 Grade 7-9 students). Schools will be randomized to intervention or control arm with equal likelihood. Students in intervention schools will be invited to take part in the Internet campaign, whereas those in control schools will receive relevant promotional leaflets. Alcohol-related attitude and behavior will be the primary outcome measures. The results of the proposed study will provide evidence on the efficacy of an Internet intervention in modifying adolescents' attitudes and behavior and guide further investigation into the prevention of and intervention in such risk behaviors as underage drinking. The project was funded July 2015, enrollment started September 2015, and results are expected July 2017. With the Internet increasingly being recognized as a practical and cost-effective platform for health information delivery, the proposed Internet-based intervention is expected to be more effective in altering adolescents' alcohol-related attitudes and behaviors than traditional health promotion. ClinicalTrials.gov NCT02450344; https://clinicaltrials.gov/ct2/show/NCT02450344 (Archived by WebCite at http://www.webcitation.org/6heB2zMBD).

  11. Training family physicians and residents in family medicine in shared decision making to improve clinical decisions regarding the use of antibiotics for acute respiratory infections: protocol for a clustered randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Frémont Pierre

    2011-01-01

    Full Text Available Abstract Background To explore ways to reduce the overuse of antibiotics for acute respiratory infections (ARIs, we conducted a pilot clustered randomized controlled trial (RCT to evaluate DECISION+, a training program in shared decision making (SDM for family physicians (FPs. This pilot project demonstrated the feasibility of conducting a large clustered RCT and showed that DECISION+ reduced the proportion of patients who decided to use antibiotics immediately after consulting their physician. Consequently, the objective of this study is to evaluate, in patients consulting for ARIs, if exposure of physicians to a modified version of DECISION+, DECISION+2, would reduce the proportion of patients who decide to use antibiotics immediately after consulting their physician. Methods/design The study is a multi-center, two-arm, parallel clustered RCT. The 12 family practice teaching units (FPTUs in the network of the Department of Family Medicine and Emergency Medicine of Université Laval will be randomized to a DECISION+2 intervention group (experimental group or to a no-intervention control group. These FPTUs will recruit patients consulting family physicians and residents in family medicine enrolled in the study. There will be two data collection periods: pre-intervention (baseline including 175 patients with ARIs in each study arm, and post-intervention including 175 patients with ARIs in each study arm (total n = 700. The primary outcome will be the proportion of patients reporting a decision to use antibiotics immediately after consulting their physician. Secondary outcome measures include: 1 physicians and patients' decisional conflict; 2 the agreement between the parties' decisional conflict scores; and 3 perception of patients and physicians that SDM occurred. Also in patients, at 2 weeks follow-up, adherence to the decision, consultation for the same reason, decisional regret, and quality of life will be assessed. Finally, in both patients

  12. Community risk factors for ocular Chlamydia infection in Niger: pre-treatment results from a cluster-randomized trachoma trial.

    Directory of Open Access Journals (Sweden)

    Abdou Amza

    Full Text Available Trachoma control programs utilize mass azithromycin distributions to treat ocular Chlamydia trachomatis as part of an effort to eliminate this disease world-wide. But it remains unclear what the community-level risk factors are for infection.This cluster-randomized, controlled trial entered 48 randomly selected communities in a 2×2 factorial design evaluating the effect of different treatment frequencies and treatment coverage levels. A pretreatment census and examination established the prevalence of risk factors for clinical trachoma and ocular chlamydia infection including years of education of household head, distance to primary water source, presence of household latrine, and facial cleanliness (ocular discharge, nasal discharge, and presence of facial flies. Univariate and multivariate associations were tested using linear regression and Bayes model averaging.There were a total of 24,536 participants (4,484 children aged 0-5 years in 6,235 households in the study. Before treatment in May to July 2010, the community-level prevalence of active trachoma (TF or TI utilizing the World Health Organization [WHO] grading system was 26.0% (95% CI: 21.9% to 30.0% and the mean community-level prevalence of chlamydia infection by Amplicor PCR was 20.7% (95% CI: 16.5% to 24.9% in children aged 0-5 years. Univariate analysis showed that nasal discharge (0.29, 95% CI: 0.04 to 0.54; P = 0.03, presence of flies on the face (0.40, 95% CI: 0.17 to 0.64; P = 0.001, and years of formal education completed by the head of household (0.07, 95% CI: 0.07 to 0.13; P = 0.03 were independent risk factors for chlamydia infection. In multivariate analysis, facial flies (0.26, 95% CI: 0.02 to 0.49; P = 0.03 and years of formal education completed by the head of household (0.06, 95% CI: 0.008 to 0.11; P = 0.02 were associated risk factors for ocular chlamydial infection.We have found that the presence of facial flies and years of education of the head

  13. Using daily text messages to improve adherence to infant micronutrient powder (MNP) packets in rural western China: A cluster-randomized controlled trial

    Science.gov (United States)

    Wang, Xu; Liu, Chengfang; Zhang, Linxiu; Yue, Ai; Medina, Alexis; Rozelle, Scott

    2018-01-01

    Objective To evaluate the effectiveness of daily text messages as a means to improve caregivers’ adherence to infant micronutrient powder (MNP) in rural Shaanxi Province of China. Methodology 638 infants aged 6–11 months in 234 villages were involved in a cluster-randomized controlled trial (RCT). All caregivers were given free infant MNP packets at baseline in April 2013 and the follow-up survey was in July 2013. We randomly assigned 318 infants in 117 villages to treatment group (receiving daily text message) and 320 infants in the other 117 villages as control group. Results On average, daily text messages increased the number of MNP packets fed (marginal effect = 4.63; 95% confidence interval (CI) = 0.16, 9.10). The text message is more likely to increase the consumption of MNP packets if the primary caregiver was the mother (marginal effect = 12.19; 95% CI = 0.69, 23.68). Receiving the text message appears to significantly increase the likelihood of full adherence when the primary caregiver can either check (odds ratio = 2.93; 95% CI = 1.34, 6.40) or knows how to send (odds ratio = 3.26; 95% CI = 1.53, 6.97) text messages. Conclusion Daily text messages improved the consumption of infant MNP packets. However, the impact was not large enough to increase the probability of caregivers being fully adherent to the feeding instruction, which is to feed 5–7 packets per week as recommended. In addition, when the mother is the caregiver and when the caregiver can check or knows how to send text messages there is greater adherence by the primary caregivers. Trial registration http://www.isrctn.com/ISRCTN44149146 PMID:29352304

  14. Using Brothel Leadership to Improve Condom Use among Brothel-based Female Sex Workers in Abuja, Nigeria : Results of a Cluster Randomized Pilot Study

    NARCIS (Netherlands)

    Okafor, Uchenna O.; Crutzen, Rik; Sylvia, Adebajo; Ifeanyi, Okekearu; Van Den Borne, Bart

    2017-01-01

    Support by brothel leaders and the promotion of a conducive environment for HIV prevention programs within brothel establishments are important to promote a safe working environment for Brothel-Based Female Sex Workers (BB FSWs). This study assesses the effects of a cluster randomized pilot trial

  15. Improving service delivery of water, sanitation, and hygiene in primary schools: a cluster-randomized trial in western Kenya.

    Science.gov (United States)

    Alexander, Kelly T; Dreibelbis, Robert; Freeman, Matthew C; Ojeny, Betty; Rheingans, Richard

    2013-09-01

    Water, sanitation, and hygiene (WASH) programs in schools have been shown to improve health and reduce absence. In resource-poor settings, barriers such as inadequate budgets, lack of oversight, and competing priorities limit effective and sustained WASH service delivery in schools. We employed a cluster-randomized trial to examine if schools could improve WASH conditions within existing administrative structures. Seventy schools were divided into a control group and three intervention groups. All intervention schools received a budget for purchasing WASH-related items. One group received no further intervention. A second group received additional funding for hiring a WASH attendant and making repairs to WASH infrastructure, and a third group was given guides for student and community monitoring of conditions. Intervention schools made significant improvements in provision of soap and handwashing water, treated drinking water, and clean latrines compared with controls. Teachers reported benefits of monitoring, repairs, and a WASH attendant, but quantitative data of WASH conditions did not determine whether expanded interventions out-performed our budget-only intervention. Providing schools with budgets for WASH operational costs improved access to necessary supplies, but did not ensure consistent service delivery to students. Further work is needed to clarify how schools can provide WASH services daily.

  16. A Physical Activity Intervention for Brazilian Students From Low Human Development Index Areas: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Filho, Valter C Barbosa; da Silva, Kelly Samara; Mota, Jorge; Beck, Carmem; da Silva Lopes, Adair

    2016-11-01

    Promoting physical activity (PA) in low- and middle-income countries is an important public health topic as well as a challenge for practice. This study aimed to assess the effect of a school-based intervention on different PA-related variables among students. This cluster-randomized-controlled trial included 548 students in the intervention group and 537 in the control group (11-18 years-old) from 6 schools in neighborhoods with low Human Development Index (0.170-0.491) in Fortaleza, Brazil. The intervention included strategies focused on training teachers, opportunities for PA in the school environment and health education. Variables measured at baseline and again at the 4-months follow-up included the weekly time in different types of moderate-to-vigorous PA (MVPA), preference for PA during leisure-time, PA behavioral change stage and active commuting to school. Generalized linear models and binary logistic regressions were used. An intervention effect was found by increasing the weekly time in MVPA (effect size = 0.17), popular games (effect size = 0.35), and the amount of PA per week (effect size = 0.27) among students (all P effective in promoting improvements in some PA outcomes, but the changes were not sufficient to increase the proportion of those meeting PA recommendations.

  17. Implementing school nursing strategies to reduce LGBTQ adolescent suicide: a randomized cluster trial study protocol.

    Science.gov (United States)

    Willging, Cathleen E; Green, Amy E; Ramos, Mary M

    2016-10-22

    Reducing youth suicide in the United States (U.S.) is a national public health priority, and lesbian, gay, bisexual, transgender, and queer or questioning (LGBTQ) youth are at elevated risk. The Centers for Disease Control and Prevention (CDC) endorses six evidence-based (EB) strategies that center on meeting the needs of LGBTQ youth in schools; however, fewer than 6 % of U.S. schools implement all of them. The proposed intervention model, "RLAS" (Implementing School Nursing Strategies to Reduce LGBTQ Adolescent Suicide), builds on the Exploration, Preparation, Implementation, and Sustainment (EPIS) conceptual framework and the Dynamic Adaptation Process (DAP) to implement EB strategies in U.S. high schools. The DAP accounts for the multilevel context of school settings and uses Implementation Resource Teams (IRTs) to facilitate appropriate expertise, advise on acceptable adaptations, and provide data feedback to make schools implementation ready and prepared to sustain changes. Mixed methods will be used to examine individual, school, and community factors influencing both implementation process and youth outcomes. A cluster randomized controlled trial will assess whether LGBTQ students and their peers in RLAS intervention schools (n = 20) report reductions in suicidality, depression, substance use, bullying, and truancy related to safety concerns compared to those in usual care schools (n = 20). Implementation progress and fidelity for each EB strategy in RLAS intervention schools will be examined using a modified version of the Stages of Implementation Completion checklist. During the implementation and sustainment phases, annual focus groups will be conducted with the 20 IRTs to document their experiences identifying and advancing adaptation supports to facilitate use of EB strategies and their perceptions of the DAP. The DAP represents a data-informed, collaborative, multiple stakeholder approach to progress from exploration to sustainment and obtain

  18. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  19. Improving elementary school quality through the use of a social-emotional and character development program: a matched-pair, cluster-randomized, controlled trial in Hawai'i.

    Science.gov (United States)

    Snyder, Frank J; Vuchinich, Samuel; Acock, Alan; Washburn, Isaac J; Flay, Brian R

    2012-01-01

    School safety and quality affect student learning and success. This study examined the effects of a comprehensive elementary school-wide social-emotional and character education program, Positive Action, on teacher, parent, and student perceptions of school safety and quality utilizing a matched-pair, cluster-randomized, controlled design. The Positive Action Hawai'i trial included 20 racially/ethnically diverse schools and was conducted from 2002-2003 through 2005-2006. School-level archival data, collected by the Hawai'i Department of Education, were used to examine program effects at 1-year post-trial. Teacher, parent, and student data were analyzed to examine indicators of school quality such as student safety and well-being, involvement, and satisfaction, as well as overall school quality. Matched-paired t-tests were used for the primary analysis, and sensitivity analyses included permutation tests and random-intercept growth curve models. Analyses comparing change from baseline to 1-year post-trial revealed that intervention schools demonstrated significantly improved school quality compared to control schools, with 21%, 13%, and 16% better overall school quality scores as reported by teachers, parents, and students, respectively. Teacher, parent, and student reports on individual school-quality indicators showed improvement in student safety and well-being, involvement, satisfaction, quality student support, focused and sustained action, standards-based learning, professionalism and system capacity, and coordinated team work. Teacher reports also showed an improvement in the responsiveness of the system. School quality was substantially improved, providing evidence that a school-wide social-emotional and character education program can enhance school quality and facilitate whole-school change. © 2011, American School Health Association.

  20. Comparison of two modes of vitamin B12 supplementation on neuroconduction and cognitive function among older people living in Santiago, Chile: a cluster randomized controlled trial. a study protocol [ISRCTN 02694183

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    Brito Alex

    2011-09-01

    Full Text Available Abstract Background Older people have a high risk of vitamin B12 deficiency; this can lead to varying degrees of cognitive and neurological impairment. CBL deficiency may present as macrocytic anemia, subacute combined degeneration of the spinal cord, or as neuropathy, but is often asymptomatic in older people. Less is known about subclinical vitamin B12 deficiency and concurrent neuroconduction and cognitive impairment. A Programme of Complementary Feeding for the Older Population (PACAM in Chile delivers 2 complementary fortified foods that provide approximately 1.4 μg/day of vitamin B12 (2.4 μg/day elderly RDA. The aim of the present study is to assess whether supplementation with vitamin B12 will improve neuroconduction and cognitive function in older people who have biochemical evidence of vitamin B12 insufficiency in the absence of clinical deficiency. Methods We designed a cluster double-blind placebo-controlled trial involving community dwelling people aged 70-79 living in Santiago, Chile. We randomized 15 clusters (health centers involving 300 people (20 per cluster. Each cluster will be randomly assigned to one of three arms: a a 1 mg vitamin B12 pill taken daily and a routine PACAM food; b a placebo pill and the milk-PACAM food fortified to provide 1 mg of vitamin B12; c the routine PACAM food and a placebo pill. The study has been designed as an 18 month follow up period. The primary outcomes assessed at baseline, 4, 9 and 18 months will be: serum levels of vitamin B12, neuroconduction and cognitive function. Conclusions In view of the high prevalence of vitamin B12 deficiency in later life, the present study has potential public health interest because since it will measure the impact of the existing program of complementary feeding as compared to two options that provide higher vitamin B12 intakes that might potentially may contribute in preserving neurophysiologic and cognitive function and thus improve quality of life for older

  1. Effectiveness of work-related medical rehabilitation in cancer patients: study protocol of a cluster-randomized multicenter trial.

    Science.gov (United States)

    Wienert, Julian; Schwarz, Betje; Bethge, Matthias

    2016-07-27

    Work is a central resource for cancer survivors as it not only provides income but also impacts health and quality of life. Additionally, work helps survivors to cope with the perceived critical life event. The German Pension Insurance provides medical rehabilitation for working-age patients with chronic diseases to improve and restore their work ability, and support returning to or staying at work, and thus tries to sustainably avoid health-related early retirement. Past research showed that conventional medical rehabilitation programs do not support returning to work sufficiently and that work-related medical rehabilitation programs report higher return-to-work rates across several health conditions, when compared to medical rehabilitation. Therefore, the current study protocol outlines an effectiveness study of such a program for cancer survivors. To evaluate the effectiveness of work-related medical rehabilitation in cancer patients we conduct a cluster-randomized multicenter trial. In total, 504 rehabilitation patients between 18 and 60 years with a Karnofsky Performance Status of ≥70 %, a preliminary positive social-medical prognosis of employability for at least 3 h/day within the next 6 months and an elevated risk of not returning to work will be recruited in four inpatient rehabilitation centers. Patients are randomized to the work-related medical rehabilitation program or the conventional medical rehabilitation program based on their week of arrival at each rehabilitation center. The work-related medical rehabilitation program comprises additional work-related diagnostics, multi-professional team meetings, an introductory session as well as work-related functional capacity training, work-related psychological groups, and social counseling. All additional components are aimed at the adjustment of the patients' capacity in relation to their individual job demands. Role functioning defines the main study outcome and will be assessed with the EORTC

  2. A mixed methods protocol for developing and testing implementation strategies for evidence-based obesity prevention in childcare: a cluster randomized hybrid type III trial.

    Science.gov (United States)

    Swindle, Taren; Johnson, Susan L; Whiteside-Mansell, Leanne; Curran, Geoffrey M

    2017-07-18

    Despite the potential to reach at-risk children in childcare, there is a significant gap between current practices and evidence-based obesity prevention in this setting. There are few investigations of the impact of implementation strategies on the uptake of evidence-based practices (EBPs) for obesity prevention and nutrition promotion. This study protocol describes a three-phase approach to developing and testing implementation strategies to support uptake of EBPs for obesity prevention practices in childcare (i.e., key components of the WISE intervention). Informed by the i-PARIHS framework, we will use a stakeholder-driven evidence-based quality improvement (EBQI) process to apply information gathered in qualitative interviews on barriers and facilitators to practice to inform the design of implementation strategies. Then, a Hybrid Type III cluster randomized trial will compare a basic implementation strategy (i.e., intervention as usual) with an enhanced implementation strategy informed by stakeholders. All Head Start centers (N = 12) within one agency in an urban area in a southern state in the USA will be randomized to receive the basic or enhanced implementation with approximately 20 classrooms per group (40 educators, 400 children per group). The educators involved in the study, the data collectors, and the biostastician will be blinded to the study condition. The basic and enhanced implementation strategies will be compared on outcomes specified by the RE-AIM model (e.g., Reach to families, Effectiveness of impact on child diet and health indicators, Adoption commitment of agency, Implementation fidelity and acceptability, and Maintenance after 6 months). Principles of formative evaluation will be used throughout the hybrid trial. This study will test a stakeholder-driven approach to improve implementation, fidelity, and maintenance of EBPs for obesity prevention in childcare. Further, this study provides an example of a systematic process to develop

  3. Impact of educational intervention on implementation of tobacco counselling among oral health professionals: a cluster-randomized community trial.

    Science.gov (United States)

    Amemori, Masamitsu; Virtanen, Jorma; Korhonen, Tellervo; Kinnunen, Taru H; Murtomaa, Heikki

    2013-04-01

    Tobacco use adversely affects oral health. Clinical guidelines recommend that oral health professionals promote tobacco abstinence and provide patients who use tobacco with brief tobacco use cessation counselling. Research shows that these guidelines are seldom implemented successfully. This study aimed to evaluate two interventions to enhance tobacco use prevention and cessation (TUPAC) counselling among oral health professionals in Finland. We used a cluster-randomized community trial to test educational and fee-for-service interventions in enhancing TUPAC counselling among a sample of dentists (n=73) and dental hygienists (n=22) in Finland. Educational intervention consisted of 1 day of training, including lectures, interactive sessions, multimedia demonstrations and a role play session with standard patient cases. Fee-for-service intervention consisted of monetary compensation for providing tobacco use prevention or cessation counselling. TUPAC counselling procedures provided were reported and measured using an electronic dental records system. In data analysis, intent-to-treat principles were followed at both individual and cluster levels. Descriptive analysis included chi-square and t-tests. A general linear model for repeated measures was used to compare the outcome measures by intervention group. Of 95 providers, 73 participated (76.8%). In preventive counselling, there was no statistically significant time effect or group-by-time interaction. In cessation counselling, statistically significant group-by-time interaction was found after a 6-month follow-up (F=2.31; P=0.007), indicating that counselling activity increased significantly in intervention groups. On average, dental hygienists showed greater activity in tobacco prevention (F=12.13; P=0.001) and cessation counselling (F=30.19; PTUPAC counselling performance. Other approaches than monetary incentives may be needed to enhance the effectiveness of educational intervention. Further studies with focus

  4. A multi-element psychosocial intervention for early psychosis (GET UP PIANO TRIAL) conducted in a catchment area of 10 million inhabitants: study protocol for a pragmatic cluster randomized controlled trial.

    Science.gov (United States)

    Ruggeri, Mirella; Bonetto, Chiara; Lasalvia, Antonio; De Girolamo, Giovanni; Fioritti, Angelo; Rucci, Paola; Santonastaso, Paolo; Neri, Giovanni; Pileggi, Francesca; Ghigi, Daniela; Miceli, Maurizio; Scarone, Silvio; Cocchi, Angelo; Torresani, Stefano; Faravelli, Carlo; Zimmermann, Christa; Meneghelli, Anna; Cremonese, Carla; Scocco, Paolo; Leuci, Emanuela; Mazzi, Fausto; Gennarelli, Massimo; Brambilla, Paolo; Bissoli, Sarah; Bertani, Maria Elena; Tosato, Sarah; De Santi, Katia; Poli, Sara; Cristofalo, Doriana; Tansella, Michele; Ruggeri, Mirella; Mirella, Maria Elena; Bissoli, Sarah; Bonetto, Chiara; Cristofalo, Doriana; De Santi, Katia; Lasalvia, Antonio; Lunardi, Silvia; Negretto, Valentina; Poli, Sara; Tosato, Sarah; Zamboni, Maria Grazia; Ballarin, Mario; De Girolamo, Giovanni; Fioritti, Angelo; Neri, Giovanni; Pileggi, Francesca; Rucci, Paola; Bocchio Chiavetto, Luisella; Scasselatti, Catia; Zanardini, Roberta; Brambilla, Paolo; Bellani, Marcella; Bertoldo, Alessandra; Marinelli, Veronica; Negretto, Valentina; Perlini, Cinzia; Rambaldelli, Gianluca; Lasalvia, Antonio; Bertani, Mariaelena; Bissoli, Sarah; Lazzarotto, Lorenza; Bardella, Sonia; Gardellin, Francesco; Lamonaca, Dario; Lasalvia, Antonio; Lunardon, Marco; Magnabosco, Renato; Martucci, Marilena; Nicolau, Stylianos; Nifosì, Francesco; Pavanati, Michele; Rossi, Massimo; Piazza, Carlo; Piccione, Gabriella; Sala, Alessandra; Sale, Annalisa; Stefan, Benedetta; Zotos, Spyridon; Balbo, Mirko; Boggian, Ileana; Ceccato, Enrico; Dall'Agnola, Rosa; Gardellin, Francesco; Girotto, Barbara; Goss, Claudia; Lamonaca, Dario; Lasalvia, Antonio; Leoni, Roberta; Mai, Alessia; Pasqualini, Annalisa; Pavanati, Michele; Piazza, Carlo; Piccione, Gabriella; Roccato, Stefano; Rossi, Alberto; Sale, Annalisa; Strizzolo, Stefania; Zotos, Spyridon; Urbani, Anna; Ald, Flavia; Bianchi, Barbara; Cappellari, Paola; Conti, Raffaello; De Battisti, Laura; Lazzarin, Ermanna; Merlin, Silvia; Migliorini, Giuseppe; Pozzan, Tecla; Sarto, Lucio; Visonà, Stefania; Brazzoli, Andrea; Campi, Antonella; Carmagnani, Roberta; Giambelli, Sabrina; Gianella, Annalisa; Lunardi, Lino; Madaghiele, Davide; Maestrelli, Paola; Paiola, Lidia; Posteri, Elisa; Viola, Loretta; Zamberlan, Valentina; Zenari, Marta; Tosato, Sarah; Zanoni, Martina; Bonadonna, Giovanni; Bonomo, Mariacristina; Santonastaso, Paolo; Cremonese, Carla; Scocco, Paolo; Veronese, Angela; Anderle, Patrizia; Angelozz, Andrea; Amalric, Isabelle; Baron, Gabriella; Candeago, Enrico Bruttomesso Fabio; Castelli, Franco; Chieco, Maria; Cremonese, Carla; Di Costanzo, Enrico; Derossi, Mario; Doriguzzi, Michele; Galvano, Osvaldo; Lattanz, Marcello; Lezzi, Roberto; Marcato, Marisa; Marcolin, Alessandro; Marini, Franco; Matranga, Manlio; Scalabrin, Donato; Zucchetto, Maria; Zadro, Flavio; Austoni, Giovanni; Bianco, Maria; Bordino, Francesca; Dario, Filippo; De Risio, Alessandro; Gatto, Aldo; Granà, Simona; Favero, Emanuele; Franceschin, Anna; Friederici, Silvia; Marangon, Vanna; Pascolo, Michela; Ramon, Luana; Scocco, Paolo; Veronese, Angela; Zambolin, Stefania; Riolo, Rossana; Buffon, Antonella; Cremonese, Carla; Di Bortolo, Elena; Friederici, Silvia; Fortin, Stefania; Marcato, Marisa; Matarrese, Francesco; Mogni, Simona; Codemo, Novella; Russi, Alessio; Silvestro, Alessandra; Turella, Elena; Viel, Paola; Dominoni, Anna; Andreose, Lorenzo; Boemio, Mario; Bressan, Loretta; Cabbia, Arianna; Canesso, Elisabetta; Cian, Romina; Dal Piccol, Claudia; Dalla Pasqua, Maria Manuela; Di Prisco, Anna; Mantellato, Lorena; Luison, Monica; Morgante, Sandra; Santi, Mirna; Sacillotto, Moreno; Scabbio, Mauro; Sponga, Patrizia; Sguotto, M Luisa; Stach, Flavia; Vettorato, M Grazia; Martinello, Giorgio; Dassiè, Francesca; Marino, Stefano; Cibiniel, Linda; Masetto, Ilenia; Marcato, Marisa; Cabianca, Oscar; Valente, Amalia; Caberlotto, Livio; Passoni, Alberto; Flumian, Patrizia; Daniel, Luigino; Gion, Massimo; Stanziale, Stanziale; Alborino, Flora; Bortolozzo, Vladimiro; Bacelle, Lucio; Bicciato, Leonarda; Basso, Daniela; Navaglia, Filippo; Manoni, Fabio; Ercolin, Mauro; Neri, Giovanni; Giubilini, Franco; Imbesi, Massimiliano; Leuci, Emanuela; Mazzi, Fausto; Semrov, Enrico; Giovanni, Castel S; Taro e Ceno, Valli; Ovest, Polo; Anelli, Silvio; Amore, Mario; Bigi, Laura; Britta, Welsch; Anna, Giovanna Barazzoni; Bonatti, Uobes; Borziani, Maria; Crosato, Isabella; Galluccio, Raffaele; Galeotti, Margherita; Gozzi, Mauro; Greco, Vanna; Guagnini, Emanuele; Pagani, Stefania; Maccherozzi, Malvasi; Marchi, Francesco; Melato, Ermanno; Mazzucchi, Elena; Marzullo, Franco; Pellegrini, Pietro; Petrolini, Nicoletta; Volta, Paolo; Anelli, Silvio; Bonara, Franca; Brusamonti, Elisabetta; Croci, Roberto; Flamia, Ivana; Fontana, Francesca; Losi, Romina; Mazzi, Fausto; Marchioro, Roberto; Pagani, Stefania; Raffaini, Luigi; Ruju, Luca; Saginario, Antonio; Tondelli, M Grazia; Marrama, Donatella; Bernardelli, Lucia; Bonacini, Federica; Florindo, Annaluisa; Merli, Marina; Nappo, Patrizia; Sola, Lorena; Tondelli, Ornella; Tonna, Matteo; Torre, M Teresa; Tosatti, Morena; Venturelli, Gloria; Zampolla, Daria; Bernardi, Antonia; Cavalli, Cinzia; Cigala, Lorena; Ciraudo, Cinzia; Di Bari, Antonia; Ferri, Lorena; Gombi, Fabiana; Leurini, Sonia; Mandatelli, Elena; Maccaferri, Stefano; Oroboncoide, Mara; Pisa, Barbara; Ricci, Cristina; Poggi, Enrica; Zurlini, Corrado; Malpeli, Monica; Colla, Rossana; Teodori, Elvira; Vecchia, Luigi; D'Andrea, Rocco; Trenti, Tommaso; Paolini, Paola; Mazzi, Fausto; Carpeggiani, Paolo; Pileggi, Francesca; Ghigi, Daniela; Gagliostro, Mariateresa; Pratelli, Michela; Rucci, Paola; Lazzaro, S; Antonelli, Antonio; Battistini, Luana; Bellini, Francesca; Bonini, Eva; Capelli, Caterina Bruschi Rossella; DiDomizio, Cinzia; Drei, Chiara; Fucci, Giuseppe; Gualandi, Alessandra; Grazia, Maria Rosaria; Losi, Anna M; Mazzoni, Federica Mazzanti Paola; Marangoni, Daniela; Monna, Giuseppe; Morselli, Marco; Oggioni, Alessandro; Oprandi, Silvio; Paganelli, Walter; Passerini, Morena; Piscitelli, Maria; Reggiani, Gregorio; Rossi, Gabriella; Salvatori, Federica; Trasforini, Simona; Uslenghi, Carlo; Veggetti, Simona; Bartolucci, Giovanna; Baruffa, Rosita; Bellini, Francesca; Bertelli, Raffaella; Borghi, Lidia; Ciavarella, Patrizia; DiDomizio, Cinzia; Monna, Giuseppe; Oggioni, Alessandro; Paltrinieri, Elisabetta; Rizzardi, Francesco; Serra, Piera; Suzzi, Damiano; Carlo, Uslenghi; Piscitelli, Maria; Arienti, Paolo; Aureli, Fabio; Avanzi, Rosita; Callegari, Vincenzo; Corsino, Alessandra; Host, Paolo; Michetti, Rossella; Pratelli, Michela; Rizzo, Francesco; Simoncelli, Paola; Soldati, Elena; Succi, Eraldo; Bertozzi, Massimo; Canetti, Elisa; Cavicchioli, Luca; Ceccarelli, Elisa; Cenni, Stefano; Marzola, Glenda; Gallina, Vanessa; Leoni, Carla; Olivieri, Andrea; Piccolo, Elena; Ravagli, Sabrina; Russo, Rosaria; Tedeschini, Daniele; Verenini, Marina; Abram, Walter; Granata, Veronica; Curcio, Alessandro; Guerra, Giovanni; Granini, Samuela; Natali, Lara; Montanari, Enrica; Pasi, Fulvia; Ventura, Umbertina; Valenti, Stefania; Francesca, Masi; Farneti, Rossano; Ravagli, Paolo; Floris, Romina; Maroncelli, Otello; Volpones, Gianbattista; Casali, Donatella; Miceli, Maurizio; Bencini, Andrea; Cellini, Massimo; De Biase, Luca; Barbara, Leonardo; Charles, Liedl; Pratesi, Cristina; Tanini, Andrea; Cellini, Massimo; Miceli, Maurizio; Loparrino, Riccardo; Pratesi, Cristina; Ulivelli, Cinzia; Cussoto, Cristina; Dei, Nico; Fumanti, Enrico; Pantani, Manuela; Zeloni, Gregorio; Bellini, Rossella; Cellesi, Roberta; Dorigo, Nadia; Gullì, Patrizia; Ialeggio, Luisa; Pisanu, Maria; Rinaldi, Graziella; Konze, Angela; Cocchi, Angelo; Meneghelli, Anna; Bianco, Mario; Modignani, Litta; Frova, Maria; Monzani, Emiliano; Zanobio, Alberto; Malagoli, Marina; Pagani, Roberto; Barbera, Simona; Morganti, Carla; Monzani, Emiliano; Amadè, Elisabetta Sarzi; Brambilla, Virginia; Montanari, Anita; Caterina, Giori; Lopez, Carmelo; Marocchi, Alessandro; Moletta, Andrea; Sberna, Maurizio; Cascio, M Teresa; Scarone, Silvio; Manzone, Maria Laura; Barbara, Barbera; Mari, Luisa; Manzone, Maria L; Razzini, Edoardo; Bianchi, Yvonne; Pellizzer, M Rosa; Verdecchia, Antonella; Sferrazza, M Gabriella; Manzone, M Laura; Pismataro, Rosa; D'Eril, Gian Vico Melzi; Barassi, Alessandra; Pacciolla, Rosana; Faraci, Gloria; Torresani, Stefano; Rosmini, Bolzano; Carpi, Fabio; Soelva, Margit; Anderlan, Monica; De Francesco, Michele; Duregger, Efi; Torresani, Stefano; Vettori, Carla; Doimo, Sabrina; Kompatscher, Erika; Soelva, Margit; Torresani, Stefano; Forer, Michael; Kerschbaumer, Helene; Gampe, Anna; Nicoletti, Maira; Acerbi, Chiara; Aquilino, Daniele; Azzali, Silvia; Bensi, Luca; Bissoli, Sarah; Cappellari, Davide; Casana, Elisa; Campagnola, Nadia; Dal Corso, Elisa; Di Micco, Elisabetta; Gobbi, Erika; Ferri, Laura; Gobbi, Erika; Mairaghi, Laura; Malak, Sara; Mesiano, Luca; Paterlini, Federica; Perini, Michela; Puliti, Elena Maria; Rispoli, Rosaria; Rizzo, Elisabetta; Sergenti, Chiara; Soave, Manuela; Alpi, Andrea; Bislenghi, Laura; Bolis, Tiziana; Colnaghi, Francesca; Fascendini, Simona; Grignani, Silvia; Meneghelli, Anna; Patelli, Giovanni; Faravelli, Carlo; Casale, Silvia; Zimmermann, Christa; Deledda, Giuseppe; Goss, Claudia; Mazzi, Mariangela; Rimondini, Michela; Gennarelli, Massimo; Scassellati, Catia; Bonvicini, Cristian; Longo, Sara; Bocchio Chiavetto, Luisella; Zanardini, Roberta; Ventriglia, Mariacarla; Squitti, Rosanna; Frisoni, Giovanni; Pievani, Michela; Balestrieri, Matteo; Brambilla, Paolo; Perlini, Cinzia; Marinelli, Veronica; Bellani, Marcella; Rambaldelli, Gianluca; Bertoldo, Alessandra; Atzori, Manfredo; Mazzi, Fausto; Carpeggiani, Paolo; Beltramello, Alberto; Alessandrini, Franco; Pizzini, Francesca; Zoccatelli, Giada; Sberna, Maurizio; Konze, Angela; Politi, Pierluigi; Emanuele, Enzo; Brondino, Natascia; Martino, Gianvito; Bergami, Alessandra; Zarbo, Roberto; Riva, Marco Andrea; Fumagalli, Fabio; Molteni, Raffaella; Calabrese, Francesca; Guidotti, Gianluigi; Luoni, Alessia; Macchi, Flavia; Artioli, Stefania; Baldetti, Marco; Bizzocchi, Milena; Bolzon, Donatella; Bonello, Elisa; Cacciari, Giorgia; Carraresi, Claudia; Cascio, M Teresa; Caselli, Gabriele; Furlato, Karin; Garlassi, Sara; Gavarini, Alessandro; Lunardi, Silvia; Macchetti, Fabio; Marteddu, Valentina; Plebiscita, Giorgia; Poli, Sara; Totaro, Stefano; Bebbington, Paul; Birchwood, Max; Dazzan, Paola; Kuipers, Elisabeth; Thornicroft, Graham; Pariante, Carmine; Lawrie, Steve; Pariante, Carmine; Soares, Jair C

    2012-05-30

    Multi-element interventions for first-episode psychosis (FEP) are promising, but have mostly been conducted in non-epidemiologically representative samples, thereby raising the risk of underestimating the complexities involved in treating FEP in 'real-world' services. The Psychosis early Intervention and Assessment of Needs and Outcome (PIANO) trial is part of a larger research program (Genetics, Endophenotypes and Treatment: Understanding early Psychosis - GET UP) which aims to compare, at 9 months, the effectiveness of a multi-component psychosocial intervention versus treatment as usual (TAU) in a large epidemiologically based cohort of patients with FEP and their family members recruited from all public community mental health centers (CMHCs) located in two entire regions of Italy (Veneto and Emilia Romagna), and in the cities of Florence, Milan and Bolzano. The GET UP PIANO trial has a pragmatic cluster randomized controlled design. The randomized units (clusters) are the CMHCs, and the units of observation are the centers' patients and their family members. Patients in the experimental group will receive TAU plus: 1) cognitive behavioral therapy sessions, 2) psycho-educational sessions for family members, and 3) case management. Patient enrollment will take place over a 1-year period. Several psychopathological, psychological, functioning, and service use variables will be assessed at baseline and follow-up. The primary outcomes are: 1) change from baseline to follow-up in positive and negative symptoms' severity and subjective appraisal; 2) relapse occurrences between baseline and follow-up, that is, episodes resulting in admission and/or any case-note records of re-emergence of positive psychotic symptoms. The expected number of recruited patients is about 400, and that of relatives about 300. Owing to the implementation of the intervention at the CMHC level, the blinding of patients, clinicians, and raters is not possible, but every effort will be made

  5. Effects of Individual Physician-Level and Practice-Level Financial Incentives on Hypertension Care: A Cluster Randomized Trial

    Science.gov (United States)

    Petersen, Laura A.; Simpson, Kate; Pietz, Kenneth; Urech, Tracy H.; Hysong, Sylvia J.; Profit, Jochen; Conrad, Douglas A.; Dudley, R. Adams; Woodard, LeChauncy D.

    2014-01-01

    Importance Pay for performance is intended to align incentives to promote high quality care, but results have been contradictory. Objective To test the effect of explicit financial incentives to reward guideline-recommended hypertension care. Design, Setting, and Participants Cluster randomized controlled trial of 12 Veterans Affairs hospital-based outpatient clinics with five performance periods and a 12-month washout. We enrolled 83 primary care physicians and 42 non-physician personnel (e.g., nurses, pharmacists) working with physicians to deliver hypertension care. Interventions Clinics randomized to one of four groups: physician-level (individual) incentives; practice-level incentives; individual- plus practice-level incentives (combined); or none. Intervention participants received up to five payments every four months; all participants could access feedback reports. Main outcome measures For each four-month period, the number of hypertensive patients among a random sample who achieved guideline-recommended blood pressure thresholds or received an appropriate response to uncontrolled blood pressure; and/or been prescribed guideline-recommended medications and the number who developed hypotension. Results Mean (standard deviation) total payments over the study were $4,270 ($459), $2,672 ($153), and $1,648 ($248) for the combined, individual, and practice-level interventions, respectively. The adjusted change over the study in patients meeting the combined blood pressure/appropriate response measure was 8.84 percentage points (95% confidence interval [CI], 4.20–11.80) for the individual-level, 3.70 (95% CI, 0.24–7.68) for the practice-level, 5.54 (95% CI, 1.92–9.52) for the combined, and 0.47 (95% CI, −3.12–4.04) for the control groups. For medications, the change was 9.07 (95% CI, 4.52–13.44), 4.98 (95% CI, 0.64–10.08), 7.26 (95% CI, 2.92–12.48), and 4.35 (95% CI, −0.28–9.28) percentage points, respectively. The adjusted estimated

  6. Effect of a brief outreach educational intervention on the translation of acute poisoning treatment guidelines to practice in rural Sri Lankan hospitals: a cluster randomized controlled trial.

    Science.gov (United States)

    Senarathna, Lalith; Buckley, Nick A; Dibley, Michael J; Kelly, Patrick J; Jayamanna, Shaluka F; Gawarammana, Indika B; Dawson, Andrew H

    2013-01-01

    In developing countries, including Sri Lanka, a high proportion of acute poisoning and other medical emergencies are initially treated in rural peripheral hospitals. Patients are then usually transferred to referral hospitals for further treatment. Guidelines are often used to promote better patient care in these emergencies. We conducted a cluster randomized controlled trial (ISRCTN73983810) which aimed to assess the effect of a brief educational outreach ('academic detailing') intervention to promote the utilization of treatment guidelines for acute poisoning. This cluster RCT was conducted in the North Central Province of Sri Lanka. All peripheral hospitals in the province were randomized to either intervention or control. All hospitals received a copy of the guidelines. The intervention hospitals received a brief out-reach academic detailing workshop which explained poisoning treatment guidelines and guideline promotional items designed to be used in daily care. Data were collected on all patients admitted due to poisoning for 12 months post-intervention in all study hospitals. Information collected included type of poison exposure, initial investigations, treatments and hospital outcome. Patients transferred from peripheral hospitals to referral hospitals had their clinical outcomes recorded. There were 23 intervention and 23 control hospitals. There were no significant differences in the patient characteristics, such as age, gender and the poisons ingested. The intervention hospitals showed a significant improvement in administration of activated charcoal [OR 2.95 (95% CI 1.28-6.80)]. There was no difference between hospitals in use of other decontamination methods. This study shows that an educational intervention consisting of brief out-reach academic detailing was effective in changing treatment behavior in rural Sri Lankan hospitals. The intervention was only effective for treatments with direct clinician involvement, such as administering activated

  7. The effects of a brief intervention to promote walking on Theory of Planned Behavior constructs: a cluster randomized controlled trial in general practice.

    Science.gov (United States)

    Williams, Stefanie L; Michie, Susan; Dale, Jeremy; Stallard, Nigel; French, David P

    2015-05-01

    Perceived behavioral control (PBC) is a consistent predictor of intentions to walk more. A previously successful intervention to promote walking by altering PBC has been adapted for delivery in general practice. This study aimed to evaluate the effect of this intervention on Theory of Planned Behavior (TPB) constructs in this context. Cluster randomized controlled trial, with n = 315 general practice patients. Practice nurses and Healthcare Assistants delivered a self-regulation intervention or information provision (control). Questionnaires assessed TPB variables at baseline, post-intervention, 6 weeks and 6 months. Walking was measured by pedometer. The control group reported significantly higher subjective norm at all follow-up time points. There were no significant differences between the two groups in PBC, intention, attitude or walking behavior. TPB variables significantly predicted intentions to walk more, but not objective walking behavior, after accounting for clustering. The lack of effect of the intervention was probably due to a failure to maintain intervention fidelity, and the unsuitability of the behavior change techniques included in the intervention for the population investigated. This previously successful intervention was not successful when delivered in this context, calling into question whether practice nurses are best placed to deliver such interventions. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  8. Long term effectiveness on prescribing of two multifaceted educational interventions: results of two large scale randomized cluster trials.

    Directory of Open Access Journals (Sweden)

    Nicola Magrini

    Full Text Available INTRODUCTION: Information on benefits and risks of drugs is a key element affecting doctors' prescribing decisions. Outreach visits promoting independent information have proved moderately effective in changing prescribing behaviours. OBJECTIVES: Testing the short and long-term effectiveness on general practitioners' prescribing of small groups meetings led by pharmacists. METHODS: Two cluster open randomised controlled trials (RCTs were carried out in a large scale NHS setting. Ad hoc prepared evidence based material were used considering a therapeutic area approach--TEA, with information materials on osteoporosis or prostatic hyperplasia--and a single drug oriented approach--SIDRO, with information materials on me-too drugs of 2 different classes: barnidipine or prulifloxacin. In each study, all 115 Primary Care Groups in a Northern Italy area (2.2 million inhabitants, 1737 general practitioners were randomised to educational small groups meetings, in which available evidence was provided together with drug utilization data and clinical scenarios. Main outcomes were changes in the six-months prescription of targeted drugs. Longer term results (24 and 48 months were also evaluated. RESULTS: In the TEA trial, one of the four primary outcomes showed a reduction (prescription of alfuzosin compared to tamsulosin and terazosin in benign prostatic hyperplasia: prescribing ratio -8.5%, p = 0.03. Another primary outcome (prescription of risedronate showed a reduction at 24 and 48 months (-7.6%, p = 0.02; and -9,8%, p = 0.03, but not at six months (-5.1%, p = 0.36. In the SIDRO trial both primary outcomes showed a statistically significant reduction (prescription of barnidipine -9.8%, p = 0.02; prescription of prulifloxacin -11.1%, p = 0.04, which persisted or increased over time. INTERPRETATION: These two cluster RCTs showed the large scale feasibility of a complex educational program in a NHS setting, and its potentially

  9. A Cluster-Randomized Controlled Trial to Reduce Diarrheal Disease and Dengue Entomological Risk Factors in Rural Primary Schools in Colombia

    Science.gov (United States)

    Overgaard, Hans J.; Alexander, Neal; Matiz, Maria Ines; Jaramillo, Juan Felipe; Olano, Victor Alberto; Vargas, Sandra; Sarmiento, Diana; Lenhart, Audrey; Stenström, Thor Axel

    2016-01-01

    Background As many neglected tropical diseases are co-endemic and have common risk factors, integrated control can efficiently reduce disease burden and relieve resource-strained public health budgets. Diarrheal diseases and dengue fever are major global health problems sharing common risk factors in water storage containers. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Integrating improved water management and educational strategies for both diseases in the school environment can potentially improve the health situation for students and the larger community. The objective of this trial was to investigate whether interventions targeting diarrhea and dengue risk factors would significantly reduce absence due to diarrheal disease and dengue entomological risk factors in schools. Methodology/Principal Findings A factorial cluster randomized controlled trial was carried out in 34 rural primary schools (1,301 pupils) in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Schools were randomized to one of four study arms: diarrhea interventions (DIA), dengue interventions (DEN), combined diarrhea and dengue interventions (DIADEN), and control (CON). Interventions had no apparent effect on pupil school absence due to diarrheal disease (p = 0.45) or on adult female Aedes aegypti density (p = 0.32) (primary outcomes). However, the dengue interventions reduced the Breteau Index on average by 78% (p = 0.029), with Breteau indices of 10.8 and 6.2 in the DEN and DIADEN arms, respectively compared to 37.5 and 46.9 in the DIA and CON arms, respectively. The diarrhea interventions improved water quality as assessed by the amount of Escherichia coli colony forming units (CFU); the ratio of Williams mean E. coli CFU being 0.22, or 78% reduction (p = 0.008). Conclusions/Significance Integrated

  10. Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial.

    Science.gov (United States)

    Emond, Yvette E J J M; Calsbeek, Hiske; Teerenstra, Steven; Bloo, Gerrit J A; Westert, Gert P; Damen, Johan; Wolff, André P; Wollersheim, Hub C

    2015-01-08

    This study is initiated to evaluate the effects, costs, and feasibility at the hospital and patient level of an evidence-based strategy to improve the use of Dutch perioperative safety guidelines. Based on current knowledge, expert opinions and expertise of the project team, a multifaceted implementation strategy has been developed. This is a stepped wedge cluster randomized trial including nine representative hospitals across The Netherlands. Hospitals are stratified into three groups according to hospital type and geographical location and randomized in terms of the period for receipt of the intervention. All adult surgical patients meeting the inclusion criteria are assessed for patient outcomes. The implementation strategy includes education, audit and feedback, organizational interventions (e.g., local embedding of the guidelines), team-directed interventions (e.g., multi-professional team training), reminders, as well as patient-mediated interventions (e.g., patient safety cards). To tailor the implementation activities, we developed a questionnaire to identify barriers for effective guideline adherence, based on (a) a theoretical framework for classifying barriers and facilitators, (b) an instrument for measuring determinants of innovations, and (c) 19 semi-structured interviews with perioperative key professionals. Primary outcome is guideline adherence measured at the hospital (i.e., cluster) and patient levels by a set of perioperative Patient Safety Indicators (PSIs), which was developed parallel to the perioperative guidelines. Secondary outcomes at the patient level are in-hospital complications, postoperative wound infections and mortality, length of hospital stay, and unscheduled transfer to the intensive care unit, non-elective readmission to the hospital and unplanned reoperation, all within 30 days after the initial surgery. Also, patient safety culture and team climate will be studied as potential determinants. Finally, a process evaluation is

  11. Improvement of pain-related self-management for cancer patients through a modular transitional nursing intervention: a cluster-randomized multicenter trial.

    Science.gov (United States)

    Jahn, Patrick; Kuss, Oliver; Schmidt, Heike; Bauer, Alexander; Kitzmantel, Maria; Jordan, Karin; Krasemann, Susann; Landenberger, Margarete

    2014-04-01

    Patients' self-management skills are affected by their knowledge, activities, and attitudes toward pain management. This trial aimed to test the Self Care Improvement through Oncology Nursing (SCION)-PAIN program, a multimodular structured intervention to reduce patients' barriers to self-management of cancer pain. Two hundred sixty-three patients with diagnosed malignancy, pain>3 days, and average pain > or = 3/10 participated in a cluster-randomized trial on 18 wards in 2 German university hospitals. Patients on the intervention wards received, in addition to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic, nonpharmacologic pain management, and discharge management. The intervention was conducted by specially trained cancer nurses and included components of patient education, skills training, and counseling. Starting with admission, patients received booster sessions every third day and one follow-up telephone counseling session within 2 to 3 days after discharge. Patients in the control group received standard care. Primary end point was the group difference in patient-related barriers to self-management of cancer pain (Barriers Questionnaire-BQ II) 7 days after discharge. The SCION-PAIN program resulted in a significant reduction of patient-related barriers to pain management 1 week after discharge from the hospital: mean difference on BQ II was -0.49 points (95% confidence interval -0.87 points to -0.12 points; P=0.02). Furthermore, patients showed improved adherence to pain medication; odds ratio 8.58 (95% confidence interval 1.66-44.40; P=0.02). A post hoc analysis indicated reduced average and worst pain intensity as well as improved quality of life. This trial reveals the positive impact of a nursing intervention to improve patients' self-management of cancer pain. Copyright © 2014 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

  12. Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via Uniject™ by peripheral health care providers at home births: design of a community-based cluster-randomized trial.

    Science.gov (United States)

    Stanton, Cynthia K; Newton, Samuel; Mullany, Luke C; Cofie, Patience; Agyemang, Charlotte Tawiah; Adiibokah, Edward; Darcy, Niamh; Khan, Sadaf; Levisay, Alice; Gyapong, John; Armbruster, Deborah; Owusu-Agyei, Seth

    2012-06-07

    Hemorrhage is the leading direct cause of maternal death globally. While oxytocin is the drug of choice for postpartum hemorrhage prevention, its use has generally been limited to health facilities. This trial assesses the effectiveness, safety, and feasibility of expanding the use of prophylactic intramuscular oxytocin to peripheral health care providers at home births in four predominantly rural districts in central Ghana. This study is designed as a community-based cluster-randomized trial in which Community Health Officers are randomized to provide (or not provide) an injection of oxytocin 10 IU via the Uniject™ injection system within one minute of delivery of the baby to women who request their presence at home at the onset of labor. The primary aim is to determine if administration of prophylactic oxytocin via Uniject™ by this cadre will reduce the risk of postpartum hemorrhage by 50 % relative to deliveries which do not receive the prophylactic intervention. Postpartum hemorrhage is examined under three sequential definitions: 1) blood loss ≥500 ml (BL); 2) treatment for bleeding (TX) and/or BL; 3) hospital referral for bleeding and/or TX and/or BL. Secondary outcomes address safety and feasibility of the intervention and include adverse maternal and fetal outcomes and logistical concerns regarding assistance at home births and the storage and handling of oxytocin, respectively. Results from this trial will build evidence for the effectiveness of expanding the delivery of this established prophylactic intervention to peripheral settings. Complementary data on safety and logistical issues related to this intervention will assist policymakers in low-income countries in selecting both the best uterotonic and service delivery strategy for postpartum hemorrhage prevention. Results of this trial are expected in mid-2013. The trial is registered at ClinicalTrials.gov: NCT01108289.

  13. Random clustering ferns for multimodal object recognition

    OpenAIRE

    Villamizar Vergel, Michael Alejandro; Garrell Zulueta, Anais; Sanfeliu Cortés, Alberto; Moreno-Noguer, Francesc

    2017-01-01

    The final publication is available at link.springer.com We propose an efficient and robust method for the recognition of objects exhibiting multiple intra-class modes, where each one is associated with a particular object appearance. The proposed method, called random clustering ferns, combines synergically a single and real-time classifier, based on the boosted assembling of extremely randomized trees (ferns), with an unsupervised and probabilistic approach in order to recognize efficient...

  14. School-Based Nutrition Education Intervention Using Social Cognitive Theory for Overweight and Obese Iranian Adolescent Girls: A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Bagherniya, Mohammad; Sharma, Manoj; Mostafavi Darani, Firoozeh; Maracy, Mohammad Reza; Safarian, Mohammad; Allipour Birgani, Ramesh; Bitarafan, Vida; Keshavarz, Seyed Ali

    2017-10-01

    Background Nowadays childhood obesity has become one the most challenging issue which is considered as a principle public health problem all around the world. This study was conducted with the aim of evaluating the impact of a 7-month school-based nutrition education intervention using social cognitive theory (SCT) to prevent obesity among overweight and obese adolescent girls. Method In this cluster randomized community trial after choosing schools, a total of 172 overweight and obese girl students participated in the study (87 in the intervention and 85 in the control group). A 7-month intervention based on SCT for students, their parents, and teachers was conducted. At baseline and end of the study, body mass index (BMI), waist circumstances (WCs), dietary intake, and psychological questionnaires regarding the SCT constructs were obtained. Results After 7 months, the mean of BMI and WCs reduced in the intervention group from 29.47 (4.05) to 28.5 (4.35) and from 89.65 (8.15) to 86.54 (9.76), respectively, but in comparison to the control group, they were not statistically significant ( p values .127 and .504, respectively). In the intervention group, nutritional behaviors and most of the psychological variables (self-efficacy, social support, intention, and situation) were improved in favor of the study and they were significant in comparison to the control group ( p < .05). Conclusion Although school-based nutrition education intervention using SCT did not change significantly BMI and WCs among the targeted population in this study, dietary habits as well as psychological factors improved significantly in the intervention group. This trial was registered in Iranian Registry of Clinical Trials, www.irct.ir (IRCT2013103115211N1).

  15. Evaluation of stability of k-means cluster ensembles with respect to random initialization.

    Science.gov (United States)

    Kuncheva, Ludmila I; Vetrov, Dmitry P

    2006-11-01

    Many clustering algorithms, including cluster ensembles, rely on a random component. Stability of the results across different runs is considered to be an asset of the algorithm. The cluster ensembles considered here are based on k-means clusterers. Each clusterer is assigned a random target number of clusters, k and is started from a random initialization. Here, we use 10 artificial and 10 real data sets to study ensemble stability with respect to random k, and random initialization. The data sets were chosen to have a small number of clusters (two to seven) and a moderate number of data points (up to a few hundred). Pairwise stability is defined as the adjusted Rand index between pairs of clusterers in the ensemble, averaged across all pairs. Nonpairwise stability is defined as the entropy of the consensus matrix of the ensemble. An experimental comparison with the stability of the standard k-means algorithm was carried out for k from 2 to 20. The results revealed that ensembles are generally more stable, markedly so for larger k. To establish whether stability can serve as a cluster validity index, we first looked at the relationship between stability and accuracy with respect to the number of clusters, k. We found that such a relationship strongly depends on the data set, varying from almost perfect positive correlation (0.97, for the glass data) to almost perfect negative correlation (-0.93, for the crabs data). We propose a new combined stability index to be the sum of the pairwise individual and ensemble stabilities. This index was found to correlate better with the ensemble accuracy. Following the hypothesis that a point of stability of a clustering algorithm corresponds to a structure found in the data, we used the stability measures to pick the number of clusters. The combined stability index gave best results.

  16. Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes.

    Science.gov (United States)

    Islam, Nadia; Gepts, Thomas; Lief, Isaac; Gore, Radhika; Levy, Natalie; Tanner, Michael; Fang, Yixin; Sherman, Scott E; Schwartz, Mark D

    2018-04-19

    Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Community health workers (CHWs) may, as frontline public health workers bridging clinic and community, help overcome these challenges. This paper presents the protocol for a pragmatic, cluster-randomized trial integrating CHWs into two primary care clinics to support DM prevention for at-risk patients. The trial will randomize 15 care teams, stratified by practice site (Bellevue Hospital and Manhattan VA), totaling 56 primary care physicians. The study cohort will consist of ~ 2000 patients who are 18-75 years of age, actively enrolled in a primary care team, able to speak English or Spanish, and have at least one glycosylated hemoglobin (HbA1c) result in the prediabetic range (5.7-6.4%) since 2012. Those with a current DM diagnosis or DM medication prescription (other than metformin) are ineligible. The intervention consists of four core activities - setting health goals, health education, activation for doctor's appointments, and referrals to DM prevention programs - adjustable according to the patient's needs and readiness. The primary outcome is DM incidence. Secondary outcomes include weight loss, HbA1C, and self-reported health behaviors. Clinical variables and health behaviors will be obtained through electronic medical records and surveys, respectively. Implementation outcomes, namely implementation fidelity and physicians' perspectives about CHW integration into the clinic, will be assessed using interviews and CHW activity logs and analyzed for the influence of moderating organizational factors. This is the first rigorous, pragmatic trial to test the effectiveness of integrating CHWs into primary care for DM prevention reaching a population-based sample. Our study's limitations include language

  17. Long term effect of depression care management on mortality in older adults: follow-up of cluster randomized clinical trial in primary care

    OpenAIRE

    Gallo, Joseph J; Morales, Knashawn H; Bogner, Hillary R; Raue, Patrick J; Zee, Jarcy; Bruce, Martha L; Reynolds, Charles F

    2013-01-01

    Objective To investigate whether an intervention to improve treatment of depression in older adults in primary care modified the increased risk of death associated with depression. Design Long term follow-up of multi-site practice randomized controlled trial (PROSPECT?Prevention of Suicide in Primary Care Elderly: Collaborative Trial). Setting 20 primary care practices in New York City, Philadelphia, and Pittsburgh, USA, randomized to intervention or usual care. Participants 1226 participants...

  18. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion—Learning, Cognition and Motion – A Cluster Randomized Controlled Trial

    Science.gov (United States)

    Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H.; Andersen, Lars Bo; Bugge, Anna

    2016-01-01

    Background Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12–14 years old adolescents. Methods A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. Results No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p’s>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4–38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39–0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0–9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p’s>0.05). Conclusions No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing

  19. Academic and Behavioral Design Parameters for Cluster Randomized Trials in Kindergarten: An Analysis of the Early Childhood Longitudinal Study 2011 Kindergarten Cohort (ECLS-K 2011).

    Science.gov (United States)

    Hedberg, E C

    2016-06-28

    There is an increased focus on randomized trials for proximal behavioral outcomes in early childhood research. However, planning sample sizes for such designs requires extant information on the size of effect, variance decomposition, and effectiveness of covariates. The purpose of this article is to employ a recent large representative sample of early childhood longitudinal study kindergartners to estimate design parameters for use in planning cluster randomized trials. A secondary objective is to compare the results of math and reading with the previous kindergartner cohort of 1999. For each measure, fall-spring gains in effect size units are calculated. In addition, multilevel models are fit to estimate variance components that are used to calculate intraclass correlations (ICCs) and R 2 statistics. The implications of the reported parameters are summarized in tables of required school sample sizes to detect small effects. The outcomes include information about student scores regarding learning behaviors, general behaviors, and academic abilities. Aside from math and reading, there were small gains in these measures from fall to spring, leading to effect sizes between about .1 and .2. In addition, the nonacademic ICCs are smaller than the academic ICCs but are still nontrivial. Use of a pretest covariate is generally effective in reducing the required sample size in power analyses. The ICCs for math and reading are smaller for the current sample compared with the 1999 sample. © The Author(s) 2016.

  20. The Aged Residential Care Healthcare Utilization Study (ARCHUS): a multidisciplinary, cluster randomized controlled trial designed to reduce acute avoidable hospitalizations from long-term care facilities.

    Science.gov (United States)

    Connolly, Martin J; Boyd, Michal; Broad, Joanna B; Kerse, Ngaire; Lumley, Thomas; Whitehead, Noeline; Foster, Susan

    2015-01-01

    To assess effect of a complex, multidisciplinary intervention aimed at reducing avoidable acute hospitalization of residents of residential aged care (RAC) facilities. Cluster randomized controlled trial. RAC facilities with higher than expected hospitalizations in Auckland, New Zealand, were recruited and randomized to intervention or control. A total of 1998 residents of 18 intervention facilities and 18 control facilities. A facility-based complex intervention of 9 months' duration. The intervention comprised gerontology nurse specialist (GNS)-led staff education, facility bench-marking, GNS resident review, and multidisciplinary (geriatrician, primary-care physician, pharmacist, GNS, and facility nurse) discussion of residents selected using standard criteria. Primary end point was avoidable hospitalizations. Secondary end points were all acute admissions, mortality, and acute bed-days. Follow-up was for a total of 14 months. The intervention did not affect main study end points: number of acute avoidable hospital admissions (RR 1.07; 95% CI 0.85-1.36; P = .59) or mortality (RR 1.11; 95% CI 0.76-1.61; P = .62). This multidisciplinary intervention, packaging selected case review, and staff education had no overall impact on acute hospital admissions or mortality. This may have considerable implications for resourcing in the acute and RAC sectors in the face of population aging. Australian and New Zealand Clinical Trials Registry (ACTRN12611000187943). Copyright © 2015 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  1. Effect of a computer-guided, quality improvement program for cardiovascular disease risk management in primary health care: the treatment of cardiovascular risk using electronic decision support cluster-randomized trial.

    Science.gov (United States)

    Peiris, David; Usherwood, Tim; Panaretto, Kathryn; Harris, Mark; Hunt, Jennifer; Redfern, Julie; Zwar, Nicholas; Colagiuri, Stephen; Hayman, Noel; Lo, Serigne; Patel, Bindu; Lyford, Marilyn; MacMahon, Stephen; Neal, Bruce; Sullivan, David; Cass, Alan; Jackson, Rod; Patel, Anushka

    2015-01-01

    Despite effective treatments to reduce cardiovascular disease risk, their translation into practice is limited. Using a parallel arm cluster-randomized controlled trial in 60 Australian primary healthcare centers, we tested whether a multifaceted quality improvement intervention comprising computerized decision support, audit/feedback tools, and staff training improved (1) guideline-indicated risk factor measurements and (2) guideline-indicated medications for those at high cardiovascular disease risk. Centers had to use a compatible software system, and eligible patients were regular attendees (Aboriginal and Torres Strait Islander people aged ≥ 35 years and others aged ≥ 45 years). Patient-level analyses were conducted using generalized estimating equations to account for clustering. Median follow-up for 38,725 patients (mean age, 61.0 years; 42% men) was 17.5 months. Mean monthly staff support was improved overall risk factor measurements (62.8% versus 53.4% risk ratio; 1.25; 95% confidence interval, 1.04-1.50; P=0.02), but there was no significant differences in recommended prescriptions for the high-risk cohort (n=10,308; 56.8% versus 51.2%; P=0.12). There were significant treatment escalations (new prescriptions or increased numbers of medicines) for antiplatelet (17.9% versus 2.7%; Pquality improvement intervention, requiring minimal support, improved cardiovascular disease risk measurement but did not increase prescription rates in the high-risk group. Computerized quality improvement tools offer an important, albeit partial, solution to improving primary healthcare system capacity for cardiovascular disease risk management. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=336630. Australian New Zealand Clinical Trials Registry No. 12611000478910. © 2015 American Heart Association, Inc.

  2. HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Michael M Chanda

    2017-11-01

    Full Text Available HIV self-testing (HIVST may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs in Zambia.Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1 delivery (direct distribution of an oral HIVST from the peer educator, (2 coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy, or (3 standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320; 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005. Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40. At 1 month, the majority of HIV tests were self-tests (88.4%. HIV self

  3. HIV self-testing among female sex workers in Zambia: A cluster randomized controlled trial.

    Science.gov (United States)

    Chanda, Michael M; Ortblad, Katrina F; Mwale, Magdalene; Chongo, Steven; Kanchele, Catherine; Kamungoma, Nyambe; Fullem, Andrew; Dunn, Caitlin; Barresi, Leah G; Harling, Guy; Bärnighausen, Till; Oldenburg, Catherine E

    2017-11-01

    HIV self-testing (HIVST) may play a role in addressing gaps in HIV testing coverage and as an entry point for HIV prevention services. We conducted a cluster randomized trial of 2 HIVST distribution mechanisms compared to the standard of care among female sex workers (FSWs) in Zambia. Trained peer educators in Kapiri Mposhi, Chirundu, and Livingstone, Zambia, each recruited 6 FSW participants. Peer educator-FSW groups were randomized to 1 of 3 arms: (1) delivery (direct distribution of an oral HIVST from the peer educator), (2) coupon (a coupon for collection of an oral HIVST from a health clinic/pharmacy), or (3) standard-of-care HIV testing. Participants in the 2 HIVST arms received 2 kits: 1 at baseline and 1 at 10 weeks. The primary outcome was any self-reported HIV testing in the past month at the 1- and 4-month visits, as HIVST can replace other types of HIV testing. Secondary outcomes included linkage to care, HIVST use in the HIVST arms, and adverse events. Participants completed questionnaires at 1 and 4 months following peer educator interventions. In all, 965 participants were enrolled between September 16 and October 12, 2016 (delivery, N = 316; coupon, N = 329; standard of care, N = 320); 20% had never tested for HIV. Overall HIV testing at 1 month was 94.9% in the delivery arm, 84.4% in the coupon arm, and 88.5% in the standard-of-care arm (delivery versus standard of care risk ratio [RR] = 1.07, 95% CI 0.99-1.15, P = 0.10; coupon versus standard of care RR = 0.95, 95% CI 0.86-1.05, P = 0.29; delivery versus coupon RR = 1.13, 95% CI 1.04-1.22, P = 0.005). Four-month rates were 84.1% for the delivery arm, 79.8% for the coupon arm, and 75.1% for the standard-of-care arm (delivery versus standard of care RR = 1.11, 95% CI 0.98-1.27, P = 0.11; coupon versus standard of care RR = 1.06, 95% CI 0.92-1.22, P = 0.42; delivery versus coupon RR = 1.05, 95% CI 0.94-1.18, P = 0.40). At 1 month, the majority of HIV tests were self-tests (88.4%). HIV self-test use

  4. Maximizing scientific knowledge from randomized clinical trials

    DEFF Research Database (Denmark)

    Gustafsson, Finn; Atar, Dan; Pitt, Bertram

    2010-01-01

    Trialists have an ethical and financial responsibility to plan and conduct clinical trials in a manner that will maximize the scientific knowledge gained from the trial. However, the amount of scientific information generated by randomized clinical trials in cardiovascular medicine is highly vari...

  5. Costs and effects of a state-wide health promotion program in primary schools in Germany – the Baden-Württemberg Study: A cluster-randomized, controlled trial

    Science.gov (United States)

    Kesztyüs, Tibor; Kilian, Reinhold; Steinacker, Jürgen M

    2017-01-01

    Aim To evaluate the cost-effectiveness of the state-wide implementation of the health promotion program “Join the Healthy Boat” in primary schools in Germany. Methods Cluster-randomized intervention trial with wait-list control group. Anthropometric data of 1733 participating children (7.1 ± 0.6 years) were taken by trained staff before and after a one year intervention period in the academic year 2010/11. Parents provided information about the health status, and the health behaviour of their children and themselves, parental anthropometrics, and socio-economic background variables. Incidence of abdominal obesity, defined as waist-to-height ratio (WHtR) ≥ 0.5, was determined. Generalized linear models were applied to account for the clustering of data within schools, and to adjust for baseline-values. Losses to follow-up and missing data were analysed. From a societal perspective, the overall costs, costs per pupil, and incremental cost-effectiveness ratio (ICER) to identify the costs per case of averted abdominal obesity were calculated. Results The final regression model for the incidence of abdominal obesity shows lower odds for the intervention group after an adjustment for grade, gender, baseline WHtR, and breakfast habits (odds ratio = 0.48, 95% CI [0.25; 0.94]). The intervention costs per child/year were €25.04. The costs per incidental case of averted abdominal obesity varied between €1515 and €1993, depending on the different dimensions of the target group. Conclusion This study demonstrates the positive effects of state-wide, school-based health promotion on incidental abdominal obesity, at affordable costs and with proven cost-effectiveness. These results should support allocative decisions of policymakers. An early start to the prevention of abdominal obesity is of particular importance because of its close relationship to non-communicable diseases. Trial registration German Clinical Trials Register (DRKS), Freiburg University, Germany

  6. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion-Learning, Cognition and Motion - A Cluster Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Jakob Tarp

    Full Text Available Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12-14 years old adolescents.A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD age: 12.9 (0.6 years completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects. The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness.No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p's>0.05 or mathematics skills (p>0.05. An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4-38.6 and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39-0.05. Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0-9. Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p's>0.05.No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing executive functioning or mathematics skills compared

  7. Effectiveness of a School-Based Physical Activity Intervention on Cognitive Performance in Danish Adolescents: LCoMotion-Learning, Cognition and Motion - A Cluster Randomized Controlled Trial.

    Science.gov (United States)

    Tarp, Jakob; Domazet, Sidsel Louise; Froberg, Karsten; Hillman, Charles H; Andersen, Lars Bo; Bugge, Anna

    2016-01-01

    Physical activity is associated not only with health-related parameters, but also with cognitive and academic performance. However, no large scale school-based physical activity interventions have investigated effects on cognitive performance in adolescents. The aim of this study was to describe the effectiveness of a school-based physical activity intervention in enhancing cognitive performance in 12-14 years old adolescents. A 20 week cluster randomized controlled trial was conducted including seven intervention and seven control schools. A total of 632 students (mean (SD) age: 12.9 (0.6) years) completed the trial with baseline and follow-up data on primary or secondary outcomes (74% of randomized subjects). The intervention targeted physical activity during academic subjects, recess, school transportation and leisure-time. Cognitive performance was assessed using an executive functions test of inhibition (flanker task) with the primary outcomes being accuracy and reaction time on congruent and incongruent trials. Secondary outcomes included mathematics performance, physical activity levels, body-mass index, waist-circumference and cardiorespiratory fitness. No significant difference in change, comparing the intervention group to the control group, was observed on the primary outcomes (p's>0.05) or mathematics skills (p>0.05). An intervention effect was found for cardiorespiratory fitness in girls (21 meters (95% CI: 4.4-38.6) and body-mass index in boys (-0.22 kg/m2 (95% CI: -0.39-0.05). Contrary to our predictions, a significantly larger change in interference control for reaction time was found in favor of the control group (5.0 milliseconds (95% CI: 0-9). Baseline to mid-intervention changes in physical activity levels did not differ significantly between groups (all p's>0.05). No evidence was found for effectiveness of a 20-week multi-faceted school-based physical activity intervention for enhancing executive functioning or mathematics skills compared to a

  8. Study design of a cluster-randomized controlled trial to evaluate a large-scale distribution of cook stoves and water filters in Western Province, Rwanda.

    Science.gov (United States)

    Nagel, Corey L; Kirby, Miles A; Zambrano, Laura D; Rosa, Ghislane; Barstow, Christina K; Thomas, Evan A; Clasen, Thomas F

    2016-12-15

    In Rwanda, pneumonia and diarrhea are the first and second leading causes of death, respectively, among children under five. Household air pollution (HAP) resultant from cooking indoors with biomass fuels on traditional stoves is a significant risk factor for pneumonia, while consumption of contaminated drinking water is a primary cause of diarrheal disease. To date, there have been no large-scale effectiveness trials of programmatic efforts to provide either improved cookstoves or household water filters at scale in a low-income country. In this paper we describe the design of a cluster-randomized trial to evaluate the impact of a national-level program to distribute and promote the use of improved cookstoves and advanced water filters to the poorest quarter of households in Rwanda. We randomly allocated 72 sectors (administratively defined units) in Western Province to the intervention, with the remaining 24 sectors in the province serving as controls. In the intervention sectors, roughly 100,000 households received improved cookstoves and household water filters through a government-sponsored program targeting the poorest quarter of households nationally. The primary outcome measures are the incidence of acute respiratory infection (ARI) and diarrhea among children under five years of age. Over a one-year surveillance period, all cases of acute respiratory infection (ARI) and diarrhea identified by health workers in the study area will be extracted from records maintained at health facilities and by community health workers (CHW). In addition, we are conducting intensive, longitudinal data collection among a random sample of households in the study area for in-depth assessment of coverage, use, environmental exposures, and additional health measures. Although previous research has examined the impact of providing household water treatment and improved cookstoves on child health, there have been no studies of national-level programs to deliver these interventions

  9. Integration of family planning services into HIV care clinics: Results one year after a cluster randomized controlled trial in Kenya.

    Directory of Open Access Journals (Sweden)

    Craig R Cohen

    Full Text Available To determine if integration of family planning (FP and HIV services led to increased use of more effective contraception (i.e. hormonal and permanent methods, and intrauterine devices and decreased pregnancy rates.Cohort analysis following cluster randomized trial, when the Kenya Ministry of Health led integration of the remaining control (delayed integration sites and oversaw integrated services at the original intervention (early integration sites.Eighteen health facilities in Kenya.Women aged 18-45 receiving care: 5682 encounters at baseline, and 11628 encounters during the fourth quarter of year 2."One-stop shop" approach to integrating FP and HIV services.Use of more effective contraceptive methods and incident pregnancy across two years of follow-up.Following integration of FP and HIV services at the six delayed integration clinics, use of more effective contraception increased from 31.7% to 44.2% of encounters (+12.5%; Prevalence ratio (PR = 1.39 (1.19-1.63. Among the twelve early integration sites, the proportion of encounters at which women used more effective contraceptive methods was sustained from the end of the first to the second year of follow-up (37.5% vs. 37.0%. Pregnancy incidence including all 18 integrated sites in year two declined in comparison to the control arm in year one (rate ratio: 0.72; 95% CI 0.60-0.87.Integration of FP services into HIV clinics led to a sustained increase in the use of more effective contraceptives and decrease in pregnancy incidence 24 months following implementation of the integrated service model.ClinicalTrials.gov NCT01001507.

  10. Minimal improvement of nurses' motivational interviewing skills in routine diabetes care one year after training: a cluster randomized trial.

    Science.gov (United States)

    Jansink, Renate; Braspenning, Jozé; Laurant, Miranda; Keizer, Ellen; Elwyn, Glyn; Weijden, Trudy van der; Grol, Richard

    2013-03-28

    The effectiveness of nurse-led motivational interviewing (MI) in routine diabetes care in general practice is inconclusive. Knowledge about the extent to which nurses apply MI skills and the factors that affect the usage can help to understand the black box of this intervention. The current study compared MI skills of trained versus non-trained general practice nurses in diabetes consultations. The nurses participated in a cluster randomized trial in which a comprehensive program (including MI training) was tested on improving clinical parameters, lifestyle, patients' readiness to change lifestyle, and quality of life. Fifty-eight general practices were randomly assigned to usual care (35 nurses) or the intervention (30 nurses). The ratings of applying 24 MI skills (primary outcome) were based on five consultation recordings per nurse at baseline and 14 months later. Two judges evaluated independently the MI skills and the consultation characteristics time, amount of nurse communication, amount of lifestyle discussion and patients' readiness to change. The effect of the training on the MI skills was analysed with a multilevel linear regression by comparing baseline and the one-year follow-up between the interventions with usual care group. The overall effect of the consultation characteristics on the MI skills was studied in a multilevel regression analyses. At one year follow up, it was demonstrated that the nurses improved on 2 of the 24 MI skills, namely, "inviting the patient to talk about behaviour change" (mean difference=0.39, p=0.009), and "assessing patient's confidence in changing their lifestyle" (mean difference=0.28, p=0.037). Consultation time and the amount of lifestyle discussion as well as the patients' readiness to change health behaviour was associated positively with applying MI skills. The maintenance of the MI skills one year after the training program was minimal. The question is whether the success of MI to change unhealthy behaviour must be

  11. Specific collaborative group intervention for patients with medically unexplained symptoms in general practice: a cluster randomized controlled trial.

    Science.gov (United States)

    Schaefert, R; Kaufmann, C; Wild, B; Schellberg, D; Boelter, R; Faber, R; Szecsenyi, J; Sauer, N; Guthrie, E; Herzog, W

    2013-01-01

    Patients with medically unexplained symptoms (MUS) are frequent in primary care and substantially impaired in their quality of life (QoL). Specific training of general practitioners (GPs) alone did not demonstrate sustained improvement at later follow-up in current reviews. We evaluated a collaborative group intervention. We conducted a cluster randomized controlled trial. Thirty-five GPs recruited 304 MUS patients (intervention group: 170; control group: 134). All GPs were trained in diagnosis and management of MUS (control condition). Eighteen randomly selected intervention GPs participated in training for a specific collaborative group intervention. They conducted 10 weekly group sessions and 2 booster meetings in their practices, together with a psychosomatic specialist. Six and 12 months after baseline, QoL was assessed with the Short-Form 36. The primary outcome was the physical composite score (PCS), and the secondary outcome was the mental composite score (MCS). At 12 months, intention-to-treat analyses showed a significant between-group effect for the MCS (p = 0.023) but not for the PCS (p = 0.674). This effect was preceded by a significant reduction of somatic symptom severity (15-item somatic symptom severity scale of the Patient Health Questionnaire, PHQ-15) at 6 months (p = 0.008) that lacked significance at 12 months (p = 0.078). As additional between-group effects at 12 months, per-protocol analyses showed less health anxiety (Whiteley-7; p = 0.038) and less psychosocial distress (PHQ; p = 0.024); GP visits were significantly (p = 0.042) reduced in the intervention group. Compared to pure GP training, collaborative group intervention achieved a progressive, clinically meaningful improvement in mental but not physical QoL. It could bridge gaps between general practice and mental health care. Copyright © 2012 S. Karger AG, Basel.

  12. Panel Management to Improve Smoking and Hypertension Outcomes by VA Primary Care Teams: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Schwartz, Mark D; Jensen, Ashley; Wang, Binhuan; Bennett, Katelyn; Dembitzer, Anne; Strauss, Shiela; Schoenthaler, Antoinette; Gillespie, Colleen; Sherman, Scott

    2015-07-01

    Panel Management can expand prevention and chronic illness management beyond the office visit, but there is limited evidence for its effectiveness or guidance on how best to incorporate it into practice. We aimed to test the effectiveness of incorporating panel management into clinical practice by incorporating Panel Management Assistants (PMAs) into primary care teams with and without panel management education. We conducted an 8-month cluster-randomized controlled trial of panel management for improving hypertension and smoking cessation outcomes among veterans. Twenty primary care teams from the Veterans Affairs New York Harbor were randomized to control, panel management support, or panel management support plus education groups. Teams included 69 clinical staff serving 8,153 hypertensive and/or smoking veterans. Teams assigned to the intervention groups worked with non-clinical Panel Management Assistants (PMAs) who monitored care gaps and conducted proactive patient outreach, including referrals, mail reminders and motivational interviewing by telephone. Measurements included mean systolic and diastolic blood pressure, proportion of patients with controlled blood pressure, self-reported quit attempts, nicotine replacement therapy (NRT) prescriptions, and referrals to disease management services. Change in mean blood pressure, blood pressure control, and smoking quit rates were similar across study groups. Patients on intervention teams were more likely to receive NRT (OR = 1.4; 95% CI 1.2-1.6) and enroll in the disease management services MOVE! (OR = 1.2; 95% CI 1.1-1.6) and Telehealth (OR = 1.7, 95% CI 1.4-2.1) than patients on control teams. Panel Management support for primary care teams improved process, but not outcome variables among veterans with hypertension and smoking. Incorporating PMAs into teams was feasible and highly valued by the clinical staff, but clinical impact may require a longer intervention.

  13. Ferromagnetic clusters induced by a nonmagnetic random disorder in diluted magnetic semiconductors

    Energy Technology Data Exchange (ETDEWEB)

    Bui, Dinh-Hoi [Institute of Research and Development, Duy Tan University, K7/25 Quang Trung, Danang (Viet Nam); Physics Department, Hue University’s College of Education, 34 Le Loi, Hue (Viet Nam); Phan, Van-Nham, E-mail: phanvannham@dtu.edu.vn [Institute of Research and Development, Duy Tan University, K7/25 Quang Trung, Danang (Viet Nam)

    2016-12-15

    In this work, we analyze the nonmagnetic random disorder leading to a formation of ferromagnetic clusters in diluted magnetic semiconductors. The nonmagnetic random disorder arises from randomness in the host lattice. Including the disorder to the Kondo lattice model with random distribution of magnetic dopants, the ferromagnetic–paramagnetic transition in the system is investigated in the framework of dynamical mean-field theory. At a certain low temperature one finds a fraction of ferromagnetic sites transiting to the paramagnetic state. Enlarging the nonmagnetic random disorder strength, the paramagnetic regimes expand resulting in the formation of the ferromagnetic clusters.

  14. Chemical and environmental vector control as a contribution to the elimination of visceral leishmaniasis on the Indian subcontinent: cluster randomized controlled trials in Bangladesh, India and Nepal

    Directory of Open Access Journals (Sweden)

    Das Pradeep

    2009-10-01

    Full Text Available Abstract Background Bangladesh, India and Nepal are working towards the elimination of visceral leishmaniasis (VL by 2015. In 2005 the World Health Organization/Training in Tropical Diseases launched an implementation research programme to support integrated vector management for the elimination of VL from Bangladesh, India and Nepal. The programme is conducted in different phases, from proof-of-concept to scaling up intervention. This study was designed in order to evaluate the efficacy of the three different interventions for VL vector management: indoor residual spraying (IRS; long-lasting insecticide treated nets (LLIN; and environmental modification (EVM through plastering of walls with lime or mud. Methods Using a cluster randomized controlled trial we compared three vector control interventions with a control arm in 96 clusters (hamlets or neighbourhoods in each of the 4 study sites: Bangladesh (one, India (one and Nepal (two. In each site four villages with high reported VL incidences were included. In each village six clusters and in each cluster five households were randomly selected for sand fly collection on two consecutive nights. Control and intervention clusters were matched with average pre-intervention vector densities. In each site six clusters were randomly assigned to each of the following interventions: indoor residual spraying (IRS; long-lasting insecticide treated nets (LLIN; environmental management (EVM or control. All the houses (50-100 in each intervention cluster underwent the intervention measures. A reduction of intra-domestic sand fly densities measured in the study households by overnight US Centres for Disease Prevention and Control light trap captures (that is the number of sand flies per trap per night was the main outcome measure. Results IRS, and to a lesser extent EVM and LLINs, significantly reduced sand fly densities for at least 5 months in the study households irrespective of type of walls or whether or

  15. Clustering, randomness, and regularity in cloud fields. 4: Stratocumulus cloud fields

    Science.gov (United States)

    Lee, J.; Chou, J.; Weger, R. C.; Welch, R. M.

    1994-01-01

    To complete the analysis of the spatial distribution of boundary layer cloudiness, the present study focuses on nine stratocumulus Landsat scenes. The results indicate many similarities between stratocumulus and cumulus spatial distributions. Most notably, at full spatial resolution all scenes exhibit a decidedly clustered distribution. The strength of the clustering signal decreases with increasing cloud size; the clusters themselves consist of a few clouds (less than 10), occupy a small percentage of the cloud field area (less than 5%), contain between 20% and 60% of the cloud field population, and are randomly located within the scene. In contrast, stratocumulus in almost every respect are more strongly clustered than are cumulus cloud fields. For instance, stratocumulus clusters contain more clouds per cluster, occupy a larger percentage of the total area, and have a larger percentage of clouds participating in clusters than the corresponding cumulus examples. To investigate clustering at intermediate spatial scales, the local dimensionality statistic is introduced. Results obtained from this statistic provide the first direct evidence for regularity among large (more than 900 m in diameter) clouds in stratocumulus and cumulus cloud fields, in support of the inhibition hypothesis of Ramirez and Bras (1990). Also, the size compensated point-to-cloud cumulative distribution function statistic is found to be necessary to obtain a consistent description of stratocumulus cloud distributions. A hypothesis regarding the underlying physical mechanisms responsible for cloud clustering is presented. It is suggested that cloud clusters often arise from 4 to 10 triggering events localized within regions less than 2 km in diameter and randomly distributed within the cloud field. As the size of the cloud surpasses the scale of the triggering region, the clustering signal weakens and the larger cloud locations become more random.

  16. Clustering, randomness, and regularity in cloud fields. 4. Stratocumulus cloud fields

    Science.gov (United States)

    Lee, J.; Chou, J.; Weger, R. C.; Welch, R. M.

    1994-07-01

    To complete the analysis of the spatial distribution of boundary layer cloudiness, the present study focuses on nine stratocumulus Landsat scenes. The results indicate many similarities between stratocumulus and cumulus spatial distributions. Most notably, at full spatial resolution all scenes exhibit a decidedly clustered distribution. The strength of the clustering signal decreases with increasing cloud size; the clusters themselves consist of a few clouds (less than 10), occupy a small percentage of the cloud field area (less than 5%), contain between 20% and 60% of the cloud field population, and are randomly located within the scene. In contrast, stratocumulus in almost every respect are more strongly clustered than are cumulus cloud fields. For instance, stratocumulus clusters contain more clouds per cluster, occupy a larger percentage of the total area, and have a larger percentage of clouds participating in clusters than the corresponding cumulus examples. To investigate clustering at intermediate spatial scales, the local dimensionality statistic is introduced. Results obtained from this statistic provide the first direct evidence for regularity among large (>900 m in diameter) clouds in stratocumulus and cumulus cloud fields, in support of the inhibition hypothesis of Ramirez and Bras (1990). Also, the size compensated point-to-cloud cumulative distribution function statistic is found to be necessary to obtain a consistent description of stratocumulus cloud distributions. A hypothesis regarding the underlying physical mechanisms responsible for cloud clustering is presented. It is suggested that cloud clusters often arise from 4 to 10 triggering events localized within regions less than 2 km in diameter and randomly distributed within the cloud field. As the size of the cloud surpasses the scale of the triggering region, the clustering signal weakens and the larger cloud locations become more random.

  17. Behavioral Reactivity Associated With Electronic Monitoring of Environmental Health Interventions--A Cluster Randomized Trial with Water Filters and Cookstoves.

    Science.gov (United States)

    Thomas, Evan A; Tellez-Sanchez, Sarita; Wick, Carson; Kirby, Miles; Zambrano, Laura; Abadie Rosa, Ghislaine; Clasen, Thomas F; Nagel, Corey

    2016-04-05

    Subject reactivity--when research participants change their behavior in response to being observed--has been documented showing the effect of human observers. Electronics sensors are increasingly used to monitor environmental health interventions, but the effect of sensors on behavior has not been assessed. We conducted a cluster randomized controlled trial in Rwanda among 170 households (70 blinded to the presence of the sensor, 100 open) testing whether awareness of an electronic monitor would result in a difference in weekly use of household water filters and improved cookstoves over a four-week surveillance period. A 63% increase in number of uses of the water filter per week between the groups was observed in week 1, an average of 4.4 times in the open group and 2.83 times in the blind group, declining in week 4 to an insignificant 55% difference of 2.82 uses in the open, and 1.93 in the blind. There were no significant differences in the number of stove uses per week between the two groups. For both filters and stoves, use decreased in both groups over four-week installation periods. This study suggests behavioral monitoring should attempt to account for reactivity to awareness of electronic monitors that persists for weeks or more.

  18. Cluster randomized controlled trial of a peer support program for people with diabetes: study protocol for the Australasian peers for progress study

    Directory of Open Access Journals (Sweden)

    Riddell Michaela A

    2012-10-01

    measures are collected on all participants at baseline, 6 and 12 months. The primary outcome is change in cardiovascular disease risk using the UKPDS risk equation. Secondary outcomes include biomedical, quality of life, psychosocial functioning, and other lifestyle measures. An economic evaluation will determine whether the program is cost effective. Discussion This manuscript presents the protocol for a cluster randomized controlled trial of group-based peer support for people with type 2 diabetes in a community setting. Results from this trial will contribute evidence about the effectiveness of peer support in achieving effective self-management of diabetes. Trial registration number Australian New Zealand Clinical Trials Registry (ANZCTR; ACTRN12609000469213

  19. A cluster randomized controlled platform trial comparing group MEmory specificity training (MEST) to group psychoeducation and supportive counselling (PSC) in the treatment of recurrent depression.

    Science.gov (United States)

    Werner-Seidler, Aliza; Hitchcock, Caitlin; Bevan, Anna; McKinnon, Anna; Gillard, Julia; Dahm, Theresa; Chadwick, Isobel; Panesar, Inderpal; Breakwell, Lauren; Mueller, Viola; Rodrigues, Evangeline; Rees, Catrin; Gormley, Siobhan; Schweizer, Susanne; Watson, Peter; Raes, Filip; Jobson, Laura; Dalgleish, Tim

    2018-06-01

    Impaired ability to recall specific autobiographical memories is characteristic of depression, which when reversed, may have therapeutic benefits. This cluster-randomized controlled pilot trial investigated efficacy and aspects of acceptability, and feasibility of MEmory Specificity Training (MEST) relative to Psychoeducation and Supportive Counselling (PSC) for Major Depressive Disorder (N = 62). A key aim of this study was to determine a range of effect size estimates to inform a later phase trial. Assessments were completed at baseline, post-treatment and 3-month follow-up. The cognitive process outcome was memory specificity. The primary clinical outcome was symptoms on the Beck Depression Inventory-II at 3-month follow-up. The MEST group demonstrated greater improvement in memory specificity relative to PSC at post-intervention (d = 0.88) and follow-up (d = 0.74), relative to PSC. Both groups experienced a reduction in depressive symptoms at 3-month follow-up (d = 0.67). However, there was no support for a greater improvement in depressive symptoms at 3 months following MEST relative to PSC (d = -0.04). Although MEST generated changes on memory specificity and improved depressive symptoms, results provide no indication that MEST is superior to PSC in the resolution of self-reported depressive symptoms. Implications for later-phase definitive trials of MEST are discussed. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

  20. Evaluation of a nurse-led dementia education and knowledge translation programme in primary care: A cluster randomized controlled trial.

    Science.gov (United States)

    Wang, Yao; Xiao, Lily Dongxia; Ullah, Shahid; He, Guo-Ping; De Bellis, Anita

    2017-02-01

    The lack of dementia education programmes for health professionals in primary care is one of the major factors contributing to the unmet demand for dementia care services. To determine the effectiveness of a nurse-led dementia education and knowledge translation programme for health professionals in primary care; participants' satisfaction with the programme; and to understand participants' perceptions of and experiences in the programme. A cluster randomized controlled trial was used as the main methodology to evaluate health professionals' knowledge, attitudes and care approach. Focus groups were used at the end of the project to understand health professionals' perceptions of and experiences in the programme. Fourteen community health service centres in a province in China participated in the study. Seven centres were randomly assigned to the intervention or control group respectively and 85 health professionals in each group completed the programme. A train-the-trainer model was used to implement a dementia education and knowledge translation programme. Outcome variables were measured at baseline, on the completion of the programme and at 3-month follow-up. A mixed effect linear regression model was applied to compare the significant differences of outcome measures over time between the two groups. Focus groups were guided by four semi-structured questions and analysed using content analysis. Findings revealed significant effects of the education and knowledge translation programme on participants' knowledge, attitudes and a person-centred care approach. Focus groups confirmed that the programme had a positive impact on dementia care practice. A dementia education and knowledge translation programme for health professionals in primary care has positive effects on their knowledge, attitudes, care approach and care practice. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Potential for Controlling Cholera Using a Ring Vaccination Strategy: Re-analysis of Data from a Cluster-Randomized Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Mohammad Ali

    2016-09-01

    Full Text Available Vaccinating a buffer of individuals around a case (ring vaccination has the potential to target those who are at highest risk of infection, reducing the number of doses needed to control a disease. We explored the potential vaccine effectiveness (VE of oral cholera vaccines (OCVs for such a strategy.This analysis uses existing data from a cluster-randomized clinical trial in which OCV or placebo was given to 71,900 participants in Kolkata, India, from 27 July to 10 September 2006. Cholera surveillance was then conducted on 144,106 individuals living in the study area, including trial participants, for 5 y following vaccination. First, we explored the risk of cholera among contacts of cholera patients, and, second, we measured VE among individuals living within 25 m of cholera cases between 8 and 28 d after onset of the index case. For the first analysis, individuals living around each index case identified during the 5-y period were assembled using a ring to define cohorts of individuals exposed to cholera index cases. An index control without cholera was randomly selected for each index case from the same population, matched by age group, and individuals living around each index control were assembled using a ring to define cohorts not exposed to cholera cases. Cholera attack rates among the exposed and non-exposed cohorts were compared using different distances from the index case/control to define the rings and different time frames to define the period at risk. For the VE analysis, the exposed cohorts were further stratified according to the level of vaccine coverage into high and low coverage strata. Overall VE was assessed by comparing the attack rates between high and low vaccine coverage strata irrespective of individuals' vaccination status, and indirect VE was assessed by comparing the attack rates among unvaccinated members between high and low vaccine coverage strata. Cholera risk among the cohort exposed to cholera cases was 5

  2. Prenatal Lipid-Based Nutrient Supplements Do Not Affect Pregnancy or Childbirth Complications or Cesarean Delivery in Bangladesh: A Cluster-Randomized Controlled Effectiveness Trial.

    Science.gov (United States)

    Mridha, Malay K; Matias, Susana L; Paul, Rina Rani; Hussain, Sohrab; Sarker, Mostofa; Hossain, Mokbul; Peerson, Janet M; Vosti, Stephen A; Dewey, Kathryn G

    2017-09-01

    Background: Pregnancy and childbirth complications and cesarean delivery are common in Bangladesh. Objective: We evaluated the effect of lipid-based nutrient supplements for pregnant and lactating women (LNS-PL) on pregnancy and childbirth complications and cesarean delivery. Methods: We conducted the Rang-Din Nutrition Study, a cluster-randomized controlled effectiveness trial within a community health program in rural Bangladesh. We enrolled 4011 pregnant women in early pregnancy. Women in 48 clusters received iron and folic acid (IFA; 60 mg Fe + 400 μg folic acid/d) and women in 16 clusters received LNS-PL (20 g/d, 118 kcal) containing essential fatty acids and 22 vitamins and minerals. Pregnancy and childbirth complications and the cesarean delivery rate were secondary outcomes of the study. Results: Women in the LNS-PL group did not differ significantly from the IFA group with respect to mean systolic blood pressure at 36 wk gestation (113 and 112 mm Hg; P = 0.17), diastolic blood pressure at 36 wk gestation (68.9 and 68.7 mmHg; P = 0.88), or mean total number of pregnancy and childbirth complications (0.32 and 0.31; P = 0.86). They also did not differ significantly with respect to the prevalence of high blood pressure at 36 wk (1.74% and 2.03%; P = 0.62), antepartum hemorrhage (0.83% and 1.39%; P = 0.21), prolonged labor (8.34% and 8.79%; P = 0.68), early rupture of membranes (9.30% and 8.45%; P = 0.43), convulsions (1.57% and 1.08%; P = 0.24), high blood pressure in labor (1.54% and 1.19%; P = 0.46), obstructed labor (2.83% and 2.91%; P = 0.90), any complications during pregnancy or childbirth (35.9% and 37.1%; P = 0.64), episiotomy (6.31% and 6.44%; P = 0.90), or cesarean delivery (15.6% and 14.2%; P = 0.48). Conclusion: Compared with IFA, antenatal LNS-PL did not increase or decrease pregnancy and childbirth complications or cesarean delivery among women in rural Bangladesh. This trial was registered at clinicaltrials.gov as NCT01715038. © 2017 American

  3. Dispensing good sleep health behaviours not pills--a cluster-randomized controlled trial to test the feasibility and efficacy of pharmacist-provided brief behavioural treatment for insomnia.

    Science.gov (United States)

    Fuller, Joanne M; Wong, Keith K; Hoyos, Camilla; Krass, Ines; Saini, Bandana

    2016-02-01

    Behavioural therapies are recommended as the first-line treatment of insomnia; however, sedatives and hypnotics constitute the main treatment modality used in primary care. Community pharmacies provide a unique conduit for identifying and providing appropriate treatment for those with insomnia either purchasing prescription sedatives or seeking over-the-counter treatments. A feasibility study using a cluster-randomized controlled trial, testing the efficacy of trained pharmacists providing behavioural interventions such as stimulus control and sleep restriction to patients with insomnia, in improving insomnia severity was conducted. The intervention involved three pharmacy visits (baseline, 1 and 3 months follow-up). The control group received usual care and information sheets on insomnia. The primary outcome was the Insomnia Severity Index. Twelve community pharmacists (five control, seven intervention) in New South Wales, Australia were recruited and trained. These pharmacists, in turn, recruited 46 patients (22 control, 24 intervention (mean age 53.7 ± 18.4, 72% females) and delivered a brief behavioural therapy intervention. The overall decrease in Insomnia Severity Index from baseline to the 3-month follow-up in the intervention group, n = 17 (7.6 ± 4.3 points), was significantly greater than for the control group, n = 19 (2.9 ± 8.8 points) (mean difference 4.6, 95% confidence interval: 0.005-9.2, P = 0.05). However, when the effect of clustering was taken into account using a mixed-effects model, the estimated difference in Insomnia Severity Index (change from baseline to visit 3) between the intervention and control groups was not significant (group difference in Insomnia Severity Index change = 3.78, 95% confidence interval: -0.81 to 8.37, P = 0.11; intracluster correlation = 0.18). The study highlights the use of a novel venue to deliver brief behavioural therapies for insomnia using trained non-psychologist health professionals. Although, when cluster

  4. An intervention to improve program implementation: findings from a two-year cluster randomized trial of Assets-Getting To Outcomes

    Science.gov (United States)

    2013-01-01

    Background Studies have shown that communities have not always been able to implement evidence-based prevention programs with quality and achieve outcomes demonstrated by prevention science. Implementation support interventions are needed to bridge this gap between science and practice. The purpose of this article is to present two-year outcomes from an evaluation of the Assets Getting To Outcomes (AGTO) intervention in 12 Maine communities engaged in promoting Developmental Assets, a positive youth development approach to prevention. AGTO is an implementation support intervention that consists of: a manual of text and tools; face-to-face training, and onsite technical assistance, focused on activities shown to be associated with obtaining positive results across any prevention program. Methods This study uses a nested and cross-sectional, cluster randomized controlled design. Participants were coalition members and program staff from 12 communities in Maine. Each coalition nominated up to five prevention programs to participate. At random, six coalitions and their respective 30 programs received the two-year AGTO intervention and the other six maintained routine operations. The study assessed prevention practitioner capacity (efficacy and behaviors), practitioner exposure to and use of AGTO, practitioner perceptions of AGTO, and prevention program performance. Capacity of coalition members and performance of their programs were compared between the two groups across the baseline, one-, and two-year time points. Results We found no significant differences between AGTO and control group’s prevention capacity. However, within the AGTO group, significant differences were found between those with greater exposure to and use of AGTO. Programs that received the highest number of technical assistance hours showed the most program improvement. Conclusions This study is the first of its kind to show that use of an implementation support intervention-AGTO -yielded

  5. Study protocol for a multi-component kindergarten-based intervention to promote healthy diets in toddlers: a cluster randomized trial.

    Science.gov (United States)

    Helland, Sissel H; Bere, Elling; Øverby, Nina Cecilie

    2016-03-17

    There is concern about the lack of diversity in children's diets, particularly low intakes of fruit and vegetables and high intakes of unhealthy processed food. This may be a factor in the rising prevalence of obesity. A reason for the lack of diversity in children's diets may be food neophobia. This study aimed to promote a healthy and varied diet among toddlers in kindergarten. The primary objectives were to reduce food neophobia in toddlers, and promote healthy feeding practices among kindergarten staff and parents. Secondary objectives were to increase food variety in toddlers' diets and reduce future overweight and obesity in these children. This is an ongoing, cluster randomized trial. The intervention finished in 2014, but follow-up data collection is not yet complete. Eighteen randomly selected kindergartens located in two counties in Norway with enrolled children born in 2012 participated in the intervention. The kindergartens were matched into pairs based on background information, and randomly assigned to the intervention or control groups. A 9-week multi-component intervention was implemented, with four main elements: 1) kindergarten staff implemented a pedagogical tool (Sapere method) in daily sessions to promote willingness to try new food; 2) kindergarten staff prepared and served the toddlers a cooked lunch from a menu corresponding to the pedagogical sessions; 3) kindergarten staff were encouraged to follow 10 meal principles on modeling, responsive feeding, repeated exposure, and enjoyable meals; and 4) parents were encouraged to read information and apply relevant feeding practices at home. The control group continued their usual practices. Preference taste tests were conducted to evaluate behavioral food neophobia, and children's height and weight were measured. Parents and staff completed questionnaires before and after the intervention. Data have not yet been analyzed. This study provides new knowledge about whether or not a Sapere

  6. Feasibility and pilot study of the effects of microfinance on mortality and nutrition in children under five amongst the very poor in India: study protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Ojha, Shalini; Szatkowski, Lisa; Sinha, Ranjeet; Yaron, Gil; Fogarty, Andrew; Allen, Stephen; Choudhary, Sunil; Smyth, Alan R

    2014-07-23

    The United Nations Millennium Development Goals include targets for the health of children under five years old. Poor health is linked to poverty and microfinance initiatives are economic interventions that may improve health by breaking the cycle of poverty. However, there is a lack of reliable evidence to support this. In addition, microfinance schemes may have adverse effects on health, for example due to increased indebtedness. Rojiroti UK and the Centre for Promoting Sustainable Livelihood run an innovative microfinance scheme that provides microcredit via women's self-help groups (SHGs). This pilot study, conducted in rural Bihar (India), will establish whether it is feasible to collect anthropometric and mortality data on children under five years old and to conduct a limited cluster randomized trial of the Rojiroti intervention. We have designed a cluster randomized trial in which participating tolas (small communities within villages) will be randomized to either receive early (SHGs and microfinance at baseline) or late intervention (SHGs and microfinance after 18 months). Using predesigned questionnaires, demographic, and mortality data for the last year and information about participating mothers and their children will be collected and the weight, height, and mid upper arm circumference (MUAC) of children will be measured at baseline and at 18 months. The late intervention group will establish SHGs and microfinance support at this point and data collection will be repeated at 36 months.The primary outcome measure will be the mean weight for height z-score of children under five years old in the early and late intervention tolas at 18 months. Secondary outcome measures will be the mortality rate, mean weight for age, height for age, prevalence of underweight, stunting, and wasting among children under five years of age. Despite economic progress, marked inequalities in child health persist in India and Bihar is one of the worst affected states. There

  7. Positive impact of child feeding training program for primary care health professionals: a cluster randomized field trial.

    Science.gov (United States)

    Vitolo, Márcia Regina; Louzada, Maria Laura da Costa; Rauber, Fernanda

    2014-12-01

    To assess the impact of a child feeding training program for primary care health professionals about breastfeeding and complementary feeding practices. Cluster-randomized field trial conducted in the city of Porto Alegre, (RS), Brazil. Twenty primary health care centers (HCC) were randomized into intervention (n = 9) and control (n = 11) groups. The health professionals (n = 200) at the intervention group centers received training about healthy feeding practices. Pregnant women were enrolled at the study. Up to six months of child's age, home visits were made to obtain variables related to breastfeeding and introduction of foods. 619 children were evaluated: 318 from the intervention group and 301 from the control group. Exclusive breastfeeding prevalence in the first (72.3 versus 59.4%; RR = 1.21; 95%CI 1.08 - 1.38), second (62.6 versus 48.2%; RR = 1.29; 95%CI 1.10 - 1.53), and third months of life (44.0% versus 34.6%; RR = 1.27; 95%CI 1.04 - 1.56) was higher in the intervention group compared to the control group. The prevalence of children who consumed meat four or five times per week was higher in the intervention group than in the control group (36.8 versus 22.6%; RR = 1.62; 95%CI 1.32 - 2.03). The prevalence of children who had consumed soft drinks (34.9 versus 52.5%; RR = 0.66; 95%CI 0.54 - 0.80), chocolate (24.5 versus 36.7% RR = 0.66 95%CI 0.53 - 0.83), petit suisse (68.9 versus 79.7; 95%CI 0.75 - 0.98) and coffee (10.4 versus 20.1%; RR = 0.51; 95%CI 0.31 - 0.85) in their six first months of life was lower in the intervention group. The training of health professionals had a positive impact on infant feeding practices, contributing to the promotion of child health.

  8. Positive impact of child feeding training program for primary care health professionals: a cluster randomized field trial

    Directory of Open Access Journals (Sweden)

    Márcia Regina Vitolo

    2014-12-01

    Full Text Available OBJECTIVE: To assess the impact of a child feeding training program for primary care health professionals about breastfeeding and complementary feeding practices. METHODS: Cluster-randomized field trial conducted in the city of Porto Alegre, (RS, Brazil. Twenty primary health care centers (HCC were randomized into intervention (n = 9 and control (n = 11 groups. The health professionals (n = 200 at the intervention group centers received training about healthy feeding practices. Pregnant women were enrolled at the study. Up to six months of child's age, home visits were made to obtain variables related to breastfeeding and introduction of foods. RESULTS: 619 children were evaluated: 318 from the intervention group and 301 from the control group. Exclusive breastfeeding prevalence in the first (72.3 versus 59.4%; RR = 1.21; 95%CI 1.08 - 1.38, second (62.6 versus 48.2%; RR = 1.29; 95%CI 1.10 - 1.53, and third months of life (44.0% versus 34.6%; RR = 1.27; 95%CI 1.04 - 1.56 was higher in the intervention group compared to the control group. The prevalence of children who consumed meat four or five times per week was higher in the intervention group than in the control group (36.8 versus 22.6%; RR = 1.62; 95%CI 1.32 - 2.03. The prevalence of children who had consumed soft drinks (34.9 versus 52.5%; RR = 0.66; 95%CI 0.54 - 0.80, chocolate (24.5 versus 36.7% RR = 0.66 95%CI 0.53 - 0.83, petit suisse (68.9 versus 79.7; 95%CI 0.75 - 0.98 and coffee (10.4 versus 20.1%; RR = 0.51; 95%CI 0.31 - 0.85 in their six first months of life was lower in the intervention group. CONCLUSION: The training of health professionals had a positive impact on infant feeding practices, contributing to the promotion of child health.

  9. Effects of patient safety culture interventions on incident reporting in general practice : A cluster randomised trial a cluster randomised trial

    NARCIS (Netherlands)

    Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M

    2015-01-01

    Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial

  10. E-Rehabilitation – an Internet and mobile phone based tailored intervention to enhance self-management of Cardiovascular Disease: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Antypas Konstantinos

    2012-07-01

    Full Text Available Abstract Background Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay. Methods/Design A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. Discussion The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively

  11. A Cluster-Randomized Controlled Trial to Reduce Diarrheal Disease and Dengue Entomological Risk Factors in Rural Primary Schools in Colombia.

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    Hans J Overgaard

    2016-11-01

    Full Text Available As many neglected tropical diseases are co-endemic and have common risk factors, integrated control can efficiently reduce disease burden and relieve resource-strained public health budgets. Diarrheal diseases and dengue fever are major global health problems sharing common risk factors in water storage containers. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Integrating improved water management and educational strategies for both diseases in the school environment can potentially improve the health situation for students and the larger community. The objective of this trial was to investigate whether interventions targeting diarrhea and dengue risk factors would significantly reduce absence due to diarrheal disease and dengue entomological risk factors in schools.A factorial cluster randomized controlled trial was carried out in 34 rural primary schools (1,301 pupils in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Schools were randomized to one of four study arms: diarrhea interventions (DIA, dengue interventions (DEN, combined diarrhea and dengue interventions (DIADEN, and control (CON. Interventions had no apparent effect on pupil school absence due to diarrheal disease (p = 0.45 or on adult female Aedes aegypti density (p = 0.32 (primary outcomes. However, the dengue interventions reduced the Breteau Index on average by 78% (p = 0.029, with Breteau indices of 10.8 and 6.2 in the DEN and DIADEN arms, respectively compared to 37.5 and 46.9 in the DIA and CON arms, respectively. The diarrhea interventions improved water quality as assessed by the amount of Escherichia coli colony forming units (CFU; the ratio of Williams mean E. coli CFU being 0.22, or 78% reduction (p = 0.008.Integrated control of dengue and diarrhea has never been conducted before

  12. Improvement of pain related self management for oncologic patients through a trans institutional modular nursing intervention: protocol of a cluster randomized multicenter trial

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    Thoke-Colberg Anette

    2010-03-01

    Full Text Available Abstract Background Pain is one of the most frequent and distressing symptoms in cancer patients. For the majority of the patients, sufficient pain relief can be obtained if adequate treatment is provided. However, pain remains often undertreated due to institutional, health care professional and patient related barriers. Patients self management skills are affected by the patients' knowledge, activities and attitude to pain management. This trial protocol is aimed to test the SCION-PAIN program, a multi modular structured intervention to improve self management in cancer patients with pain. Methods 240 patients with diagnosed malignancy and pain > 3 days and average pain ≥ 3/10 will participate in a cluster randomized trial on 18 wards in 2 German university hospitals. Patients from the intervention wards will receive, additionally to standard pain treatment, the SCION-PAIN program consisting of 3 modules: pharmacologic pain management, nonpharmacologic pain management and discharge management. The intervention will be conducted by specially trained oncology nurses and includes components of patient education, skills training and counseling to improve self care regarding pain management beginning with admission followed by booster session every 3rd day and one follow up telephone counseling within 2 to 3 days after discharge. Patients in the control group will receive standard care. Primary endpoint is the group difference in patient related barriers to management of cancer pain (BQII, 7 days after discharge. Secondary endpoints are: pain intensity & interference, adherence, coping and HRQoL. Discussion The study will determine if the acquired self management skills of the patients continue to be used after discharge from hospital. It is hypothesized that patients who receive the multi modular structured intervention will have less patient related barriers and a better self management of cancer pain. Trial Registration ClinicalTrials NCT

  13. RTOG: Updated results of randomized trials

    International Nuclear Information System (INIS)

    Curran, Walter J.

    1997-01-01

    Objective: To review the background, rationale and available results for recently completed randomized comparative clinical trials of the Radiation Therapy Oncology Group (RTOG), including inter group trials in which the RTOG has been the managing group or a major participant. When available, laboratory studies will be correlated with clinical results

  14. Effectiveness of the Spirometry 360 Quality Improvement Program for Improving Asthma Care: A Cluster Randomized Trial.

    Science.gov (United States)

    Mangione-Smith, Rita; Zhou, Chuan; Corwin, Michael J; Taylor, James A; Rice, Fiona; Stout, James W

    To determine the effectiveness of the Spirometry 360 distance learning quality improvement (QI) program for enhancing the processes and outcomes of care for children with asthma. Cluster randomized controlled trial involving 25 matched pairs of pediatric primary care practices. Practices were recruited from 2 practice-based research networks: the Slone Center Office-based Research Network at Boston University, Boston, Mass, and the Puget Sound Pediatric Research Network, Seattle, Wash. Study participants included providers from one of the 50 enrolled pediatric practices and 626 of their patients with asthma. Process measures assessed included spirometry test quality and appropriate prescription of asthma controller medications. Outcome measures included asthma-specific health-related quality of life, and outpatient, emergency department, and inpatient utilization for asthma. At baseline, 25.4% of spirometry tests performed in control practices and 50.4% of tests performed in intervention practices were of high quality. During the 6-month postintervention period, 28.7% of spirometry tests performed in control practices and 49.9% of tests performed in intervention practices were of high quality. The adjusted difference-of-differences analysis revealed no intervention effect on spirometry test quality. Adjusted differences-of-differences analysis also revealed no intervention effect on appropriate use of controller medications or any of the parent- or patient-reported outcomes examined. In this study, the Spirometry 360 distance learning QI program was ineffective in improving spirometry test quality or parent- or patient-reported outcomes. QI programs like the one assessed here may need to focus on practices with lower baseline performance levels or may need to be tailored for those with higher baseline performance. Copyright © 2017 Academic Pediatric Association. Published by Elsevier Inc. All rights reserved.

  15. Influence of a lifestyle intervention in preschool children on physiological and psychological parameters (Ballabeina): study design of a cluster randomized controlled trial.

    Science.gov (United States)

    Niederer, Iris; Kriemler, Susi; Zahner, Lukas; Bürgi, Flavia; Ebenegger, Vincent; Hartmann, Tim; Meyer, Ursina; Schindler, Christian; Nydegger, Andreas; Marques-Vidal, Pedro; Puder, Jardena J

    2009-03-31

    ), attention and spatial working memory ability (two validated tests). Researchers were blinded to group allocation. The purpose of this paper is to outline the design of a school-based multicenter cluster randomized, controlled trial aiming to reduce body mass index and to increase aerobic fitness in preschool children in culturally different parts of Switzerland with a high migrant population. Trial Registration: (clinicaltrials.gov) NCT00674544.

  16. Healthy lifestyle promotion in primary schools through the board game Kaledo: a pilot cluster randomized trial.

    Science.gov (United States)

    Viggiano, Emanuela; Viggiano, Alessandro; Di Costanzo, Anna; Viggiano, Adela; Viggiano, Andrea; Andreozzi, Eleonora; Romano, Vincenzo; Vicidomini, Claudia; Di Tuoro, Daniela; Gargano, Giuliana; Incarnato, Lucia; Fevola, Celeste; Volta, Pietro; Tolomeo, Caterina; Scianni, Giuseppina; Santangelo, Caterina; Apicella, Maria; Battista, Roberta; Raia, Maddalena; Valentino, Ilaria; Palumbo, Marianna; Messina, Giovanni; Messina, Antonietta; Monda, Marcellino; De Luca, Bruno; Amaro, Salvatore

    2018-01-20

    The board game Kaledo was proven to be effective in improving nutrition knowledge and in modifying dietary behavior in students attending middle and high school. The present pilot study aims to reproduce these results in younger students (7-11 years old) attending primary school. A total of 1313 children from ten schools were recruited to participate in the present study. Participants were randomized into two groups: (1) the treatment group which consisted of playing Kaledo over 20 sessions and (2) the no intervention group. Anthropometric measures were carried out for both groups at baseline (prior to any treatment) and at two follow-up post-assessments (8 and 18 months). All the participants completed a questionnaire concerning physical activity and a 1-week food diary at each assessment. The primary outcomes were (i) BMI z-score, (ii) scores on physical activity, and (iii) scores on a dietary questionnaire. BMI z-score was significantly lower in the treated group compared to the control group at 8 months. Frequency and duration of self-reported physical activity were also significantly augmented in the treated group compared to the control group at both post-assessments. Moreover, a significant increase in the consumption of healthy food and a significant decrease in junk food intake were observed in the treated group. The present results confirm the efficacy of Kaledo in younger students in primary schools, and it can be used as a useful nutritional tool for obesity prevention programs in children. What is Known: • Kaledo is a new educational board game to improve nutrition knowledge and to promote a healthy lifestyle. • In two cluster randomized trials conducted in Campania region (Italy), we showed that Kaledo could improve nutrition knowledge and dietary behavior and have a positive effect on the BMI z-score in children with age ranging from 9 to 14 years old attending school. • Kaledo may be used as an effective tool for obesity prevention

  17. Impact on postpartum hemorrhage of prophylactic administration of oxytocin 10 IU via UnijectTM by peripheral health care providers at home births: design of a community-based cluster-randomized trial

    Directory of Open Access Journals (Sweden)

    Stanton Cynthia K

    2012-06-01

    Full Text Available Abstract Background Hemorrhage is the leading direct cause of maternal death globally. While oxytocin is the drug of choice for postpartum hemorrhage prevention, its use has generally been limited to health facilities. This trial assesses the effectiveness, safety, and feasibility of expanding the use of prophylactic intramuscular oxytocin to peripheral health care providers at home births in four predominantly rural districts in central Ghana. Methods This study is designed as a community-based cluster-randomized trial in which Community Health Officers are randomized to provide (or not provide an injection of oxytocin 10 IU via the UnijectTM injection system within one minute of delivery of the baby to women who request their presence at home at the onset of labor. The primary aim is to determine if administration of prophylactic oxytocin via Uniject™ by this cadre will reduce the risk of postpartum hemorrhage by 50 % relative to deliveries which do not receive the prophylactic intervention. Postpartum hemorrhage is examined under three sequential definitions: 1 blood loss ≥500 ml (BL; 2 treatment for bleeding (TX and/or BL; 3 hospital referral for bleeding and/or TX and/or BL. Secondary outcomes address safety and feasibility of the intervention and include adverse maternal and fetal outcomes and logistical concerns regarding assistance at home births and the storage and handling of oxytocin, respectively. Discussion Results from this trial will build evidence for the effectiveness of expanding the delivery of this established prophylactic intervention to peripheral settings. Complementary data on safety and logistical issues related to this intervention will assist policymakers in low-income countries in selecting both the best uterotonic and service delivery strategy for postpartum hemorrhage prevention. Results of this trial are expected in mid-2013. The trial is registered at ClinicalTrials.gov: NCT01108289.

  18. Evaluating a community-based early childhood education and development program in Indonesia: study protocol for a pragmatic cluster randomized controlled trial with supplementary matched control group.

    Science.gov (United States)

    Pradhan, Menno; Brinkman, Sally A; Beatty, Amanda; Maika, Amelia; Satriawan, Elan; de Ree, Joppe; Hasan, Amer

    2013-08-16

    This paper presents the study protocol for a pragmatic cluster randomized controlled trial (RCT) with a supplementary matched control group. The aim of the trial is to evaluate a community-based early education and development program launched by the Government of Indonesia. The program was developed in collaboration with the World Bank with a total budget of US$127.7 million, and targets an estimated 738,000 children aged 0 to 6 years living in approximately 6,000 poor communities. The aim of the program is to increase access to early childhood services with the secondary aim of improving school readiness. The study is being conducted across nine districts. The baseline survey contained 310 villages, of which 100 were originally allocated to the intervention arm, 20 originally allocated to a 9-month delay staggered start, 100 originally allocated to an 18-month delay staggered start and 90 allocated to a matched control group (no intervention). The study consists of two cohorts, one comprising children aged 12 to 23 months and the other comprising children aged 48 to 59 months at baseline. The data collection instruments include child observations and task/game-based assessments as well as a questionnaire suite, village head questionnaire, service level questionnaires, household questionnaire, and child caretaker questionnaire. The baseline survey was conducted from March to April 2009, midline was conducted from April to August 2010 and endline conducted early 2013. The resultant participation rates at both the district and village levels were 90%. At the child level, the participation rate was 99.92%. The retention rate at the child level at midline was 99.67%. This protocol paper provides a detailed record of the trial design including a discussion regarding difficulties faced with compliance to the randomization, compliance to the dispersion schedule of community block grants, and procurement delays for baseline and midline data collections. Considering the

  19. Effectiveness of Provider and Community Interventions to Improve Treatment of Uncomplicated Malaria in Nigeria: A Cluster Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Obinna Onwujekwe

    Full Text Available The World Health Organization recommends that malaria be confirmed by parasitological diagnosis before treatment using Artemisinin-based Combination Therapy (ACT. Despite this, many health workers in malaria endemic countries continue to diagnose malaria based on symptoms alone. This study evaluates interventions to help bridge this gap between guidelines and provider practice. A stratified cluster-randomized trial in 42 communities in Enugu state compared 3 scenarios: Rapid Diagnostic Tests (RDTs with basic instruction (control; RDTs with provider training (provider arm; and RDTs with provider training plus a school-based community intervention (provider-school arm. The primary outcome was the proportion of patients treated according to guidelines, a composite indicator requiring patients to be tested for malaria and given treatment consistent with the test result. The primary outcome was evaluated among 4946 (93% of the 5311 patients invited to participate. A total of 40 communities (12 in control, 14 per intervention arm were included in the analysis. There was no evidence of differences between the three arms in terms of our composite indicator (p = 0.36: stratified risk difference was 14% (95% CI -8.3%, 35.8%; p = 0.26 in the provider arm and 1% (95% CI -21.1%, 22.9%; p = 0.19 in the provider-school arm, compared with control. The level of testing was low across all arms (34% in control; 48% provider arm; 37% provider-school arm; p = 0.47. Presumptive treatment of uncomplicated malaria remains an ingrained behaviour that is difficult to change. With or without extensive supporting interventions, levels of testing in this study remained critically low. Governments and researchers must continue to explore alternative ways of encouraging providers to deliver appropriate treatment and avoid the misuse of valuable medicines.ClinicalTrials.gov NCT01350752.

  20. The influence of socioeconomic environment on the effectiveness of alcohol prevention among European students: a cluster randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Faggiano Fabrizio

    2011-05-01

    Full Text Available Abstract Background Although social environments may influence alcohol-related behaviours in youth, the relationship between neighbourhood socioeconomic context and effectiveness of school-based prevention against underage drinking has been insufficiently investigated. We study whether the social environment affects the impact of a new school-based prevention programme on alcohol use among European students. Methods During the school year 2004-2005, 7079 students 12-14 years of age from 143 schools in nine European centres participated in this cluster randomised controlled trial. Schools were randomly assigned to either control or a 12-session standardised curriculum based on the comprehensive social influence model. Randomisation was blocked within socioeconomic levels of the school environment. Alcohol use and alcohol-related problem behaviours were investigated through a self-completed anonymous questionnaire at baseline and 18 months thereafter. Data were analysed using multilevel models, separately by socioeconomic level. Results At baseline, adolescents in schools of low socioeconomic level were more likely to report problem drinking than other students. Participation in the programme was associated in this group with a decreased odds of reporting episodes of drunkenness (OR = 0.60, 95% CI = 0.44-0.83, intention to get drunk (OR = 0.60, 95% CI = 0.45-0.79, and marginally alcohol-related problem behaviours (OR = 0.70, 95% CI = 0.46-1.06. No significant programme's effects emerged for students in schools of medium or high socioeconomic level. Effects on frequency of alcohol consumption were also stronger among students in disadvantaged schools, although the estimates did not attain statistical significance in any subgroup. Conclusions It is plausible that comprehensive social influence programmes have a more favourable effect on problematic drinking among students in underprivileged social environments. Trial registration ISRCTN: ISRCTN

  1. Multifaceted intervention to enhance the screening and care of hospitalised malnourished children: study protocol for the PREDIRE cluster randomized controlled trial

    Science.gov (United States)

    2013-01-01

    Background Hospital malnutrition is an underestimated problem and as many as half of malnourished patients do not receive appropriate treatment. In order to extend the management of malnutrition in health care facilities, multidisciplinary teams focusing on clinical nutrition were established in France. The establishment of such teams within hospital facilities remains nonetheless difficult. We have consequently developed a multifaceted intervention coordinated by a Nutritional Support Team (NST). Our study aims to evaluate the impact of this multifaceted intervention coordinated by a NST, in adherence to recommended practices for the care of malnourished children, among health care workers of a paediatric university hospital. Methods/design We carried out 1) a six-month observational phase focusing on the medical care procedures relative to malnourished children followed by 2) a cluster randomised controlled trial phase to evaluate the impact of a multidisciplinary nutrition team over an 18 month time frame. Based on power analyses and assuming a conservative intracluster correlation coefficient, 1289 children were needed to detect a 25% difference in rates between the two groups of the cluster trial. The implementation of our intervention was coordinated by the NST and had three major components: a) access to a computerised malnutrition screening system associated with an automatic alert system, b) an awareness campaign directed toward the health care workers and c) a leadership based strategy. Main outcomes included the number of daily weighings during hospitalisation, the investigation of malnutrition etiology and the management of malnutrition by a dietician and/or the NST. Due to the clustered nature of the data with children nested in departments, a generalized estimated equations approach will be used to analyse the impact of the multifaceted intervention on primary and secondary outcomes. Discussion Our results will provide an overall response regarding

  2. Workplace health and safety intervention for child care staff: Rationale, design, and baseline results from the CARE cluster randomized control trial.

    Science.gov (United States)

    Ward, Dianne S; Vaughn, Amber E; Hales, Derek; Viera, Anthony J; Gizlice, Ziya; Bateman, Lori A; Grummon, Anna H; Arandia, Gabriela; Linnan, Laura A

    2018-05-01

    Low-wage workers suffer disproportionately high rates of chronic disease and are important targets for workplace health and safety interventions. Child care centers offer an ideal opportunity to reach some of the lowest paid workers, but these settings have been ignored in workplace intervention studies. Caring and Reaching for Health (CARE) is a cluster-randomized controlled trial evaluating efficacy of a multi-level, workplace-based intervention set in child care centers that promotes physical activity and other health behaviors among staff. Centers are randomized (1:1) into the Healthy Lifestyles (intervention) or the Healthy Finances (attention control) program. Healthy Lifestyles is delivered over six months including a kick-off event and three 8-week health campaigns (magazines, goal setting, behavior monitoring, tailored feedback, prompts, center displays, director coaching). The primary outcome is minutes of moderate and vigorous physical activity (MVPA); secondary outcomes are health behaviors (diet, smoking, sleep, stress), physical assessments (body mass index (BMI), waist circumference, blood pressure, fitness), and workplace supports for health and safety. In total, 56 centers and 553 participants have been recruited and randomized. Participants are predominately female (96.7%) and either Non-Hispanic African American (51.6%) or Non-Hispanic White (36.7%). Most participants (63.4%) are obese. They accumulate 17.4 (±14.2) minutes/day of MVPA and consume 1.3 (±1.4) and 1.3 (±0.8) servings/day of fruits and vegetables, respectively. Also, 14.2% are smokers; they report 6.4 (±1.4) hours/night of sleep; and 34.9% are high risk for depression. Baseline data demonstrate several serious health risks, confirming the importance of workplace interventions in child care. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

  3. Improved HIV and TB Knowledge and Competence Among Mid-level Providers in a Cluster-Randomized Trial of One-on-One Mentorship for Task Shifting.

    Science.gov (United States)

    Naikoba, Sarah; Senjovu, Kaggwa D; Mugabe, Pallen; McCarthy, Carey F; Riley, Patricia L; Kadengye, Damazo T; Dalal, Shona

    2017-08-15

    Health worker shortages pose a challenge to the scale up of HIV care and treatment in Uganda. Training mid-level providers (MLPs) in the provision of HIV and tuberculosis (TB) treatment can expand existing health workforce capacity and access to HIV services. We conducted a cluster-randomized trial of on-site clinical mentorship for HIV and TB care at 10 health facilities in rural Uganda. Twenty MLPs at 5 randomly assigned to an intervention facilities received 8 hours a week of one-on-one mentorship, every 6 weeks over a 9-month period; and another 20 at 5 control facilities received no clinical mentorship. Enrolled MLPs' clinical knowledge and competence in management of HIV and TB was assessed using case scenarios and clinical observation at baseline and immediately after the 9-month intervention. The performance of the study health facilities on 8 TB and HIV care indicators was tracked over the 9-month period using facility patient records. Thirty-nine out 40 enrolled MLPs had case scenario and clinical observation scores for both the baseline and end of intervention assessments. Mentorship was associated with a mean score increase of 16.7% (95% confidence interval: 9.8 to 23.6, P shifting.

  4. Testing the feasibility of a knowledge translation intervention designed to improve chiropractic care for adults with neck pain disorders: study protocol for a pilot cluster-randomized controlled trial.

    Science.gov (United States)

    Dhopte, Prakash; Ahmed, Sara; Mayo, Nancy; French, Simon; Quon, Jeffrey A; Bussières, André

    2016-01-01

    Neck pain in adults is common and a leading cause of physical disability. Recently, a guideline was developed for the management of non-specific neck pain (NSNP) with an aim to improve the quality of the delivery of chiropractic care. One key guideline recommendation is to undertake multimodal care for patients with NSNP. The aim of this pilot study is to determine the feasibility of implementing a multifaceted knowledge translation intervention by promoting the use of multimodal care by chiropractors managing patients with NSNP. The design is a cluster-randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be approached to participate in the study. Thirty consenting chiropractors will be randomized to receive either a theory-based educational intervention in the experimental group or simply a printed copy of the guideline in the control group. Each chiropractor will recruit five neck pain patients (a total of 150 patients) into the study. Development of the multifaceted intervention was informed by the results of a related qualitative study based on the Theoretical Domains Framework and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning, and a printed copy of the practice guideline. Primary feasibility outcomes for both chiropractors and patients include rates of (1) recruitment, (2) retention, and (3) adherence to the intervention. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations (e.g. exercise and self-care prescriptions) at study onset and at 3 months. Secondary outcomes include scores of behavioural constructs (level of knowledge and self-efficacy) for recommended multimodal care. Clinical outcomes include pain intensity and neck pain-specific disability. Analyses from this study will focus on generating point estimates and corresponding 95

  5. Physical exercise at the workplace prevents deterioration of work ability among healthcare workers: cluster randomized controlled trial.

    Science.gov (United States)

    Jakobsen, Markus D; Sundstrup, Emil; Brandt, Mikkel; Jay, Kenneth; Aagaard, Per; Andersen, Lars L

    2015-11-25

    Imbalance between individual resources and work demands can lead to musculoskeletal disorders and reduced work ability. The purpose of this study was to investigate the effect of workplace- versus home-based physical exercise on work ability among healthcare workers. Two hundred female healthcare workers (Age: 42.0, BMI: 24.1, work ability index [WAI]: 43.1) from 18 departments at three Danish hospitals participated (Copenhagen, Denmark, Aug 2013-Jan 2014). Participants were randomly allocated at the cluster level to 10 weeks of: 1) workplace physical exercise (WORK) performed during working hours for 5x10 min per week and up to 5 group-based coaching sessions on motivation for regular physical exercise, or 2) home-based physical exercise (HOME) performed during leisure time for 5x10 min per week. Both groups received ergonomic counseling on patient handling and use of lifting aides. The main outcome measure was the change from baseline to 10-week follow-up in WAI. Significant group by time interaction was observed for WAI (p WORK compared with HOME corresponding to a small effect size (Cohens'd = 0.24). Within-group changes indicated that between-group differences were mainly caused by a reduction in WAI in HOME. Of the seven items of WAI, item 2 (work ability in relation to the demands of the job) and item 5 (sickness absence during the past year) were improved in WORK compared with HOME (P work ability among female healthcare workers. ClinicalTrials.gov NCT01921764 . Registered 10 August 2013.

  6. [Efficacy of motivational interviewing for reducing medication errors in chronic patients over 65 years with polypharmacy: Results of a cluster randomized trial].

    Science.gov (United States)

    Pérula de Torres, Luis Angel; Pulido Ortega, Laura; Pérula de Torres, Carlos; González Lama, Jesús; Olaya Caro, Inmaculada; Ruiz Moral, Roger

    2014-10-21

    To evaluate the effectiveness of an intervention based on motivational interviewing to reduce medication errors in chronic patients over 65 with polypharmacy. Cluster randomized trial that included doctors and nurses of 16 Primary Care centers and chronic patients with polypharmacy over 65 years. The professionals were assigned to the experimental or the control group using stratified randomization. Interventions consisted of training of professionals and revision of patient treatments, application of motivational interviewing in the experimental group and also the usual approach in the control group. The primary endpoint (medication error) was analyzed at individual level, and was estimated with the absolute risk reduction (ARR), relative risk reduction (RRR), number of subjects to treat (NNT) and by multiple logistic regression analysis. Thirty-two professionals were randomized (19 doctors and 13 nurses), 27 of them recruited 154 patients consecutively (13 professionals in the experimental group recruited 70 patients and 14 professionals recruited 84 patients in the control group) and completed 6 months of follow-up. The mean age of patients was 76 years (68.8% women). A decrease in the average of medication errors was observed along the period. The reduction was greater in the experimental than in the control group (F=5.109, P=.035). RRA 29% (95% confidence interval [95% CI] 15.0-43.0%), RRR 0.59 (95% CI:0.31-0.76), and NNT 3.5 (95% CI 2.3-6.8). Motivational interviewing is more efficient than the usual approach to reduce medication errors in patients over 65 with polypharmacy. Copyright © 2013 Elsevier España, S.L.U. All rights reserved.

  7. A cluster randomized controlled cross-over bed net acceptability and preference trial in Solomon Islands: community participation in shaping policy for malaria elimination

    Directory of Open Access Journals (Sweden)

    Appleyard Bridget

    2009-12-01

    Full Text Available Abstract Background A key component of the malaria elimination strategy in Solomon Islands (SI is widespread coverage of long-lasting insecticidal nets (LLINs. The success of this strategy is dependent on LLIN acceptability and compliance. There has been unresolved debate among policy makers and donors as to which type of LLIN would be most appropriate for large-scale distribution in SI, and anecdotal reports of a lack of acceptability of certain brands of LLINs. A cluster randomized controlled crossover bed net acceptability and preference trial was therefore carried out from July to September, 2008 to inform policy and to facilitate community engagement and participation in the selection of the most appropriate LLIN for use in SI. Method A three-stage sampling method was used to randomly select the study population from Malaita Province, SI. Three brands of LLINs were assessed in this study: Olyset®, PermaNet® and DuraNet®. Bed net acceptability and preference were evaluated through surveys at three defined time points after short and longer-term trial of each LLIN. Results The acceptability of PermaNet® after short-term use (96.5% was significantly greater than Olyset® (67.3%, p and DuraNet® (69.8%, p . The acceptability of DuraNet® and Olyset® after short-term use was not significantly different at the 5% level. LLINs that were perceived not to prevent mosquito bites were significantly less acceptable than LLINs that were perceived to prevent mosquito bites (OR 0.15; 95%CI 0.03 to 0.6. LLINs that allow a pleasant night's sleep (OR 6.3; 95%CI:3.3-12.3 and have a soft texture (OR 5.7; 95%CI:1.9-20.5 were considered more acceptable than those that did not. Olyset®'s acceptability decreased over time and this was due to net wrinkling/shrinkage after washing resulting in reduced efficiency in preventing mosquito bites. The increase in DuraNet® acceptability was a result of a reduction in minor adverse events following longer-term use

  8. Baseline characteristics of study sites and women enrolled in a three-arm cluster randomized controlled trial: PMTCT uptake and retention (pure) Malawi.

    Science.gov (United States)

    van Lettow, Monique; Tweya, Hannock; Rosenberg, Nora E; Trapence, Clement; Kayoyo, Virginia; Kasende, Florence; Kaunda, Blessings; Hosseinipour, Mina C; Eliya, Michael; Cataldo, Fabian; Gugsa, Salem; Phiri, Sam

    2017-07-11

    Malawi introduced an ambitious public health program known as "Option B+" which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of WHO clinical stage or CD4 cell count. The PMTCT Uptake and REtention (PURE) study aimed at evaluating the effect of peer-support on care-seeking and retention in care. PURE Malawi was a three-arm cluster randomized controlled trial that compared facility-based and community-based models of peer support to standard of care under Option B+ strategy. Each arm was expected to enroll a minimum of 360 women with a total minimum sample size of 1080 participants. 21 sites (clusters) were selected for inclusion in the study. This paper describes the site selection, recruitment, enrollment process and baseline characteristics of study sites and women enrolled in the trial. Study implementation was managed by 3 partner organizations; each responsible for 7 study sites. The trial was conducted in the South East, South West, and Central West zones of Malawi, the zones where the implementing partners operate. Study sites included 2 district hospitals, 2 mission hospitals, 2 rural hospitals, 13 health centers and 1 private clinic. Enrollment occurred from November 2013 to November 2014, over a median period of 31 weeks (range 17-51) by site. A total of 1269 HIV-infected pregnant (1094) and breastfeeding (175) women, who were eligible to initiate ART under Option B+, were enrolled. Each site reached or surpassed the minimum sample size. Comparing the number of women enrolled versus antenatal cohort reports, sites recruited a median of 90% (IQR 75-100) of eligible reported women. In the majority of sites the ratio of pregnant and lactating women enrolled in the study was similar to the ratio of reported pregnant and lactating women starting ART in the same sites. The median age of all women was 27 (IQR 22-31) years. All women have ≥20 months of possible follow-up time; 96%

  9. Effectiveness of a clinical practice guideline implementation strategy for patients with anxiety disorders in primary care: cluster randomized trial.

    Science.gov (United States)

    Tello-Bernabé, Eugenia; Sanz-Cuesta, Teresa; del Cura-González, Isabel; de Santiago-Hernando, María L; Jurado-Sueiro, Montserrat; Fernández-Girón, Mercedes; García-de Blas, Francisca; Pensado-Freire, Higinio; Góngora-Maldonado, Francisco; de la Puente-Chamorro, María J; Rodríguez-Pasamontes, Carmen; Martín-Iglesias, Susana

    2011-12-01

    Anxiety is a common mental health problem seen in primary care. However, its management in clinical practice varies greatly. Clinical practice guidelines (CPGs) have the potential to reduce variations and improve the care received by patients by promoting interventions of proven benefit. However, uptake and adherence to their recommendations can be low. This study involves a community based on cluster randomized trial in primary healthcare centres in the Madrid Region (Spain). The project aims to determine whether the use of implementation strategy (including training session, information, opinion leader, reminders, audit, and feed-back) of CPG for patients with anxiety disorders in primary care is more effective than usual diffusion. The number of patients required is 296 (148 in each arm), all older than 18 years and diagnosed with generalized anxiety disorder, panic disorder, and panic attacks by the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV). They are chosen by consecutive sampling. The main outcome variable is the change in two or more points into Goldberg anxiety scale at six and twelve months. Secondary outcome variables include quality of life (EuroQol 5D), and degree of compliance with the CPG recommendations on treatment, information, and referrals to mental health services. Main effectiveness will be analyzed by comparing the patients percentage improvement on the Goldberg scale between the intervention group and the control group. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. There is a need to identify effective implementation strategies for CPG for the management of anxiety disorders present in primary care. Ensuring the appropriate uptake of guideline recommendations can reduce clinical variation and improve the care patients receive. ISRCTN: ISRCTN83365316.

  10. Effectiveness of advertising availability of prenatal ultrasound on uptake of antenatal care in rural Uganda: A cluster randomized trial.

    Science.gov (United States)

    Cherniak, William; Anguyo, Geoffrey; Meaney, Christopher; Yuan Kong, Ling; Malhame, Isabelle; Pace, Romina; Sodhi, Sumeet; Silverman, Michael

    2017-01-01

    In rural Uganda pregnant women often lack access to health services, do not attend antenatal care, and tend to utilize traditional healers/birth attendants. We hypothesized that receiving a message advertising that "you will be able to see your baby by ultrasound" would motivate rural Ugandan women who otherwise might use a traditional birth attendant to attend antenatal care, and that those women would subsequently be more satisfied with care. A cluster randomized trial was conducted across eight rural sub-counties in southwestern Uganda. Sub-counties were randomized to a control arm, with advertisement of antenatal care with no mention of portable obstetric ultrasound (four communities, n = 59), or an intervention arm, with advertisement of portable obstetric ultrasound. Advertisement of portable obstetric ultrasound was further divided into intervention A) word of mouth advertisement of portable obstetric ultrasound and antenatal care (one communitity, n = 16), B) radio advertisement of only antenatal care and word of mouth advertisement of antenatal care and portable obstetric ultrasound (one community, n = 7), or C) word of mouth + radio advertisement of both antenatal care and portable obstetric ultrasound (two communities, n = 75). The primary outcome was attendance to antenatal care. 159 women presented to antenatal care across eight sub-counties. The rate of attendance was 65.1 (per 1000 pregnant women, 95% CI 38.3-110.4) where portable obstetric ultrasound was advertised by radio and word of mouth, as compared to a rate of 11.1 (95% CI 6.1-20.1) in control communities (rate ratio 5.9, 95% CI 2.6-13.0, padvertising antenatal care and portable obstetric ultrasound by radio attendance was significantly improved. This study suggests that women can be motivated to attend antenatal care when offered the concrete incentive of seeing their baby.

  11. A Cluster Randomized Controlled Trial on the Effects of Technology-aided Testing and Feedback on Physical Activity and Biological Age Among Employees in a Medium-sized Enterprise.

    Science.gov (United States)

    Liukkonen, Mika; Nygård, Clas-Håkan; Laukkanen, Raija

    2017-12-01

    It has been suggested that engaging technology can empower individuals to be more proactive about their health and reduce their health risks. The aim of the present intervention was to study the effects of technology-aided testing and feedback on physical activity and biological age of employees in a middle-sized enterprise. In all, 121 employees (mean age 42 ± 10 years) participated in the 12-month three-arm cluster randomized trial. The fitness measurement process (Body Age) determined the participants' biological age in years. Physical activity was measured with the International Physical Activity Questionnaire Short Form. Physical activity did not change during the intervention. Biological age (better fitness) improved in all groups statistically significantly ( p  physical activity but may enhance physical fitness measured by biological age.

  12. The effects of humor therapy on nursing home residents measured using observational methods: the SMILE cluster randomized trial.

    Science.gov (United States)

    Low, Lee-Fay; Goodenough, Belinda; Fletcher, Jennifer; Xu, Kenny; Casey, Anne-Nicole; Chenoweth, Lynn; Fleming, Richard; Spitzer, Peter; Bell, Jean-Paul; Brodaty, Henry

    2014-08-01

    To evaluate the effects of humor therapy assessed using observational methods on agitation, engagement, positive behaviors, affect, and contentment. Single-blind cluster randomized controlled trial. A total of 35 Sydney nursing homes. All eligible residents within geographically defined areas within each nursing home were invited to participate. Professional "ElderClowns" provided 9 to 12 weekly humor therapy sessions, augmented by resident engagement by trained staff "LaughterBosses." Controls received usual care. The Behavior Engagement Affect Measure (BEAM) touchpad observational tool was used to capture real-time behavioral data. The tool assesses the duration in seconds of agitation, positive behavior toward others, engagement, and affect (angry, anxious, happy, neutral, sad). Seventeen nursing homes (189 residents) received the intervention and 18 homes (209 residents) received usual care. Over 26 weeks, in comparison with controls, the humor therapy group decreased in duration of high agitation (effect size = 0.168 and 0.129 at 13 and 26 weeks, respectively) and increased in duration of happiness (effect size = 0.4 and 0.236 at 13 and 26 weeks, respectively). We confirmed that humor therapy decreases agitation and also showed that it increases happiness. Researchers may consider evaluating impacts of nonpharmaceutical interventions on positive outcomes. Computer-assisted observational measures should be considered, particularly for residents with dementia and when the reliability of staff is uncertain. Copyright © 2014 AMDA – The Society for Post-Acute and Long-Term Care Medicine. Published by Elsevier Inc. All rights reserved.

  13. Subjective and objective outcomes in randomized clinical trials

    DEFF Research Database (Denmark)

    Moustgaard, Helene; Bello, Segun; Miller, Franklin G

    2014-01-01

    explicitly defined the terms. CONCLUSION: The terms "subjective" and "objective" are ambiguous when used to describe outcomes in randomized clinical trials. We suggest that the terms should be defined explicitly when used in connection with the assessment of risk of bias in a clinical trial......OBJECTIVES: The degree of bias in randomized clinical trials varies depending on whether the outcome is subjective or objective. Assessment of the risk of bias in a clinical trial will therefore often involve categorization of the type of outcome. Our primary aim was to examine how the concepts...... "subjective outcome" and "objective outcome" are defined in methodological publications and clinical trial reports. To put this examination into perspective, we also provide an overview of how outcomes are classified more broadly. STUDY DESIGN AND SETTING: A systematic review of methodological publications...

  14. Using the 4 Pillars™ Practice Transformation Program to increase adult Tdap immunization in a randomized controlled cluster trial.

    Science.gov (United States)

    Nowalk, Mary Patricia; Lin, Chyongchiou J; Pavlik, Valory N; Brown, Anthony E; Zhang, Song; Moehling, Krissy K; Raviotta, Jonathan M; South-Paul, Jeannette E; Hawk, Mary; Ricci, Edmund M; Middleton, Donald B; Patel, Suchita A; Ahmed, Faruque; Zimmerman, Richard K

    2016-09-22

    National adult Tdap vaccination rates are low, reinforcing the need to increase vaccination efforts in primary care offices. The 4 Pillars™ Practice Transformation Program is an evidence-based, step-by-step guide to improving primary care adult vaccination with an online implementation tracking dashboard. This study tested the effectiveness of an intervention to increase adult Tdap vaccination that included the 4 Pillars™ Program, provider education, and one-on-one coaching of practice-based immunization champions. 25 primary care practices participated in a randomized controlled cluster trial (RCCT) in Year 1 (6/1/2013-5/31/2014) and a pre-post study in Year 2 (6/1/2014-1/31/2015). Baseline year was 6/1/2012-5/31/2013, with data analyzed in 2016. Demographic and vaccination data were derived from de-identified electronic medical record (EMR) extractions. The primary outcomes were vaccination rates and percentage point (PP) changes/year. The cohort consisted of 70,549 patients ⩾18years who were seen in the practices ⩾1 time each year, with a baseline mean age=55years; 35% were men; 56% were non-white; 35% were Hispanic and 20% were on Medicare. Baseline vaccination rate averaged 35%. In the Year 1 RCCT, cumulative Tdap vaccination increased significantly in both intervention and control groups; in both cities, the percentage point increases in the intervention groups (7.7 PP in Pittsburgh and 9.9 PP in Houston) were significantly higher (P<0.001) than in the control groups (6.4 PP in Pittsburgh and 7.6 PP in Houston). In the Year 2 pre-post study, in both cities, active intervention groups increased rates significantly more (6.2 PP for both) than maintenance groups (2.2 PP in Pittsburgh and 4.1 PP in Houston; P<0.001). An intervention that includes the 4 Pillars™ Practice Transformation Program, staff education and coaching is effective for increasing adult Tdap immunization rates within primary care practices. Clinical Trial Registry Name/Number: NCT

  15. Family-Based Cluster Randomized Controlled Trial Enhancing Physical Activity and Motor Competence in 4-7-Year-Old Children.

    Directory of Open Access Journals (Sweden)

    Arto Laukkanen

    Full Text Available Little is known of how to involve families in physical activity (PA interventions for children. In this cluster randomized controlled trial, we recruited families with four- to seven-year-old children to participate in a year-long study where parents in the intervention group families (n = 46 received tailored counseling to increase children’s PA. Structured PA was not served. Control group families (n = 45 did not receive any counseling. PA in all children (n = 91; mean age 6.16 ± 1.13 years at the baseline was measured by accelerometers at the baseline and after three, six, nine and 12 months. Motor competence (MC (n = 89 was measured at the baseline and after six and 12 months by a KTK (KörperkoordinationsTest für Kinder and throwing and catching a ball (TCB protocols. The effect of parental counseling on study outcomes was analyzed by a linear mixed-effects model fit by REML and by a Mann-Whitney U test in the case of the TCB. As season was hypothesized to affect counseling effect, an interaction of season on the study outcomes was examined. The results show significant decrease of MVPA in the intervention group when compared to the control group (p < .05. The TCB showed a nearly significant improvement at six months in the intervention group compared to the controls (p = .051, but not at 12 months. The intervention group had a steadier development of the KTK when the interaction of season was taken into account. In conclusion, more knowledge of family constructs associating with the effectiveness of counseling is needed for understanding how to enhance PA in children by parents. However, a hypothesis may be put forward that family-based counseling during an inactive season rather than an active season may provide a more lasting effect on the development of KTK in children.Controlled-Trials.com ISRCTN28668090.

  16. Effects of Prenatal Multiple Micronutrient Supplementation on Fetal Growth Factors: A Cluster-Randomized, Controlled Trial in Rural Bangladesh.

    Directory of Open Access Journals (Sweden)

    Alison D Gernand

    Full Text Available Prenatal multiple micronutrient (MM supplementation improves birth weight through increased fetal growth and gestational age, but whether maternal or fetal growth factors are involved is unclear. Our objective was to examine the effect of prenatal MM supplementation on intrauterine growth factors and the associations between growth factors and birth outcomes in a rural setting in Bangladesh. In a double-blind, cluster-randomized, controlled trial of MM vs. iron and folic acid (IFA supplementation, we measured placental growth hormone (PGH at 10 weeks and PGH and human placental lactogen (hPL at 32 weeks gestation in maternal plasma (n = 396 and insulin, insulin-like growth factor-1 (IGF-1, and IGF binding protein-1 (IGFBP-1 in cord plasma (n = 325. Birth size and gestational age were also assessed. Early pregnancy mean (SD BMI was 19.5 (2.4 kg/m2 and birth weight was 2.68 (0.41 kg. There was no effect of MM on concentrations of maternal hPL or PGH, or cord insulin, IGF-1, or IGFBP-1. However, among pregnancies of female offspring, hPL concentration was higher by 1.1 mg/L in the third trimester (95% CI: 0.2, 2.0 mg/L; p = 0.09 for interaction; and among women with height <145 cm, insulin was higher by 59% (95% CI: 3, 115%; p = 0.05 for interaction in the MM vs. IFA group. Maternal hPL and cord blood insulin and IGF-1 were positively, and IGFBP-1 was negatively, associated with birth weight z score and other measures of birth size (all p<0.05. IGF-1 was inversely associated with gestational age (p<0.05, but other growth factors were not associated with gestational age or preterm birth. Prenatal MM supplementation had no overall impact on intrauterine growth factors. MM supplementation altered some growth factors differentially by maternal early pregnancy nutritional status and sex of the offspring, but this should be examined in other studies.ClinicalTrials.gov NCT00860470.

  17. A store-based intervention to increase fruit and vegetable consumption: The El Valor de Nuestra Salud cluster randomized controlled trial.

    Science.gov (United States)

    Ayala, Guadalupe X; Baquero, Barbara; Pickrel, Julie L; Mayer, Joni; Belch, George; Rock, Cheryl L; Linnan, Laura; Gittelsohn, Joel; Sanchez-Flack, Jennifer; Elder, John P

    2015-05-01

    Most evidence-based interventions to improve fruit and vegetable (FV) consumption target individual behaviors and family systems; however, these changes are difficult to sustain without environmental support. This paper describes an innovative social and structural food store-based intervention to increase availability and accessibility of FVs in tiendas (small- to medium-sized Latino food stores) and purchasing and consumption of FVs among tienda customers. Using a cluster randomized controlled trial with 16 tiendas pair-matched and randomized to an intervention or wait-list control condition, this study will evaluate a 2-month intervention directed at tiendas, managers, and employees followed by a 4-month customer-directed food marketing campaign. The intervention involves social (e.g., employee trainings) and structural (e.g., infrastructure) environmental changes. Three hundred sixty-nine customers (approximately 23 per tienda) serve on an evaluation cohort and complete assessments (interviews and measurements of weight) at 3 time points: baseline, 6-months post-baseline, and 12-months post-baseline. The primary study outcome is customer-reported daily consumption of FVs. Manager interviews and monthly tienda audits and collection of sales data will provide evidence of tienda-level intervention effects, our secondary outcomes. Process evaluation methods assess dose delivered, dose received, and fidelity. Recruitment of tiendas, managers, employees, and customers is complete. Demographic data shows that 30% of the customers are males, thus providing a unique opportunity to examine the effects of a tienda-based intervention on Latino men. Determining whether a tienda-based intervention can improve customers' FV purchasing and consumption will provide key evidence for how to create healthier consumer food environments. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. A store-based intervention to increase fruit and vegetable consumption: The El Valor de Nuestra Salud cluster randomized controlled trial

    Science.gov (United States)

    Ayala, Guadalupe X.; Baquero, Barbara; Pickrel, Julie L.; Mayer, Joni; Belch, George; Rock, Cheryl L.; Linnan, Laura; Gittelsohn, Joel; Sanchez-Flack, Jennifer; Elder, John P.

    2015-01-01

    Introduction Most evidence-based interventions to improve fruit and vegetable (FV) consumption target individual behaviors and family systems; however, these changes are difficult to sustain without environmental support. This paper describes an innovative social and structural food store-based intervention to increase availability and accessibility of FVs in tiendas (small-to medium-sized Latino food stores) and purchasing and consumption of FVs among tienda customers. Methods Using a cluster randomized controlled trial with 16 tiendas pair-matched and randomized to an intervention or wait-list control condition, this study will evaluate a 2-month intervention directed at tiendas, managers, and employees followed by a 4-month customer-directed food marketing campaign. The intervention involves social (e.g., employee trainings) and structural (e.g., infrastructure) environmental changes. Three hundred sixty-nine customers (approximately 23 per tienda) serve on an evaluation cohort and complete assessments (interviews and measurements of weight) at 3 time points: baseline, 6-months post-baseline, and 12-months post-baseline. The primary study outcome is customer-reported daily consumption of FVs. Manager interviews and monthly tienda audits and collection of sales data will provide evidence of tienda-level intervention effects, our secondary outcomes. Process evaluation methods assess dose delivered, dose received, and fidelity. Results Recruitment of tiendas, managers, employees, and customers is complete. Demographic data shows that 30% of the customers are males, thus providing a unique opportunity to examine the effects of a tienda-based intervention on Latino men. Conclusions Determining whether a tienda-based intervention can improve customers’ FV purchasing and consumption will provide key evidence for how to create healthier consumer food environments. PMID:25924592

  19. Diagnosing Cervical Neoplasia in Rural Brazil Using a Mobile Van Equipped with In Vivo Microscopy: A Cluster-Randomized Community Trial.

    Science.gov (United States)

    Hunt, Brady; Fregnani, José Humberto Tavares Guerreiro; Schwarz, Richard A; Pantano, Naitielle; Tesoni, Suelen; Possati-Resende, Júlio César; Antoniazzi, Marcio; de Oliveira Fonseca, Bruno; de Macêdo Matsushita, Graziela; Scapulatempo-Neto, Cristovam; Kerr, Ligia; Castle, Philip E; Schmeler, Kathleen; Richards-Kortum, Rebecca

    2018-06-01

    Cervical cancer is a leading cause of death in underserved areas of Brazil. This prospective randomized trial involved 200 women in southern/central Brazil with abnormal Papanicolaou tests. Participants were randomized by geographic cluster and referred for diagnostic evaluation either at a mobile van upon its scheduled visit to their local community, or at a central hospital. Participants in both arms underwent colposcopy, in vivo microscopy, and cervical biopsies. We compared rates of diagnostic follow-up completion between study arms, and also evaluated the diagnostic performance of in vivo microscopy compared with colposcopy. There was a 23% absolute and 37% relative increase in diagnostic follow-up completion rates for patients referred to the mobile van (102/117, 87%) compared with the central hospital (53/83, 64%; P = 0.0001; risk ratio = 1.37, 95% CI, 1.14-1.63). In 229 cervical sites in 144 patients, colposcopic examination identified sites diagnosed as cervical intraepithelial neoplasia grade 2 or more severe (CIN2+; 85 sites) with a sensitivity of 94% (95% CI, 87%-98%) and specificity of 50% (95% CI, 42%-58%). In vivo microscopy with real-time automated image analysis identified CIN2+ with a sensitivity of 92% (95% CI, 84%-97%) and specificity of 48% (95% CI, 40%-56%). Women referred to the mobile van were more likely to complete their diagnostic follow-up compared with those referred to a central hospital, without compromise in clinical care. In vivo microscopy in a mobile van provides automated diagnostic imaging with sensitivity and specificity similar to colposcopy. Cancer Prev Res; 11(6); 359-70. ©2018 AACR . ©2018 American Association for Cancer Research.

  20. Effects of a lighter, smaller football on acute match injuries in adolescent female football: a pilot cluster-randomized controlled trial.

    Science.gov (United States)

    Zebis, Mette K; Thorborg, Kristian; Andersen, Lars L; Møller, Merete; Christensen, Karl B; Clausen, Mikkel B; Hölmich, Per; Wedderkopp, Niels; Andersen, Thomas B; Krustrup, Peter

    2018-05-01

    The high injury incidence during match-play in female adolescent football is a major concern. In football, males and females play matches with the same football size. No studies have investigated the effect of football size on injury incidence in female adolescent football. Thus, the aim of the present study was to investigate the effects of introducing a lighter, smaller football on the injury pattern in female adolescent football. We conducted a pilot cluster randomized controlled trial including 26 football teams representing 346 adolescent female football players (age 15-18 years). The teams were randomized to a new lighter, smaller football (INT, N.=12 teams) or a traditional FIFA size 5 football (CON, N.=14 teams) during a full match-season. Acute time-loss injuries and football-exposure during match-play were reported weekly by text-message questions and verified subsequently by telephone interview. In total, 46 acute time-loss injuries were registered (5 severe injuries), yielding an incidence rate of 15.2 injuries per 1000 hours of match-play (95% CI: 8.5-27.2) in INT and 18.6 injuries per 1000 hours of match-play (95% CI: 14.0-24.8) in CON. The estimated 22% greater injury incidence rate risk (IRR: 1.22 [95% CI: 0.64-2.35]) in the CON group was not significant. With an IRR of 1.22, a future RCT main study would need to observe 793 acute time-loss injuries during match-play, in order to have a power of 80%. A large-scaled RCT is required to definitively test for beneficial or harmful effects of a lighter, smaller football in adolescent female football.

  1. A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria

    Science.gov (United States)

    Mbonye, Anthony K.; Magnussen, Pascal; Lal, Sham; Hansen, Kristian S.; Cundill, Bonnie; Chandler, Clare; Clarke, Siân E.

    2015-01-01

    Background Inappropriate treatment of malaria is widely reported particularly in areas where there is poor access to health facilities and self-treatment of fevers with anti-malarial drugs bought in shops is the most common form of care-seeking. The main objective of the study was to examine the impact of introducing rapid diagnostic tests for malaria (mRDTs) in registered drug shops in Uganda, with the aim to increase appropriate treatment of malaria with artemisinin-based combination therapy (ACT) in patients seeking treatment for fever in drug shops. Methods A cluster-randomized trial of introducing mRDTs in registered drug shops was implemented in 20 geographical clusters of drug shops in Mukono district, central Uganda. Ten clusters were randomly allocated to the intervention (diagnostic confirmation of malaria by mRDT followed by ACT) and ten clusters to the control arm (presumptive treatment of fevers with ACT). Treatment decisions by providers were validated by microscopy on a reference blood slide collected at the time of consultation. The primary outcome was the proportion of febrile patients receiving appropriate treatment with ACT defined as: malaria patients with microscopically-confirmed presence of parasites in a peripheral blood smear receiving ACT or rectal artesunate, and patients with no malaria parasites not given ACT. Findings A total of 15,517 eligible patients (8672 intervention and 6845 control) received treatment for fever between January-December 2011. The proportion of febrile patients who received appropriate ACT treatment was 72·9% versus 33·7% in the control arm; a difference of 36·1% (95% CI: 21·3 – 50·9), pshop vendors adhered to the mRDT results, reducing over-treatment of malaria by 72·6% (95% CI: 46·7– 98·4), pshop vendors using presumptive diagnosis (control arm). Conclusion Diagnostic testing with mRDTs compared to presumptive treatment of fevers implemented in registered drug shops substantially improved appropriate

  2. The impact of nurse-driven targeted HIV screening in 8 emergency departments: study protocol for the DICI-VIH cluster-randomized two-period crossover trial.

    Science.gov (United States)

    Leblanc, Judith; Rousseau, Alexandra; Hejblum, Gilles; Durand-Zaleski, Isabelle; de Truchis, Pierre; Lert, France; Costagliola, Dominique; Simon, Tabassome; Crémieux, Anne-Claude

    2016-02-01

    In 2010, to reduce late HIV diagnosis, the French national health agency endorsed non-targeted HIV screening in health care settings. Despite these recommendations, non-targeted screening has not been implemented and only physician-directed diagnostic testing is currently performed. A survey conducted in 2010 in 29 French Emergency Departments (EDs) showed that non-targeted nurse-driven screening was feasible though only a few new HIV diagnoses were identified, predominantly among high-risk groups. A strategy targeting high-risk groups combined with current practice could be shown to be feasible, more efficient and cost-effective than current practice alone. DICI-VIH (acronym for nurse-driven targeted HIV screening) is a multicentre, cluster-randomized, two-period crossover trial. The primary objective is to compare the effectiveness of 2 strategies for diagnosing HIV among adult patients visiting EDs: nurse-driven targeted HIV screening combined with current practice (physician-directed diagnostic testing) versus current practice alone. Main secondary objectives are to compare access to specialist consultation and how early HIV diagnosis occurs in the course of the disease between the 2 groups, and to evaluate the implementation, acceptability and cost-effectiveness of nurse-driven targeted screening. The 2 strategies take place during 2 randomly assigned periods in 8 EDs of metropolitan Paris, where 42 % of France's new HIV patients are diagnosed every year. All patients aged 18 to 64, not presenting secondary to HIV exposure are included. During the intervention period, patients are invited to fill a 7-item questionnaire (country of birth, sexual partners and injection drug use) in order to select individuals who are offered a rapid test. If the rapid test is reactive, a follow-up visit with an infectious disease specialist is scheduled within 72 h. Assuming an 80 % statistical power and a 5 % type 1 error, with 1.04 and 3.38 new diagnoses per 10,000 patients in

  3. Effectiveness of a girls' empowerment programme on early childbearing, marriage and school dropout among adolescent girls in rural Zambia: study protocol for a cluster randomized trial.

    Science.gov (United States)

    Sandøy, Ingvild Fossgard; Mudenda, Mweetwa; Zulu, Joseph; Munsaka, Ecloss; Blystad, Astrid; Makasa, Mpundu C; Mæstad, Ottar; Tungodden, Bertil; Jacobs, Choolwe; Kampata, Linda; Fylkesnes, Knut; Svanemyr, Joar; Moland, Karen Marie; Banda, Richard; Musonda, Patrick

    2016-12-09

    Adolescent pregnancies pose a risk to the young mothers and their babies. In Zambia, 35% of young girls in rural areas have given birth by the age of 18 years. Pregnancy rates are particularly high among out-of-school girls. Poverty, low enrolment in secondary school, myths and community norms all contribute to early childbearing. This protocol describes a trial aiming to measure the effect on early childbearing rates in a rural Zambian context of (1) economic support to girls and their families, and (2) combining economic support with a community intervention to enhance knowledge about sexual and reproductive health and supportive community norms. This cluster randomized controlled trial (CRCT) will have three arms. The clusters are rural schools with surrounding communities. Approximately 4900 girls in grade 7 in 2016 will be recruited from 157 schools in 12 districts. In one intervention arm, participating girls and their guardians will be offered cash transfers and payment of school fees. In the second intervention arm, there will be both economic support and a community intervention. The interventions will be implemented for approximately 2 years. The final survey will be 4.5 years after recruitment. The primary outcomes will be "incidence of births within 8 months of the end of the intervention period", "incidence of births before girls' 18th birthday" and "proportion of girls who sit for the grade 9 exam". Final survey interviewers will be unaware of the intervention status of respondents. Analysis will be by intention-to-treat and adjusted for cluster design and confounders. Qualitative process evaluation will be conducted. This is the first CRCT to measure the effect of combining economic support with a community intervention to prevent adolescent childbearing in a low- or middle-income country. We have designed a programme that will be sustainable and feasible to scale up. The findings will be relevant for programmes for adolescent reproductive health in

  4. Cluster-randomized trial on complementary and responsive feeding education to caregivers found improved dietary intake, growth and development among rural Indian toddlers.

    Science.gov (United States)

    Vazir, Shahnaz; Engle, Patrice; Balakrishna, Nagalla; Griffiths, Paula L; Johnson, Susan L; Creed-Kanashiro, Hilary; Fernandez Rao, Sylvia; Shroff, Monal R; Bentley, Margaret E

    2013-01-01

    Inadequate feeding and care may contribute to high rates of stunting and underweight among children in rural families in India. This cluster-randomized trial tested the hypothesis that teaching caregivers appropriate complementary feeding and strategies for how to feed and play responsively through home-visits would increase children's dietary intake, growth and development compared with home-visit-complementary feeding education alone or routine care. Sixty villages in Andhra Pradesh were randomized into three groups of 20 villages with 200 mother-infant dyads in each group. The control group (CG) received routine Integrated Child Development Services (ICDS); the complementary feeding group (CFG) received the ICDS plus the World Health Organization recommendations on breastfeeding and complementary foods; and the responsive complementary feeding and play group (RCF&PG) received the same intervention as the CFG plus skills for responsive feeding and psychosocial stimulation. Both intervention groups received bi-weekly visits by trained village women. The groups did not differ at 3 months on socioeconomic status, maternal and child nutritional indices, and maternal depression. After controlling for potential confounding factors using the mixed models approach, the 12-month intervention to the CFG and RCF&PG significantly (P Mental Development scores (mean = 3.1, CI: 0.8-5.3) in the RCF&PG (but not CFG) compared with CG. Community-based educational interventions can improve dietary intake, length (CFG) and mental development (RCF&PG) for children under 2 years in food-secure rural Indian families. © 2012 Blackwell Publishing Ltd.

  5. Cluster-randomized trial on complementary and responsive feeding education to caregivers found improved dietary intake, growth, and development among rural Indian toddlers

    Science.gov (United States)

    Vazir, Shahnaz; Engle, Patrice; Balakrishna, Nagalla; Griffiths, Paula L.; Johnson, Susan L.; Creed-Kanashiro, Hilary; Rao, Sylvia Fernandez; Shroff, Monal R.; Bentley, Margaret E.

    2012-01-01

    Inadequate feeding and care may contribute to high rates of stunting and underweight among children in rural families in India. This cluster-randomized trial tested the hypothesis that teaching caregivers appropriate complementary feeding, and strategies for how to feed and play responsively through home-visits would increase children’s dietary intake, growth, and development compared to home-visit-complementary feeding education alone or routine care. Sixty villages in Andhra Pradesh were randomized into 3 groups1 of 20 villages with 200 mother-infant dyads in each group. The Control Group (CG), received routine Integrated Child Development Services (ICDS); the Complementary Feeding Group (CFG), received the ICDS plus the World Health Organization recommendations on breastfeeding and complementary foods; and the Responsive Complementary Feeding & Play Group (RCF&PG) received the same intervention as the CFG plus skills for responsive feeding and psychosocial stimulation. Both intervention groups received bi-weekly visits by trained village women. The groups did not differ at 3 months on socioeconomic status, maternal and child nutritional indices and maternal depression. After controlling for potential confounding factors using the mixed models approach, the twelve-month intervention to the CFG and RCF&PG significantly (pDevelopment scores(Mean=3.1, CI: 0.8–5.3) in the RCF&PG (but not CFG) compared to CG. Community-based educational interventions can improve dietary intake, length (CFG), and mental development (RCF&PG) for children under two years in food-secure rural Indian families. PMID:22625182

  6. Special features of health services and register based trials – experiences from a randomized trial of childbirth classes

    Directory of Open Access Journals (Sweden)

    Sevón Tiina

    2008-06-01

    Full Text Available Abstract Background Evaluating complex interventions in health services faces various difficulties, such as making practice changes and costs. Ways to increase research capacity and decrease costs include making research an integral part of health services and using routine data to judge outcomes. The purpose of this article is to report the feasibility of a pilot trial relying solely on routinely collected register data and being based on ordinary health services. Methods The example intervention was education to public health nurses (PHN (childbirth classes to reduce caesarean section rates via pre-delivery considerations of pregnant women. 20 maternity health centers (MHC were paired and of each 10 pairs, one MHC was randomly allocated to an intervention group and the other to a control; 8 pairs with successful intervention were used in the analyses (1601 mothers. The women visiting to the study maternity centers were identified from the Customer Register of Helsinki City. A list of the study women was made using the mother's personal identification number, visit date, the maternity center code, birth date and gestation length. The mode of delivery and health outcomes were retrieved from the Finnish Medical Birth Register (MBR. Process data of the intervention are based on observations, written feedback and questionnaires from PHNs, and project correspondence. Results It took almost two years to establish how to obtain permissions and to actually obtain it for the trial. Obtaining permissions for the customer and outcome data and register linkages was unproblematic and the cluster randomization provided comparable groups. The intervention did not succeed well. Had the main aim of the trial been to cause a change in PHNs behavior, we would have very likely intensified the intervention during the trial. Conclusion Our experiences encourage the use of trials that obtain their outcomes from registers. Changing the behavior of ordinary health

  7. Randomized controlled trial on promoting influenza vaccination in general practice waiting rooms.

    Directory of Open Access Journals (Sweden)

    Christophe Berkhout

    Full Text Available Most of general practitioners (GPs use advertising in their waiting rooms for patient's education purposes. Patients vaccinated against seasonal influenza have been gradually lessening. The objective of this trial was to assess the effect of an advertising campaign for influenza vaccination using posters and pamphlets in GPs' waiting rooms.Registry based 2/1 cluster randomized controlled trial, a cluster gathering the enlisted patients of 75 GPs aged over 16 years. The trial, run during the 2014-2015 influenza vaccination campaign, compared patient's awareness from being in 50 GPs' standard waiting rooms (control group versus that of waiting in 25 rooms from GPs who had received and exposed pamphlets and one poster on influenza vaccine (intervention group, in addition to standard mandatory information. The main outcome was the number of vaccination units delivered in pharmacies. Data were extracted from the SIAM-ERASME claim database of the Health Insurance Fund of Lille-Douai (France. The association between the intervention (yes/no and the main outcome was assessed through a generalized estimating equation. Seventy-five GPs enrolled 10,597 patients over 65 years or suffering from long lasting diseases (intervention/control as of 3781/6816 patients from October 15, 2014 to February 28, 2015. No difference was found regarding the number of influenza vaccination units delivered (Relative Risk (RR = 1.01; 95% Confidence interval: 0.97 to 1.05; p = 0.561.Effects of the monothematic campaign promoting vaccination against influenza using a poster and pamphlets exposed in GPs' waiting rooms could not be demonstrated.

  8. Effects of community-wide vaccination with PCV-7 on pneumococcal nasopharyngeal carriage in the Gambia: a cluster-randomized trial.

    Directory of Open Access Journals (Sweden)

    Anna Roca

    2011-10-01

    Full Text Available Introduction of pneumococcal conjugate vaccines (PCVs of limited valency is justified in Africa by the high burden of pneumococcal disease. Long-term beneficial effects of PCVs may be countered by serotype replacement. We aimed to determine the impact of PCV-7 vaccination on pneumococcal carriage in rural Gambia.A cluster-randomized (by village trial of the impact of PCV-7 on pneumococcal nasopharyngeal carriage was conducted in 21 Gambian villages between December 2003 to June 2008 (5,441 inhabitants in 2006. Analysis was complemented with data obtained before vaccination. Because efficacy of PCV-9 in young Gambian children had been shown, it was considered unethical not to give PCV-7 to young children in all of the study villages. PCV-7 was given to children below 30 mo of age and to those born during the trial in all study villages. Villages were randomized (older children and adults to receive one dose of PCV-7 (11 vaccinated villages or meningococcal serogroup C conjugate vaccine (10 control villages. Cross-sectional surveys (CSSs to collect nasopharyngeal swabs were conducted before vaccination (2,094 samples in the baseline CSS, and 4-6, 12, and 22 mo after vaccination (1,168, 1,210, and 446 samples in CSS-1, -2, and -3, respectively. A time trend analysis showed a marked fall in the prevalence of vaccine-type pneumococcal carriage in all age groups following vaccination (from 23.7% and 26.8% in the baseline CSS to 7.1% and 8.5% in CSS-1, in vaccinated and control villages, respectively. The prevalence of vaccine-type pneumococcal carriage was lower in vaccinated than in control villages among older children (5 y to <15 y of age and adults (≥15 y of age at CSS-2 (odds ratio [OR] = 0.15 [95% CI 0.04-0.57] and OR = 0.32 [95% CI 0.10-0.98], respectively and at CSS-3 (OR = 0.37 [95% CI 0.15-0.90] for older children, and 0% versus 7.6% for adults in vaccinated and control villages, respectively. Differences in the prevalence of

  9. Study protocol: cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care: cluster randomized controlled trial.

    Science.gov (United States)

    Beck, Anne Marie; Gøgsig Christensen, Annette; Stenbæk Hansen, Birthe; Damsbo-Svendsen, Signe; Kreinfeldt Skovgaard Møller, Tina; Boll Hansen, Eigil; Keiding, Hans

    2014-08-28

    Older adults in nursing home and home-care are a particularly high-risk population for weight loss or poor nutrition. One negative consequence of undernutrition is increased health care costs. Several potentially modifiable nutritional risk factors increase the likelihood of weight loss or poor nutrition. Hence a structured and multidisciplinary approach, focusing on the nutritional risk factors and involving e.g. dieticians, occupational therapists, and physiotherapist, may be necessary to achieve benefits. Up till now a few studies have been done evaluating the cost-effectiveness of nutritional support among undernourished older adults and none of these have used such a multidisciplinary approach. An 11 week cluster randomized trial to assess the cost-effectiveness of multidisciplinary nutritional support for undernutrition in older adults in nursing home and home-care, identified by screening with the Eating validation Scheme. Before start of the study there will be performed a train-the-trainer intervention involving educated nutrition coordinators.In addition to the nutrition coordinator, the participants assigned to the intervention group strategy will receive multidisciplinary nutrition support. Focus will be on treatment of the potentially modifiable nutritional risk factors identified by screening, by involving physiotherapist, registered dietician, and occupational therapist, as relevant and independent of the municipality's ordinary assessment and referral system.The primary outcome parameter will be change in quality of life (by means of Euroquol-5D-3L). Secondary outcomes will be: physical performance (chair stand), nutritional status (weight, Body Mass Index and hand-grip strength), oral care, fall incidents, hospital admissions, rehabilitation stay, moving to nursing homes (for participants from home-care), use of social services and mortality.An economic evaluation will be conducted to evaluate the cost-effectiveness of the multidisciplinary

  10. On the limiting characteristics of quantum random number generators at various clusterings of photocounts

    Science.gov (United States)

    Molotkov, S. N.

    2017-03-01

    Various methods for the clustering of photocounts constituting a sequence of random numbers are considered. It is shown that the clustering of photocounts resulting in the Fermi-Dirac distribution makes it possible to achieve the theoretical limit of the random number generation rate.

  11. Does training frequency and supervision affect compliance, performance and muscular health? A cluster randomized controlled trial.

    Science.gov (United States)

    Dalager, Tina; Bredahl, Thomas G V; Pedersen, Mogens T; Boyle, Eleanor; Andersen, Lars L; Sjøgaard, Gisela

    2015-10-01

    The aim was to determine the effect of one weekly hour of specific strength training within working hours, performed with the same total training volume but with different training frequencies and durations, or with different levels of supervision, on compliance, muscle health and performance, behavior and work performance. In total, 573 office workers were cluster-randomized to: 1 WS: one 60-min supervised session/week, 3 WS: three 20-min supervised sessions/week, 9 WS: nine 7-min supervised sessions/week, 3 MS: three 20-min sessions/week with minimal supervision, or REF: a reference group without training. Outcomes were diary-based compliance, total training volume, muscle performance and questionnaire-based health, behavior and work performance. Comparisons were made among the WS training groups and between 3 WS and 3 MS. If no difference, training groups were collapsed (TG) and compared with REF. Results demonstrated similar degrees of compliance, mean(range) of 39(33-44)%, and total training volume, 13.266(11.977-15.096)kg. Musculoskeletal pain in neck and shoulders were reduced with approx. 50% in TG, which was significant compared with REF. Only the training groups improved significantly their muscle strength 8(4-13)% and endurance 27(12-37)%, both being significant compared with REF. No change in workability, productivity or self-rated health was demonstrated. Secondary analysis showed exercise self-efficacy to be a significant predictor of compliance. Regardless of training schedule and supervision, similar degrees of compliance were shown together with reduced musculoskeletal pain and improved muscle performance. These findings provide evidence that a great degree of flexibility is legitimate for companies in planning future implementation of physical exercise programs at the workplace. ClinicalTrials.gov, number NCT01027390. Copyright © 2015 Elsevier Ltd. All rights reserved.

  12. Interventions to address deficits of pharmacological pain management in nursing home residents--A cluster-randomized trial.

    Science.gov (United States)

    Könner, F; Budnick, A; Kuhnert, R; Wulff, I; Kalinowski, S; Martus, P; Dräger, D; Kreutz, R

    2015-10-01

    To evaluate the effect of interventions for general practitioners and nursing home staff to improve pain severity and appropriateness of pain medication in nursing home residents (NHR). This cluster-randomized controlled trial was conducted in six nursing homes in the intervention and control group, respectively. Pain management was analysed before (T0) and after (T1, T2) an educational intervention in 239 NHR, aged ≥65 years, without moderate or severe cognitive impairment. Primary and secondary outcomes were average pain severity and appropriateness of pain medication as determined with the Numeric Rating Scale and Pain Medication Appropriateness Scale (PMASD ), respectively. At T0, 72.2% and 73.7% of NHR (mean age 83 years) reported pain (average pain severity 2.4) in the intervention and control group, respectively. The PMASD at T0 was 53.9 in the intervention group and 60.8 in the control group (p = 0.12), while 20.6% compared to 6.9% (p = 0.009) received no pain medication in the two groups. At T2, non-significant improvements in the average pain severity (1.59) and PMASD (61.07) were observed in the intervention group. Moreover, the mean individual PMASD increased by 8.09 (p = 0.03) and the proportion of NHR without pain medication decreased by 50% (p = 0.03) in the intervention group. No appreciable changes were found in the control group at T2. NHR exhibited a high prevalence of pain with overall low severity, while a high proportion of individuals received inappropriate pain medications. Both findings were not significantly improved by the intervention, although some aspects of drug treatment were meaningful improved. © 2015 European Pain Federation - EFIC®

  13. Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial

    Directory of Open Access Journals (Sweden)

    Suijker Jacqueline J

    2012-04-01

    Full Text Available Abstract Background Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination. Methods/Design In a cluster randomized controlled trial, with the general practice as the unit of randomization, 1281 participants from 25 general practices will be enrolled in each condition to compare the intervention with usual care. The intervention will focus on older persons who are at increased risk for functional decline, identified by an Identification of Seniors at Risk Primary Care (ISAR-PC score (≥ 2. These older persons will receive a comprehensive geriatric assessment, an individually tailored care and treatment plan, consisting of multifactorial, evidence-based interventions and subsequent nurse-led care coordination. The control group will receive 'care as usual' by the general practitioner (GP. The main outcome after 12 months is the level of physical functioning on the modified Katz-15 index score. The secondary outcomes are health-related quality of life, psychological and social functioning, healthcare utilization and institutionalization. Furthermore, a process evaluation and cost-effectiveness analysis will be performed. Discussion This study will provide new knowledge regarding the effectiveness and feasibility of a comprehensive geriatric assessment, multifactorial interventions and nurse-led elderly care in general practice. Trial registration NTR2653 Grant Unrestricted grant 'The Netherlands Organisation for Health Research and development' no 313020201

  14. Validity of randomized clinical trials in gastroenterology from 1964-2000

    DEFF Research Database (Denmark)

    Kjaergard, Lise L; Frederiksen, Sarah L; Gluud, Christian

    2002-01-01

    The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000.......The internal validity of clinical trials depends on the adequacy of the reported methodological quality. We assessed the methodological quality of all 383 randomized clinical trials published in GASTROENTEROLOGY as original articles from 1964 to 2000....

  15. An integrated intervention to reduce intimate partner violence and psychological distress with refugees in low-resource settings: study protocol for the Nguvu cluster randomized trial.

    Science.gov (United States)

    Tol, Wietse A; Greene, M Claire; Likindikoki, Samuel; Misinzo, Lusia; Ventevogel, Peter; Bonz, Ann G; Bass, Judith K; Mbwambo, Jessie K K

    2017-05-18

    Intimate partner violence (IPV) is a critical public health and human rights concern globally, including for refugee women in low-resource settings. Little is known about effective interventions for this population. IPV and psychological distress have a bi-directional relationship, indicating the potential benefit of a structured psychological component as part of efforts to reduce IPV for women currently in violent relationships. This protocol describes a cluster randomized controlled trial aimed at evaluating an 8-session integrated psychological and advocacy intervention (Nguvu) with female adult survivors of past-year IPV displaying moderate to severe psychological distress. Outcomes are reductions in: recurrence of IPV; symptoms of anxiety, depression and post-traumatic stress (primary); and functional impairment (secondary). Hypothesized mediators of the intervention are improvements in social support, coping skills and support seeking. We will recruit 400 participants from existing women's support groups operating within villages in Nyarugusu refugee camp, Tanzania. Women's groups will be randomized to receive the intervention (Nguvu and usual care) or usual care alone. All eligible women will complete a baseline assessment (week 0) followed by a post-treatment (week 9) and a 3-month post-treatment assessment (week 20). The efficacy of the intervention will be determined by between-group differences in the longitudinal trajectories of primary outcomes evaluated using mixed-effects models. Study procedures have been approved by Institutional Review Boards in the United States and Tanzania. This trial will provide evidence on the efficacy of a novel integrated group intervention aimed at secondary prevention of IPV that includes a structured psychological component to address psychological distress. The psychological and advocacy components of the proposed intervention have been shown to be efficacious for their respective outcomes when delivered in

  16. Improving detection and initial management of gestational diabetes through the primary level of care in Morocco: protocol for a cluster randomized controlled trial.

    Science.gov (United States)

    Utz, Bettina; Assarag, Bouchra; Essolbi, Amina; Barkat, Amina; El Ansari, Nawal; Fakhir, Bouchra; Delamou, Alexandre; De Brouwere, Vincent

    2017-06-19

    Morocco is facing a growing prevalence of diabetes and according to latest figures of the World Health Organization, already 12.4% of the population are affected. A similar prevalence has been reported for gestational diabetes (GDM) and although it is not yet high on the national agenda, immediate and long-term complications threaten the health of mothers and future generations. A situational analysis on GDM conducted in 2015 revealed difficulties in access to screening and delays in receiving appropriate care. This implementation study has as objective to evaluate a decentralized GDM detection and management approach through the primary level of care and assess its potential for scaling up. We will conduct a hybrid effectiveness-implementation research using a cluster randomized controlled trial design in two districts of Morocco. Using the health center as unit of randomization we randomly selected 20 health centers with 10 serving as intervention and 10 as control facilities. In the intervention arm, providers will screen pregnant women attending antenatal care for GDM by capillary glucose testing during antenatal care. Women tested positive will receive nutritional counselling and will be followed up through the health center. In the control facilities, screening and initial management of GDM will follow standard practice. Primary outcome will be birthweight with weight gain during pregnancy, average glucose levels and pregnancy outcomes including mode of delivery, presence or absence of obstetric or newborn complications and the prevalence of GDM at health center level as secondary outcomes. Furthermore we will assess the quality of life /care experienced by the women in both arms. Qualitative methods will be applied to evaluate the feasibility of the intervention at primary level and its adoption by the health care providers. In Morocco, gestational diabetes screening and its initial management is fragmented and coupled with difficulties in access and

  17. Costs and effects of a state-wide health promotion program in primary schools in Germany - the Baden-Württemberg Study: A cluster-randomized, controlled trial.

    Directory of Open Access Journals (Sweden)

    Dorothea Kesztyüs

    Full Text Available To evaluate the cost-effectiveness of the state-wide implementation of the health promotion program "Join the Healthy Boat" in primary schools in Germany.Cluster-randomized intervention trial with wait-list control group. Anthropometric data of 1733 participating children (7.1 ± 0.6 years were taken by trained staff before and after a one year intervention period in the academic year 2010/11. Parents provided information about the health status, and the health behaviour of their children and themselves, parental anthropometrics, and socio-economic background variables. Incidence of abdominal obesity, defined as waist-to-height ratio (WHtR ≥ 0.5, was determined. Generalized linear models were applied to account for the clustering of data within schools, and to adjust for baseline-values. Losses to follow-up and missing data were analysed. From a societal perspective, the overall costs, costs per pupil, and incremental cost-effectiveness ratio (ICER to identify the costs per case of averted abdominal obesity were calculated.The final regression model for the incidence of abdominal obesity shows lower odds for the intervention group after an adjustment for grade, gender, baseline WHtR, and breakfast habits (odds ratio = 0.48, 95% CI [0.25; 0.94]. The intervention costs per child/year were €25.04. The costs per incidental case of averted abdominal obesity varied between €1515 and €1993, depending on the different dimensions of the target group.This study demonstrates the positive effects of state-wide, school-based health promotion on incidental abdominal obesity, at affordable costs and with proven cost-effectiveness. These results should support allocative decisions of policymakers. An early start to the prevention of abdominal obesity is of particular importance because of its close relationship to non-communicable diseases.German Clinical Trials Register (DRKS, Freiburg University, Germany, DRKS-ID: DRKS00000494.

  18. Using the 4 Pillars Practice Transformation Program to Increase Pneumococcal Immunizations for Older Adults: A Cluster-Randomized Trial.

    Science.gov (United States)

    Zimmerman, Richard K; Brown, Anthony E; Pavlik, Valory N; Moehling, Krissy K; Raviotta, Jonathan M; Lin, Chyongchiou J; Zhang, Song; Hawk, Mary; Kyle, Shakala; Patel, Suchita; Ahmed, Faruque; Nowalk, Mary Patricia

    2017-01-01

    To test the effectiveness of a step-by step, evidence-based guide, the 4 Pillars Practice Transformation Program, to increase adult pneumococcal vaccination. Randomized controlled cluster trial (RCCT) in Year 1 (June 1, 2013 to May 31, 2014) and pre-post study in Year 2 (June 1, 2014 to January 31, 2015) with data analyzed in 2016. Baseline year was June 1, 2012, to May 31, 2013. Demographic and vaccination data were derived from deidentified electronic medical record extractions. Primary care practices (n = 25) stratified according to metropolitan area (Houston, Pittsburgh), location (rural, urban, suburban), and type (family medicine, internal medicine), randomized to receive the intervention in Year 1 (n = 13) or Year 2 (n = 12). Individuals aged 65 and older at baseline (N = 18,107; mean age 74.2; 60.7% female, 16.5% non-white, 15.7% Hispanic). The 4 Pillars Program, provider education, and one-on-one coaching of practice-based immunization champions. Outcome measures were 23-valent pneumococcal polysaccharide vaccine (PPSV) and pneumococcal conjugate vaccine (PCV) vaccination rates and percentage point (PP) changes in vaccination rates. In the Year 1 RCCT, PPSV vaccination rates increased significantly in all intervention and control groups, with average increases ranging from 6.5 to 8.7 PP (P < .001). The intervention was not related to greater likelihood of PPSV vaccination. In the Year 2 pre-post study, the likelihood of PPSV and PCV vaccination was significantly higher in the active intervention sites than the maintenance sites in Pittsburgh but not in Houston. In a RCCT, PPSV vaccination rates increased in the intervention and control groups in Year 1. In a pre-post study, private primary care practices actively participating in the 4 Pillars Practice Transformation Program improved PPSV and PCV uptake significantly more than practices that were in the maintenance phase of the study. © 2016, Copyright the Authors Journal compilation © 2016, The American

  19. Self-monitoring of blood glucose versus self-monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes receiving structured education: a cluster randomized controlled trial.

    Science.gov (United States)

    Dallosso, H M; Bodicoat, D H; Campbell, M; Carey, M E; Davies, M J; Eborall, H C; Hadjiconstantinou, M; Khunti, K; Speight, J; Heller, S

    2015-03-01

    To compare the effectiveness and acceptability of self-monitoring of blood glucose with self-monitoring of urine glucose in adults with newly diagnosed Type 2 diabetes. We conducted a multi-site cluster randomized controlled trial with practice-level randomization. Participants attended a structured group education programme, which included a module on self-monitoring using blood glucose or urine glucose monitoring. HbA1c and other biomedical measures as well as psychosocial data were collected at 6, 12 and 18 months. A total of 292 participants with Type 2 diabetes were recruited from 75 practices. HbA1c levels were significantly lower at 18 months than at baseline in both the blood monitoring group [mean (se) -12 (2) mmol/mol; -1.1 (0.2) %] and the urine monitoring group [mean (se) -13 (2) mmol/mol; -1.2 (0.2)%], with no difference between groups [mean difference adjusted for cluster effect and baseline value = -1 mmol/mol (95% CI -3, 2); -0.1% (95% CI -0.3, 0.2)]. Similar improvements were observed for the other biomedical outcomes, with no differences between groups. Both groups showed improvements in total treatment satisfaction, generic well-being, and diabetes-specific well-being, and had a less threatening view of diabetes, with no differences between groups at 18 months. Approximately one in five participants in the urine monitoring arm switched to blood monitoring, while those in the blood monitoring arm rarely switched (18 vs 1% at 18 months; P self-monitoring. © 2014 The Authors. Diabetic Medicine © 2014 Diabetes UK.

  20. E-Rehabilitation - an Internet and mobile phone based tailored intervention to enhance self-management of cardiovascular disease: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Antypas, Konstantinos; Wangberg, Silje C

    2012-07-09

    Cardiac rehabilitation is very important for the recovery and the secondary prevention of cardiovascular disease, and one of its main strategies is to increase the level of physical activity. Internet and mobile phone based interventions have been successfully used to help people to achieve this. One of the components that are related to the efficacy of these interventions is tailoring of content to the individual. This trial is studying the effect of a longitudinally tailored Internet and mobile phone based intervention that is based on models of health behaviour, on the level of physical activity and the adherence to the intervention, as an extension of a face-to-face cardiac rehabilitation stay. A parallel group, cluster randomized controlled trial. The study population is adult participants of a cardiac rehabilitation programme in Norway with home Internet access and mobile phone, who in monthly clusters are randomized to the control or the intervention condition. Participants have access to a website with information regarding cardiac rehabilitation, an online discussion forum and an online activity calendar. Those randomized to the intervention condition, receive in addition tailored content based on models of health behaviour, through the website and mobile text messages. The objective is to assess the effect of the intervention on maintenance of self-management behaviours after the rehabilitation stay. Main outcome is the level of physical activity one month, three months and one year after the end of the cardiac rehabilitation programme. The randomization of clusters is based on a true random number online service, and participants, investigators and outcome assessor are blinded to the condition of the clusters. The study suggests a theory-based intervention that combines models of health behaviour in an innovative way, in order to tailor the delivered content. The users have been actively involved in its design, and because of the use of Open