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Sample records for country cluster randomised

  1. Reducing child conduct problems and promoting social skills in a middle-income country: cluster randomised controlled trial.

    Science.gov (United States)

    Baker-Henningham, Helen; Scott, Stephen; Jones, Kelvyn; Walker, Susan

    2012-08-01

    There is an urgent need for effective, affordable interventions to prevent child mental health problems in low- and middle-income countries. To determine the effects of a universal pre-school-based intervention on child conduct problems and social skills at school and at home. In a cluster randomised design, 24 community pre-schools in inner-city areas of Kingston, Jamaica, were randomly assigned to receive the Incredible Years Teacher Training intervention (n = 12) or to a control group (n = 12). Three children from each class with the highest levels of teacher-reported conduct problems were selected for evaluation, giving 225 children aged 3-6 years. The primary outcome was observed child behaviour at school. Secondary outcomes were child behaviour by parent and teacher report, child attendance and parents' attitude to school. The study is registered as ISRCTN35476268. Children in intervention schools showed significantly reduced conduct problems (effect size (ES) = 0.42) and increased friendship skills (ES = 0.74) through observation, significant reductions to teacher-reported (ES = 0.47) and parent-reported (ES = 0.22) behaviour difficulties and increases in teacher-reported social skills (ES = 0.59) and child attendance (ES = 0.30). Benefits to parents' attitude to school were not significant. A low-cost, school-based intervention in a middle-income country substantially reduces child conduct problems and increases child social skills at home and at school.

  2. Reducing child conduct problems and promoting social skills in a middle-income country: cluster randomised controlled trial†

    Science.gov (United States)

    Baker-Henningham, Helen; Scott, Stephen; Jones, Kelvyn; Walker, Susan

    2012-01-01

    Background There is an urgent need for effective, affordable interventions to prevent child mental health problems in low- and middle-income countries. Aims To determine the effects of a universal pre-school-based intervention on child conduct problems and social skills at school and at home. Method In a cluster randomised design, 24 community pre-schools in inner-city areas of Kingston, Jamaica, were randomly assigned to receive the Incredible Years Teacher Training intervention (n = 12) or to a control group (n = 12). Three children from each class with the highest levels of teacher-reported conduct problems were selected for evaluation, giving 225 children aged 3–6 years. The primary outcome was observed child behaviour at school. Secondary outcomes were child behaviour by parent and teacher report, child attendance and parents’ attitude to school. The study is registered as ISRCTN35476268. Results Children in intervention schools showed significantly reduced conduct problems (effect size (ES) = 0.42) and increased friendship skills (ES = 0.74) through observation, significant reductions to teacher-reported (ES = 0.47) and parent-reported (ES = 0.22) behaviour difficulties and increases in teacher-reported social skills (ES = 0.59) and child attendance (ES = 0.30). Benefits to parents’ attitude to school were not significant. Conclusions A low-cost, school-based intervention in a middle-income country substantially reduces child conduct problems and increases child social skills at home and at school. PMID:22500015

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

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    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

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

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    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

  5. 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

  6. Social Upgrading in Developing Country Industrial Clusters

    DEFF Research Database (Denmark)

    Pyke, Frank; Lund-Thomsen, Peter

    2016-01-01

    In this article, we examine the role of social upgrading in developing country industrial clusters. We argue that while economic growth and productivity enhancement matter, social conditions within clusters are influenced by state monetary, fiscal, and labour policies and regulations, as well...

  7. Industrial Clusters and CSR in Developing Countries

    DEFF Research Database (Denmark)

    Fayyaz, Anjum; Lund-Thomsen, Peter; Lindgreen, Adam

    2017-01-01

    - and medium-sized enterprises (SMEs). A case study of the Sialkot football-manufacturing cluster in Pakistan indicates that donor-funded support of CSR initiatives in industrial clusters in developing countries may be short-lived, due to the political economy of aid, the national context of CSR implementation...

  8. 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

  9. 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.

  10. A pragmatic cluster randomised trial evaluating three implementation interventions

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    Rycroft-Malone Jo

    2012-08-01

    Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first

  11. Preventing Weight Gain in Women in Rural Communities: A Cluster Randomised Controlled Trial.

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    Catherine Lombard

    2016-01-01

    Full Text Available Obesity is reaching epidemic proportions in both developed and developing countries. Even modest weight gain increases the risk for chronic illness, yet evidence-based interventions to prevent weight gain are rare. This trial will determine if a simple low-intensity intervention can prevent weight gain in women compared to general health information.We conducted a 1-yr pragmatic, cluster randomised controlled trial in 41 Australian towns (clusters randomised using a computer-generated randomisation list for intervention (n = 21 or control (n = 20. Women aged 18 to 50 yr were recruited from the general population to receive a 1-yr self-management lifestyle intervention (HeLP-her consisting of one group session, monthly SMS text messages, one phone coaching session, and a program manual, or to a control group receiving one general women's health education session. From October 2012 to April 2014 we studied 649 women, mean age 39.6 yr (+/- SD 6.7 and BMI of 28.8 kg/m(2 (+/- SD 6.9 with the primary outcome weight change between groups at 1 yr. The mean change in the control was +0.44 kg (95% CI -0.09 to 0.97 and in the intervention group -0.48 kg (95% CI -0.99 to 0.03 with an unadjusted between group difference of -0.92 kg (95% CI -1.67 to -0.16 or -0.87 kg (95% CI -1.62 to -0.13 adjusted for baseline values and clustering. Secondary outcomes included improved diet quality and greater self-management behaviours. The intervention appeared to be equally efficacious across all age, BMI, income, and education subgroups. Loss to follow-up included 23.8% in the intervention group and 21.8% in the control group and was within the anticipated range. Limitations include lack of sensitive tools to measure the small changes to energy intake and physical activity. Those who gained weight may have been less inclined to return for 1 yr weight measures.A low intensity lifestyle program can prevent the persistent weight gain observed in women. Key features included

  12. Industrial Clusters and Social Upgrading in Developing Countries

    DEFF Research Database (Denmark)

    Pyke, Frank; Lund-Thomsen, Peter

    In this article, we explore the relationship between industrial clusters and social upgrading in developing countries. Our article focuses on the hitherto little-considered influence of the economic and regulatory environment on the social upgrading of a cluster and on its governance system....... In doing so, we develop an analytical framework that seeks to explain how the enabling environment and different actors in cluster governance can either facilitate and/or hinder the process of social upgrading in cluster settings in developing countries. Finally, the conclusion outlines our main findings...

  13. Effect and process evaluation of a kindergarten-based, family-involved cluster randomised controlled trial in six European countries on four- to six-year-old children's steps per day: the ToyBox-study.

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    De Craemer, Marieke; Verloigne, Maïté; De Bourdeaudhuij, Ilse; Androutsos, Odysseas; Iotova, Violeta; Moreno, Luis; Koletzko, Berthold; Socha, Piotr; Manios, Yannis; Cardon, Greet

    2017-08-29

    The ToyBox-intervention is a theory- and evidence-based intervention delivered in kindergartens to improve four- to six-year-old children's energy balance-related behaviours and prevent obesity. The current study aimed to (1) examine the effect of the ToyBox-intervention on increasing European four- to six-year-old children' steps per day, and (2) examine if a higher process evaluation score from teachers and parents was related to a more favourable effect on steps per day. A sample of 2438 four- to six-year-old children (51.9% boys, mean age 4.75 ± 0.43 years) from 6 European countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain) wore a motion sensor (pedometer or accelerometer) for a minimum of two weekdays and one weekend day both at baseline and follow-up to objectively measure their steps per day. Kindergarten teachers implemented the physical activity component of the ToyBox-intervention for 6 weeks in total, with a focus on (1) environmental changes in the classroom, (2) the child performing the actual behaviour and (3) classroom activities. Children's parents received newsletters, tip cards and posters. To assess intervention effects, multilevel repeated measures analyses were conducted for the total sample and the six intervention countries separately. In addition, process evaluation questionnaires were used to calculate a total process evaluation score (with implementation and satisfaction as a part of the overall score) for teachers and parents which was then linked with the physical activity outcomes. No significant intervention effects on four- to six-year-old children' steps per weekday, steps per weekend day and steps per average day were found, both in the total sample and in the country-specific samples (all p > 0.05). In general, the intervention effects on steps per day were least favourable in four- to six-year-old children with a low teachers process evaluation score and most favourable in four- to six-year-old children with a

  14. Missing continuous outcomes under covariate dependent missingness in cluster randomised trials.

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    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.

  15. HLM in Cluster-Randomised Trials--Measuring Efficacy across Diverse Populations of Learners

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    Hegedus, Stephen; Tapper, John; Dalton, Sara; Sloane, Finbarr

    2013-01-01

    We describe the application of Hierarchical Linear Modelling (HLM) in a cluster-randomised study to examine learning algebraic concepts and procedures in an innovative, technology-rich environment in the US. HLM is applied to measure the impact of such treatment on learning and on contextual variables. We provide a detailed description of such…

  16. Clustered tuberculosis in a low-burden country

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Z; Andersen, A B; Kok-Jensen, A

    2012-01-01

    Molecular genotyping of Mycobacterium tuberculosis has proved to be a powerful tool in tuberculosis surveillance, epidemiology, and control. Based on results obtained through 15 years of nationwide IS6110 restriction fragment length polymorphism (RFLP) genotyping of M. tuberculosis cases in Denmark......, a country on the way toward tuberculosis elimination, we discuss M. tuberculosis transmission dynamics and point to areas for control interventions. Cases with 100% identical genotypes (RFLP patterns) were defined as clustered, and a cluster was defined as cases with an identical genotype. Of 4,601 included...... cases, corresponding to 76% of reported and 97% of culture-verified tuberculosis cases in the country, 56% were clustered, of which 69% were Danes. Generally, Danes were more often in large clusters (= 50 persons), older (mean age, 45 years), and male (male/female ratio, 2.5). Also, Danes had a higher...

  17. Industrial Clusters and Corporate Social Responsibility in Developing Countries

    DEFF Research Database (Denmark)

    Lund-Thomsen, Peter; Lindgreen, Adam; Vanhamme, Joelle

    2016-01-01

    This article provides a review of what we know, what we do not know, and what we need to know about the relationship between industrial clusters and corporate social responsibility (CSR) in developing countries. In addition to the drivers of and barriers to the adoption of CSR initiatives......, this study highlights key lessons learned from empirical studies of CSR initiatives that aimed to improve environmental management and work conditions and reduce poverty in local industrial districts. Academic work in this area remains embryonic, lacking in empirical evidence about the effects of CSR...... a theoretical model to explain why CSR has not become institutionalized in many developing country clusters, which in turn suggests that the vast majority of industrial clusters in developing countries are likely to engage in socially irresponsible behavior....

  18. Task shifting of frontline community health workers for cardiovascular risk reduction: design and rationale of a cluster randomised controlled trial (DISHA study) in India.

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    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.

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

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    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

  20. ENHANCED IMMUNIZATION COVERAGE THROUGH INTERVENTIONS FOR CHILDHOOD CLUSTER DISEASES IN DEVELOPING COUNTRIES.

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    Mureed, Sheh; Somronghtong, Ratana; Kumar, Ramesh; Ghaffar, Abdul; Chapman, Robert S

    2015-01-01

    Globally immunisation has to be considered as a most effective and efficient public health intervention to reduce morbidity and mortality among children. Most of the children from developing countries are still not fully immunized due to multiple factors including lack of interventions, awareness, and financial constraints and due to limited resource. Conversely, this review has identified the effectiveness of interventions to increase the immunisation coverage among children of developing countries. Systematic review by using PRISMA statement ("preferred reporting items for systematic reviews and meta-analyses") has been conducted in English. published articles on Pub Med, Scopus, Cochrane, Medline and ISI by searching keywords like immunizations, childhood vaccination and developing countries has been accessed. Only randomised controlled trial and quasi-experimental studies designs were included in the final analysis based on quality assessment by adopting the Down and Black checklist and finally pooled analysis was done by random effect model. This systematic review has been approved and registered by University of York. A total of 16,570 published articles were accessed and finally 10 fulfilled our criteria that were analysed and interpreted. It demonstrated that the interventions has shown significantly increase vaccine coverage for childhood cluster diseases (OR 2.136 and p 0.05) and full vaccination schedule (OR 1.342 and p>0.05). Systematic review has concluded that the professional interventions are an effective while in improving the child immunisation coverage for cluster diseases in developing countries, major effect on DTP an.d measles.

  1. Early combined immunosuppression for the management of Crohn's disease (REACT): a cluster randomised controlled trial.

    Science.gov (United States)

    Khanna, Reena; Bressler, Brian; Levesque, Barrett G; Zou, Guangyong; Stitt, Larry W; Greenberg, Gordon R; Panaccione, Remo; Bitton, Alain; Paré, Pierre; Vermeire, Séverine; D'Haens, Geert; MacIntosh, Donald; Sandborn, William J; Donner, Allan; Vandervoort, Margaret K; Morris, Joan C; Feagan, Brian G

    2015-11-07

    Conventional management of Crohn's disease features incremental use of therapies. However, early combined immunosuppression (ECI), with a TNF antagonist and antimetabolite might be a more effective strategy. We compared the efficacy of ECI with that of conventional management for treatment of Crohn's disease. In this open-label cluster randomised controlled trial (Randomised Evaluation of an Algorithm for Crohn's Treatment, REACT), we included community gastroenterology practices from Belgium and Canada that were willing to be assigned to either of the study groups, participate in all aspects of the study, and provide data on up to 60 patients with Crohn's disease. These practices were randomly assigned (1:1) to either ECI or conventional management. The computer-generated randomisation was minimised by country and practice size. Up to 60 consecutive adult patients were assessed within practices. Patients who were aged 18 years or older; documented to have Crohn's disease; able to speak or understand English, French, or Dutch; able to access a telephone; and able to provide written informed consent were followed up for 2 years. The primary outcome was the proportion of patients in corticosteroid-free remission (Harvey-Bradshaw Index score ≤ 4) at 12 months at the practice level. This trial is registered with ClinicalTrials.gov, number NCT01030809. This study took place between March 15, 2010, and Oct 1, 2013. Of the 60 practices screened, 41 were randomly assigned to either ECI (n=22) or conventional management (n=19). Two practices (one in each group) discontinued because of insufficient resources. 921 (85%) of the 1084 patients at ECI practices and 806 (90%) of 898 patients at conventional management practices completed 12 months follow-up and were included in an intention-to-treat analysis. The 12 month practice-level remission rates were similar at ECI and conventional management practices (66·0% [SD 14·0] and 61·9% [16·9]; adjusted difference 2·5%, 95

  2. Sample size calculations for cluster randomised crossover trials in Australian and New Zealand intensive care research.

    Science.gov (United States)

    Arnup, Sarah J; McKenzie, Joanne E; Pilcher, David; Bellomo, Rinaldo; Forbes, Andrew B

    2018-06-01

    The cluster randomised crossover (CRXO) design provides an opportunity to conduct randomised controlled trials to evaluate low risk interventions in the intensive care setting. Our aim is to provide a tutorial on how to perform a sample size calculation for a CRXO trial, focusing on the meaning of the elements required for the calculations, with application to intensive care trials. We use all-cause in-hospital mortality from the Australian and New Zealand Intensive Care Society Adult Patient Database clinical registry to illustrate the sample size calculations. We show sample size calculations for a two-intervention, two 12-month period, cross-sectional CRXO trial. We provide the formulae, and examples of their use, to determine the number of intensive care units required to detect a risk ratio (RR) with a designated level of power between two interventions for trials in which the elements required for sample size calculations remain constant across all ICUs (unstratified design); and in which there are distinct groups (strata) of ICUs that differ importantly in the elements required for sample size calculations (stratified design). The CRXO design markedly reduces the sample size requirement compared with the parallel-group, cluster randomised design for the example cases. The stratified design further reduces the sample size requirement compared with the unstratified design. The CRXO design enables the evaluation of routinely used interventions that can bring about small, but important, improvements in patient care in the intensive care setting.

  3. Enhanced immunization coverage through interventions for childhood cluster diseases in developing countries

    International Nuclear Information System (INIS)

    Mureed, S.; Somronghtong, R.; Kumar, R.

    2015-01-01

    Globally immunisation has to be considered as a most effective and efficient public health intervention to reduce morbidity and mortality among children. Most of the children from developing countries are still not fully immunized due to multiple factors including lack of interventions, awareness, and financial constraints and due to limited resource. Conversely, this review has identified the effectiveness of interventions to increase the immunisation coverage among children of developing countries. Methods: Systematic review by using PRISMA statement (preferred reporting items for systematic reviews and meta-analyses) has been conducted in English published articles on Pub Med, Scopus, Cochrane, Medline and ISI by searching keywords like immunizations, childhood vaccination and developing countries has been accessed. Only randomised controlled trial and quasi-experimental studies designs were included in the final analysis based on quality assessment by adopting the Down and Black checklist and finally pooled analysis was done by random effect model. This systematic review has been approved and registered by University of York. Results: A total of 16,570 published articles were accessed and finally 10 fulfilled our criteria that were analysed and interpreted. It demonstrated that the interventions has shown significantly increase vaccine coverage for childhood cluster diseases (OR 2.136 and p <0.05).Furthermore, it has been proved that an effect was more prominent for DTP (OR 2.397 and p<0.05) and measles (OR 2.628 and p<0.05), not as much for polio (OR 2.284 and p>0.05) and full vaccination schedule (OR 1.342 and p>0.05). Conclusions: Systematic review has concluded that the professional interventions are an effective while in improving the child immunisation coverage for cluster diseases in developing countries, major effect on DTP and measles. (author)

  4. Renewable energy clusters recurring barriers to cluster development in eleven countries

    CERN Document Server

    Jaegersberg, Gudrun

    2017-01-01

    Taking eleven countries in Europe, Canada, South Africa, America, Latin America and Australia, this book discusses recurring barriers to cluster development in the renewable energy sector. The authors look at the real-world dynamics and tensions between stakeholders on the ground, with a particular focus on the relationships between SMEs and other actors. This trans-regional study is unique in its scale and scope, drawing on a decade of field research to show how by learning from the successes and failures of other clusters, costs and risk can be reduced. The book fills a significant gap in the literature for policymakers, managers and economic developers in a key market.

  5. Classifying OECD Countries According to Health Indicators Using Fuzzy Clustering Ana lysis

    Directory of Open Access Journals (Sweden)

    Nesrin Alptekin

    2015-12-01

    Full Text Available This study was conducted in order to classify OECD countries according to health indicators using fuzzy clustering analysis, to identify the cluster in which Turkey is in and the other countries located in the same cluster with Turkey and to determine whether Turkey shows similar characteristics with other countries located in the same cluster or not. In the study, 34 OECD member countries were discussed. With ten variables that directly and indirectly affect the health, c- means clustering analysis was performed. The NCSS 10 software package was used to analyze the data.In the analysis, it was determined that the most appropriate cluster number is five; three countries involved in the first cluster, nine countries involved in the second cluster, nine countries involved in the third cluster, six countries involved in the fourth cluster and seven countries involved in the fifth cluster. Turkey is located in the fourth cluster. Other countries in the same cluster along with Turkey are Estonia, Hungary, Mexico, Poland and Chile

  6. Dental care resistance prevention and antibiotic prescribing modification-the cluster-randomised controlled DREAM trial.

    Science.gov (United States)

    Löffler, Christin; Böhmer, Femke; Hornung, Anne; Lang, Hermann; Burmeister, Ulrike; Podbielski, Andreas; Wollny, Anja; Kundt, Günther; Altiner, Attila

    2014-02-22

    Bacterial resistance development is one of the most urgent problems in healthcare worldwide. In Europe, dentistry accounts for a comparatively high amount of antibiotic prescriptions. In light of increasing levels of bacterial resistance, this development is alarming. So far, very few interventional studies have been performed, and further research is urgently needed. By means of a complex educational intervention, the DREAM trial aims at optimising antibiotic prescribing behaviour of general dentists in Germany. This is a cluster-randomised controlled trial, where each cluster consists of one dental practice and all of its patients in a defined period. Participants are general dentists practicing in the German region of Mecklenburg-Western Pomerania. Randomisation takes place after baseline data collection (6 months) and will be stratified by the antibiotic prescribing rates of the participating dental practices. Dentists randomised into the intervention group will participate in a complex small group educational seminar that aims at: increasing knowledge on bacterial resistance, pharmacology, and prophylaxis of infectious endocarditis; increasing awareness of dentist-patient communication using video-taped vignettes of dentist-patient communication on antibiotic treatment; improving collaboration between general dentists, general practitioners, and practice-based cardiologists on the necessity of antibiotic prophylaxis; enhancing awareness of the dentists' own prescribing habits by providing antibiotic prescribing feedback; and increasing patient knowledge on antibiotic treatment by providing patient-centred information material on antibiotic prophylaxis of endocarditis. The dentists randomised into the control group will not receive any educational programme and provide care as usual. Primary outcome is the overall antibiotic prescribing rate measured at T1 (period of six months after intervention). In a subgroup of adult patients affected by odontogenic

  7. Social marketing and community mobilisation to reduce underage alcohol consumption in Australia: A cluster randomised community trial.

    Science.gov (United States)

    Rowland, Bosco Charles; Williams, Joanne; Smith, Rachel; Hall, Jessica Kate; Osborn, Amber; Kremer, Peter; Kelly, Adrian B; Leslie, Eva; Patton, George; Mohebbi, Mohammadreza; Toumbourou, John W

    2018-08-01

    In many countries adolescent alcohol use is a major health problem. To supplement national policies, it is important to trial community interventions as a potential strategy to prevent adolescent alcohol use. This study evaluated a multicomponent community intervention that included community mobilisation, social marketing, and the monitoring of alcohol sales to minors. Evaluation was a clustered randomised trial design with 14 intervention and 14 control communities. Prior to randomisation, communities were matched on socioeconomic status and location. Intervention communities were not blinded. 3545 Year 8 students (M = 12 years) were surveyed at baseline from 75 schools; 3377 students were surveyed post intervention in 2013 from 54 schools. It was hypothesised that the primary outcome, individual alcohol consumption in last 30 days, after the intervention would be 15% lower in intervention communities. Secondary outcomes were consumption in the past year and intention not to drink before age 18. The intervention communities showed larger relative reductions compared to the controls in last 30-day consumption and past year (10%), but not significantly different. A significantly lower proportion of participants in the intervention community (63%), compared to the controls (71%), reported intending to drink before 18 years old. Subgroup analysis identified regional and state differences for some secondary measures. Intervention assignment was associated with lower adolescent intention to drink before the age of 18. However, more intensive and longer-term intervention may be required to measure significant differences in behaviour change. ACTRN12612000384853. Rowland B, Toumbourou JW, Osborn A, et al. BMJ Open 2013;3:e002423. doi:10.1136/bmjopen-2012-002423. Copyright © 2018 Elsevier Inc. All rights reserved.

  8. Information and Choice of A-Level Subjects: A Cluster Randomised Controlled Trial with Linked Administrative Data

    Science.gov (United States)

    Davies, Peter; Davies, Neil M.; Qiu, Tian

    2017-01-01

    We estimated the effects of an intervention which provided information about graduate wages to 5593 students in England, using a blinded cluster randomised controlled trial in 50 schools (registration: AEARCTR-0000468). Our primary outcome was students' choice of A-level subjects at age 16. We also recorded the students' expectations of future…

  9. The effectiveness of a clinically integrated e-learning course in evidence-based medicine: A cluster randomised controlled trial

    NARCIS (Netherlands)

    Kulier, Regina; Coppus, Sjors F. P. J.; Zamora, Javier; Hadley, Julie; Malick, Sadia; Das, Kausik; Weinbrenner, Susanne; Meyerrose, Berrit; Decsi, Tamas; Horvath, Andrea R.; Nagy, Eva; Emparanza, Jose I.; Arvanitis, Theodoros N.; Burls, Amanda; Cabello, Juan B.; Kaczor, Marcin; Zanrei, Gianni; Pierer, Karen; Stawiarz, Katarzyna; Kunz, Regina; Mol, Ben W. J.; Khan, Khalid S.

    2009-01-01

    ABSTRACT: BACKGROUND: To evaluate the educational effects of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM) among postgraduates compared to a traditional lecture-based course of equivalent content. METHODS: We conducted a cluster randomised controlled

  10. 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

  11. Educational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sladden Michael

    2007-09-01

    Full Text Available Abstract Background Childhood asthma is common in Cape Town, a province of South Africa, but is underdiagnosed by general practitioners. Medications are often prescribed inappropriately, and care is episodic. The objective of this study is to assess the impact of educational outreach to general practitioners on asthma symptoms of children in their practice. Methods This is a cluster randomised trial with general practices as the unit of intervention, randomisation, and analysis. The setting is Mitchells Plain (population 300,000, a dormitory town near Cape Town. Solo general practitioners, without nurse support, operate from storefront practices. Caregiver-reported symptom data were collected for 318 eligible children (2 to 17 years with moderate to severe asthma, who were attending general practitioners in Mitchells Plain. One year post-intervention follow-up data were collected for 271 (85% of these children in all 43 practices. Practices randomised to intervention (21 received two 30-minute educational outreach visits by a trained pharmacist who left materials describing key interventions to improve asthma care. Intervention and control practices received the national childhood asthma guideline. Asthma severity was measured in a parent-completed survey administered through schools using a symptom frequency and severity scale. We compared intervention and control group children on the change in score from pre-to one-year post-intervention. Results Symptom scores declined an additional 0.84 points in the intervention vs. control group (on a nine-point scale. p = 0.03. For every 12 children with asthma exposed to a doctor allocated to the intervention, one extra child will have substantially reduced symptoms. Conclusion Educational outreach was accepted by general practitioners and was effective. It could be applied to other health care quality problems in this setting.

  12. The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swift Louise

    2011-07-01

    Full Text Available Abstract Background The serious mental illness Health Improvement Profile [HIP] is a brief pragmatic tool, which enables mental health nurses to work together with patients to screen physical health and take evidence-based action when variables are identified to be at risk. Piloting has demonstrated clinical utility and acceptability. Methods/Design A single blind parallel group cluster randomised controlled trial with secondary economic analysis and process observation. Unit of randomisation: mental health nurses [MHNs] working in adult community mental health teams across two NHS Trusts. Subjects: Patients over 18 years with a diagnosis of schizophrenia, schizoaffective or bipolar disorder on the caseload of participating MHNs. Primary objective: To determine the effects of the HIP programme on patients' physical wellbeing assessed by the physical component score of the Medical Outcome Study (MOS 36 Item Short Form Health Survey version 2 [SF-36v2]. Secondary objectives: To determine the effects of the HIP programme on: cost effectiveness, mental wellbeing, cardiovascular risk, physical health care attitudes and knowledge of MHNs and to determine the acceptability of the HIP Programme in the NHS. Consented nurses (and patients will be randomised to receive the HIP Programme or treatment as usual. Outcomes will be measured at baseline and 12 months with a process observation after 12 months to include evaluation of patients' and professionals' experience and observation of any effect on care plans and primary-secondary care interface communication. Outcomes will be analysed on an intention-to-treat (ITT basis. Discussion The results of the trial and process observation will provide information about the effectiveness of the HIP Programme in supporting MHNs to address physical comorbidity in serious mental illness. Given the current unacceptable prevalence of physical comorbidity and mortality in the serious mental illness population, it is

  13. A cluster randomised controlled trial of a nutrition education intervention in the community.

    Science.gov (United States)

    Madigan, S M; Fleming, P; Wright, M E; Stevenson, M; Macauley, D

    2014-04-01

    Patients with enteral feeding tubes are increasingly managed in their home environment and these patients require support from a range of healthcare professionals. A cluster randomised trial of an educational intervention was undertaken among General Practitioners and nurses both in the community and in nursing home caring for patients recently discharged to primary care. This was a short, duration (nutrition education programme delivered in the work place soon after the patient was discharged from hospital. The primary outcome was an improvement in knowledge immediately after the intervention and the secondary outcome was knowledge at 6 months. Those in the intervention group had improved knowledge, which was significantly greater than those in the control group (P work-based targeted nutrition education programme is effective for improving knowledge among general practitioners and nurses both in the community and in nursing homes. © 2013 The Authors Journal of Human Nutrition and Dietetics © 2013 The British Dietetic Association Ltd.

  14. Cluster Randomised Trials in Cochrane Reviews: Evaluation of Methodological and Reporting Practice.

    Directory of Open Access Journals (Sweden)

    Marty Richardson

    Full Text Available Systematic reviews can include cluster-randomised controlled trials (C-RCTs, which require different analysis compared with standard individual-randomised controlled trials. However, it is not known whether review authors follow the methodological and reporting guidance when including these trials. The aim of this study was to assess the methodological and reporting practice of Cochrane reviews that included C-RCTs against criteria developed from existing guidance.Criteria were developed, based on methodological literature and personal experience supervising review production and quality. Criteria were grouped into four themes: identifying, reporting, assessing risk of bias, and analysing C-RCTs. The Cochrane Database of Systematic Reviews was searched (2nd December 2013, and the 50 most recent reviews that included C-RCTs were retrieved. Each review was then assessed using the criteria.The 50 reviews we identified were published by 26 Cochrane Review Groups between June 2013 and November 2013. For identifying C-RCTs, only 56% identified that C-RCTs were eligible for inclusion in the review in the eligibility criteria. For reporting C-RCTs, only eight (24% of the 33 reviews reported the method of cluster adjustment for their included C-RCTs. For assessing risk of bias, only one review assessed all five C-RCT-specific risk-of-bias criteria. For analysing C-RCTs, of the 27 reviews that presented unadjusted data, only nine (33% provided a warning that confidence intervals may be artificially narrow. Of the 34 reviews that reported data from unadjusted C-RCTs, only 13 (38% excluded the unadjusted results from the meta-analyses.The methodological and reporting practices in Cochrane reviews incorporating C-RCTs could be greatly improved, particularly with regard to analyses. Criteria developed as part of the current study could be used by review authors or editors to identify errors and improve the quality of published systematic reviews incorporating

  15. An imbalance in cluster sizes does not lead to notable loss of power in cross-sectional, stepped-wedge cluster randomised trials with a continuous outcome.

    Science.gov (United States)

    Kristunas, Caroline A; Smith, Karen L; Gray, Laura J

    2017-03-07

    The current methodology for sample size calculations for stepped-wedge cluster randomised trials (SW-CRTs) is based on the assumption of equal cluster sizes. However, as is often the case in cluster randomised trials (CRTs), the clusters in SW-CRTs are likely to vary in size, which in other designs of CRT leads to a reduction in power. The effect of an imbalance in cluster size on the power of SW-CRTs has not previously been reported, nor what an appropriate adjustment to the sample size calculation should be to allow for any imbalance. We aimed to assess the impact of an imbalance in cluster size on the power of a cross-sectional SW-CRT and recommend a method for calculating the sample size of a SW-CRT when there is an imbalance in cluster size. The effect of varying degrees of imbalance in cluster size on the power of SW-CRTs was investigated using simulations. The sample size was calculated using both the standard method and two proposed adjusted design effects (DEs), based on those suggested for CRTs with unequal cluster sizes. The data were analysed using generalised estimating equations with an exchangeable correlation matrix and robust standard errors. An imbalance in cluster size was not found to have a notable effect on the power of SW-CRTs. The two proposed adjusted DEs resulted in trials that were generally considerably over-powered. We recommend that the standard method of sample size calculation for SW-CRTs be used, provided that the assumptions of the method hold. However, it would be beneficial to investigate, through simulation, what effect the maximum likely amount of inequality in cluster sizes would be on the power of the trial and whether any inflation of the sample size would be required.

  16. School-based suicide prevention programmes: the SEYLE cluster-randomised, controlled trial.

    Science.gov (United States)

    Wasserman, Danuta; Hoven, Christina W; Wasserman, Camilla; Wall, Melanie; Eisenberg, Ruth; Hadlaczky, Gergö; Kelleher, Ian; Sarchiapone, Marco; Apter, Alan; Balazs, Judit; Bobes, Julio; Brunner, Romuald; Corcoran, Paul; Cosman, Doina; Guillemin, Francis; Haring, Christian; Iosue, Miriam; Kaess, Michael; Kahn, Jean-Pierre; Keeley, Helen; Musa, George J; Nemes, Bogdan; Postuvan, Vita; Saiz, Pilar; Reiter-Theil, Stella; Varnik, Airi; Varnik, Peeter; Carli, Vladimir

    2015-04-18

    Suicidal behaviours in adolescents are a major public health problem and evidence-based prevention programmes are greatly needed. We aimed to investigate the efficacy of school-based preventive interventions of suicidal behaviours. The Saving and Empowering Young Lives in Europe (SEYLE) study is a multicentre, cluster-randomised controlled trial. The SEYLE sample consisted of 11,110 adolescent pupils, median age 15 years (IQR 14-15), recruited from 168 schools in ten European Union countries. We randomly assigned the schools to one of three interventions or a control group. The interventions were: (1) Question, Persuade, and Refer (QPR), a gatekeeper training module targeting teachers and other school personnel, (2) the Youth Aware of Mental Health Programme (YAM) targeting pupils, and (3) screening by professionals (ProfScreen) with referral of at-risk pupils. Each school was randomly assigned by random number generator to participate in one intervention (or control) group only and was unaware of the interventions undertaken in the other three trial groups. The primary outcome measure was the number of suicide attempt(s) made by 3 month and 12 month follow-up. Analysis included all pupils with data available at each timepoint, excluding those who had ever attempted suicide or who had shown severe suicidal ideation during the 2 weeks before baseline. This study is registered with the German Clinical Trials Registry, number DRKS00000214. Between Nov 1, 2009, and Dec 14, 2010, 168 schools (11,110 pupils) were randomly assigned to interventions (40 schools [2692 pupils] to QPR, 45 [2721] YAM, 43 [2764] ProfScreen, and 40 [2933] control). No significant differences between intervention groups and the control group were recorded at the 3 month follow-up. At the 12 month follow-up, YAM was associated with a significant reduction of incident suicide attempts (odds ratios [OR] 0·45, 95% CI 0·24-0·85; p=0·014) and severe suicidal ideation (0·50, 0·27-0·92; p=0·025

  17. Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Toity Deave

    Full Text Available Many developed countries have high mortality rates for fire-related deaths in children aged 0-14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children's services has not been assessed. We developed an Injury Prevention Briefing (IPB, which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation.We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children's centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+, IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children's centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children's centre.1112 parents at 36 children's centres participated. There was no significant effect of the intervention on families' possession of plans for escaping from a house fire (adjusted odds ratio (AOR IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20. However, significantly more

  18. Community-based Rehabilitation Intervention for people with Schizophrenia in Ethiopia (RISE): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Asher, Laura; De Silva, Mary; Hanlon, Charlotte; Weiss, Helen A; Birhane, Rahel; Ejigu, Dawit A; Medhin, Girmay; Patel, Vikram; Fekadu, Abebaw

    2016-06-24

    Care for most people with schizophrenia is best delivered in the community and evidence-based guidelines recommend combining both medication and a psychosocial intervention, such as community-based rehabilitation. There is emerging evidence that community-based rehabilitation for schizophrenia is effective at reducing disability in middle-income country settings, yet there is no published evidence on the effectiveness in settings with fewer mental health resources. This paper describes the protocol of a study that aims to evaluate the effectiveness of community-based rehabilitation as an adjunct to health facility-based care in rural Ethiopia. This is a cluster randomised trial set in a rural district in Ethiopia, with sub-district as the unit of randomisation. Participants will be recruited from an existing cohort of people with schizophrenia receiving treatment in primary care. Fifty-four sub-districts will be randomly allocated in a 1:1 ratio to facility-based care plus community-based rehabilitation (intervention arm) or facility-based care alone (control arm). Facility-based care consists of treatment by a nurse or health officer in primary care (antipsychotic medication, basic psychoeducation and follow-up) with referral to a psychiatric nurse-led outpatient clinic or psychiatric hospital when required. Trained community-based rehabilitation workers will deliver a manualised community-based rehabilitation intervention, with regular individual and group supervision. We aim to recruit 182 people with schizophrenia and their caregivers. Potential participants will be screened for eligibility, including enduring or disabling illness. Participants will be recruited after providing informed consent or, for participants without decision-making capacity, after the primary caregiver gives permission on behalf of the participant. The primary outcome is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS) version 2.0 at 12 months. The sample

  19. Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial.

    Science.gov (United States)

    Merom, Dafna; Mathieu, Erin; Cerin, Ester; Morton, Rachael L; Simpson, Judy M; Rissel, Chris; Anstey, Kaarin J; Sherrington, Catherine; Lord, Stephen R; Cumming, Robert G

    2016-08-01

    The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i) reducing the number of falls and ii) improving physical and cognitive fall-related risk factors. A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters) around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters) were offered twice weekly one-hour social dancing classes (folk or ballroom dancing) over 12 mo (80 h in total). Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters) were advised to continue with their regular activities. falls during the 12 mo trial and Trail Making Tests. The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength) and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12) Survey. Data on falls were obtained from 522 of 530 (98%) randomised participants (mean age 78 y, 85% women) and 424 (80%) attended the 12-mo reassessment, which was lower among folk dance participants (71%) than ballroom dancing (82%) or control

  20. Cluster Policy in the Light of Institutional Context—A Comparative Study of Transition Countries

    OpenAIRE

    Tine Lehmann; Maximilian Benner

    2015-01-01

    The business environment in transition countries is often extraordinarily challenging for companies. The transition process these countries find themselves in leads to constant changes in the institutional environment. Hence, institutional voids prevail. These institutional voids cause competitive disadvantages for small and medium enterprises. Cluster policy can address these competitive disadvantages. As cluster policy generally aims at supporting companies’ competitive advantage by spurrin...

  1. Promoting Recruitment using Information Management Efficiently (PRIME): a stepped-wedge, cluster randomised trial of a complex recruitment intervention embedded within the REstart or Stop Antithrombotics Randomised Trial.

    Science.gov (United States)

    Maxwell, Amy E; Parker, Richard A; Drever, Jonathan; Rudd, Anthony; Dennis, Martin S; Weir, Christopher J; Al-Shahi Salman, Rustam

    2017-12-28

    Few interventions are proven to increase recruitment in clinical trials. Recruitment to RESTART, a randomised controlled trial of secondary prevention after stroke due to intracerebral haemorrhage, has been slower than expected. Therefore, we sought to investigate an intervention to boost recruitment to RESTART. We conducted a stepped-wedge, cluster randomised trial of a complex intervention to increase recruitment, embedded within the RESTART trial. The primary objective was to investigate if the PRIME complex intervention (a recruitment co-ordinator who conducts a recruitment review, provides access to bespoke stroke audit data exports, and conducts a follow-up review after 6 months) increases the recruitment rate to RESTART. We included 72 hospital sites located in England, Wales, or Scotland that were active in RESTART in June 2015. All sites began in the control state and were allocated using block randomisation stratified by hospital location (Scotland versus England/Wales) to start the complex intervention in one of 12 different months. The primary outcome was the number of patients randomised into RESTART per month per site. We quantified the effect of the complex intervention on the primary outcome using a negative binomial, mixed model adjusting for site, December/January months, site location, and background time trends in recruitment rate. We recruited and randomised 72 sites and recorded their monthly recruitment to RESTART over 24 months (March 2015 to February 2017 inclusive), providing 1728 site-months of observations for the primary analysis. The adjusted rate ratio for the number of patients randomised per month after allocation to the PRIME complex intervention versus control time before allocation to the PRIME complex intervention was 1.06 (95% confidence interval 0.55 to 2.03, p = 0.87). Although two thirds of respondents to the 6-month follow-up questionnaire agreed that the audit reports were useful, only six patients were reported to

  2. A cluster-randomised quality improvement study to improve two inpatient stroke quality indicators.

    Science.gov (United States)

    Williams, Linda; Daggett, Virginia; Slaven, James E; Yu, Zhangsheng; Sager, Danielle; Myers, Jennifer; Plue, Laurie; Woodward-Hagg, Heather; Damush, Teresa M

    2016-04-01

    Quality indicator collection and feedback improves stroke care. We sought to determine whether quality improvement training plus indicator feedback was more effective than indicator feedback alone in improving inpatient stroke indicators. We conducted a cluster-randomised quality improvement trial, randomising hospitals to quality improvement training plus indicator feedback versus indicator feedback alone to improve deep vein thrombosis (DVT) prophylaxis and dysphagia screening. Intervention sites received collaborative-based quality improvement training, external facilitation and indicator feedback. Control sites received only indicator feedback. We compared indicators pre-implementation (pre-I) to active implementation (active-I) and post-implementation (post-I) periods. We constructed mixed-effect logistic models of the two indicators with a random intercept for hospital effect, adjusting for patient, time, intervention and hospital variables. Patients at intervention sites (1147 admissions), had similar race, gender and National Institutes of Health Stroke Scale scores to control sites (1017 admissions). DVT prophylaxis improved more in intervention sites during active-I period (ratio of ORs 4.90, pimproved similarly in both groups during active-I, but control sites improved more in post-I period (ratio of ORs 0.67, p=0.04). In logistic models, the intervention was independently positively associated with DVT performance during active-I period, and negatively associated with dysphagia performance post-I period. Quality improvement training was associated with early DVT improvement, but the effect was not sustained over time and was not seen with dysphagia screening. External quality improvement programmes may quickly boost performance but their effect may vary by indicator and may not sustain over time. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  3. Effectiveness of job rotation for preventing work-related musculoskeletal diseases: a cluster randomised controlled trial.

    Science.gov (United States)

    Comper, Maria Luiza Caires; Dennerlein, Jack Tigh; Evangelista, Gabriela Dos Santos; Rodrigues da Silva, Patricia; Padula, Rosimeire Simprini

    2017-08-01

    Job rotation is an organisational strategy widely used on assembly lines in manufacturing industries to mitigate workers' exposure so as to prevent musculoskeletal disorders. This study aimed to evaluate the effectiveness of job rotation for reducing working hours lost due to sick leave resulting from musculoskeletal diseases. The design consisted of a 1-year cluster randomised controlled trial with a blinded assessor. Production sectors of the textile industry were randomised to intervention and control groups. Both groups received ergonomic training. The intervention group performed a job rotation programme. The primary outcome measure was number of working hours lost due to sick leave as a result of musculoskeletal disease (ICD-10). The secondary outcome measures were musculoskeletal symptoms (Yes/No), risk factors for musculoskeletal diseases (0-10), psychosocial factors and fatigue (0-100), general health (0-100), and productivity (0-10). All secondary outcomes were measured at baseline and 12-month follow-up. At the 12-month follow-up, both groups showed an increase in the number of working hours lost due to sick leave for musculoskeletal disease. There was no significant difference between the job rotation intervention group (mean deviation -5.6 hours, 95% CI -25.0 to 13.8) at the 12-month follow-up and the control group. There were no significant differences between groups for the secondary outcomes (p>0.05). The job rotation programme was not effective in reducing the number of working hours lost due to sick leave, decreasing the prevalence of musculoskeletal symptoms, or improving perception of musculoskeletal pain and workplace risk factors, psychosocial risk factors and productivity. NCT01979731. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  4. Simulation-based team training for multi-professional obstetric care teams to improve patient outcome : a multicentre, cluster randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

    OBJECTIVE: To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. DESIGN: Multicentre, open, cluster randomised controlled trial. SETTING: Obstetric units in the Netherlands. POPULATION: Women with a singleton pregnancy beyond 24 weeks of

  5. Efficacy of infant simulator programmes to prevent teenage pregnancy: a school-based cluster randomised controlled trial in Western Australia.

    Science.gov (United States)

    Brinkman, Sally A; Johnson, Sarah E; Codde, James P; Hart, Michael B; Straton, Judith A; Mittinty, Murthy N; Silburn, Sven R

    2016-11-05

    Infant simulator-based programmes, which aim to prevent teenage pregnancy, are used in high-income as well as low-income and middle-income countries but, despite growing popularity, no published evidence exists of their long-term effect. The aim of this trial was to investigate the effect of such a programme, the Virtual Infant Parenting (VIP) programme, on pregnancy outcomes of birth and induced abortion in Australia. In this school-based pragmatic cluster randomised controlled trial, eligible schools in Perth, Western Australia, were enrolled and randomised 1:1 to the intervention and control groups. Randomisation using a table of random numbers without blocking, stratification, or matching was done by a researcher who was masked to the identity of the schools. Between 2003 and 2006, the VIP programme was administered to girls aged 13-15 years in the intervention schools, while girls of the same age in the control schools received the standard health education curriculum. Participants were followed until they reached 20 years of age via data linkage to hospital medical and abortion clinic records. The primary endpoint was the occurrence of pregnancy during the teenage years. Binomial and Cox proportional hazards regression was used to test for differences in pregnancy rates between study groups. This study is registered as an international randomised controlled trial, number ISRCTN24952438. 57 (86%) of 66 eligible schools were enrolled into the trial and randomly assigned 1:1 to the intervention (28 schools) or the control group (29 schools). Then, between Feb 1, 2003, and May 31, 2006, 1267 girls in the intervention schools received the VIP programme while 1567 girls in the control schools received the standard health education curriculum. Compared with girls in the control group, a higher proportion of girls in the intervention group recorded at least one birth (97 [8%] of 1267 in the intervention group vs 67 [4%] of 1567 in the control group) or at least one

  6. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol

    OpenAIRE

    Tan, Ai May; LaMontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-01-01

    Background Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. Method/Design A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculat...

  7. Community-led trials: Intervention co-design in a cluster randomised controlled trial.

    Science.gov (United States)

    Andersson, Neil

    2017-05-30

    In conventional randomised controlled trials (RCTs), researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control.Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies.A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a "male competence".Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the conventional wisdom about how

  8. Community-led trials: Intervention co-design in a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Neil Andersson

    2017-05-01

    Full Text Available Abstract In conventional randomised controlled trials (RCTs, researchers design the interventions. In the Camino Verde trial, each intervention community designed its own programmes to prevent dengue. Instead of fixed actions or menus of activities to choose from, the trial randomised clusters to a participatory research protocol that began with sharing and discussing evidence from a local survey, going on to local authorship of the action plan for vector control. Adding equitable stakeholder engagement to RCT infrastructure anchors the research culturally, making it more meaningful to stakeholders. Replicability in other conditions is straightforward, since all intervention clusters used the same engagement protocol to discuss and to mobilize for dengue prevention. The ethical codes associated with RCTs play out differently in community-led pragmatic trials, where communities essentially choose what they want to do. Several discussion groups in each intervention community produced multiple plans for prevention, recognising different time lines. Some chose fast turnarounds, like elimination of breeding sites, and some chose longer term actions like garbage disposal and improving water supplies. A big part of the skill set for community-led trials is being able to stand back and simply support communities in what they want to do and how they want to do it, something that does not come naturally to many vector control programs or to RCT researchers. Unexpected negative outcomes can come from the turbulence implicit in participatory research. One example was the gender dynamic in the Mexican arm of the Camino Verde trial. Strong involvement of women in dengue control activities seems to have discouraged men in settings where activity in public spaces or outside of the home would ordinarily be considered a “male competence”. Community-led trials address the tension between one-size-fits-all programme interventions and local needs. Whatever the

  9. Early intervention for adolescents with Patellofemoral Pain Syndrome - a pragmatic cluster randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Self-reported knee pain is highly prevalent among adolescents. As much as 50% of the non-specific knee pain may be attributed to Patellofemoral Pain Syndrome (PFPS). In the short term, exercise therapy appears to have a better effect than patient education consisting of written information and general advice on exercise or compared with placebo treatment. But the long-term effect of exercise therapy compared with patient education is conflicting. The purpose of this study is to examine the short- and long-term effectiveness of patient education compared with patient education and multimodal physiotherapy applied at a very early stage of the condition among adolescents. Methods/Design This study is a single blind pragmatic cluster randomised controlled trial. Four upper secondary schools have been invited to participate in the study (approximately 2500 students, aged 15-19 years). Students are asked to answer an online questionnaire regarding musculoskeletal pain. The students who report knee pain are contacted by telephone and offered a clinical examination by a rheumatologist. Subjects who fit the inclusion criteria and are diagnosed with PFPS are invited to participate in the study. A minimum of 102 students with PFPS are then cluster-randomised into two intervention groups based on which school they attend. Both intervention groups receive written information and education. In addition to patient education, one group receives multimodal physiotherapy consisting primarily of neuromuscular training of the muscles around the foot, knee and hip and home exercises. The students with PFPS fill out self-reported questionnaires at baseline, 3, 6, 12 and 24 months after inclusion in the study. The primary outcome measure is perception of recovery measured on a 7-point Likert scale ranging from "completely recovered" to "worse than ever" at 12 months. Discussion This study is designed to investigate the effectiveness of patient education compared with patient

  10. The cost-effectiveness of a patient centred pressure ulcer prevention care bundle: Findings from the INTACT cluster randomised trial.

    OpenAIRE

    Whitty, Jennifer A; McInnes, Elizabeth; Bucknall, Tracey; Webster, Joan; Gillespie, Brigid M; Banks, Merrilyn; Thalib, Lukman; Wallis, Marianne; Cumsille, Jose; Roberts, Shelley; Chaboyer, Wendy

    2017-01-01

    Pressure ulcers are serious, avoidable, costly and common adverse outcomes of healthcare. To evaluate the cost-effectiveness of a patient-centred pressure ulcer prevention care bundle compared to standard care. Cost-effectiveness and cost-benefit analyses of pressure ulcer prevention performed from the health system perspective using data collected alongside a cluster-randomised trial. Eight tertiary hospitals in Australia. Adult patients receiving either a patient-centred pressure ulcer prev...

  11. Stepped-wedge cluster randomised controlled trials: a generic framework including parallel and multiple-level designs.

    Science.gov (United States)

    Hemming, Karla; Lilford, Richard; Girling, Alan J

    2015-01-30

    Stepped-wedge cluster randomised trials (SW-CRTs) are being used with increasing frequency in health service evaluation. Conventionally, these studies are cross-sectional in design with equally spaced steps, with an equal number of clusters randomised at each step and data collected at each and every step. Here we introduce several variations on this design and consider implications for power. One modification we consider is the incomplete cross-sectional SW-CRT, where the number of clusters varies at each step or where at some steps, for example, implementation or transition periods, data are not collected. We show that the parallel CRT with staggered but balanced randomisation can be considered a special case of the incomplete SW-CRT. As too can the parallel CRT with baseline measures. And we extend these designs to allow for multiple layers of clustering, for example, wards within a hospital. Building on results for complete designs, power and detectable difference are derived using a Wald test and obtaining the variance-covariance matrix of the treatment effect assuming a generalised linear mixed model. These variations are illustrated by several real examples. We recommend that whilst the impact of transition periods on power is likely to be small, where they are a feature of the design they should be incorporated. We also show examples in which the power of a SW-CRT increases as the intra-cluster correlation (ICC) increases and demonstrate that the impact of the ICC is likely to be smaller in a SW-CRT compared with a parallel CRT, especially where there are multiple levels of clustering. Finally, through this unified framework, the efficiency of the SW-CRT and the parallel CRT can be compared. © 2014 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

  12. A systematic review of cluster randomised trials in residential facilities for older people suggests how to improve quality.

    Science.gov (United States)

    Diaz-Ordaz, Karla; Froud, Robert; Sheehan, Bart; Eldridge, Sandra

    2013-10-22

    Previous reviews of cluster randomised trials have been critical of the quality of the trials reviewed, but none has explored determinants of the quality of these trials in a specific field over an extended period of time. Recent work suggests that correct conduct and reporting of these trials may require more than published guidelines. In this review, our aim was to assess the quality of cluster randomised trials conducted in residential facilities for older people, and to determine whether (1) statistician involvement in the trial and (2) strength of journal endorsement of the Consolidated Standards of Reporting Trials (CONSORT) statement influence quality. We systematically identified trials randomising residential facilities for older people, or parts thereof, without language restrictions, up to the end of 2010, using National Library of Medicine (Medline) via PubMed and hand-searching. We based quality assessment criteria largely on the extended CONSORT statement for cluster randomised trials. We assessed statistician involvement based on statistician co-authorship, and strength of journal endorsement of the CONSORT statement from journal websites. 73 trials met our inclusion criteria. Of these, 20 (27%) reported accounting for clustering in sample size calculations and 54 (74%) in the analyses. In 29 trials (40%), methods used to identify/recruit participants were judged by us to have potentially caused bias or reporting was unclear to reach a conclusion. Some elements of quality improved over time but this appeared not to be related to the publication of the extended CONSORT statement for these trials. Trials with statistician/epidemiologist co-authors were more likely to account for clustering in sample size calculations (unadjusted odds ratio 5.4, 95% confidence interval 1.1 to 26.0) and analyses (unadjusted OR 3.2, 1.2 to 8.5). Journal endorsement of the CONSORT statement was not associated with trial quality. Despite international attempts to improve

  13. Hand sanitisers for reducing illness absences in primary school children in New Zealand: a cluster randomised controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Poore Marion R

    2010-01-01

    Full Text Available Abstract Background New Zealand has relatively high rates of morbidity and mortality from infectious disease compared with other OECD countries, with infectious disease being more prevalent in children compared with others in the population. Consequences of infectious disease in children may have significant economic and social impact beyond the direct effects of the disease on the health of the child; including absence from school, transmission of infectious disease to other pupils, staff, and family members, and time off work for parents/guardians. Reduction of the transmission of infectious disease between children at schools could be an effective way of reducing the community incidence of infectious disease. Alcohol based no-rinse hand sanitisers provide an alternative hand cleaning technology, for which there is some evidence that they may be effective in achieving this. However, very few studies have investigated the effectiveness of hand sanitisers, and importantly, the potential wider economic implications of this intervention have not been established. Aims The primary objective of this trial is to establish if the provision of hand sanitisers in primary schools in the South Island of New Zealand, in addition to an education session on hand hygiene, reduces the incidence rate of absence episodes due to illness in children. In addition, the trial will establish the cost-effectiveness and conduct a cost-benefit analysis of the intervention in this setting. Methods/Design A cluster randomised controlled trial will be undertaken to establish the effectiveness and cost-effectiveness of hand sanitisers. Sixty-eight primary schools will be recruited from three regions in the South Island of New Zealand. The schools will be randomised, within region, to receive hand sanitisers and an education session on hand hygiene, or an education session on hand hygiene alone. Fifty pupils from each school in years 1 to 6 (generally aged from 5 to 11 years

  14. A Study on Logistics Cluster Competitiveness among Asia Main Countries using the Porter's Diamond Model

    Directory of Open Access Journals (Sweden)

    Tae Won Chung

    2016-12-01

    Full Text Available Measurement and discussions of logistics cluster competitiveness with a national approach are required to boost agglomeration effects and potentially create logistics efficiency and productivity. This study developed assessment criteria of logistics cluster competitiveness based on Porter's diamond model, calculated the weight of each criterion by the AHP method, and finally evaluated and discussed logistics cluster competitiveness among Asia main countries. The results indicate that there was a large difference in logistics cluster competitiveness among six countries. The logistics cluster competitiveness scores of Singapore (7.93, Japan (7.38, and Hong Kong (7.04 are observably different from those of China (5.40, Korea (5.08, and Malaysia (3.46. Singapore, with the highest competitiveness score, revealed its absolute advantage in logistics cluster indices. These research results intend to provide logistics policy makers with some strategic recommendations, and may serve as a baseline for further logistics cluster studies using Porter's diamond model.

  15. Use of malaria rapid diagnostic tests by community health workers in Afghanistan: cluster randomised trial.

    Science.gov (United States)

    Leslie, Toby; Rowland, Mark; Mikhail, Amy; Cundill, Bonnie; Willey, Barbara; Alokozai, Asif; Mayan, Ismail; Hasanzai, Anwar; Baktash, Sayed Habibullah; Mohammed, Nader; Wood, Molly; Rahimi, Habib-U-Rahman; Laurent, Baptiste; Buhler, Cyril; Whitty, Christopher J M

    2017-07-07

    The World Health Organisation (WHO) recommends parasitological diagnosis of malaria before treatment, but use of malaria rapid diagnostic tests (mRDTs) by community health workers (CHWs) has not been fully tested within health services in south and central Asia. mRDTs could allow CHWs to diagnose malaria accurately, improving treatment of febrile illness. A cluster randomised trial in community health services was undertaken in Afghanistan. The primary outcome was the proportion of suspected malaria cases correctly treated for polymerase chain reaction (PCR)-confirmed malaria and PCR negative cases receiving no antimalarial drugs measured at the level of the patient. CHWs from 22 clusters (clinics) received standard training on clinical diagnosis and treatment of malaria; 11 clusters randomised to the intervention arm received additional training and were provided with mRDTs. CHWs enrolled cases of suspected malaria, and the mRDT results and treatments were compared to blind-read PCR diagnosis. In total, 256 CHWs enrolled 2400 patients with 2154 (89.8%) evaluated. In the intervention arm, 75.3% (828/1099) were treated appropriately vs. 17.5% (185/1055) in the control arm (cluster adjusted risk ratio: 3.72, 95% confidence interval 2.40-5.77; p < 0.001). In the control arm, 85.9% (164/191) with confirmed Plasmodium vivax received chloroquine compared to 45.1% (70/155) in the intervention arm (p < 0.001). Overuse of chloroquine in the control arm resulted in 87.6% (813/928) of those with no malaria (PCR negative) being treated vs. 10.0% (95/947) in the intervention arm, p < 0.001. In the intervention arm, 71.4% (30/42) of patients with P. falciparum did not receive artemisinin-based combination therapy, partly because operational sensitivity of the RDTs was low (53.2%, 38.1-67.9). There was high concordance between recorded RDT result and CHW prescription decisions: 826/950 (87.0%) with a negative test were not prescribed an antimalarial. Co

  16. Delivering prevention for alcohol and cannabis using the Internet: a cluster randomised controlled trial.

    Science.gov (United States)

    Newton, Nicola C; Andrews, Gavin; Teesson, Maree; Vogl, Laura E

    2009-06-01

    To establish the efficacy of an internet based prevention program to reduce alcohol and cannabis use in adolescents. A cluster randomised controlled trial was conducted with 764 13-year olds from ten Australian secondary schools in 2007-2008. Half the schools were randomly allocated to the computerised prevention program (n=397), and half to their usual health classes (n=367). The Climate Schools: Alcohol and Cannabis prevention course is facilitated by the internet and consists of novel, evidence-based, curriculum consistent lessons aimed at reducing alcohol and cannabis use. Participants were assessed at baseline, immediately post, and at six months following the intervention. Compared to the control group, students in the intervention group showed significant improvements in alcohol and cannabis knowledge at the end of the course and the six month follow-up. In addition, the intervention group showed a reduction in average weekly alcohol consumption and frequency of cannabis use at the six month follow-up. No differences between groups were found on alcohol expectancies, cannabis attitudes, or alcohol and cannabis related harms. The course is acceptable, scalable and fidelity is assured. It increased knowledge regarding alcohol and cannabis, and decreased use of these drugs.

  17. Randomised cluster trial to support informed parental decision-making for the MMR vaccine

    Directory of Open Access Journals (Sweden)

    Bekker Hilary

    2011-06-01

    Full Text Available Abstract Background In the UK public concern about the safety of the combined measles, mumps and rubella [MMR] vaccine continues to impact on MMR coverage. Whilst the sharp decline in uptake has begun to level out, first and second dose uptake rates remain short of that required for population immunity. Furthermore, international research consistently shows that some parents lack confidence in making a decision about MMR vaccination for their children. Together, this work suggests that effective interventions are required to support parents to make informed decisions about MMR. This trial assessed the impact of a parent-centred, multi-component intervention (balanced information, group discussion, coaching exercise on informed parental decision-making for MMR. Methods This was a two arm, cluster randomised trial. One hundred and forty two UK parents of children eligible for MMR vaccination were recruited from six primary healthcare centres and six childcare organisations. The intervention arm received an MMR information leaflet and participated in the intervention (parent meeting. The control arm received the leaflet only. The primary outcome was decisional conflict. Secondary outcomes were actual and intended MMR choice, knowledge, attitude, concern and necessity beliefs about MMR and anxiety. Results Decisional conflict decreased for both arms to a level where an 'effective' MMR decision could be made one-week (effect estimate = -0.54, p Conclusions Whilst both the leaflet and the parent meeting reduced parents' decisional conflict, the parent meeting appeared to enable parents to act upon their decision leading to vaccination uptake.

  18. Health workforce planning in Europe: creating learning country clusters.

    NARCIS (Netherlands)

    Batenburg, R.

    2015-01-01

    In this article, the different dimensions and determinants of health workforce planning (HWF) are investigated to improve context-sensitivity and mutual learning among groups of countries with similar HWF characteristics. A novel approach to scoring countries according to their HFW characteristics

  19. Cluster Policy in the Light of Institutional Context—A Comparative Study of Transition Countries

    Directory of Open Access Journals (Sweden)

    Tine Lehmann

    2015-10-01

    Full Text Available The business environment in transition countries is often extraordinarily challenging for companies. The transition process these countries find themselves in leads to constant changes in the institutional environment. Hence, institutional voids prevail. These institutional voids cause competitive disadvantages for small and medium enterprises. Cluster policy can address these competitive disadvantages. As cluster policy generally aims at supporting companies’ competitive advantage by spurring innovation and productivity, it can help to bridge institutional voids. This article’s research question aims at analyzing and comparing cluster policies in the institutional context of two transition countries (Serbia and Tunisia and analyzes to what extent cluster policies in these two countries are adapted to institutional voids prevailing there. The case studies offer insights into apparent difficulties of clusters in bridging formal institutional voids, as well as, notably, into the informal void of skill mismatches in the labor market. Still, for some specific voids, clusters do at least implicitly assume a bridging role. While the cluster policies examined do not explicitly target the institutional voids identified, cluster management can—in the course of time—align its service offering more closely with these voids. Bottom-up designed cluster policies can play an especially important role in such an evolution towards bridging institutional voids.

  20. Child Centred Approach to Climate Change and Health Adaptation through Schools in Bangladesh: A Cluster Randomised Intervention Trial

    Science.gov (United States)

    Kabir, Md Iqbal; Rahman, Md Bayzidur; Smith, Wayne; Lusha, Mirza Afreen Fatima; Milton, Abul Hasnat

    2015-01-01

    Background Bangladesh is one of the most vulnerable countries to climate change. People are getting educated at different levels on how to deal with potential impacts. One such educational mode was the preparation of a school manual, for high school students on climate change and health protection endorsed by the National Curriculum and Textbook Board, which is based on a 2008 World Health Organization manual. The objective of this study was to test the effectiveness of the manual in increasing the knowledge level of the school children about climate change and health adaptation. Methods This cluster randomized intervention trial involved 60 schools throughout Bangladesh, with 3293 secondary school students participating. School upazilas (sub-districts) were randomised into intervention and control groups, and two schools from each upazila were randomly selected. All year seven students from both groups of schools sat for a pre-test of 30 short questions of binary response. A total of 1515 students from 30 intervention schools received the intervention through classroom training based on the school manual and 1778 students of the 30 control schools did not get the manual but a leaflet on climate change and health issues. Six months later, a post-intervention test of the same questionnaire used in the pre-test was performed at both intervention and control schools. The pre and post test scores were analysed along with the demographic data by using random effects model. Results None of the various school level and student level variables were significantly different between the control and intervention group. However, the intervention group had a 17.42% (95% CI: 14.45 to 20.38, P = school-based intervention for climate change and health adaptation is effective for increasing the knowledge level of school children on this topic. PMID:26252381

  1. Child Centred Approach to Climate Change and Health Adaptation through Schools in Bangladesh: A Cluster Randomised Intervention Trial.

    Science.gov (United States)

    Kabir, Md Iqbal; Rahman, Md Bayzidur; Smith, Wayne; Lusha, Mirza Afreen Fatima; Milton, Abul Hasnat

    2015-01-01

    Bangladesh is one of the most vulnerable countries to climate change. People are getting educated at different levels on how to deal with potential impacts. One such educational mode was the preparation of a school manual, for high school students on climate change and health protection endorsed by the National Curriculum and Textbook Board, which is based on a 2008 World Health Organization manual. The objective of this study was to test the effectiveness of the manual in increasing the knowledge level of the school children about climate change and health adaptation. This cluster randomized intervention trial involved 60 schools throughout Bangladesh, with 3293 secondary school students participating. School upazilas (sub-districts) were randomised into intervention and control groups, and two schools from each upazila were randomly selected. All year seven students from both groups of schools sat for a pre-test of 30 short questions of binary response. A total of 1515 students from 30 intervention schools received the intervention through classroom training based on the school manual and 1778 students of the 30 control schools did not get the manual but a leaflet on climate change and health issues. Six months later, a post-intervention test of the same questionnaire used in the pre-test was performed at both intervention and control schools. The pre and post test scores were analysed along with the demographic data by using random effects model. None of the various school level and student level variables were significantly different between the control and intervention group. However, the intervention group had a 17.42% (95% CI: 14.45 to 20.38, P = school-based intervention for climate change and health adaptation is effective for increasing the knowledge level of school children on this topic.

  2. Text messaging reminders for influenza vaccine in primary care: protocol for a cluster randomised controlled trial (TXT4FLUJAB).

    Science.gov (United States)

    Herrett, Emily; van Staa, Tjeerd; Free, Caroline; Smeeth, Liam

    2014-05-02

    The UK government recommends that at least 75% of people aged under 64 with certain conditions receive an annual influenza vaccination. Primary care practices often fall short of this target and strategies to increase vaccine uptake are required. Text messaging reminders are already used in 30% of practices to remind patients about vaccination, but there has been no trial addressing their effectiveness in increasing influenza vaccine uptake in the UK. The aims of the study are (1) to develop the methodology for conducting cluster randomised trials of text messaging interventions utilising routine electronic health records and (2) to assess the effectiveness of using a text messaging influenza vaccine reminder in achieving an increase in influenza vaccine uptake in patients aged 18-64 with chronic conditions, compared with standard care. This cluster randomised trial will recruit general practices across three settings in English primary care (Clinical Practice Research Datalink, ResearchOne and London iPLATO text messaging software users) and randomise them to either standard care or a text messaging campaign to eligible patients. Flu vaccine uptake will be ascertained using routinely collected, anonymised electronic patient records. This protocol outlines the proposed study design and analysis methods. This study will determine the effectiveness of text messaging vaccine reminders in primary care in increasing influenza vaccine uptake, and will strengthen the methodology for using electronic health records in cluster randomised trials of text messaging interventions. This trial was approved by the Surrey Borders Ethics Committee (13/LO/0872). The trial results will be disseminated at national conferences and published in a peer-reviewed medical journal. The results will also be distributed to the Primary Care Research Network and to all participating general practices. This study is registered at controlled-trials.com ISRCTN48840025, July 2013.

  3. Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya: the WASH Benefits study design and rationale

    Science.gov (United States)

    Arnold, Benjamin F; Null, Clair; Luby, Stephen P; Unicomb, Leanne; Stewart, Christine P; Dewey, Kathryn G; Ahmed, Tahmeed; Ashraf, Sania; Christensen, Garret; Clasen, Thomas; Dentz, Holly N; Fernald, Lia C H; Haque, Rashidul; Hubbard, Alan E; Kariger, Patricia; Leontsini, Elli; Lin, Audrie; Njenga, Sammy M; Pickering, Amy J; Ram, Pavani K; Tofail, Fahmida; Winch, Peter J; Colford, John M

    2013-01-01

    Introduction Enteric infections are common during the first years of life in low-income countries and contribute to growth faltering with long-term impairment of health and development. Water quality, sanitation, handwashing and nutritional interventions can independently reduce enteric infections and growth faltering. There is little evidence that directly compares the effects of these individual and combined interventions on diarrhoea and growth when delivered to infants and young children. The objective of the WASH Benefits study is to help fill this knowledge gap. Methods and analysis WASH Benefits includes two cluster-randomised trials to assess improvements in water quality, sanitation, handwashing and child nutrition—alone and in combination—to rural households with pregnant women in Kenya and Bangladesh. Geographically matched clusters (groups of household compounds in Bangladesh and villages in Kenya) will be randomised to one of six intervention arms or control. Intervention arms include water quality, sanitation, handwashing, nutrition, combined water+sanitation+handwashing (WSH) and WSH+nutrition. The studies will enrol newborn children (N=5760 in Bangladesh and N=8000 in Kenya) and measure outcomes at 12 and 24 months after intervention delivery. Primary outcomes include child length-for-age Z-scores and caregiver-reported diarrhoea. Secondary outcomes include stunting prevalence, markers of environmental enteropathy and child development scores (verbal, motor and personal/social). We will estimate unadjusted and adjusted intention-to-treat effects using semiparametric estimators and permutation tests. Ethics and dissemination Study protocols have been reviewed and approved by human subjects review boards at the University of California, Berkeley, Stanford University, the International Centre for Diarrheal Disease Research, Bangladesh, the Kenya Medical Research Institute, and Innovations for Poverty Action. Independent data safety monitoring

  4. The Diabetes Remission Clinical Trial (DiRECT): protocol for a cluster randomised trial.

    Science.gov (United States)

    Leslie, Wilma S; Ford, Ian; Sattar, Naveed; Hollingsworth, Kieren G; Adamson, Ashley; Sniehotta, Falko F; McCombie, Louise; Brosnahan, Naomi; Ross, Hazel; Mathers, John C; Peters, Carl; Thom, George; Barnes, Alison; Kean, Sharon; McIlvenna, Yvonne; Rodrigues, Angela; Rehackova, Lucia; Zhyzhneuskaya, Sviatlana; Taylor, Roy; Lean, Mike E J

    2016-02-16

    Despite improving evidence-based practice following clinical guidelines to optimise drug therapy, Type 2 diabetes (T2DM) still exerts a devastating toll from vascular complications and premature death. Biochemical remission of T2DM has been demonstrated with weight loss around 15kg following bariatric surgery and in several small studies of non-surgical energy-restriction treatments. The non-surgical Counterweight-Plus programme, running in Primary Care where obesity and T2DM are routinely managed, produces >15 kg weight loss in 33% of all enrolled patients. The Diabetes UK-funded Counterpoint study suggested that this should be sufficient to reverse T2DM by removing ectopic fat in liver and pancreas, restoring first-phase insulin secretion. The Diabetes Remission Clinical Trial (DiRECT) was designed to determine whether a structured, intensive, weight management programme, delivered in a routine Primary Care setting, is a viable treatment for achieving durable normoglycaemia. Other aims are to understand the mechanistic basis of remission and to identify psychological predictors of response. Cluster-randomised design with GP practice as the unit of randomisation: 280 participants from around 30 practices in Scotland and England will be allocated either to continue usual guideline-based care or to add the Counterweight-Plus weight management programme, which includes primary care nurse or dietitian delivery of 12-20weeks low calorie diet replacement, food reintroduction, and long-term weight loss maintenance. Main inclusion criteria: men and women aged 20-65 years, all ethnicities, T2DM 0-6years duration, BMI 27-45 kg/m(2). Tyneside participants will undergo Magnetic Resonance (MR) studies of pancreatic and hepatic fat, and metabolic studies to determine mechanisms underlying T2DM remission. Co-primary endpoints: weight reduction ≥ 15 kg and HbA1c <48 mmol/mol at one year. Further follow-up at 2 years. This study will establish whether a structured weight

  5. A cluster randomised controlled effectiveness trial evaluating perinatal home visiting among South African mothers/infants.

    Directory of Open Access Journals (Sweden)

    Mary Jane Rotheram-Borus

    Full Text Available Interventions are needed to reduce poor perinatal health. We trained community health workers (CHWs as home visitors to address maternal/infant risks.In a cluster randomised controlled trial in Cape Town townships, neighbourhoods were randomised within matched pairs to 1 the control, healthcare at clinics (n = 12 neighbourhoods; n = 594 women, or 2 a home visiting intervention by CBW trained in cognitive-behavioural strategies to address health risks (by the Philani Maternal, Child Health and Nutrition Programme, in addition to clinic care (n = 12 neighbourhoods; n = 644 women. Participants were assessed during pregnancy (2% refusal and 92% were reassessed at two weeks post-birth, 88% at six months and 84% at 18 months later. We analysed 32 measures of maternal/infant well-being over the 18 month follow-up period using longitudinal random effects regressions. A binomial test for correlated outcomes evaluated overall effectiveness over time. The 18 month post-birth assessment outcomes also were examined alone and as a function of the number of home visits received.Benefits were found on 7 of 32 measures of outcomes, resulting in significant overall benefits for the intervention compared to the control when using the binomial test (p = 0.008; nevertheless, no effects were observed when only the 18 month outcomes were analyzed. Benefits on individual outcomes were related to the number of home visits received. Among women living with HIV, intervention mothers were more likely to implement the PMTCT regimens, use condoms during all sexual episodes (OR = 1.25; p = 0.014, have infants with healthy weight-for-age measurements (OR = 1.42; p = 0.045, height-for-age measurements (OR = 1.13, p<0.001, breastfeed exclusively for six months (OR = 3.59; p<0.001, and breastfeed longer (OR = 3.08; p<0.001. Number of visits was positively associated with infant birth weight ≥2500 grams (OR = 1.07; p = 0

  6. Training practitioners to deliver opportunistic multiple behaviour change counselling in primary care: a cluster randomised trial.

    Science.gov (United States)

    Butler, Christopher C; Simpson, Sharon A; Hood, Kerenza; Cohen, David; Pickles, Tim; Spanou, Clio; McCambridge, Jim; Moore, Laurence; Randell, Elizabeth; Alam, M Fasihul; Kinnersley, Paul; Edwards, Adrian; Smith, Christine; Rollnick, Stephen

    2013-03-19

    To evaluate the effect of training primary care health professionals in behaviour change counselling on the proportion of patients self reporting change in four risk behaviours (smoking, alcohol use, exercise, and healthy eating). Cluster randomised trial with general practices as the unit of randomisation. General practices in Wales. 53 general practitioners and practice nurses from 27 general practices (one each at all but one practice) recruited 1827 patients who screened positive for at least one risky behaviour. Behaviour change counselling was developed from motivational interviewing to enable clinicians to enhance patients' motivation to change health related behaviour. Clinicians were trained using a blended learning programme called Talking Lifestyles. Proportion of patients who reported making beneficial changes in at least one of the four risky behaviours at three months. 1308 patients from 13 intervention and 1496 from 14 control practices were approached: 76% and 72% respectively agreed to participate, with 831 (84%) and 996 (92%) respectively screening eligible for an intervention. There was no effect on the primary outcome (beneficial change in behaviour) at three months (362 (44%) v 404 (41%), odds ratio 1.12 (95% CI 0.90 to 1.39)) or on biochemical or biometric measures at 12 months. More patients who had consulted with trained clinicians recalled consultation discussion about a health behaviour (724/795 (91%) v 531/966 (55%), odds ratio 12.44 (5.85 to 26.46)) and intended to change (599/831 (72%) v 491/996 (49%), odds ratio 2.88 (2.05 to 4.05)). More intervention practice patients reported making an attempt to change (328 (39%) v 317 (32%), odds ratio 1.40 (1.15 to 1.70)), a sustained behaviour change at three months (288 (35%) v 280 (28%), odds ratio 1.36 (1.11 to 1.65)), and reported slightly greater improvements in healthy eating at three and 12 months, plus improved activity at 12 months. Training cost £1597 per practice. Training primary

  7. A Study on Logistics Cluster Competitiveness among Asia Main Countries using the Porter's Diamond Model

    OpenAIRE

    Tae Won Chung

    2016-01-01

    Measurement and discussions of logistics cluster competitiveness with a national approach are required to boost agglomeration effects and potentially create logistics efficiency and productivity. This study developed assessment criteria of logistics cluster competitiveness based on Porter's diamond model, calculated the weight of each criterion by the AHP method, and finally evaluated and discussed logistics cluster competitiveness among Asia main countries. The results indicate that there wa...

  8. Social Dancing and Incidence of Falls in Older Adults: A Cluster Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Dafna Merom

    2016-08-01

    Full Text Available The prevention of falls among older people is a major public health challenge. Exercises that challenge balance are recognized as an efficacious fall prevention strategy. Given that small-scale trials have indicated that diverse dance styles can improve balance and gait of older adults, two of the strongest risk factors for falls in older people, this study aimed to determine whether social dance is effective in i reducing the number of falls and ii improving physical and cognitive fall-related risk factors.A parallel two-arm cluster randomized controlled trial was undertaken in 23 self-care retirement villages (clusters around Sydney, Australia. Eligible villages had to have an appropriate hall for dancing, house at least 60 residents, and not be currently offering dance as a village activity. Retirement villages were randomised using a computer generated randomisation method, constrained using minimisation. Eligible participants had to be a resident of the village, be able to walk at least 50 m, and agree to undergo physical and cognitive testing without cognitive impairment. Residents of intervention villages (12 clusters were offered twice weekly one-hour social dancing classes (folk or ballroom dancing over 12 mo (80 h in total. Programs were standardized across villages and were delivered by eight dance teachers. Participants in the control villages (11 clusters were advised to continue with their regular activities.falls during the 12 mo trial and Trail Making Tests.The Physiological Performance Assessment (i.e., postural sway, proprioception, reaction time, leg strength and the Short Physical Performance Battery; health-related physical and mental quality of life from the Short-Form 12 (SF-12 Survey. Data on falls were obtained from 522 of 530 (98% randomised participants (mean age 78 y, 85% women and 424 (80% attended the 12-mo reassessment, which was lower among folk dance participants (71% than ballroom dancing (82% or control

  9. A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol.

    Science.gov (United States)

    Tan, Ai May; Lamontagne, Anthony D; Sarmugam, Rani; Howard, Peter

    2013-04-29

    Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculations incorporated the cluster design. Final number of clusters was determined to be 16, based on a cluster size of 20 and calcium intake parameters (effect size 250 mg, ICC 0.5 and standard deviation 290 mg) as it required the highest number of clusters.Sixteen workplaces were recruited from a pool of 97 workplaces and randomly assigned to intervention and control arms (eight in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organisation wide educational activities. Workplaces in the control/standard care arm received print resources. Intervention workshops were guided by self-efficacy theory and included participatory activities such as goal setting, problem solving, local food sampling, exercise trials, group discussion and behaviour feedback.Outcomes measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, four weeks and six months post intervention. This study addresses the current lack of evidence for behaviour change interventions focussing on osteoporosis prevention. It addresses missed opportunities of using workplaces as a platform to target high-risk individuals with sedentary occupations. The intervention was designed to modify behaviour levels to bring about risk reduction. It is the first to address dietary and physical activity components each with unique intervention strategies in the context of osteoporosis

  10. A community-based cluster randomised trial of safe storage to reduce pesticide self-poisoning in rural Sri Lanka

    DEFF Research Database (Denmark)

    Pearson, Melissa; Konradsen, Flemming; Gunnell, David

    2011-01-01

    . One approach to reducing access to pesticides is for households to store pesticides in lockable "safe-storage" containers. However, before this approach can be promoted, evidence is required on its effectiveness and safety. Methods/Design A community-based cluster randomised controlled trial has been...... at the 5% significance level. Secondary outcomes will include the incidence of all pesticide poisoning and total self-harm. Discussion This paper describes a large effectiveness study of a community intervention to reduce the burden of intentional poisoning in rural Sri Lanka. The study builds on a strong...... partnership between provincial health services, local and international researchers, and local communities. We discuss issues in relation to randomisation and contamination, engaging control villages, the intervention, and strategies to improve adherence. Trial Registritation The trial is registered...

  11. Mobile phones as a health communication tool to improve skilled attendance at delivery in Zanzibar: a cluster-randomised controlled trial.

    Science.gov (United States)

    Lund, S; Hemed, M; Nielsen, B B; Said, A; Said, K; Makungu, M H; Rasch, V

    2012-09-01

    To examine the association between a mobile phone intervention and skilled delivery attendance in a resource-limited setting. Pragmatic cluster-randomised controlled trial with primary healthcare facilities as the unit of randomisation. Primary healthcare facilities in Zanzibar. Two thousand, five hundred and fifty pregnant women (1311 interventions and 1239 controls) who attended antenatal care at one of the selected primary healthcare facilities were included at their first antenatal care visit and followed until 42 days after delivery. All pregnant women were eligible for study participation. Twenty-four primary healthcare facilities in six districts in Zanzibar were allocated by simple randomisation to either mobile phone intervention (n = 12) or standard care (n = 12). The intervention consisted of a short messaging service (SMS) and mobile phone voucher component. Skilled delivery attendance. The mobile phone intervention was associated with an increase in skilled delivery attendance: 60% of the women in the intervention group versus 47% in the control group delivered with skilled attendance. The intervention produced a significant increase in skilled delivery attendance amongst urban women (odds ratio, 5.73; 95% confidence interval, 1.51-21.81), but did not reach rural women. The mobile phone intervention significantly increased skilled delivery attendance amongst women of urban residence. Mobile phone solutions may contribute to the saving of lives of women and their newborns and the achievement of Millennium Development Goals 4 and 5, and should be considered by maternal and child health policy makers in developing countries. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

  12. Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. Methods This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. Results At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). Conclusions A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Trial registration Current Controlled Trials ISRCTN72839675. PMID:24365274

  13. Ask: a health advocacy program for adolescents with an intellectual disability: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Lennox Nicholas

    2012-09-01

    Full Text Available Abstract Background Adolescents with intellectual disability often have poor health and healthcare. This is partly as a consequence of poor communication and recall difficulties, and the possible loss of specialised paediatric services. Methods/Design A cluster randomised trial was conducted with adolescents with intellectual disability to investigate a health intervention package to enhance interactions among adolescents with intellectual disability, their parents/carers, and general practitioners (GPs. The trial took place in Queensland, Australia, between February 2007 and September 2010. The intervention package was designed to improve communication with health professionals and families’ organisation of health information, and to increase clinical activities beneficial to improved health outcomes. It consisted of the Comprehensive Health Assessment Program (CHAP, a one-off health check, and the Ask Health Diary, designed for on-going use. Participants were drawn from Special Education Schools and Special Education Units. The education component of the intervention was delivered as part of the school curriculum. Educators were surveyed at baseline and followed-up four months later. Carers were surveyed at baseline and after 26 months. Evidence of health promotion, disease prevention and case-finding activities were extracted from GPs clinical records. Qualitative interviews of educators occurred after completion of the educational component of the intervention and with adolescents and carers after the CHAP. Discussion Adolescents with intellectual disability have difficulty obtaining many health services and often find it difficult to become empowered to improve and protect their health. The health intervention package proposed may aid them by augmenting communication, improving documentation of health encounters, and improving access to, and quality of, GP care. Recruitment strategies to consider for future studies in this population

  14. Ask: a health advocacy program for adolescents with an intellectual disability: a cluster randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background Adolescents with intellectual disability often have poor health and healthcare. This is partly as a consequence of poor communication and recall difficulties, and the possible loss of specialised paediatric services. Methods/Design A cluster randomised trial was conducted with adolescents with intellectual disability to investigate a health intervention package to enhance interactions among adolescents with intellectual disability, their parents/carers, and general practitioners (GPs). The trial took place in Queensland, Australia, between February 2007 and September 2010. The intervention package was designed to improve communication with health professionals and families’ organisation of health information, and to increase clinical activities beneficial to improved health outcomes. It consisted of the Comprehensive Health Assessment Program (CHAP), a one-off health check, and the Ask Health Diary, designed for on-going use. Participants were drawn from Special Education Schools and Special Education Units. The education component of the intervention was delivered as part of the school curriculum. Educators were surveyed at baseline and followed-up four months later. Carers were surveyed at baseline and after 26 months. Evidence of health promotion, disease prevention and case-finding activities were extracted from GPs clinical records. Qualitative interviews of educators occurred after completion of the educational component of the intervention and with adolescents and carers after the CHAP. Discussion Adolescents with intellectual disability have difficulty obtaining many health services and often find it difficult to become empowered to improve and protect their health. The health intervention package proposed may aid them by augmenting communication, improving documentation of health encounters, and improving access to, and quality of, GP care. Recruitment strategies to consider for future studies in this population include ensuring potential

  15. A physiotherapy-directed occupational health programme for Austrian school teachers: a cluster randomised pilot study.

    Science.gov (United States)

    Figl-Hertlein, A; Horsak, B; Dean, E; Schöny, W; Stamm, T

    2014-03-01

    Although physiotherapists have long advocated workplace health, school teachers have not traditionally been a focus of study by these professionals. However, classroom teaching contributes to a range of occupational health issues related to general health as well as ergonomics that can be prevented or addressed by physiotherapists. To undertake a pilot study to explore the potential effects of a physiotherapy-directed occupational health programme individualised for school teachers, develop study methodology and gather preliminary data to establish a 'proof of concept' to inform future studies. Cluster randomised pilot study using a convenience sample. Eight Austrian regional secondary schools. Schools and their teachers were recruited and allocated to an intervention group (IG, n=26 teachers) or a control group (CG, n=43 teachers). Teachers were eligible to participate if they reported no health issues that compromised their classroom responsibilities. The IG participated in an individualised physiotherapy-directed occupational health programme (six 30-minute sessions) related to ergonomics and stress management conducted over a 5-month semester. The CG had a pseudo-intervention of one oral education session. Primary outcomes included scores from the physical and mental components and health transition item of the Short-Form-36 Health Survey questionnaire (SF-36), and emotional well-being and resistance to stress items from the work-related behaviour and experience patterns questionnaire. Data were collected before and after one semester. The primary outcome measure, the SF-36 physical component score, showed a reduction in the CG and no change in the IG, meaning that the CG deteriorated over the study semester while the IG did not show any change. A physiotherapy-directed occupational health programme may prevent deterioration of physical health of school teachers in one semester (proof of concept). This pilot study provided valuable information to inform the

  16. 6-PACK programme to decrease fall injuries in acute hospitals: cluster randomised controlled trial.

    Science.gov (United States)

    Barker, Anna L; Morello, Renata T; Wolfe, Rory; Brand, Caroline A; Haines, Terry P; Hill, Keith D; Brauer, Sandra G; Botti, Mari; Cumming, Robert G; Livingston, Patricia M; Sherrington, Catherine; Zavarsek, Silva; Lindley, Richard I; Kamar, Jeannette

    2016-01-26

    To evaluate the effect of the 6-PACK programme on falls and fall injuries in acute wards. Cluster randomised controlled trial. Six Australian hospitals. All patients admitted to 24 acute wards during the trial period. Participating wards were randomly assigned to receive either the nurse led 6-PACK programme or usual care over 12 months. The 6-PACK programme included a fall risk tool and individualised use of one or more of six interventions: "falls alert" sign, supervision of patients in the bathroom, ensuring patients' walking aids are within reach, a toileting regimen, use of a low-low bed, and use of a bed/chair alarm. The co-primary outcomes were falls and fall injuries per 1000 occupied bed days. During the trial, 46 245 admissions to 16 medical and eight surgical wards occurred. As many people were admitted more than once, this represented 31 411 individual patients. Patients' characteristics and length of stay were similar for intervention and control wards. Use of 6-PACK programme components was higher on intervention wards than on control wards (incidence rate ratio 3.05, 95% confidence interval 2.14 to 4.34; Pcontrol wards. Positive changes in falls prevention practice occurred following the introduction of the 6-PACK programme. However, no difference was seen in falls or fall injuries between groups. High quality evidence showing the effectiveness of falls prevention interventions in acute wards remains absent. Novel solutions to the problem of in-hospital falls are urgently needed. Australian New Zealand Clinical Trials Registry ACTRN12611000332921. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  17. A novel school-based intervention to improve nutrition knowledge in children: cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ong Ken K

    2010-03-01

    Full Text Available Abstract Background Improving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a novel educational intervention to increase nutrition knowledge among primary school children. Methods We developed a card game 'Top Grub' and a 'healthy eating' curriculum for use in primary schools. Thirty-eight state primary schools comprising 2519 children in years 5 and 6 (aged 9-11 years were recruited in a pragmatic cluster randomised controlled trial. The main outcome measures were change in nutrition knowledge scores, attitudes to healthy eating and acceptability of the intervention by children and teachers. Results Twelve intervention and 13 control schools (comprising 1133 children completed the trial. The main reason for non-completion was time pressure of the school curriculum. Mean total nutrition knowledge score increased by 1.1 in intervention (baseline to follow-up: 28.3 to 29.2 and 0.3 in control schools (27.3 to 27.6. Total nutrition knowledge score at follow-up, adjusted for baseline score, deprivation, and school size, was higher in intervention than in control schools (mean difference = 1.1; 95% CI: 0.05 to 2.16; p = 0.042. At follow-up, more children in the intervention schools said they 'are currently eating a healthy diet' (39.6% or 'would try to eat a healthy diet' (35.7% than in control schools (34.4% and 31.7% respectively; chi-square test p Conclusions The 'Top Grub' card game facilitated the enjoyable delivery of nutrition education in a sample of UK primary school age children. Further studies should determine whether improvements in nutrition knowledge are sustained and lead to changes in dietary behaviour.

  18. Group hypnosis vs. relaxation for smoking cessation in adults: a cluster-randomised controlled trial.

    Science.gov (United States)

    Dickson-Spillmann, Maria; Haug, Severin; Schaub, Michael P

    2013-12-23

    Despite the popularity of hypnotherapy for smoking cessation, the efficacy of this method is unclear. We aimed to investigate the efficacy of a single-session of group hypnotherapy for smoking cessation compared to relaxation in Swiss adult smokers. This was a cluster-randomised, parallel-group, controlled trial. A single session of hypnosis or relaxation for smoking cessation was delivered to groups of smokers (median size = 11). Participants were 223 smokers consuming ≥ 5 cigarettes per day, willing to quit and not using cessation aids (47.1% females, M = 37.5 years [SD = 11.8], 86.1% Swiss). Nicotine withdrawal, smoking abstinence self-efficacy, and adverse reactions were assessed at a 2-week follow-up. The main outcome, self-reported 30-day point prevalence of smoking abstinence, was assessed at a 6-month follow up. Abstinence was validated through salivary analysis. Secondary outcomes included number of cigarettes smoked per day, smoking abstinence self-efficacy, and nicotine withdrawal. At the 6-month follow up, 14.7% in the hypnosis group and 17.8% in the relaxation group were abstinent. The intervention had no effect on smoking status (p = .73) or on the number of cigarettes smoked per day (p = .56). Smoking abstinence self-efficacy did not differ between the interventions (p = .14) at the 2-week follow-up, but non-smokers in the hypnosis group experienced reduced withdrawal (p = .02). Both interventions produced few adverse reactions (p = .81). A single session of group hypnotherapy does not appear to be more effective for smoking cessation than a group relaxation session. Current Controlled Trials ISRCTN72839675.

  19. Impact of a participatory intervention with women's groups on psychological distress among mothers in rural Bangladesh: secondary analysis of a cluster-randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Kelly Clarke

    Full Text Available Perinatal common mental disorders (PCMDs are a major cause of disability among women and disproportionately affect lower income countries. Interventions to address PCMDs are urgently needed in these settings, and group-based and peer-led approaches are potential strategies to increase access to mental health interventions. Participatory women's health groups led by local women previously reduced postpartum psychological distress in eastern India. We assessed the effect of a similar intervention on postpartum psychological distress in rural Bangladesh.We conducted a secondary analysis of data from a cluster-randomised controlled trial with 18 clusters and an estimated population of 532,996. Nine clusters received an intervention comprising monthly meetings during which women's groups worked through a participatory learning and action cycle to develop strategies for improving women's and children's health. There was one group for every 309 individuals in the population, 810 groups in total. Mothers in nine control clusters had access to usual perinatal care. Postpartum psychological distress was measured with the 20-item Self Reporting Questionnaire (SRQ-20 between six and 52 weeks after delivery, during the months of January to April, in 2010 and 2011.We analysed outcomes for 6275 mothers. Although the cluster mean SRQ-20 score was lower in the intervention arm (mean 5.2, standard deviation 1.8 compared to control (5.3, 1.2, the difference was not significant (β 1.44, 95% CI 0.28, 3.08.Despite promising results in India, participatory women's groups focused on women's and children's health had no significant effect on postpartum psychological distress in rural Bangladesh.

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

    DEFF Research Database (Denmark)

    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...

  1. Hand sanitiser provision for reducing illness absences in primary school children: a cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Patricia Priest

    2014-08-01

    Full Text Available BACKGROUND: The potential for transmission of infectious diseases offered by the school environment are likely to be an important contributor to the rates of infectious disease experienced by children. This study aimed to test whether the addition of hand sanitiser in primary school classrooms compared with usual hand hygiene would reduce illness absences in primary school children in New Zealand. METHODS AND FINDINGS: This parallel-group cluster randomised trial took place in 68 primary schools, where schools were allocated using restricted randomisation (1:1 ratio to the intervention or control group. All children (aged 5 to 11 y in attendance at participating schools received an in-class hand hygiene education session. Schools in the intervention group were provided with alcohol-based hand sanitiser dispensers in classrooms for the winter school terms (27 April to 25 September 2009. Control schools received only the hand hygiene education session. The primary outcome was the number of absence episodes due to any illness among 2,443 follow-up children whose caregivers were telephoned after each absence from school. Secondary outcomes measured among follow-up children were the number of absence episodes due to specific illness (respiratory or gastrointestinal, length of illness and illness absence episodes, and number of episodes where at least one other member of the household became ill subsequently (child or adult. We also examined whether provision of sanitiser was associated with experience of a skin reaction. The number of absences for any reason and the length of the absence episode were measured in all primary school children enrolled at the schools. Children, school administrative staff, and the school liaison research assistants were not blind to group allocation. Outcome assessors of follow-up children were blind to group allocation. Of the 1,301 and 1,142 follow-up children in the hand sanitiser and control groups, respectively, the

  2. Characteristics of non-clustered tuberculosis in a low burden country

    DEFF Research Database (Denmark)

    Kamper-Jørgensen, Zaza; Andersen, Aase Bengaard; Kok-Jensen, Axel

    2012-01-01

    Molecular genotyping studies often focus on clustered tuberculosis and recent transmission. Less attention has been paid to non-clustered tuberculosis. However, non-clustered cases also contribute significantly to the tuberculosis burden, especially in low-incidence countries. The objective...... of this study is to characterize non-clustered tuberculosis cases in Denmark and point out potential implications for tuberculosis control. The study is based on nationwide IS6110-RFLP genotyping of tuberculosis cases from 1992 through 2004, corresponding to 98% of culture verified cases. Of 3988 cases, 45......% were non-clustered. Both Danes and immigrants had a peak incidence of non-clustered tuberculosis at older ages, 80-89 years (4.3 cases/10(5) population/year) and 60-69 years (28.8 cases/10(5) population/year), respectively. In addition, immigrants had a peak at 20-29 years (43.2 cases/10(5) inhabitants...

  3. Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial.

    Science.gov (United States)

    Richards, David A; Hill, Jacqueline J; Gask, Linda; Lovell, Karina; Chew-Graham, Carolyn; Bower, Peter; Cape, John; Pilling, Stephen; Araya, Ricardo; Kessler, David; Bland, J Martin; Green, Colin; Gilbody, Simon; Lewis, Glyn; Manning, Chris; Hughes-Morley, Adwoa; Barkham, Michael

    2013-08-19

    To compare the clinical effectiveness of collaborative care with usual care in the management of patients with moderate to severe depression. Cluster randomised controlled trial. 51 primary care practices in three primary care districts in the United Kingdom. 581 adults aged 18 years and older who met ICD-10 (international classification of diseases, 10th revision) criteria for a depressive episode on the revised Clinical Interview Schedule. We excluded acutely suicidal patients and those with psychosis, or with type I or type II bipolar disorder; patients whose low mood was associated with bereavement or whose primary presenting problem was alcohol or drug abuse; and patients receiving psychological treatment for their depression by specialist mental health services. We identified potentially eligible participants by searching computerised case records in general practices for patients with depression. Collaborative care, including depression education, drug management, behavioural activation, relapse prevention, and primary care liaison, was delivered by care managers. Collaborative care involved six to 12 contacts with participants over 14 weeks, supervised by mental health specialists. Usual care was family doctors' standard clinical practice. Depression symptoms (patient health questionnaire 9; PHQ-9), anxiety (generalised anxiety disorder 7; GAD-7), and quality of life (short form 36 questionnaire; SF-36) at four and 12 months; satisfaction with service quality (client satisfaction questionnaire; CSQ-8) at four months. 276 participants were allocated to collaborative care and 305 allocated to usual care. At four months, mean depression score was 11.1 (standard deviation 7.3) for the collaborative care group and 12.7 (6.8) for the usual care group. After adjustment for baseline depression, mean depression score was 1.33 PHQ-9 points lower (95% confidence interval 0.35 to 2.31, P=0.009) in participants receiving collaborative care than in those receiving usual

  4. Implementing telephone triage in general practice: a process evaluation of a cluster randomised controlled trial.

    Science.gov (United States)

    Murdoch, Jamie; Varley, Anna; Fletcher, Emily; Britten, Nicky; Price, Linnie; Calitri, Raff; Green, Colin; Lattimer, Valerie; Richards, Suzanne H; Richards, David A; Salisbury, Chris; Taylor, Rod S; Campbell, John L

    2015-04-10

    Telephone triage represents one strategy to manage demand for face-to-face GP appointments in primary care. However, limited evidence exists of the challenges GP practices face in implementing telephone triage. We conducted a qualitative process evaluation alongside a UK-based cluster randomised trial (ESTEEM) which compared the impact of GP-led and nurse-led telephone triage with usual care on primary care workload, cost, patient experience, and safety for patients requesting a same-day GP consultation. The aim of the process study was to provide insights into the observed effects of the ESTEEM trial from the perspectives of staff and patients, and to specify the circumstances under which triage is likely to be successfully implemented. Here we report perspectives of staff. The intervention comprised implementation of either GP-led or nurse-led telephone triage for a period of 2-3 months. A qualitative evaluation was conducted using staff interviews recruited from eight general practices (4 GP triage, 4 Nurse triage) in the UK, implementing triage as part of the ESTEEM trial. Qualitative interviews were undertaken with 44 staff members in GP triage and nurse triage practices (16 GPs, 8 nurses, 7 practice managers, 13 administrative staff). Staff reported diverse experiences and perceptions regarding the implementation of telephone triage, its effects on workload, and on the benefits of triage. Such diversity were explained by the different ways triage was organised, the staffing models used to support triage, how the introduction of triage was communicated across practice staff, and by how staff roles were reconfigured as a result of implementing triage. The findings from the process evaluation offer insight into the range of ways GP practices participating in ESTEEM implemented telephone triage, and the circumstances under which telephone triage can be successfully implemented beyond the context of a clinical trial. Staff experiences and perceptions of telephone

  5. Women's evaluation of abuse and violence care in general practice: a cluster randomised controlled trial (weave

    Directory of Open Access Journals (Sweden)

    Feder Gene

    2010-01-01

    Full Text Available Abstract Background Intimate partner abuse (IPA is a major public health problem with serious implications for the physical and psychosocial wellbeing of women, particularly women of child-bearing age. It is a common, hidden problem in general practice and has been under-researched in this setting. Opportunities for early intervention and support in primary care need to be investigated given the frequency of contact women have with general practice. Despite the high prevalence and health consequences of abuse, there is insufficient evidence for screening in primary care settings. Furthermore, there is little rigorous evidence to guide general practitioners (GPs in responding to women identified as experiencing partner abuse. This paper describes the design of a trial of a general practice-based intervention consisting of screening for fear of partner with feedback to GPs, training for GPs, brief counselling for women and minimal practice organisational change. It examines the effect on women's quality of life, mental health and safety behaviours. Methods/Design weave is a cluster randomised controlled trial involving 40 general practices in Victoria, Australia. Approximately 500 women (16-50 years seen by the GP in the previous year are mailed a short lifestyle survey containing an item to screen for IPA. Women who indicate that they were afraid of a partner/ex-partner in the last year and provide contact details are invited to participate. Once baseline data are collected, GPs are randomly assigned to either a group involving healthy relationship and responding to IPA training plus inviting women for up to 6 sessions of counselling or to a group involving basic education and usual care for women. Outcomes will be evaluated by postal survey at 6 and 12 months following delivery of the intervention. There will be an economic evaluation, and process evaluation involving interviews with women and GPs, to inform understanding about implementation

  6. The Diabetes Care Project: an Australian multicentre, cluster randomised controlled trial [study protocol].

    Science.gov (United States)

    Leach, Matthew J; Segal, Leonie; Esterman, Adrian; Armour, Caroline; McDermott, Robyn; Fountaine, Tim

    2013-12-20

    Diabetes mellitus is an increasingly prevalent metabolic disorder that is associated with substantial disease burden. Australia has an opportunity to improve ways of caring for the growing number of people with diabetes, but this may require changes to the way care is funded, organised and delivered. To inform how best to care for people with diabetes, and to identify the extent of change that is required to achieve this, the Diabetes Care Project (DCP) will evaluate the impact of two different, evidence-based models of care (compared to usual care) on clinical quality, patient and provider experience, and cost. The DCP uses a pragmatic, cluster randomised controlled trial design. Accredited general practices that are situated within any of the seven Australian Medicare Locals/Divisions of General Practice that have agreed to take part in the study were invited to participate. Consenting practices will be randomly assigned to one of three treatment groups for approximately 18 to 22 months: (a) control group (usual care); (b) Intervention 1 (which tests improvements that could be made within the current funding model, facilitated through the use of an online chronic disease management network); or (c) Intervention 2 (which includes the same components as Intervention 1, as well as altered funding to support voluntary patient registration with their practice, incentive payments and a care facilitator). Adult patients who attend the enrolled practices and have established (≥12 month's duration) type 1 diabetes mellitus or newly diagnosed or established type 2 diabetes mellitus are invited to participate. Multiple outcomes will be studied, including changes in glycosylated haemoglobin (primary outcome), changes in other biochemical and clinical metrics, incidence of diabetes-related complications, quality of life, clinical depression, success of tailored care, patient and practitioner satisfaction, and budget sustainability. This project responds to a need for robust

  7. Precommitting to choose wisely about low-value services: a stepped wedge cluster randomised trial.

    Science.gov (United States)

    Kullgren, Jeffrey Todd; Krupka, Erin; Schachter, Abigail; Linden, Ariel; Miller, Jacquelyn; Acharya, Yubraj; Alford, James; Duffy, Richard; Adler-Milstein, Julia

    2018-05-01

    Little is known about how to discourage clinicians from ordering low-value services. Our objective was to test whether clinicians committing their future selves (ie, precommitting) to follow Choosing Wisely recommendations with decision supports could decrease potentially low-value orders. We conducted a 12-month stepped wedge cluster randomised trial among 45 primary care physicians and advanced practice providers in six adult primary care clinics of a US community group practice.Clinicians were invited to precommit to Choosing Wisely recommendations against imaging for uncomplicated low back pain, imaging for uncomplicated headaches and unnecessary antibiotics for acute sinusitis. Clinicians who precommitted received 1-6 months of point-of-care precommitment reminders as well as patient education handouts and weekly emails with resources to support communication about low-value services.The primary outcome was the difference between control and intervention period percentages of visits with potentially low-value orders. Secondary outcomes were differences between control and intervention period percentages of visits with possible alternate orders, and differences between control and 3-month postintervention follow-up period percentages of visits with potentially low-value orders. The intervention was not associated with a change in the percentage of visits with potentially low-value orders overall, for headaches or for acute sinusitis, but was associated with a 1.7% overall increase in alternate orders (p=0.01). For low back pain, the intervention was associated with a 1.2% decrease in the percentage of visits with potentially low-value orders (p=0.001) and a 1.9% increase in the percentage of visits with alternate orders (p=0.007). No changes were sustained in follow-up. Clinician precommitment to follow Choosing Wisely recommendations was associated with a small, unsustained decrease in potentially low-value orders for only one of three targeted conditions and

  8. The efficacy of Protected Mealtimes in hospitalised patients: a stepped wedge cluster randomised controlled trial.

    Science.gov (United States)

    Porter, Judi; Haines, Terry P; Truby, Helen

    2017-02-07

    Protected Mealtimes is an intervention developed to address the problem of malnutrition in hospitalised patients through increasing positive interruptions (such as feeding assistance) whilst minimising unnecessary interruptions (including ward rounds and diagnostic procedures) during mealtimes. This clinical trial aimed to measure the effect of implementing Protected Mealtimes on the energy and protein intake of patients admitted to the subacute setting. A prospective, stepped wedge cluster randomised controlled trial was undertaken across three hospital sites at one health network in Melbourne, Australia. All patients, except those receiving end-of-life care or not receiving oral nutrition, admitted to these wards during the study period participated. The intervention was guided by the British Hospital Caterers Association reference policy on Protected Mealtimes and by principles of implementation science. Primary outcome measures were daily energy and protein intake. The study was powered to determine whether the intervention closed the daily energy deficit between estimated intake and energy requirements measured as 1900 kJ/day in the pilot study for this trial. There were 149 unique participants, including 38 who crossed over from the control to intervention period as the Protected Mealtimes intervention was implemented. In total, 416 observations of 24-hour food intake were obtained. Energy intake was not significantly different between the intervention ([mean ± SD] 6479 ± 2486 kJ/day) and control (6532 ± 2328 kJ/day) conditions (p = 0.88). Daily protein intake was also not significantly different between the intervention (68.6 ± 26.0 g/day) and control (67.0 ± 25.2 g/day) conditions (p = 0.86). The differences between estimated energy/protein requirements and estimated energy/protein intakes were also limited between groups. The adjusted analysis yielded significant findings for energy deficit: (coefficient [robust 95% CI], p

  9. Understanding the cluster randomised crossover design: a graphical illustraton of the components of variation and a sample size tutorial.

    Science.gov (United States)

    Arnup, Sarah J; McKenzie, Joanne E; Hemming, Karla; Pilcher, David; Forbes, Andrew B

    2017-08-15

    In a cluster randomised crossover (CRXO) design, a sequence of interventions is assigned to a group, or 'cluster' of individuals. Each cluster receives each intervention in a separate period of time, forming 'cluster-periods'. Sample size calculations for CRXO trials need to account for both the cluster randomisation and crossover aspects of the design. Formulae are available for the two-period, two-intervention, cross-sectional CRXO design, however implementation of these formulae is known to be suboptimal. The aims of this tutorial are to illustrate the intuition behind the design; and provide guidance on performing sample size calculations. Graphical illustrations are used to describe the effect of the cluster randomisation and crossover aspects of the design on the correlation between individual responses in a CRXO trial. Sample size calculations for binary and continuous outcomes are illustrated using parameters estimated from the Australia and New Zealand Intensive Care Society - Adult Patient Database (ANZICS-APD) for patient mortality and length(s) of stay (LOS). The similarity between individual responses in a CRXO trial can be understood in terms of three components of variation: variation in cluster mean response; variation in the cluster-period mean response; and variation between individual responses within a cluster-period; or equivalently in terms of the correlation between individual responses in the same cluster-period (within-cluster within-period correlation, WPC), and between individual responses in the same cluster, but in different periods (within-cluster between-period correlation, BPC). The BPC lies between zero and the WPC. When the WPC and BPC are equal the precision gained by crossover aspect of the CRXO design equals the precision lost by cluster randomisation. When the BPC is zero there is no advantage in a CRXO over a parallel-group cluster randomised trial. Sample size calculations illustrate that small changes in the specification of

  10. Improvement of perinatal and newborn care in rural Pakistan through community-based strategies: a cluster-randomised effectiveness trial.

    Science.gov (United States)

    Bhutta, Zulfiqar A; Soofi, Sajid; Cousens, Simon; Mohammad, Shah; Memon, Zahid A; Ali, Imran; Feroze, Asher; Raza, Farrukh; Khan, Amanullah; Wall, Steve; Martines, Jose

    2011-01-29

    Newborn deaths account for 57% of deaths in children younger than 5 years in Pakistan. Although a large programme of trained lady health workers (LHWs) exists, the effectiveness of this training on newborn outcomes has not been studied. We aimed to evaluate the effectiveness of a community-based intervention package, principally delivered through LHWs working with traditional birth attendants and community health committees, for reduction of perinatal and neonatal mortality in a rural district of Pakistan. We undertook a cluster randomised trial between February, 2006, and March, 2008, in Hala and Matiari subdistricts, Pakistan. Catchment areas of primary care facilities and all affiliated LHWs were used to define clusters, which were allocated to intervention and control groups by restricted, stratified randomisation. The intervention package delivered by LHWs through group sessions consisted of promotion of antenatal care and maternal health education, use of clean delivery kits, facility births, immediate newborn care, identification of danger signs, and promotion of careseeking; control clusters received routine care. Independent data collectors undertook quarterly household surveillance to capture data for births, deaths, and household practices related to maternal and newborn care. Data collectors were masked to cluster allocation; those analysing data were not. The primary outcome was perinatal and all-cause neonatal mortality. Analysis was by intention to treat. This trial is registered, ISRCTN16247511. 16 clusters were assigned to intervention (23,353 households, 12,391 total births) and control groups (23,768 households, 11,443 total births). LHWs in the intervention clusters were able to undertake 4428 (63%) of 7084 planned group sessions, but were only able to visit 2943 neonates (24%) of a total 12,028 livebirths in their catchment villages. Stillbirths were reduced in intervention clusters (39·1 stillbirths per 1000 total births) compared with

  11. Changes in body weight and food choice in those attempting smoking cessation: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Leslie Wilma S

    2012-05-01

    Full Text Available Abstract Background Fear of weight gain is a barrier to smoking cessation and significant cause of relapse for many people. The provision of nutritional advice as part of a smoking cessation programme may assist some in smoking cessation and perhaps limit weight gain. The aim of this study was to determine the effect of a structured programme of dietary advice on weight change and food choice, in adults attempting smoking cessation. Methods Cluster randomised controlled design. Classes randomised to intervention commenced a 24-week intervention, focussed on improving food choice and minimising weight gain. Classes randomised to control received “usual care”. Results Twenty-seven classes in Greater Glasgow were randomised between January and August 2008. Analysis, including those who continued to smoke, showed that actual weight gain and percentage weight gain was similar in both groups. Examination of data for those successful at giving up smoking showed greater mean weight gain in intervention subjects (3.9 (SD 3.1 vs. 2.7 (SD 3.7 kg. Between group differences were not significant (p = 0.23, 95% CI −0.9 to 3.5. In comparison to baseline improved consumption of fruit and vegetables and breakfast cereal were reported in the intervention group. A higher percentage of control participants continued smoking (74% vs. 66%. Conclusions The intervention was not successful at minimising weight gain in comparison to control but was successful in facilitating some sustained improvements in the dietary habits of intervention participants. Improved quit rates in the intervention group suggest that continued contact with advisors may have reduced anxieties regarding weight gain and encouraged cessation despite weight gain. Research should continue in this area as evidence suggests that the negative effects of obesity could outweigh the health benefits achieved through reductions in smoking prevalence. Trial registration Current Controlled Trials

  12. Child Centred Approach to Climate Change and Health Adaptation through Schools in Bangladesh: A Cluster Randomised Intervention Trial.

    Directory of Open Access Journals (Sweden)

    Md Iqbal Kabir

    Full Text Available Bangladesh is one of the most vulnerable countries to climate change. People are getting educated at different levels on how to deal with potential impacts. One such educational mode was the preparation of a school manual, for high school students on climate change and health protection endorsed by the National Curriculum and Textbook Board, which is based on a 2008 World Health Organization manual. The objective of this study was to test the effectiveness of the manual in increasing the knowledge level of the school children about climate change and health adaptation.This cluster randomized intervention trial involved 60 schools throughout Bangladesh, with 3293 secondary school students participating. School upazilas (sub-districts were randomised into intervention and control groups, and two schools from each upazila were randomly selected. All year seven students from both groups of schools sat for a pre-test of 30 short questions of binary response. A total of 1515 students from 30 intervention schools received the intervention through classroom training based on the school manual and 1778 students of the 30 control schools did not get the manual but a leaflet on climate change and health issues. Six months later, a post-intervention test of the same questionnaire used in the pre-test was performed at both intervention and control schools. The pre and post test scores were analysed along with the demographic data by using random effects model.None of the various school level and student level variables were significantly different between the control and intervention group. However, the intervention group had a 17.42% (95% CI: 14.45 to 20.38, P = <0.001 higher score in the post-test after adjusting for pre-test score and other covariates in a multi-level linear regression model.These results suggest that school-based intervention for climate change and health adaptation is effective for increasing the knowledge level of school children on

  13. Feasibility and acceptability of training community health workers in ear and hearing care in Malawi: a cluster randomised controlled trial.

    Science.gov (United States)

    Mulwafu, Wakisa; Kuper, Hannah; Viste, Asgaut; Goplen, Frederik K

    2017-10-11

    To assess the feasibility and acceptability of training community health workers (CHWs) in ear and hearing care, and their ability to identify patients with ear and hearing disorders. Cluster randomised controlled trial (RCT). Health centres in Thyolo district, Malawi. Ten health centres participated, 5 intervention (29 CHWs) and 5 control (28 CHWs). Intervention CHWs received 3 days of training in primary ear and hearing care, while among control CHWs, training was delayed for 6 months. Both groups were given a pretest that assessed knowledge about ear and hearing care, only the intervention group was given the posttest on the third day of training. The intervention group was given 1 month to identify patients with ear and hearing disorders in their communities, and these people were screened for hearing disorders by ear, nose and throat clinical specialists. Primary outcome measure was improvement in knowledge of ear and hearing care among CHWs after the training. Secondary outcome measures were number of patients with ear or hearing disorders identified by CHWs and number recorded at health centres during routine activities, and the perceived feasibility and acceptability of the intervention. The average overall correct answers increased from 55% to 68% (95% CI 65 to 71) in the intervention group (phearing disorders were identified by CHWs and 860 patients attended the screening camps, of whom 400 had hearing loss (73 patients determined through bilateral fail on otoacoustic emissions, 327 patients through audiometry). Where cause could be determined, the most common cause of ear and hearing disorders was chronic suppurative otitis media followed by impacted wax. The intervention was perceived as feasible and acceptable to implement. Training was effective in improving the knowledge of CHW in ear and hearing care in Malawi and allowing them to identify patients with ear and hearing disorders. This intervention could be scaled up to other CHWs in low-income and

  14. Effect of a mass radio campaign on family behaviours and child survival in Burkina Faso: a repeated cross-sectional, cluster-randomised trial

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    Sophie Sarrassat, PhD

    2018-03-01

    Full Text Available Summary: Background: Media campaigns can potentially reach a large audience at relatively low cost but, to our knowledge, no randomised controlled trials have assessed their effect on a health outcome in a low-income country. We aimed to assess the effect of a radio campaign addressing family behaviours on all-cause post-neonatal under-5 child mortality in rural Burkina Faso. Methods: In this repeated cross-sectional, cluster randomised trial, clusters (distinct geographical areas in rural Burkina Faso with at least 40 000 inhabitants were selected by Development Media International based on their high radio listenership (>60% of women listening to the radio in the past week and minimum distances between radio stations to exclude population-level contamination. Clusters were randomly allocated to receive the intervention (a comprehensive radio campaign or control group (no radio media campaign. Household surveys were performed at baseline (from December, 2011, to February, 2012, midline (in November, 2013, and after 20 months of campaigning, and endline (from November, 2014, to March, 2015, after 32 months of campaigning. Primary analyses were done on an intention-to-treat basis, based on cluster-level summaries and adjusted for imbalances between groups at baseline. The primary outcome was all-cause post-neonatal under-5 child mortality. The trial was designed to detect a 20% reduction in the primary outcome with a power of 80%. Routine data from health facilities were also analysed for evidence of changes in use and these data had high statistical power. The indicators measured were new antenatal care attendances, facility deliveries, and under-5 consultations. This trial is registered with ClinicalTrial.gov, number NCT01517230. Findings: The intervention ran from March, 2012, to January, 2015. 14 clusters were selected and randomly assigned to the intervention group (n=7 or the control group (n=7. The average number of villages included per

  15. 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

  16. Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in elderly care units: study protocol.

    Science.gov (United States)

    Drahota, Amy; Gal, Diane; Windsor, Julie; Dixon, Simon; Udell, Julie; Ward, Derek; Soilemezi, Dia; Dean, Taraneh; Severs, Martin

    2011-12-01

    Falls are an issue disproportionately affecting older people who are at increased risk of falls and injury. This protocol describes a pilot study investigating shock-absorbing flooring for fall-related injuries in wards for older people. To inform future research by evaluating fall-related injuries on the intervention and existing flooring, assessing the sustainability of the flooring in ward environments, estimating the cost-effectiveness of the floor and assessing how the floor affects patients and other users. This study uses mixed methods a pilot cluster randomised controlled trial, observation via mechanical testing and interviews. Eight participating wards (clusters) are randomised using a computer-generated list. No blinding is incorporated into the study. Each site has a baseline period of approximately 6 months. Then, four sites receive the intervention floor, while four continue using standard floors. Sites are then followed up for approximately 1 year. Any person admitted to a bed in the 'study area' of a participating ward can be entered into the trial. Orientated patients, visitors and any hospital staff who use the floor in a study area are eligible for inclusion in an interview. An 8.3 mm thick vinyl floor covering with polyvinyl chloride foam backing (Tarkett Omnisports EXCEL). The primary outcome is fall-related injuries. Severity of injuries, falls, cost-effectiveness, user views and mechanical performance (shock absorbency and slip resistance) are also being assessed.

  17. Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomised feasibility trial.

    Science.gov (United States)

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

    2015-07-11

    Transfusion thresholds for acute upper gastrointestinal bleeding are controversial. So far, only three small, underpowered studies and one single-centre trial have been done. Findings from the single-centre trial showed reduced mortality with restrictive red blood cell (RBC) transfusion. We aimed to assess whether a multicentre, cluster randomised trial is a feasible method to substantiate or refute this finding. In this pragmatic, open-label, cluster randomised feasibility trial, done in six university hospitals in the UK, we enrolled all patients aged 18 years or older with new presentations of acute upper gastrointestinal bleeding, irrespective of comorbidity, except for exsanguinating haemorrhage. We randomly assigned hospitals (1:1) with a computer-generated randomisation sequence (random permuted block size of 6, without stratification or matching) to either a restrictive (transfusion when haemoglobin concentration fell below 80 g/L) or liberal (transfusion when haemoglobin concentration fell below 100 g/L) RBC transfusion policy. Neither patients nor investigators were masked to treatment allocation. Feasibility outcomes were recruitment rate, protocol adherence, haemoglobin concentration, RBC exposure, selection bias, and information to guide design and economic evaluation of the phase 3 trial. Main exploratory clinical outcomes were further bleeding and mortality at day 28. We did analyses on all enrolled patients for whom an outcome was available. This trial is registered, ISRCTN85757829 and NCT02105532. Between Sept 3, 2012, and March 1, 2013, we enrolled 936 patients across six hospitals (403 patients in three hospitals with a restrictive policy and 533 patients in three hospitals with a liberal policy). Recruitment rate was significantly higher for the liberal than for the restrictive policy (62% vs 55%; p=0·04). Despite some baseline imbalances, Rockall and Blatchford risk scores were identical between policies. Protocol adherence was 96% (SD 10) in

  18. Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol

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    Myles Judy

    2009-11-01

    Full Text Available Abstract Background A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However, although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlled trial with Offender Managers (OMs as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients. Methods and design Ninety-six OMs from 9 probation areas across 3 English regions (the North East Region (n = 4 and London and the South East Regions (n = 5 will be recruited. OMs will be randomly allocated to one of three intervention conditions: a client information leaflet control condition (n = 32 OMs; 5-minute simple structured advice (n = 32 OMs and 20-minute brief lifestyle counselling delivered by an Alcohol Health Worker (n = 32 OMs. Randomisation will be stratified by probation area. To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire (M-SASQ or the Fast Alcohol Screening Test (FAST. There will be a minimum of 480 clients recruited into the trial. There will be an intention to treat analysis of study outcomes at 6 and 12 months post intervention. Analysis will include client measures (screening result, weekly alcohol consumption, alcohol-related problems, re-offending, public service use and quality of life and implementation measures from OMs (the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention. We will also examine the

  19. Screening and brief interventions for hazardous and harmful alcohol use in probation services: a cluster randomised controlled trial protocol.

    Science.gov (United States)

    Newbury-Birch, Dorothy; Bland, Martin; Cassidy, Paul; Coulton, Simon; Deluca, Paolo; Drummond, Colin; Gilvarry, Eilish; Godfrey, Christine; Heather, Nick; Kaner, Eileen; Myles, Judy; Oyefeso, Adenekan; Parrott, Steve; Perryman, Katherine; Phillips, Tom; Shenker, Don; Shepherd, Jonathan

    2009-11-18

    A large number of randomised controlled trials in health settings have consistently reported positive effects of brief intervention in terms of reductions in alcohol use. However, although alcohol misuse is common amongst offenders, there is limited evidence of alcohol brief interventions in the criminal justice field. This factorial pragmatic cluster randomised controlled trial with Offender Managers (OMs) as the unit of randomisation will evaluate the effectiveness and cost-effectiveness of different models of screening to identify hazardous and harmful drinkers in probation and different intensities of brief intervention to reduce excessive drinking in probation clients. Ninety-six OMs from 9 probation areas across 3 English regions (the North East Region (n = 4) and London and the South East Regions (n = 5)) will be recruited. OMs will be randomly allocated to one of three intervention conditions: a client information leaflet control condition (n = 32 OMs); 5-minute simple structured advice (n = 32 OMs) and 20-minute brief lifestyle counselling delivered by an Alcohol Health Worker (n = 32 OMs). Randomisation will be stratified by probation area. To test the relative effectiveness of different screening methods all OMs will be randomised to either the Modified Single Item Screening Questionnaire (M-SASQ) or the Fast Alcohol Screening Test (FAST). There will be a minimum of 480 clients recruited into the trial. There will be an intention to treat analysis of study outcomes at 6 and 12 months post intervention. Analysis will include client measures (screening result, weekly alcohol consumption, alcohol-related problems, re-offending, public service use and quality of life) and implementation measures from OMs (the extent of screening and brief intervention beyond the minimum recruitment threshold will provide data on acceptability and feasibility of different models of brief intervention). We will also examine the practitioner and organisational factors

  20. Cost-effectiveness of a multifaceted implementation strategy for the Dutch multidisciplinary guideline for nonspecific low back pain: design of a stepped-wedge cluster randomised controlled trial.

    Science.gov (United States)

    Suman, Arnela; Schaafsma, Frederieke G; Elders, Petra J M; van Tulder, Maurits W; Anema, Johannes R

    2015-05-31

    Low back pain (LBP) is one of the most prevalent and expensive health care problems in industrialised countries. LBP leads to high health care utility and productivity losses; leaving the individual, the employer, and society with substantial costs. To improve the care for LBP patients and reduce the high societal and financial burden of LBP, in 2010 the 'Multidisciplinary care guideline for nonspecific low back pain' was developed in the Netherlands. The current paper describes the design of a study aiming to evaluate the (cost-) effectiveness of a multifaceted strategy to implement this guideline. In a cluster-randomised controlled trial, the (cost-) effectiveness of a multifaceted implementation strategy will be compared to passive guideline dissemination. Using a stepped-wedge approach, participating general practitioners, physiotherapists, and occupational physicians are allocated into clusters and will attend a multidisciplinary continuing medical education training session. The timing these clusters receive the training is the unit of randomisation. LBP patients visiting the participating health care providers are invited to participate in the trial and will receive access to a multimedia intervention aimed at improving beliefs, cognitions, and self-management. The primary outcome measure of this study is patient back beliefs. Secondary outcome measures on patient level include pain, functional status, quality of life, health care utility, and productivity losses. Outcome measures on professional level include knowledge and attitude towards the guideline, and guideline adherence. A process evaluation for the implementation strategy will be performed among the health care providers and the patients. Furthermore, a qualitative subgroup analysis among patients with various ethnic backgrounds will be performed. This study will give insight into the (cost-) effectiveness of a multifaceted implementation strategy for the Dutch multidisciplinary guideline for non

  1. Do Country Stereotypes Exist in PISA? A Clustering Approach for Large, Sparse, and Weighted Data

    Science.gov (United States)

    Saarela, Mirka; Kärkkäinen, Tommi

    2015-01-01

    Certain stereotypes can be associated with people from different countries. For example, the Italians are expected to be emotional, the Germans functional, and the Chinese hard-working. In this study, we cluster all 15-year-old students representing the 68 different nations and territories that participated in the latest Programme for…

  2. A School Based Cluster Randomised Health Education Intervention Trial for Improving Knowledge and Attitudes Related to Taenia solium Cysticercosis and Taeniasis in Mbulu District, Northern Tanzania

    Science.gov (United States)

    Mwidunda, Sylvester A.; Carabin, Hélène; Matuja, William B. M.; Winkler, Andrea S.; Ngowi, Helena A.

    2015-01-01

    Taenia solium causes significant economic and public health impacts in endemic countries. This study determined effectiveness of a health education intervention at improving school children’s knowledge and attitudes related to T. solium cysticercosis and taeniasis in Tanzania. A cluster randomised controlled health education intervention trial was conducted in 60 schools (30 primary, 30 secondary) in Mbulu district. Baseline data were collected using a structured questionnaire in the 60 schools and group discussions in three other schools. The 60 schools stratified by baseline knowledge were randomised to receive the intervention or serve as control. The health education consisted of an address by a trained teacher, a video show and a leaflet given to each pupil. Two post-intervention re-assessments (immediately and 6 months post-intervention) were conducted in all schools and the third (12 months post-intervention) was conducted in 28 secondary schools. Data were analysed using Bayesian hierarchical log-binomial models for individual knowledge and attitude questions and Bayesian hierarchical linear regression models for scores. The overall score (percentage of correct answers) improved by about 10% in all schools after 6 months, but was slightly lower among secondary schools. Monitoring alone was associated with improvement in scores by about 6%. The intervention was linked to improvements in knowledge regarding taeniasis, porcine cysticercosis, human cysticercosis, epilepsy, the attitude of condemning infected meat but it reduced the attitude of contacting a veterinarian if a pig was found to be infected with cysticercosis. Monitoring alone was linked to an improvement in how best to raise pigs. This study demonstrates the potential value of school children as targets for health messages to control T. solium cysticercosis and taeniasis in endemic areas. Studies are needed to assess effectiveness of message transmission from children to parents and the general

  3. A cluster randomised controlled trial evaluating the effectiveness of eHealth-supported patient recruitment in primary care research: the TRANSFoRm study protocol.

    Science.gov (United States)

    Mastellos, Nikolaos; Andreasson, Anna; Huckvale, Kit; Larsen, Mark; Curcin, Vasa; Car, Josip; Agreus, Lars; Delaney, Brendan

    2015-02-03

    Opportunistic recruitment is a highly laborious and time-consuming process that is currently performed manually, increasing the workload of already busy practitioners and resulting in many studies failing to achieve their recruitment targets. The Translational Medicine and Patient Safety in Europe (TRANSFoRm) platform enables automated recruitment, data collection and follow-up of patients, potentially improving the efficiency, time and costs of clinical research. This study aims to assess the effectiveness of TRANSFoRm in improving patient recruitment and follow-up in primary care trials. This multi-centre, parallel-arm cluster randomised controlled trial will compare TRANSFoRm-supported with standard opportunistic recruitment. Participants will be general practitioners and patients with gastro-oesophageal reflux disease from 40 primary care centres in five European countries. Randomisation will take place at the care centre level. The intervention arm will use the TRANSFoRm tools for recruitment, baseline data collection and follow-up. The control arm will use web-based case report forms and paper self-completed questionnaires. The primary outcome will be the proportion of eligible patients successfully recruited at the end of the 16-week recruitment period. Secondary outcomes will include the proportion of recruited patients with complete baseline and follow-up data and the proportion of participants withdrawn or lost to follow-up. The study will also include an economic evaluation and measures of technology acceptance and user experience. The study should shed light on the use of eHealth to improve the effectiveness of recruitment and follow-up in primary care research and provide an evidence base for future eHealth-supported recruitment initiatives. Reporting of results is expected in October 2015. EudraCT: 2014-001314-25.

  4. A school based cluster randomised health education intervention trial for improving knowledge and attitudes related to Taenia solium cysticercosis and taeniasis in Mbulu district, northern Tanzania.

    Science.gov (United States)

    Mwidunda, Sylvester A; Carabin, Hélène; Matuja, William B M; Winkler, Andrea S; Ngowi, Helena A

    2015-01-01

    Taenia solium causes significant economic and public health impacts in endemic countries. This study determined effectiveness of a health education intervention at improving school children's knowledge and attitudes related to T. solium cysticercosis and taeniasis in Tanzania. A cluster randomised controlled health education intervention trial was conducted in 60 schools (30 primary, 30 secondary) in Mbulu district. Baseline data were collected using a structured questionnaire in the 60 schools and group discussions in three other schools. The 60 schools stratified by baseline knowledge were randomised to receive the intervention or serve as control. The health education consisted of an address by a trained teacher, a video show and a leaflet given to each pupil. Two post-intervention re-assessments (immediately and 6 months post-intervention) were conducted in all schools and the third (12 months post-intervention) was conducted in 28 secondary schools. Data were analysed using Bayesian hierarchical log-binomial models for individual knowledge and attitude questions and Bayesian hierarchical linear regression models for scores. The overall score (percentage of correct answers) improved by about 10% in all schools after 6 months, but was slightly lower among secondary schools. Monitoring alone was associated with improvement in scores by about 6%. The intervention was linked to improvements in knowledge regarding taeniasis, porcine cysticercosis, human cysticercosis, epilepsy, the attitude of condemning infected meat but it reduced the attitude of contacting a veterinarian if a pig was found to be infected with cysticercosis. Monitoring alone was linked to an improvement in how best to raise pigs. This study demonstrates the potential value of school children as targets for health messages to control T. solium cysticercosis and taeniasis in endemic areas. Studies are needed to assess effectiveness of message transmission from children to parents and the general

  5. A school based cluster randomised health education intervention trial for improving knowledge and attitudes related to Taenia solium cysticercosis and taeniasis in Mbulu district, northern Tanzania.

    Directory of Open Access Journals (Sweden)

    Sylvester A Mwidunda

    Full Text Available Taenia solium causes significant economic and public health impacts in endemic countries. This study determined effectiveness of a health education intervention at improving school children's knowledge and attitudes related to T. solium cysticercosis and taeniasis in Tanzania. A cluster randomised controlled health education intervention trial was conducted in 60 schools (30 primary, 30 secondary in Mbulu district. Baseline data were collected using a structured questionnaire in the 60 schools and group discussions in three other schools. The 60 schools stratified by baseline knowledge were randomised to receive the intervention or serve as control. The health education consisted of an address by a trained teacher, a video show and a leaflet given to each pupil. Two post-intervention re-assessments (immediately and 6 months post-intervention were conducted in all schools and the third (12 months post-intervention was conducted in 28 secondary schools. Data were analysed using Bayesian hierarchical log-binomial models for individual knowledge and attitude questions and Bayesian hierarchical linear regression models for scores. The overall score (percentage of correct answers improved by about 10% in all schools after 6 months, but was slightly lower among secondary schools. Monitoring alone was associated with improvement in scores by about 6%. The intervention was linked to improvements in knowledge regarding taeniasis, porcine cysticercosis, human cysticercosis, epilepsy, the attitude of condemning infected meat but it reduced the attitude of contacting a veterinarian if a pig was found to be infected with cysticercosis. Monitoring alone was linked to an improvement in how best to raise pigs. This study demonstrates the potential value of school children as targets for health messages to control T. solium cysticercosis and taeniasis in endemic areas. Studies are needed to assess effectiveness of message transmission from children to parents and

  6. Effectiveness of a minimal intervention for stress-related mental disorders with sick leave (MISS): study protocol of a cluster randomised controlled trial in general practice [ISRCTN43779641

    NARCIS (Netherlands)

    Bakker, I.M.; Terluin, B.; van Marwijk, H.W.J.; Cundy, C.M.; Smit, J.H.; van Mechelen, W.; Stalman, W.A.B.

    2006-01-01

    Background: The main aims of this paper are to describe the setting and design of a Minimal Intervention in general practice for Stress-related mental disorders in patients on Sick leave (MISS), as well as to ascertain the study complies with the requirements for a cluster randomised controlled

  7. Menstrual cups and sanitary pads to reduce school attrition, and sexually transmitted and reproductive tract infections: a cluster randomised controlled feasibility study in rural Western Kenya

    NARCIS (Netherlands)

    Phillips-Howard, Penelope A.; Nyothach, Elizabeth; ter Kuile, Feiko O.; Omoto, Jackton; Wang, Duolao; Zeh, Clement; Onyango, Clayton; Mason, Linda; Alexander, Kelly T.; Odhiambo, Frank O.; Eleveld, Alie; Mohammed, Aisha; van Eijk, Anna M.; Edwards, Rhiannon Tudor; Vulule, John; Faragher, Brian; Laserson, Kayla F.

    2016-01-01

    Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes. 3-arm single-site open cluster randomised controlled pilot study. 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System. Primary

  8. Participatory ergonomics to reduce exposure to psychosocial and physical risk factors for low back pain and neck pain: Results of a cluster randomised 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

    Objectives: This study investigated the effectiveness of the Stay@Work participatory ergonomics programme to reduce workers9 exposure to psychosocial and physical risk factors. Methods: 37 departments (n=3047 workers) from four Dutch companies participated in this cluster randomised controlled

  9. A structural multidisciplinary approach to depression management in nursing-home residents: a multicentre, stepped-wedge cluster-randomised trial

    NARCIS (Netherlands)

    Leontjevas, R.; Gerritsen, D.L.; Smalbrugge, M.; Teerenstra, S.; Vernooij-Dassen, M.J.F.J.; Koopmans, R.T.C.M.

    2013-01-01

    BACKGROUND: Depression in nursing-home residents is often under-recognised. We aimed to establish the effectiveness of a structural approach to its management. METHODS: Between May 15, 2009, and April 30, 2011, we undertook a multicentre, stepped-wedge cluster-randomised trial in four provinces of

  10. The Effect of Brief Interventions on the Drinking Behaviour of Pregnant Women in a High-Risk Rural South African Community: A Cluster Randomised Trial

    Science.gov (United States)

    Marais, Sandra; Jordaan, Esme; Viljoen, Dennis; Olivier, Leana; de Waal, Johanna; Poole, Caroline

    2011-01-01

    The purpose of this paper is to assess the impact of a series of brief interventions (BIs) on anti-natal alcohol consumption of women from a disadvantaged and high-risk background attending state health clinics in a rural district, Western Cape Province, South Africa. A pragmatic cluster randomised trial design was followed. All pregnant women,…

  11. Effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain: a cluster randomised controlled trial

    NARCIS (Netherlands)

    Bekkering, G.E.; Hendriks, H.J.M.; Tulder, van M.; Knol, D.L.; Hoeijenbos, M.; Oostendorp, R.A.B.; Bouter, L.M.

    2005-01-01

    OBJECTIVES: To evaluate the effect on the process of care of an active strategy to implement clinical guidelines on physiotherapy for low back pain. DESIGN: A cluster randomised controlled trial comparing an active strategy with standard dissemination. SETTING: Primary care physiotherapy practices.

  12. Effects of a multi-faceted program to increase influenza vaccine uptake among health care workers in nursing homes : A cluster randomised controlled trial

    NARCIS (Netherlands)

    Looijmans-van den Akker, I.; van Delden, J.J.M.; Verheij, T.J.M.; van der Sande, M.A.B.; van Essen, G.A.; Riphagen-Dalhuisen, J.; Hulscher, M.E.; Hak, E.

    2010-01-01

    Despite the recommendation of the Dutch association of nursing home physicians (NVVA) to be immunized against influenza, vaccine uptake among HCWs in nursing homes remains unacceptably low. Therefore we conducted a cluster randomised controlled trial among 33 Dutch nursing homes to assess the

  13. Cost and cost-effectiveness of newborn home visits: findings from the Newhints cluster-randomised controlled trial in rural Ghana

    NARCIS (Netherlands)

    Pitt, Catherine; Tawiah, Theresa; Soremekun, Seyi; ten Asbroek, Augustinus H. A.; Manu, Alexander; Tawiah-Agyemang, Charlotte; Hill, Zelee; Owusu-Agyei, Seth; Kirkwood, Betty R.; Hanson, Kara

    2016-01-01

    Every year, 2·9 million newborn babies die worldwide. A meta-analysis of four cluster-randomised controlled trials estimated that home visits by trained community members in programme settings in Ghana and south Asia reduced neonatal mortality by 12% (95% CI 5-18). We aimed to estimate the costs and

  14. Behavioural graded activity results in better exercise adherence and more physical activity than usual care in people with osteoarthritis: a cluster-randomised trial

    NARCIS (Netherlands)

    Pisters, M.F.; Veenhof, C.; de Bakker, D.H.; Schellevis, F.G.; Dekker, J.

    2010-01-01

    Question: Does behavioural graded activity result in better exercise adherence and more physical activity than usual care in people with osteoarthritis of the hip or knee? Design: Analysis of secondary outcomes of a cluster-randomised trial with concealed allocation, assessor blinding, and

  15. Return-to-work intervention versus usual care for sick-listed employees : Health-economic investment appraisal alongside a cluster randomised trial

    NARCIS (Netherlands)

    Lokman, S.; Volker, D.; Zijlstra-Vlasveld, M.C.; Brouwers, E.P.M.; Boon, B.; Beekman, A.T.; Smit, F.; van der Feltz-Cornelis, C.M.

    2017-01-01

    To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. A two-armed cluster randomised trial with occupational physicians (OPs) (n=62),

  16. Effectiveness of single dose rifampicin in preventing leprosy in close contacts of patients with newly diagnosed leprosy: cluster randomised controlled trial

    NARCIS (Netherlands)

    Moet, F. Johannes; Pahan, David; Oskam, Linda; Richardus, Jan H.; van Brakel, Wim H.; Klatser, Paul R.; Saunderson, Paul R.; Smith, W. Cairns S.; Withington, Steve G.; Richardus, Jan Hendrik; Schuring, Ron P.; Faber, Roel; Borsboom, Gerard J. J. M.

    2008-01-01

    OBJECTIVE: To determine the effectiveness of chemoprophylaxis using a single dose of rifampicin to prevent leprosy in close contacts. DESIGN: Single centre, double blind, cluster randomised, placebo controlled trial. SETTING: Leprosy control programme in two districts of northwest Bangladesh with a

  17. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Hart Michael B

    2010-10-01

    Full Text Available Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools in Perth, Australia were recruited to the clustered (by school randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide

  18. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial.

    Science.gov (United States)

    Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith A Y; Silburn, Sven

    2010-10-21

    This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. ISRCTN24952438.

  19. Economic Inequalities and the Level of Decentralization in European Countries: Cluster Analysis

    Directory of Open Access Journals (Sweden)

    Laboutková Šárka

    2016-12-01

    Full Text Available This submitted article identifies relations between the degree of decentralization and economic imbalances on the basis of a cluster (exploratory analysis. Two indicators have been chosen for measuring economic inequalities: an indicator of dispersion of regional GDP per capita as representative of the performance imbalances within countries (it measures the economic development gap among regions in European countries; and a multidimensional inequality-adjusted human development index as representative of inequalities in the distribution of wealth in the countries. Decentralization is measured by means of a decentralization index, which contains both quantitative and qualitative components. Although groups of countries characterised by a high degree of decentralization do not necessarily show the lowest degrees of economic imbalances, it is however possible to conclude that the countries in groups with a higher degree of decentralization are among those countries with more favourable values of the economic imbalances indicators monitored. As a part of the research, two clusters of countries were identified which are identical in their degree of decentralization, but differ in the results connected with economic imbalances. The differences are caused by different institutional qualities in the two groups.

  20. Process evaluation of a cluster-randomised trial testing a pressure ulcer prevention care bundle: a mixed-methods study.

    Science.gov (United States)

    Roberts, Shelley; McInnes, Elizabeth; Bucknall, Tracey; Wallis, Marianne; Banks, Merrilyn; Chaboyer, Wendy

    2017-02-13

    As pressure ulcers contribute to significant patient burden and increased health care costs, their prevention is a clinical priority. Our team developed and tested a complex intervention, a pressure ulcer prevention care bundle promoting patient participation in care, in a cluster-randomised trial. The UK Medical Research Council recommends process evaluation of complex interventions to provide insight into why they work or fail and how they might be improved. This study aimed to evaluate processes underpinning implementation of the intervention and explore end-users' perceptions of it, in order to give a deeper understanding of its effects. A pre-specified, mixed-methods process evaluation was conducted as an adjunct to the main trial, guided by a framework for process evaluation of cluster-randomised trials. Data was collected across eight Australian hospitals but mainly focused on the four intervention hospitals. Quantitative and qualitative data were collected across the evaluation domains: recruitment, reach, intervention delivery and response to intervention, at both cluster and individual patient level. Quantitative data were analysed using descriptive and inferential statistics. Qualitative data were analysed using thematic analysis. In the context of the main trial, which found a 42% reduction in risk of pressure ulcer with the intervention that was not significant after adjusting for clustering and covariates, this process evaluation provides important insights. Recruitment and reach among clusters and individuals was high, indicating that patients, nurses and hospitals are willing to engage with a pressure ulcer prevention care bundle. Of 799 intervention patients in the trial, 96.7% received the intervention, which took under 10 min to deliver. Patients and nurses accepted the care bundle, recognising benefits to it and describing how it enabled participation in pressure ulcer prevention (PUP) care. This process evaluation found no major failures

  1. The Effects of Skill Training on Social Workers' Professional Competences in Norway: Results of a Cluster-Randomised Study

    Science.gov (United States)

    Malmberg-Heimonen, Ira; Natland, Sidsel; Tøge, Anne Grete; Hansen, Helle Cathrine

    2016-01-01

    Using a cluster-randomised design, this study analyses the effects of a government-administered skill training programme for social workers in Norway. The training programme aims to improve social workers' professional competences by enhancing and systematising follow-up work directed towards longer-term unemployed clients in the following areas: encountering the user, system-oriented efforts and administrative work. The main tools and techniques of the programme are based on motivational interviewing and appreciative inquiry. The data comprise responses to baseline and eighteen-month follow-up questionnaires administered to all social workers (n = 99) in eighteen participating Labour and Welfare offices randomised into experimental and control groups. The findings indicate that the skill training programme positively affected the social workers' evaluations of their professional competences and quality of work supervision received. The acquisition and mastering of combinations of specific tools and techniques, a comprehensive supervision structure and the opportunity to adapt the learned skills to local conditions were important in explaining the results. PMID:27559232

  2. The Happy Life Club™ study protocol: A cluster randomised controlled trial of a type 2 diabetes health coach intervention

    Directory of Open Access Journals (Sweden)

    Yang Hui

    2011-02-01

    Full Text Available Abstract Background The Happy Life Club™ is an intervention that utilises health coaches trained in behavioural change and motivational interviewing techniques to assist with the management of type 2 diabetes mellitus (T2DM in primary care settings in China. Health coaches will support participants to improve modifiable risk factors and adhere to effective self-management treatments associated with T2DM. Methods/Design A cluster randomised controlled trial involving 22 Community Health Centres (CHCs in Fengtai District of Beijing, China. CHCs will be randomised into a control or intervention group, facilitating recruitment of at least 1320 individual participants with T2DM into the study. Participants in the intervention group will receive a combination of both telephone and face-to-face health coaching over 18 months, in addition to usual care received by the control group. Health coaching will be performed by CHC doctors and nurses certified in coach-assisted chronic disease management. Outcomes will be assessed at baseline and again at 6, 12 and 18 months by means of a clinical health check and self-administered questionnaire. The primary outcome measure is HbA1c level. Secondary outcomes include metabolic, physiological and psychological variables. Discussion This cluster RCT has been developed to suit the Chinese health care system and will contribute to the evidence base for the management of patients with T2DM. With a strong focus on self-management and health coach support, the study has the potential to be adapted to other chronic diseases, as well as other regions of China. Trial Registration Current Controlled Trials ISRCTN01010526

  3. Poor uptake of an online intervention in a cluster randomised controlled trial of online diabetes education for rural general practitioners.

    Science.gov (United States)

    Paul, Christine L; Piterman, Leon; Shaw, Jonathan E; Kirby, Catherine; Forshaw, Kristy L; Robinson, Jennifer; Thepwongsa, Isaraporn; Sanson-Fisher, Robert W

    2017-03-23

    In Australia, rural and remote communities have high rates of diabetes-related death and hospitalisation. General practitioners (GPs) play a major role in diabetes detection and management. Education of GPs could optimise diabetes management and improve patient outcomes at a population level. The study aimed to describe the uptake of a continuing medical education intervention for rural GPs and its impact on the viability of a cluster randomised controlled trial of the effects of continuing medical education on whole-town diabetes monitoring and control. Trial design: the cluster randomised controlled trial involved towns as the unit of allocation and analysis with outcomes assessed by de-identified pathology data (not reported here). The intervention programme consisted of an online active learning module, direct electronic access to specialist advice and performance feedback. Multiple rounds of invitation were used to engage GPs with the online intervention content. Evidence-based strategies (e.g. pre-notification, rewards, incentives) were incorporated into the invitations to enrol in the programme. Recruitment to the programme was electronically monitored through the hosting software package during the study intervention period. Eleven matched pairs of towns were included in the study. There were 146 GPs in the 11 intervention towns, of whom 34 (23.3%) enrolled in the programme, and 8 (5.5%) completed the online learning module. No town had more than 10% of the resident GPs complete the learning module. There were no contacts made by GPs regarding requests for specialist advice. Consequently, the trial was discontinued. There is an ongoing need to engage primary care physicians in improving diabetes monitoring and management in rural areas. Online training options, while notionally attractive and accessible, are not likely to have high levels of uptake, even when evidence-based recruitment strategies are implemented. Australian New Zealand Clinical Trials

  4. Initiating change locally in bullying and aggression through the school environment (INCLUSIVE) trial: update to cluster randomised controlled trial protocol.

    Science.gov (United States)

    Bonell, Chris; Mathiot, Anne; Allen, Elizabeth; Bevilacqua, Leonardo; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; Legood, Rosa; Scott, Stephen; Warren, Emily; Wiggins, Meg; Viner, Russell M

    2017-05-25

    Systematic reviews suggest that multi-component interventions are effective in reducing bullying victimisation and perpetration. We are undertaking a phase III randomised trial of the INCLUSIVE multi-component intervention. This trial aims to assess the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying victimisation in English secondary schools. This paper updates the original trial protocol published in 2014 (Trials 15:381, 2014) and presents the changes in the process evaluation protocol and the secondary outcome data collection. The methods are summarised as follows. cluster randomised trial. 40 state secondary schools. Outcomes assessed among the cohort of students at the end of year 7 (n = 6667) at baseline. INCLUSIVE is a multi-component school intervention including a social and emotional learning curriculum, changes to school environment (an action group comprising staff and students reviews local data on needs to review rules and policies and determine other local actions) and staff training in restorative practice. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third intervention year involving no external facilitation but all other elements. Comparator: normal practice. Primary: Two primary outcomes at student level assessed at baseline and at 36 months: 1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC) 2. Bullying and victimisation: Gatehouse Bullying Scale (GBS) Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level. Randomisation: eligible consenting schools were

  5. Quality of reporting of randomised controlled trials of herbal interventions in ASEAN Plus Six Countries: a systematic review.

    Science.gov (United States)

    Pratoomsoot, Chayanin; Sruamsiri, Rosarin; Dilokthornsakul, Piyameth; Chaiyakunapruk, Nathorn

    2015-01-01

    Many randomised controlled trials (RCTs) of herbal interventions have been conducted in the ASEAN Communities. Good quality reporting of RCTs is essential for assessing clinical significance. Given the importance ASEAN placed on herbal medicines, the reporting quality of RCTs of herbal interventions among the ASEAN Communities deserved a special attention. To systematically review the quality of reporting of RCTs of herbal interventions conducted in the ASEAN Plus Six Countries. Searches were performed using PubMed, EMBASE, The Cochrane Library, and Allied and Complementary Medicine (AMED), from inception through October 2013. These were limited to studies specific to humans and RCTs. Herbal species search terms were based on those listed in the National List of Essential Medicines [NLEM (Thailand, 2011)]. Studies conducted in the ASEAN Plus Six Countries, published in English were included. Seventy-one articles were identified. Thirty (42.25%) RCTs were from ASEAN Countries, whereas 41 RCTs (57.75%) were from Plus Six Group. Adherence to the recommended CONSORT checklist items for reporting of RCTs of herbal interventions among ASEAN Plus Six Countries ranged from 0% to 97.18%. Less than a quarter of the RCTs (18.31%) reported information on standardisation of the herbal products. However, the scope of our interventions of interest was limited to those developed from 20 herbal species listed in the NLEM of Thailand. The present study highlights the need to improve reporting quality of RCTs of herbal interventions across ASEAN Plus Six Communities.

  6. Investigating a tuberculosis cluster among Filipino health care workers in a low-incidence country.

    Science.gov (United States)

    Davidson, J A; Fulton, N; Thomas, H L; Lalor, M K; Zenner, D; Brown, T; Murphy, S; Anderson, L F

    2018-03-01

    Nearly 8% of adult tuberculosis (TB) cases in England, Wales and Northern Ireland (EW&NI) occur among health care workers (HCWs), the majority of whom are from high TB incidence countries. To determine if a TB cluster containing multiple HCWs was due to nosocomial transmission. A cluster of TB cases notified in EW&NI from 2009 to 2014, with indistinguishable 24-locus mycobacterial interspersed repetitive unit-variable number of tandem repeats (MIRU-VNTR) profiles, was identified through routine national cluster review. Cases were investigated to identify epidemiological links, and occupational health (OH) information was collected for HCW cases. To further discriminate strains, typing of eight additional loci was conducted. Of the 53 cases identified, 22 were HCWs. The majority (n = 43), including 21 HCWs, were born in the Philippines. Additional typing split the cluster into three subclusters and seven unique strains. No epidemiological links were identified beyond one household and a common residential area. HCWs in this cluster received no or inadequate OH assessment. The MIRU-VNTR profile of this cluster probably reflects common endemic strains circulating in the Philippines, with reactivation occurring in the UK. Furthermore, 32-locus typing showed that 24-locus MIRU-VNTR failed to distinguish strain diversity. The lack of OH assessment indicates that latent tuberculous infection could have been identified and treated, thereby preventing active cases from occurring.

  7. A continuous quality improvement intervention to improve the effectiveness of community health workers providing care to mothers and children: a cluster randomised controlled trial in South Africa.

    Science.gov (United States)

    Horwood, Christiane; Butler, Lisa; Barker, Pierre; Phakathi, Sifiso; Haskins, Lyn; Grant, Merridy; Mntambo, Ntokozo; Rollins, Nigel

    2017-06-13

    Community health workers (CHWs) play key roles in delivering health programmes in many countries worldwide. CHW programmes can improve coverage of maternal and child health services for the most disadvantaged and remote communities, leading to substantial benefits for mothers and children. However, there is limited evidence of effective mentoring and supervision approaches for CHWs. This is a cluster randomised controlled trial to investigate the effectiveness of a continuous quality improvement (CQI) intervention amongst CHWs providing home-based education and support to pregnant women and mothers. Thirty CHW supervisors were randomly allocated to intervention (n = 15) and control (n = 15) arms. Four CHWs were randomly selected from those routinely supported by each supervisor (n = 60 per arm). In the intervention arm, these four CHWs and their supervisor formed a quality improvement team. Intervention CHWs received a 2-week training in WHO Community Case Management followed by CQI mentoring for 12 months (preceded by 3 months lead-in to establish QI processes). Baseline and follow-up surveys were conducted with mothers of infants Improved training and CQI-based mentoring of CHWs can improve quantity and quality of CHW-mother interactions at household level, leading to improvements in mothers' knowledge and infant feeding practices. ClinicalTrials.Gov NCT01774136.

  8. Provision of medical supply kits to improve quality of antenatal care in Mozambique: a stepped-wedge cluster randomised trial.

    Science.gov (United States)

    Betrán, Ana Pilar; Bergel, Eduardo; Griffin, Sally; Melo, Armando; Nguyen, My Huong; Carbonell, Alicia; Mondlane, Santos; Merialdi, Mario; Temmerman, Marleen; Gülmezoglu, A Metin

    2018-01-01

    High levels of maternal and newborn mortality and morbidity remain a daunting reality in many low-income countries. Several interventions delivered during antenatal care have been shown to improve maternal and newborn outcomes, but stockouts of medical supplies at point of care can prevent implementation of these services. We aimed to evaluate whether a supply chain strategy based on the provision of kits could improve quality of care. We did a pragmatic, stepped-wedge, cluster-randomised controlled trial at ten antenatal care clinics in Mozambique. Clinics were eligible if they were not already implementing the proposed antenatal care package; they served at least 200 new pregnant women per year; they had Maternal and Child Health (MCH) nurses; and they were willing to participate. All women attending antenatal care visits at the participating clinics were included in the trial. Participating clinics were randomly assigned to shift from control to intervention on prespecified start dates. The intervention involved four components (kits with medical supplies, a cupboard to store these supplies, a tracking sheet to monitor stocks, and a one-day training session). The primary outcomes were the proportion of women screened for anaemia and proteinuria, and the proportion of women who received mebendazole in the first antenatal care visit. The intervention was delivered under routine care conditions, and analyses were done according to the intention-to-treat principle. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201306000550192. Between March, 2014, and January, 2016, 218 277 antenatal care visits were registered, with 68 598 first and 149 679 follow-up visits. We found significant improvements in all three primary outcomes. In first visits, 5519 (14·6%) of 37 826 women were screened for anaemia in the control period, compared with 30 057 (97·7%) of 30 772 in the intervention period (adjusted odds ratio 832·40; 99

  9. CLUSTERING OF THE COUNTRIES ACCORDING TO CONSUMER CONFIDENCE INDEX AND EVALUATING WITH HUMAN DEVELOPMENT INDEX

    Directory of Open Access Journals (Sweden)

    Seda BAĞDATLI KALKAN

    2018-01-01

    Full Text Available Consumer confidence index is a national indicator that suggest about current and future expectations of the economic conditions. With consumer confidence index, it is aimed to determine the trends and expectations of consumers according to their general economic situation, employment opportunities, their financial situations and developments in the markets. Another parameter is also the Human Development Index (HDI. This index is an indicator that examines the development of countries both economically and socially. Countries are sorted by these two indices and are considered as basic parameters in international platforms. The purpose of this study is to group the selected countries according to the consumer confidence index and reveal the features of the groups and then determine the position of the grouped countries with the Human Development Index. According to the results of cluster analysis, it is shown that India, China, Sweden and USA have the highest total consumer confidence index, employment, expectation and investment index

  10. Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation.

    Science.gov (United States)

    Gates, Simon; Lall, Ranjit; Quinn, Tom; Deakin, Charles D; Cooke, Matthew W; Horton, Jessica; Lamb, Sarah E; Slowther, Anne-Marie; Woollard, Malcolm; Carson, Andy; Smyth, Mike; Wilson, Kate; Parcell, Garry; Rosser, Andrew; Whitfield, Richard; Williams, Amanda; Jones, Rebecca; Pocock, Helen; Brock, Nicola; Black, John Jm; Wright, John; Han, Kyee; Shaw, Gary; Blair, Laura; Marti, Joachim; Hulme, Claire; McCabe, Christopher; Nikolova, Silviya; Ferreira, Zenia; Perkins, Gavin D

    2017-03-01

    Mechanical chest compression devices may help to maintain high-quality cardiopulmonary resuscitation (CPR), but little evidence exists for their effectiveness. We evaluated whether or not the introduction of Lund University Cardiopulmonary Assistance System-2 (LUCAS-2; Jolife AB, Lund, Sweden) mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest (OHCA). Evaluation of the LUCAS-2 device as a routine ambulance service treatment for OHCA. Pragmatic, cluster randomised trial including adults with non-traumatic OHCA. Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. We also conducted a health economic evaluation and a systematic review of all trials of out-of-hospital mechanical chest compression. Four UK ambulance services (West Midlands, North East England, Wales and South Central), comprising 91 urban and semiurban ambulance stations. Clusters were ambulance service vehicles, which were randomly assigned (approximately 1 : 2) to the LUCAS-2 device or manual CPR. Patients were included if they were in cardiac arrest in the out-of-hospital environment. Exclusions were patients with cardiac arrest as a result of trauma, with known or clinically apparent pregnancy, or aged CPR groups [193/2819, 6.8%; adjusted odds ratio (OR) 0.86, 95% confidence interval (CI) 0.64 to 1.15]. Survival with a CPC score of 1 or 2 may have been worse in the LUCAS-2 group (adjusted OR 0.72, 95% CI 0.52 to 0.99). No serious adverse events were noted. The systematic review found no evidence of a survival advantage if mechanical chest compression was used. The health economic analysis showed that LUCAS-2 was dominated by manual chest compression. There was substantial non-compliance in the LUCAS-2 arm. For 272 out of 1652 patients (16.5%), mechanical

  11. Menstruation and the Cycle of Poverty: A Cluster Quasi-Randomised Control Trial of Sanitary Pad and Puberty Education Provision in Uganda.

    Science.gov (United States)

    Montgomery, Paul; Hennegan, Julie; Dolan, Catherine; Wu, Maryalice; Steinfield, Laurel; Scott, Linda

    2016-01-01

    Poor menstrual knowledge and access to sanitary products have been proposed as barriers to menstrual health and school attendance. In response, interventions targeting these needs have seen increasing implementation in public and private sectors. However, there has been limited assessment of their effectiveness. Assess the impact of providing reusable sanitary pads and puberty education on girls' school attendance and psychosocial wellbeing outcomes. A cluster quasi-randomised controlled trial was conducted across 8 schools, including 1124 girls, in rural Uganda. Schools were allocated to one of four conditions: the provision of puberty education alone; reusable sanitary pads alone; puberty education and reusable sanitary pads; and a control (no intervention). The primary outcome was school attendance. Secondary outcomes reflected psychosocial wellbeing. At follow-up, school attendance had worsened for girls across all conditions. Per-protocol analysis revealed that this decline was significantly greater for those in the control condition d = 0.52 (95%CI 0.26-0.77), with those in control schools having a 17.1% (95%CI: 8.7-25.5) greater drop in attendance than those in any intervention school. There were no differences between the intervention conditions. High rates of school drop-out and transfer meant the trial suffered from substantial participant drop-out. Intention-to-treat analyses using two different imputation strategies were consistent with the main results, with mean differences of 5.2% attendance in best-case and 24.5% in worst-case imputations. Results were robust to adjustments for clustering. There was no impact of the interventions on girls' self-reported shame or insecurity during menstruation. Results of the trial support the hypothesised positive impact of providing sanitary pads or puberty education for girls' school attendance in a developing country context. Findings must be interpreted with caution in light of poor participant retention

  12. A 10-Week Multimodal Nutrition Education Intervention Improves Dietary Intake among University Students: Cluster Randomised Controlled Trial

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    Mohd Razif Shahril

    2013-01-01

    Full Text Available The aim of the study was to evaluate the effectiveness of implementing multimodal nutrition education intervention (NEI to improve dietary intake among university students. The design of study used was cluster randomised controlled design at four public universities in East Coast of Malaysia. A total of 417 university students participated in the study. They were randomly selected and assigned into two arms, that is, intervention group (IG or control group (CG according to their cluster. The IG received 10-week multimodal intervention using three modes (conventional lecture, brochures, and text messages while CG did not receive any intervention. Dietary intake was assessed before and after intervention and outcomes reported as nutrient intakes as well as average daily servings of food intake. Analysis of covariance (ANCOVA and adjusted effect size were used to determine difference in dietary changes between groups and time. Results showed that, compared to CG, participants in IG significantly improved their dietary intake by increasing their energy intake, carbohydrate, calcium, vitamin C and thiamine, fruits and 100% fruit juice, fish, egg, milk, and dairy products while at the same time significantly decreased their processed food intake. In conclusion, multimodal NEI focusing on healthy eating promotion is an effective approach to improve dietary intakes among university students.

  13. The effectiveness of the Austrian disease management programme for type 2 diabetes: a cluster-randomised controlled trial

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    Klima Gert

    2010-11-01

    Full Text Available Abstract Background Disease management programmes (DMPs are costly and impose additional work load on general practitioners (GPs. Data on their effectiveness are inconclusive. We therefore conducted a cluster-randomised controlled trial to evaluate the effectiveness of the Austrian DMP for diabetes mellitus type 2 on HbA1c and quality of care for adult patients in primary care. Methods All GPs of Salzburg-province were invited to participate. After cluster-randomisation by district, all patients with diabetes type 2 were recruited consecutively from 7-11/2007. The DMP, consisting mainly of physician and patient education, standardised documentation and agreement on therapeutic goals, was implemented in the intervention group while the control group received usual care. We aimed to show superiority of the intervention regarding metabolic control and process quality. The primary outcome measure was a change in HbA1c after one year. Secondary outcomes were days in the hospital, blood pressure, lipids, body mass index (BMI, enrolment in patient education and regular guideline-adherent examination. Blinding was not possible. Results 92 physicians recruited 1489 patients (649 intervention, 840 control. After 401 ± 47 days, 590 intervention-patients and 754 controls had complete data. In the intention to treat analysis (ITT of all 1489 patients, HbA1c decreased 0.41% in the intervention group and 0.28% in controls. The difference of -0.13% (95% CI -0.24; -0.02 was significant at p = 0.026. Significance was lost in mixed models adjusted for baseline value and cluster-effects (adjusted mean difference -0.03 (95% CI -0.15; 0.09, p = 0.607. Of the secondary outcome measures, BMI and cholesterol were significantly reduced in the intervention group compared to controls in ITT after adjustments (-0.53 kg/m²; 95% CI -1.03;-0.02; p = 0.014 and -0.10 mmol/l; 95% CI -0.21; -0.003; p = 0.043. Additionally, more patients received patient education (49.5% vs. 20

  14. Country clustering applied to the water and sanitation sector: a new tool with potential applications in research and policy.

    Science.gov (United States)

    Onda, Kyle; Crocker, Jonny; Kayser, Georgia Lyn; Bartram, Jamie

    2014-03-01

    The fields of global health and international development commonly cluster countries by geography and income to target resources and describe progress. For any given sector of interest, a range of relevant indicators can serve as a more appropriate basis for classification. We create a new typology of country clusters specific to the water and sanitation (WatSan) sector based on similarities across multiple WatSan-related indicators. After a literature review and consultation with experts in the WatSan sector, nine indicators were selected. Indicator selection was based on relevance to and suggested influence on national water and sanitation service delivery, and to maximize data availability across as many countries as possible. A hierarchical clustering method and a gap statistic analysis were used to group countries into a natural number of relevant clusters. Two stages of clustering resulted in five clusters, representing 156 countries or 6.75 billion people. The five clusters were not well explained by income or geography, and were distinct from existing country clusters used in international development. Analysis of these five clusters revealed that they were more compact and well separated than United Nations and World Bank country clusters. This analysis and resulting country typology suggest that previous geography- or income-based country groupings can be improved upon for applications in the WatSan sector by utilizing globally available WatSan-related indicators. Potential applications include guiding and discussing research, informing policy, improving resource targeting, describing sector progress, and identifying critical knowledge gaps in the WatSan sector. Copyright © 2013 Elsevier GmbH. All rights reserved.

  15. Parenting for Lifelong Health: a pragmatic cluster randomised controlled trial of a non-commercialised parenting programme for adolescents and their families in South Africa

    Science.gov (United States)

    Cluver, Lucie D; Meinck, Franziska; Steinert, Janina I; Shenderovich, Yulia; Doubt, Jenny; Herrero Romero, Rocio; Lombard, Carl J; Redfern, Alice; Ward, Catherine L; Tsoanyane, Sibongile; Nzima, Divane; Sibanda, Nkosiyapha; Wittesaele, Camille; De Stone, Sachin; Boyes, Mark E; Catanho, Ricardo; Lachman, Jamie McLaren; Salah, Nasteha; Nocuza, Mzuvukile; Gardner, Frances

    2018-01-01

    Objective To assess the impact of ‘Parenting for Lifelong Health: Sinovuyo Teen’, a parenting programme for adolescents in low-income and middle-income countries, on abuse and parenting practices. Design Pragmatic cluster randomised controlled trial. Setting 40 villages/urban sites (clusters) in the Eastern Cape province, South Africa. Participants 552 families reporting conflict with their adolescents (aged 10–18). Intervention Intervention clusters (n=20) received a 14-session parent and adolescent programme delivered by trained community members. Control clusters (n=20) received a hygiene and hand-washing promotion programme. Main outcome measures Primary outcomes: abuse and parenting practices at 1 and 5–9 months postintervention. Secondary outcomes: caregiver and adolescent mental health and substance use, adolescent behavioural problems, social support, exposure to community violence and family financial well-being at 5–9 months postintervention. Blinding was not possible. Results At 5–9 months postintervention, the intervention was associated with lower abuse (caregiver report incidence rate ratio (IRR) 0.55 (95% CI 0.40 to 0.75, Pcorporal punishment (caregiver report IRR=0.55 (95% CI 0.37 to 0.83, P=0.004)); improved positive parenting (caregiver report d=0.25 (95% CI 0.03 to 0.47, P=0.024)), involved parenting (caregiver report d=0.86 (95% CI 0.64 to 1.08, Pcorporal punishment IRR=1.05 (95% CI 0.70 to 1.57, P=0.819). Secondary outcomes showed reductions in caregiver corporal punishment endorsement, mental health problems, parenting stress, substance use and increased social support (all caregiver report). Intervention adolescents reported no differences in mental health, behaviour or community violence, but had lower substance use (all adolescent report). Intervention families had improved economic welfare, financial management and more violence avoidance planning (in caregiver and adolescent report). No adverse effects were detected

  16. Does a pre-hospital emergency pathway improve early diagnosis and referral in suspected stroke patients? – Study protocol of a cluster randomised trial [ISRCTN41456865

    Directory of Open Access Journals (Sweden)

    Lori Giuliano

    2005-10-01

    Full Text Available Abstract Background Early interventions proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, become essential part of effective treatment. The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational standards required to grant appropriate care. We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways. We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients. We designed a cluster randomised controlled trial (C-RCT, the most powerful study design to assess the impact of complex interventions. The study was registered in the Current Controlled Trials Register: ISRCTN41456865 – Implementation of pre-hospital emergency pathway for stroke – a cluster randomised trial. Methods/design Two-arm cluster-randomised trial (C-RCT. 16 emergency services and 14 emergency rooms were randomised either to arm 1 (comprising a training module and administration of the guideline, or to arm 2 (no intervention, current practice. Arm 1 participants (152 physicians, 280 nurses, 50 drivers attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway. We estimated that around 750 patients will be met by the services in the 6 months of observation. This duration allows recruiting a sample of patients sufficient to observe a 30% improvement in the proportion of appropriate diagnoses. Data collection will be performed using current information systems. Process outcomes will be measured at the cluster level six months after the

  17. Growth effects of exclusive breastfeeding promotion by peer counsellors in sub-Saharan Africa: the cluster-randomised PROMISE EBF trial.

    Science.gov (United States)

    Engebretsen, Ingunn Marie Stadskleiv; Jackson, Debra; Fadnes, Lars Thore; Nankabirwa, Victoria; Diallo, Abdoulaye Hama; Doherty, Tanya; Lombard, Carl; Swanvelder, Sonja; Nankunda, Jolly; Ramokolo, Vundli; Sanders, David; Wamani, Henry; Meda, Nicolas; Tumwine, James K; Ekström, Eva-Charlotte; Van de Perre, Philippe; Kankasa, Chipepo; Sommerfelt, Halvor; Tylleskär, Thorkild

    2014-06-21

    In this multi-country cluster-randomized behavioural intervention trial promoting exclusive breastfeeding (EBF) in Africa, we compared growth of infants up to 6 months of age living in communities where peer counsellors promoted EBF with growth in those infants living in control communities. A total of 82 clusters in Burkina Faso, Uganda and South Africa were randomised to either the intervention or the control arm. Feeding data and anthropometric measurements were collected at visits scheduled 3, 6, 12 and 24 weeks post-partum. We calculated weight-for-length (WLZ), length-for-age (LAZ) and weight-for-age (WAZ) z-scores. Country specific adjusted Least Squares Means with 95% confidence intervals (CI) based on a longitudinal analysis are reported. Prevalence ratios (PR) for the association between peer counselling for EBF and wasting (WLZ economic status, the mean WLZ at 24 weeks were in Burkina Faso -0.20 (95% CI -0.39 to -0.01) and in Uganda -0.23 (95% CI -0.43 to -0.03) lower in the intervention than in the control arm. In South Africa the mean WLZ at 24 weeks was 0.23 (95% CI 0.03 to 0.43) greater in the intervention than in the control arm. Differences in LAZ between the study arms were small and not statistically significant. In Uganda, infants in the intervention arm were more likely to be wasted compared to those in the control arm at 24 weeks (PR 2.36; 95% CI 1.11 to 5.00). Differences in wasting in South Africa and Burkina Faso and stunting and underweight in all three countries were small and not significantly different. There were small differences in mean anthropometric indicators between the intervention and control arms in the study, but in Uganda and Burkina Faso, a tendency to slightly lower ponderal growth (weight-for-length z-scores) was found in the intervention arms. ClinicalTrials.gov: NCT00397150.

  18. Effectiveness of the EMPOWER-PAR Intervention in Improving Clinical Outcomes of Type 2 Diabetes Mellitus in Primary Care: A Pragmatic Cluster Randomised Controlled Trial.

    Science.gov (United States)

    Ramli, Anis Safura; Selvarajah, Sharmini; Daud, Maryam Hannah; Haniff, Jamaiyah; Abdul-Razak, Suraya; Tg-Abu-Bakar-Sidik, Tg Mohd Ikhwan; Bujang, Mohamad Adam; Chew, Boon How; Rahman, Thuhairah; Tong, Seng Fah; Shafie, Asrul Akmal; Lee, Verna K M; Ng, Kien Keat; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md Yasin; Mat-Nasir, Nafiza; Chan, Chun W; Yong-Rafidah, Abdul Rahman; Ismail, Mastura; Lakshmanan, Sharmila; Low, Wilson H H

    2016-11-14

    The chronic care model was proven effective in improving clinical outcomes of diabetes in developed countries. However, evidence in developing countries is scarce. The objective of this study was to evaluate the effectiveness of EMPOWER-PAR intervention (based on the chronic care model) in improving clinical outcomes for type 2 diabetes mellitus using readily available resources in the Malaysian public primary care setting. This was a pragmatic, cluster-randomised, parallel, matched pair, controlled trial using participatory action research approach, conducted in 10 public primary care clinics in Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Patients who fulfilled the criteria were recruited over a 2-week period by each clinic. The obligatory intervention components were designed based on four elements of the chronic care model i.e. healthcare organisation, delivery system design, self-management support and decision support. The primary outcome was the change in the proportion of patients achieving HbA1c diabetes mellitus patients were recruited at baseline (intervention: 471 vs. 417). At 1-year, 96.6 and 97.8% of patients in the intervention and control groups completed the study, respectively. The baseline demographic and clinical characteristics of both groups were comparable. The change in the proportion of patients achieving HbA1c target was significantly higher in the intervention compared to the control group (intervention: 3.0% vs. -4.1%, P diabetes in the Malaysian public primary care setting. Registered with: ClinicalTrials.gov.: NCT01545401 . Date of registration: 1st March 2012.

  19. Fever, hyperglycaemia and swallowing dysfunction management in acute stroke: A cluster randomised controlled trial of knowledge transfer

    Directory of Open Access Journals (Sweden)

    Quinn Clare

    2009-03-01

    Full Text Available Abstract Background Hyperglycaemia, fever, and swallowing dysfunction are poorly managed in the admission phase of acute stroke, and patient outcomes are compromised. Use of evidence-based guidelines could improve care but have not been effectively implemented. Our study aims to develop and trial an intervention based on multidisciplinary team-building to improve management of fever, hyperglycaemia, and swallowing dysfunction in patients following acute stroke. Methods and design Metropolitan acute stroke units (ASUs located in New South Wales, Australia will be stratified by service category (A or B and, within strata, by baseline patient recruitment numbers (high or low in this prospective, multicentre, single-blind, cluster randomised controlled trial (CRCT. ASUs then will be randomised independently to either intervention or control groups. ASUs allocated to the intervention group will receive: unit-based workshops to identify local barriers and enablers; a standardised core education program; evidence-based clinical treatment protocols; and ongoing engagement of local staff. Control group ASUs will receive only an abridged version of the National Clinical Guidelines for Acute Stroke Management. The following outcome measures will be collected at 90 days post-hospital admission: patient death, disability (modified Rankin Score; dependency (Barthel Index and Health Status (SF-36. Additional measures include: performance of swallowing screening within 24 hours of admission; glycaemic control and temperature control. Discussion This is a unique study of research transfer in acute stroke. Providing optimal inpatient care during the admission phase is essential if we are to combat the rising incidence of debilitating stroke. Our CRCT will also allow us to test interventions focussed on multidisciplinary ASU teams rather than individual disciplines, an imperative of modern hospital services. Trial Registration Australia New Zealand Clinical Trial

  20. Cluster randomised controlled trial of a consumer behaviour intervention to improve healthy food purchases from online canteens: study protocol.

    Science.gov (United States)

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

    2017-04-17

    School canteens represent an opportune setting in which to deliver public health nutrition strategies given 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 behaviour strategies that impact on purchasing decisions. The aim of this study is to assess the efficacy of a consumer behaviour intervention implemented in an online school canteen ordering system in reducing the kilojoule, saturated fat, sugar and sodium content of primary student lunch orders. The study will employ a cluster randomised controlled trial design. Approximately 1040 students (aged 5-12 years) from 10 primary schools in New South Wales, Australia, currently using an online canteen ordering system will be invited to participate. Schools will be randomised in a 1:1 ratio to receive either the intervention (enhanced system) or control (standard online ordering only). The intervention will include evidence-based strategies shown to influence healthy food purchasing (strategies targeting availability, menu labelling, placement and prompting). The primary outcomes of the trial will be the mean content per student online lunch order of (1) energy (kJ), (2) saturated fat (g), (3) sugar (g) and (4) sodium (mg). The impact of the intervention will be determined by between-group assessment of the nutritional content of lunch purchases over a 2-month period postintervention initiation. The study was approved by the Hunter New England Human Research Ethics Committee, University of Newcastle Human Research Ethics Committee and New South Wales Department of Education and School Communities. Study findings will be disseminated widely through peer-reviewed publications and relevant presentations in international conferences and to stakeholders. ACTRN12616000499482. Published by the BMJ Publishing Group Limited. For permission to

  1. Individual music therapy for managing neuropsychiatric symptoms for people with dementia and their carers: a cluster randomised controlled feasibility study.

    Science.gov (United States)

    Hsu, Ming Hung; Flowerdew, Rosamund; Parker, Michael; Fachner, Jörg; Odell-Miller, Helen

    2015-07-18

    Previous research highlights the importance of staff involvement in psychosocial interventions targeting neuropsychiatric symptoms of dementia. Music therapy has shown potential effects, but it is not clear how this intervention can be programmed to involve care staff within the delivery of patients' care. This study reports initial feasibility and outcomes from a five month music therapy programme including weekly individual active music therapy for people with dementia and weekly post-therapy video presentations for their carers in care homes. 17 care home residents and 10 care staff were randomised to the music therapy intervention group or standard care control group. The cluster randomised, controlled trial included baseline, 3-month, 5-month and post-intervention 7-month measures of residents' symptoms and well-being. Carer-resident interactions were also assessed. Feasibility was based on carers' feedback through semi-structured interviews, programme evaluations and track records of the study. The music therapy programme appeared to be a practicable and acceptable intervention for care home residents and staff in managing dementia symptoms. Recruitment and retention data indicated feasibility but also challenges. Preliminary outcomes indicated differences in symptoms (13.42, 95 % CI: [4.78 to 22.07; p = 0.006]) and in levels of wellbeing (-0.74, 95 % CI: [-1.15 to -0.33; p = 0.003]) between the two groups, indicating that residents receiving music therapy improved. Staff in the intervention group reported enhanced caregiving techniques as a result of the programme. The data supports the value of developing a music therapy programme involving weekly active individual music therapy sessions and music therapist-carer communication. The intervention is feasible with modifications in a more rigorous evaluation of a larger sample size. Clinicaltrials.gov, number NCT01744600.

  2. Pilot cluster randomised controlled trial of flooring to reduce injuries from falls in wards for older people.

    Science.gov (United States)

    Drahota, Amy Kim; Ward, Derek; Udell, Julie E; Soilemezi, Dia; Ogollah, Reuben; Higgins, Bernard; Dean, Taraneh P; Severs, Martin

    2013-09-01

    falls disproportionately affect older people, who are at increased risk of falls and injury. This pilot study investigates shock-absorbing flooring for fall-related injuries in wards for frail older people. we conducted a non-blinded cluster randomised trial in eight hospitals in England between April 2010 and August 2011. Each site allocated one bay as the 'study area', which was randomised via computer to intervention (8.3-mm thick Tarkett Omnisports EXCEL) or control (2-mm standard in situ flooring). Sites had an intervention period of 1 year. Anybody admitted to the study area was eligible. The primary outcome was the fall-related injury rate. Secondary outcomes were injury severity, fall rate and adverse events. during the intervention period, 226 participants were recruited to each group (219 and 223 were analysed in the intervention and control group, respectively). Of 35 falls (31 fallers) in the intervention group, 22.9% were injurious, compared with 42.4% of 33 falls (22 fallers) in the control group [injury incident rate ratio (IRR) = 0.58, 95% CI = 0.18-1.91]. There were no moderate or major injuries in the intervention group and six in the control group. The fall IRR was 1.07 (95% CI = 0.64-1.81). Staff at intervention sites raised concerns about pushing equipment, documenting one pulled back. future research should assess shock-absorbing flooring with better 'push/pull' properties and explore increased faller risk. We estimate a future trial will need 33,480-52,840 person bed-days per arm.

  3. Effectiveness of an online SUpport PRogramme (SUPR) for older hearing aid users: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Meijerink, Janine Fj; Pronk, Marieke; Paulissen, Bernadette; Witte, Birgit I; Wouden, Bregje van der; Jansen, Vera; Kramer, Sophia E

    2017-06-20

    An educational SUpport PRogramme called SUPR has been developed for hearing aid users (HAUs) and their communication partners (CPs) offering care beyond hearing aid fitting. SUPR teaches its users communication strategies, hearing aid handling skills and personal adjustment to hearing impairment. Using a cluster randomised controlled trial design, 70 Dutch hearing aid dispenser practices were randomised into hearing aid fitting (care as usual, 34 practices) and hearing aid fitting including SUPR (36 practices). The aim was to recruit a total of 569 older (aged 50+ years) first-time (n=258) and experienced (n=311) HAUs and their CPs. SUPR consists of a Practical Support Booklet and online material offered via email over a period of 6-7 months. The booklet provides practical information on hearing aids, advice on communication strategies and home exercises. The online material consists of educational videos on hearing aid functionality and usage, communication strategies and peer testimonials. Finally, noncommittal email contact with the dispenser is offered. Every HAU is asked to assign a CP who is advised to be involved intensively. Effect measurements for HAUs and their CPs will occur at baseline and at 6, 12 and 18 months follow-up via online questionnaires. The primary outcomes for HAUs will be the use of communication strategies as measured by the subscales of the Communication Profile for the Hearing Impaired. A process evaluation will be performed. The study was approved by the Dutch Institutional Review Board of the VU Medical University Center Amsterdam. This intervention could contribute to lowering the hearing impairment burden in our ageing society. The results will be disseminated through peer-reviewed publications and scientific conferences. ISRCTN77340339; Pre-results. © 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

  4. Implementing core NICE guidelines for osteoarthritis in primary care with a model consultation (MOSAICS): a cluster randomised controlled trial.

    Science.gov (United States)

    Dziedzic, K S; Healey, E L; Porcheret, M; Afolabi, E K; Lewis, M; Morden, A; Jinks, C; McHugh, G A; Ryan, S; Finney, A; Main, C; Edwards, J J; Paskins, Z; Pushpa-Rajah, A; Hay, E M

    2018-01-01

    To determine the effectiveness of a model osteoarthritis consultation, compared with usual care, on physical function and uptake of National Institute for Health and Care Excellence (NICE) osteoarthritis recommendations, in adults ≥45 years consulting with peripheral joint pain in UK general practice. Two-arm cluster-randomised controlled trial with baseline health survey. Eight general practices in England. 525 adults ≥45 years consulting for peripheral joint pain, amongst 28,443 population survey recipients. Four intervention practices delivered the model osteoarthritis consultation to patients consulting with peripheral joint pain; four control practices continued usual care. The primary clinical outcome of the trial was the SF-12 physical component score (PCS) at 6 months; the main secondary outcome was uptake of NICE core recommendations by 6 months, measured by osteoarthritis quality indicators. A Linear Mixed Model was used to analyse clinical outcome data (SF-12 PCS). Differences in quality indicator outcomes were assessed using logistic regression. 525 eligible participants were enrolled (mean age 67.3 years, SD 10.5; 59.6% female): 288 from intervention and 237 from control practices. There were no statistically significant differences in SF-12 PCS: mean difference at the 6-month primary endpoint was -0.37 (95% CI -2.32, 1.57). Uptake of core NICE recommendations by 6 months was statistically significantly higher in the intervention arm compared with control: e.g., increased written exercise information, 20.5% (7.9, 28.3). Whilst uptake of core NICE recommendations was increased, there was no evidence of benefit of this intervention, as delivered in this pragmatic randomised trial, on the primary outcome of physical functioning at 6 months. ISRCTN06984617. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

  5. Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial

    International Nuclear Information System (INIS)

    Schofield, Penelope; Gough, Karla; Lotfi-Jam, Kerryann; Bergin, Rebecca; Ugalde, Anna; Dudgeon, Paul; Crellin, Wallace; Schubach, Kathryn; Foroudi, Farshard; Tai, Keen Hun; Duchesne, Gillian; Sanson-Fisher, Rob; Aranda, Sanchia

    2016-01-01

    Radiotherapy for localised prostate cancer has many known and distressing side effects. The efficacy of group interventions for reducing psychological morbidity is lacking. This study investigated the relative benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns and prostate cancer-specific quality of life in men receiving curative intent radiotherapy for prostate cancer. This phase III, two-arm cluster randomised controlled trial included 331 men (consent rate: 72 %; attrition: 5 %) randomised to the intervention (n = 166) or usual care (n = 165). The intervention comprised four group and one individual consultation all delivered by specialist uro-oncology nurses. Primary outcomes were anxious and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale. Unmet needs were assessed with the Supportive Care Needs Survey-SF34 Revised, treatment-related concerns with the Cancer Treatment Scale and quality of life with the Expanded Prostate Cancer Index −26. Assessments occurred before, at the end of and 6 months post-radiotherapy. Primary outcome analysis was by intention-to-treat and performed by fitting a linear mixed model to each outcome separately using all observed data. Mixed models analysis indicated that group consultations had a significant beneficial effect on one of two primary endpoints, depressive symptoms (p = 0.009), and one of twelve secondary endpoints, procedural concerns related to cancer treatment (p = 0.049). Group consultations did not have a significant beneficial effect on generalised anxiety, unmet needs and prostate cancer-specific quality of life. Compared with individual consultations offered as part of usual care, the intervention provides a means of delivering patient education and is associated with modest reductions in depressive symptoms and procedural concerns. Future work should seek to confirm the clinical feasibility and cost-effectiveness of group

  6. Effectiveness and implementation of an obesity prevention intervention: the HeLP-her Rural cluster randomised controlled trial.

    Science.gov (United States)

    Lombard, Catherine B; Harrison, Cheryce L; Kozica, Samantha L; Zoungas, Sophia; Keating, Catherine; Teede, Helena J

    2014-06-16

    To impact on the obesity epidemic, interventions that prevent weight gain across populations are urgently needed. However, even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings. Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle. Despite the recognised need, few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities. Here we describe the rationale, design and implementation of a Healthy Lifestyle Program for women living in small rural communities (HeLP-her Rural). The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity, self-management intervention. Six hundred women from 42 small rural communities in Australia will be randomised as clusters (n-21 control towns and n = 21 intervention towns). A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program. Implementing population interventions to prevent obesity is complex, costly and challenging. To address these barriers, evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation. Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level. Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level. The learnings from this trial will impact on the design and implementation of population obesity prevention strategies

  7. A universal harm-minimisation approach to preventing psychostimulant and cannabis use in adolescents: a cluster randomised controlled trial.

    Science.gov (United States)

    Vogl, Laura Elise; Newton, Nicola Clare; Champion, Katrina Elizabeth; Teesson, Maree

    2014-06-18

    Psychostimulants and cannabis are two of the three most commonly used illicit drugs by young Australians. As such, it is important to deliver prevention for these substances to prevent their misuse and to reduce associated harms. The present study aims to evaluate the feasibility and effectiveness of the universal computer-based Climate Schools: Psychostimulant and Cannabis Module. A cluster randomised controlled trial was conducted with 1734 Year 10 students (mean age = 15.44 years; SD = 0.41) from 21 secondary schools in Australia. Schools were randomised to receive either the six lesson computer-based Climate Schools program or their usual health classes, including drug education, over the year. The Climate Schools program was shown to increase knowledge of cannabis and psychostimulants and decrease pro-drug attitudes. In the short-term the program was effective in subduing the uptake and plateauing the frequency of ecstasy use, however there were no changes in meth/amphetamine use. In addition, females who received the program used cannabis significantly less frequently than students who received drug education as usual. Finally, the Climate Schools program was related to decreasing students' intentions to use meth/amphetamine and ecstasy in the future, however these effects did not last over time. These findings provide support for the use of a harm-minimisation approach and computer technology as an innovative platform for the delivery of prevention education for illicit drugs in schools. The current study indicated that teachers and students enjoyed the program and that it is feasible to extend the successful Climate Schools model to the prevention of other drugs, namely cannabis and psychostimulants. Australian and New Zealand Clinical Trials Registry ACTRN12613000492752.

  8. Preoperative airway assessment - experience gained from a multicentre cluster randomised trial and the Danish Anaesthesia Database

    DEFF Research Database (Denmark)

    Nørskov, Anders Kehlet

    2016-01-01

    difficult intubation compared with usual care for airway assessment. This thesis is based on data from the Danish Anaesthesia Database (DAD). Paper 1 presents an observational cohort study on 188,064 patients who underwent tracheal intubation from 2008 to 2011. Data on the anaesthesiologists' preoperative...... to the DIFFICAIR trial described in Paper 4. The trial was designed to randomise anaesthesia department to either thorough education in, and subsequent use of the SARI for preoperative airway assessment or to continue usual care. Registration of the SARI in DAD was made mandatory in SARI departments and impossible...... unanticipated. Furthermore, 94% of all difficult mask ventilations were unanticipated. In Paper 4, 59,514 patients were included in the primary analyses. The proportion of unanticipated difficult intubations was 2.38% (696/29,209) in SARI departments and 2.39% (723/30,305) in usual care departments...

  9. Efficacy of the FIFA 11+ Warm-Up Programme in Male Youth Football: A Cluster Randomised Controlled Trial

    Science.gov (United States)

    Owoeye, Oluwatoyosi B. A.; Akinbo, Sunday R. A.; Tella, Bosede A.; Olawale, Olajide A.

    2014-01-01

    The FIFA 11+ is a structured warm-up programme specially designed to prevent injuries among football players from age 14 years and above. However, studies to prove its efficacy are generally few and it is yet to be tested in male youth footballers and among African players. The purpose of the study was to examine the efficacy of the FIFA 11+ programme in reducing the risk of injuries among male youth football players of the Lagos Junior League. A cluster randomised controlled trial was conducted. All the 20 teams (414 players aged 14 -19 years) in the Premier League division were block-randomised into either an intervention (INT) or a control (CON) group. The INT group performed the FIFA 11+ exercises as warm-up during training sessions and the CON group performed usual warm-up. Participating teams were prospectively followed through an entire league season of 6 months in which they were visited every week to assess injured players for time-loss injuries in both groups. The primary outcomes were any injury to the players, injuries by type of exposure and injuries specific to the lower extremities. The secondary outcomes were injuries reported by body location, aetiology, mechanism and severity. In total, 130 injuries were recorded affecting 104 (25%) of the 416 players. Team and player compliance with the INT was 60% and 74% respectively. Based on the primary outcome measures of the study, the FIFA 11+ programme significantly reduced the overall rate of injury in the INT group by 41% [RR = 0.59 (95% CI: 0.40 – 0.86; p = 0.006)] and all lower extremity injuries by 48% [RR = 0.52 (95% CI: 0.34 – 0.82; p = 0.004)]. However, the rate of injury reduction based on secondary outcomes mostly did not reach the level of statistical significance. The FIFA 11+ programme is effective in reducing the rates of injuries in male youth football players. Key points The FIFA 11+ has only been tested in randomised controlled trials conducted on female youth football players; this

  10. Hepatitis C - Assessment to Treatment Trial (HepCATT) in primary care: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Roberts, Kirsty; Macleod, John; Metcalfe, Chris; Simon, Joanne; Horwood, Jeremy; Hollingworth, William; Marlowe, Sharon; Gordon, Fiona H; Muir, Peter; Coleman, Barbara; Vickerman, Peter; Harrison, Graham I; Waldron, Cherry-Ann; Irving, William; Hickman, Matthew

    2016-07-29

    Public Health England (PHE) estimates that there are upwards of 160,000 individuals in England and Wales with chronic hepatitis C virus (HCV) infection, but until now only around 100,000 laboratory diagnoses have been reported to PHE and of these 28,000 have been treated. Targeted case-finding in primary care is estimated to be cost-effective; however, there has been no robust randomised controlled trial evidence available of specific interventions. Therefore, this study aims to develop and conduct a complex intervention within primary care and to evaluate this approach using a cluster randomised controlled trial. A total of 46 general practices in South West England will be randomised in a 1:1 ratio to receive either a complex intervention comprising: educational training on HCV for the practice; poster and leaflet display in the practice waiting rooms to raise awareness and encourage opportunistic testing; a HCV risk prediction algorithm based on information on possible risk markers in the electronic patient record run using Audit + software (BMJ Informatica). The audit will then be used to recall and offer patients a HCV test. Control practices will follow usual care. The effectiveness of the intervention will be measured by comparing number and rates of HCV testing, the number and proportion of patients testing positive, onward referral, rates of specialist assessment and treatment in control and intervention practices. Intervention costs and health service utilisation will be recorded to estimate the NHS cost per new HCV diagnosis and new HCV patient initiating treatment. Longer-term cost-effectiveness of the intervention in improving quality-adjusted life years (QALYs) will be extrapolated using a pre-existing dynamic health economic model. Patients' and health care workers' experiences and acceptability of the intervention will be explored through semi-structured qualitative interviews. This trial has the potential to make an important impact on patient

  11. 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

  12. Initiating change locally in bullying and aggression through the school environment (INCLUSIVE): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Bonell, Chris; Allen, Elizabeth; Christie, Deborah; Elbourne, Diana; Fletcher, Adam; Grieve, Richard; LeGood, Rosa; Mathiot, Anne; Scott, Stephen; Wiggins, Meg; Viner, Russell M

    2014-09-30

    Systematic reviews suggest that interventions that address school organisation are effective in reducing victimisation and bullying. We successfully piloted a school environment intervention modified from international studies to incorporate 'restorative justice' approaches. This trial aims to establish the effectiveness and cost-effectiveness of the INCLUSIVE intervention in reducing aggression and bullying in English secondary schools. cluster randomised trial. 40 state-supported secondary schools. OUTCOMES assessed among the cohort of students in year 8 (n = approximately 6,000) in intervention year 1. INCLUSIVE is a school-led intervention which combines changes to the school environment with the promotion of social and emotional skills and restorative practices through: the formation of a school action group involving students and staff supported by an external facilitator to review local data on needs, determine priorities, and develop and implement an action plan for revising relevant school policies/rules and other actions to improve relationships at school and reduce aggression; staff training in restorative practices; and a new social and emotional skills curriculum. The intervention will be delivered by schools supported in the first two years by educational facilitators independent of the research team, with a third locally facilitated intervention year.Comparator: normal practice. primary: 2 primary outcomes at student level assessed at baseline and at 36 months:1. Aggressive behaviours in school: Edinburgh Study of Youth Transitions and Crime school misbehaviour subscale (ESYTC)2. Bullying and victimisation: Gatehouse Bullying Scale (GBS)Secondary outcomes assessed at baseline, 24 and 36 months will include measures relating to the economic evaluation, psychosocial outcomes in students and staff and school-level truancy and exclusion rates. 20 schools per arm will provide 90% power to identify an effect size of 0.25 SD with a 5% significance level.Randomisation

  13. Quit in General Practice: a cluster randomised trial of enhanced in-practice support for smoking cessation

    Directory of Open Access Journals (Sweden)

    Zwar Nicholas

    2010-08-01

    Full Text Available Abstract Background This study will test the uptake and effectiveness of a flexible package of smoking cessation support provided primarily by the practice nurse (PN and tailored to meet the needs of a diversity of patients. Methods/Design This study is a cluster randomised trial, with practices allocated to one of three groups 1 Quit with Practice Nurse 2 Quitline referral 3 GP usual care. PNs from practices randomised to the intervention group will receive a training course in smoking cessation followed by access to mentoring. GPs from practices randomised to the Quitline referral group will receive information about the study and the process of written referral and GPs in the usual care group will receive information about the study. Eligible patients are those aged 18 and over presenting to their GP who are daily or weekly smokers and who are able to give informed consent. Patients on low incomes in all three groups will be able to access free nicotine patches. Primary outcomes are sustained abstinence and point prevalence abstinence at the three month and 12 month follow-up points; and incremental cost effectiveness ratios at 12 months. Process evaluation on the reach and acceptability of the intervention approached will be collected through Computer Assisted Telephone Interviews (CATI with patients and semi-structured interviews with PNs and GPs. The primary analysis will be by intention to treat. Cessation outcomes will be compared between the three arms at three months and 12 month follow-up using multiple logistic regression. The incremental cost effectiveness ratios will be estimated for the 12 month quit rate for the intervention groups compared to usual care and to each other. Analysis of qualitative data on process outcomes will be based on thematic analysis. Discussion High quality evidence on effectiveness of practice nurse interventions is needed to inform health policy on development of practice nurse roles. If effective

  14. A cluster randomised controlled trial of the efficacy of a brief walking intervention delivered in primary care: Study protocol

    Directory of Open Access Journals (Sweden)

    Szczepura Ala

    2011-06-01

    Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in

  15. Pupil-led sex education in England (RIPPLE study): cluster-randomised intervention trial.

    Science.gov (United States)

    Stephenson, J M; Strange, V; Forrest, S; Oakley, A; Copas, A; Allen, E; Babiker, A; Black, S; Ali, M; Monteiro, H; Johnson, A M

    Improvement of sex education in schools is a key part of the UK government's strategy to reduce teenage pregnancy in England. We examined the effectiveness of one form of peer-led sex education in a school-based randomised trial of over 8000 pupils. 29 schools were randomised to either peer-led sex education (intervention) or to continue their usual teacher-led sex education (control). In intervention schools, peer educators aged 16-17 years delivered three sessions of sex education to 13-14 year-old pupils from the same schools. Primary outcome was unprotected (without condom) first heterosexual intercourse by age 16 years. Analysis was by intention to treat. By age 16 years, significantly fewer girls reported intercourse in the peer-led arm than in the control arm, but proportions were similar for boys. The proportions of pupils reporting unprotected first sex did not differ for girls (8.4% intervention vs 8.3% control) or for boys (6.2% vs 4.7%). Stratified estimates of the difference between arms were -0.4% (95% CI -3.7% to 2.8%, p=0.79) for girls and -1.4% (-4.4% to 1.6%, p=0.36) for boys. At follow-up (mean age 16.0 years [SD 0.32]), girls in the intervention arm reported fewer unintended pregnancies, although the difference was borderline (2.3% vs 3.3%, p=0.07). Girls and boys were more satisfied with peer-led than teacher-led sex education, but 57% of girls and 32% of boys wanted sex education in single-sex groups. Peer-led sex education was effective in some ways, but broader strategies are needed to improve young people's sexual health. The role of single-sex sessions should be investigated further.

  16. Design of the South East Asian Nutrition Survey (SEANUTS): a four-country multistage cluster design study.

    Science.gov (United States)

    Schaafsma, Anne; Deurenberg, Paul; Calame, Wim; van den Heuvel, Ellen G H M; van Beusekom, Christien; Hautvast, Jo; Sandjaja; Bee Koon, Poh; Rojroongwasinkul, Nipa; Le Nguyen, Bao Khanh; Parikh, Panam; Khouw, Ilse

    2013-09-01

    Nutrition is a well-known factor in the growth, health and development of children. It is also acknowledged that worldwide many people have dietary imbalances resulting in over- or undernutrition. In 2009, the multinational food company FrieslandCampina initiated the South East Asian Nutrition Survey (SEANUTS), a combination of surveys carried out in Indonesia, Malaysia, Thailand and Vietnam, to get a better insight into these imbalances. The present study describes the general study design and methodology, as well as some problems and pitfalls encountered. In each of these countries, participants in the age range of 0·5-12 years were recruited according to a multistage cluster randomised or stratified random sampling methodology. Field teams took care of recruitment and data collection. For the health status of children, growth and body composition, physical activity, bone density, and development and cognition were measured. For nutrition, food intake and food habits were assessed by questionnaires, whereas in subpopulations blood and urine samples were collected to measure the biochemical status parameters of Fe, vitamins A and D, and DHA. In Thailand, the researchers additionally studied the lipid profile in blood, whereas in Indonesia iodine excretion in urine was analysed. Biochemical data were analysed in certified laboratories. Study protocols and methodology were aligned where practically possible. In December 2011, data collection was finalised. In total, 16,744 children participated in the present study. Information that will be very relevant for formulating nutritional health policies, as well as for designing innovative food and nutrition research and development programmes, has become available.

  17. Symptom Clusters in People Living with HIV Attending Five Palliative Care Facilities in Two Sub-Saharan African Countries: A Hierarchical Cluster Analysis.

    Science.gov (United States)

    Moens, Katrien; Siegert, Richard J; Taylor, Steve; Namisango, Eve; Harding, Richard

    2015-01-01

    Symptom research across conditions has historically focused on single symptoms, and the burden of multiple symptoms and their interactions has been relatively neglected especially in people living with HIV. Symptom cluster studies are required to set priorities in treatment planning, and to lessen the total symptom burden. This study aimed to identify and compare symptom clusters among people living with HIV attending five palliative care facilities in two sub-Saharan African countries. Data from cross-sectional self-report of seven-day symptom prevalence on the 32-item Memorial Symptom Assessment Scale-Short Form were used. A hierarchical cluster analysis was conducted using Ward's method applying squared Euclidean Distance as the similarity measure to determine the clusters. Contingency tables, X2 tests and ANOVA were used to compare the clusters by patient specific characteristics and distress scores. Among the sample (N=217) the mean age was 36.5 (SD 9.0), 73.2% were female, and 49.1% were on antiretroviral therapy (ART). The cluster analysis produced five symptom clusters identified as: 1) dermatological; 2) generalised anxiety and elimination; 3) social and image; 4) persistently present; and 5) a gastrointestinal-related symptom cluster. The patients in the first three symptom clusters reported the highest physical and psychological distress scores. Patient characteristics varied significantly across the five clusters by functional status (worst functional physical status in cluster one, ppeople living with HIV with longitudinally collected symptom data to test cluster stability and identify common symptom trajectories is recommended.

  18. Neoadjuvant chemoradiotherapy plus surgery versus active surveillance for oesophageal cancer: a stepped-wedge cluster randomised trial.

    Science.gov (United States)

    Noordman, Bo Jan; Wijnhoven, Bas P L; Lagarde, Sjoerd M; Boonstra, Jurjen J; Coene, Peter Paul L O; Dekker, Jan Willem T; Doukas, Michael; van der Gaast, Ate; Heisterkamp, Joos; Kouwenhoven, Ewout A; Nieuwenhuijzen, Grard A P; Pierie, Jean-Pierre E N; Rosman, Camiel; van Sandick, Johanna W; van der Sangen, Maurice J C; Sosef, Meindert N; Spaander, Manon C W; Valkema, Roelf; van der Zaag, Edwin S; Steyerberg, Ewout W; van Lanschot, J Jan B

    2018-02-06

    Neoadjuvant chemoradiotherapy (nCRT) plus surgery is a standard treatment for locally advanced oesophageal cancer. With this treatment, 29% of patients have a pathologically complete response in the resection specimen. This provides the rationale for investigating an active surveillance approach. The aim of this study is to assess the (cost-)effectiveness of active surveillance vs. standard oesophagectomy after nCRT for oesophageal cancer. This is a phase-III multi-centre, stepped-wedge cluster randomised controlled trial. A total of 300 patients with clinically complete response (cCR, i.e. no local or disseminated disease proven by histology) after nCRT will be randomised to show non-inferiority of active surveillance to standard oesophagectomy (non-inferiority margin 15%, intra-correlation coefficient 0.02, power 80%, 2-sided α 0.05, 12% drop-out). Patients will undergo a first clinical response evaluation (CRE-I) 4-6 weeks after nCRT, consisting of endoscopy with bite-on-bite biopsies of the primary tumour site and other suspected lesions. Clinically complete responders will undergo a second CRE (CRE-II), 6-8 weeks after CRE-I. CRE-II will include 18F-FDG-PET-CT, followed by endoscopy with bite-on-bite biopsies and ultra-endosonography plus fine needle aspiration of suspected lymph nodes and/or PET- positive lesions. Patients with cCR at CRE-II will be assigned to oesophagectomy (first phase) or active surveillance (second phase of the study). The duration of the first phase is determined randomly over the 12 centres, i.e., stepped-wedge cluster design. Patients in the active surveillance arm will undergo diagnostic evaluations similar to CRE-II at 6/9/12/16/20/24/30/36/48 and 60 months after nCRT. In this arm, oesophagectomy will be offered only to patients in whom locoregional regrowth is highly suspected or proven, without distant dissemination. The main study parameter is overall survival; secondary endpoints include percentage of patients who do not

  19. A cluster randomised controlled trial to investigate the effectiveness and cost effectiveness of the 'Girls Active' intervention: a study protocol.

    Science.gov (United States)

    Edwardson, C L; Harrington, D M; Yates, T; Bodicoat, D H; Khunti, K; Gorely, T; Sherar, L B; Edwards, R T; Wright, C; Harrington, K; Davies, M J

    2015-06-04

    Despite the health benefits of physical activity, data from the UK suggest that a large proportion of adolescents do not meet the recommended levels of moderate-to-vigorous physical activity (MVPA). This is particularly evident in girls, who are less active than boys across all ages and may display a faster rate of decline in physical activity throughout adolescence. The 'Girls Active' intervention has been designed by the Youth Sport Trust to target the lower participation rates observed in adolescent girls. 'Girls Active' uses peer leadership and marketing to empower girls to influence decision making in their school, develop as role models and promote physical activity to other girls. Schools are provided with training and resources to review their physical activity, sport and PE provision, culture and practices to ensure they are relevant and attractive to adolescent girls. This study is a two-arm cluster randomised controlled trial (RCT) aiming to recruit 20 secondary schools. Clusters will be randomised at the school level (stratified by school size and proportion of Black and Minority Ethnic (BME) pupils) to receive either the 'Girls Active' intervention or carry on with usual practice (1:1). The 20 secondary schools will be recruited from state secondary schools within the Midlands area. We aim to recruit 80 girls aged 11-14 years in each school. Data will be collected at three time points; baseline and seven and 14 months after baseline. Our primary aim is to investigate whether 'Girls Active' leads to higher objectively measured (GENEActiv) moderate-to-vigorous physical activity in adolescent girls at 14 months after baseline assessment compared to the control group. Secondary outcomes include other objectively measured physical activity variables, adiposity, physical activity-related psychological factors and the cost-effectiveness of the 'Girls Active' intervention. A thorough process evaluation will be conducted during the course of the intervention

  20. Getting better at chronic care in remote communities: study protocol for a pragmatic cluster randomised controlled of community based management

    Directory of Open Access Journals (Sweden)

    Schmidt Barbara

    2012-11-01

    Full Text Available Abstract Background Prevalence and incidence of diabetes and other common comorbid conditions (hypertension, coronary heart disease, renal disease and chronic lung disease are extremely high among Indigenous Australians. Recent measures to improve quality of preventive care in Indigenous community settings, while apparently successful at increasing screening and routine check-up rates, have shown only modest or little improvements in appropriate care such as the introduction of insulin and other scaled-up drug regimens in line with evidence-based guidelines, together with support for risk factor reduction. A new strategy is required to ensure high quality integrated family-centred care is available locally, with continuity and cultural safety, by community-based care coordinators with appropriate system supports. Methods/design The trial design is open parallel cluster randomised controlled trial. The objective of this pragmatic trial is to test the effectiveness of a model of health service delivery that facilitates integrated community-based, intensive chronic condition management, compared with usual care, in rural and remote Indigenous primary health care services in north Queensland. Participants are Indigenous adults (aged 18–65 years with poorly controlled diabetes (HbA1c>=8.5 and at least one other chronic condition. The intervention is to employ an Indigenous Health Worker to case manage the care of a maximum caseload of 30 participants. The Indigenous Health Workers receive intensive clinical training initially, and throughout the study, to ensure they are competent to coordinate care for people with chronic conditions. The Indigenous Health Workers, supported by the local primary health care (PHC team and an Indigenous Clinical Support Team, will manage care, including coordinating access to multidisciplinary team care based on best practice standards. Allocation by cluster to the intervention and control groups is by simple

  1. Getting better at chronic care in remote communities: study protocol for a pragmatic cluster randomised controlled of community based management.

    Science.gov (United States)

    Schmidt, Barbara; Wenitong, Mark; Esterman, Adrian; Hoy, Wendy; Segal, Leonie; Taylor, Sean; Preece, Cilla; Sticpewich, Alex; McDermott, Robyn

    2012-11-21

    Prevalence and incidence of diabetes and other common comorbid conditions (hypertension, coronary heart disease, renal disease and chronic lung disease) are extremely high among Indigenous Australians. Recent measures to improve quality of preventive care in Indigenous community settings, while apparently successful at increasing screening and routine check-up rates, have shown only modest or little improvements in appropriate care such as the introduction of insulin and other scaled-up drug regimens in line with evidence-based guidelines, together with support for risk factor reduction. A new strategy is required to ensure high quality integrated family-centred care is available locally, with continuity and cultural safety, by community-based care coordinators with appropriate system supports. The trial design is open parallel cluster randomised controlled trial. The objective of this pragmatic trial is to test the effectiveness of a model of health service delivery that facilitates integrated community-based, intensive chronic condition management, compared with usual care, in rural and remote Indigenous primary health care services in north Queensland. Participants are Indigenous adults (aged 18-65 years) with poorly controlled diabetes (HbA1c>=8.5) and at least one other chronic condition. The intervention is to employ an Indigenous Health Worker to case manage the care of a maximum caseload of 30 participants. The Indigenous Health Workers receive intensive clinical training initially, and throughout the study, to ensure they are competent to coordinate care for people with chronic conditions. The Indigenous Health Workers, supported by the local primary health care (PHC) team and an Indigenous Clinical Support Team, will manage care, including coordinating access to multidisciplinary team care based on best practice standards. Allocation by cluster to the intervention and control groups is by simple randomisation after participant enrolment. Participants in

  2. Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial

    OpenAIRE

    Ayisha Diop, MPH; Bocar Daff, MD; Maimouna Sow, MA; Jennifer Blum, MPH; Mamadou Diagne, PhD; Nancy L Sloan, DrPH; Beverly Winikoff, MD

    2016-01-01

    Background: Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. Methods: We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxili...

  3. Menstrual cups and sanitary pads to reduce school attrition, and sexually transmitted and reproductive tract infections: a cluster randomised controlled feasibility study in rural Western Kenya

    OpenAIRE

    Phillips-Howard, Penelope; Nyothach, Elizabeth; terKuile, Feiko; Omoto, Jackton; Wang, Duolao; Zeh, Clement; Onyango, Clayton; Mason, Linda; Alexander, Kelly T; Odhiambo, Frank; Eleveld, Alie; Mohammed, Aisha; vanEijk, Anna; Tudor Edwards, Rhiannon; Vulule, John

    2016-01-01

    Objectives Conduct a feasibility study on the effect of menstrual hygiene on schoolgirls' school and health (reproductive/sexual) outcomes. Design 3-arm single-site open cluster randomised controlled pilot study. Setting 30 primary schools in rural western Kenya, within a Health and Demographic Surveillance System. Participants Primary schoolgirls 14?16?years, experienced 3 menses, no precluding disability, and resident in the study area. Interventions 1 insertable menstrual cup, or monthly s...

  4. Change in cardiovascular risk factors following early diagnosis of type 2 diabetes: a cohort analysis of a cluster-randomised trial

    OpenAIRE

    Black, James A; Sharp, Stephen J; Wareham, Nicholas J; Sandbæk, Annelli; Rutten, Guy EHM; Lauritzen, Torsten; Khunti, Kamlesh; Davies, Melanie J; Borch-Johnsen, Knut; Griffin, Simon J; Simmons, Rebecca K

    2014-01-01

    Background There is little evidence to inform the targeted treatment of individuals found early in the diabetes disease trajectory. Aim To describe cardiovascular disease (CVD) risk profiles and treatment of individual CVD risk factors by modelled CVD risk at diagnosis; changes in treatment, modelled CVD risk, and CVD risk factors in the 5 years following diagnosis; and how these are patterned by socioeconomic status. Design and setting Cohort analysis of a cluster-randomised trial (ADDITION-...

  5. A Cluster-Randomised Trial of Staff Education to Improve the Quality of Life of People with Dementia Living in Residential Care: The DIRECT Study

    OpenAIRE

    Beer, Christopher; Horner, Barbara; Flicker, Leon; Scherer, Samuel; Lautenschlager, Nicola T.; Bretland, Nick; Flett, Penelope; Schaper, Frank; Almeida, Osvaldo P.

    2011-01-01

    BACKGROUND: The Dementia In Residential care: EduCation intervention Trial (DIRECT) was conducted to determine if delivery of education designed to meet the perceived need of GPs and care staff improves the quality of life of participants with dementia living in residential care. METHODOLOGY/PRINCIPAL FINDINGS: This cluster-randomised controlled trial was conducted in 39 residential aged care facilities in the metropolitan area of Perth, Western Australia. 351 care facility residents aged 65 ...

  6. Effects of unconditional and conditional cash transfers on child health and development in Zimbabwe: a cluster-randomised trial.

    Science.gov (United States)

    Robertson, Laura; Mushati, Phyllis; Eaton, Jeffrey W; Dumba, Lovemore; Mavise, Gideon; Makoni, Jeremiah; Schumacher, Christina; Crea, Tom; Monasch, Roeland; Sherr, Lorraine; Garnett, Geoffrey P; Nyamukapa, Constance; Gregson, Simon

    2013-04-13

    Cash-transfer programmes can improve the wellbeing of vulnerable children, but few studies have rigorously assessed their effectiveness in sub-Saharan Africa. We investigated the effects of unconditional cash transfers (UCTs) and conditional cash transfers (CCTs) on birth registration, vaccination uptake, and school attendance in children in Zimbabwe. We did a matched, cluster-randomised controlled trial in ten sites in Manicaland, Zimbabwe. We divided each study site into three clusters. After a baseline survey between July, and September, 2009, clusters in each site were randomly assigned to UCT, CCT, or control, by drawing of lots from a hat. Eligible households contained children younger than 18 years and satisfied at least one other criteria: head of household was younger than 18 years; household cared for at least one orphan younger than 18 years, a disabled person, or an individual who was chronically ill; or household was in poorest wealth quintile. Between January, 2010, and January, 2011, households in UCT clusters collected payments every 2 months. Households in CCT clusters could receive the same amount but were monitored for compliance with several conditions related to child wellbeing. Eligible households in all clusters, including control clusters, had access to parenting skills classes and received maize seed and fertiliser in December, 2009, and August, 2010. Households and individuals delivering the intervention were not masked, but data analysts were. The primary endpoints were proportion of children younger than 5 years with a birth certificate, proportion younger than 5 years with up-to-date vaccinations, and proportion aged 6-12 years attending school at least 80% of the time. This trial is registered with ClinicalTrials.gov, number NCT00966849. 1199 eligible households were allocated to the control group, 1525 to the UCT group, and 1319 to the CCT group. Compared with control clusters, the proportion of children aged 0-4 years with birth

  7. Enhancing Recruitment Using Teleconference and Commitment Contract (ERUTECC): study protocol for a randomised, stepped-wedge cluster trial within the EFFECTS trial.

    Science.gov (United States)

    Lundström, Erik; Isaksson, Eva; Wester, Per; Laska, Ann-Charlotte; Näsman, Per

    2018-01-08

    Many randomised controlled trials (RCTs) fail to meet their recruitment goals in time. Trialists are advised to include study recruitment strategies within their trials. EFFECTS is a Swedish, academic-led RCT of fluoxetine for stroke recovery. The trial's primary objective is to investigate whether 20 mg fluoxetine daily compared with placebo for 6 months after an acute stroke improves the patient's functional outcome. The first patient was included on 20 October 2014 and, as of 31 August 2017, EFFECTS has included 810 of planned 1500 individuals. EFFECTS currently has 32 active centres. The primary objective of the ERUTECC (Enhancing Recruitment Using Teleconference and Commitment Contract) study is to investigate whether a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% at 60 days post intervention, compared with 60 days pre-intervention, in an ongoing RCT. ERUTECC is a randomised, stepped-wedge cluster trial embedded in EFFECTS. The plan is to start ERUTECC with a running-in period of September 2017. The first intervention is due in October 2017, and the study will continue for 12 months. We are planning to intervene at all active centres in EFFECTS, except the five top recruiting centres (n = 27). The rationale for not intervening at the top recruiting centres is that we believe they have reached their full potential and the intervention would be too weak for them. The hypothesis of this study is that a structured teleconference re-visit with the study personnel at the centres, accompanied by a commitment contract, can enhance recruitment by 20% 60 days post intervention, compared to 60 days pre-intervention, in an ongoing RCT. EFFECTS is a large, pragmatic RCT of stroke in Sweden. Results from the embedded ERUTECC study could probably be generalised to high-income Western countries, and is relevant to trial management and could improve trial management in the

  8. The (cost-effectiveness of an individually tailored long-term worksite health promotion programme on physical activity and nutrition: design of a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Burdorf Alex

    2007-09-01

    Full Text Available Abstract Background Cardiovascular disease is the leading cause of disability and mortality in most Western countries. The prevalence of several risk factors, most notably low physical activity and poor nutrition, is very high. Therefore, lifestyle behaviour changes are of great importance. The worksite offers an efficient structure to reach large groups and to make use of a natural social network. This study investigates a worksite health promotion programme with individually tailored advice in physical activity and nutrition and individual counselling to increase compliance with lifestyle recommendations and sustainability of a healthy lifestyle. Methods/Design The study is a pragmatic cluster randomised controlled trial with the worksite as the unit of randomisation. All workers will receive a standard worksite health promotion program. Additionally, the intervention group will receive access to an individual Health Portal consisting of four critical features: a computer-tailored advice, a monitoring function, a personal coach, and opportunities to contact professionals at request. Participants are employees working for companies in the Netherlands, being literate enough to read and understand simple Internet-based messages in the Dutch language. A questionnaire to assess primary outcomes (compliance with national recommendations on physical activity and on fruit and vegetable intake will take place at baseline and after 12 and 24 months. This questionnaire also assesses secondary outcomes including fat intake, self-efficacy and self-perceived barriers on physical activity and fruit and vegetable intake. Other secondary outcomes, including a cardiovascular risk profile and physical fitness, will be measured at baseline and after 24 months. Apart from the effect evaluation, a process evaluation will be carried out to gain insight into participation and adherence to the worksite health promotion programme. A cost-effectiveness analysis and

  9. Effects of a multi-level intervention on the pattern of physical activity among in-school adolescents in Oyo state Nigeria: a cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Mojisola Morenike Oluwasanu

    2017-10-01

    Full Text Available Abstract Background Physical inactivity contributes to the global burden of non-communicable diseases. The pattern of physical activity in adulthood are often established during adolescence and sedentary behaviours in the early years could influence the development of diseases later in life. Studies on physical activity in Nigeria have focused largely on individual behaviours and the effects of school-based interventions have not been well investigated. The aim of the proposed study is to identify factors influencing; and evaluate the effects of a multi-level intervention on the physical activity behaviours of in-school adolescents in Oyo state, Nigeria. Methods The study will adopt a cluster randomised controlled trial design and schools will serve as the unit of randomisation. The sample size is 1000 in-school adolescents aged 10–19 years. The study will be guided by the socio-ecological model and theory of reasoned action and baseline data will be obtained through a mixed methods approach comprising a cross sectional survey to document the self-reported physical activity levels coupled with objectively measured physical activity levels using pedometers for a subset of the sample. Other measurements including weight, height, waist and hip circumferences, fitness level using the 20-m shuttle run test (20-mSRT and blood pressure will be obtained. The schools’ built environment and policy support for physical activity will be assessed using structured questionnaires coupled with key informant interviews and focus group discussions with the school authorities. Baseline findings will guide the design and implementation of a 12-week multi-level intervention. The primary outcome measures are self–reported and 7-day objectively measured physical activity. Other secondary outcome measures are body-mass-index for age, waist-to-hip ratio, cardioresiratory fitness and blood pressure. The association between behavioural factors and physical activity

  10. Workplace mental health training for managers and its effect on sick leave in employees: a cluster randomised controlled trial.

    Science.gov (United States)

    Milligan-Saville, Josie S; Tan, Leona; Gayed, Aimée; Barnes, Caryl; Madan, Ira; Dobson, Mark; Bryant, Richard A; Christensen, Helen; Mykletun, Arnstein; Harvey, Samuel B

    2017-11-01

    Mental illness is one of the most rapidly increasing causes of long-term sickness absence, despite improved rates of detection and development of more effective interventions. However, mental health training for managers might help improve occupational outcomes for people with mental health problems. We aimed to investigate the effect of mental health training on managers' knowledge, attitudes, confidence, and behaviour towards employees with mental health problems, and its effect on employee sickness absence. We did a cluster randomised controlled trial of manager mental health training within a large Australian fire and rescue service, with a 6-month follow-up. Managers (clusters) at the level of duty commander or equivalent were randomly assigned (1:1) using an online random sequence generator to either a 4-h face-to-face RESPECT mental health training programme or a deferred training control group. Researchers, managers, and employees were not masked to the outcome of randomisation. Firefighters and station officers supervised by each manager were included in the study via their anonymised sickness absence records. The primary outcome measure was change in sickness absence among those supervised by each of the managers. We analysed rates of work-related sick leave and standard sick leave seperately, with rate being defined as sickness absence hours divided by the sum of hours of sickness absence and hours of attendance. This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613001156774). 128 managers were recruited between Feb 18, 2014, and May 17, 2014. 46 (71%) of 65 managers allocated to the intervention group received the intervention, and 42 (67%) of 63 managers allocated to the control group were entered in the deferred training group. Managers and their employees were followed up and reassessed at 6 months after randomisation. 25 managers (1233 employees) in the intervention group and 19 managers (733 employees) in

  11. Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

    Science.gov (United States)

    Leamy, Mary; Clarke, Eleanor; Le Boutillier, Clair; Bird, Victoria; Janosik, Monika; Sabas, Kai; Riley, Genevieve; Williams, Julie; Slade, Mike

    2014-01-01

    To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. Process evaluation nested within a cluster randomised controlled trial (RCT). 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. 14 community-based mental health teams in two UK sites (one urban, one semi-rural) who received the intervention. The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would maximise the likelihood of adequate implementation and hence reduce waste in research

  12. The effectiveness of a clinically integrated e-learning course in evidence-based medicine: A cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Arvanitis Theodoros N

    2009-05-01

    Full Text Available Abstract Background To evaluate the educational effects of a clinically integrated e-learning course for teaching basic evidence-based medicine (EBM among postgraduates compared to a traditional lecture-based course of equivalent content. Methods We conducted a cluster randomised controlled trial in the Netherlands and the UK involving postgraduate trainees in six obstetrics and gynaecology departments. Outcomes (knowledge gain and change in attitude towards EBM were compared between the clinically integrated e-learning course (intervention and the traditional lecture based course (control. We measured change from pre- to post-intervention scores using a validated questionnaire assessing knowledge (primary outcome and attitudes (secondary outcome. Results There were six clusters involving teaching of 61 postgraduate trainees (28 in the intervention and 33 in the control group. The intervention group achieved slightly higher scores for knowledge gain compared to the control, but these results were not statistically significant (difference in knowledge gain: 3.5 points, 95% CI -2.7 to 9.8, p = 0.27. The attitudinal changes were similar for both groups. Conclusion A clinically integrated e-learning course was at least as effective as a traditional lecture based course and was well accepted. Being less costly than traditional teaching and allowing for more independent learning through materials that can be easily updated, there is a place for incorporating e-learning into postgraduate EBM curricula that offer on-the-job training for just-in-time learning. Trial registration Trial registration number: ACTRN12609000022268.

  13. Implementing a complex intervention to support personal recovery: a qualitative study nested within a cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Mary Leamy

    Full Text Available OBJECTIVE: To investigate staff and trainer perspectives on the barriers and facilitators to implementing a complex intervention to help staff support the recovery of service users with a primary diagnosis of psychosis in community mental health teams. DESIGN: Process evaluation nested within a cluster randomised controlled trial (RCT. PARTICIPANTS: 28 interviews with mental health care staff, 3 interviews with trainers, 4 focus groups with intervention teams and 28 written trainer reports. SETTING: 14 community-based mental health teams in two UK sites (one urban, one semi-rural who received the intervention. RESULTS: The factors influencing the implementation of the intervention can be organised under two over-arching themes: Organisational readiness for change and Training effectiveness. Organisational readiness for change comprised three sub-themes: NHS Trust readiness; Team readiness; and Practitioner readiness. Training effectiveness comprised three sub-themes: Engagement strategies; Delivery style and Modelling recovery principles. CONCLUSIONS: Three findings can inform future implementation and evaluation of complex interventions. First, the underlying intervention model predicted that three areas would be important for changing practice: staff skill development; intention to implement; and actual implementation behaviour. This study highlighted the importance of targeting the transition from practitioners' intent to implement to actual implementation behaviour, using experiential learning and target setting. Second, practitioners make inferences about organisational commitment by observing the allocation of resources, Knowledge Performance Indicators and service evaluation outcome measures. These need to be aligned with recovery values, principles and practice. Finally, we recommend the use of organisational readiness tools as an inclusion criteria for selecting both organisations and teams in cluster RCTs. We believe this would

  14. Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Passey Megan E

    2012-08-01

    Full Text Available Abstract Background Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP offered as part of a cluster randomised controlled trial (RCT of prevention of vascular disease in primary care. Methods Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors. Results Of 301 eligible patients, 190 (63.1% were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47, physical inactivity (OR 2.90 95%CI:1.36,6.14, contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03, rural location (OR 12.50 95%CI:1.43, 109.7 and smaller practice size (1–3 GPs (OR 16.05 95%CI:2.74, 94.24. Conclusions Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs. Trial registration ACTRN

  15. Predictors of primary care referrals to a vascular disease prevention lifestyle program among participants in a cluster randomised trial.

    Science.gov (United States)

    Passey, Megan E; Laws, Rachel A; Jayasinghe, Upali W; Fanaian, Mahnaz; McKenzie, Suzanne; Powell-Davies, Gawaine; Lyle, David; Harris, Mark F

    2012-08-03

    Cardiovascular disease accounts for a large burden of disease, but is amenable to prevention through lifestyle modification. This paper examines patient and practice predictors of referral to a lifestyle modification program (LMP) offered as part of a cluster randomised controlled trial (RCT) of prevention of vascular disease in primary care. Data from the intervention arm of a cluster RCT which recruited 36 practices through two rural and three urban primary care organisations were used. In each practice, 160 eligible high risk patients were invited to participate. Practices were randomly allocated to intervention or control groups. Intervention practice staff were trained in screening, motivational interviewing and counselling and encouraged to refer high risk patients to a LMP involving individual and group sessions. Data include patient surveys; clinical audit; practice survey on capacity for preventive care; referral records from the LMP. Predictors of referral were examined using multi-level logistic regression modelling after adjustment for confounding factors. Of 301 eligible patients, 190 (63.1%) were referred to the LMP. Independent predictors of referral were baseline BMI ≥ 25 (OR 2.87 95%CI:1.10, 7.47), physical inactivity (OR 2.90 95%CI:1.36,6.14), contemplation/preparation/action stage of change for physical activity (OR 2.75 95%CI:1.07, 7.03), rural location (OR 12.50 95%CI:1.43, 109.7) and smaller practice size (1-3 GPs) (OR 16.05 95%CI:2.74, 94.24). Providing a well-structured evidence-based lifestyle intervention, free of charge to patients, with coordination and support for referral processes resulted in over 60% of participating high risk patients being referred for disease prevention. Contrary to expectations, referrals were more frequent from rural and smaller practices suggesting that these practices may be more ready to engage with these programs. ACTRN12607000423415.

  16. The Agrupation-Cluster of Knowledge. The intellectual capital of Vasque Country

    International Nuclear Information System (INIS)

    Panera Mendieta, F.; Luengo Valderrey, M. J.; Perianez Canadillas, I.; Panda Garcia, J.

    2007-01-01

    This paper seeks to identify the influence of the activities of the Agrupacion-Cluster de Conocimiento in the improvement of the Intellectual Capital of its partners, especially of their Relational Capital through the generation of inter-organizational spaces for our organizations in the Basque Country. The transmission of this knowledge requires the physical proximity of the people between whom the exchange can to be made. This exchange is facilitated when spaces are created with an atmosphere of total confidence and equality, in which one can express in complete liberty. (Author)

  17. Children and youth perceive smoking messages in an unbranded advertisement from a NIKE marketing campaign: a cluster randomised controlled trial

    Science.gov (United States)

    2011-01-01

    Background How youth perceive marketing messages in sports is poorly understood. We evaluated whether youth perceive that the imagery of a specific sports marketing advertisement contained smoking-related messages. Methods Twenty grade 7 to 11 classes (397 students) from two high schools in Montréal, Canada were recruited to participate in a cluster randomised single-blind controlled trial. Classes were randomly allocated to either a NIKE advertisement containing the phrase 'LIGHT IT UP' (n = 205) or to a neutral advertisement with smoking imagery reduced and the phrase replaced by 'GO FOR IT' (n = 192). The NIKE logo was removed from both advertisements. Students responded in class to a questionnaire asking open-ended questions about their perception of the messages in the ad. Reports relating to the appearance and text of the ad, and the product being promoted were evaluated. Results Relative to the neutral ad, more students reported that the phrase 'LIGHT IT UP' was smoking-related (37.6% vs. 0.5%) and that other parts of the ad resembled smoking-related products (50.7% vs. 10.4%). The relative risk of students reporting that the NIKE ad promoted cigarettes was 4.41 (95% confidence interval: 2.64-7.36; P promoting NIKE hockey products appears to have contained smoking-related messages. This particular marketing campaign may have promoted smoking. This suggests that the regulation of marketing to youth may need to be more tightly controlled. PMID:21477307

  18. Structured functional assessments in general practice increased the use of part-time sick leave: a cluster randomised controlled trial.

    Science.gov (United States)

    Osterås, Nina; Gulbrandsen, Pål; Kann, Inger Cathrine; Brage, Søren

    2010-03-01

    A method for structured functional assessments of persons with long-term sick leave was implemented in a cluster randomised controlled trial in general practice. The aim was to analyse intervention effects on general practitioner (GP) sick-listing practice and patient sick leave. 57 GPs were randomly assigned to an intervention or a control group. The intervention group GPs learned the method at a 1-day workshop including teamwork and role-playing. The control group GPs were requested to assess functional ability as usual during the 8 months intervention period in 2005. Outcome measures included duration of patient sick leave episodes, GP prescription of part-time sick leave, active sick leave, and vocational rehabilitation. This data was extracted from a national register. The GPs in the intervention group prescribed part-time sick leave more often (p part-time and less active sick leave compared to the control group GPs. As a result, more intervention GP patients returned to part-time work compared to control GP patients. No intervention effect was seen on duration of patient sick leave episodes or on prescription of vocational rehabilitation.

  19. Effects of a worksite tobacco control intervention in India: the Mumbai worksite tobacco control study, a cluster-randomised trial.

    Science.gov (United States)

    Sorensen, Glorian; Pednekar, Mangesh; Cordeira, Laura Shulman; Pawar, Pratibha; Nagler, Eve M; Stoddard, Anne M; Kim, Hae-Young; Gupta, Prakash C

    2017-03-01

    We assessed a worksite intervention designed to promote tobacco control among workers in the manufacturing sector in Greater Mumbai, India. We used a cluster-randomised design to test an integrated health promotion/health protection intervention, the Healthy, Safe, and Tobacco-free Worksites programme. Between July 2012 and July 2013, we recruited 20 worksites on a rolling basis and randomly assigned them to intervention or delayed-intervention control conditions. The follow-up survey was conducted between December 2013 and November 2014. The difference in 30-day quit rates between intervention and control conditions was statistically significant for production workers (OR=2.25, p=0.03), although not for the overall sample (OR=1.70; p=0.12). The intervention resulted in a doubling of the 6-month cessation rates among workers in the intervention worksites compared to those in the control, for production workers (OR=2.29; p=0.07) and for the overall sample (OR=1.81; p=0.13), but the difference did not reach statistical significance. These findings demonstrate the potential impact of a tobacco control intervention that combined tobacco control and health protection programming within Indian manufacturing worksites. NCT01841879. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  20. Children and youth perceive smoking messages in an unbranded advertisement from a NIKE marketing campaign: a cluster randomised controlled trial.

    Science.gov (United States)

    Auger, Nathalie; Daniel, Mark; Knäuper, Bärbel; Raynault, Marie-France; Pless, Barry

    2011-04-08

    How youth perceive marketing messages in sports is poorly understood. We evaluated whether youth perceive that the imagery of a specific sports marketing advertisement contained smoking-related messages. Twenty grade 7 to 11 classes (397 students) from two high schools in Montréal, Canada were recruited to participate in a cluster randomised single-blind controlled trial. Classes were randomly allocated to either a NIKE advertisement containing the phrase 'LIGHT IT UP' (n = 205) or to a neutral advertisement with smoking imagery reduced and the phrase replaced by 'GO FOR IT' (n = 192). The NIKE logo was removed from both advertisements. Students responded in class to a questionnaire asking open-ended questions about their perception of the messages in the ad. Reports relating to the appearance and text of the ad, and the product being promoted were evaluated. Relative to the neutral ad, more students reported that the phrase 'LIGHT IT UP' was smoking-related (37.6% vs. 0.5%) and that other parts of the ad resembled smoking-related products (50.7% vs. 10.4%). The relative risk of students reporting that the NIKE ad promoted cigarettes was 4.41 (95% confidence interval: 2.64-7.36; P NIKE hockey products appears to have contained smoking-related messages. This particular marketing campaign may have promoted smoking. This suggests that the regulation of marketing to youth may need to be more tightly controlled.

  1. Factors associated with non-participation and dropout among cancer patients in a cluster-randomised controlled trial.

    Science.gov (United States)

    Roick, J; Danker, H; Kersting, A; Briest, S; Dietrich, A; Dietz, A; Einenkel, J; Papsdorf, K; Lordick, F; Meixensberger, J; Mössner, J; Niederwieser, D; Prietzel, T; Schiefke, F; Stolzenburg, J-U; Wirtz, H; Singer, S

    2018-01-01

    We investigated the impact of demographic and disease related factors on non-participation and dropout in a cluster-randomised behavioural trial in cancer patients with measurements taken between hospitalisation and 6 months thereafter. The percentages of non-participation and dropout were documented at each time point. Factors considered to be potentially related with non-participation and dropout were as follows: age, sex, marital status, education, income, employment status, tumour site and stage of disease. Of 1,338 eligible patients, 24% declined participation at baseline. Non-participation was higher in older patients (Odds Ratio [OR] 2.1, CI: 0.6-0.9) and those with advanced disease (OR 2.0, CI: 0.1-1.3). Dropout by 6 months was 25%. Dropout was more frequent with increased age (OR 2.8, CI: 0.8-1.2), advanced disease (OR 3.0, CI: 1.0-1.2), being married (OR 2.4, CI 0.7-1.1) and less frequent with university education (OR 0.4, CI -1.3 to -0.8) and middle income (OR 0.4, CI -0.9 to -0.7). When planning clinical trials, it is important to be aware of patient groups at high risk of non-participation or dropout, for example older patients or those with advanced disease. Trial designs should consider their special needs to increase their rate of participation. © 2017 John Wiley & Sons Ltd.

  2. A cluster-randomised intervention trial against Schistosoma japonicum in the Peoples' Republic of China: bovine and human transmission.

    Directory of Open Access Journals (Sweden)

    Darren J Gray

    2009-06-01

    Full Text Available Zoonotic schistosomiasis japonica is a major public health problem in China. Bovines, particularly water buffaloes, are thought to play a major role in the transmission of schistosomiasis to humans in China. Preliminary results (1998-2003 of a praziquantel (PZQ-based pilot intervention study we undertook provided proof of principle that water buffaloes are major reservoir hosts for S. japonicum in the Poyang Lake region, Jiangxi Province.Here we present the results of a cluster-randomised intervention trial (2004-2007 undertaken in Hunan and Jiangxi Provinces, with increased power and more general applicability to the lake and marshlands regions of southern China. The trial involved four matched pairs of villages with one village within each pair randomly selected as a control (human PZQ treatment only, leaving the other as the intervention (human and bovine PZQ treatment. A sentinel cohort of people to be monitored for new infections for the duration of the study was selected from each village. Results showed that combined human and bovine chemotherapy with PZQ had a greater effect on human incidence than human PZQ treatment alone.The results from this study, supported by previous experimental evidence, confirms that bovines are the major reservoir host of human schistosomiasis in the lake and marshland regions of southern China, and reinforce the rationale for the development and deployment of a transmission blocking anti-S. japonicum vaccine targeting bovines.Australian New Zealand Clinical Trials Registry ACTRN12609000263291.

  3. Effectiveness of routine antihelminthic treatment on anaemia in pregnancy in Rufiji District, Tanzania: a cluster randomised controlled trial.

    Science.gov (United States)

    Urassa, David P; Nystrom, Lennarth; Carlsted, Anders

    2011-09-01

    The aim of this study was to estimate the effect of an antihelminthic drug, given at booking and at term to antenatal care visits, on the prevalence of anaemia at term and 4 months post-partum in Rufiji district, Tanzania, the area with high prevalence of intestinal parasites. A cluster randomised controlled trial was conducted on 3080 pregnant women. Out of these 1475 (study arm) received albendazole and 1605 (control arm) placebo. All women also received routine daily iron folate supplements (36 mg iron and 5 mg folate), and sulphadoxine pyramethamine (SP) to prevent malaria. Haemoglobin levels were assessed at booking, at term and 4 months post-partum. At term, median and mean haemoglobin level and the prevalence of severe (anaemia did not differ. The reduction in the prevalence of anaemia from booking to term, was significantly larger in the study arm compared to control arm (26.1% vs. 18.8%; p anaemia (Hb pregnancy. However benefits for deworming may be limited in areas with an antenatal iron supplementation programme or low intensity of hookworm infections and hence future research should be directed towards the cost-effectiveness of the de-worming compared to other interventions for reducing anaemia in pregnancy.

  4. Study protocol for the SMART2D adaptive implementation trial: a cluster randomised trial comparing facility-only care with integrated facility and community care to improve type 2 diabetes outcomes in Uganda, South Africa and Sweden.

    Science.gov (United States)

    Guwatudde, David; Absetz, Pilvikki; Delobelle, Peter; Östenson, Claes-Göran; Olmen Van, Josefien; Alvesson, Helle Molsted; Mayega, Roy William; Ekirapa Kiracho, Elizabeth; Kiguli, Juliet; Sundberg, Carl Johan; Sanders, David; Tomson, Göran; Puoane, Thandi; Peterson, Stefan; Daivadanam, Meena

    2018-03-17

    Type 2 diabetes (T2D) is increasingly contributing to the global burden of disease. Health systems in most parts of the world are struggling to diagnose and manage T2D, especially in low-income and middle-income countries, and among disadvantaged populations in high-income countries. The aim of this study is to determine the added benefit of community interventions onto health facility interventions, towards glycaemic control among persons with diabetes, and towards reduction in plasma glucose among persons with prediabetes. An adaptive implementation cluster randomised trial is being implemented in two rural districts in Uganda with three clusters per study arm, in an urban township in South Africa with one cluster per study arm, and in socially disadvantaged suburbs in Stockholm, Sweden with one cluster per study arm. Clusters are communities within the catchment areas of participating primary healthcare facilities. There are two study arms comprising a facility plus community interventions arm and a facility-only interventions arm. Uganda has a third arm comprising usual care. Intervention strategies focus on organisation of care, linkage between health facility and the community, and strengthening patient role in self-management, community mobilisation and a supportive environment. Among T2D participants, the primary outcome is controlled plasma glucose; whereas among prediabetes participants the primary outcome is reduction in plasma glucose. The study has received approval in Uganda from the Higher Degrees, Research and Ethics Committee of Makerere University School of Public Health and from the Uganda National Council for Science and Technology; in South Africa from the Biomedical Science Research Ethics Committee of the University of the Western Cape; and in Sweden from the Regional Ethical Board in Stockholm. Findings will be disseminated through peer-reviewed publications and scientific meetings. ISRCTN11913581; Pre-results. © Article author(s) (or their

  5. Quality of care, risk management, and technology in obstetrics to reduce hospital-based maternal mortality in Senegal and Mali (QUARITE): a cluster-randomised trial.

    Science.gov (United States)

    Dumont, Alexandre; Fournier, Pierre; Abrahamowicz, Michal; Traoré, Mamadou; Haddad, Slim; Fraser, William D

    2013-07-13

    Maternal mortality is higher in west Africa than in most industrialised countries, so the development and validation of effective interventions is essential. We did a trial to assess the effect of a multifaceted intervention to promote maternity death reviews and onsite training in emergency obstetric care in referral hospitals with high maternal mortality rates in Senegal and Mali. We did a pragmatic cluster-randomised controlled trial, with hospitals as the units of randomisation and patients as the unit of analysis. 46 public first-level and second-level referral hospitals with more than 800 deliveries a year were enrolled, stratified by country and hospital type, and randomly assigned to either the intervention group (n=23) or the control group with no external intervention (n=23). All women who delivered in each of the participating facilities during the baseline and post-intervention periods were included. The intervention, implemented over a period of 2 years at the hospital level, consisted of an initial interactive workshop and quarterly educational clinically-oriented and evidence-based outreach visits focused on maternal death reviews and best practices implementation. The primary outcome was reduction of risk of hospital-based mortality. Analysis was by intention-to-treat and relied on the generalised estimating equations extension of the logistic regression model to account for clustering of women within hospitals. This study is registered with ClinicalTrials.gov, number ISRCTN46950658. 191,167 patients who delivered in the participating hospitals were analysed (95,931 in the intervention groups and 95,236 in the control groups). Overall, mortality reduction in intervention hospitals was significantly higher than in control hospitals (odds ratio [OR] 0·85, 95% CI 0·73-0·98, p=0·0299), but this effect was limited to capital and district hospitals, which mainly acted as first-level referral hospitals in this trial. There was no effect in second

  6. Efficacy of the FIFA 11+ Warm-Up Programme in Male Youth Football: A Cluster Randomised Controlled Trial

    Directory of Open Access Journals (Sweden)

    Oluwatoyosi B. A. Owoeye

    2014-06-01

    Full Text Available The FIFA 11+ is a structured warm-up programme specially designed to prevent injuries among football players from age 14 years and above. However, studies to prove its efficacy are generally few and it is yet to be tested in male youth footballers and among African players. The purpose of the study was to examine the efficacy of the FIFA 11+ programme in reducing the risk of injuries among male youth football players of the Lagos Junior League. A cluster randomised controlled trial was conducted. All the 20 teams (414 players aged 14 -19 years in the Premier League division were block-randomised into either an intervention (INT or a control (CON group. The INT group performed the FIFA 11+ exercises as warm-up during training sessions and the CON group performed usual warm-up. Participating teams were prospectively followed through an entire league season of 6 months in which they were visited every week to assess injured players for time-loss injuries in both groups. The primary outcomes were any injury to the players, injuries by type of exposure and injuries specific to the lower extremities. The secondary outcomes were injuries reported by body location, aetiology, mechanism and severity. In total, 130 injuries were recorded affecting 104 (25% of the 416 players. Team and player compliance with the INT was 60% and 74% respectively. Based on the primary outcome measures of the study, the FIFA 11+ programme significantly reduced the overall rate of injury in the INT group by 41% [RR = 0.59 (95% CI: 0.40 – 0.86; p = 0.006] and all lower extremity injuries by 48% [RR = 0.52 (95% CI: 0.34 – 0.82; p = 0.004]. However, the rate of injury reduction based on secondary outcomes mostly did not reach the level of statistical significance. The FIFA 11+ programme is effective in reducing the rates of injuries in male youth football players.

  7. A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial.

    Science.gov (United States)

    Riis, Allan; Jensen, Cathrine Elgaard; Bro, Flemming; Maindal, Helle Terkildsen; Petersen, Karin Dam; Bendtsen, Mette Dahl; Jensen, Martin Bach

    2016-10-21

    Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP) guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS). In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate. Practices were randomised (1:1) and stratified by practice size to MuIS (28 practices) or a passive implementation strategy (PaIS; 32 practices). Included were patients with LBP aged 18 to 65 years who were able to complete questionnaires, had no serious underlying pathology, and were not pregnant. We developed a MuIS including outreach visits, quality reports, and the STarT Back Tool for subgrouping patients with LBP. Both groups were offered the usual dissemination of guidelines, guideline-concordant structuring of the medical record, and a new referral opportunity for patients with psycho-social problems. In an intention-to-treat analysis, the primary and secondary outcomes pertained to the patient, and a cost-effectiveness analysis was performed from a healthcare sector perspective. Patients and the assessment of outcomes were blinded. Practices and caregivers delivering the interventions were not blinded. Between January 2013 and July 2014, 60 practices were included, of which 54 practices (28 MuIS, 26 PaIS) included 1101 patients (539 MuIS, 562 PaIS). Follow-up data for the primary outcome were available on 100 % of these patients. Twenty-seven patients (5.0 %) in the MuIS group were referred to secondary care vs. 59 patients (10.5 %) in the PaIS group. The adjusted odds ratio (AOR) was 0.52 [95 % CI 0.30 to 0.90; p = 0.020]. The MuIS was cost-saving £-93.20 (£406.51 vs. £499.71 per patient

  8. Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial.

    Science.gov (United States)

    Panella, M; Marchisio, S; Demarchi, M L; Manzoli, L; Di Stanislao, F

    2009-10-01

    Hospital treatment of heart failure (HF) frequently does not follow published guidelines, potentially contributing to HF high morbidity, mortality and economic cost. The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was undertaken to determine how clinical pathways (CP) for hospital treatment of HF affected care variability, guidelines adherence, in-hospital mortality and outcomes at discharge. Methods/ Two-arm, cluster-randomised trial. Fourteen community hospitals were randomised either to the experimental arm (CP: appropriate therapeutic guidelines use, new organisation and procedures, patient education) or to the control arm (usual care). The main outcome was in-hospital mortality; secondary outcomes were length and appropriateness of the stay, rate of unscheduled readmissions, customer satisfaction, usage of diagnostic and therapeutic procedures during hospital stay and quality indicators at discharge. All outcomes were measured using validated instruments available in literature. In-hospital mortality was 5.6% in the experimental arm (n = 12); 15.4% in controls (n = 33, p = 0.001). In CP and usual care groups, the mean rates of unscheduled readmissions were 7.9% and 13.9%, respectively. Adjusting for age, smoking, New York Heart Association score, hypertension and source of referral, patients in the CP group, as compared to controls, had a significantly lower risk of in-hospital death (OR 0.18; 95% CI 0.07 to 0.46) and unscheduled readmissions (OR 0.42; 95% CI 0.20 to 0.87). No differences were found between CP and control with respect to the appropriateness of the stay, costs and patient's satisfaction. Except for electrocardiography, all recommended diagnostic procedures were used more in the CP group. Similarly, pharmaceuticals use was significantly greater in CP, with the exception of diuretics and anti-platelets agents. The introduction of a specifically tailored CP for the hospital

  9. Impact of contact on adolescents' mental health literacy and stigma: the SchoolSpace cluster randomised controlled trial.

    Science.gov (United States)

    Chisholm, Katharine; Patterson, Paul; Torgerson, Carole; Turner, Erin; Jenkinson, David; Birchwood, Max

    2016-02-19

    To investigate whether intergroup contact in addition to education is more effective than education alone in reducing stigma of mental illness in adolescents. A pragmatic cluster randomised controlled trial compared education alone with education plus contact. Blocking was used to randomly stratify classes within schools to condition. Random allocation was concealed, generated by a computer algorithm, and undertaken after pretest. Data was collected at pretest and 2-week follow-up. Analyses use an intention-to-treat basis. Secondary schools in Birmingham, UK. The parents and guardians of all students in year 8 (age 12-13 years) were approached to take part. A 1-day educational programme in each school led by mental health professional staff. Students in the 'contact' condition received an interactive session with a young person with lived experience of mental illness. The primary outcome was students' attitudinal stigma of mental illness. Secondary outcomes included knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Participants were recruited between 1 May 2011 and 30 April 2012. 769 participants completed the pretest and were randomised to condition. 657 (85%) provided follow-up data. At 2-week follow-up, attitudinal stigma improved in both conditions with no significant effect of condition (95% CI -0.40 to 0.22, p=0.5, d=0.01). Significant improvements were found in the education-alone condition compared with the contact and education condition for the secondary outcomes of knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Contact was found to reduce the impact of the intervention for a number of outcomes. Caution is advised before employing intergroup contact with younger student age groups. The education intervention appeared to be successful in reducing stigma, promoting mental health knowledge, and increasing mental health literacy, as

  10. Impact of contact on adolescents’ mental health literacy and stigma: the SchoolSpace cluster randomised controlled trial

    Science.gov (United States)

    Chisholm, Katharine; Patterson, Paul; Torgerson, Carole; Turner, Erin; Jenkinson, David; Birchwood, Max

    2016-01-01

    Objectives To investigate whether intergroup contact in addition to education is more effective than education alone in reducing stigma of mental illness in adolescents. Design A pragmatic cluster randomised controlled trial compared education alone with education plus contact. Blocking was used to randomly stratify classes within schools to condition. Random allocation was concealed, generated by a computer algorithm, and undertaken after pretest. Data was collected at pretest and 2-week follow-up. Analyses use an intention-to-treat basis. Setting Secondary schools in Birmingham, UK. Participants The parents and guardians of all students in year 8 (age 12–13 years) were approached to take part. Interventions A 1-day educational programme in each school led by mental health professional staff. Students in the ‘contact’ condition received an interactive session with a young person with lived experience of mental illness. Outcomes The primary outcome was students’ attitudinal stigma of mental illness. Secondary outcomes included knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Results Participants were recruited between 1 May 2011 and 30 April 2012. 769 participants completed the pretest and were randomised to condition. 657 (85%) provided follow-up data. At 2-week follow-up, attitudinal stigma improved in both conditions with no significant effect of condition (95% CI −0.40 to 0.22, p=0.5, d=0.01). Significant improvements were found in the education-alone condition compared with the contact and education condition for the secondary outcomes of knowledge-based stigma, mental health literacy, emotional well-being and resilience, and help-seeking attitudes. Conclusions Contact was found to reduce the impact of the intervention for a number of outcomes. Caution is advised before employing intergroup contact with younger student age groups. The education intervention appeared to be successful in

  11. Efficacy of a movement control injury prevention programme in adult men's community rugby union: a cluster randomised controlled trial.

    Science.gov (United States)

    Attwood, Matthew J; Roberts, Simon P; Trewartha, Grant; England, Mike E; Stokes, Keith A

    2018-03-01

    Exercise programmes aimed at reducing injury have been shown to be efficacious for some non-collision sports, but evidence in adult men's collision sports such as rugby union is lacking. To evaluate the efficacy of a movement control injury prevention exercise programme for reducing match injuries in adult men's community rugby union players. 856 clubs were invited to participate in this prospective cluster randomised (single-blind) controlled trial where clubs were the unit of randomisation. 81 volunteered and were randomly assigned (intervention/control). A 42-week exercise programme was followed throughout the season. The control programme reflected 'normal practice' exercises, whereas the intervention focused on proprioception, balance, cutting, landing and resistance exercises.Outcome measures were match injury incidence and burden for: (1) all ≥8 days time-loss injuries and (2) targeted (lower limb, shoulder, head and neck, excluding fractures and lacerations) ≥8 days time-loss injuries. Poisson regression identified no clear effects on overall injury outcomes. A likely beneficial difference in targeted injury incidence (rate ratio (RR), 90% CI=0.6, 0.4 to 1.0) was identified, with a 40% reduction in lower-limb incidence (RR, 90% CI=0.6, 0.4 to 1.0) and a 60% reduction in concussion incidence (RR, 90% CI=0.4, 0.2 to 0.7) in the intervention group. Comparison between arms for clubs with highest compliance (≥median compliance) demonstrated very likely beneficial 60% reductions in targeted injury incidence (RR, 90% CI=0.4, 0.2 to 0.8) and targeted injury burden (RR, 90% CI=0.4, 0.2 to 0.7). The movement control injury prevention programme resulted in likely beneficial reductions in lower-limb injuries and concussion. Higher intervention compliance was associated with reduced targeted injury incidence and burden. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is

  12. Improving immunisation coverage in rural India: clustered randomised controlled evaluation of immunisation campaigns with and without incentives.

    Science.gov (United States)

    Banerjee, Abhijit Vinayak; Duflo, Esther; Glennerster, Rachel; Kothari, Dhruva

    2010-05-17

    To assess the efficacy of modest non-financial incentives on immunisation rates in children aged 1-3 and to compare it with the effect of only improving the reliability of the supply of services. Clustered randomised controlled study. Rural Rajasthan, India. 1640 children aged 1-3 at end point. 134 villages were randomised to one of three groups: a once monthly reliable immunisation camp (intervention A; 379 children from 30 villages); a once monthly reliable immunisation camp with small incentives (raw lentils and metal plates for completed immunisation; intervention B; 382 children from 30 villages), or control (no intervention, 860 children in 74 villages). Surveys were undertaken in randomly selected households at baseline and about 18 months after the interventions started (end point). Proportion of children aged 1-3 at the end point who were partially or fully immunised. Among children aged 1-3 in the end point survey, rates of full immunisation were 39% (148/382, 95% confidence interval 30% to 47%) for intervention B villages (reliable immunisation with incentives), 18% (68/379, 11% to 23%) for intervention A villages (reliable immunisation without incentives), and 6% (50/860, 3% to 9%) for control villages. The relative risk of complete immunisation for intervention B versus control was 6.7 (4.5 to 8.8) and for intervention B versus intervention A was 2.2 (1.5 to 2.8). Children in areas neighbouring intervention B villages were also more likely to be fully immunised than those from areas neighbouring intervention A villages (1.9, 1.1 to 2.8). The average cost per immunisation was $56 (2202 rupees) in intervention A and $28 (1102 rupees, about pound16 or euro19) in intervention B. Improving reliability of services improves immunisation rates, but the effect remains modest. Small incentives have large positive impacts on the uptake of immunisation services in resource poor areas and are more cost effective than purely improving supply. IRSCTN87759937.

  13. Maternal and child health nurse screening and care for mothers experiencing domestic violence (MOVE): a cluster randomised trial.

    Science.gov (United States)

    Taft, Angela J; Hooker, Leesa; Humphreys, Cathy; Hegarty, Kelsey; Walter, Ruby; Adams, Catina; Agius, Paul; Small, Rhonda

    2015-06-25

    Mothers are at risk of domestic violence (DV) and its harmful consequences postpartum. There is no evidence to date for sustainability of DV screening in primary care settings. We aimed to test whether a theory-informed, maternal and child health (MCH) nurse-designed model increased and sustained DV screening, disclosure, safety planning and referrals compared with usual care. Cluster randomised controlled trial of 12 month MCH DV screening and care intervention with 24 month follow-up. The study was set in community-based MCH nurse teams (91 centres, 163 nurses) in north-west Melbourne, Australia. Eight eligible teams were recruited. Team randomisation occurred at a public meeting using opaque envelopes. Teams were unable to be blinded. The intervention was informed by Normalisation Process Theory, the nurse-designed good practice model incorporated nurse mentors, strengthened relationships with DV services, nurse safety, a self-completion maternal health screening checklist at three or four month consultations and DV clinical guidelines. Usual care involved government mandated face-to-face DV screening at four weeks postpartum and follow-up as required. Primary outcomes were MCH team screening, disclosure, safety planning and referral rates from routine government data and a postal survey sent to 10,472 women with babies ≤ 12 months in study areas. Secondary outcomes included DV prevalence (Composite Abuse Scale, CAS) and harm measures (postal survey). No significant differences were found in routine screening at four months (IG 2,330/6,381 consultations (36.5 %) versus CG 1,792/7,638 consultations (23.5 %), RR = 1.56 CI 0.96-2.52) but data from maternal health checklists (n = 2,771) at three month IG consultations showed average screening rates of 63.1 %. Two years post-intervention, IG safety planning rates had increased from three (RR 2.95, CI 1.11-7.82) to four times those of CG (RR 4.22 CI 1.64-10.9). Referrals remained low in both intervention groups (IGs

  14. The CORE Service Improvement Programme for mental health crisis resolution teams: study protocol for a cluster-randomised controlled trial.

    Science.gov (United States)

    Lloyd-Evans, Brynmor; Fullarton, Kate; Lamb, Danielle; Johnston, Elaine; Onyett, Steve; Osborn, David; Ambler, Gareth; Marston, Louise; Hunter, Rachael; Mason, Oliver; Henderson, Claire; Goater, Nicky; Sullivan, Sarah A; Kelly, Kathleen; Gray, Richard; Nolan, Fiona; Pilling, Stephen; Bond, Gary; Johnson, Sonia

    2016-03-22

    As an alternative to hospital admission, crisis resolution teams (CRTs) provide intensive home treatment to people experiencing mental health crises. Trial evidence supports the effectiveness of the CRT model, but research suggests that the anticipated reductions in inpatient admissions and increased user satisfaction with acute care have been less than hoped for following the scaling up of CRTs nationally in England, as mandated by the National Health Service (NHS) Plan in 2000. The organisation and service delivery of the CRTs vary substantially. This may reflect the lack of a fully specified CRT model and the resources to enhance team model fidelity and to improve service quality. We will evaluate the impact of a CRT service improvement programme over a 1-year period on the service users' experiences of care, service use, staff well-being, and team model fidelity. Twenty-five CRTs from eight NHS Trusts across England will be recruited to this cluster-randomised trial: 15 CRTs will be randomised to receive the service improvement programme over a 1-year period, and ten CRTs will not receive the programme. Data will be collected from 15 service users and all clinical staff from each participating CRT at baseline and at the end of the intervention. Service use data will be collected from the services' electronic records systems for two 6-month periods: the period preceding and the period during months 7-12 of the intervention. The study's primary outcome is service user satisfaction with CRT care, measured using a client satisfaction questionnaire. Secondary outcomes include the following: perceived continuity of care, hospital admission rates and bed use, rates of readmission to acute care following CRT support, staff morale, job satisfaction, and general health. The adherence of the services to a model of best practice will be assessed at baseline and follow-up. Outcomes will be compared between the intervention and control teams, adjusting for baseline

  15. Data feedback and behavioural change intervention to improve primary care prescribing safety (EFIPPS): multicentre, three arm, cluster randomised controlled trial.

    Science.gov (United States)

    Guthrie, Bruce; Kavanagh, Kimberley; Robertson, Chris; Barnett, Karen; Treweek, Shaun; Petrie, Dennis; Ritchie, Lewis; Bennie, Marion

    2016-08-18

     To evaluate the effectiveness of feedback on safety of prescribing compared with moderately enhanced usual care.  Three arm, highly pragmatic cluster randomised trial.  262/278 (94%) primary care practices in three Scottish health boards.  Practices were randomised to: "usual care," consisting of emailed educational material with support for searching to identify patients (88 practices at baseline, 86 analysed); usual care plus feedback on practice's high risk prescribing sent quarterly on five occasions (87 practices, 86 analysed); or usual care plus the same feedback incorporating a behavioural change component (87 practices, 86 analysed).  The primary outcome was a patient level composite of six prescribing measures relating to high risk use of antipsychotics, non-steroidal anti-inflammatories, and antiplatelets. Secondary outcomes were the six individual measures. The primary analysis compared high risk prescribing in the two feedback arms against usual care at 15 months. Secondary analyses examined immediate change and change in trend of high risk prescribing associated with implementation of the intervention within each arm.  In the primary analysis, high risk prescribing as measured by the primary outcome fell from 6.0% (3332/55 896) to 5.1% (2845/55 872) in the usual care arm, compared with 5.9% (3341/56 194) to 4.6% (2587/56 478) in the feedback only arm (odds ratio 0.88 (95% confidence interval 0.80 to 0.96) compared with usual care; P=0.007) and 6.2% (3634/58 569) to 4.6% (2686/58 582) in the feedback plus behavioural change component arm (0.86 (0.78 to 0.95); P=0.002). In the pre-specified secondary analysis of change in trend within each arm, the usual care educational intervention had no effect on the existing declining trend in high risk prescribing. Both types of feedback were associated with significantly more rapid decline in high risk prescribing after the intervention compared with before.  Feedback of prescribing safety data

  16. Reducing the default dispense quantity for new opioid analgesic prescriptions: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Bachhuber, Marcus A; Nash, Denis; Southern, William N; Heo, Moonseong; Berger, Matthew; Schepis, Mark; Cunningham, Chinazo O

    2018-04-20

    As opioid analgesic consumption has grown, so have opioid use disorder and opioid-related overdoses. Reducing the quantity of opioid analgesics prescribed for acute non-cancer pain can potentially reduce risks to the individual receiving the prescription and to others who might unintentionally or intentionally consume any leftover tablets. Reducing the default dispense quantity for new opioid analgesic prescriptions in the electronic health record (EHR) is a promising intervention to reduce prescribing. This study is a prospective cluster randomised controlled trial with two parallel arms. Primary care sites (n=32) and emergency departments (n=4) will be randomised in matched pairs to either a modification of the EHR so that new opioid analgesic prescriptions default to a dispense quantity of 10 tablets (intervention) or to no EHR change (control). The dispense quantity will remain fully modifiable by providers in both arms. From 6 months preintervention to 18 months postintervention, patient-level data will be analysed (ie, the patient is the unit of inference). Patient eligibility criteria are: (A) received a new opioid analgesic prescription, defined as no other opioid analgesic prescription in the prior 6 months; (B) age ≥18 years; and (C) no cancer diagnosis within 1 year prior to the new opioid analgesic prescription. The primary outcome will be the quantity of opioid analgesics prescribed in the initial prescription. Secondary outcomes will include opioid analgesic reorders and health service utilisation within 30 days after the initial prescription. Outcomes will be compared between study arms using a difference-in-differences analysis. This study has been approved by the Montefiore Medical Center/Albert Einstein College of Medicine Institutional Review Board with a waiver of informed consent (2016-6036) and is registered on ClinicalTrials.gov (NCT03003832, 6 December 2016). Findings will be disseminated through publication, conferences and meetings

  17. A cluster randomised trial testing an intervention to improve parents' recognition of their child's weight status: study protocol.

    Science.gov (United States)

    Parkinson, Kathryn N; Jones, Angela R; Tovee, Martin J; Ells, Louisa J; Pearce, Mark S; Araujo-Soares, Vera; Adamson, Ashley J

    2015-06-12

    Parents typically do not recognise their child's weight status accurately according to clinical criteria, and thus may not take appropriate action if their child is overweight. We developed a novel visual intervention designed to improve parental perceptions of child weight status according to clinical criteria for children aged 4-5 and 10-11 years. The Map Me intervention comprises age- and sex-specific body image scales of known body mass index and supporting information about the health risks of childhood overweight. This cluster randomised trial will test the effectiveness of the Map Me intervention. Primary schools will be randomised to: paper-based Map Me; web-based Map Me; no information (control). Parents of reception (4-5 years) and year 6 (10-11 years) children attending the schools will be recruited. The study will work with the National Child Measurement Programme which measures the height and weight of these year groups and provides feedback to parents about their child's weight status. Before receiving the feedback, parents will complete a questionnaire which includes assessment of their perception of their child's weight status and knowledge of the health consequences of childhood overweight. The control group will provide pre-intervention data with assessment soon after recruitment; the intervention groups will provide post-intervention data after access to Map Me for one month. The study will subsequently obtain the child height and weight measurements from the National Child Measurement Programme. Families will be followed-up by the study team at 12 months. The primary outcome is any difference in accuracy in parental perception of child weight status between pre-intervention and post-intervention at one month. The secondary outcomes include differences in parent knowledge, intention to change lifestyle behaviours and/or seek advice or support, perceived control, action planning, coping planning, and child weight status at 12 month follow-up. The

  18. A Cluster Randomised Controlled Trial of a Brief Child Health Nurse Intervention to Reduce Infant Secondhand Smoke Exposure.

    Science.gov (United States)

    Daly, Justine B; Freund, Megan; Burrows, Sally; Considine, Robyn; Bowman, Jennifer A; Wiggers, John H

    2017-01-01

    Background Exposure to secondhand smoke (SHS) is a significant contributor to ill health in children. A study was undertaken to determine the effectiveness of two brief multi-strategic child health nurse delivered interventions in: decreasing the prevalence of infants exposed to SHS; decreasing the prevalence of smoking amongst parent/carers of infants and increasing the prevalence of household smoking bans. Methods This study was a 3 arm, cluster randomised controlled trial. Clusters were 39 community based well child health clinics in one local area health service. Clinics were stratified according to annual number of client appointments and then randomly assigned in a 1:1:1 ratio, (Intervention 1: Intervention 2: Control), with 13 clinics in each cluster. Parents/carers of infants in the intervention groups received a brief multi-strategic intervention from child health nurses during clinic consultations. Treatment condition 1 included computer delivered risk assessment and feedback and nurse brief advice. Treatment condition 2 included all elements of Treatment condition 1 with the addition of biochemical feedback of infant SHS exposure. Results When compared to the Control group at 12 months, no significant differences in the prevalence of infant exposure to SHS were detected from baseline to follow-up for Treatment condition 1 (OR 1.16, 95 % CI 0.73-1.85, p = 0.53) or Treatment condition 2 (OR 1.30, 95 % CI 0.88-1.92, p = 0.19) Similarly, no significant differences were detected in the proportion of parent/carers who reported that they were smokers (T1:OR 0.95, 95 % CI 0.78-1.15, p = 0.58 and T2:OR 0.97, 95 % CI 0.80-1.18, p = 0.77), or in the proportion of households reported to have a complete smoking ban (T1:OR 1.21, 95 % CI 0.89-1.64, p = 0.23 and T2:OR 1.06, 95 % CI 0.79-1.43, p = 0.68). Conclusions Further research is required to identify effective interventions that can be consistently provided by child health nurses if the

  19. Confidence in Government and Attitudes toward Bribery: A Country-Cluster Analysis of Demographic and Religiosity Perspectives

    Directory of Open Access Journals (Sweden)

    Serkan Benk

    2017-01-01

    Full Text Available In this study, we try to classify the countries by the levels of confidence in government and attitudes toward accepting bribery by using the data of the sixth wave (2010–2014 of the World Values Survey (WVS. We are also interested in which demographic, attitudinal, and religiosity variables affect each class of countries. For these purposes cluster analysis, linear regression analysis, and ordered logistic regression analysis were used. The study found that countries could be grouped into two clusters which had varying levels of opposition to bribe taking and confidence in government. Another finding was that certain demographic, attitudinal, and religiosity variables that were significant in one cluster might not be significant in another cluster.

  20. A cluster-randomised trial of a multifaceted quality improvement intervention in Brazilian intensive care units (Checklist-ICU trial): statistical analysis plan.

    Science.gov (United States)

    Damiani, Lucas P; Cavalcanti, Alexandre B; Moreira, Frederico R; Machado, Flavia; Bozza, Fernando A; Salluh, Jorge I F; Campagnucci, Valquiria P; Normilio-Silva, Karina; Chiattone, Viviane C; Angus, Derek C; Berwanger, Otavio; Chou H Chang, Chung-

    2015-06-01

    The Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units (Checklist- ICU) trial is a pragmatic, two-arm, cluster-randomised trial involving 118 intensive care units in Brazil, with the primary objective of determining if a multifaceted qualityimprovement intervention with a daily checklist, definition of daily care goals during multidisciplinary daily rounds and clinician prompts can reduce inhospital mortality. To describe our trial statistical analysis plan (SAP). This is an ongoing trial conducted in two phases. In the preparatory observational phase, we collect three sets of baseline data: ICU characteristics; patient characteristics, processes of care and outcomes; and completed safety attitudes questionnaires (SAQs). In the randomised phase, ICUs are assigned to the experimental or control arms and we collect patient data and repeat the SAQ. Our SAP includes the prespecified model for the primary and secondary outcome analyses, which account for the cluster-randomised design and availability of baseline data. We also detail the multiple mediation models that we will use to assess our secondary hypothesis (that the effect of the intervention on inhospital mortality is mediated not only through care processes targeted by the checklist, but also through changes in safety culture). We describe our approach to sensitivity and subgroup analyses and missing data. We report our SAP before closing our study database and starting analysis. We anticipate that this should prevent analysis bias and enhance the utility of results.

  1. The effect of direct referral for fast CT scan in early lung cancer detection in general practice. A clinical, cluster-randomised trial.

    Science.gov (United States)

    Guldbrandt, Louise Mahncke

    2015-03-01

    This PhD thesis is based on the project "The effect of direct referral for fast CT scan in early lung cancer detection in general practice. A clinical, cluster-randomised trial", performed in Denmark in 2010-2013. The thesis includes four papers and focuses on early lung cancer diagnostics in general practice. A total of 4200 new cases of lung cancer are diagnosed in Denmark annually. The stage of the disease is an important prognostic factor; thus, the opportunity for curative treatment declines with more advanced tumour stage. Lung cancer patients in Denmark (like in the UK) have a poorer prognosis than lung cancer patients in other European countries. One explanation could be delayed diagnosis. A fast-track pathway was therefore introduced in an attempt to expedite the diagnosis of cancer. However, it seems that not all patients can be diagnosed through this pathway. In order to ensure fast and early lung cancer diagnosis, it is crucial to examine the initial diagnostic process in general and the role general practice plays in lung cancer diagnostics in particular. The specific areas of investigation include the pathways to diagnosis, the characteristics of patients who are at special risk of delayed diagnosis and the level of prediagnostic activity in general practice. A chest radiograph is often the first choice in the investigation of lung cancer. Unfortunately, radiographs are less suitable for central and small tumours. Low-dose computer tomography (LDCT), however, has a high sensitivity for lung cancer which implies that it can be used to detect patients with localised, potentially curable disease. The aim of this thesis was to increase our knowledge of the initial stages of lung cancer diagnostics in general practice. The thesis also examined the effect of a direct referral from general practice to an additional diagnostic test, the LDCT. The aims of this thesis were: 1) To describe Danish patients' pathways to the diagnosis of lung cancer in general and

  2. Clustering of smoking, alcohol drinking and cannabis use in adolescents in a rapidly developing country

    Directory of Open Access Journals (Sweden)

    Chiolero Arnaud

    2006-06-01

    Full Text Available Abstract Background Smoking, alcohol drinking and cannabis use ("risk behaviors" are often initiated at a young age but few epidemiological studies have assessed their joined prevalence in children in developing countries. This study aims at examining the joint prevalence of these behaviors in adolescents in the Seychelles, a rapidly developing country in the Indian Ocean. Methods Cross-sectional survey in a representative sample of secondary school students using an anonymous self-administered questionnaire (Global Youth Tobacco Survey. The questionnaire was completed by 1,321 (92% of 1,442 eligible students aged 11 to 17 years. Main variables of interest included smoking cigarettes on ≥1 day in the past 30 days; drinking any alcohol beverage on ≥1 day in the past 30 days and using cannabis at least once in the past 12 months. Results In boys and girls, respectively, prevalence (95% CI was 30% (26–34/21% (18–25 for smoking, 49% (45–54/48% (43–52 for drinking, and 17% (15–20/8% (6–10 for cannabis use. The prevalence of all these behaviors increased with age. Smokers were two times more likely than non-smokers to drink and nine times more likely to use cannabis. Drinkers were three times more likely than non-drinkers to smoke or to use cannabis. Comparison of observed versus expected frequencies of combination categories demonstrated clustering of these risk behaviors in students (P Conclusion Smoking, drinking and cannabis use were common and clustered among adolescents of a rapidly developing country. These findings stress the need for early and integrated prevention programs.

  3. Supporting recovery in patients with psychosis through care by community-based adult mental health teams (REFOCUS): a multisite, cluster, randomised, controlled trial.

    Science.gov (United States)

    Slade, Mike; Bird, Victoria; Clarke, Eleanor; Le Boutillier, Clair; McCrone, Paul; Macpherson, Rob; Pesola, Francesca; Wallace, Genevieve; Williams, Julie; Leamy, Mary

    2015-06-01

    Mental health policy in many countries is oriented around recovery, but the evidence base for service-level recovery-promotion interventions is lacking. We did a cluster, randomised, controlled trial in two National Health Service Trusts in England. REFOCUS is a 1-year team-level intervention targeting staff behaviour to increase focus on values, preferences, strengths, and goals of patients with psychosis, and staff-patient relationships, through coaching and partnership. Between April, 2011, and May, 2012, community-based adult mental health teams were randomly allocated to provide usual treatment plus REFOCUS or usual treatment alone (control). Baseline and 1-year follow-up outcomes were assessed in randomly selected patients. The primary outcome was recovery and was assessed with the Questionnaire about Processes of Recovery (QPR). We also calculated overall service costs. We used multiple imputation to estimate missing data, and the imputation model captured clustering at the team level. Analysis was by intention to treat. This trial is registered, number ISRCTN02507940. 14 teams were included in the REFOCUS group and 13 in the control group. Outcomes were assessed in 403 patients (88% of the target sample) at baseline and in 297 at 1 year. Mean QPR total scores did not differ between the two groups (REFOCUS group 40·6 [SD 10·1] vs control 40·0 [10·2], adjusted difference 0·68, 95% CI -1·7 to 3·1, p=0·58). High team participation was associated with higher staff-rated scores for recovery-promotion behaviour change (adjusted difference -0·4, 95% CI -0·7 to -0·2, p=0·001) and patient-rated QPR interpersonal scores (-1·6, -2·7 to -0·5, p=0·005) at follow-up than low participation. Patients treated in the REFOCUS group incurred £1062 (95% CI -1103 to 3017) lower adjusted costs than those in the control group. Although the primary endpoint was negative, supporting recovery might, from the staff perspective, improve functioning and reduce needs

  4. Irie Classroom Toolbox: a study protocol for a cluster-randomised trial of a universal violence prevention programme in Jamaican preschools.

    Science.gov (United States)

    Baker-Henningham, Helen; Vera-Hernández, Marcos; Alderman, Harold; Walker, Susan

    2016-05-10

    We aim to determine the effectiveness of a school-based violence prevention programme implemented in Jamaican preschools, on reducing the levels of aggression among children at school, and violence against children by teachers. This is a 2-arm, single-blind, cluster-randomised controlled trial with parallel assignment. Clusters are 76 preschools in Kingston, and all teachers and classrooms in the selected schools are included in the study. In addition, a random sample of up to 12 children in the 4-year-old classes have been selected for evaluation of child-level outcomes. The intervention involves training teachers in classroom behaviour management and in strategies to promote children's social-emotional competence. Training is delivered through five full-day workshops, monthly in-class coaching over 2 school terms, and weekly text messages. The primary outcome measures are: (1) observed levels of child aggression and (2) observed violence against children by teachers. Secondary outcomes include observations of the levels of children's prosocial behaviour and the quality of the classroom environment, teachers' reports of their mental health, teacher-reported child mental health, direct tests of children's self-regulation and child attendance. If this intervention were effective at improving the caregiving environment of young children in school, this would have significant implications for the prevention of child mental health problems, and prevention of violence against children in low and middle-income countries where services are often limited. The intervention is integrated into the school system and involves training existing staff, and thus, represents an appropriate strategy for large-scale implementation and benefits at the population level. Ethical consent for the study was given by the School of Psychology Ethics and Research Committee, Bangor University (ref: 2014-14167), and by the University of the West Indies Ethics Committee (ref: ECP 50

  5. Menstruation and the Cycle of Poverty: A Cluster Quasi-Randomised Control Trial of Sanitary Pad and Puberty Education Provision in Uganda.

    Directory of Open Access Journals (Sweden)

    Paul Montgomery

    Full Text Available Poor menstrual knowledge and access to sanitary products have been proposed as barriers to menstrual health and school attendance. In response, interventions targeting these needs have seen increasing implementation in public and private sectors. However, there has been limited assessment of their effectiveness.Assess the impact of providing reusable sanitary pads and puberty education on girls' school attendance and psychosocial wellbeing outcomes.A cluster quasi-randomised controlled trial was conducted across 8 schools, including 1124 girls, in rural Uganda. Schools were allocated to one of four conditions: the provision of puberty education alone; reusable sanitary pads alone; puberty education and reusable sanitary pads; and a control (no intervention. The primary outcome was school attendance. Secondary outcomes reflected psychosocial wellbeing.At follow-up, school attendance had worsened for girls across all conditions. Per-protocol analysis revealed that this decline was significantly greater for those in the control condition d = 0.52 (95%CI 0.26-0.77, with those in control schools having a 17.1% (95%CI: 8.7-25.5 greater drop in attendance than those in any intervention school. There were no differences between the intervention conditions. High rates of school drop-out and transfer meant the trial suffered from substantial participant drop-out. Intention-to-treat analyses using two different imputation strategies were consistent with the main results, with mean differences of 5.2% attendance in best-case and 24.5% in worst-case imputations. Results were robust to adjustments for clustering. There was no impact of the interventions on girls' self-reported shame or insecurity during menstruation.Results of the trial support the hypothesised positive impact of providing sanitary pads or puberty education for girls' school attendance in a developing country context. Findings must be interpreted with caution in light of poor participant

  6. Menstruation and the Cycle of Poverty: A Cluster Quasi-Randomised Control Trial of Sanitary Pad and Puberty Education Provision in Uganda

    Science.gov (United States)

    Montgomery, Paul; Hennegan, Julie; Dolan, Catherine; Wu, Maryalice; Steinfield, Laurel; Scott, Linda

    2016-01-01

    Background Poor menstrual knowledge and access to sanitary products have been proposed as barriers to menstrual health and school attendance. In response, interventions targeting these needs have seen increasing implementation in public and private sectors. However, there has been limited assessment of their effectiveness. Objectives Assess the impact of providing reusable sanitary pads and puberty education on girls’ school attendance and psychosocial wellbeing outcomes. Methods A cluster quasi-randomised controlled trial was conducted across 8 schools, including 1124 girls, in rural Uganda. Schools were allocated to one of four conditions: the provision of puberty education alone; reusable sanitary pads alone; puberty education and reusable sanitary pads; and a control (no intervention). The primary outcome was school attendance. Secondary outcomes reflected psychosocial wellbeing. Results At follow-up, school attendance had worsened for girls across all conditions. Per-protocol analysis revealed that this decline was significantly greater for those in the control condition d = 0.52 (95%CI 0.26–0.77), with those in control schools having a 17.1% (95%CI: 8.7–25.5) greater drop in attendance than those in any intervention school. There were no differences between the intervention conditions. High rates of school drop-out and transfer meant the trial suffered from substantial participant drop-out. Intention-to-treat analyses using two different imputation strategies were consistent with the main results, with mean differences of 5.2% attendance in best-case and 24.5% in worst-case imputations. Results were robust to adjustments for clustering. There was no impact of the interventions on girls’ self-reported shame or insecurity during menstruation. Conclusion Results of the trial support the hypothesised positive impact of providing sanitary pads or puberty education for girls’ school attendance in a developing country context. Findings must be interpreted

  7. Implementing knowledge into practice for improved neonatal survival; a cluster-randomised, community-based trial in Quang Ninh province, Vietnam

    Directory of Open Access Journals (Sweden)

    Huy Tran Q

    2011-09-01

    Full Text Available Abstract Background Globally, almost 4 million newborns die during the first 4 weeks of life every year. By increased use of evidence-based knowledge in the healthcare system a large proportion of these neonatal deaths could be prevented. But there is a severe lack of knowledge on effective methods for successful implementation of evidence into practice, particularly in low- and middle-income countries. Recent studies have demonstrated promising results with increased survival among both mothers and newborns using community-based approaches. In Vietnam evidence-based guidelines on reproductive health were launched in 2003 and revised in 2009. The overall objective of the current project is to evaluate if a facilitation intervention on the community level, with a problem-solving approach involving local representatives if the healthcare system and the community, results in improvements of neonatal health and survival. Methods/Design The study, which has been given the acronym NeoKIP (Neonatal Health - Knowledge Into Practice, took place in 8 districts composed by 90 communes in a province in northern Vietnam, where neonatal mortality rate was 24/1000 in 2005. A cluster randomised design was used, allocating clusters, as defined as a commune and its correponding Commune Health Center (CHC to either intervention or control arm. The facilitation intervention targeted staff at healthcare centres and key persons in the communes. The facilitator role was performed by lay women (Women's Union representatives using quality improvement techniques to initiate and sustain improvement processes targeting identified problem areas. The intervention has been running over 3 years and data were collected on the facilitation process, healthcare staff knowledge in neonatal care and their behaviour in clinical practice, and reproductive and perinatal health indicators. Primary outcome is neonatal mortality. Discussion The intervention is participatory and dynamic

  8. Randomised trial on episodic cluster headache with an angiotensin II receptor blocker

    DEFF Research Database (Denmark)

    Tronvik, Erling; Wienecke, Troels; Monstad, Inge

    2013-01-01

    OBJECTIVES: The aim of this study was to evaluate the angiotensin II receptor antagonist candesartan as prophylactic medication in patients with episodic cluster headache. METHODS: This study comprised a prospective, placebo-controlled, double-blind, parallel-designed trial performed in seven cen...... the candesartan and placebo group was not significant with the pre-planned non-parametric ranking test, but a post-hoc exact Poisson test, which takes into account the temporal properties of the data, revealed a significant result ( P  ...... (primary efficacy variable) during the three-week treatment period was reduced from 14.3 ± 9.2 attacks in week 1 to 5.6 ± 7.0 attacks in week 3 (-61%) in the candesartan group and from 16.8 ± 14.1 attacks in week 1 to 10.5 ± 11.3 attacks in week 3 (-38%) in the placebo group. The difference between...

  9. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention - Project Tomato.

    Science.gov (United States)

    Kitchen, Meaghan S; Ransley, Joan K; Greenwood, Darren C; Clarke, Graham P; Conner, Mark T; Jupp, Jennifer; Cade, Janet E

    2009-06-16

    The School Fruit and Vegetable Scheme (SFVS) is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3) their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group), consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET), and height and weight measurements collected, at baseline (Year 2) and 18 month follow-up (Year 4). The primary outcome will be the ability of the intervention (Project Tomato) to maintain consumption of fruit and vegetable portions compared to the control group. A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Medical Research Council Registry code G0501297.

  10. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention – Project Tomato

    Science.gov (United States)

    Kitchen, Meaghan S; Ransley, Joan K; Greenwood, Darren C; Clarke, Graham P; Conner, Mark T; Jupp, Jennifer; Cade, Janet E

    2009-01-01

    Background The School Fruit and Vegetable Scheme (SFVS) is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3) their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. Method This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group), consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET), and height and weight measurements collected, at baseline (Year 2) and 18 month follow-up (Year 4). The primary outcome will be the ability of the intervention (Project Tomato) to maintain consumption of fruit and vegetable portions compared to the control group. Discussion A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Trial registration Medical Research Council Registry code G0501297 PMID:19531246

  11. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention – Project Tomato

    Directory of Open Access Journals (Sweden)

    Conner Mark T

    2009-06-01

    Full Text Available Abstract Background The School Fruit and Vegetable Scheme (SFVS is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3 their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. Method This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group, consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET, and height and weight measurements collected, at baseline (Year 2 and 18 month follow-up (Year 4. The primary outcome will be the ability of the intervention (Project Tomato to maintain consumption of fruit and vegetable portions compared to the control group. Discussion A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Trial registration Medical Research Council Registry code G0501297

  12. The effect of a soap promotion and hygiene education campaign on handwashing behaviour in rural India: a cluster randomised trial.

    Science.gov (United States)

    Biran, Adam; Schmidt, Wolf-Peter; Wright, Richard; Jones, Therese; Seshadri, M; Isaac, Pradeep; Nathan, N A; Hall, Peter; McKenna, Joeleen; Granger, Stewart; Bidinger, Pat; Curtis, Val

    2009-10-01

    To investigate the effectiveness of a hygiene promotion intervention based on germ awareness in increasing handwashing with soap on key occasions (after faecal contact and before eating) in rural Indian households. Cluster randomised trial of a hygiene promotion intervention in five intervention and five control villages. Handwashing was assessed through structured observation in a random sample of 30 households per village. Additionally, soap use was monitored in a sub-sample of 10 households per village using electronic motion detectors embedded in soap bars. The intervention reached 40% of the target population. Germ awareness increased as well as reported handwashing (a possible indicator of perceived social norms). Observed handwashing with soap on key occasions was rare (6%), especially after faecal contact (2%). Observed handwashing with soap on key occasions did not change 4 weeks after the intervention in either the intervention arm (-1%, 95% CI -2%/+0.3%), or the control arm (+0.4%, 95% CI -1%/+2%). Data from motion detectors indicated a significant but small increase in overall soap use in the intervention arm. We cannot confidently identify the nature of this increase except to say that there was no change in a key measure of handwashing after defecation. The intervention proved scalable and effective in raising hygiene awareness. There was some evidence of an impact on soap use but not on the primary outcome of handwashing at key times. However, the results do not exclude that changes in knowledge and social norms may lay the foundations for behaviour change in the longer term.

  13. A cluster randomised controlled trial of the Climate Schools: Ecstasy and Emerging Drugs Module in Australian secondary schools: study protocol.

    Science.gov (United States)

    Champion, Katrina E; Teesson, Maree; Newton, Nicola C

    2013-12-12

    The use of ecstasy is a public health problem and is associated with a range of social costs and harms. In recent years, there has been growing concern about the availability and misuse of new and emerging drugs designed to mimic the effects of illicit drugs, including ecstasy. This, coupled with the fact that the age of use and the risk factors for using ecstasy and emerging drugs are similar, provides a compelling argument to implement prevention for these substances simultaneously. The proposed study will evaluate whether a universal Internet-based prevention program, known as the Climate Schools: Ecstasy and Emerging Drugs Module, can address and prevent the use of ecstasy and emerging drugs among adolescents. A cluster randomised controlled trial will be conducted among Year 10 students (aged 15-16 years) from 12 secondary schools in Sydney, Australia. Schools will be randomly assigned to either the Climate Schools intervention group or the control group. All students will complete a self-report questionnaire at baseline, immediately post-intervention, and 6-, 12- and 24-months post-baseline. The primary outcome measures will include ecstasy and emerging drug-related knowledge, intentions to use these substances in the future, and the patterns of use of ecstasy and emerging drugs. A range of secondary outcomes will also be assessed, including beliefs and attitudes about ecstasy and emerging drugs, peer pressure resistance, other substance use and mental health outcomes. To our knowledge, this will be the first evaluation of an Internet-based program designed to specifically target ecstasy and NED use among adolescents. If deemed effective, the Climate Schools: Ecstasy and Emerging Drugs Module will provide schools with an interactive and novel prevention program for ecstasy and emerging drugs that can be readily implemented by teachers. This trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12613000708752.

  14. Tackling risky alcohol consumption in sport: a cluster randomised controlled trial of an alcohol management intervention with community football clubs.

    Science.gov (United States)

    Kingsland, Melanie; Wolfenden, Luke; Tindall, Jennifer; Rowland, Bosco C; Lecathelinais, Christophe; Gillham, Karen E; Dodds, Pennie; Sidey, Maree N; Rogerson, John C; McElduff, Patrick; Crundall, Ian; Wiggers, John H

    2015-10-01

    An increased prevalence of risky alcohol consumption and alcohol-related harm has been reported for members of sporting groups and at sporting venues compared with non-sporting populations. While sports clubs and venues represent opportune settings to implement strategies to reduce such risks, no controlled trials have been reported. The purpose of the study was to examine the effectiveness of an alcohol management intervention in reducing risky alcohol consumption and the risk of alcohol-related harm among community football club members. A cluster randomised controlled trial of an alcohol management intervention was undertaken with non-elite, community football clubs and their members in New South Wales, Australia. Risky alcohol consumption (5+ drinks) at the club and risk of alcohol-related harm using the Alcohol Use Disorders Identification Test (AUDIT) were measured at baseline and postintervention. Eighty-eight clubs participated in the trial (n=43, INTERVENTION; n=45, CONTROL) and separate cross-sectional samples of club members completed the baseline (N=1411) and postintervention (N=1143) surveys. Postintervention, a significantly lower proportion of intervention club members reported: risky alcohol consumption at the club ( 19%; 24%; OR: 0.63 (95% CI 0.40 to 1.00); p=0.05); risk of alcohol-related harm ( 38%; 45%; OR: 0.58 (95% CI 0.38 to 0.87); psports officiating, enhancing club-based alcohol management interventions could make a substantial contribution to reducing the burden of alcohol misuse in communities. ACTRN12609000224224. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  15. Next-generation audit and feedback for inpatient quality improvement using electronic health record data: a cluster randomised controlled trial.

    Science.gov (United States)

    Patel, Sajan; Rajkomar, Alvin; Harrison, James D; Prasad, Priya A; Valencia, Victoria; Ranji, Sumant R; Mourad, Michelle

    2018-03-05

    Audit and feedback improves clinical care by highlighting the gap between current and ideal practice. We combined best practices of audit and feedback with continuously generated electronic health record data to improve performance on quality metrics in an inpatient setting. We conducted a cluster randomised control trial comparing intensive audit and feedback with usual audit and feedback from February 2016 to June 2016. The study subjects were internal medicine teams on the teaching service at an urban tertiary care hospital. Teams in the intensive feedback arm received access to a daily-updated team-based data dashboard as well as weekly inperson review of performance data ('STAT rounds'). The usual feedback arm received ongoing twice-monthly emails with graphical depictions of team performance on selected quality metrics. The primary outcome was performance on a composite discharge metric (Discharge Mix Index, 'DMI'). A washout period occurred at the end of the trial (from May through June 2016) during which STAT rounds were removed from the intensive feedback arm. A total of 40 medicine teams participated in the trial. During the intervention period, the primary outcome of completion of the DMI was achieved on 79.3% (426/537) of patients in the intervention group compared with 63.2% (326/516) in the control group (Paudit and feedback using timely data and STAT rounds significantly increased performance on a composite discharge metric compared with usual feedback. With the cessation of STAT rounds, performance between the intensive and usual feedback groups did not differ significantly, highlighting the importance of feedback delivery on effecting change. The trial was registered with ClinicalTrials.gov (NCT02593253). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  16. Effectiveness of an injury prevention programme for adult male amateur soccer players: a cluster-randomised controlled trial

    Science.gov (United States)

    van Beijsterveldt, Anna M C; van de Port, Ingrid G L; Krist, Mark R; Schmikli, Sandor L; Stubbe, Janine H; Frederiks, Janet E; Backx, Frank J G

    2012-01-01

    Background The incidence rate of soccer injuries is among the highest in sports, particularly for adult male soccer players. Purpose To investigate the effect of the ‘The11’ injury prevention programme on injury incidence and injury severity in adult male amateur soccer players. Study design Cluster-randomised controlled trial. Methods Teams from two high-level amateur soccer competitions were randomly assigned to an intervention (n=11 teams, 223 players) or control group (n=12 teams, 233 players). The intervention group was instructed to perform The11 in each practice session during one soccer season. The11 focuses on core stability, eccentric training of thigh muscles, proprioceptive training, dynamic stabilisation and plyometrics with straight leg alignment. All participants of the control group continued their practice sessions as usual. Results In total, 427 injuries were recorded, affecting 274 of 456 players (60.1%). Compliance with the intervention programme was good (team compliance=73%, player compliance=71%). Contrary to the hypothesis, injury incidences were almost equal between the two study groups: 9.6 per 1000 sports hours (8.4–11.0) for the intervention group and 9.7 (8.5–11.1) for the control group. No significant differences were found in injury severity, but a significant difference was observed in the location of the injuries: players in the intervention group sustained significantly less knee injuries. Conclusions This study did not find significant differences in the overall injury incidence or injury severity between the intervention and control group of adult male soccer players. More research is recommended, focusing on injury aetiology and risk factors in adult male amateur soccer players. PMID:22878257

  17. The efficacy of a movement control exercise programme to reduce injuries in youth rugby: a cluster randomised controlled trial

    Science.gov (United States)

    Hislop, M D; Stokes, K A; Williams, S; McKay, C D; England, M; Kemp, S P T

    2016-01-01

    Background Injuries to youth rugby players have become an increasingly prominent health concern, highlighting the importance of developing and implementing appropriate preventive strategies. A growing body of evidence from other youth sports has demonstrated the efficacy of targeted exercise regimens to reduce injury risk. However, studies have yet to investigate the effect of such interventions in youth contact sport populations like rugby union. Objective To determine the efficacy of an evidence-based movement control exercise programme compared with a sham exercise programme to reduce injury risk in youth rugby players. Exercise programme compliance between trial arms and the effect of coach attitudes on compliance will also be evaluated. Setting School rugby coaches in England will be the target of the researcher intervention, with the effects of the injury prevention programmes being measured in male youth players aged 14–18 years in school rugby programmes over the 2015–2016 school winter term. Methods A cluster-randomised controlled trial with schools randomly allocated to either a movement control exercise programme or a sham exercise programme, both of which are coach-delivered. Injury measures will derive from field-based injury surveillance, with match and training exposure and compliance recorded. A questionnaire will be used to evaluate coach attitudes, knowledge, beliefs and behaviours both prior to and on the conclusion of the study period. Outcome measures Summary injury measures (incidence, severity and burden) will be compared between trial arms, as will the influence of coach attitudes on compliance and injury burden. Additionally, changes in these outcomes through using the exercise programmes will be evaluated. Trial registration number ISRTCNN13422001. PMID:27900148

  18. Assessing the impact of a restorative home care service in New Zealand: a cluster randomised controlled trial.

    Science.gov (United States)

    King, Anna I I; Parsons, Matthew; Robinson, Elizabeth; Jörgensen, Diane

    2012-07-01

    Due to the ageing population, there is an increased demand for home care services. Restorative care is one approach to improving home care services, although there is little evidence to support its use in the community setting. The objective of this trial was to evaluate the impact of a restorative home care service for community-dwelling older people. The study was a cluster randomised controlled trial undertaken at a home care agency in New Zealand. The study period was from December 2005 to May 2007. Older people were interviewed face-to-face at baseline, four and 7 months. A total of 186 older people who received assistance from a home care agency participated in the study, 93 received restorative home care and 93 older people received usual home care. The primary outcome measure was change in health-related quality of life (measured by the Short Form 36 [SF36] Health Survey). Secondary outcomes were the physical, mental, and social well-being of older people (Nottingham Extended Activities of Daily Living, Timed Up and Go, Mastery scale, Duke Social Support Index). Findings revealed that compared with usual care, the intervention demonstrated a statistically significant benefit in health-related quality of life (SF36) at 7 months for older people (mean difference 3.8, 95% CI -0.0 to 7.7, P = 0.05). There were no changes in other scale measurements for older people in either group over time. There was a statistically significant difference in the number of older people in the intervention group identified for reduced hours or discharge (29%) compared with the control group (0%) (P home care service may be of benefit to older people, and improves home care service efficacy. © 2011 Blackwell Publishing Ltd.

  19. Children and youth perceive smoking messages in an unbranded advertisement from a NIKE marketing campaign: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Daniel Mark

    2011-04-01

    Full Text Available Abstract Background How youth perceive marketing messages in sports is poorly understood. We evaluated whether youth perceive that the imagery of a specific sports marketing advertisement contained smoking-related messages. Methods Twenty grade 7 to 11 classes (397 students from two high schools in Montréal, Canada were recruited to participate in a cluster randomised single-blind controlled trial. Classes were randomly allocated to either a NIKE advertisement containing the phrase 'LIGHT IT UP' (n = 205 or to a neutral advertisement with smoking imagery reduced and the phrase replaced by 'GO FOR IT' (n = 192. The NIKE logo was removed from both advertisements. Students responded in class to a questionnaire asking open-ended questions about their perception of the messages in the ad. Reports relating to the appearance and text of the ad, and the product being promoted were evaluated. Results Relative to the neutral ad, more students reported that the phrase 'LIGHT IT UP' was smoking-related (37.6% vs. 0.5% and that other parts of the ad resembled smoking-related products (50.7% vs. 10.4%. The relative risk of students reporting that the NIKE ad promoted cigarettes was 4.41 (95% confidence interval: 2.64-7.36; P Conclusions The unbranded imagery of an advertisement in a specific campaign aimed at promoting NIKE hockey products appears to have contained smoking-related messages. This particular marketing campaign may have promoted smoking. This suggests that the regulation of marketing to youth may need to be more tightly controlled.

  20. Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico

    Science.gov (United States)

    Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill

    2018-01-01

    Introduction Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. Methods and analysis The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico’s national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. Ethics and dissemination This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at

  1. Cost effectiveness of group follow-up after structured education for type 1 diabetes: a cluster randomised controlled trial

    Science.gov (United States)

    2014-01-01

    Background This study examines the cost effectiveness of group follow-up after participation in the Dose Adjustment for Normal Eating (DAFNE) structured education programme for type 1 diabetes. Methods Economic evaluation conducted alongside a cluster randomised controlled trial involving 437 adults with type 1 diabetes in Ireland. Group follow-up involved two group education ‘booster’ sessions post-DAFNE. Individual follow-up involved two standard one-to-one hospital clinic visits. Incremental costs, quality-adjusted life years (QALYs) gained and cost effectiveness were estimated at 18 months. Uncertainty was explored using sensitivity analysis and by estimating cost effectiveness acceptability curves. Results Group follow-up was associated with a mean reduction in QALYs gained of 0.04 per patient (P value, 0.052; 95% CI, −0.08 to 0.01, intra-class correlation (ICC), 0.033) and a mean reduction in total healthcare costs of €772 (P value, 0.020; 95% CI, −1,415 to −128: ICC, 0.016) per patient. At alternative threshold values of €5,000, €15,000, €25,000, €35,000, and €45,000, the probability of group follow-up being cost effective was estimated to be 1.000, 0.762, 0.204, 0.078, and 0.033 respectively. Conclusions The results do not support implementation of group follow-up as the sole means of follow-up post-DAFNE. Given the reported cost savings, future studies should explore the cost effectiveness of alternative models of group care for diabetes. Trial registration Current Controlled Trials ISRCTN79759174 (assigned: 9 February 2007). PMID:24927851

  2. Enhancing implementation of tobacco use prevention and cessation counselling guideline among dental providers: a cluster randomised controlled trial.

    Science.gov (United States)

    Amemori, Masamitsu; Korhonen, Tellervo; Kinnunen, Taru; Michie, Susan; Murtomaa, Heikki

    2011-02-14

    Tobacco use adversely affects oral health. Tobacco use prevention and cessation (TUPAC) counselling guidelines recommend that healthcare providers ask about each patient's tobacco use, assess the patient's readiness and willingness to stop, document tobacco use habits, advise the patient to stop, assist and help in quitting, and arrange monitoring of progress at follow-up appointments. Adherence to such guidelines, especially among dental providers, is poor. To improve guideline implementation, it is essential to understand factors influencing it and find effective ways to influence those factors. The aim of the present study protocol is to introduce a theory-based approach to diagnose implementation difficulties of TUPAC counselling guidelines among dental providers. Theories of behaviour change have been used to identify key theoretical domains relevant to the behaviours of healthcare providers involved in implementing clinical guidelines. These theoretical domains will inform the development of a questionnaire aimed at assessing the implementation of the TUPAC counselling guidelines among Finnish municipal dental providers. Specific items will be drawn from the guidelines and the literature on TUPAC studies. After identifying potential implementation difficulties, we will design two interventions using theories of behaviour change to link them with relevant behaviour change techniques aiming to improve guideline adherence. For assessing the implementation of TUPAC guidelines, the electronic dental record audit and self-reported questionnaires will be used. To improve guideline adherence, the theoretical-domains approach could provide a comprehensive basis for assessing implementation difficulties, as well as designing and evaluating interventions. After having identified implementation difficulties, we will design and test two interventions to enhance TUPAC guideline adherence. Using the cluster randomised controlled design, we aim to provide further evidence on

  3. The economics of dementia-care mapping in nursing homes: a cluster-randomised controlled trial.

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    Geertje van de Ven

    Full Text Available BACKGROUND: Dementia-care mapping (DCM is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. METHODS: Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units. RESULTS: 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05 than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02. CONCLUSIONS: DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes' preferences, may determine whether they

  4. Mitigating Diseases Transmitted by Aedes Mosquitoes: A Cluster-Randomised Trial of Permethrin-Impregnated School Uniforms.

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    Pattamaporn Kittayapong

    2017-01-01

    Full Text Available Viral diseases transmitted via Aedes mosquitoes are on the rise, such as Zika, dengue, and chikungunya. Novel tools to mitigate Aedes mosquitoes-transmitted diseases are urgently needed. We tested whether commercially insecticide-impregnated school uniforms can reduce dengue incidence in school children.We designed a cluster-randomised controlled trial in Thailand. The primary endpoint was laboratory-confirmed dengue infections. Secondary endpoints were school absenteeism; and impregnated uniforms' 1-hour knock-down and 24 hour mosquito mortality as measured by standardised WHOPES bioassay cone tests at baseline and after repeated washing. Furthermore, entomological assessments inside classrooms and in outside areas of schools were conducted.We enrolled 1,811 pupils aged 6-17 from 5 intervention and 5 control schools. Paired serum samples were obtained from 1,655 pupils. In the control schools, 24/641 (3.7% and in the intervention schools 33/1,014 (3.3% students had evidence of new dengue infections during one school term (5 months. There was no significant difference in proportions of students having incident dengue infections between the intervention and control schools, with adjustment for clustering by school. WHOPES cone tests showed a 100% knock down and mortality of Aedes aegypti mosquitoes exposed to impregnated clothing at baseline and up to 4 washes, but this efficacy rapidly declined to below 20% after 20 washes, corresponding to a weekly reduction in knock-down and mosquito mortality by 4.7% and 4.4% respectively. Results of the entomological assessments showed that the mean number of Aedes aegypti mosquitoes caught inside the classrooms of the intervention schools was significantly reduced in the month following the introduction of the impregnated uniforms, compared to those collected in classrooms of the control schools (p = 0.04.Entomological assessments showed that the intervention had some impact on the number of Aedes

  5. Effectiveness and cost-effectiveness of a physical activity loyalty scheme for behaviour change maintenance: a cluster randomised controlled trial

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    Ruth F. Hunter

    2016-07-01

    Full Text Available Abstract Background Increasing physical activity in the workplace can provide employee physical and mental health benefits, and employer economic benefits through reduced absenteeism and increased productivity. The workplace is an opportune setting to encourage habitual activity. However, there is limited evidence on effective behaviour change interventions that lead to maintained physical activity. This study aims to address this gap and help build the necessary evidence base for effective, and cost-effective, workplace interventions. Methods/design This cluster randomised control trial will recruit 776 office-based employees from public sector organisations in Belfast and Lisburn city centres, Northern Ireland. Participants will be randomly allocated by cluster to either the Intervention Group or Control Group (waiting list control. The 6-month intervention consists of rewards (retail vouchers, based on similar principles to high street loyalty cards, feedback and other evidence-based behaviour change techniques. Sensors situated in the vicinity of participating workplaces will promote and monitor minutes of physical activity undertaken by participants. Both groups will complete all outcome measures. The primary outcome is steps per day recorded using a pedometer (Yamax Digiwalker CW-701 for 7 consecutive days at baseline, 6, 12 and 18 months. Secondary outcomes include health, mental wellbeing, quality of life, work absenteeism and presenteeism, and use of healthcare resources. Process measures will assess intervention “dose”, website usage, and intervention fidelity. An economic evaluation will be conducted from the National Health Service, employer and retailer perspective using both a cost-utility and cost-effectiveness framework. The inclusion of a discrete choice experiment will further generate values for a cost-benefit analysis. Participant focus groups will explore who the intervention worked for and why, and interviews with

  6. The cost-effectiveness of a patient centred pressure ulcer prevention care bundle: Findings from the INTACT cluster randomised trial.

    Science.gov (United States)

    Whitty, Jennifer A; McInnes, Elizabeth; Bucknall, Tracey; Webster, Joan; Gillespie, Brigid M; Banks, Merrilyn; Thalib, Lukman; Wallis, Marianne; Cumsille, Jose; Roberts, Shelley; Chaboyer, Wendy

    2017-10-01

    Pressure ulcers are serious, avoidable, costly and common adverse outcomes of healthcare. To evaluate the cost-effectiveness of a patient-centred pressure ulcer prevention care bundle compared to standard care. Cost-effectiveness and cost-benefit analyses of pressure ulcer prevention performed from the health system perspective using data collected alongside a cluster-randomised trial. Eight tertiary hospitals in Australia. Adult patients receiving either a patient-centred pressure ulcer prevention care bundle (n=799) or standard care (n=799). Direct costs related to the intervention and preventative strategies were collected from trial data and supplemented by micro-costing data on patient turning and skin care from a 4-week substudy (n=317). The time horizon for the economic evaluation matched the trial duration, with the endpoint being diagnosis of a new pressure ulcer, hospital discharge/transfer or 28days; whichever occurred first. For the cost-effectiveness analysis, the primary outcome was the incremental costs of prevention per additional hospital acquired pressure ulcer case avoided, estimated using a two-stage cluster-adjusted non-parametric bootstrap method. The cost-benefit analysis estimated net monetary benefit, which considered both the costs of prevention and any difference in length of stay. All costs are reported in AU$(2015). The care bundle cost AU$144.91 (95%CI: $74.96 to $246.08) more per patient than standard care. The largest contributors to cost were clinical nurse time for repositioning and skin inspection. In the cost-effectiveness analysis, the care bundle was estimated to cost an additional $3296 (95%CI: dominant to $144,525) per pressure ulcer avoided. This estimate is highly uncertain. Length of stay was unexpectedly higher in the care bundle group. In a cost-benefit analysis which considered length of stay, the net monetary benefit for the care bundle was estimated to be -$2320 (95%CI -$3900, -$1175) per patient, suggesting the care

  7. Mitigating Diseases Transmitted by Aedes Mosquitoes: A Cluster-Randomised Trial of Permethrin-Impregnated School Uniforms.

    Science.gov (United States)

    Kittayapong, Pattamaporn; Olanratmanee, Phanthip; Maskhao, Pongsri; Byass, Peter; Logan, James; Tozan, Yesim; Louis, Valérie; Gubler, Duane J; Wilder-Smith, Annelies

    2017-01-01

    Viral diseases transmitted via Aedes mosquitoes are on the rise, such as Zika, dengue, and chikungunya. Novel tools to mitigate Aedes mosquitoes-transmitted diseases are urgently needed. We tested whether commercially insecticide-impregnated school uniforms can reduce dengue incidence in school children. We designed a cluster-randomised controlled trial in Thailand. The primary endpoint was laboratory-confirmed dengue infections. Secondary endpoints were school absenteeism; and impregnated uniforms' 1-hour knock-down and 24 hour mosquito mortality as measured by standardised WHOPES bioassay cone tests at baseline and after repeated washing. Furthermore, entomological assessments inside classrooms and in outside areas of schools were conducted. We enrolled 1,811 pupils aged 6-17 from 5 intervention and 5 control schools. Paired serum samples were obtained from 1,655 pupils. In the control schools, 24/641 (3.7%) and in the intervention schools 33/1,014 (3.3%) students had evidence of new dengue infections during one school term (5 months). There was no significant difference in proportions of students having incident dengue infections between the intervention and control schools, with adjustment for clustering by school. WHOPES cone tests showed a 100% knock down and mortality of Aedes aegypti mosquitoes exposed to impregnated clothing at baseline and up to 4 washes, but this efficacy rapidly declined to below 20% after 20 washes, corresponding to a weekly reduction in knock-down and mosquito mortality by 4.7% and 4.4% respectively. Results of the entomological assessments showed that the mean number of Aedes aegypti mosquitoes caught inside the classrooms of the intervention schools was significantly reduced in the month following the introduction of the impregnated uniforms, compared to those collected in classrooms of the control schools (p = 0.04). Entomological assessments showed that the intervention had some impact on the number of Aedes mosquitoes inside

  8. A cluster-randomised clinical trial comparing two cardiovascular health education strategies in a child population: the Savinghearts project

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    Sánchez-Gómez Luis

    2012-11-01

    Full Text Available Abstract Background This paper describes a methodology for comparing the effects of an eduentertainment strategy involving a music concert, and a participatory class experience involving the description and making of a healthy breakfast, as educational vehicles for delivering obesity-preventing/cardiovascular health messages to children aged 7–8 years. Methods/design This study will involve a cluster-randomised trial with blinded assessment. The study subjects will be children aged 7–8 years of both sexes attending public primary schools in the Madrid Region. The participating schools (n=30 will be randomly assigned to one of two groups: 1 Group MC, in which the children will attend a music concert that delivers obesity-preventing/cardiovascular health messages, or 2 Group HB, in which the children will attend a participatory class providing the same information but involving the description and making of a healthy breakfast. The main outcome measured will be the increase in the number of correct answers scored on a knowledge questionnaire and in an attitudes test administered before and after the above interventions. The secondary outcome recorded will be the reduction in BMI percentile among children deemed overweight/obese prior to the interventions. The required sample size (number of children was calculated for a comparison of proportions with an α of 0.05 and a β of 0.20, assuming that the Group MC subjects would show values for the measured variables at least 10% higher than those recorded for the subjects of Group HB. Corrections were made for the design effect and assuming a loss to follow-up of 10%. The maximum sample size required will be 2107 children. Data will be analysed using summary measurements for each cluster, both for making estimates and for hypothesis testing. All analyses will be made on an intention-to-treat basis. Discussion The intervention providing the best results could be recommended as part of health

  9. Silence is deadly: a cluster-randomised controlled trial of a mental health help-seeking intervention for young men.

    Science.gov (United States)

    Calear, Alison L; Banfield, Michelle; Batterham, Philip J; Morse, Alyssa R; Forbes, Owen; Carron-Arthur, Bradley; Fisk, Martin

    2017-10-23

    Young men are consistently less likely to seek help for mental health problems than their female peers. This is particularly concerning given the high rates of suicide among male adolescents. The school system has been identified as an ideal setting for the implementation of prevention and early intervention programs for young people. The current trial aims to determine the effectiveness of the Silence is Deadly program in increasing positive help-seeking intentions for mental health problems and suicide among male secondary school students. This study is a two-arm, cluster-randomised, controlled trial that will compare the Silence is Deadly program to a wait-list control condition. Eight Australian high schools will be recruited to the trial, with male students in grades 11 and 12 (16 to 18 years of age) targeted for participation. The program is an innovative male-tailored suicide prevention intervention, comprising a presentation that emphasises role-modelling and legitimises help-seeking for personal and emotional problems, and a brief video that features celebrity athletes who counter existing male norms around help-seeking and encourage communication about personal and emotional issues. The program also includes a discussion of how to help a friend in distress and ends with a question and answer session. The primary outcome measure for the current study is help-seeking intentions. Secondary outcomes include help-seeking behaviour, help-seeking attitudes, help-seeking stigma, mental health symptoms, and suicidal ideation. Data will be collected pre-intervention, post-intervention, and at 3-month follow-up. Primary analyses will compare changes in help-seeking intentions for the intervention condition relative to the wait-list control condition using mixed-effects repeated-measures analyses that account for clustering within schools. If proven to be effective, this targeted help-seeking intervention for adolescent males, which is currently only delivered in

  10. Silence is deadly: a cluster-randomised controlled trial of a mental health help-seeking intervention for young men

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    Alison L. Calear

    2017-10-01

    Full Text Available Abstract Background Young men are consistently less likely to seek help for mental health problems than their female peers. This is particularly concerning given the high rates of suicide among male adolescents. The school system has been identified as an ideal setting for the implementation of prevention and early intervention programs for young people. The current trial aims to determine the effectiveness of the Silence is Deadly program in increasing positive help-seeking intentions for mental health problems and suicide among male secondary school students. Methods This study is a two-arm, cluster-randomised, controlled trial that will compare the Silence is Deadly program to a wait-list control condition. Eight Australian high schools will be recruited to the trial, with male students in grades 11 and 12 (16 to 18 years of age targeted for participation. The program is an innovative male-tailored suicide prevention intervention, comprising a presentation that emphasises role-modelling and legitimises help-seeking for personal and emotional problems, and a brief video that features celebrity athletes who counter existing male norms around help-seeking and encourage communication about personal and emotional issues. The program also includes a discussion of how to help a friend in distress and ends with a question and answer session. The primary outcome measure for the current study is help-seeking intentions. Secondary outcomes include help-seeking behaviour, help-seeking attitudes, help-seeking stigma, mental health symptoms, and suicidal ideation. Data will be collected pre-intervention, post-intervention, and at 3-month follow-up. Primary analyses will compare changes in help-seeking intentions for the intervention condition relative to the wait-list control condition using mixed-effects repeated-measures analyses that account for clustering within schools. Discussion If proven to be effective, this targeted help-seeking intervention for

  11. Effectiveness and cost-effectiveness of a physical activity loyalty scheme for behaviour change maintenance: a cluster randomised controlled trial.

    Science.gov (United States)

    Hunter, Ruth F; Brennan, Sarah F; Tang, Jianjun; Smith, Oliver J; Murray, Jennifer; Tully, Mark A; Patterson, Chris; Longo, Alberto; Hutchinson, George; Prior, Lindsay; French, David P; Adams, Jean; McIntosh, Emma; Kee, Frank

    2016-07-22

    Increasing physical activity in the workplace can provide employee physical and mental health benefits, and employer economic benefits through reduced absenteeism and increased productivity. The workplace is an opportune setting to encourage habitual activity. However, there is limited evidence on effective behaviour change interventions that lead to maintained physical activity. This study aims to address this gap and help build the necessary evidence base for effective, and cost-effective, workplace interventions. This cluster randomised control trial will recruit 776 office-based employees from public sector organisations in Belfast and Lisburn city centres, Northern Ireland. Participants will be randomly allocated by cluster to either the Intervention Group or Control Group (waiting list control). The 6-month intervention consists of rewards (retail vouchers, based on similar principles to high street loyalty cards), feedback and other evidence-based behaviour change techniques. Sensors situated in the vicinity of participating workplaces will promote and monitor minutes of physical activity undertaken by participants. Both groups will complete all outcome measures. The primary outcome is steps per day recorded using a pedometer (Yamax Digiwalker CW-701) for 7 consecutive days at baseline, 6, 12 and 18 months. Secondary outcomes include health, mental wellbeing, quality of life, work absenteeism and presenteeism, and use of healthcare resources. Process measures will assess intervention "dose", website usage, and intervention fidelity. An economic evaluation will be conducted from the National Health Service, employer and retailer perspective using both a cost-utility and cost-effectiveness framework. The inclusion of a discrete choice experiment will further generate values for a cost-benefit analysis. Participant focus groups will explore who the intervention worked for and why, and interviews with retailers will elucidate their views on the sustainability

  12. Acute Whiplash Injury Study (AWIS): a protocol for a cluster randomised pilot and feasibility trial of an Active Behavioural Physiotherapy Intervention in an insurance private setting

    Science.gov (United States)

    Wiangkham, Taweewat; Duda, Joan; Haque, M Sayeed; Price, Jonathan; Rushton, Alison

    2016-01-01

    Introduction Whiplash-associated disorder (WAD) causes substantial social and economic burden internationally. Up to 60% of patients with WAD progress to chronicity. Research therefore needs to focus on effective management in the acute stage to prevent the development of chronicity. Approximately 93% of patients are classified as WADII (neck complaint and musculoskeletal sign(s)), and in the UK, most are managed in the private sector. In our recent systematic review, a combination of active and behavioural physiotherapy was identified as potentially effective in the acute stage. An Active Behavioural Physiotherapy Intervention (ABPI) was developed through combining empirical (modified Delphi study) and theoretical (social cognitive theory focusing on self-efficacy) evidence. This pilot and feasibility trial has been designed to inform the design of an adequately powered definitive randomised controlled trial. Methods and analysis Two parallel phases. (1) An external pilot and feasibility cluster randomised double-blind (assessor and participants), parallel two-arm (ABPI vs standard physiotherapy) clinical trial to evaluate procedures and feasibility. Six UK private physiotherapy clinics will be recruited and cluster randomised by a computer-generated randomisation sequence. Sixty participants (30 each arm) will be assessed at recruitment (baseline) and at 3 months postbaseline. The planned primary outcome measure is the neck disability index. (2) An embedded exploratory qualitative study using semistructured indepth interviews (n=3–4 physiotherapists) and a focus group (n=6–8 patients) and entailing the recruitment of purposive samples will explore perceptions of the ABPI. Quantitative data will be analysed descriptively. Qualitative data will be coded and analysed deductively (identify themes) and inductively (identify additional themes). Ethics and dissemination This trial is approved by the University of Birmingham Ethics Committee (ERN_15-0542). Trial

  13. A youth-led social marketing intervention to encourage healthy lifestyles, the EYTO (European Youth Tackling Obesity) project: a cluster randomised controlled0 trial in Catalonia, Spain.

    Science.gov (United States)

    Llauradó, Elisabet; Aceves-Martins, Magaly; Tarro, Lucia; Papell-Garcia, Ignasi; Puiggròs, Francesc; Arola, Lluís; Prades-Tena, Jordi; Montagut, Marta; Moragas-Fernández, Carlota M; Solà, Rosa; Giralt, Montse

    2015-07-03

    The encouragement of healthy lifestyles for obesity prevention in young people is a public health priority. The European Youth Tackling Obesity (EYTO) project is a multicentric intervention project with participation from the United Kingdom, Portugal, the Czech Republic and Spain. The general aim of the EYTO project is to improve lifestyles, including nutritional habits and physical activity practice, and to prevent obesity in socioeconomically disadvantaged and vulnerable adolescents. The EYTO project works through a peer-led social marketing intervention that is designed and implemented by the adolescents of each participating country. Each country involved in the project acts independently. This paper describes the "Som la Pera" intervention Spanish study that is part of the EYTO project. In Spain, the research team performed a cluster randomised controlled intervention over 2 academic years (2013-2015) in which 2 high-schools were designated as the control group and 2 high-schools were designated as the intervention group, with a minimum of 121 schoolchildren per group. From the intervention group, 5 adolescents with leadership characteristics, called "Adolescent Challenge Creators" (ACCs), were recruited. These 5 ACCs received an initial 4 h training session about social marketing principles and healthy lifestyle theory, followed by 24 sessions (1.30 h/session) divided in two academic years to design and implement activities presented as challenges to encourage healthy lifestyles among their peers, the approximately 180-200 high-school students in the intervention group. During the design of the intervention, it was essential that the ACCs used the 8 social marketing criteria (customer orientation, behaviour, theory, insight, exchange, competition, segmentation and methods mix). The expected primary outcomes from the Spanish intervention will be as follows: increases in the consumption of fruits and vegetables and physical activity practice along with

  14. Effectiveness of an implementation strategy for a breastfeeding guideline in Primary Care: cluster randomised trial

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    Martín-Iglesias Susana

    2011-12-01

    Full Text Available Abstract Background The protection and promotion of breastfeeding is considered a priority in Europe where only 22% of infants less than 6 months old are exclusively breastfed. In Spain this percentage reaches 24.8% but in our city it falls to 18.26%. Various studies emphasise that the improvement of these results should be based upon the training of health professionals. Following the recommendations of a breastfeeding guide can modify the practice of health professionals and improve results with respect to exclusively or predominatly breastfed children at 6 months of age. Method/Design This study involves a community based cluster randomized trial in primary healthcare centres in Leganés (Madrid, Spain. The project aims to determine whether the use of an implementation strategy (including training session, information distribution, opinion leader of a breastfeeding guideline in primary care is more effective than usual diffusion. The number of patients required will be 240 (120 in each arm. It will be included all the mothers of infants born during the study period (6 months who come to the health centre on the first visit of the child care programme and who give their consent to participate. The main outcome variable is the exclusive o predominant breastfeeding at 6 moths of age.. Main effectiveness will be analyzed by comparing the percentage of infants with exclusive or predominant breastfeeding at 6 months between the intervention group and the control group. All statistical tests will be performed with intention to treat. 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 Strategies need to be found which facilitate the giving of effective advice on breastfeeding by professionals and which provide support to women during the breastfeeding period. By applying the guide

  15. A multifaceted strategy using mobile technology to assist rural primary healthcare doctors and frontline health workers in cardiovascular disease risk management: protocol for the SMARTHealth India cluster randomised controlled trial.

    Science.gov (United States)

    Praveen, Devarsetty; Patel, Anushka; McMahon, Stephen; Prabhakaran, Dorairaj; Clifford, Gari D; Maulik, Pallab K; Joshi, Rohina; Jan, Stephen; Heritier, Stephane; Peiris, David

    2013-11-25

    Blood Pressure related disease affected 118 million people in India in the year 2000; this figure will double by 2025. Around one in four adults in rural India have hypertension, and of those, only a minority are accessing appropriate care. Health systems in India face substantial challenges to meet these gaps in care, and innovative solutions are needed. We hypothesise that a multifaceted intervention involving capacity strengthening of primary healthcare doctors and non-physician healthcare workers through use of a mobile device-based clinical decision support system will result in improved blood pressure control for individuals at high risk of a cardiovascular disease event when compared with usual healthcare. This intervention will be implemented as a stepped wedge, cluster randomised controlled trial in 18 primary health centres and 54 villages in rural Andhra Pradesh involving adults aged ≥40 years at high cardiovascular disease event risk (approximately 15,000 people). Cardiovascular disease event risk will be calculated based on World Health Organisation/International Society of Hypertension's region-specific risk charts. Cluster randomisation will occur at the level of the primary health centres. Outcome analyses will be conducted blinded to intervention allocation. The primary study outcome is the difference in the proportion of people meeting guideline-recommended blood pressure targets in the intervention period vs. the control period. Secondary outcomes include mean reduction in blood pressure levels; change in other cardiovascular disease risk factors, including body mass index, current smoking, reported healthy eating habits, and reported physical activity levels; self-reported use of blood pressure and other cardiovascular medicines; quality of life (using the EQ-5D); and cardiovascular disease events (using hospitalisation data). Trial outcomes will be accompanied by detailed process and economic evaluations. The findings are likely to inform

  16. Cluster-randomised trial to evaluate the ‘Change for Life’ mass media/ social marketing campaign in the UK

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    Croker Helen

    2012-06-01

    Full Text Available Abstract Background Social marketing campaigns offer a promising approach to the prevention of childhood obesity. Change4Life (C4L is a national obesity prevention campaign in England. It included mass media coverage aiming to reframe obesity into a health issue relevant to all and provided the opportunity for parents to complete a brief questionnaire (‘How are the Kids’ and receive personalised feedback about their children’s eating and activity. Print and online C4L resources were available with guidance about healthy eating and physical activity. The study aims were to examine the impact of personalised feedback and print material from the C4L campaign on parents’ attitudes and behaviours about their children’s eating and activity in a community-based cluster-randomised controlled trial. Methods Parents of 5–11 year old children were recruited from 40 primary schools across England. Schools were randomised to intervention or control (‘usual care’. Basic demographic data and brief information about their attitudes to their children’s health were collected. Families in intervention schools were mailed the C4L print materials and the ‘How are the Kids’ questionnaire; those returning the questionnaire were sent personalised feedback and others received generic materials. Outcomes included awareness of C4L, attitudes to the behaviours recommended in C4L, parenting behaviours (monitoring and modelling, and child health behaviours (diet, physical activity and television viewing. Follow-up data were collected from parents by postal questionnaire after six months. Qualitative interviews were carried out with a subset of parents (n = 12. Results 3,774 families completed baseline questionnaires and follow-up data were obtained from 1,419 families (37.6%. Awareness was high in both groups at baseline (75%, but increased significantly in the intervention group by follow-up (96% vs. 87%. Few parents (5.2% of the intervention

  17. The effectiveness of community action in reducing risky alcohol consumption and harm: a cluster randomised controlled trial.

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    Anthony Shakeshaft

    2014-03-01

    Full Text Available The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community, and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data.We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000-20,000, were at least 100 km from an urban centre (population ≥ 100,000, and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI; feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department-based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001-2009 were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n

  18. Cluster-randomised trial to evaluate the 'Change for Life' mass media/ social marketing campaign in the UK.

    Science.gov (United States)

    Croker, Helen; Lucas, Rebecca; Wardle, Jane

    2012-06-06

    Social marketing campaigns offer a promising approach to the prevention of childhood obesity. Change4Life (C4L) is a national obesity prevention campaign in England. It included mass media coverage aiming to reframe obesity into a health issue relevant to all and provided the opportunity for parents to complete a brief questionnaire ('How are the Kids') and receive personalised feedback about their children's eating and activity. Print and online C4L resources were available with guidance about healthy eating and physical activity. The study aims were to examine the impact of personalised feedback and print material from the C4L campaign on parents' attitudes and behaviours about their children's eating and activity in a community-based cluster-randomised controlled trial. Parents of 5-11 year old children were recruited from 40 primary schools across England. Schools were randomised to intervention or control ('usual care'). Basic demographic data and brief information about their attitudes to their children's health were collected. Families in intervention schools were mailed the C4L print materials and the 'How are the Kids' questionnaire; those returning the questionnaire were sent personalised feedback and others received generic materials. Outcomes included awareness of C4L, attitudes to the behaviours recommended in C4L, parenting behaviours (monitoring and modelling), and child health behaviours (diet, physical activity and television viewing). Follow-up data were collected from parents by postal questionnaire after six months. Qualitative interviews were carried out with a subset of parents (n = 12). 3,774 families completed baseline questionnaires and follow-up data were obtained from 1,419 families (37.6%). Awareness was high in both groups at baseline (75%), but increased significantly in the intervention group by follow-up (96% vs. 87%). Few parents (5.2% of the intervention group) returned the questionnaire to get personalised feedback. There

  19. A multifaceted implementation strategy versus passive implementation of low back pain guidelines in general practice: a cluster randomised controlled trial

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    Allan Riis

    2016-10-01

    Full Text Available Abstract Background Guidelines are often slowly adapted into clinical practice. However, actively supporting healthcare professionals in evidence-based treatment may speed up guideline implementation. Danish low back pain (LBP guidelines focus on primary care treatment of LBP, to reduce referrals from primary care to secondary care. The primary aim of this project was to reduce secondary care referral within 12 weeks by a multifaceted implementation strategy (MuIS. Methods In a cluster randomised design, 189 general practices from the North Denmark Region were invited to participate. Practices were randomised (1:1 and stratified by practice size to MuIS (28 practices or a passive implementation strategy (PaIS; 32 practices. Included were patients with LBP aged 18 to 65 years who were able to complete questionnaires, had no serious underlying pathology, and were not pregnant. We developed a MuIS including outreach visits, quality reports, and the STarT Back Tool for subgrouping patients with LBP. Both groups were offered the usual dissemination of guidelines, guideline-concordant structuring of the medical record, and a new referral opportunity for patients with psycho-social problems. In an intention-to-treat analysis, the primary and secondary outcomes pertained to the patient, and a cost-effectiveness analysis was performed from a healthcare sector perspective. Patients and the assessment of outcomes were blinded. Practices and caregivers delivering the interventions were not blinded. Results Between January 2013 and July 2014, 60 practices were included, of which 54 practices (28 MuIS, 26 PaIS included 1101 patients (539 MuIS, 562 PaIS. Follow-up data for the primary outcome were available on 100 % of these patients. Twenty-seven patients (5.0 % in the MuIS group were referred to secondary care vs. 59 patients (10.5 % in the PaIS group. The adjusted odds ratio (AOR was 0.52 [95 % CI 0.30 to 0.90; p = 0.020]. The MuIS was cost

  20. Cluster-randomised trial to evaluate the ‘Change for Life’ mass media/ social marketing campaign in the UK

    Science.gov (United States)

    2012-01-01

    Background Social marketing campaigns offer a promising approach to the prevention of childhood obesity. Change4Life (C4L) is a national obesity prevention campaign in England. It included mass media coverage aiming to reframe obesity into a health issue relevant to all and provided the opportunity for parents to complete a brief questionnaire (‘How are the Kids’) and receive personalised feedback about their children’s eating and activity. Print and online C4L resources were available with guidance about healthy eating and physical activity. The study aims were to examine the impact of personalised feedback and print material from the C4L campaign on parents’ attitudes and behaviours about their children’s eating and activity in a community-based cluster-randomised controlled trial. Methods Parents of 5–11 year old children were recruited from 40 primary schools across England. Schools were randomised to intervention or control (‘usual care’). Basic demographic data and brief information about their attitudes to their children’s health were collected. Families in intervention schools were mailed the C4L print materials and the ‘How are the Kids’ questionnaire; those returning the questionnaire were sent personalised feedback and others received generic materials. Outcomes included awareness of C4L, attitudes to the behaviours recommended in C4L, parenting behaviours (monitoring and modelling), and child health behaviours (diet, physical activity and television viewing). Follow-up data were collected from parents by postal questionnaire after six months. Qualitative interviews were carried out with a subset of parents (n = 12). Results 3,774 families completed baseline questionnaires and follow-up data were obtained from 1,419 families (37.6%). Awareness was high in both groups at baseline (75%), but increased significantly in the intervention group by follow-up (96% vs. 87%). Few parents (5.2% of the intervention group) returned the

  1. The effectiveness of community action in reducing risky alcohol consumption and harm: a cluster randomised controlled trial.

    Science.gov (United States)

    Shakeshaft, Anthony; Doran, Christopher; Petrie, Dennis; Breen, Courtney; Havard, Alys; Abudeen, Ansari; Harwood, Elissa; Clifford, Anton; D'Este, Catherine; Gilmour, Stuart; Sanson-Fisher, Rob

    2014-03-01

    The World Health Organization, governments, and communities agree that community action is likely to reduce risky alcohol consumption and harm. Despite this agreement, there is little rigorous evidence that community action is effective: of the six randomised trials of community action published to date, all were US-based and focused on young people (rather than the whole community), and their outcomes were limited to self-report or alcohol purchase attempts. The objective of this study was to conduct the first non-US randomised controlled trial (RCT) of community action to quantify the effectiveness of this approach in reducing risky alcohol consumption and harms measured using both self-report and routinely collected data. We conducted a cluster RCT comprising 20 communities in Australia that had populations of 5,000-20,000, were at least 100 km from an urban centre (population ≥ 100,000), and were not involved in another community alcohol project. Communities were pair-matched, and one member of each pair was randomly allocated to the experimental group. Thirteen interventions were implemented in the experimental communities from 2005 to 2009: community engagement; general practitioner training in alcohol screening and brief intervention (SBI); feedback to key stakeholders; media campaign; workplace policies/practices training; school-based intervention; general practitioner feedback on their prescribing of alcohol medications; community pharmacy-based SBI; web-based SBI; Aboriginal Community Controlled Health Services support for SBI; Good Sports program for sports clubs; identifying and targeting high-risk weekends; and hospital emergency department-based SBI. Primary outcomes based on routinely collected data were alcohol-related crime, traffic crashes, and hospital inpatient admissions. Routinely collected data for the entire study period (2001-2009) were obtained in 2010. Secondary outcomes based on pre- and post-intervention surveys (n = 2,977 and 2

  2. Financial incentives to improve adherence to antipsychotic maintenance medication in non-adherent patients: a cluster randomised controlled trial.

    Science.gov (United States)

    Priebe, Stefan; Bremner, Stephen A; Lauber, Christoph; Henderson, Catherine; Burns, Tom

    2016-09-01

    Poor adherence to long-term antipsychotic injectable (LAI) medication in patients with psychotic disorders is associated with a range of negative outcomes. No psychosocial intervention has been found to be consistently effective in improving adherence. To test whether or not offering financial incentives is effective and cost-effective in improving adherence and to explore patient and clinician experiences with such incentives. A cluster randomised controlled trial with economic and nested qualitative evaluation. The intervention period lasted for 12 months with 24 months' follow-up. The unit of randomisation was mental health teams in the community. Community teams in secondary mental health care. Patients with a diagnosis of schizophrenia, schizoaffective psychosis or bipolar illness, receiving ≤ 75% of their prescribed LAI medication. In total, 73 teams with 141 patients (intervention n = 78 and control n = 63) were included. Participants in the intervention group received £15 for each LAI medication. Patients in the control group received treatment as usual. adherence to LAI medication (the percentage of received out of those prescribed). percentage of patients with at least 95% adherence; clinical global improvement; subjective quality of life; satisfaction with medication; hospitalisation; adverse events; and costs. Qualitative evaluation: semistructured interviews with patients in the intervention group and their clinicians. outcome data were available for 131 patients. Baseline adherence was 69% in the intervention group and 67% in the control group. During the intervention period, adherence was significantly higher in the intervention group than in the control group (85% vs. 71%) [adjusted mean difference 11.5%, 95% confidence interval (CI) 3.9% to 19.0%; p = 0.003]. Secondary outcome: patients in the intervention group showed statistically significant improvement in adherence of at least 95% (adjusted odds ratio 8.21, 95% CI 2.00 to 33

  3. Participatory women's groups and counselling through home visits to improve child growth in rural eastern India: protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Nair, Nirmala; Tripathy, Prasanta; Sachdev, Harshpal S; Bhattacharyya, Sanghita; Gope, Rajkumar; Gagrai, Sumitra; Rath, Shibanand; Rath, Suchitra; Sinha, Rajesh; Roy, Swati Sarbani; Shewale, Suhas; Singh, Vijay; Srivastava, Aradhana; Pradhan, Hemanta; Costello, Anthony; Copas, Andrew; Skordis-Worrall, Jolene; Haghparast-Bidgoli, Hassan; Saville, Naomi; Prost, Audrey

    2015-04-15

    Child stunting (low height-for-age) is a marker of chronic undernutrition and predicts children's subsequent physical and cognitive development. Around one third of the world's stunted children live in India. Our study aims to assess the impact, cost-effectiveness, and scalability of a community intervention with a government-proposed community-based worker to improve growth in children under two in rural India. The study is a cluster randomised controlled trial in two rural districts of Jharkhand and Odisha (eastern India). The intervention tested involves a community-based worker carrying out two activities: (a) one home visit to all pregnant women in the third trimester, followed by subsequent monthly home visits to all infants aged 0-24 months to support appropriate feeding, infection control, and care-giving; (b) a monthly women's group meeting using participatory learning and action to catalyse individual and community action for maternal and child health and nutrition. Both intervention and control clusters also receive an intervention to strengthen Village Health Sanitation and Nutrition Committees. The unit of randomisation is a purposively selected cluster of approximately 1000 population. A total of 120 geographical clusters covering an estimated population of 121,531 were randomised to two trial arms: 60 clusters in the intervention arm receive home visits, group meetings, and support to Village Health Sanitation and Nutrition Committees; 60 clusters in the control arm receive support to Committees only. The study participants are pregnant women identified in the third trimester of pregnancy and their children (n = 2520). Mothers and their children are followed up at seven time points: during pregnancy, within 72 hours of delivery, and at 3, 6, 9, 12 and 18 months after birth. The trial's primary outcome is children's mean length-for-age Z scores at 18 months. Secondary outcomes include wasting and underweight at all time points, birth weight, growth

  4. Gender-informed, psychoeducational programme for couples to prevent postnatal common mental disorders among primiparous women: cluster randomised controlled trial.

    Science.gov (United States)

    Fisher, Jane; Rowe, Heather; Wynter, Karen; Tran, Thach; Lorgelly, Paula; Amir, Lisa H; Proimos, Jenny; Ranasinha, Sanjeeva; Hiscock, Harriet; Bayer, Jordana; Cann, Warren

    2016-03-07

    Interventions to prevent postpartum common mental disorders (PCMD) among unselected populations of women have had limited success. The aim was to determine whether What Were We Thinking (WWWT) a gender-informed, psychoeducational programme for couples and babies can prevent PCMD among primiparous women 6 months postpartum. Cluster-randomised controlled trial. 48 Maternal and Child Health Centres (MCHCs) from 6 Local Government Areas in Melbourne, Australia were allocated randomly to usual care (24) or usual care plus WWWT (24). English-speaking primiparous women receiving primary care at trial MCHCs were recruited to the intervention (204) and control (196) conditions. Of these, 187 (91.7%) and 177 (90.3%) provided complete data. WWWT is a manualised programme comprising primary care from a trained nurse, print materials and a face-to-face seminar. Data sources were standardised and study-specific measures collected in blinded computer-assisted telephone interviews at 6 and 26 weeks postpartum. The primary outcome was PCMD assessed by Composite International Diagnostic Interviews and Patient Health Questionnaire (PHQ) Depression and Generalised Anxiety Disorder modules. In intention-to-treat analyses the adjusted OR (AOR) of PCMD in the intervention compared to the usual care group was 0.78 (95% CI 0.38 to 1.63, ns), but mild to moderate anxiety symptoms (AOR 0.58, 95% CI 0.35 to 0.97) and poor self-rated health (AOR 0.46, 95% CI 0.22 to 0.97) were significantly lower. In a per protocol analysis, comparing the full (three component) intervention and usual care groups, the AOR of PCMD was 0.36, (95% CI 0.14 to 0.95). The WWWT seminar was appraised as salient, comprehensible and useful by >85% participants. No harms were detected. WWWT is readily integrated into primary care, enables inclusion of fathers and addresses modifiable risks for PCMD directly. The full intervention appears a promising programme for preventing PCMD, optimising family functioning, and as the

  5. Preventing overuse shoulder injuries among throwing athletes: a cluster-randomised controlled trial in 660 elite handball players.

    Science.gov (United States)

    Andersson, Stig Haugsboe; Bahr, Roald; Clarsen, Benjamin; Myklebust, Grethe

    2017-07-01

    Shoulder problems are highly prevalent among elite handball players. Reduced glenohumeral rotation, external rotation weakness and scapula dyskinesis have been identified as risk factors. Evaluate the effect of an exercise programme designed to reduce the prevalence of shoulder problems in elite handball. 45 elite handball teams (22 female teams, 23 male teams, 660 players) were cluster randomised (22 teams, 331 players in the intervention group, 23 teams, 329 players in the control group) and followed for 1 competitive season (7 months). The Oslo Sports Trauma Research Center (OSTRC) Shoulder Injury Prevention Programme, an exercise programme to increase glenohumeral internal rotation, external rotation strength and scapular muscle strength, as well as improve kinetic chain and thoracic mobility, was delivered by coaches and captains 3 times per week as a part of the handball warm-up. The main outcome measures, prevalence of shoulder problems and substantial shoulder problems, were measured monthly. The average prevalence of shoulder problems during the season was 17% (95% CI 16% to 19%) in the intervention group and 23% (95% CI 21% to 26%) in the control group (mean difference 6%). The average prevalence of substantial shoulder problems was 5% (95% CI 4% to 6%) in the intervention group and 8% (95% CI 7% to 9%) in the control group (mean difference 3%). Using generalised estimating equation models, a 28% lower risk of shoulder problems (OR 0.72, 95% CI 0.52 to 0.98, p=0.038) and 22% lower risk of substantial shoulder problems (OR 0.78, 95% CI 0.53 to 1.16, p=0.23) were observed in the intervention group compared with the control group. The OSTRC Shoulder Injury Prevention Programme reduced the prevalence of shoulder problems in elite handball and should be included as a part of the warm-up. ISRCTN96217107. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  6. Improving help-seeking for postnatal depression and anxiety: a cluster randomised controlled trial of motivational interviewing.

    Science.gov (United States)

    Holt, Charlene; Milgrom, Jeannette; Gemmill, Alan W

    2017-12-01

    Low uptake of treatment by women with symptoms of postnatal depression and anxiety is consistently reported. This study examined whether a brief motivational interviewing (MI) intervention delivered by Maternal and Child Health Nurses (MCHNs) during routine emotional health assessments improves help-seeking following childbirth. In this parallel two-group cluster randomised controlled trial, MCHNs delivered a MI intervention ('PRIMER', n = 20) or Routine Care (n = 20) at women's (n = 541) postnatal consultations. The primary outcome was help-seeking over the 12 months post-birth. Other outcomes were emotional distress measured by the Edinburgh Postnatal Depression Scale, Beck Depression Inventory-Revised and Depression Anxiety Stress Scales, and barriers to help-seeking obtained by self-report via a checklist of potential barriers that was presented to women to select from if applicable. 27.4% of the sample experienced emotional distress over the 12 months post-birth. When comparing women who experienced emotional distress with those who did not, odds of seeking help were 4.0 times higher for the MI condition than Routine Care (p = .004). Of the women who sought help from a psychologist, 47.6% in the MI condition attended 6 + sessions versus 20.0% in Routine Care (numbers too small for reliable significance test). There was a non-significant trend of lower depression, anxiety and stress in the MI condition. Three risk factors for postnatal depression predicted help-seeking: antenatal anxiety (OR = 2.8, p = .002), depression history (OR = 2.5, p = .002) and self-esteem (OR = 0.7, p = .04). Common barriers to seeking help were thinking that one would or should be able to manage without help (endorsed by 11.1%). Treatment uptake for postnatal distress can be increased with MI. Training MCHNs in MI was feasible and valued. Given the devastating effects of depression, further research is needed to ascertain whether MI can improve mental health

  7. A cluster randomised trial to assess the impact of clinical pathways on AMI management in rural Australian emergency departments

    Directory of Open Access Journals (Sweden)

    Snow Pamela C

    2009-05-01

    Full Text Available Abstract Background People living in rural Australia are more likely to die in hospital following an acute myocardial infarction than those living in major cities. While several factors, including time taken to access hospital care, contribute to this risk, it is also partially attributable to the lower uptake of evidence-based guidelines for the administration of thrombolytic drugs in rural emergency departments where up to one-third of eligible patients do not receive this life-saving intervention. Clinical pathways have the potential to link evidence to practice by integrating guidelines into local systems, but their impact has been hampered by variable implementation strategies and sub-optimal research designs. The purpose of this study is to determine the impact of a five-step clinical pathways implementation process on the timely and efficient administration of thrombolytic drugs for acute myocardial infarctions managed in rural Australian emergency departments. Methods/Design The design is a two-arm, cluster-randomised trial with rural hospital emergency departments that treat and do not routinely transfer acute myocardial infarction patients. Six rural hospitals in the state of Victoria will participate, with three in the intervention group and three in the control group. Intervention hospitals will participate in a five-step clinical pathway implementation process: engagement of clinicians, pathway development according to local resources and systems, reminders, education, and audit and feedback. Hospitals in the control group will each receive a hard copy of Australian national guidelines for chest pain and acute myocardial infarction management. Each group will include 90 cases to give a power of 80% at 5% significance level for the two primary outcome measures: proportion of those eligible for thrombolysis receiving the drug and time to delivery of thrombolytic drug. Discussion Improved compliance with thrombolytic guidelines via

  8. The use of feasibility studies for stepped-wedge cluster randomised trials: protocol for a review of impact and scope.

    Science.gov (United States)

    Kristunas, Caroline A; Hemming, Karla; Eborall, Helen C; Gray, Laura J

    2017-08-01

    The stepped-wedge cluster randomised trial (SW-CRT) is a complex design, for which many decisions about key design parameters must be made during the planning. These include the number of steps and the duration of time needed to embed the intervention. Feasibility studies are likely to be useful for informing these decisions and increasing the likelihood of the main trial's success. However, the number of feasibility studies being conducted for SW-CRTs is currently unknown. This review aims to establish the number of feasibility studies being conducted for SW-CRTs and determine which feasibility issues are commonly investigated. Fully published feasibility studies for SW-CRTs will be identified, according to predefined inclusion criteria, from searches conducted in Ovid MEDLINE, Scopus, Embase and PsycINFO. To also identify and gain information on unpublished feasibility studies the following will be contacted: authors of published SW-CRTs (identified from the most recent systematic reviews); contacts for registered SW-CRTs (identified from clinical trials registries); lead statisticians of UK registered clinical trials units and researchers known to work in the area of SW-CRTs.Data extraction will be conducted independently by two reviewers. For the fully published feasibility studies, data will be extracted on the study characteristics, the rationale for the study, the process for determining progression to a main trial, how the study informed the main trial and whether the main trial went ahead. The researchers involved in the unpublished feasibility studies will be contacted to elicit the same information.A narrative synthesis will be conducted and provided alongside a descriptive analysis of the study characteristics. This review does not require ethical approval, as no individual patient data will be used. The results of this review will be published in an open-access peer-reviewed journal. © Article author(s) (or their employer(s) unless otherwise stated in

  9. Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Katherine E Halliday

    2014-01-01

    Full Text Available Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement. However, there is limited experimental evidence of the benefits of alternative school-based malaria interventions or how the impacts of interventions vary according to intensity of malaria transmission. We investigated the effect of intermittent screening and treatment (IST for malaria on the health and education of school children in an area of low to moderate malaria transmission.A cluster randomised trial was implemented with 5,233 children in 101 government primary schools on the south coast of Kenya in 2010-2012. The intervention was delivered to children randomly selected from classes 1 and 5 who were followed up for 24 months. Once a school term, children were screened by public health workers using malaria rapid diagnostic tests (RDTs, and children (with or without malaria symptoms found to be RDT-positive were treated with a six dose regimen of artemether-lumefantrine (AL. Given the nature of the intervention, the trial was not blinded. The primary outcomes were anaemia and sustained attention. Secondary outcomes were malaria parasitaemia and educational achievement. Data were analysed on an intention-to-treat basis. During the intervention period, an average of 88.3% children in intervention schools were screened at each round, of whom 17.5% were RDT-positive. 80.3% of children in the control and 80.2% in the intervention group were followed-up at 24 months. No impact of the malaria IST intervention was observed for prevalence of anaemia at either 12 or 24 months (adjusted risk ratio [Adj.RR]: 1.03, 95% CI 0.93-1.13, p = 0.621 and Adj.RR: 1.00, 95% CI 0.90-1.11, p = 0.953 respectively, or on prevalence of P. falciparum infection or scores of classroom attention. No effect of IST was observed on educational achievement in the older class, but an apparent negative effect was seen on spelling scores in

  10. Evaluation of community level interventions to address social and structural determinants of health: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Draper Alizon

    2009-06-01

    Full Text Available Abstract Background In London and the rest of the UK, diseases associated with poor diet, inadequate physical activity and mental illness account for a large proportion of area based health inequality. There is a lack of evidence on interventions promoting healthier behaviours especially in marginalised populations, at a structural or ecological level and utilising a community development approach. The Well London project financed by the Big Lottery 'Wellbeing' Fund and implemented by a consortium of London based agencies led by the Greater London Authority and the London Health Commission is implementing a set of complex interventions across 20 deprived areas of London. The interventions focus on healthy eating, healthy physical activity and mental health and wellbeing and are designed and executed with community participation complementing existing facilities and services. Methods/Design The programme will be evaluated through a cluster randomised controlled trial. Forty areas across London were chosen based on deprivation scores. Areas were characterised by high proportion of Black and Minority Ethnic residents, worklessness, ill-health and poor physical environments. Twenty areas were randomly assigned to the intervention arm of Well London project and twenty 'matched' areas assigned as controls. Measures of physical activity, diet and mental health are collected at start and end of the project and compared to assess impact. The quantitative element will be complemented by a longitudinal qualitative study elucidating pathways of influence between intervention activities and health outcomes. A related element of the study investigates the health-related aspects of the structural and ecological characteristics of the project areas. The project 'process' will also be evaluated. Discussion The size of the project and the fact that the interventions are 'complex' in the sense that firstly, there are a number of interacting components with a wide

  11. Support and Assessment for Fall Emergency Referrals (SAFER 1: cluster randomised trial of computerised clinical decision support for paramedics.

    Directory of Open Access Journals (Sweden)

    Helen Anne Snooks

    Full Text Available To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS for paramedics attending older people who fall.Cluster trial randomised by paramedic; modelling.13 ambulance stations in two UK emergency ambulance services.42 of 409 eligible paramedics, who attended 779 older patients for a reported fall.Intervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture.Effectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care.Further emergency contacts or death within one month.Costs and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness.17 intervention paramedics used CCDS for 54 (12.4% of 436 participants. They referred 42 (9.6% to falls services, compared with 17 (5.0% of 343 participants seen by 19 control paramedics [Odds ratio (OR 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72; quality of life (mean SF12 differences: MCS -0.74, 95% CI -2.83 to +1.28; PCS -0.13, 95% CI -1.65 to +1.39 and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52. However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3. Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without.Intervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture.ISRCTN Register ISRCTN

  12. Study protocol: Brief intervention for medication overuse headache - A double-blinded cluster randomised parallel controlled trial in primary care

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    Kristoffersen Espen

    2012-08-01

    Full Text Available Abstract Background Chronic headache (headache ≥ 15 days/month for at least 3 months affects 2–5% of the general population. Medication overuse contributes to the problem. Medication-overuse headache (MOH can be identified by using the Severity of Dependence Scale (SDS. A “brief intervention” scheme (BI has previously been used for detoxification from drug and alcohol overuse in other settings. Short, unstructured, individualised simple information may also be enough to detoxify a large portion of those with MOH. We have adapted the structured (BI scheme to be used for MOH in primary care. Methods/Design A double-blinded cluster randomised parallel controlled trial (RCT of BI vs. business as usual. Intervention will be performed in primary care by GPs trained in BI. Patients with MOH will be identified through a simple screening questionnaire sent to patients on the GPs lists. The BI method involves an approach for identifying patients with high likelihood of MOH using simple questions about headache frequency and the SDS score. Feedback is given to the individual patient on his/her score and consequences this might have regarding the individual risk of medication overuse contributing to their headache. Finally, advice is given regarding measures to be taken, how the patient should proceed and the possible gains for the patient. The participating patients complete a headache diary and receive a clinical interview and neurological examination by a GP experienced in headache diagnostics three months after the intervention. Primary outcomes are number of headache days and number of medication days per month at 3 months. Secondary outcomes include proportions with 25 and 50% improvement at 3 months and maintenance of improvement and quality of life after 12 months. Discussion There is a need for evidence-based and cost-effective strategies for treatment of MOH but so far no consensus has been reached regarding an optimal medication

  13. Improvement in neonatal intensive care unit care: a cluster randomised controlled trial of active dissemination of information.

    Science.gov (United States)

    Acolet, Dominique; Allen, Elizabeth; Houston, Rosie; Wilkinson, Andrew R; Costeloe, Kate; Elbourne, Diana

    2011-11-01

    Research findings are not rapidly or fully implemented into policies and practice in care. To assess whether an 'active' strategy was more likely to lead to changes in policy and practice in preterm baby care than traditional information dissemination. Cluster randomised trial. 180 neonatal units (87 active, 93 control) in England; clinicians from active arm units; babies born Dissemination of research report; slides; information about newborn care position statement. ACTIVE ARM: As above plus offer to become 'regional 'champion' (attend two workshops, support clinicians to implement research evidence regionally), or attend one workshop, promote implementation of research evidence locally. timing of surfactant administration; admission temperature; staffing of resuscitation team present at birth. 48/87 Lead clinicians in the active arm attended one or both workshops. There was no evidence of difference in post-intervention policies between trial arms. Practice outcomes based on babies in the active (169) and control arms (186), in 45 and 49 neonatal units respectively, showed active arm babies were more likely to have been given surfactant on labour ward (RR=1.30; 95% CI 0.99 to 1.70); p=0.06); to have a higher temperature on admission to neonatal intensive care unit (mean difference=0.29(o)C; 95% CI 0.22 to 0.55; p=0.03); and to have had the baby's trunk delivered into a plastic bag (RR=1.27; 95% CI 1.01 to 1.60; p=0.04) than the control group. The effect on having an 'ideal' resuscitation team at birth was in the same direction of benefit for the active arm (RR=1.18; 95% CI 0.97 to 1.43; p=0.09). The costs of the intervention were modest. This is the first trial to evaluate methods for transferring information from neonatal research into local policies and practice in England. An active approach to research dissemination is both feasible and cost-effective. Current controlled trials ISRCTN89683698.

  14. Target for improvement: a cluster randomised trial of public involvement in quality-indicator prioritisation (intervention development and study protocol

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    Burgers Jako

    2011-05-01

    Full Text Available Abstract Background Public priorities for improvement often differ from those of clinicians and managers. Public involvement has been proposed as a way to bridge the gap between professional and public clinical care priorities but has not been studied in the context of quality-indicator choice. Our objective is to assess the feasibility and impact of public involvement on quality-indicator choice and agreement with public priorities. Methods We will conduct a cluster randomised controlled trial comparing quality-indicator prioritisation with and without public involvement. In preparation for the trial, we developed a 'menu' of quality indicators, based on a systematic review of existing validated indicator sets. Participants (public representatives, clinicians, and managers will be recruited from six participating sites. In intervention sites, public representatives will be involved through direct participation (public representatives, clinicians, and managers will deliberate together to agree on quality-indicator choice and use and consultation (individual public recommendations for improvement will be collected and presented to decision makers. In control sites, only clinicians and managers will take part in the prioritisation process. Data on quality-indicator choice and intended use will be collected. Our primary outcome will compare quality-indicator choice and agreement with public priorities between intervention and control groups. A process evaluation based on direct observation, videorecording, and participants' assessment will be conducted to help explain the study's results. The marginal cost of public involvement will also be assessed. Discussion We identified 801 quality indicators that met our inclusion criteria. An expert panel agreed on a final set of 37 items containing validated quality indicators relevant for chronic disease prevention and management in primary care. We pilot tested our public-involvement intervention with 27

  15. The Effect of Intermittent Antenatal Iron Supplementation on Maternal and Infant Outcomes in Rural Viet Nam: A Cluster Randomised Trial

    Science.gov (United States)

    Hanieh, Sarah; Ha, Tran T.; Simpson, Julie A.; Casey, Gerard J.; Khuong, Nguyen C.; Thoang, Dang D.; Thuy, Tran T.; Pasricha, Sant-Rayn; Tran, Thach D.; Tuan, Tran; Dwyer, Terence; Fisher, Jane; Biggs, Beverley-Ann

    2013-01-01

    Background Anemia affects over 500 million women, and in pregnancy is associated with impaired maternal and infant outcomes. Intermittent antenatal iron supplementation is an attractive alternative to daily dosing; however, the impact of this strategy on infant outcomes remains unclear. We compared the effect of intermittent antenatal iron supplementation with daily iron supplementation on maternal and infant outcomes in rural Viet Nam. Methods and Findings This cluster randomised trial was conducted in Ha Nam province, Viet Nam. 1,258 pregnant women (<16 wk gestation) in 104 communes were assigned to daily iron–folic acid (IFA), twice weekly IFA, or twice weekly multiple micronutrient (MMN) supplementation. Primary outcome was birth weight. Mean birth weight was 3,148 g (standard deviation 416). There was no difference in the birth weights of infants of women receiving twice weekly IFA compared to daily IFA (mean difference [MD] 28 g; 95% CI −22 to 78), or twice weekly MMN compared to daily IFA (MD −36.8 g; 95% CI −82 to 8.2). At 32 wk gestation, maternal ferritin was lower in women receiving twice weekly IFA compared to daily IFA (geometric mean ratio 0.73; 95% CI 0.67 to 0.80), and in women receiving twice weekly MMN compared to daily IFA (geometric mean ratio 0.62; 95% CI 0.57 to 0.68), but there was no difference in hemoglobin levels. Infants of mothers who received twice weekly IFA had higher cognitive scores at 6 mo of age compared to those who received daily IFA (MD 1.89; 95% CI 0.23 to 3.56). Conclusions Twice weekly antenatal IFA or MMN did not produce a clinically important difference in birth weight, when compared to daily IFA supplementation. The significant improvement in infant cognitive outcomes at 6 mo of age following twice weekly antenatal IFA requires further exploration, and provides additional support for the use of intermittent, rather than daily, antenatal IFA in populations with low rates of iron deficiency. Trial registration

  16. Translating staff experience into organisational improvement: the HEADS-UP stepped wedge, cluster controlled, non-randomised trial

    Science.gov (United States)

    Athanasiou, Thanos; Long, Susannah J; Beveridge, Iain; Sevdalis, Nick

    2017-01-01

    Objectives Frontline insights into care delivery correlate with patients’ clinical outcomes. These outcomes might be improved through near-real time identification and mitigation of staff concerns. We evaluated the effects of a prospective frontline surveillance system on patient and team outcomes. Design Prospective, stepped wedge, non-randomised, cluster controlled trial; prespecified per protocol analysis for high-fidelity intervention delivery. Participants Seven interdisciplinary medical ward teams from two hospitals in the UK. Intervention Prospective clinical team surveillance (PCTS): structured daily interdisciplinary briefings to capture staff concerns, with organisational facilitation and feedback. Main measures The primary outcome was excess length of stay (eLOS): an admission more than 24 hours above the local average for comparable patients. Secondary outcomes included safety and teamwork climates, and incident reporting. Mixed-effects models adjusted for time effects, age, comorbidity, palliation status and ward admissions. Safety and teamwork climates were measured with the Safety Attitudes Questionnaire. High-fidelity PCTS delivery comprised high engagement and high briefing frequency. Results Implementation fidelity was variable, both in briefing frequency (median 80% working days/month, IQR 65%–90%) and engagement (median 70 issues/ward/month, IQR 34–113). 1714/6518 (26.3%) intervention admissions had eLOS versus 1279/4927 (26.0%) control admissions, an absolute risk increase of 0.3%. PCTS increased eLOS in the adjusted intention-to-treat model (OR 1.32, 95% CI 1.10 to 1.58, p=0.003). Conversely, high-fidelity PCTS reduced eLOS (OR 0.79, 95% CI 0.67 to 0.94, p=0.006). High-fidelity PCTS also increased total, high-yield and non-nurse incident reports (incidence rate ratios 1.28–1.79, all p<0.002). Sustained PCTS significantly improved safety and teamwork climates over time. Conclusions This study highlighted the potential benefits and

  17. Meta Salud Diabetes study protocol: a cluster-randomised trial to reduce cardiovascular risk among a diabetic population of Mexico.

    Science.gov (United States)

    Sabo, Samantha; Denman Champion, Catalina; Bell, Melanie L; Cornejo Vucovich, Elsa; Ingram, Maia; Valenica, Celina; Castro Vasquez, Maria Del Carmen; Gonzalez-Fagoaga, Eduardo; Geurnsey de Zapien, Jill; Rosales, Cecilia B

    2018-03-12

    Northern Mexico has among the highest rates of cardiovascular disease (CVD) and diabetes in the world. This research addresses core gaps in implementation science to develop, test and scale-up CVD risk-reduction interventions in diabetics through a national primary care health system. The Meta Salud Diabetes (MSD) research project is a parallel two-arm cluster-randomised clinical behavioural trial based in 22 (n=22) health centres in Sonora, Mexico. MSD aims to evaluate the effectiveness of the MSD intervention for the secondary prevention of CVD risk factors among a diabetic population (n=320) compared with the study control of usual care. The MSD intervention consists of 2-hour class sessions delivered over a 13-week period providing educational information to encourage sustainable behavioural change to prevent disease complications including the adoption of physical activity. MSD is delivered within the context of Mexico's national primary care health centre system by health professionals, including nurses, physicians and community health workers via existing social support groups for individuals diagnosed with chronic disease. Mixed models are used to estimate the effect of MSD by comparing cardiovascular risk, as measured by the Framingham Risk Score, between the trial arms. Secondary outcomes include hypertension, behavioural risk factors and psychosocial factors. This work is supported by the National Institutes of Health, National Heart Lung and Blood Institute (1R01HL125996-01) and approved by the University of Arizona Research Institutional Review Board (Protocol 1508040144) and the Research Bioethics Committee at the University of Sonora. The first Internal Review Board approval date was 31 August 2015 with five subsequent approved amendments. This article refers to protocol V.0.2, dated 30 January 2017. Results will be disseminated via peer-reviewed publication and presentation at international conferences and will be shared through meetings with health

  18. Enhancing implementation of tobacco use prevention and cessation counselling guideline among dental providers: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Michie Susan

    2011-02-01

    Full Text Available Abstract Background Tobacco use adversely affects oral health. Tobacco use prevention and cessation (TUPAC counselling guidelines recommend that healthcare providers ask about each patient's tobacco use, assess the patient's readiness and willingness to stop, document tobacco use habits, advise the patient to stop, assist and help in quitting, and arrange monitoring of progress at follow-up appointments. Adherence to such guidelines, especially among dental providers, is poor. To improve guideline implementation, it is essential to understand factors influencing it and find effective ways to influence those factors. The aim of the present study protocol is to introduce a theory-based approach to diagnose implementation difficulties of TUPAC counselling guidelines among dental providers. Methods Theories of behaviour change have been used to identify key theoretical domains relevant to the behaviours of healthcare providers involved in implementing clinical guidelines. These theoretical domains will inform the development of a questionnaire aimed at assessing the implementation of the TUPAC counselling guidelines among Finnish municipal dental providers. Specific items will be drawn from the guidelines and the literature on TUPAC studies. After identifying potential implementation difficulties, we will design two interventions using theories of behaviour change to link them with relevant behaviour change techniques aiming to improve guideline adherence. For assessing the implementation of TUPAC guidelines, the electronic dental record audit and self-reported questionnaires will be used. Discussion To improve guideline adherence, the theoretical-domains approach could provide a comprehensive basis for assessing implementation difficulties, as well as designing and evaluating interventions. After having identified implementation difficulties, we will design and test two interventions to enhance TUPAC guideline adherence. Using the cluster

  19. From hypertension control to global cardiovascular risk management: an educational intervention in a cluster-randomised controlled trial.

    Science.gov (United States)

    Mortsiefer, Achim; Meysen, Tobias; Schumacher, Martin; Abholz, Heinz-Harald; Wegscheider, Karl; In der Schmitten, Jürgen

    2015-05-07

    Guidelines on hypertension management recommend adjusting therapeutic efforts in accordance with global cardiovascular risk (CVR) rather than by blood pressure levels alone. However, this paradigm change has not yet arrived in German General Practice. We have evaluated the effect of an educational outreach visit with general practitioners (GPs), encouraging them to consider CVR in treatment decisions for patients with hypertension. Prospective cluster-randomised trial comprising 3443 patients with known hypertension treated by 87 GPs. Practices were randomly assigned to complex (A) or simple (B) intervention. Both groups received a guideline by mail; group A also received complex peer intervention promoting the concept of global CVR. Clinical data were collected at baseline and 6-9 months after intervention. Main outcome was improvement of calculated CVR in the predefined subpopulation of patients with a high CVR (10-year mortality ≥5%), but no manifest cardiovascular disease. Adjusted for baseline the follow-up CVR were 13.1% (95% CI 12.6%-13.6%) (A) and 12.6% (95% CI 12.2%-13.1%) (B) with a group difference (A vs. B) of 0.5% (-0.2%-1.1%), p = 0.179. The group difference was -0.05% in patients of GPs familiar with global CVR and 1.1% in patients of GPs not familiar with with global CVR. However, this effect modification was not significant (p = 0.165). Pooled over groups, the absolute CVR reduction from baseline was 1.0%, p intervention group, and from 35.6 to 46.5% in the simple intervention group, with adjusted follow-up control rates of 46.7% (95% CI 40.4%-53.1%) (A) and 46.9% (95% CI 40.3%-53.5% (B) and an adjusted odds ratio (A vs B) of 0.99 (95% CI 0.68-1.45), p = 0.966. Our complex educational intervention, including a clinical outreach visit, had no significant effect on CVR of patients with known hypertension at high risk compared to a simple postal intervention. ISRCTN44478543 .

  20. Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Ørner Roderick

    2009-01-01

    Full Text Available Abstract Background Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety. Methods and design This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs. Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing. Discussion Previous studies in adults

  1. Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers

    Directory of Open Access Journals (Sweden)

    Barton Pelham

    2011-08-01

    Full Text Available Abstract Background Smoking prevalence is high among Pakistani and Bangladeshi men in the UK, but there are few tailored smoking cessation programmes for Pakistani and Bangladeshi communities. The aim of this study was to pilot a cluster randomised controlled trial comparing the effectiveness of Pakistani and Bangladeshi smoking cessation outreach workers with standard care to improve access to and the success of English smoking cessation services. Methods A pilot cluster randomised controlled trial was conducted in Birmingham, UK. Geographical lower layer super output areas were used to identify natural communities where more than 10% of the population were of Pakistani and Bangladeshi origin. 16 agglomerations of super output areas were randomised to normal care controls vs. outreach intervention. The number of people setting quit dates using NHS services, validated abstinence from smoking at four weeks, and stated abstinence at three and six months were assessed. The impact of the intervention on choice and adherence to treatments, attendance at clinic appointments and patient satisfaction were also assessed. Results We were able to randomise geographical areas and deliver the outreach worker-based services. More Pakistani and Bangladeshi men made quit attempts with NHS services in intervention areas compared with control areas, rate ratio (RR 1.32 (95%CI: 1.03-1.69. There was a small increase in the number of 4-week abstinent smokers in intervention areas (RR 1.30, 95%CI: 0.82-2.06. The proportion of service users attending weekly appointments was lower in intervention areas than control areas. No difference was found between intervention and control areas in choice and adherence to treatments or patient satisfaction with the service. The total cost of the intervention was £124,000; an estimated cost per quality-adjusted life year (QALY gained of £8,500. Conclusions The intervention proved feasible and acceptable. Outreach workers expanded

  2. Using Cluster Analysis to Group Countries for Cost-effectiveness Analysis: An Application to Sub-Saharan Africa.

    Science.gov (United States)

    Russell, Louise B; Bhanot, Gyan; Kim, Sun-Young; Sinha, Anushua

    2018-02-01

    To explore the use of cluster analysis to define groups of similar countries for the purpose of evaluating the cost-effectiveness of a public health intervention-maternal immunization-within the constraints of a project budget originally meant for an overall regional analysis. We used the most common cluster analysis algorithm, K-means, and the most common measure of distance, Euclidean distance, to group 37 low-income, sub-Saharan African countries on the basis of 24 measures of economic development, general health resources, and past success in public health programs. The groups were tested for robustness and reviewed by regional disease experts. We explored 2-, 3- and 4-group clustering. Public health performance was consistently important in determining the groups. For the 2-group clustering, for example, infant mortality in Group 1 was 81 per 1,000 live births compared with 51 per 1,000 in Group 2, and 67% of children in Group 1 received DPT immunization compared with 87% in Group 2. The experts preferred four groups to fewer, on the ground that national decision makers would more readily recognize their country among four groups. Clusters defined by K-means clustering made sense to subject experts and allowed a more detailed evaluation of the cost-effectiveness of maternal immunization within the constraint of the project budget. The method may be useful for other evaluations that, without having the resources to conduct separate analyses for each unit, seek to inform decision makers in numerous countries or subdivisions within countries, such as states or counties.

  3. Free breakfasts in schools: design and conduct of a cluster randomised controlled trial of the Primary School Free Breakfast Initiative in Wales [ISRCTN18336527].

    Science.gov (United States)

    Moore, Laurence; Moore, Graham F; Tapper, Katy; Lynch, Rebecca; Desousa, Carol; Hale, Janine; Roberts, Chris; Murphy, Simon

    2007-09-21

    School-based breakfast provision is increasingly being seen as a means of improving educational performance and dietary behaviour amongst children. Furthermore, recognition is growing that breakfast provision offers potential as a means of addressing social inequalities in these outcomes. At present however, the evidence base on the effectiveness of breakfast provision in bringing about these improvements is limited. This paper describes the research design of a large scale evaluation of the effectiveness of the Welsh Assembly Government's Primary School Free Breakfast Initiative. A cluster randomised trial, with school as the unit of randomisation was used for the outcome evaluation, with a nested qualitative process evaluation. Quantitative outcome measures included dietary habits, attitudes, cognitive function, classroom behaviour, and school attendance. The study recruited 111 primary schools in Wales, of which 56 were randomly assigned to control condition and 55 to intervention. Participants were Year 5 and 6 students (aged 9-11 years) in these schools. Data were collected for all 111 schools at each of three time points: baseline, 4 month and 12 month follow-up. This was achieved through a repeated cross-sectional survey of approximately 4350 students on each of these occasions. Of those students in Year 5 at baseline, 1975 provided data at one or both of the follow-ups, forming a nested cohort. The evaluation also included a nested process evaluation, using questionnaires, semi-structured interviews and case studies with students, school staff, and local authority scheme coordinators as key informants. An overview of the methods used for the evaluation is presented, providing an example of the feasibility of conducting robust evaluations of policy initiatives using a randomised trial design with nested process evaluation. Details are provided of response rates and the flow of participants. Reflection is offered on methodological issues encountered at

  4. Epidemiology of intestinal parasite infections in three departments of south-central Côte d’Ivoire before the implementation of a cluster-randomised trial

    Directory of Open Access Journals (Sweden)

    Gaoussou Coulibaly

    2018-05-01

    affected a considerable proportion of rural dwellers in south-central Côte d’Ivoire at the onset of a cluster-randomised intervention trial. Our results will serve as baseline to monitor the effect of a package of interventions, including preventive chemotherapy, sanitation and health education on re-infection with helminths and intestinal protozoa.Trial registration: ISRCTN53102033 (date assigned: 26 March 2014 Keywords: Côte d’Ivoire, Integrated control, Intestinal protozoa, Sanitation and hygiene, Schistosomiasis, Soil-transmitted helminthiasis

  5. Cardiovascular risk outcome and program evaluation of a cluster randomised controlled trial of a community-based, lay peer led program for people with diabetes

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    M. A. Riddell

    2016-08-01

    Full Text Available Abstract Background The 2013 Global Burden of Disease Study demonstrated the increasing burden of diabetes and the challenge it poses to the health systems of all countries. The chronic and complex nature of diabetes requires active self-management by patients in addition to clinical management in order to achieve optimal glycaemic control and appropriate use of available clinical services. This study is an evaluation of a “real world” peer support program aimed at improving the control and management of type 2 diabetes (T2DM in Australia. Methods The trial used a randomised cluster design with a peer support intervention and routine care control arms and 12-month follow up. Participants in both arms received a standardised session of self-management education at baseline. The intervention program comprised monthly community-based group meetings over 12 months led by trained peer supporters and active encouragement to use primary health care and other community resources and supports related to diabetes. Clinical, behavioural and other measures were collected at baseline, 6 and 12 months. The primary outcome was the predicted 5 year cardiovascular disease risk using the United Kingdom Prospective Diabetes Study (UKPDS Risk Equation at 12 months. Secondary outcomes included clinical measures, quality of life, measures of support, psychosocial functioning and lifestyle measures. Results Eleven of 12 planned groups were successfully implemented in the intervention arm. Both the usual care and the intervention arms demonstrated a small reduction in 5 year UKPDS risk and the mean values for biochemical and anthropometric outcomes were close to target at 12 months. There were some small positive changes in self-management behaviours. Conclusions The positive changes in self-management behaviours among intervention participants were not sufficient to reduce cardiovascular risk, possibly because approximately half of the study participants

  6. Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia.

    Science.gov (United States)

    Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen

    2014-01-01

    In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health

  7. Community-based trial of annual versus biannual single-dose ivermectin plus albendazole against Wuchereria bancrofti infection in human and mosquito populations: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    de Souza, Dziedzom K; Ahorlu, Collins S; Adu-Amankwah, Susan; Otchere, Joseph; Mensah, Sedzro K; Larbi, Irene A; Mensah, George E; Biritwum, Nana-Kwadwo; Boakye, Daniel A

    2017-10-02

    The Global Programme for the Elimination of Lymphatic Filariasis (GPELF) has been in operation since the year 2000, with the aim of eliminating the disease by the year 2020, following five to six rounds of effective annual mass drug administration (MDA). The treatment regimen is ivermectin (IVM) in combination with diethylcarbamazine (DEC) or albendazole (ALB). In Ghana, MDA has been undertaken since 2001. While the disease has been eliminated in many areas, transmission has persisted in some implementation units that had experienced 15 or more rounds of MDA. Thus, new intervention strategies could eliminate residual infection in areas of persistent transmission and speed up the lymphatic filariasis (LF)-elimination process. This study, therefore, seeks to test the hypothesis that biannual treatment of LF-endemic communities will accelerate the interruption of LF in areas of persistent transmission. A cluster randomised trial will be implemented in LF-endemic communities in Ghana. The interventions will be yearly or twice-yearly MDA delivered to entire endemic communities. Allocation to study group will be by clusters identified using the prevalence of LF. Clusters will be randomised to one of two groups: receiving either (1) annual treatment with IVM + ALB or (2) annual MDA with IVM + ALB, followed by an additional MDA 6 months later. The primary outcome measure is the prevalence of LF infection, assessed by four cross-sectional surveys. Entomological assessments will also be undertaken to evaluate the transmission intensity of the disease in the study clusters. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, microfilaria prevalence will be assessed longitudinally. A nested process evaluation, using semi-structured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system. It is expected that this study will add to

  8. The evaluation of enhanced feedback interventions to reduce unnecessary blood transfusions (AFFINITIE): protocol for two linked cluster randomised factorial controlled trials.

    Science.gov (United States)

    Hartley, Suzanne; Foy, Robbie; Walwyn, Rebecca E A; Cicero, Robert; Farrin, Amanda J; Francis, Jill J; Lorencatto, Fabiana; Gould, Natalie J; Grant-Casey, John; Grimshaw, Jeremy M; Glidewell, Liz; Michie, Susan; Morris, Stephen; Stanworth, Simon J

    2017-07-03

    Blood for transfusion is a frequently used clinical intervention, and is also a costly and limited resource with risks. Many transfusions are given to stable and non-bleeding patients despite no clear evidence of benefit from clinical studies. Audit and feedback (A&F) is widely used to improve the quality of healthcare, including appropriate use of blood. However, its effects are often inconsistent, indicating the need for coordinated research including more head-to-head trials comparing different ways of delivering feedback. A programmatic series of research projects, termed the 'Audit and Feedback INterventions to Increase evidence-based Transfusion practIcE' (AFFINITIE) programme, aims to test different ways of developing and delivering feedback within an existing national audit structure. The evaluation will comprise two linked 2×2 factorial, cross-sectional cluster-randomised controlled trials. Each trial will estimate the effects of two feedback interventions, 'enhanced content' and 'enhanced follow-on support', designed in earlier stages of the AFFINITIE programme, compared to current practice. The interventions will be embedded within two rounds of the UK National Comparative Audit of Blood Transfusion (NCABT) focusing on patient blood management in surgery and use of blood transfusions in patients with haematological malignancies. The unit of randomisation will be National Health Service (NHS) trust or health board. Clusters providing care relevant to the audit topics will be randomised following each baseline audit (separately for each trial), with stratification for size (volume of blood transfusions) and region (Regional Transfusion Committee). The primary outcome for each topic will be the proportion of patients receiving a transfusion coded as unnecessary. For each audit topic a linked, mixed-method fidelity assessment and cost-effectiveness analysis will be conducted in parallel to the trial. AFFINITIE involves a series of studies to explore how A

  9. An exploratory cluster randomised trial of a university halls of residence based social norms marketing campaign to reduce alcohol consumption among 1st year students.

    Science.gov (United States)

    Moore, Graham F; Williams, Annie; Moore, Laurence; Murphy, Simon

    2013-04-18

    This exploratory trial examines the feasibility of implementing a social norms marketing campaign to reduce student drinking in universities in Wales, and evaluating it using cluster randomised trial methodology. Fifty residence halls in 4 universities in Wales were randomly assigned to intervention or control arms. Web and paper surveys were distributed to students within these halls (n = 3800), assessing exposure/contamination, recall of and evaluative responses to intervention messages, perceived drinking norms and personal drinking behaviour. Measures included the Drinking Norms Rating Form, the Daily Drinking Questionnaire and AUDIT-C. A response rate of 15% (n = 554) was achieved, varying substantially between sites. Intervention posters were seen by 80% and 43% of students in intervention and control halls respectively, with most remaining materials seen by a minority in both groups. Intervention messages were rated as credible and relevant by little more than half of students, though fewer felt they would influence their behaviour, with lighter drinkers more likely to perceive messages as credible. No differences in perceived norms were observed between intervention and control groups. Students reporting having seen intervention materials reported lower descriptive and injunctive norms than those who did not. Attention is needed to enhancing exposure, credibility and perceived relevance of intervention messages, particularly among heavier drinkers, before definitive evaluation can be recommended. A definitive evaluation would need to consider how it would achieve sufficient response rates, whilst hall-level cluster randomisation appears subject to a significant degree of contamination. ISRCTN: ISRCTN48556384.

  10. Prediction of difficult mask ventilation using a systematic assessment of risk factors vs. existing practice - a cluster randomised clinical trial in 94,006 patients

    DEFF Research Database (Denmark)

    Nørskov, A K; Wetterslev, J; Rosenstock, C V

    2017-01-01

    We compared implementation of systematic airway assessment with existing practice of airway assessment on prediction of difficult mask ventilation. Twenty-six departments were cluster-randomised to assess eleven risk factors for difficult airway management (intervention) or to continue with their......We compared implementation of systematic airway assessment with existing practice of airway assessment on prediction of difficult mask ventilation. Twenty-six departments were cluster-randomised to assess eleven risk factors for difficult airway management (intervention) or to continue...... with their existing airway assessment (control). In both groups, patients predicted as a difficult mask ventilation and/or difficult intubation were registered in the Danish Anaesthesia Database, with a notational summary of airway management. The trial's primary outcome was the respective incidence of unpredicted...... difficult and easy mask ventilation in the two groups. Among 94,006 patients undergoing mask ventilation, the incidence of unpredicted difficult mask ventilation in the intervention group was 0.91% and 0.88% in the control group; (OR) 0.98 (95% CI 0.66-1.44), p = 0.90. The incidence of patients predicted...

  11. POSSIBILITIES FOR DEVELOPMENT OF BUSINESS CLUSTER NETWORK BETWEEN SMEs FROM VISEGRAD COUNTRIES AND SERBIA

    Directory of Open Access Journals (Sweden)

    Ivan Mihajlović

    2014-10-01

    Full Text Available This issue of Serbian Journal of Management (SJM 9(2 2014, besides containing regular research papers, is containing the papers which resulted from the project “Possibilities for development of business cluster network between SMEs from Visegrad countries and Serbia” and the International May Conference on Strategic Management – IMKSM2014 (http://mksm.sjm06.com . The manuscripts: Entrepreneurs of the Future (Lazani, 2014; The level of process management principles application in SMEs in the selected region of the Czech Republic (Rolinek et al., 2014 and Roles of Socialisation in Strengthening the labour-market positions of young entrants (Marosi, 2014 are the direct result of the Project, which was approved and financially supported by the Visegrad Fund (http://visegradfund.org . On the other hand, the manuscript Workspace as a factor of job satisfaction in the banking and ICT industries in Macedonia (Tomovska, et al., 2014 and Organizational routines in russian companies - review of practicesis (Valieva, 2014 are resulting from the IMKSM2014.

  12. Cost and cost-effectiveness of newborn home visits: findings from the Newhints cluster-randomised controlled trial in rural Ghana.

    Science.gov (United States)

    Pitt, Catherine; Tawiah, Theresa; Soremekun, Seyi; ten Asbroek, Augustinus H A; Manu, Alexander; Tawiah-Agyemang, Charlotte; Hill, Zelee; Owusu-Agyei, Seth; Kirkwood, Betty R; Hanson, Kara

    2016-01-01

    Every year, 2·9 million newborn babies die worldwide. A meta-analysis of four cluster-randomised controlled trials estimated that home visits by trained community members in programme settings in Ghana and south Asia reduced neonatal mortality by 12% (95% CI 5-18). We aimed to estimate the costs and cost-effectiveness of newborn home visits in a programme setting. We prospectively collected detailed cost data alongside the Newhints trial, which tested the effect of a home-visits intervention in seven districts in rural Ghana and showed a reduction of 8% (95% CI -12 to 25%) in neonatal mortality. The intervention consisted of a package of home visits to pregnant women and their babies in the first week of life by community-based surveillance volunteers. We calculated incremental cost-effectiveness ratios (ICERs) with Monte Carlo simulation and one-way sensitivity analyses and characterised uncertainty with cost-effectiveness planes and cost-effectiveness acceptability curves. We then modelled the potential cost-effectiveness for baseline neonatal mortality rates of 20-60 deaths per 1000 livebirths with use of a meta-analysis of effectiveness estimates. In the 49 zones randomly allocated to receive the Newhints intervention, a mean of 407 (SD 18) community-based surveillance volunteers undertook home visits for 7848 pregnant women who gave birth to 7786 live babies in 2009. Annual economic cost of implementation was US$203 998, or $0·53 per person. In the base-case analysis, the Newhints intervention cost a mean of $10 343 (95% CI 2963 to -7674) per newborn life saved, or $352 (95% CI 104 to -268) per discounted life-year saved, and had a 72% chance of being highly cost effective with respect to Ghana's 2009 gross domestic product per person. Key determinants of cost-effectiveness were the discount rate, protective effectiveness, baseline neonatal mortality rate, and implementation costs. In the scenarios modelled with the meta-analysis results, the ICER

  13. Conspicuous multidrug-resistant Mycobacterium tuberculosis cluster strains do not trespass country borders in Latin America and Spain.

    Science.gov (United States)

    Ritacco, Viviana; Iglesias, María-José; Ferrazoli, Lucilaine; Monteserin, Johana; Dalla Costa, Elis R; Cebollada, Alberto; Morcillo, Nora; Robledo, Jaime; de Waard, Jacobus H; Araya, Pamela; Aristimuño, Liselotte; Díaz, Raúl; Gavin, Patricia; Imperiale, Belen; Simonsen, Vera; Zapata, Elsa M; Jiménez, María S; Rossetti, Maria L; Martin, Carlos; Barrera, Lucía; Samper, Sofia

    2012-06-01

    Multidrug-resistant Mycobacterium tuberculosis strain diversity in Ibero-America was examined by comparing extant genotype collections in national or state tuberculosis networks. To this end, genotypes from over 1000 patients with multidrug-resistant tuberculosis diagnosed from 2004 through 2008 in Argentina, Brazil, Chile, Colombia, Venezuela and Spain were compared in a database constructed ad hoc. Most of the 116 clusters identified by IS6110 restriction fragment length polymorphism were small and restricted to individual countries. The three largest clusters, of 116, 49 and 25 patients, were found in Argentina and corresponded to previously documented locally-epidemic strains. Only 13 small clusters involved more than one country, altogether accounting for 41 patients, of whom 13 were, in turn, immigrants from Latin American countries different from those participating in the study (Peru, Ecuador and Bolivia). Most of these international clusters belonged either to the emerging RD(Rio) LAM lineage or to the Haarlem family of M. tuberculosis and four were further split by country when analyzed with spoligotyping and rifampin resistance-conferring mutations, suggesting that they did not represent ongoing transnational transmission events. The Beijing genotype accounted for 1.3% and 10.2% of patients with multidrug-resistant tuberculosis in Latin America and Spain, respectively, including one international cluster of two cases. In brief, Euro-American genotypes were widely predominant among multidrug-resistant M. tuberculosis strains in Ibero-America, reflecting closely their predominance in the general M. tuberculosis population in the region, and no evidence was found of acknowledged outbreak strains trespassing country borders. Copyright © 2011 Elsevier B.V. All rights reserved.

  14. Evidence-based care of older people with suspected cognitive impairment in general practice: protocol for the IRIS cluster randomised trial.

    Science.gov (United States)

    McKenzie, Joanne E; French, Simon D; O'Connor, Denise A; Mortimer, Duncan S; Browning, Colette J; Russell, Grant M; Grimshaw, Jeremy M; Eccles, Martin P; Francis, Jill J; Michie, Susan; Murphy, Kerry; Kossenas, Fiona; Green, Sally E

    2013-08-19

    Dementia is a common and complex condition. Evidence-based guidelines for the management of people with dementia in general practice exist; however, detection, diagnosis and disclosure of dementia have been identified as potential evidence-practice gaps. Interventions to implement guidelines into practice have had varying success. The use of theory in designing implementation interventions has been limited, but is advocated because of its potential to yield more effective interventions and aid understanding of factors modifying the magnitude of intervention effects across trials. This protocol describes methods of a randomised trial that tests a theory-informed implementation intervention that, if effective, may provide benefits for patients with dementia and their carers. This trial aims to estimate the effectiveness of a theory-informed intervention to increase GPs' (in Victoria, Australia) adherence to a clinical guideline for the detection, diagnosis, and management of dementia in general practice, compared with providing GPs with a printed copy of the guideline. Primary objectives include testing if the intervention is effective in increasing the percentage of patients with suspected cognitive impairment who receive care consistent with two key guideline recommendations: receipt of a i) formal cognitive assessment, and ii) depression assessment using a validated scale (primary outcomes for the trial). The design is a parallel cluster randomised trial, with clusters being general practices. We aim to recruit 60 practices per group. Practices will be randomised to the intervention and control groups using restricted randomisation. Patients meeting the inclusion criteria, and GPs' detection and diagnosis behaviours directed toward these patients, will be identified and measured via an electronic search of the medical records nine months after the start of the intervention. Practitioners in the control group will receive a printed copy of the guideline. In

  15. Action to Support Practices Implement Research Evidence (ASPIRE): protocol for a cluster-randomised evaluation of adaptable implementation packages targeting 'high impact' clinical practice recommendations in general practice.

    Science.gov (United States)

    Willis, Thomas A; Hartley, Suzanne; Glidewell, Liz; Farrin, Amanda J; Lawton, Rebecca; McEachan, Rosemary R C; Ingleson, Emma; Heudtlass, Peter; Collinson, Michelle; Clamp, Susan; Hunter, Cheryl; Ward, Vicky; Hulme, Claire; Meads, David; Bregantini, Daniele; Carder, Paul; Foy, Robbie

    2016-02-29

    There are recognised gaps between evidence and practice in general practice, a setting which provides particular challenges for implementation. We earlier screened clinical guideline recommendations to derive a set of 'high impact' indicators based upon criteria including potential for significant patient benefit, scope for improved practice and amenability to measurement using routinely collected data. We aim to evaluate the effectiveness and cost-effectiveness of a multifaceted, adaptable intervention package to implement four targeted, high impact recommendations in general practice. The research programme Action to Support Practice Implement Research Evidence (ASPIRE) includes a pair of pragmatic cluster-randomised trials which use a balanced incomplete block design. Clusters are general practices in West Yorkshire, United Kingdom (UK), recruited using an 'opt-out' recruitment process. The intervention package adapted to each recommendation includes combinations of audit and feedback, educational outreach visits and computerised prompts with embedded behaviour change techniques selected on the basis of identified needs and barriers to change. In trial 1, practices are randomised to adapted interventions targeting either diabetes control or risky prescribing and those in trial 2 to adapted interventions targeting either blood pressure control in patients at risk of cardiovascular events or anticoagulation in atrial fibrillation. The respective primary endpoints comprise achievement of all recommended target levels of haemoglobin A1c (HbA1c), blood pressure and cholesterol in patients with type 2 diabetes, a composite indicator of risky prescribing, achievement of recommended blood pressure targets for specific patient groups and anticoagulation prescribing in patients with atrial fibrillation. We are also randomising practices to a fifth, non-intervention control group to further assess Hawthorne effects. Outcomes will be assessed using routinely collected data

  16. 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

  17. Screening for type 2 diabetes and population mortality over 10 years (ADDITION-Cambridge): a cluster-randomised controlled trial.

    Science.gov (United States)

    Simmons, Rebecca K; Echouffo-Tcheugui, Justin B; Sharp, Stephen J; Sargeant, Lincoln A; Williams, Kate M; Prevost, A Toby; Kinmonth, Ann Louise; Wareham, Nicholas J; Griffin, Simon J

    2012-11-17

    The increasing prevalence of type 2 diabetes poses a major public health challenge. Population-based screening and early treatment for type 2 diabetes could reduce this growing burden. However, uncertainty persists around the benefits of screening for type 2 diabetes. We assessed the effect of a population-based stepwise screening programme on mortality. In a pragmatic parallel group, cluster-randomised trial, 33 general practices in eastern England were randomly assigned by the method of minimisation in an unbalanced design to: screening followed by intensive multifactorial treatment for people diagnosed with diabetes (n=15); screening plus routine care of diabetes according to national guidelines (n=13); and a no-screening control group (n=5). The study population consisted of 20,184 individuals aged 40-69 years (mean 58 years), at high risk of prevalent undiagnosed diabetes, on the basis of a previously validated risk score. In screening practices, individuals were invited to a stepwise programme including random capillary blood glucose and glycated haemoglobin (HbA(1c)) tests, a fasting capillary blood glucose test, and a confirmatory oral glucose tolerance test. The primary outcome was all-cause mortality. All participants were flagged for mortality surveillance by the England and Wales Office of National Statistics. Analysis was by intention-to-screen and compared all-cause mortality rates between screening and control groups. This study is registered, number ISRCTN86769081. Of 16,047 high-risk individuals in screening practices, 15,089 (94%) were invited for screening during 2001-06, 11,737 (73%) attended, and 466 (3%) were diagnosed with diabetes. 4137 control individuals were followed up. During 184,057 person-years of follow up (median duration 9·6 years [IQR 8·9-9·9]), there were 1532 deaths in the screening practices and 377 in control practices (mortality hazard ratio [HR] 1·06, 95% CI 0·90-1·25). We noted no significant reduction in

  18. Effect of the Uganda Newborn Study on care-seeking and care practices: a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Peter Waiswa

    2015-03-01

    Full Text Available Background: Care for women and babies before, during, and after the time of birth is a sensitive measure of the functionality of any health system. Engaging communities in preventing newborn deaths is a promising strategy to achieve further progress in child survival in sub-Saharan Africa. Objective: To assess the effect of a home visit strategy combined with health facility strengthening on uptake of newborn care-seeking, practices and services, and to link the results to national policy and scale-up in Uganda. Design: The Uganda Newborn Study (UNEST was a two-arm cluster-randomised controlled trial in rural eastern Uganda. In intervention villages volunteer community health workers (CHWs were trained to identify pregnant women and make five home visits (two during pregnancy and three in the first week after birth to offer preventive and promotive care and counselling, with extra visits for sick and small newborns to assess and refer. Health facility strengthening was done in all facilities to improve quality of care. Primary outcomes were coverage of key essential newborn care behaviours (breastfeeding, thermal care, and cord care. Analyses were by intention to treat. This study is registered as a clinical trial, number ISRCTN50321130. Results: The intervention significantly improved essential newborn care practices, although many interventions saw major increases in both arms over the study period. Immediate breastfeeding after birth and exclusive breastfeeding were significantly higher in the intervention arm compared to the control arm (72.6% vs. 66.0%; p=0.016 and 81.8% vs. 75.9%, p=0.042, respectively. Skin-to-skin care immediately after birth and cord cutting with a clean instrument were marginally higher in the intervention arm versus the control arm (80.7% vs. 72.2%; p=0.071 and 88.1% vs. 84.4%; p=0.023, respectively. Half (49.6% of the mothers in the intervention arm waited more than 24 hours to bathe the baby, compared to 35.5% in

  19. NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France.

    Science.gov (United States)

    Bardou, Marc; Crépon, Bruno; Bertaux, Anne-Claire; Godard-Marceaux, Aurélie; Eckman-Lacroix, Astrid; Thellier, Elise; Falchier, Frédérique; Deruelle, Philippe; Doret, Muriel; Carcopino-Tusoli, Xavier; Schmitz, Thomas; Barjat, Thiphaine; Morin, Mathieu; Perrotin, Franck; Hatem, Ghada; Deneux-Tharaux, Catherine; Fournel, Isabelle; Laforet, Laurent; Meunier-Beillard, Nicolas; Duflo, Esther; Le Ray, Isabelle

    2017-10-30

    Prenatal care is recommended during pregnancy to improve neonatal and maternal outcomes. Women of lower socioeconomic status (SES) are less compliant to recommended prenatal care and suffer a higher risk of adverse perinatal outcomes. Several attempts to encourage optimal pregnancy follow-up have shown controversial results, particularly in high-income countries. Few studies have assessed financial incentives to encourage prenatal care, and none reported materno-fetal events as the primary outcome. Our study aims to determine whether financial incentives could improve pregnancy outcomes in women with low SES in a high-income country. This pragmatic cluster-randomised clinical trial includes pregnant women with the following criteria: (1) age above 18 years, (2) first pregnancy visit before 26 weeks of gestation and (3) belonging to a socioeconomically disadvantaged group. The intervention consists in offering financial incentives conditional on attending scheduled pregnancy follow-up consultations. Clusters are 2-month periods with random turnover across centres. A composite outcome of maternal and neonatal morbidity and mortality is the primary endpoint. Secondary endpoints include maternal or neonatal outcomes assessed separately, qualitative assessment of the perception of the intervention and cost-effectiveness analysis for which children will be followed to the end of their first year through the French health insurance database. The study started in June 2016, and based on an expected decrease in the primary endpoint from 18% to 14% in the intervention group, we plan to include 2000 women in each group. Ethics approval was first gained on 28 September 2014. An independent data security and monitoring committee has been established. Results of the main trial and each of the secondary analyses will be submitted for publication in a peer-reviewed journal. NCT02402855; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of

  20. Protocol for a feasibility cluster randomised controlled trial of a peer-led school-based intervention to increase the physical activity of adolescent girls (PLAN-A).

    Science.gov (United States)

    Sebire, Simon J; Edwards, Mark J; Campbell, Rona; Jago, Russell; Kipping, Ruth; Banfield, Kathryn; Tomkinson, Keeley; Garfield, Kirsty; Lyons, Ronan A; Simon, Joanne; Blair, Peter S; Hollingworth, William

    2016-01-01

    Physical activity levels are low amongst adolescent girls, and this population faces specific barriers to being active. Peer influences on health behaviours are important in adolescence and peer-led interventions might hold promise to change behaviour. This paper describes the protocol for a feasibility cluster randomised controlled trial of Peer-Led physical Activity iNtervention for Adolescent girls (PLAN-A), a peer-led intervention aimed at increasing adolescent girls' physical activity levels. A two-arm cluster randomised feasibility trial will be conducted in six secondary schools (intervention n  = 4; control n  = 2) with year 8 (12-13 years old) girls. The intervention will operate at a year group level and consist of year 8 girls nominating influential peers within their year group to become peer-supporters. Approximately 15 % of the cohort will receive 3 days of training about physical activity and interpersonal communication skills. Peer-supporters will then informally diffuse messages about physical activity amongst their friends for 10 weeks. Data will be collected at baseline (time 0 (T0)), immediately after the intervention (time 1 (T1)) and 12 months after baseline measures (time 2 (T2)). In this feasibility trial, the primary interest is in the recruitment of schools and participants (both year 8 girls and peer-supporters), delivery and receipt of the intervention, data provision rates and identifying the cost categories for future economic analysis. Physical activity will be assessed using 7-day accelerometry, with the likely primary outcome in a fully-powered trial being daily minutes of moderate-to-vigorous physical activity. Participants will also complete psychosocial questionnaires at each time point: assessing motivation, self-esteem and peer physical activity norms. Data analysis will be largely descriptive and focus on recruitment, attendance and data provision rates. The findings will inform the sample size required for a

  1. Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial

    NARCIS (Netherlands)

    van de Ven, J.; Fransen, A F; Schuit, E.; van Runnard Heimel, P.J.; Mol, Ben W.; Oei, Swan G.

    2017-01-01

    Does the effect of one-day simulation team training in obstetric emergencies decline within one year? A post-hoc analysis of a multicentre cluster randomised controlled trial. J van de Ven, AF Fransen, E Schuit, PJ van Runnard Heimel, BW Mol, SG Oei Objective To investigate whether the effect of a

  2. Adding a post-training FIFA 11+ exercise program to the pre-training FIFA 11+ injury prevention program reduces injury rates among male amateur soccer players: a cluster-randomised trial

    Directory of Open Access Journals (Sweden)

    Wesam Saleh A Al Attar

    2017-10-01

    Trial registration: ACTRN12615001206516. [Al Attar WSA, Soomro N, Pappas E, Sinclair PJ, Sanders RH (2017 Adding a post-training FIFA 11+ exercise program to the pre-training FIFA 11+ injury prevention program reduces injury rates among male amateur soccer players: a cluster-randomised trial. Journal of Physiotherapy 63: 235–242

  3. Up-skilling associate clinicians in Malawi in emergency obstetric, neonatal care and clinical leadership: the ETATMBA cluster randomised controlled trial.

    Science.gov (United States)

    Ellard, David R; Chimwaza, Wanangwa; Davies, David; Simkiss, Doug; Kamwendo, Francis; Mhango, Chisale; Quenby, Siobhan; Kandala, Ngianga-Bakwin; O'Hare, Joseph Paul

    2016-01-01

    The ETATMBA (Enhancing Training And Technology for Mothers and Babies in Africa) project-trained associate clinicians (ACs/clinical officers) as advanced clinical leaders in emergency obstetric and neonatal care. This trial aimed to evaluate the impact of training on obstetric health outcomes in Malawi. A cluster randomised controlled trial with 14 districts of Malawi (8 intervention, 6 control) as units of randomisation. Intervention districts housed the 46 ACs who received the training programme. The primary outcome was district (health facility-based) perinatal mortality rates. Secondary outcomes included maternal mortality ratios, neonatal mortality rate, obstetric and birth variables. The study period was 2011-2013. Mortality rates/ratios were examined using an interrupted time series (ITS) to identify trends over time. The ITS reveals an improving trend in perinatal mortality across both groups, but better in the control group (intervention, effect -3.58, SE 2.65, CI (-9.85 to 2.69), p=0.20; control, effect -17.79, SE 6.83, CI (-33.95 to -1.64), p=0.03). Maternal mortality ratios are seen to have improved in intervention districts while worsening in the control districts (intervention, effect -38.11, SE 50.30, CI (-157.06 to 80.84), p=0.47; control, effect 11.55, SE 87.72, CI (-195.87 to 218.98), p=0.90). There was a 31% drop in neonatal mortality rate in intervention districts while in control districts, the rate rises by 2%. There are no significant differences in the other secondary outcomes. This is one of the first randomised studies looking at the effect of structured training on health outcomes in this setting. Notwithstanding a number of limitations, this study suggests that up-skilling this cadre is possible, and could impact positively on health outcomes. ISRCTN63294155; Results.

  4. Helping adolescents to better support their peers with a mental health problem: A cluster-randomised crossover trial of teen Mental Health First Aid.

    Science.gov (United States)

    Hart, Laura M; Morgan, Amy J; Rossetto, Alyssia; Kelly, Claire M; Mackinnon, Andrew; Jorm, Anthony F

    2018-02-01

    teen Mental Health First Aid (tMHFA) is a classroom-based training programme for students aged 15-18 years to improve supportive behaviours towards peers, increase mental health literacy and reduce stigma. This research evaluated tMHFA by comparing it to a matched emergency Physical First Aid (PFA) training programme. A cluster-randomised crossover trial matched four public schools in two pairs and then randomised each to first receive tMHFA or PFA for all Year 10 students. In the subsequent calendar year, the new Year 10 cohort received the opposite intervention, giving eight cohorts. Online surveys were administered at baseline and 1 week post-training, measuring quality of first aid intentions, mental health literacy, problem recognition and stigmatising beliefs, towards fictional adolescents with depression and suicidality (John) and social anxiety (Jeanie). A total of 1942 students were randomised (979 received tMHFA, 948 received PFA), 1605 (84%) analysed for the John vignette at baseline and 1116 (69% of baseline) provided post-training data. The primary outcomes, 'helpful first aid intentions' towards John/Jeanie, showed significant group-by-time interactions with medium effect sizes favouring tMHFA ( ds = 0.50-0.58). Compared to PFA, tMHFA students also reported significantly greater improvements in confidence supporting a peer ( ds = 0.22-0.37) and number of adults rated as helpful ( ds = 0.45-0.46) and greater reductions in stigmatising beliefs ( ds = 0.12-0.40) and 'harmful first aid intentions' towards John/Jeanie ( ds = 0.15-0.41). tMHFA is an effective and feasible programme for increasing supportive first aid intentions and mental health literacy in adolescents in the short term. tMHFA could be widely disseminated to positively impact on help seeking for adolescent mental illness.

  5. Effects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial

    Directory of Open Access Journals (Sweden)

    Maddison Ralph

    2010-11-01

    Full Text Available Abstract Background Approximately 55,000 children in New Zealand do not eat breakfast on any given day. Regular breakfast skipping has been associated with poor diets, higher body mass index, and adverse effects on children's behaviour and academic performance. Research suggests that regular breakfast consumption can improve academic performance, nutrition and behaviour. This paper describes the protocol for a stepped wedge cluster randomised trial of a free school breakfast programme. The aim of the trial is to determine the effects of the breakfast intervention on school attendance, achievement, psychosocial function, dietary habits and food security. Methods/Design Sixteen primary schools in the North Island of New Zealand will be randomised in a sequential stepped wedge design to a free before-school breakfast programme consisting of non-sugar coated breakfast cereal, milk products, and/or toast and spreads. Four hundred children aged 5-13 years (approximately 25 per school will be recruited. Data collection will be undertaken once each school term over the 2010 school year (February to December. The primary trial outcome is school attendance, defined as the proportion of students achieving an attendance rate of 95% or higher. Secondary outcomes are academic achievement (literacy, numeracy, self-reported grades, sense of belonging at school, psychosocial function, dietary habits, and food security. A concurrent process evaluation seeks information on parents', schools' and providers' perspectives of the breakfast programme. Discussion This randomised controlled trial will provide robust evidence of the effects of a school breakfast programme on students' attendance, achievement and nutrition. Furthermore the study provides an excellent example of the feasibility and value of the stepped wedge trial design in evaluating pragmatic public health intervention programmes. Trial Registration Number Australian New Zealand Clinical Trials Registry

  6. Effects of a free school breakfast programme on school attendance, achievement, psychosocial function, and nutrition: a stepped wedge cluster randomised trial.

    Science.gov (United States)

    Ni Mhurchu, Cliona; Turley, Maria; Gorton, Delvina; Jiang, Yannan; Michie, Jo; Maddison, Ralph; Hattie, John

    2010-11-29

    Approximately 55,000 children in New Zealand do not eat breakfast on any given day. Regular breakfast skipping has been associated with poor diets, higher body mass index, and adverse effects on children's behaviour and academic performance. Research suggests that regular breakfast consumption can improve academic performance, nutrition and behaviour. This paper describes the protocol for a stepped wedge cluster randomised trial of a free school breakfast programme. The aim of the trial is to determine the effects of the breakfast intervention on school attendance, achievement, psychosocial function, dietary habits and food security. Sixteen primary schools in the North Island of New Zealand will be randomised in a sequential stepped wedge design to a free before-school breakfast programme consisting of non-sugar coated breakfast cereal, milk products, and/or toast and spreads. Four hundred children aged 5-13 years (approximately 25 per school) will be recruited. Data collection will be undertaken once each school term over the 2010 school year (February to December). The primary trial outcome is school attendance, defined as the proportion of students achieving an attendance rate of 95% or higher. Secondary outcomes are academic achievement (literacy, numeracy, self-reported grades), sense of belonging at school, psychosocial function, dietary habits, and food security. A concurrent process evaluation seeks information on parents', schools' and providers' perspectives of the breakfast programme. This randomised controlled trial will provide robust evidence of the effects of a school breakfast programme on students' attendance, achievement and nutrition. Furthermore the study provides an excellent example of the feasibility and value of the stepped wedge trial design in evaluating pragmatic public health intervention programmes. Australian New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12609000854235.

  7. Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

    OpenAIRE

    Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith AY; Silburn, Sven

    2010-01-01

    Abstract Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-c...

  8. Preventive evidence into practice (PEP study: implementation of guidelines to prevent primary vascular disease in general practice protocol for a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Harris Mark F

    2013-01-01

    Full Text Available Abstract Background There are significant gaps in the implementation and uptake of evidence-based guideline recommendations for cardiovascular disease (CVD and diabetes in Australian general practice. This study protocol describes the methodology for a cluster randomised trial to evaluate the effectiveness of a model that aims to improve the implementation of these guidelines in Australian general practice developed by a collaboration between researchers, non-government organisations, and the profession. Methods We hypothesise that the intervention will alter the behaviour of clinicians and patients resulting in improvements of recording of lifestyle and physiological risk factors (by 20% and increased adherence to guideline recommendations for: the management of CVD and diabetes risk factors (by 20%; and lifestyle and physiological risk factors of patients at risk (by 5%. Thirty-two general practices will be randomised in a 1:1 allocation to receive either the intervention or continue with usual care, after stratification by state. The intervention will be delivered through: small group education; audit of patient records to determine preventive care; and practice facilitation visits adapted to the needs of the practices. Outcome data will be extracted from electronic medical records and patient questionnaires, and qualitative evaluation from provider and patient interviews. Discussion We plan to disseminate study findings widely and directly inform implementation strategies by governments, professional bodies, and non-government organisations including the partner organisations.

  9. The Feedback Intervention Trial (FIT) — Improving Hand-Hygiene Compliance in UK Healthcare Workers: A Stepped Wedge Cluster Randomised Controlled Trial

    Science.gov (United States)

    Fuller, Christopher; Michie, Susan; Savage, Joanne; McAteer, John; Besser, Sarah; Charlett, Andre; Hayward, Andrew; Cookson, Barry D.; Cooper, Ben S.; Duckworth, Georgia; Jeanes, Annette; Roberts, Jenny; Teare, Louise; Stone, Sheldon

    2012-01-01

    Introduction Achieving a sustained improvement in hand-hygiene compliance is the WHO’s first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness. Methods Three year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards) routinely implementing a national cleanyourhands campaign). Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week) of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation. Primary outcome: direct blinded hand hygiene compliance (%). Results All 16 trusts (60 wards) randomised, 33 wards implemented intervention (11 ITU, 22 ACE). Mixed effects regression analysis (all wards) accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used). Intention to Treat Analysis Estimated odds ratio (OR) for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;phand-hygiene compliance, in wards implementing a national hand-hygiene campaign. Further implementation studies are needed to maximise the intervention’s effect in different settings. Trial Registration Controlled-Trials.com ISRCTN65246961 PMID:23110040

  10. Remote video auditing with real-time feedback in an academic surgical suite improves safety and efficiency metrics: a cluster randomised study.

    Science.gov (United States)

    Overdyk, Frank J; Dowling, Oonagh; Newman, Sheldon; Glatt, David; Chester, Michelle; Armellino, Donna; Cole, Brandon; Landis, Gregg S; Schoenfeld, David; DiCapua, John F

    2016-12-01

    Compliance with the surgical safety checklist during operative procedures has been shown to reduce inhospital mortality and complications but proper execution by the surgical team remains elusive. We evaluated the impact of remote video auditing with real-time provider feedback on checklist compliance during sign-in, time-out and sign-out and case turnover times. Prospective, cluster randomised study in a 23-operating room (OR) suite. Surgeons, anaesthesia providers, nurses and support staff. ORs were randomised to receive, or not receive, real-time feedback on safety checklist compliance and efficiency metrics via display boards and text messages, followed by a period during which all ORs received feedback. Checklist compliance (Pass/Fail) during sign-in, time-out and sign-out demonstrated by (1) use of checklist, (2) team attentiveness, (3) required duration, (4) proper sequence and duration of case turnover times. Sign-in, time-out and sign-out PASS rates increased from 25%, 16% and 32% during baseline phase (n=1886) to 64%, 84% and 68% for feedback ORs versus 40%, 77% and 51% for no-feedback ORs (pauditing with feedback improves surgical safety checklist compliance for all cases, and turnover time for scheduled cases, but not for unscheduled cases. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  11. The efficacy of a group Cognitive Behavioural Therapy for war-affected young migrants living in Australia: A cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Chew Sia Ooi

    2016-10-01

    Full Text Available BackgroundPreventative and treatment programmes for people at risk of developing psychological problems after exposure to war trauma have mushroomed in the last decade. However, there is still much contention about evidence-based and culturally sensitive interventions for children. The aim of this study was to examine the efficacy of the Teaching Recovery Techniques in improving the emotional and behavioural outcomes of war-affected children resettled in Australia. Methods and findings A cluster randomised controlled trial with pretest, posttest, and 3-month follow-up design was employed. A total of 82 participants (aged 10 to 17 years were randomised by school into the 8-week intervention (n = 45 or the waiting list (WL control condition (n = 37. Study outcomes included symptoms of posttraumatic stress disorder, depression, internalising and externalising problems, as well as psychosocial functioning. A medium intervention effect was found for depression symptoms. Participants in the intervention condition experienced a greater symptom reduction than participants in the WL control condition, F(1,155 = 5.20, p = .024, partial ƞ2 = 0.07. This improvement was maintained at the 3-month follow-up, F(2,122 = 7.24, p = .001, partial ƞ2 = 0.20. ConclusionsThese findings suggest the potential benefit of the school and group-based intervention on depression symptoms but not on other outcomes, when compared to a waiting list control group.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12611000948998

  12. Effectiveness of educational poster on knowledge of emergency management of dental trauma--part 2: cluster randomised controlled trial for secondary school students.

    Science.gov (United States)

    Young, Cecilia; Wong, Kin Yau; Cheung, Lim K

    2014-01-01

    To investigate the effectiveness of educational poster on improving secondary school students' knowledge of emergency management of dental trauma. A cluster randomised controlled trial was conducted. 16 schools with total 671 secondary students who can read Chinese or English were randomised into intervention (poster, 8 schools, 364 students) and control groups (8 schools, 305 students) at the school level. Baseline knowledge of dental trauma was obtained by a questionnaire. Poster containing information of dental trauma management was displayed in a classroom for 2 weeks in each school in the intervention group whereas in the control group there was no display of such posters. Students of both groups completed the same questionnaire after 2 weeks. Two-week display of posters improved the knowledge score by 1.25 (p-value = 0.0407) on average. Educational poster on dental trauma management significantly improved the level of knowledge of secondary school students in Hong Kong. HKClinicalTrial.com HKCTR-1343 ClinicalTrials.gov NCT01809457.

  13. Effectiveness and feasibility of long-lasting insecticide-treated curtains and water container covers for dengue vector control in Colombia: a cluster randomised trial.

    Science.gov (United States)

    Quintero, Juliana; García-Betancourt, Tatiana; Cortés, Sebastian; García, Diana; Alcalá, Lucas; González-Uribe, Catalina; Brochero, Helena; Carrasquilla, Gabriel

    2015-02-01

    Long-lasting insecticide-treated net (LLIN) window and door curtains alone or in combination with LLIN water container covers were analysed regarding effectiveness in reducing dengue vector density, and feasibility of the intervention. A cluster randomised trial was conducted in an urban area of Colombia comparing 10 randomly selected control and 10 intervention clusters. In control clusters, routine vector control activities were performed. The intervention delivered first, LLIN curtains (from July to August 2013) and secondly, water container covers (from October to March 2014). Cross-sectional entomological surveys were carried out at baseline (February 2013 to June 2013), 9 weeks after the first intervention (August to October 2013), and 4-6 weeks after the second intervention (March to April 2014). Curtains were installed in 922 households and water container covers in 303 households. The Breteau index (BI) fell from 14 to 6 in the intervention group and from 8 to 5 in the control group. The additional intervention with LLIN covers for water containers showed a significant reduction in pupae per person index (PPI) (p=0.01). In the intervention group, the PPI index showed a clear decline of 71% compared with 25% in the control group. Costs were high but options for cost savings were identified. Short term impact evaluation indicates that the intervention package can reduce dengue vector density but sustained effect will depend on multiple factors. © The author 2015. The World Health Organization has granted Oxford University Press permission for the reproduction of this article.

  14. The impact of training non-physician clinicians in Malawi on maternal and perinatal mortality: a cluster randomised controlled evaluation of the enhancing training and appropriate technologies for mothers and babies in Africa (ETATMBA project

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    Ellard David

    2012-10-01

    Full Text Available Abstract Background Maternal mortality in much of sub-Saharan Africa is very high whereas there has been a steady decline in over the past 60 years in Europe. Perinatal mortality is 12 times higher than maternal mortality accounting for about 7 million neonatal deaths; many of these in sub-Saharan countries. Many of these deaths are preventable. Countries, like Malawi, do not have the resources nor highly trained medical specialists using complex technologies within their healthcare system. Much of the burden falls on healthcare staff other than doctors including non-physician clinicians (NPCs such as clinical officers, midwives and community health-workers. The aim of this trial is to evaluate a project which is training NPCs as advanced leaders by providing them with skills and knowledge in advanced neonatal and obstetric care. Training that will hopefully be cascaded to their colleagues (other NPCs, midwives, nurses. Methods/design This is a cluster randomised controlled trial with the unit of randomisation being the 14 districts of central and northern Malawi (one large district was divided into two giving an overall total of 15. Eight districts will be randomly allocated the intervention. Within these eight districts 50 NPCs will be selected and will be enrolled on the training programme (the intervention. Primary outcome will be maternal and perinatal (defined as until discharge from health facility mortality. Data will be harvested from all facilities in both intervention and control districts for the lifetime of the project (3–4 years and comparisons made. In addition a process evaluation using both quantitative and qualitative (e.g. interviews will be undertaken to evaluate the intervention implementation. Discussion Education and training of NPCs is a key to improving healthcare for mothers and babies in countries like Malawi. Some of the challenges faced are discussed as are the potential limitations. It is hoped that the findings

  15. Little effect of transfer technique instruction and physical fitness training in reducing low back pain among nurses: a cluster randomised intervention study

    DEFF Research Database (Denmark)

    Warming, S; Ebbehøj, N E; Wiese, N

    2008-01-01

    intervention (six wards) or to control (five wards). The intervention cluster was individually randomised to TT (55 nurses) and TTPT (50 nurses), control (76 nurses). The transfer technique programme was a 4-d course of train-the-trainers to teach transfer technique to their colleagues. The physical training...... consisted of supervised physical fitness training 1 h twice per week for 8 weeks. Implementing transfer technique alone or in combination with physical fitness training among a hospital nursing staff did not, when compared to a control group, show any statistical differences according to self-reported low...... to nurses in a hospital setting needs to be thoroughly considered. Other priorities such as physical training may be taken into consideration. The current study supports the findings of other studies that introducing transfer technique alone has no effect in targeting LBP. However, physical training seems...

  16. Effectiveness of a Minimal Intervention for Stress-related mental disorders with Sick leave (MISS; study protocol of a cluster randomised controlled trial in general practice [ISRCTN43779641

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    van Marwijk Harm WJ

    2006-05-01

    Full Text Available Abstract Background The main aims of this paper are to describe the setting and design of a Minimal Intervention in general practice for Stress-related mental disorders in patients on Sick leave (MISS, as well as to ascertain the study complies with the requirements for a cluster randomised controlled trial (RCT. The potential adverse consequences of sick leave due to Stress-related Mental Disorders (SMDs are extensive, but often not recognised. Since most people having SMDs with sick leave consult their general practitioner (GP at an early stage, a tailored intervention given by GPs is justified. We provide a detailed description of the MISS; that is more accurate assessment, education, advice and monitoring to treat SMDs in patients on sick leave. Our hypothesis is that the MISS will be more effective compared to the usual care, in reducing days of sick leave of these patients. Methods The design is a pragmatic RCT. Randomisation is at the level of GPs. They received the MISS-training versus no training, in order to compare the MISS vs. usual care at patient level. Enrolment of patients took place after screening in the source population, that comprised 20–60 year old primary care attendees. Inclusion criteria were: moderately elevated distress levels, having a paid job and sick leave for no longer than three months. There is a one year follow up. The primary outcome measure is lasting full return to work. Reduction of SMD- symptoms is one of the secondary outcome measures. Forty-six GPs and 433 patients agreed to participate. Discussion In our study design, attention is given to the practical application of the requirements for a pragmatic trial. The results of this cluster RCT will add to the evidence about treatment options in general practice for SMDs in patients on sick leave, and might contribute to a new and appropriate guideline. These results will be available at the end of 2006.

  17. The CLIMATE schools combined study: a cluster randomised controlled trial of a universal Internet-based prevention program for youth substance misuse, depression and anxiety.

    Science.gov (United States)

    Teesson, Maree; Newton, Nicola C; Slade, Tim; Chapman, Cath; Allsop, Steve; Hides, Leanne; McBride, Nyanda; Mewton, Louise; Tonks, Zoe; Birrell, Louise; Brownhill, Louise; Andrews, Gavin

    2014-02-05

    Anxiety, depressive and substance use disorders account for three quarters of the disability attributed to mental disorders and frequently co-occur. While programs for the prevention and reduction of symptoms associated with (i) substance use and (ii) mental health disorders exist, research is yet to determine if a combined approach is more effective. This paper describes the study protocol of a cluster randomised controlled trial to evaluate the effectiveness of the CLIMATE Schools Combined intervention, a universal approach to preventing substance use and mental health problems among adolescents. Participants will consist of approximately 8400 students aged 13 to 14-years-old from 84 secondary schools in New South Wales, Western Australia and Queensland, Australia. The schools will be cluster randomised to one of four groups; (i) CLIMATE Schools Combined intervention; (ii) CLIMATE Schools - Substance Use; (iii) CLIMATE Schools - Mental Health, or (iv) Control (Health and Physical Education as usual). The primary outcomes of the trial will be the uptake and harmful use of alcohol and other drugs, mental health symptomatology and anxiety, depression and substance use knowledge. Secondary outcomes include substance use related harms, self-efficacy to resist peer pressure, general disability, and truancy. The link between personality and substance use will also be examined. Compared to students who receive the universal CLIMATE Schools - Substance Use, or CLIMATE Schools - Mental Health or the Control condition (who received usual Health and Physical Education), we expect students who receive the CLIMATE Schools Combined intervention to show greater delays to the initiation of substance use, reductions in substance use and mental health symptoms, and increased substance use and mental health knowledge. This trial is registered with the Australian and New Zealand Clinical Trials registry, ACTRN12613000723785.

  18. Influence of a lifestyle intervention among persons with a psychiatric disability: a cluster randomised controlled trail on symptoms, quality of life and sense of coherence.

    Science.gov (United States)

    Forsberg, Karl A; Björkman, Tommy; Sandman, Per O; Sandlund, Mikael

    2010-06-01

    The aim of this study was to investigate how a lifestyle intervention programme influences psychiatric and psychosocial factors among persons with psychiatric disabilities. Persons with psychiatric disabilities often suffer from a simultaneous physical health problem, where circulatory disorder, hyperlipideamia, digestive disease, diabetes mellitus and obesity are prevalent. Studies have also shown a relationship between physical activity and mental health. But few randomised controlled trails have been aimed specifically at lifestyle interventions and their effect on psychiatric health and quality of life among persons with psychiatric disabilities. A cluster randomised controlled trail. Forty-one persons with a DSM-IV diagnosis in eight supported housing facilities and two housing support programmes and their carers were on cluster level randomly assigned to a 12-month health intervention programme in the form of study circles with diet sessions and physical activities or a control programme. The changes in the mean of quality of life, level of functioning, psychiatric symptoms and sense of coherence was investigated and its relationship to physical health and attendance. A significant increase in the sense of coherence was seen in both programmes but also significant improvements in the intervention group compared to controls at the follow-up. Structured activities in the form of lifestyle intervention programmes with a sufficient level of challenge that encourage persons with psychiatric disabilities to participate in activities in a social context may contribute to a significant increase in the sense of coherence. Improving physical health with lifestyle programmes in the form of study circles and when involving their cares will in addition to increased physical health end in improved sense of coherence.

  19. The CLIMATE schools combined study: a cluster randomised controlled trial of a universal Internet-based prevention program for youth substance misuse, depression and anxiety

    Science.gov (United States)

    2014-01-01

    Background Anxiety, depressive and substance use disorders account for three quarters of the disability attributed to mental disorders and frequently co-occur. While programs for the prevention and reduction of symptoms associated with (i) substance use and (ii) mental health disorders exist, research is yet to determine if a combined approach is more effective. This paper describes the study protocol of a cluster randomised controlled trial to evaluate the effectiveness of the CLIMATE Schools Combined intervention, a universal approach to preventing substance use and mental health problems among adolescents. Methods/design Participants will consist of approximately 8400 students aged 13 to 14-years-old from 84 secondary schools in New South Wales, Western Australia and Queensland, Australia. The schools will be cluster randomised to one of four groups; (i) CLIMATE Schools Combined intervention; (ii) CLIMATE Schools - Substance Use; (iii) CLIMATE Schools - Mental Health, or (iv) Control (Health and Physical Education as usual). The primary outcomes of the trial will be the uptake and harmful use of alcohol and other drugs, mental health symptomatology and anxiety, depression and substance use knowledge. Secondary outcomes include substance use related harms, self-efficacy to resist peer pressure, general disability, and truancy. The link between personality and substance use will also be examined. Discussion Compared to students who receive the universal CLIMATE Schools - Substance Use, or CLIMATE Schools - Mental Health or the Control condition (who received usual Health and Physical Education), we expect students who receive the CLIMATE Schools Combined intervention to show greater delays to the initiation of substance use, reductions in substance use and mental health symptoms, and increased substance use and mental health knowledge. Trial registration This trial is registered with the Australian and New Zealand Clinical Trials registry, ACTRN12613000723785

  20. 5 year efficacy of a bivalent killed whole-cell oral cholera vaccine in Kolkata, India: a cluster-randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Bhattacharya, Sujit K; Sur, Dipika; Ali, Mohammad; Kanungo, Suman; You, Young Ae; Manna, Byomkesh; Sah, Binod; Niyogi, Swapan K; Park, Jin Kyung; Sarkar, Banwarilal; Puri, Mahesh K; Kim, Deok Ryun; Deen, Jacqueline L; Holmgren, Jan; Carbis, Rodney; Dhingra, Mandeep Singh; Donner, Allan; Nair, G Balakrish; Lopez, Anna Lena; Wierzba, Thomas F; Clemens, John D

    2013-12-01

    Efficacy and safety of a two-dose regimen of bivalent killed whole-cell oral cholera vaccine (Shantha Biotechnics, Hyderabad, India) to 3 years is established, but long-term efficacy is not. We aimed to assess protective efficacy up to 5 years in a slum area of Kolkata, India. In our double-blind, cluster-randomised, placebo-controlled trial, we assessed incidence of cholera in non-pregnant individuals older than 1 year residing in 3933 dwellings (clusters) in Kolkata, India. We randomly allocated participants, by dwelling, to receive two oral doses of modified killed bivalent whole-cell cholera vaccine or heat-killed Escherichia coli K12 placebo, 14 days apart. Randomisation was done by use of a computer-generated sequence in blocks of four. The primary endpoint was prevention of episodes of culture-confirmed Vibrio cholerae O1 diarrhoea severe enough for patients to seek treatment in a health-care facility. We identified culture-confirmed cholera cases among participants seeking treatment for diarrhoea at a study clinic or government hospital between 14 days and 1825 days after receipt of the second dose. We assessed vaccine protection in a per-protocol population of participants who had completely ingested two doses of assigned study treatment. 69 of 31 932 recipients of vaccine and 219 of 34 968 recipients of placebo developed cholera during 5 year follow-up (incidence 2·2 per 1000 in the vaccine group and 6·3 per 1000 in the placebo group). Cumulative protective efficacy of the vaccine at 5 years was 65% (95% CI 52-74; pcholera vaccines. Established long-term efficacy of this vaccine could assist policy makers formulate rational vaccination strategies to reduce overall cholera burden in endemic settings. Bill & Melinda Gates Foundation and the governments of South Korea and Sweden. Copyright © 2013 Elsevier Ltd. All rights reserved.

  1. Free breakfasts in schools: design and conduct of a cluster randomised controlled trial of the Primary School Free Breakfast Initiative in Wales [ISRCTN18336527

    Directory of Open Access Journals (Sweden)

    Hale Janine

    2007-09-01

    Full Text Available Abstract Background School-based breakfast provision is increasingly being seen as a means of improving educational performance and dietary behaviour amongst children. Furthermore, recognition is growing that breakfast provision offers potential as a means of addressing social inequalities in these outcomes. At present however, the evidence base on the effectiveness of breakfast provision in bringing about these improvements is limited. Methods/Design This paper describes the research design of a large scale evaluation of the effectiveness of the Welsh Assembly Government's Primary School Free Breakfast Initiative. A cluster randomised trial, with school as the unit of randomisation was used for the outcome evaluation, with a nested qualitative process evaluation. Quantitative outcome measures included dietary habits, attitudes, cognitive function, classroom behaviour, and school attendance. The study recruited 111 primary schools in Wales, of which 56 were randomly assigned to control condition and 55 to intervention. Participants were Year 5 and 6 students (aged 9–11 years in these schools. Data were collected for all 111 schools at each of three time points: baseline, 4 month and 12 month follow-up. This was achieved through a repeated cross-sectional survey of approximately 4350 students on each of these occasions. Of those students in Year 5 at baseline, 1975 provided data at one or both of the follow-ups, forming a nested cohort. The evaluation also included a nested process evaluation, using questionnaires, semi-structured interviews and case studies with students, school staff, and local authority scheme coordinators as key informants. Discussion An overview of the methods used for the evaluation is presented, providing an example of the feasibility of conducting robust evaluations of policy initiatives using a randomised trial design with nested process evaluation. Details are provided of response rates and the flow of participants

  2. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China.

    Science.gov (United States)

    Tang, Wenxi; Sun, Xiaowei; Zhang, Yan; Ye, Ting; Zhang, Liang

    2015-01-01

    While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1) improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2) improvement on quality of care through continuous care and coordinated supplier behaviours; (3) improvement on the system efficiency through active interaction between suppliers and patients. The integrated care system needs collaborative work from different levels

  3. A cluster randomised feasibility trial evaluating six-month nutritional interventions in the treatment of malnutrition in care home-dwelling adults: recruitment, data collection and protocol.

    Science.gov (United States)

    Stow, Ruth; Rushton, Alison; Ives, Natalie; Smith, Christina; Rick, Caroline

    2015-01-01

    Protein energy malnutrition predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents are especially vulnerable, with an estimated 30%-42% at risk. There is no internationally agreed protocol for the nutritional treatment of malnutrition in the care home setting. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements, but a trial comparing the efficacy of interventions is necessary. In order to define outcomes and optimise the design for an adequately powered, low risk of bias cluster randomised controlled trial, a feasibility trial with 6-month intervention is being run, to assess protocol procedures, recruitment and retention rates, consent processes and resident and staff acceptability. Trial recruitment began in September 2013 and concluded in December 2013. Six privately run care homes in Solihull, England, were selected to establish feasibility within different care home types. Residents with or at risk of malnutrition with no existing dietetic intervention in place were considered for receipt of the allocated intervention. Randomisation took place at the care home level, using a computer-generated random number list to allocate each home to either a dietetic intervention arm (food-based or prescribed supplements) or the standard care arm, continued for 6 months. Dietetic intervention aimed to increase daily calorie intake by 600 kcal and protein by 20-25 g. The primary outcomes will be trial feasibility and acceptability of trial design and allocated interventions. A range of outcome assessments and data collection tools will be evaluated for feasibility, including change in nutrient intake, anthropometric parameters and patient-centric measures, such as quality of life and self-perceived appetite. The complexities inherent in care home research has resulted in the under representation of this population in research trials. The results of this

  4. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

    Directory of Open Access Journals (Sweden)

    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system.Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences.Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients

  5. How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

    Directory of Open Access Journals (Sweden)

    Wenxi Tang

    2015-03-01

    Full Text Available Background: While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. Methods: To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. Discussion: This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1 improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2 improvement on quality of care through continuous care and coordinated supplier behaviours; (3 improvement on the system efficiency through active interaction between suppliers and patients. Conclusion

  6. Does Interpersonal Psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

    Directory of Open Access Journals (Sweden)

    Villanueva Elmer V

    2007-10-01

    Full Text Available Abstract Background Depression amongst adolescents is a costly societal problem. Little research documents the effectiveness of public mental health services in mapping this problem. Further, it is not clear whether usual care in such services can be improved via clinician training in a relevant evidence based intervention. One such intervention, found to be effective and easily learned amongst novice clinicians, is Interpersonal Psychotherapy (IPT. The study described in the current paper has two main objectives. First, it aims to investigate the impact on clinical care of implementing Interpersonal Psychotherapy for Adolescents for the treatment of adolescent depression within a rural mental health service compared with Treatment as Usual (TAU. The second objective is to record the process and challenges (i.e. feasibility, acceptability, sustainability associated with implementing and evaluating an evidence-based intervention within a community service. This paper outlines the study rationale and design for this community based research trial. Methods/design The study involves a cluster randomisation trial to be conducted within a Child and Adolescent Mental Health Service in rural Australia. All clinicians in the service will be invited to participate. Participating clinicians will be randomised via block design at each of four sites to (a training and delivery of IPT, or (b TAU. The primary measure of impact on care will be a clinically significant change in depressive symptomatology, with secondary outcomes involving treatment satisfaction and changes in other symptomatology. Participating adolescents with significant depressive symptomatology, aged 12 to 18 years, will complete assessment measures at Weeks 0, 12 and 24 of treatment. They will also complete a depression inventory once a month during that period. This study aims to recruit 60 adolescent participants and their parent/guardian/s. A power analysis is not indicated as an intra

  7. Cluster randomised controlled trial of 'whole school' child maltreatment prevention programme in primary schools in Northern Ireland: study protocol for Keeping Safe.

    Science.gov (United States)

    McElearney, Aisling; Brennan-Wilson, Aoibheann; Murphy, Christina; Stephenson, Phyllis; Bunting, Brendan

    2018-05-03

    Child maltreatment has a pervasive, detrimental impact on children's wellbeing. Despite a growing focus on prevention through school based education, few programmes adopt a whole- school approach, are multi-component, seek to address all forms of maltreatment, or indeed have been robustly evaluated. This paper describes a cluster randomised controlled trial designed to evaluate a school based child maltreatment prevention programme: 'Keeping Safe' in primary schools in Northern Ireland. The intervention has been designed by a non-profit agency. Programme resources include 63 lessons taught incrementally to children between four and 11 years old, and is premised on three core themes: healthy relationships, my body, and being safe. There are programme resources to engage parents and to build the capacity and skills of school staff. A cluster Randomised Controlled Trial (RCT) will be conducted with children in 80 schools over a two-year period. The unit of randomisation is the school. Schools will be allocated to intervention or wait-list control groups using a computer-generated list. Data will be collected at three time points: baseline, end of year one, and end of year two of programme implementation. Primary outcomes will include: children's understanding of key programme concepts, self-efficacy to keep safe in situations of maltreatment, anxiety arising from programme participation, and disclosure of maltreatment. Secondary outcomes include teachers' comfort and confidence in teaching the programme and parents' confidence in talking to their children about programme concepts. This RCT will address gaps in current practice and evidence regarding school based child maltreatment prevention programmes. This includes the use of a whole- school approach and multi-component programme that addresses all maltreatment concepts, a two-year period of programme implementation, and the tracking of outcomes for children, parents, and teachers. Methodologically, it will extend

  8. Protocol for a Cluster Randomised Controlled Trial to Compare the “Taste & See” Programme—A Church-Based Programme to Develop a Healthy Relationship with Food—With a Wait-List Control

    Directory of Open Access Journals (Sweden)

    Deborah Lycett

    2018-03-01

    Full Text Available (1 Background: Obesity is strongly associated with poor mental-health. Spiritual and religious wellbeing is associated with improved mental well-being and reduced emotional eating. “Taste & See”, a church based programme to help develop a healthy relationship with food has been successfully tested for feasibility in the UK but an adequately powered randomised controlled trial is needed to test efficacy. This paper reports on the protocol for such a trial; (2 Method: A cluster, randomised controlled trial where Christian churches (any denomination are the unit of randomisation. 150 overweight adults will be recruited from approximately 15 churches (clusters in the UK, each church (cluster will recruit approximately 10 participants. Churches will be randomised 2:1 to either begin the “Taste & See” programme immediately or in 10 weeks’ time. Data on eating habits, mental and spiritual health will be collected online before and after the intervention and control period and follow-up will continue until 2 years; (3 Implication of Results: Should the programme prove effective it will provide strong clinical evidence of the role of churches in improving the health and well-being of those struggling with food and weight issues.

  9. Effects of a parenting intervention to address maternal psychological wellbeing and child development and growth in rural Uganda: a community-based, cluster randomised trial.

    Science.gov (United States)

    Singla, Daisy R; Kumbakumba, Elias; Aboud, Frances E

    2015-08-01

    Parenting interventions have been implemented to improve the compromised developmental potential among 39% of children younger than 5 years living in low-income and middle-income countries. Maternal wellbeing is important for child development, especially in children younger than 3 years who are vulnerable and dependent on their mothers for nutrition and stimulation. We assessed an integrated, community-based parenting intervention that targeted both child development and maternal wellbeing in rural Uganda. In this community-based, cluster randomised trial, we assessed the effectiveness of a manualised, parenting intervention in Lira, Uganda. We selected and randomly assigned 12 parishes (1:1) to either parenting intervention or control (inclusion on a waitlist with a brief message on nutrition) groups using a computer-generated list of random numbers. Within each parish, we selected two to three eligible communities that had a parish office or a primary school in which a preschool could be established, more than 75 households with children younger than 6 years, and at least 15 socially disadvantaged families (ie, maternal education of primary school level or lower) with at least one child younger than 36 months. Participants within communities were mother-child dyads, where the child was 12-36 months of age at enrollment, and the mother had low maternal education. In the parenting intervention group, participants attended 12 fortnightly peer-led group sessions focusing on child care and maternal wellbeing. The primary outcomes were cognitive and receptive language development, as measured with the Bayley Scales of Infant Development, 3rd edn. Secondary outcomes included self-reported maternal depressive symptoms, using the Center for Epidemiologic Studies Depression Scale, and child growth. Theoretically-relevant parenting practices, including the Home Observation for Measurement of the Environment inventory, and mother-care variables, such as perceived spousal

  10. Does training family physicians in shared decision making promote optimal use of antibiotics for acute respiratory infections? Study protocol of a pilot clustered randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Côté Luc

    2007-11-01

    Full Text Available Abstract Background In North America, although it varies according to the specific type of acute respiratory infections (ARI, use of antibiotics is estimated to be well above the expected prevalence of bacterial infections. The objective of this pilot clustered randomized controlled trial (RCT is to assess the feasibility of a larger clustered RCT aiming at evaluating the impact of DECISION+, a continuing professional development (CPD program in shared decision making, on the optimal use of antibiotics in the context of ARI. Methods/design This pilot study is a cluster RCT conducted with family physicians from Family Medicine Groups (FMG in the Quebec City area, Canada. Participating FMG are randomised to an immediate DECISION+ group, a CPD program in shared decision making, (experimental group, or a delayed DECISION+ group (control group. Data collection involves recruiting five patients consulting for ARI per physician from both study groups before (Phase 1 and after (Phase 2 exposure of the experimental group to the DECISION+ program, and after exposure of the control group to the DECISION+ program (Phase 3. The primary outcome measures to assess the feasibility of a larger RCT include: 1 proportion of contacted FMG that agree to participate; 2 proportion of recruited physicians who participate in the DECISION+ program; 3 level of satisfaction of physicians regarding DECISION+; and 4 proportion of missing data in each data collection phase. Levels of agreement of the patient-physician dyad on the Decisional Conflict Scale and physicians' prescription profile for ARI are performed as secondary outcome measures. Discussion This study protocol is informative for researchers and clinicians interested in designing and/or conducting clustered RCT with FMG regarding training of physicians in shared decision making. Trial Registration ClinicalTrials.gov Identifier: NCT00354315

  11. Efficacy and effectiveness of an rVSV-vectored vaccine expressing Ebola surface glycoprotein: interim results from the Guinea ring vaccination cluster-randomised trial.

    Science.gov (United States)

    Henao-Restrepo, Ana Maria; Longini, Ira M; Egger, Matthias; Dean, Natalie E; Edmunds, W John; Camacho, Anton; Carroll, Miles W; Doumbia, Moussa; Draguez, Bertrand; Duraffour, Sophie; Enwere, Godwin; Grais, Rebecca; Gunther, Stephan; Hossmann, Stefanie; Kondé, Mandy Kader; Kone, Souleymane; Kuisma, Eeva; Levine, Myron M; Mandal, Sema; Norheim, Gunnstein; Riveros, Ximena; Soumah, Aboubacar; Trelle, Sven; Vicari, Andrea S; Watson, Conall H; Kéïta, Sakoba; Kieny, Marie Paule; Røttingen, John-Arne

    2015-08-29

    A recombinant, replication-competent vesicular stomatitis virus-based vaccine expressing a surface glycoprotein of Zaire Ebolavirus (rVSV-ZEBOV) is a promising Ebola vaccine candidate. We report the results of an interim analysis of a trial of rVSV-ZEBOV in Guinea, west Africa. For this open-label, cluster-randomised ring vaccination trial, suspected cases of Ebola virus disease in Basse-Guinée (Guinea, west Africa) were independently ascertained by Ebola response teams as part of a national surveillance system. After laboratory confirmation of a new case, clusters of all contacts and contacts of contacts were defined and randomly allocated 1:1 to immediate vaccination or delayed (21 days later) vaccination with rVSV-ZEBOV (one dose of 2 × 10(7) plaque-forming units, administered intramuscularly in the deltoid muscle). Adults (age ≥18 years) who were not pregnant or breastfeeding were eligible for vaccination. Block randomisation was used, with randomly varying blocks, stratified by location (urban vs rural) and size of rings (≤20 vs >20 individuals). The study is open label and masking of participants and field teams to the time of vaccination is not possible, but Ebola response teams and laboratory workers were unaware of allocation to immediate or delayed vaccination. Taking into account the incubation period of the virus of about 10 days, the prespecified primary outcome was laboratory-confirmed Ebola virus disease with onset of symptoms at least 10 days after randomisation. The primary analysis was per protocol and compared the incidence of Ebola virus disease in eligible and vaccinated individuals in immediate vaccination clusters with the incidence in eligible individuals in delayed vaccination clusters. This trial is registered with the Pan African Clinical Trials Registry, number PACTR201503001057193. Between April 1, 2015, and July 20, 2015, 90 clusters, with a total population of 7651 people were included in the planned interim analysis. 48 of

  12. Effect of participatory women's groups and counselling through home visits on children's linear growth in rural eastern India (CARING trial): a cluster-randomised controlled trial.

    Science.gov (United States)

    Nair, Nirmala; Tripathy, Prasanta; Sachdev, H S; Pradhan, Hemanta; Bhattacharyya, Sanghita; Gope, Rajkumar; Gagrai, Sumitra; Rath, Shibanand; Rath, Suchitra; Sinha, Rajesh; Roy, Swati Sarbani; Shewale, Suhas; Singh, Vijay; Srivastava, Aradhana; Costello, Anthony; Copas, Andrew; Skordis-Worrall, Jolene; Haghparast-Bidgoli, Hassan; Saville, Naomi; Prost, Audrey

    2017-10-01

    Around 30% of the world's stunted children live in India. The Government of India has proposed a new cadre of community-based workers to improve nutrition in 200 districts. We aimed to find out the effect of such a worker carrying out home visits and participatory group meetings on children's linear growth. We did a cluster-randomised controlled trial in two adjoining districts of Jharkhand and Odisha, India. 120 clusters (around 1000 people each) were randomly allocated to intervention or control using a lottery. Randomisation took place in July, 2013, and was stratified by district and number of hamlets per cluster (0, 1-2, or ≥3), resulting in six strata. In each intervention cluster, a worker carried out one home visit in the third trimester of pregnancy, monthly visits to children younger than 2 years to support feeding, hygiene, care, and stimulation, as well as monthly women's group meetings to promote individual and community action for nutrition. Participants were pregnant women identified and recruited in the study clusters and their children. We excluded stillbirths and neonatal deaths, infants whose mothers died, those with congenital abnormalities, multiple births, and mother and infant pairs who migrated out of the study area permanently during the trial period. Data collectors visited each woman in pregnancy, within 72 h of her baby's birth, and at 3, 6, 9, 12, and 18 months after birth. The primary outcome was children's length-for-age Z score at 18 months of age. Analyses were by intention to treat. Due to the nature of the intervention, participants and the intervention team were not masked to allocation. Data collectors and the data manager were masked to allocation. The trial is registered as ISCRTN (51505201) and with the Clinical Trials Registry of India (number 2014/06/004664). Between Oct 1, 2013, and Dec 31, 2015, we recruited 5781 pregnant women. 3001 infants were born to pregnant women recruited between Oct 1, 2013, and Feb 10, 2015

  13. Protocol of a cluster randomised stepped-wedge trial of behavioural interventions targeting amphetamine-type stimulant use and sexual risk among female entertainment and sex workers in Cambodia.

    Science.gov (United States)

    Page, Kimberly; Stein, Ellen S; Carrico, Adam W; Evans, Jennifer L; Sokunny, Muth; Nil, Ean; Ngak, Song; Sophal, Chhit; McCulloch, Charles; Maher, Lisa

    2016-05-09

    HIV risk among female entertainment and sex workers (FESW) remains high and use of amphetamine-type stimulants (ATS) significantly increases this risk. We designed a cluster randomised stepped wedge trial (The Cambodia Integrated HIV and Drug Prevention Implementation (CIPI) study) to test sequentially delivered behavioural interventions targeting ATS use. The trial combines a 12-week Conditional Cash Transfer (CCT) intervention with 4 weeks of cognitive-behavioural group aftercare (AC) among FESW who use ATS. The primary goal is to reduce ATS use and unprotected sex among FESW. The CCT+AC intervention is being implemented in 10 provinces where order of delivery was randomised. Outcome assessments (OEs) including biomarkers and self-reported measures of recent sexual and drug use behaviours are conducted prior to implementation, and at three 6-month intervals after completion. Consultation with multiple groups and stakeholders on implementation factors facilitated acceptance and operationalisation of the trial. Statistical power and sample size calculations were based on expected changes in ATS use and unprotected sex at the population level as well as within subjects. Ethical approvals were granted by the Cambodia National Ethics Committee; University of New Mexico; University of California, San Francisco; and FHI360. The trial is registered with ClinicalTrials.gov. Dissemination of process indicators during the multiyear trial is carried out through annual in-country Stakeholder Meetings. Provincial 'Close-Out' forums are held at the conclusion of data collection in each province. When analysis is completed, dissemination meetings will be held in Cambodia with stakeholders, including community-based discussion sessions, policy briefs and results published and presented in the HIV prevention scientific journals and conferences. CIPI is the first trial of an intervention to reduce ATS use and HIV risk among FESW in Cambodia. Will inform both CCT+AC implementation

  14. Performance and economic evaluation of the molecular detection of pathogens for patients with severe infections: the EVAMICA open-label, cluster-randomised, interventional crossover trial.

    Science.gov (United States)

    Cambau, Emmanuelle; Durand-Zaleski, Isabelle; Bretagne, Stéphane; Brun-Buisson, Christian; Cordonnier, Catherine; Duval, Xavier; Herwegh, Stéphanie; Pottecher, Julien; Courcol, René; Bastuji-Garin, Sylvie

    2017-11-01

    Microbiological diagnosis (MD) of infections remains insufficient. The resulting empirical antimicrobial therapy leads to multidrug resistance and inappropriate treatments. We therefore evaluated the cost-effectiveness of direct molecular detection of pathogens in blood for patients with severe sepsis (SES), febrile neutropenia (FN) and suspected infective endocarditis (SIE). Patients were enrolled in a multicentre, open-label, cluster-randomised crossover trial conducted during two consecutive periods, randomly assigned as control period (CP; standard diagnostic workup) or intervention period (IP; additional testing with LightCycler ® SeptiFast). Multilevel models used to account for clustering were stratified by clinical setting (SES, FN, SIE). A total of 1416 patients (907 SES, 440 FN, 69 SIE) were evaluated for the primary endpoint (rate of blood MD). For SES patients, the MD rate was higher during IP than during CP [42.6% (198/465) vs. 28.1% (125/442), odds ratio (OR) 1.89, 95% confidence interval (CI) 1.43-2.50; P analysis of the incremental cost-effectiveness ratio showed weak dominance of intervention in SES patients. Addition of molecular detection to standard care improves MD and thus efficiency of healthcare resource usage in patients with SES. ClinicalTrials.gov registration number: NCT00709358.

  15. Translating Evidence for Low Back Pain Management into a Consumer-Focussed Resource for Use in Community Pharmacies: A Cluster-Randomised Controlled Trial

    Science.gov (United States)

    2013-01-01

    Background This cluster-randomised controlled trial determined the effectiveness of an evidence-based, pamphlet intervention in improving low back pain (LBP)-related beliefs among pharmacy consumers. Methods Thirty five community pharmacies were randomised to three groups: pamphlet+education intervention [n = 11]; pamphlet only intervention [n = 11]; control: usual care [n = 13]. Eligibility requirements for clusters included: community-based pharmacies and proprietor participation consent. Pharmacy consumers (N = 317) aged 18–65 years currently experiencing LBP participated. Intervention group allocation depended on the pharmacy attended. Individual-level outcomes were measured at pre-intervention (T0), at two (T1) and eight (T2) weeks post-intervention and included beliefs about LBP [Back Pain Beliefs Questionnaire (BBQ); Fear Avoidance Beliefs Questionnaire (FABQ)]. Secondary outcomes included pain severity, activity impairment and pamphlet perceived usefulness. Blinding to group allocation included primary investigators, outcome assessors and the statistician. Pharmacy staff and consumers were un-blinded. Results Of 35 pharmacies recruited (317 consumers), no clusters were lost to follow-up. Follow-up was available for n = 24 at 2 weeks only; n = 38 at 8 weeks only; n = 148 at both time points, with n = 148+24+38 = 210 analysed (107 excluded: no follow up). Adjusting for baseline scores demonstrated no significant differences in beliefs (2 or at 8 weeks) between pamphlet (with or without education) versus control, or between ‘pamphlet with’ versus ‘without’ education. Work-related fear (FABQ) was significantly lower in consumers receiving pamphlet (with or without education) versus control (difference −2.3, 95%CI: −4.4 to −0.2). There was no significant difference between “pamphlet with” versus “pamphlet without” groups. Consumers receiving the “pamphlet with” reported greater perceived usefulness

  16. The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial.

    Science.gov (United States)

    Jeon, Yun-Hee; Simpson, Judy M; Chenoweth, Lynn; Cunich, Michelle; Kendig, Hal

    2013-10-25

    A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care--CLiAC) was developed to improve managers' leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be compared by cluster

  17. Building the capacity of family day care educators to promote children's social and emotional wellbeing: an exploratory cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sims Margaret

    2011-11-01

    Full Text Available Abstract Background Childhood mental health problems are highly prevalent, experienced by one in five children living in socioeconomically disadvantaged families. Although childcare settings, including family day care are ideal to promote children's social and emotional wellbeing at a population level in a sustainable way, family day care educators receive limited training in promoting children's mental health. This study is an exploratory wait-list control cluster randomised controlled trial to test the appropriateness, acceptability, cost, and effectiveness of "Thrive," an intervention program to build the capacity of family day care educators to promote children's social and emotional wellbeing. Thrive aims to increase educators' knowledge, confidence and skills in promoting children's social and emotional wellbeing. Methods/Design This study involves one family day care organisation based in a low socioeconomic area of Melbourne. All family day care educators (term used for registered carers who provide care for children for financial reimbursement in the carers own home are eligible to participate in the study. The clusters for randomisation will be the fieldworkers (n = 5 who each supervise 10-15 educators. The intervention group (field workers and educators will participate in a variety of intervention activities over 12 months, including workshops; activity exchanges with other educators; and focused discussion about children's social and emotional wellbeing during field worker visits. The control group will continue with their normal work practice. The intervention will be delivered to the intervention group and then to the control group after a time delay of 15 months post intervention commencement. A baseline survey will be conducted with all consenting educators and field workers (n = ~70 assessing outcomes at the cluster and individual level. The survey will also be administered at one month, six months and 12 months post

  18. The effectiveness of an aged care specific leadership and management program on workforce, work environment, and care quality outcomes: design of a cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background A plethora of observational evidence exists concerning the impact of management and leadership on workforce, work environment, and care quality. Yet, no randomised controlled trial has been conducted to test the effectiveness of leadership and management interventions in aged care. An innovative aged care clinical leadership program (Clinical Leadership in Aged Care − CLiAC) was developed to improve managers’ leadership capacities to support the delivery of quality care in Australia. This paper describes the study design of the cluster randomised controlled trial testing the effectiveness of the program. Methods Twenty-four residential and community aged care sites were recruited as managers at each site agreed in writing to participate in the study and ensure that leaders allocated to the control arm would not be offered the intervention program. Sites undergoing major managerial or structural changes were excluded. The 24 sites were randomly allocated to receive the CLiAC program (intervention) or usual care (control), stratified by type (residential vs. community, six each for each arm). Treatment allocation was masked to assessors and staff of all participating sites. The objective is to establish the effectiveness of the CLiAC program in improving work environment, workforce retention, as well as care safety and quality, when compared to usual care. The primary outcomes are measures of work environment, care quality and safety, and staff turnover rates. Secondary outcomes include manager leadership capacity, staff absenteeism, intention to leave, stress levels, and job satisfaction. Differences between intervention and control groups will be analysed by researchers blinded to treatment allocation using linear regression of individual results adjusted for stratification and clustering by site (primary analysis), and additionally for baseline values and potential confounders (secondary analysis). Outcomes measured at the site level will be

  19. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial

    Science.gov (United States)

    2012-01-01

    Background The effectiveness and efficiency of nursing-home dementia care are suboptimal: there are high rates of neuropsychiatric symptoms among the residents and work-related stress among the staff. Dementia-care mapping is a person-centred care method that may alleviate both the resident and the staff problems. The main objective of this study is to evaluate the effectiveness and cost-effectiveness of dementia-care mapping in nursing-home dementia care. Methods/Design The study is a cluster-randomised controlled trial, with nursing homes grouped in clusters. Studywise minimisation is the allocation method. Nursing homes in the intervention group will receive a dementia-care-mapping intervention, while the control group will receive usual care. The primary outcome measure is resident agitation, to be assessed with the Cohen-Mansfield Agitation Inventory. The secondary outcomes are resident neuropsychiatric symptoms, assessed with the Neuropsychiatric Inventory - Nursing Homes and quality of life, assessed with Qualidem and the EQ-5D. The staff outcomes are stress reactions, job satisfaction and job-stress-related absenteeism, and staff turnover rate, assessed with the Questionnaire about Experience and Assessment of Work, the General Health Questionnaire-12, and the Maastricht Job Satisfaction Scale for Health Care, respectively. We will collect the data from the questionnaires and electronic registration systems. We will employ linear mixed-effect models and cost-effectiveness analyses to evaluate the outcomes. We will use structural equation modelling in the secondary analysis to evaluate the plausibility of a theoretical model regarding the effectiveness of the dementia-care mapping intervention. We will set up process analyses, including focus groups with staff, to determine the relevant facilitators of and barriers to implementing dementia-care mapping broadly. Discussion A novelty of dementia-care mapping is that it offers an integral person

  20. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van de Ven Geertje

    2012-01-01

    Full Text Available Abstract Background The effectiveness and efficiency of nursing-home dementia care are suboptimal: there are high rates of neuropsychiatric symptoms among the residents and work-related stress among the staff. Dementia-care mapping is a person-centred care method that may alleviate both the resident and the staff problems. The main objective of this study is to evaluate the effectiveness and cost-effectiveness of dementia-care mapping in nursing-home dementia care. Methods/Design The study is a cluster-randomised controlled trial, with nursing homes grouped in clusters. Studywise minimisation is the allocation method. Nursing homes in the intervention group will receive a dementia-care-mapping intervention, while the control group will receive usual care. The primary outcome measure is resident agitation, to be assessed with the Cohen-Mansfield Agitation Inventory. The secondary outcomes are resident neuropsychiatric symptoms, assessed with the Neuropsychiatric Inventory - Nursing Homes and quality of life, assessed with Qualidem and the EQ-5D. The staff outcomes are stress reactions, job satisfaction and job-stress-related absenteeism, and staff turnover rate, assessed with the Questionnaire about Experience and Assessment of Work, the General Health Questionnaire-12, and the Maastricht Job Satisfaction Scale for Health Care, respectively. We will collect the data from the questionnaires and electronic registration systems. We will employ linear mixed-effect models and cost-effectiveness analyses to evaluate the outcomes. We will use structural equation modelling in the secondary analysis to evaluate the plausibility of a theoretical model regarding the effectiveness of the dementia-care mapping intervention. We will set up process analyses, including focus groups with staff, to determine the relevant facilitators of and barriers to implementing dementia-care mapping broadly. Discussion A novelty of dementia-care mapping is that it offers an

  1. Community engagement and integrated health and polio immunisation campaigns in conflict-affected areas of Pakistan: a cluster randomised controlled trial.

    Science.gov (United States)

    Habib, Muhammad Atif; Soofi, Sajid; Cousens, Simon; Anwar, Saeed; Haque, Najib Ul; Ahmed, Imran; Ali, Noshad; Tahir, Rehman; Bhutta, Zulfiqar A

    2017-06-01

    Pakistan faces huge challenges in eradicating polio due to widespread poliovirus transmission and security challenges. Innovative interventions are urgently needed to strengthen community buy-in, to increase the coverage of oral polio vaccine (OPV) and other routine immunisations, and to enhance immunity through the introduction of inactivated polio vaccine (IPV) in combination with OPV. We aimed to evaluate the acceptability and effect on immunisation coverage of an integrated strategy for community engagement and maternal and child health immunisation campaigns in insecure and conflict-affected polio-endemic districts of Pakistan. We did a community-based three-arm cluster randomised trial in healthy children aged 1 month to 5 years that resided within the study sites in three districts of Pakistan at high risk of polio. Clusters were randomly assigned by a computer algorithm using restricted randomisation in blocks of 20 by an external statistician (1:1:1) to receive routine polio programme activities (control, arm A), additional interventions with community outreach and mobilisation using an enhanced communication package and provision of short-term preventive maternal and child health services and routine immunisation (health camps), including OPV (arm B), or all interventions of arm B with additional provision of IPV delivered at the maternal and child health camps (arm C). An independent team conducted surveys at baseline, endline, and after each round of supplementary immunisation activity for acceptability and effect. The primary outcome measures for the study were coverage of OPV, IPV, and routine extended programme on immunisation vaccines and changes in the proportion of unvaccinated and fully vaccinated children. This trial is registered with ClinicalTrials.gov, number NCT01908114. Between June 4, 2013, and May 31, 2014, 387 clusters were randomised (131 to arm A, 127 to arm B, and 129 to arm C). At baseline, 28 760 children younger than 5 years were

  2. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years

    DEFF Research Database (Denmark)

    Gluud, Christian; Nikolova, Dimitrinka

    2007-01-01

    The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study.......The number of publications on clinical trials is unknown as well as the countries publishing most trial reports. To try to examine these questions we performed an ecological study....

  3. Can child restraint product information developed using consumer testing sustain correct use 6 months after child restraint purchase? Study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Brown, Julie; Elkington, Jane; Hall, Alexandra; Keay, Lisa; Charlton, Judith L; Hunter, Kate; Koppel, Sjaan; Hayen, Andrew; Bilston, Lynne E

    2018-03-07

    With long-standing and widespread high rates of errors in child restraint use, there is a need to identify effective methods to address this problem. Information supplied with products at the point of sale may be a potentially efficient delivery point for such a countermeasure. The aim of this study is to establish whether product materials developed using a consumer-driven approach reduce errors in restraint use among purchasers of new child restraint systems. A cluster randomised controlled trial (cRCT) will be conducted. Retail stores (n=22) in the greater Sydney area will be randomised into intervention sites (n=11) and control sites (n=11), stratified by geographical and socioeconomic indicators. Participants (n=836) will enter the study on purchase of a restraint. Outcome measures are errors in installation of the restraint as observed by a trained researcher during a 6-month follow-up home assessment, and adjustment checks made by the parent when the child is placed into the restraint (observed using naturalistic methods). Process evaluation measures will also be collected during the home visit. An intention-to-treat approach will be used for all analyses. Correct use and adjustment checks made by the parent will be compared between control and intervention groups using a logistic regression model. The number of installation errors between groups will be compared using Poisson regression. This cRCT will determine the effectiveness of targeted, consumer-driven information on actual error rates in use of restraints. More broadly, it may provide a best practice model for developing safety product information. ACTRN12617001252303p; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. Protocol for the ‘Virtual Traveller’ cluster-randomised controlled trial: a behaviour change intervention to increase physical activity in primary-school Maths and English lessons

    Science.gov (United States)

    Norris, E; Dunsmuir, S; Duke-Williams, O; Stamatakis, E; Shelton, N

    2016-01-01

    Introduction Physical activity (PA) has been shown to be an important factor for health and educational outcomes in children. However, a large proportion of children's school day is spent in sedentary lesson-time. There is emerging evidence about the effectiveness of physically active lessons: integrating physical movements and educational content in the classroom. ‘Virtual Traveller’ is a novel 6-week intervention of 10-min sessions performed 3 days per week, using classroom interactive whiteboards to integrate movement into primary-school Maths and English teaching. The primary aim of this project is to evaluate the effect of the Virtual Traveller intervention on children's PA, on-task behaviour and student engagement. Methods and analysis This study will be a cluster-randomised controlled trial with a waiting-list control group. Ten year 4 (aged 8–9 years) classes across 10 primary schools will be randomised by class to either the 6-week Virtual Traveller intervention or the waiting-list control group. Data will be collected 5 times: at baseline, at weeks 2 and 4 of the intervention, and 1 week and 3 months postintervention. At baseline, anthropometric measures, 4-day objective PA monitoring (including 2 weekend days; Actigraph accelerometer), PA and on-task behaviour observations and student engagement questionnaires will be performed. All but anthropometric measures will be repeated at all other data collection points. Changes in overall PA levels and levels during different time-periods (eg, lesson-time) will be examined. Changes in on-task behaviour and student engagement between intervention groups will also be examined. Multilevel regression modelling will be used to analyse the data. Process evaluation will be carried out during the intervention period. Ethics and dissemination The results of this study will be disseminated through peer-review publications and conference presentations. Ethical approval was obtained through the University

  5. Effect of mobile application-based versus DVD-based CPR training on students’ practical CPR skills and willingness to act: a cluster randomised study

    Science.gov (United States)

    Nord, Anette; Svensson, Leif; Hult, Håkan; Kreitz-Sandberg, Susanne; Nilsson, Lennart

    2016-01-01

    Objectives The aim was to compare students’ practical cardiopulmonary resuscitation (CPR) skills and willingness to perform bystander CPR, after a 30 min mobile application (app)-based versus a 50 min DVD-based training. Settings Seventh grade students in two Swedish municipalities. Design A cluster randomised trial. The classes were randomised to receive app-based or DVD-based training. Willingness to act and practical CPR skills were assessed, directly after training and at 6 months, by using a questionnaire and a PC Skill Reporting System. Data on CPR skills were registered in a modified version of the Cardiff test, where scores were given in 12 different categories, adding up to a total score of 12–48 points. Training and measurements were performed from December 2013 to October 2014. Participants 63 classes or 1232 seventh grade students (13-year-old) were included in the study. Primary and secondary outcome measures Primary end point was the total score of the modified Cardiff test. The individual variables of the test and self-reported willingness to make a life-saving intervention were secondary end points. Results The DVD-based group was superior to the app-based group in CPR skills; a total score of 36 (33–38) vs 33 (30–36) directly after training (pCPR skill components. Both groups improved compression depth from baseline to follow-up. If a friend suffered cardiac arrest, 78% (DVD) versus 75% (app) would do compressions and ventilations, whereas only 31% (DVD) versus 32% (app) would perform standard CPR if the victim was a stranger. Conclusions At 6 months follow-up, the 50 min DVD-based group showed superior CPR skills compared with the 30 min app-based group. The groups did not differ in regard to willingness to make a life-saving effort. PMID:27130166

  6. Use of a decision aid for prenatal testing of fetal abnormalities to improve women's informed decision making: a cluster randomised controlled trial [ISRCTN22532458].

    Science.gov (United States)

    Nagle, C; Gunn, J; Bell, R; Lewis, S; Meiser, B; Metcalfe, S; Ukoumunne, O C; Halliday, J

    2008-02-01

    To evaluate the effectiveness of a decision aid for prenatal testing of fetal abnormalities compared with a pamphlet in supporting women's decision making. A cluster randomised controlled trial. Primary health care. Women in early pregnancy consulting a GP. GPs were randomised to provide women with either a decision aid or a pamphlet. The decision aid was a 24-page booklet designed using the Ottowa Decision Framework. The pamphlet was an existing resource available in the trial setting. Validated scales were used to measure the primary outcomes, informed choice and decisional conflict, and the secondary outcomes, anxiety, depression, attitudes to the pregnancy/fetus and acceptability of the resource. Outcomes were measured at 14 weeks of gestation from questionnaires that women completed and returned by post. Women in the intervention group were more likely to make an informed decision 76% (126/165) than those in the control group 65% (107/165) (adjusted OR 2.08; 95% CI 1.14-3.81). A greater proportion of women in the intervention group 88% (147/167) had a 'good' level of knowledge than those in the control group 72% (123/171) (adjusted OR 3.43; 95% CI 1.79-6.58). Mean (SD) decisional conflict scores were low in both groups, decision aid 1.71 (0.49), pamphlet 1.65 (0.55) (adjusted mean difference 0.10; 95% CI -0.02 to 0.22). There was no strong evidence of differences between the trial arms in the measures of psychological or acceptability outcomes. A tailored prenatal testing decision aid plays an important role in improving women's knowledge of first and second trimester screening tests and assisting them to make decisions about screening and diagnostic tests that are consistent with their values.

  7. Improving educational achievement and anaemia of school children: design of a cluster randomised trial of school-based malaria prevention and enhanced literacy instruction in Kenya

    Directory of Open Access Journals (Sweden)

    Halliday Katherine E

    2010-10-01

    Full Text Available Abstract Background Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement. However, there is limited experimental evidence on the benefits of school-based malaria prevention or how health interventions interact with other efforts to improve education quality. This study aims to evaluate the impact of school-based malaria prevention and enhanced literacy instruction on the health and educational achievement of school children in Kenya. Design A factorial, cluster randomised trial is being implemented in 101 government primary schools on the coast of Kenya. The interventions are (i intermittent screening and treatment of malaria in schools by public health workers and (ii training workshops and support for teachers to promote explicit and systematic literacy instruction. Schools are randomised to one of four groups: receiving either (i the malaria intervention alone; (ii the literacy intervention alone; (iii both interventions combined; or (iv control group where neither intervention is implemented. Children from classes 1 and 5 are randomly selected and followed up for 24 months. The primary outcomes are educational achievement and anaemia, the hypothesised mediating variables through which education is affected. Secondary outcomes include malaria parasitaemia, school attendance and school performance. A nested process evaluation, using semi-structured interviews, focus group discussion and a stakeholder analysis will investigate the community acceptability, feasibility and cost-effectiveness of the interventions. Discussion Across Africa, governments are committed to improve health and education of school-aged children, but seek clear policy and technical guidance as to the optimal approach to address malaria and improved literacy. This evaluation will be one of the first to simultaneously evaluate the impact of health and education interventions in the improvement of

  8. Helping hands: A cluster randomised trial to evaluate the effectiveness of two different strategies for promoting hand hygiene in hospital nurses

    Directory of Open Access Journals (Sweden)

    Hulscher Marlies

    2011-09-01

    Full Text Available Abstract Background Hand hygiene prescriptions are the most important measure in the prevention of hospital-acquired infections. Yet, compliance rates are generally below 50% of all opportunities for hand hygiene. This study aims at evaluating the short- and long-term effects of two different strategies for promoting hand hygiene in hospital nurses. Methods/design This study is a cluster randomised controlled trial with inpatient wards as the unit of randomisation. Guidelines for hand hygiene will be implemented in this study. Two strategies will be used to improve the adherence to guidelines for hand hygiene. The state-of-the-art strategy is derived from the literature and includes education, reminders, feedback, and targeting adequate products and facilities. The extended strategy also contains activities aimed at influencing social influence in groups and enhancing leadership. The unique contribution of the extended strategy is built upon relevant behavioural science theories. The extended strategy includes all elements of the state-of-the-art strategy supplemented with gaining active commitment and initiative of ward management, modelling by informal leaders at the ward, and setting norms and targets within the team. Data will be collected at four points in time, with six-month intervals. An average of 3,000 opportunities for hand hygiene in approximately 900 nurses will be observed at each time point. Discussion Performing and evaluating an implementation strategy that also targets the social context of teams may considerably add to the general body of knowledge in this field. Results from our study will allow us to draw conclusions on the effects of different strategies for the implementation of hand hygiene guidelines, and based on these results we will be able to define a preferred implementation strategy for hospital based nursing. Trial registration The study is registered as a Clinical Trial in ClinicalTrials.gov, dossier number: NCT

  9. The BLISS cluster randomised controlled trial of the effect of 'active dissemination of information' on standards of care for premature babies in England (BEADI study protocol [ISRCTN89683698

    Directory of Open Access Journals (Sweden)

    Houston Rosie

    2007-10-01

    Full Text Available Abstract Background Gaps between research knowledge and practice have been consistently reported. Traditional ways of communicating information have limited impact on practice changes. Strategies to disseminate information need to be more interactive and based on techniques reported in systematic reviews of implementation of changes. There is a need for clarification as to which dissemination strategies work best to translate evidence into practice in neonatal units across England. The objective of this trial is to assess whether an innovative active strategy for the dissemination of neonatal research findings, recommendations, and national neonatal guidelines is more likely to lead to changes in policy and practice than the traditional (more passive forms of dissemination in England. Methods/design Cluster randomised controlled trial of all neonatal units in England (randomised by hospital, n = 182 and stratified by neonatal regional networks and neonatal units level of care to assess the relative effectiveness of active dissemination strategies on changes in local policies and practices. Participants will be mainly consultant lead clinicians in each unit. The intervention will be multifaceted using: audit and feedback; educational meetings for local staff (evidence-based lectures on selected topics, interactive workshop to examine current practice and draw up plans for change; and quality improvement and organisational changes methods. Policies and practice outcomes for the babies involved will be collected before and after the intervention. Outcomes will assess all premature babies born in England during a three month period for timing of surfactant administration at birth, temperature control at birth, and resuscitation team (qualification and numbers present at birth. Trial registration Current controlled trials ISRCTN89683698

  10. Cluster randomised controlled trial of a multicomponent intervention to support the implementation of policies and practices that promote healthier environments at junior sports clubs: study protocol.

    Science.gov (United States)

    Milner, Sharin; Sherker, Shauna; Clinton-McHarg, Tara; Dray, Julia; Zukowski, Nadya; Gonzalez, Sharleen; Kingsland, Melanie; Ooi, Jia Ying; Murphy, Allan; Brooke, Daisy; Wiggers, John; Wolfenden, Luke

    2018-01-23

    A large proportion of children and adolescents participate in organised sport, making community sports clubs a promising setting to support healthy behaviours. To date, however, there have been few interventions conducted in junior sports clubs that have targeted health-promoting practices. The primary aim of this pilot study is to assess the potential effectiveness of an intervention to implement health-promoting policies and practices in junior sporting clubs targeting alcohol and tobacco practices, healthy food and beverage availability, and physical activity via participation in sport. A secondary outcome is to assess the impact of such strategies on child exposure to alcohol and tobacco use at the club, purchasing behaviours by/for children at the club canteen and child sports participation opportunities. The study will employ a cluster randomised controlled trial design and be conducted in metropolitan and regional areas of two Australian states. Randomisation will occur at the level of the football league. Community football clubs with over 40 junior players (players under 18 years) within each league will be eligible to participate. The intervention will be developed based on frameworks that consider the social, cultural and environmental factors that influence health behaviours. Intervention clubs will be supported to implement 16 practices targeting alcohol management, tobacco use, nutrition practices, new player recruitment activity, equal participation for players and the development of policies to support these practices. Trained research staff will collect outcome data via telephone interviews at baseline and follow-up. Interviews will be conducted with both club representatives and parents of junior players. The study has been approved by the University of Newcastle Human Research Ethics Committee (H-2013-0429). The results of the study will be disseminated via peer-reviewed publications and presentations at conferences. ACTRN12617001044314; Pre

  11. Cluster randomised controlled trial of a multicomponent intervention to support the implementation of policies and practices that promote healthier environments at junior sports clubs: study protocol

    Science.gov (United States)

    Milner, Sharin; Sherker, Shauna; Clinton-McHarg, Tara; Dray, Julia; Zukowski, Nadya; Gonzalez, Sharleen; Kingsland, Melanie; Ooi, Jia Ying; Murphy, Allan; Brooke, Daisy; Wiggers, John

    2018-01-01

    Introduction A large proportion of children and adolescents participate in organised sport, making community sports clubs a promising setting to support healthy behaviours. To date, however, there have been few interventions conducted in junior sports clubs that have targeted health-promoting practices. The primary aim of this pilot study is to assess the potential effectiveness of an intervention to implement health-promoting policies and practices in junior sporting clubs targeting alcohol and tobacco practices, healthy food and beverage availability, and physical activity via participation in sport. A secondary outcome is to assess the impact of such strategies on child exposure to alcohol and tobacco use at the club, purchasing behaviours by/for children at the club canteen and child sports participation opportunities. Methods and analysis The study will employ a cluster randomised controlled trial design and be conducted in metropolitan and regional areas of two Australian states. Randomisation will occur at the level of the football league. Community football clubs with over 40 junior players (players under 18 years) within each league will be eligible to participate. The intervention will be developed based on frameworks that consider the social, cultural and environmental factors that influence health behaviours. Intervention clubs will be supported to implement 16 practices targeting alcohol management, tobacco use, nutrition practices, new player recruitment activity, equal participation for players and the development of policies to support these practices. Trained research staff will collect outcome data via telephone interviews at baseline and follow-up. Interviews will be conducted with both club representatives and parents of junior players. Ethics and dissemination The study has been approved by the University of Newcastle Human Research Ethics Committee (H-2013-0429). The results of the study will be disseminated via peer-reviewed publications and

  12. Characteristics of the home food environment that mediate immediate and sustained increases in child fruit and vegetable consumption: mediation analysis from the Healthy Habits cluster randomised controlled trial.

    Science.gov (United States)

    Wyse, Rebecca; Wolfenden, Luke; Bisquera, Alessandra

    2015-09-17

    The home food environment can influence the development of dietary behaviours in children, and interventions that modify characteristics of the home food environment have been shown to increase children's fruit and vegetable consumption. However to date, interventions to increase children's fruit and vegetable consumption have generally produced only modest effects. Mediation analysis can help in the design of more efficient and effective interventions by identifying the mechanisms through which interventions have an effect. This study aimed to identify characteristics of the home food environment that mediated immediate and sustained increases in children's fruit and vegetable consumption following the 4-week Healthy Habits telephone-based parent intervention. Analysis was conducted using 2-month (immediate) and 12-month (sustained) follow-up data from a cluster randomised control trial of a home food environment intervention to increase the fruit and vegetable consumption of preschool children. Using recursive path analysis, a series of mediation models were created to investigate the direct and indirect effects of immediate and sustained changes to characteristics of the home food environment (fruit and vegetable availability, accessibility, parent intake, parent providing behaviour, role-modelling, mealtime eating practices, child feeding strategies, and pressure to eat), on the change in children's fruit and vegetable consumption. Of the 394 participants in the randomised trial, 357 and 329 completed the 2- and 12-month follow-up respectively. The final mediation model suggests that the effect of the intervention on the children's fruit and vegetable consumption was mediated by parent fruit and vegetable intake and parent provision of these foods at both 2- and 12-month follow-up. Analysis of data from the Healthy Habits trial suggests that two environmental variables (parental intake and parent providing) mediate the immediate and sustained effect of the

  13. Efficacy of a movement control injury prevention programme in adult men’s community rugby union: a cluster randomised controlled trial

    Science.gov (United States)

    Attwood, Matthew J; Roberts, Simon P; Trewartha, Grant; England, Mike E; Stokes, Keith A

    2018-01-01

    Background Exercise programmes aimed at reducing injury have been shown to be efficacious for some non-collision sports, but evidence in adult men’s collision sports such as rugby union is lacking. Objective To evaluate the efficacy of a movement control injury prevention exercise programme for reducing match injuries in adult men’s community rugby union players. Methods 856 clubs were invited to participate in this prospective cluster randomised (single-blind) controlled trial where clubs were the unit of randomisation. 81 volunteered and were randomly assigned (intervention/control). A 42-week exercise programme was followed throughout the season. The control programme reflected ‘normal practice’ exercises, whereas the intervention focused on proprioception, balance, cutting, landing and resistance exercises. Outcome measures were match injury incidence and burden for: (1) all ≥8 days time-loss injuries and (2) targeted (lower limb, shoulder, head and neck, excluding fractures and lacerations) ≥8 days time-loss injuries. Results Poisson regression identified no clear effects on overall injury outcomes. A likely beneficial difference in targeted injury incidence (rate ratio (RR), 90% CI=0.6, 0.4 to 1.0) was identified, with a 40% reduction in lower-limb incidence (RR, 90% CI=0.6, 0.4 to 1.0) and a 60% reduction in concussion incidence (RR, 90% CI=0.4, 0.2 to 0.7) in the intervention group. Comparison between arms for clubs with highest compliance (≥median compliance) demonstrated very likely beneficial 60% reductions in targeted injury incidence (RR, 90% CI=0.4, 0.2 to 0.8) and targeted injury burden (RR, 90% CI=0.4, 0.2 to 0.7). Conclusions The movement control injury prevention programme resulted in likely beneficial reductions in lower-limb injuries and concussion. Higher intervention compliance was associated with reduced targeted injury incidence and burden. PMID:29055883

  14. Participatory ergonomics to reduce exposure to psychosocial and physical risk factors for low back pain and neck pain: results of a cluster randomised controlled trial.

    Science.gov (United States)

    Driessen, Maurice T; Proper, Karin I; Anema, Johannes R; Knol, Dirk L; Bongers, Paulien M; van der Beek, Allard J

    2011-09-01

    This study investigated the effectiveness of the Stay@Work participatory ergonomics programme to reduce workers' exposure to psychosocial and physical risk factors. 37 departments (n=3047 workers) from four Dutch companies participated in this cluster randomised controlled trial; 19 (n=1472 workers) were randomised to an intervention group (participatory ergonomics) and 18 (n=1575 workers) to a control group (no participatory ergonomics). During a 6 h meeting guided by an ergonomist, working groups devised ergonomic measures to reduce psychosocial and physical workload and implemented them within 3months in their departments. Data on psychosocial and physical risk factors for low back pain and neck pain were collected at baseline and after 6 months. Psychosocial risk factors were measured using the Job Content Questionnaire and physical risk factors using the Dutch Musculoskeletal Questionnaire. Intervention effects were studied using multilevel analysis. Intervention group workers significantly increased on decision latitude (0.29 points; 95% CI 0.07 to 0.52) and decision authority (0.16 points; 95% CI 0.04 to 0.28) compared to control workers. However, exposure to awkward trunk working postures significantly increased in the intervention group (OR 1.86; 95% CI 1.15 to 3.01) compared to the control group. No significant differences between the intervention and control group were found for the remaining risk factors. After 6months, loss to follow-up was 35% in the intervention group and 29% in the control group. Participatory ergonomics was not effective in reducing exposure to psychosocial and physical risk factors for low back pain and neck pain among a large group of workers. ISRCTN27472278.

  15. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial.

    Science.gov (United States)

    Veldhuis, Lydian; Struijk, Mirjam K; Kroeze, Willemieke; Oenema, Anke; Renders, Carry M; Bulk-Bunschoten, Anneke Mw; Hirasing, Remy A; Raat, Hein

    2009-06-08

    The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change.The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games), parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years), and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the use of this protocol will result in a healthier lifestyle of the

  16. Promoting smoking cessation in Bangladeshi and Pakistani male adults: design of a pilot cluster randomised controlled trial of trained community smoking cessation workers

    Directory of Open Access Journals (Sweden)

    Gill Paramjit

    2009-08-01

    Full Text Available Abstract Background The prevalence of smoking is higher among Pakistani and Bangladeshi males than among the general population. Smokers who receive behavioural support and medication quadruple their chances of stopping smoking, but evidence suggests that these populations do not use National Health Service run stop smoking clinics as frequently as would be expected given their high prevalence of smoking. This study aims to tackle some of the main barriers to use of stop smoking services and adherence to treatment programmes by redesigning service delivery to be more acceptable to these adult male populations. The study compares the effectiveness of trained Pakistani and Bangladeshi smoking cessation workers operating in an outreach capacity ('clinic + outreach' with standard care ('clinic only' to improve access to and success of National Health Service smoking cessation services. Methods/design This is a pilot cluster randomised controlled trial based in Birmingham, UK. Super output areas of Birmingham will be identified in which more than 10% of the population are of Pakistani and/or Bangladeshi origin. From these areas, 'natural geographical communities' will be identified. Sixteen aggregated agglomerations of super output areas will be identified, separating areas from each other using buffer regions in order to reduce potential contamination. These natural communities will be randomised to 'clinic + outreach' (intervention or 'clinic only' (control arms. The use of stop smoking services and the numbers of people quitting smoking (defined as prolonged self-reported abstinence at four weeks, three months and six months will be assessed in each area. In addition, we will assess the impact of the intervention on adherence to smoking cessation treatments and patient satisfaction. Trial registration Current Controlled Trials ISRCTN 82127540.

  17. A cluster-randomised controlled trial to promote physical activity in adolescents: the Raising Awareness of Physical Activity (RAW-PA) Study.

    Science.gov (United States)

    Ridgers, Nicola D; Timperio, Anna; Brown, Helen; Ball, Kylie; Macfarlane, Susie; Lai, Samuel K; Richards, Kara; Ngan, Winsfred; Salmon, Jo

    2017-01-04

    Recent technological advances provide an alternative yet underutilised opportunity for promoting physical activity in youth. The primary aim of the Raising Awareness of Physical Activity (RAW-PA) Study is to examine the short- and longer-term impact of a wearable activity monitor combined with digital behaviour change resources on adolescents' daily physical activity levels. RAW-PA is a 12 week, multicomponent physical activity intervention that utilises a popular activity tracker (Fitbit® Flex) and supporting digital materials that will be delivered online via social media. The resources target key behaviour change techniques. The intervention structure and components have been informed by participatory research principles. RAW-PA will be evaluated using a cluster randomised controlled trial design with schools as the unit of randomisation. Twelve schools located in Melbourne, Australia, will allocated to either the intervention or wait-list control group. The target sample size is 300 Year 8 adolescents (aged 13-14 years). Participants' moderate- to vigorous-intensity physical activity will be the primary outcome. Survey measures will be completed. Process factors (e.g. feasibility, acceptability/appeal, fidelity) will also be collected. To our knowledge, this study will provide some of the first evidence concerning the effect of wearable activity trackers and digital behaviour change resources on adolescents' physical activity levels. This study will provide insights into the use of such technologies for physical activity promotion, which may have a significant impact on health education, promotion, practice and policy. Australian and New Zealand Clinical Trials Registry No: ACTRN12616000899448 . Date of registration: July 7, 2016.

  18. Improving oxygen therapy for children and neonates in secondary hospitals in Nigeria: study protocol for a stepped-wedge cluster randomised trial.

    Science.gov (United States)

    Graham, Hamish R; Ayede, Adejumoke I; Bakare, Ayobami A; Oyewole, Oladapo B; Peel, David; Gray, Amy; McPake, Barbara; Neal, Eleanor; Qazi, Shamim; Izadnegahdar, Rasa; Falade, Adegoke G; Duke, Trevor

    2017-10-27

    Oxygen is a life-saving, essential medicine that is important for the treatment of many common childhood conditions. Improved oxygen systems can reduce childhood pneumonia mortality substantially. However, providing oxygen to children is challenging, especially in small hospitals with weak infrastructure and low human resource capacity. This trial will evaluate the implementation of improved oxygen systems at secondary-level hospitals in southwest Nigeria. The improved oxygen system includes: a standardised equipment package; training of clinical and technical staff; infrastructure support (including improved power supply); and quality improvement activities such as supportive supervision. Phase 1 will involve the introduction of pulse oximetry alone; phase 2 will involve the introduction of the full, improved oxygen system package. We have based the intervention design on a theory-based analysis of previous oxygen projects, and used quality improvement principles, evidence-based teaching methods, and behaviour-change strategies. We are using a stepped-wedge cluster randomised design with participating hospitals randomised to receive an improved oxygen system at 4-month steps (three hospitals per step). Our mixed-methods evaluation will evaluate effectiveness, impact, sustainability, process and fidelity. Our primary outcome measures are childhood pneumonia case fatality rate and inpatient neonatal mortality rate. Secondary outcome measures include a range of clinical, quality of care, technical, and health systems outcomes. The planned study duration is from 2015 to 2018. Our study will provide quality evidence on the effectiveness of improved oxygen systems, and how to better implement and scale-up oxygen systems in resource-limited settings. Our results should have important implications for policy-makers, hospital administrators, and child health organisations in Africa and globally. Australian New Zealand Clinical Trials Registry: ACTRN12617000341325

  19. A cluster-randomised controlled trial to promote physical activity in adolescents: the Raising Awareness of Physical Activity (RAW-PA Study

    Directory of Open Access Journals (Sweden)

    Nicola D. Ridgers

    2017-01-01

    Full Text Available Abstract Background Recent technological advances provide an alternative yet underutilised opportunity for promoting physical activity in youth. The primary aim of the Raising Awareness of Physical Activity (RAW-PA Study is to examine the short- and longer-term impact of a wearable activity monitor combined with digital behaviour change resources on adolescents’ daily physical activity levels. Methods/Design RAW-PA is a 12 week, multicomponent physical activity intervention that utilises a popular activity tracker (Fitbit® Flex and supporting digital materials that will be delivered online via social media. The resources target key behaviour change techniques. The intervention structure and components have been informed by participatory research principles. RAW-PA will be evaluated using a cluster randomised controlled trial design with schools as the unit of randomisation. Twelve schools located in Melbourne, Australia, will allocated to either the intervention or wait-list control group. The target sample size is 300 Year 8 adolescents (aged 13–14 years. Participants’ moderate- to vigorous-intensity physical activity will be the primary outcome. Survey measures will be completed. Process factors (e.g. feasibility, acceptability/appeal, fidelity will also be collected. Discussion To our knowledge, this study will provide some of the first evidence concerning the effect of wearable activity trackers and digital behaviour change resources on adolescents’ physical activity levels. This study will provide insights into the use of such technologies for physical activity promotion, which may have a significant impact on health education, promotion, practice and policy. Trial registration Australian and New Zealand Clinical Trials Registry No: ACTRN12616000899448 . Date of registration: July 7, 2016.

  20. Reducing Medical Admissions into Hospital through Optimising Medicines (REMAIN HOME) Study: protocol for a stepped-wedge, cluster-randomised trial

    Science.gov (United States)

    Foot, Holly; Freeman, Christopher; Hemming, Karla; Scott, Ian; Coombes, Ian D; Williams, Ian D; Connelly, Luke; Whitty, Jennifer A; Sturman, Nancy; Kirsa, Sue; Nicholson, Caroline; Russell, Grant; Kirkpatrick, Carl; Cottrell, Neil

    2017-01-01

    Introduction A model of general practitioner (GP) and pharmacist collaboration in primary care may be an effective strategy to reduce medication-related problems and provide better support to patients after discharge. The aim of this study is to investigate whether a model of structured pharmacist and GP care reduces hospital readmissions in high-risk patients. Methods and analysis This protocol details a stepped-wedge, cluster-randomised trial that will recruit participants over 9 months with a 12-month follow-up. There will be 14 clusters each representing a different general practice medical centre. A total of 2240 participants will be recruited from hospital who attend an enrolled medical centre, take five or more long-term medicines or whose reason for admission was related to heart failure or chronic obstructive pulmonary disease. The intervention is a multifaceted service, involving a pharmacist integrated into a medical centre to assist patients after hospitalisation. Participants will meet with the practice pharmacist and their GP after discharge to review and reconcile their medicines and discuss changes made in hospital. The pharmacist will follow-up with the participant and liaise with other health professionals involved in the participant’s care. The control will be usual care, which usually involves a patient self-organising a visit to their GP after hospital discharge. The primary outcome is the rate of unplanned, all-cause hospital readmissions over 12 months, which will be analysed using a mixed effects Poisson regression model with a random effect for cluster and a fixed effect to account for any temporal trend. A cost analysis will be undertaken to compare the healthcare costs associated with the intervention to those of usual care. Ethics and dissemination The study has received ethical approval (HREC/16/QRBW/410). The study findings will be disseminated through peer-reviewed publications, conferences and reports to key stakeholders. Trial

  1. Effectiveness of a Peer Support Programme versus Usual Care in Disease Management of Diabetes Mellitus Type 2 regarding Improvement of Metabolic Control: A Cluster-Randomised Controlled Trial.

    Science.gov (United States)

    Johansson, Tim; Keller, Sophie; Winkler, Henrike; Ostermann, Thomas; Weitgasser, Raimund; Sönnichsen, Andreas C

    2016-01-01

    Testing the effectiveness of peer support additionally to a disease management programme (DMP) for type 2 diabetes patients. Unblinded cluster-randomised controlled trial (RCT) involving 49 general practices, province of Salzburg, Austria. All patients enrolled in the DMP were eligible, n = 337 participated (intervention: 148 in 19 clusters; control: 189 in 20 clusters). The peer support intervention ran over 24 months and consisted of peer supporter recruitment and training, and group meetings weekly for physical exercise and monthly for discussion of diabetes related topics. At two-year follow-up, adjusted analysis revealed a nonsignificant difference in HbA1c change of 0.14% (21.97 mmol/mol) in favour of the intervention (95% CI -0.08 to 0.36%, p = 0.22). Baseline values were 7.02 ± 1.25% in the intervention and 7.08 ± 1.25 in the control group. None of the secondary outcome measures showed significant differences except for improved quality of life (EQ-5D-VAS) in controls (4.3 points on a scale of 100; 95% CI 0.08 to 8.53, p = 0.046) compared to the intervention group. Our peer support intervention as an additional DMP component showed no significant effect on HbA1c and secondary outcome measures. Further RTCs with a longer follow-up are needed to reveal whether peer support will have clinically relevant effects. This trial has been registered with Current Controlled Trials Ltd. (ISRCTN10291077).

  2. Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial.

    Science.gov (United States)

    French, Simon D; McKenzie, Joanne E; O'Connor, Denise A; Grimshaw, Jeremy M; Mortimer, Duncan; Francis, Jill J; Michie, Susan; Spike, Neil; Schattner, Peter; Kent, Peter; Buchbinder, Rachelle; Page, Matthew J; Green, Sally E

    2013-01-01

    This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP) in general practice. General practices were randomised to either access to a guideline for acute LBP (control) or facilitated interactive workshops (intervention). We measured behavioural predictors (e.g. knowledge, attitudes and intentions) and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP) level: behavioural simulation (clinical decision about vignettes) and rates of x-ray and CT-scan (medical administrative data). All those not involved in the delivery of the intervention were blinded to allocation. 47 practices (53 GPs) were randomised to the control and 45 practices (59 GPs) to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05) and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60). Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10) for x-ray or CT-scan. The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant changes in actual behaviour. Australian New Zealand

  3. START NOW - a comprehensive skills training programme for female adolescents with oppositional defiant and conduct disorders: study protocol for a cluster-randomised controlled trial.

    Science.gov (United States)

    Kersten, Linda; Prätzlich, Martin; Mannstadt, Sandra; Ackermann, Katharina; Kohls, Gregor; Oldenhof, Helena; Saure, Daniel; Krieger, Katrin; Herpertz-Dahlmann, Beate; Popma, Arne; Freitag, Christine M; Trestman, Robert L; Stadler, Christina

    2016-12-01

    In Europe, the number of females exhibiting oppositional defiant disorder (ODD) and conduct disorder (CD) is growing. Many of these females live in youth welfare institutions. Consequently, there is a great need for evidence-based interventions within youth welfare settings. A recently developed approach targeting the specific needs of girls with ODD and CD in residential care is START NOW. The aim of this group-based behavioural skills training programme is to specifically enhance emotional regulation capacities to enable females with CD or ODD to appropriately deal with daily-life demands. It is intended to enhance psychosocial adjustment and well-being as well as reduce oppositional and aggressive behaviour. We present the study protocol (version 4.1; 10 February 2016) of the FemNAT-CD intervention trial titled 'Group-Based Treatment of Adolescent Female Conduct Disorders: The Central Role of Emotion Regulation'. The study is a prospective, confirmatory, cluster-randomised, parallel-group, multi-centre, randomised controlled trial with 128 institutionalised female adolescents who fulfil the diagnostic criteria of ODD and/or CD. Institutions/wards will be randomised either to provide the 12-week skills training as an add-on intervention or to provide treatment as usual. Once the first cycle is completed, each institution will run a second cycle with the opposite condition. Primary endpoints are the pre-post change in number of CD/ODD symptoms as assessed by a standardised, semi-structured psychiatric interview (Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime, CD/ODD section) between baseline and the end of intervention, as well as between baseline and a 3-month follow-up point. Secondary objectives include pre-post change in CD/ODD-related outcome measures, most notably emotional regulation on a behavioural and neurobiological level after completion of START NOW compared with treatment as usual. To our

  4. The effect of using an interactive booklet on childhood respiratory tract infections in consultations: Study protocol for a cluster randomised controlled trial in primary care

    Directory of Open Access Journals (Sweden)

    Nuttall Jacqueline

    2008-04-01

    Full Text Available Abstract Background Respiratory tract infections in children result in more primary care consultations than any other acute condition, and are the most common reason for prescribing antibiotics (which are largely unnecessary. About a fifth of children consult again for the same illness episode. Providing parents with written information on respiratory tract infections may result in a reduction in re-consultation rates and antibiotic prescribing for these illnesses. Asking clinicians to provide and discuss the information during the consultation may enhance effectiveness. This paper outlines the protocol for a study designed to evaluate the use of a booklet on respiratory tract infections in children within primary care consultations. Methods/Design This will be a cluster randomised controlled trial. General practices will be randomised to provide parents consulting because their child has an acute respiratory tract infection with either an interactive booklet, or usual care. The booklet provides information on the expected duration of their child's illness, the likely benefits of various treatment options, signs and symptoms that should prompt re-consultation, and symptomatic treatment advice. It has been designed for use within the consultation and aims to enhance communication through the use of specific prompts. Clinicians randomised to using the interactive booklet will receive online training in its use. Outcomes will be assessed via a telephone interview with the parent two weeks after first consulting. The primary outcome will be the proportion of children who re-consult for the same illness episode. Secondary outcomes include: antibiotic use, parental satisfaction and enablement, and illness costs. Consultation rates for respiratory tract infections for the subsequent year will be assessed by a review of practice notes. Discussion Previous studies in adults and children have shown that educational interventions can result in reductions

  5. A structured physical activity and fitness programme for older adults with intellectual disabilities: results of a cluster-randomised clinical trial.

    Science.gov (United States)

    van Schijndel-Speet, M; Evenhuis, H M; van Wijck, R; van Montfort, K C A G M; Echteld, M A

    2017-01-01

    The physical activity level of older adults with intellectual disabilities (ID) is extremely low, and their fitness levels are far beneath accepted norms for older people with normal intelligence and comparable with frail older people. A physical activity programme, including an education programme, was developed for older adults with ID using behaviour change techniques. The programme aimed at improving or maintaining adequate levels of physical activity (primary outcome measure) and motor fitness, cardio respiratory fitness, morphologic and metabolic fitness, activities of daily living, cognitive functioning and depressive symptoms (secondary outcome measures). The programme's efficacy was evaluated in a cluster-randomised clinical trial among people aged 43 years and over with mild-moderate levels of ID. Five day-activity centres were randomised to the participation group. In these centres, 81 older adults participated in groups of 8 to 10 in the programme, three times a week during 8 months. The programme was executed by physical activity instructors and staff of day-activity centres. Five other day-activity centres were randomised to the control group; 70 older adults in these centres received care as usual. The generalised linear model with mixed effects was used to test the programme's effectiveness. Significant effects were found on physical activity, muscle strength, systolic and diastolic blood pressure, serum cholesterol level and cognitive functioning, in favour of the programme's participants. No significant improvements were found on balance, serum glucose, weight, waist circumference, walking speed, mobility, depression or instrumental activities of daily living. The physical activity and fitness programme has established small but significant effects in this sample, but generalising the findings to other settings is difficult due to significant participant dropout. Implementation of evidence-based physical activity programmes among older adults

  6. Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Simon D French

    Full Text Available INTRODUCTION: This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP in general practice. METHODS: General practices were randomised to either access to a guideline for acute LBP (control or facilitated interactive workshops (intervention. We measured behavioural predictors (e.g. knowledge, attitudes and intentions and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP level: behavioural simulation (clinical decision about vignettes and rates of x-ray and CT-scan (medical administrative data. All those not involved in the delivery of the intervention were blinded to allocation. RESULTS: 47 practices (53 GPs were randomised to the control and 45 practices (59 GPs to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05 and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60. Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10 for x-ray or CT-scan. CONCLUSIONS: The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant

  7. Electronic audit and feedback intervention with action implementation toolbox to improve pain management in intensive care: protocol for a laboratory experiment and cluster randomised trial.

    Science.gov (United States)

    Gude, Wouter T; Roos-Blom, Marie-José; van der Veer, Sabine N; de Jonge, Evert; Peek, Niels; Dongelmans, Dave A; de Keizer, Nicolette F

    2017-05-25

    Audit and feedback is often used as a strategy to improve quality of care, however, its effects are variable and often marginal. In order to learn how to design and deliver effective feedback, we need to understand their mechanisms of action. This theory-informed study will investigate how electronic audit and feedback affects improvement intentions (i.e. information-intention gap), and whether an action implementation toolbox with suggested actions and materials helps translating those intentions into action (i.e. intention-behaviour gap). The study will be executed in Dutch intensive care units (ICUs) and will be focused on pain management. We will conduct a laboratory experiment with individual ICU professionals to assess the impact of feedback on their intentions to improve practice. Next, we will conduct a cluster randomised controlled trial with ICUs allocated to feedback without or feedback with action implementation toolbox group. Participants will not be told explicitly what aspect of the intervention is randomised; they will only be aware that there are two variations of providing feedback. ICUs are eligible for participation if they submit indicator data to the Dutch National Intensive Care Evaluation (NICE) quality registry and agree to allocate a quality improvement team that spends 4 h per month on the intervention. All participating ICUs will receive access to an online quality dashboard that provides two functionalities: gaining insight into clinical performance on pain management indicators and developing action plans. ICUs with access to the toolbox can develop their action plans guided by a list of potential barriers in the care process, associated suggested actions, and supporting materials to facilitate implementation of the actions. The primary outcome measure for the laboratory experiment is the proportion of improvement intentions set by participants that are consistent with recommendations based on peer comparisons; for the randomised

  8. Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!).

    Science.gov (United States)

    Henao-Restrepo, Ana Maria; Camacho, Anton; Longini, Ira M; Watson, Conall H; Edmunds, W John; Egger, Matthias; Carroll, Miles W; Dean, Natalie E; Diatta, Ibrahima; Doumbia, Moussa; Draguez, Bertrand; Duraffour, Sophie; Enwere, Godwin; Grais, Rebecca; Gunther, Stephan; Gsell, Pierre-Stéphane; Hossmann, Stefanie; Watle, Sara Viksmoen; Kondé, Mandy Kader; Kéïta, Sakoba; Kone, Souleymane; Kuisma, Eewa; Levine, Myron M; Mandal, Sema; Mauget, Thomas; Norheim, Gunnstein; Riveros, Ximena; Soumah, Aboubacar; Trelle, Sven; Vicari, Andrea S; Røttingen, John-Arne; Kieny, Marie-Paule

    2017-02-04

    rVSV-ZEBOV is a recombinant, replication competent vesicular stomatitis virus-based candidate vaccine expressing a surface glycoprotein of Zaire Ebolavirus. We tested the effect of rVSV-ZEBOV in preventing Ebola virus disease in contacts and contacts of contacts of recently confirmed cases in Guinea, west Africa. We did an open-label, cluster-randomised ring vaccination trial (Ebola ça Suffit!) in the communities of Conakry and eight surrounding prefectures in the Basse-Guinée region of Guinea, and in Tomkolili and Bombali in Sierra Leone. We assessed the efficacy of a single intramuscular dose of rVSV-ZEBOV (2×10 7 plaque-forming units administered in the deltoid muscle) in the prevention of laboratory confirmed Ebola virus disease. After confirmation of a case of Ebola virus disease, we definitively enumerated on a list a ring (cluster) of all their contacts and contacts of contacts including named contacts and contacts of contacts who were absent at the time of the trial team visit. The list was archived, then we randomly assigned clusters (1:1) to either immediate vaccination or delayed vaccination (21 days later) of all eligible individuals (eg, those aged ≥18 years and not pregnant, breastfeeding, or severely ill). An independent statistician generated the assignment sequence using block randomisation with randomly varying blocks, stratified by location (urban vs rural) and size of rings (≤20 individuals vs >20 individuals). Ebola response teams and laboratory workers were unaware of assignments. After a recommendation by an independent data and safety monitoring board, randomisation was stopped and immediate vaccination was also offered to children aged 6-17 years and all identified rings. The prespecified primary outcome was a laboratory confirmed case of Ebola virus disease with onset 10 days or more from randomisation. The primary analysis compared the incidence of Ebola virus disease in eligible and vaccinated individuals assigned to immediate

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

    NARCIS (Netherlands)

    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

  10. 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

  11. Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial.

    Science.gov (United States)

    Kalra, Lalit; Irshad, Saddif; Hodsoll, John; Simpson, Matthew; Gulliford, Martin; Smithard, David; Patel, Anita; Rebollo-Mesa, Irene

    2015-11-07

    Post-stroke pneumonia is associated with increased mortality and poor functional outcomes. This study assessed the effectiveness of antibiotic prophylaxis for reducing pneumonia in patients with dysphagia after acute stroke. We did a prospective, multicentre, cluster-randomised, open-label controlled trial with masked endpoint assessment of patients older than 18 years with dysphagia after new stroke recruited from 48 stroke units in the UK, accredited and included in the UK National Stroke Audit. We excluded patients with contraindications to antibiotics, pre-existing dysphagia, or known infections, or who were not expected to survive beyond 14 days. We randomly assigned the units (1:1) by computer to give either prophylactic antibiotics for 7 days plus standard stroke unit care or standard stroke unit care only to patients clustered in the units within 48 h of stroke onset. We did the randomisation with minimisation to stratify for number of admissions and access to specialist care. Patient and staff who did the assessments and analyses were masked to stroke unit allocation. The primary outcome was post-stroke pneumonia in the first 14 days, assessed with both a criteria-based, hierarchical algorithm and by physician diagnosis in the intention-to-treat population. Safety was also analysed by intention to treat. This trial is closed to new participants and is registered with isrctn.com, number ISRCTN37118456. Between April 21, 2008, and May 17, 2014, we randomly assigned 48 stroke units (and 1224 patients clustered within the units) to the two treatment groups: 24 to antibiotics and 24 to standard care alone (control). 11 units and seven patients withdrew after randomisation before 14 days, leaving 1217 patients in 37 units for the intention-to-treat analysis (615 patients in the antibiotics group, 602 in control). Prophylactic antibiotics did not affect the incidence of algorithm-defined post-stroke pneumonia (71 [13%] of 564 patients in antibiotics group vs 52

  12. clusters

    Indian Academy of Sciences (India)

    2017-09-27

    Sep 27, 2017 ... Author for correspondence (zh4403701@126.com). MS received 15 ... lic clusters using density functional theory (DFT)-GGA of the DMOL3 package. ... In the process of geometric optimization, con- vergence thresholds ..... and Postgraduate Research & Practice Innovation Program of. Jiangsu Province ...

  13. clusters

    Indian Academy of Sciences (India)

    environmental as well as technical problems during fuel gas utilization. ... adsorption on some alloys of Pd, namely PdAu, PdAg ... ried out on small neutral and charged Au24,26,27, Cu,28 ... study of Zanti et al.29 on Pdn (n = 1–9) clusters.

  14. Effects of water quality, sanitation, handwashing, and nutritional interventions on child development in rural Kenya (WASH Benefits Kenya): a cluster-randomised controlled trial.

    Science.gov (United States)

    Stewart, Christine P; Kariger, Patricia; Fernald, Lia; Pickering, Amy J; Arnold, Charles D; Arnold, Benjamin F; Hubbard, Alan E; Dentz, Holly N; Lin, Audrie; Meerkerk, Theodora J; Milner, Erin; Swarthout, Jenna; Colford, John M; Null, Clair

    2018-04-01

    Poor nutrition and infectious diseases can prevent children from reaching their developmental potential. We aimed to assess the effects of improvements in water, sanitation, handwashing, and nutrition on early child development in rural Kenya. In this cluster-randomised controlled trial, we enrolled pregnant women in their second or third trimester from three counties (Kakamega, Bungoma, and Vihiga) in Kenya's western region, with an average of 12 households per cluster. Groups of nine geographically adjacent clusters were block-randomised, using a random number generator, into the six intervention groups (including monthly visits to promote target behaviours), a passive control group (no visits), or a double-sized active control group (monthly household visits to measure child mid-upper arm circumference). The six intervention groups were: chlorinated drinking water; improved sanitation; handwashing with soap; combined water, sanitation, and handwashing; improved nutrition through counselling and provision of lipid-based nutrient supplements; and combined water, sanitation, handwashing, and nutrition. Here we report on the prespecified secondary child development outcomes: gross motor milestone achievement assessed with the WHO module at year 1, and communication, gross motor, personal social, and combined scores measured by the Extended Ages and Stages Questionnaire (EASQ) at year 2. Masking of participants was not possible, but data assessors were masked. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01704105. Between Nov 27, 2012, and May 21, 2014, 8246 women residing in 702 clusters were enrolled. No clusters were lost to follow-up, but 2212 households with 2279 children were lost to follow-up by year 2. 5791 (69%) children were measured at year 1 and 6107 (73%) at year 2. At year 1, compared with the active control group, the combined water, sanitation, handwashing, and nutrition group had greater rates of

  15. Interrupting transmission of soil-transmitted helminths: a study protocol for cluster randomised trials evaluating alternative treatment strategies and delivery systems in Kenya.

    Science.gov (United States)

    Brooker, Simon J; Mwandawiro, Charles S; Halliday, Katherine E; Njenga, Sammy M; Mcharo, Carlos; Gichuki, Paul M; Wasunna, Beatrice; Kihara, Jimmy H; Njomo, Doris; Alusala, Dorcas; Chiguzo, Athuman; Turner, Hugo C; Teti, Caroline; Gwayi-Chore, Claire; Nikolay, Birgit; Truscott, James E; Hollingsworth, T Déirdre; Balabanova, Dina; Griffiths, Ulla K; Freeman, Matthew C; Allen, Elizabeth; Pullan, Rachel L; Anderson, Roy M

    2015-10-19

    In recent years, an unprecedented emphasis has been given to the control of neglected tropical diseases, including soil-transmitted helminths (STHs). The mainstay of STH control is school-based deworming (SBD), but mathematical modelling has shown that in all but very low transmission settings, SBD is unlikely to interrupt transmission, and that new treatment strategies are required. This study seeks to answer the question: is it possible to interrupt the transmission of STH, and, if so, what is the most cost-effective treatment strategy and delivery system to achieve this goal? Two cluster randomised trials are being implemented in contrasting settings in Kenya. The interventions are annual mass anthelmintic treatment delivered to preschool- and school-aged children, as part of a national SBD programme, or to entire communities, delivered by community health workers. Allocation to study group is by cluster, using predefined units used in public health provision-termed community units (CUs). CUs are randomised to one of three groups: receiving either (1) annual SBD; (2) annual community-based deworming (CBD); or (3) biannual CBD. The primary outcome measure is the prevalence of hookworm infection, assessed by four cross-sectional surveys. Secondary outcomes are prevalence of Ascaris lumbricoides and Trichuris trichiura, intensity of species infections and treatment coverage. Costs and cost-effectiveness will be evaluated. Among a random subsample of participants, worm burden and proportion of unfertilised eggs will be assessed longitudinally. A nested process evaluation, using semistructured interviews, focus group discussions and a stakeholder analysis, will investigate the community acceptability, feasibility and scale-up of each delivery system. Study protocols have been reviewed and approved by the ethics committees of the Kenya Medical Research Institute and National Ethics Review Committee, and London School of Hygiene and Tropical Medicine. The study has a

  16. Improvement of primary care for patients with chronic heart failure: a study protocol for a cluster randomised trial comparing two strategies.

    Science.gov (United States)

    van Lieshout, Jan; Steenkamer, Betty; Knippenberg, Marjan; Wensing, Michel

    2011-03-25

    Many patients with chronic heart failure (CHF), a common condition with high morbidity and mortality rates, receive treatment in primary care. To improve the management of CHF in primary care, we developed an implementation programme comprised of educational and organisational components, with support by a practice visitor and focus both on drug treatment and lifestyle advice, and on organisation of care within the practice and collaboration with other healthcare providers. Tailoring has been shown to improve the success of implementation programmes, but little is known about what would be best methods for tailoring, specifically with respect to CHF in primary care. We describe the study protocol of a cluster randomised controlled trial to examine the effectiveness of tailoring a CHF implementation programme to general practices compared to a standardised way of delivering a programme. The study population will consist of 60 general practitioners (GPs) and the CHF patients they include. GPs are randomised in blocks of four, stratified according to practice size. With a tailored implementation programme GPs prioritise the issues that will form the bases of the support for the practice visits. These may comprise several issues, both educational and organizational.The primary outcome measures are patient's experience of receiving structured primary care for CHF (PACIC, a questionnaire related to the Chronic Care Model), patients' health-related utilities (EQ-5D), and drugs prescriptions using the guideline adherence index. Patients being clustered in practices, multilevel regression analyses will be used to explore the effect of practice size and type of intervention programme. In addition we will examine both changes within groups and differences at follow-up between groups with respect to drug dosages and advice on lifestyle issues. Furthermore, in interviews the feasibility of the programme and goal attainment, organisational changes in CHF care, and formalised

  17. Improvement of primary care for patients with chronic heart failure: A study protocol for a cluster randomised trial comparing two strategies

    Directory of Open Access Journals (Sweden)

    Wensing Michel

    2011-03-01

    Full Text Available Abstract Background Many patients with chronic heart failure (CHF, a common condition with high morbidity and mortality rates, receive treatment in primary care. To improve the management of CHF in primary care, we developed an implementation programme comprised of educational and organisational components, with support by a practice visitor and focus both on drug treatment and lifestyle advice, and on organisation of care within the practice and collaboration with other healthcare providers. Tailoring has been shown to improve the success of implementation programmes, but little is known about what would be best methods for tailoring, specifically with respect to CHF in primary care. Methods/design We describe the study protocol of a cluster randomised controlled trial to examine the effectiveness of tailoring a CHF implementation programme to general practices compared to a standardised way of delivering a programme. The study population will consist of 60 general practitioners (GPs and the CHF patients they include. GPs are randomised in blocks of four, stratified according to practice size. With a tailored implementation programme GPs prioritise the issues that will form the bases of the support for the practice visits. These may comprise several issues, both educational and organizational. The primary outcome measures are patient's experience of receiving structured primary care for CHF (PACIC, a questionnaire related to the Chronic Care Model, patients' health-related utilities (EQ-5D, and drugs prescriptions using the guideline adherence index. Patients being clustered in practices, multilevel regression analyses will be used to explore the effect of practice size and type of intervention programme. In addition we will examine both changes within groups and differences at follow-up between groups with respect to drug dosages and advice on lifestyle issues. Furthermore, in interviews the feasibility of the programme and goal attainment

  18. INTroducing A Care bundle To prevent pressure injury (INTACT) in at-risk patients: A protocol for a cluster randomised trial.

    Science.gov (United States)

    Chaboyer, Wendy; Bucknall, Tracey; Webster, Joan; McInnes, Elizabeth; Banks, Merrilyn; Wallis, Marianne; Gillespie, Brigid M; Whitty, Jennifer A; Thalib, Lukman; Roberts, Shelley; Cullum, Nicky

    2015-11-01

    Pressure injuries are a significant clinical and economic issue, affecting both patients and the health care system. Many pressure injuries in hospitals are facility acquired, and are largely preventable. Despite growing evidence and directives for pressure injury prevention, implementation of preventative strategies is suboptimal, and pressure injuries remain a serious problem in hospitals. This study will test the effectiveness and cost-effectiveness of a patient-centred pressure injury prevention care bundle on the development of hospital acquired pressure injury in at-risk patients. This is a multi-site, parallel group cluster randomised trial. The hospital is the unit of randomisation. Adult medical and surgical patients admitted to the study wards of eight hospitals who are (a) deemed to be at risk of pressure injury (i.e. have reduced mobility), (b) expected to stay in hospital for ≥48h, (c) admitted to hospital in the past 36h; and (d) able to provide informed consent will be eligible to participate. Consenting patients will receive either the pressure injury prevention care bundle or standard care. The care bundle contains three main messages: (1) keep moving; (2) look after your skin; and (3) eat a healthy diet. Nurses will receive education about the intervention. Patients will exit the study upon development of a pressure injury, hospital discharge or 28 days, whichever comes first; transfer to another hospital or transfer to critical care and mechanically ventilated. The primary outcome is incidence of hospital acquired pressure injury. Secondary outcomes are pressure injury stage, patient participation in care and health care costs. A health economic sub-study and a process evaluation will be undertaken alongside the trial. Data will be analysed at the cluster (hospital) and patient level. Estimates of hospital acquired pressure injury incidence in each group, group differences and 95% confidence interval and p values will be reported. To our

  19. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    de Groot, Jeanny Ja; Maessen, José Mc; Slangen, Brigitte Fm; Winkens, Bjorn; Dirksen, Carmen D; van der Weijden, Trudy

    2015-07-30

    Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands. All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary

  20. REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams.

    Science.gov (United States)

    Slade, Mike; Bird, Victoria; Le Boutillier, Clair; Williams, Julie; McCrone, Paul; Leamy, Mary

    2011-11-23

    There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1) To establish the effectiveness of the intervention described in the REFOCUS Manual; (2) To validate the REFOCUS Model; (3) To establish and optimise trial parameters for the REFOCUS Manual; and (4) To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR) and client satisfaction (as measured by the CSQ) compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR). Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning). 29 teams (15 intervention and 14 control) will be randomised. Within each team, 15 services users will be randomly

  1. Adolescent Cancer Education (ACE) to increase adolescent and parent cancer awareness and communication: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Kyle, Richard G; Macmillan, Iona; Rauchhaus, Petra; O'Carroll, Ronan; Neal, Richard D; Forbat, Liz; Haw, Sally; Hubbard, Gill

    2013-09-08

    Raising cancer awareness among adolescents has potential to increase their knowledge and confidence in identifying cancer symptoms and seeking timely medical help in adolescence and adulthood. Detecting cancer at an early stage is important because it reduces the risk of dying of some cancers and thereby contributes to improved cancer survival. Adolescents may also play an important role in increasing cancer communication within families. However, there are no randomised controlled trials (RCT) of the effectiveness of school-based educational interventions to increase adolescents' cancer awareness, and little is known about the role of adolescents in the upward diffusion of cancer knowledge to parents/carers. The aim of this study is to determine the effectiveness of a school-based educational intervention to raise adolescent and parent cancer awareness and adolescent-parent cancer communication. The Adolescent Cancer Education (ACE) study is a school-based, cluster RCT. Twenty secondary schools in the area covered by Glasgow City Council will be recruited. Special schools for adolescents whose additional needs cannot be met in mainstream education are excluded. Schools are randomised to receive a presentation delivered by a Teenage Cancer Trust educator in Autumn 2013 (intervention group) or Spring 2014 following completion of six-month follow-up measures (control group). Participants will be students recruited at the end of their first year of secondary education (S1) (age 12 to 13 years) and one parent/carer for each student, of the student's choice. The primary outcome is recognition of cancer symptoms two weeks post-intervention. Secondary outcomes are parents' cancer awareness and adolescent-parent cancer communication. Outcomes will be assessed at baseline (when adolescents are in the final term of S1), two-week, and six-month follow-up (when adolescents are in S2, age 13 to 14 years). Differences in outcomes between trial arms will be tested using

  2. Trial baseline characteristics of a cluster randomised controlled trial of a school-located obesity prevention programme; the Healthy Lifestyles Programme (HeLP trial

    Directory of Open Access Journals (Sweden)

    Jenny Lloyd

    2017-04-01

    Full Text Available Abstract Background We have developed a healthy lifestyles programme (HeLP for primary school aged children (9–10 years, currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity by gender, cluster level socio-economic status, school size and time of recruitment into the trial. Methods Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP or control (usual practice stratified by the proportion of children eligible for free school meals (FSM, 1 Year 5 class. The primary outcome is change in body mass index standard deviation score (BMI sds at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample and food intake at 18 months. Results At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8% and children from schools in FSM category 2 (28.2% vs 23.2% were overweight or obese. Children were consuming a mean (range of 4.15 (0–13 energy dense snacks (EDS and 3.23 (0–9 healthy snacks (HS per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8 in MVPA and thirteen hours (779.3 min per day (11 h to 15 h doing less than ‘light’ intensity activity. Less than 5% of children achieved the Departments of Health’s recommendation of 60 min of MVPA every day. Conclusion We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not

  3. Exercise and self-management for people with chronic knee, hip or lower back pain: a cluster randomised controlled trial of clinical and cost-effectiveness. Study protocol.

    Science.gov (United States)

    Walsh, Nicola; Cramp, Fiona; Palmer, Shea; Pollock, Jon; Hampson, Lisa; Gooberman-Hill, Rachael; Green, Colin; Jones, Louise; Phillips, Sonia; Johnson, Liz; Hurley, Mike

    2013-12-01

    Chronic musculoskeletal pain and osteoarthritis can significantly limit the functional independence of individuals, and given that 25% of the population experience these problems, the socioeconomic impact is immense. Exercise and self-management have proven benefits for these conditions, but most trials tailor interventions for specific joints. Epidemiological data demonstrates that many older people with degenerative joint problems experience pain and functional difficulty in other joints, seeking further healthcare input when these present. Managing multiple joint presentations simultaneously could potentially reduce the need for repeat visits to healthcare professionals as advice is frequently the same for differing site presentations. This single-blind cluster randomised controlled trial will determine the clinical and cost-effectiveness of an exercise and self-management intervention delivered to people over-50 with either hip, knee or lower back pain, compared to 'standard' GP care. A qualitative analysis will also establish the acceptability of the intervention. 352 people with chronic degenerative musculoskeletal pain of the hip, knee or lower back will be recruited from primary care. GP surgeries will be randomised to either the intervention or control arms. Participants in the intervention arm will receive a 6-week group exercise and self-management programme facilitated by a physiotherapist in primary care. Participants allocated to the control arm will continue under 'standard' GP care. The primary outcome measure is the Dysfunction Index of the Short Musculoskeletal Functional Assessment (SMFA). Individual patient responses will be modelled using a mixed effects linear regression, allowing for the clustering effects. Resource use and related intervention costs will be estimated and broader resource use data will be collected using a version of the Client Service Receipt Inventory adapted for musculoskeletal relevance. In addition, a cost

  4. REFOCUS Trial: protocol for a cluster randomised controlled trial of a pro-recovery intervention within community based mental health teams

    Directory of Open Access Journals (Sweden)

    Slade Mike

    2011-11-01

    Full Text Available Abstract Background There is a consensus about the importance of 'recovery' in mental health services, but the evidence base is limited. Methods/Design A two centre, cluster randomised controlled trial. Participants are community-based mental health teams, and service users aged 18-65 years with a primary clinical diagnosis of psychosis. In relation to the REFOCUS Manual researchintorecovery.com/refocus, which describes a 12-month, pro-recovery intervention based on the REFOCUS Model, the objectives are: (1 To establish the effectiveness of the intervention described in the REFOCUS Manual; (2 To validate the REFOCUS Model; (3 To establish and optimise trial parameters for the REFOCUS Manual; and (4 To understand the relationship between clinical outcomes and recovery outcomes. The hypothesis for the main study is that service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR compared to service users receiving care from control teams. The hypothesis for the secondary study is that black service users in the intervention arm will experience significantly greater increases in measures of personal recovery (as measured by the QPR and client satisfaction (as measured by the CSQ compared to Black service users receiving care from control teams. The intervention comprises treatment as usual plus two components: recovery-promoting relationships and working practices. The control condition is treatment as usual. The primary outcme is the Process of Recovery Questionnaire (QPR. Secondary outcomes are satisfaction, Goal setting - Personal Primary Outcome, hope, well-being, empowerment, and quality of life. Primary outcomes for the secondary study will be QPR and satisfaction. Cost data will be estimated, and clinical outcomes will also be reported (symptomatology, need, social disability, functioning. 29 teams (15 intervention and 14 control will be randomised. Within

  5. Return-to-work intervention versus usual care for sick-listed employees: health-economic investment appraisal alongside a cluster randomised trial

    Science.gov (United States)

    Lokman, Suzanne; Volker, Danielle; Zijlstra-Vlasveld, Moniek C; Brouwers, Evelien PM; Boon, Brigitte; Beekman, Aartjan TF; Smit, Filip; Van der Feltz-Cornelis, Christina M

    2017-01-01

    Objective To evaluate the health-economic costs and benefits of a guided eHealth intervention (E-health module embedded in Collaborative Occupational healthcare (ECO)) encouraging sick-listed employees to a faster return to work. Design A two-armed cluster randomised trial with occupational physicians (OPs) (n=62), clustered and randomised by region into an experimental and a control group, to conduct a health-economic investment appraisal. Online self-reported data were collected from employees at baseline, after 3, 6, 9 and 12 months. Setting Occupational health care in the Netherlands. Participants Employees from small-sized and medium-sized companies (≥18 years), sick-listed between 4 and 26 weeks with (symptoms of) common mental disorders visiting their OP. Interventions In the intervention group, employees (N=131) received an eHealth module aimed at changing cognitions regarding return to work, while OPs were supported by a decision aid for treatment and referral options. Employees in the control condition (N=89) received usual sickness guidance. Outcomes Measures Net benefits and return on investment based on absenteeism, presenteeism, health care use and quality-adjusted life years (QALYs) gained. Results From the employer’s perspective, the incremental net benefits were €3187 per employee over a single year, representing a return of investment of €11 per invested Euro, with a break-even point at 6 months. The economic case was also favourable from the employee’s perspective, partly because of QALY health gains. The intervention was costing €234 per employee from a health service financier’s perspective. The incremental net benefits from a social perspective were €4210. This amount dropped to €3559 in the sensitivity analysis trimming the 5% highest costs. Conclusions The data suggest that the ECO intervention offers good value for money for virtually all stakeholders involved, because initial investments were more than recouped within a

  6. Patient participation in postoperative care activities in patients undergoing total knee replacement surgery: Multimedia Intervention for Managing patient Experience (MIME). Study protocol for a cluster randomised crossover trial.

    Science.gov (United States)

    McDonall, Jo; de Steiger, Richard; Reynolds, John; Redley, Bernice; Livingston, Patricia; Botti, Mari

    2016-07-18

    Patient participation is an important indicator of quality care. Currently, there is little evidence to support the belief that participation in care is possible for patients during the acute postoperative period. Previous work indicates that there is very little opportunity for patients to participate in care in the acute context. Patients require both capability, in terms of having the required knowledge and understanding of how they can be involved in their care, and the opportunity, facilitated by clinicians, to engage in their acute postoperative care. This cluster randomised crossover trial aims to test whether a multimedia intervention improves patient participation in the acute postoperative context, as determined by pain intensity and recovery outcomes. A total of 240 patients admitted for primary total knee replacement surgery will be invited to participate in a cluster randomised, crossover trial and concurrent process evaluation in at least two wards at a major non-profit private hospital in Melbourne, Australia. Patients admitted to the intervention ward will receive the multimedia intervention daily from Day 1 to Day 5 (or day of discharge, if prior). The intervention will be delivered by nurses via an iPad™, comprising information on the goals of care for each day following surgery. Patients admitted to the control ward will receive usual care as determined by care pathways currently in use across the organization. The primary endpoint is the "worst pain experienced in the past 24 h" on Day 3 following TKR surgery. Pain intensity will be measured using the numerical rating scale. Secondary outcomes are interference of pain on activities of daily living, length of stay in hospital, function and pain following TKR surgery, overall satisfaction with hospitalisation, postoperative complications and hospital readmission. The results of this study will contribute to our understanding of the effectiveness of interventions that provide knowledge and

  7. Effectiveness of guideline-based care by occupational physicians on the return-to-work of workers with common mental disorders: design of a cluster-randomised controlled trial.

    Science.gov (United States)

    van Beurden, Karlijn M; Brouwers, Evelien P M; Joosen, Margot C W; Terluin, Berend; van der Klink, Jac J L; van Weeghel, Jaap

    2013-03-06

    Sickness absence due to common mental disorders (such as depression, anxiety disorder, adjustment disorder) is a problem in many Western countries. Long-term sickness absence leads to substantial societal and financial costs. In workers with common mental disorders, sickness absence costs are much higher than medical costs. In the Netherlands, a practice guideline was developed that promotes an activating approach of the occupational physician to establish faster return-to-work by enhancing the problem-solving capacity of workers, especially in relation to their work environment. Studies on this guideline indicate a promising association between guideline adherence and a shortened sick leave duration, but also minimal adherence to the guideline by occupational physicians. Therefore, this study evaluates the effect of guideline-based care on the full return-to-work of workers who are sick listed due to common mental disorders. This is a two-armed cluster-randomised controlled trial with randomisation at the occupational physician level. During one year, occupational physicians in the intervention group receive innovative training to improve their guideline-based care whereas occupational physicians in the control group provide care as usual. A total of 232 workers, sick listed due to common mental disorders and counselled by participating occupational physicians, will be included. Data are collected via the registration system of the occupational health service, and by questionnaires at baseline and at 3, 6 and 12 months. The primary outcome is time to full return-to-work. Secondary outcomes are partial return-to-work, total number of sick leave days, symptoms, and workability. Personal and work characteristics are the prognostic measures. Additional measures are coping, self-efficacy, remoralization, personal experiences, satisfaction with consultations with the occupational physician and with contact with the supervisor, experiences and behaviour of the supervisor

  8. Staff training and outreach support for Cognitive Stimulation Therapy and its implementation in practice: a cluster randomised trial.

    Science.gov (United States)

    Streater, Amy; Spector, Aimee; Hoare, Zoe; Aguirre, Elisa; Russell, Ian; Orrell, Martin

    2017-12-01

    There is evidence that Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy are effective in mild to moderate dementia. There is, however, little evidence available for its implementation in practice and the impact of outreach support on the sustainability of the programme. Two hundred and forty-one staff members were randomised from 63 dementia care settings between outreach support including an online forum, email, and telephone support, compared to usual Cognitive Stimulation Therapy control group. The primary outcome was average number of attendees to the Cognitive Stimulation Therapy and maintenance Cognitive Stimulation Therapy programmes. There was no difference in average number of attendees between the intervention and usual Cognitive Stimulation Therapy control groups for the Cognitive Stimulation Therapy (p = 0.82) or the maintenance Cognitive Stimulation Therapy programme (p = 0.97). Outreach support does not affect the average number of people with dementia attending the Cognitive Stimulation Therapy or maintenance Cognitive Stimulation Therapy programme. Irrespective of outreach support, the programmes remain widely implemented and yield perceived benefits for people with dementia. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

  9. Study protocol for the optimisation, feasibility testing and pilot cluster randomised trial of Positive Choices: a school-based social marketing intervention to promote sexual health, prevent unintended teenage pregnancies and address health inequalities in England.

    Science.gov (United States)

    Ponsford, Ruth; Allen, Elizabeth; Campbell, Rona; Elbourne, Diana; Hadley, Alison; Lohan, Maria; Melendez-Torres, G J; Mercer, Catherine H; Morris, Steve; Young, Honor; Bonell, Chris

    2018-01-01

    Since the introduction of the Teenage Pregnancy Strategy (TPS), England's under-18 conception rate has fallen by 55%, but a continued focus on prevention is needed to maintain and accelerate progress. The teenage birth rate remains higher in the UK than comparable Western European countries. Previous trials indicate that school-based social marketing interventions are a promising approach to addressing teenage pregnancy and improving sexual health. Such interventions are yet to be trialled in the UK. This study aims to optimise and establish the feasibility and acceptability of one such intervention: Positive Choices. Design: Optimisation, feasibility testing and pilot cluster randomised trial.Interventions: The Positive Choices intervention comprises a student needs survey, a student/staff led School Health Promotion Council (SHPC), a classroom curriculum for year nine students covering social and emotional skills and sex education, student-led social marketing activities, parent information and a review of school sexual health services.Systematic optimisation of Positive Choices will be carried out with the National Children's Bureau Sex Education Forum (NCB SEF), one state secondary school in England and other youth and policy stakeholders.Feasibility testing will involve the same state secondary school and will assess progression criteria to advance to the pilot cluster RCT.Pilot cluster RCT with integral process evaluation will involve six different state secondary schools (four interventions and two controls) and will assess the feasibility and utility of progressing to a full effectiveness trial.The following outcome measures will be trialled as part of the pilot:Self-reported pregnancy and unintended pregnancy (initiation of pregnancy for boys) and sexually transmitted infections,Age of sexual debut, number of sexual partners, use of contraception at first and last sex and non-volitional sexEducational attainmentThe feasibility of linking administrative

  10. Generic care pathway for elderly patients in need of home care services after discharge from hospital: a cluster randomised controlled trial.

    Science.gov (United States)

    Røsstad, Tove; Salvesen, Øyvind; Steinsbekk, Aslak; Grimsmo, Anders; Sletvold, Olav; Garåsen, Helge

    2017-04-17

    Improved discharge arrangements and targeted post-discharge follow-up can reduce the risk of adverse events after hospital discharge for elderly patients. Although more care is to shift from specialist to primary care, there are few studies on post-discharge interventions run by primary care. A generic care pathway, Patient Trajectory for Home-dwelling elders (PaTH) including discharge arrangements and follow-up by primary care, was developed and introduced in Central Norway Region in 2009, applying checklists at defined stages in the patient trajectory. In a previous paper, we found that PaTH had potential of improving follow-up in primary care. The aim of this study was to establish the effect of PaTH-compared to usual care-for elderly in need of home care services after discharge from hospital. We did an unblinded, cluster randomised controlled trial with 12 home care clusters. Outcomes were measured at the patient level during a 12-month follow-up period for the individual patient and analysed applying linear and logistic mixed models. Primary outcomes were readmissions within 30 days and functional level assessed by Nottingham extended ADL scale. Secondary outcomes were number and length of inpatient hospital care and nursing home care, days at home, consultations with the general practitioners (GPs), mortality and health related quality of life (SF-36). One-hundred and sixty-three patients were included in the PaTH group (six clusters), and 141 patients received care as usual (six clusters). We found no statistically significant differences between the groups for primary and secondary outcomes except for more consultations with the GPs in PaTH group (p = 0.04). Adherence to the intervention was insufficient as only 36% of the patients in the intervention group were assessed by at least three of the four main checklists in PaTH, but this improved over time. Lack of adherence to PaTH rendered the study inconclusive regarding the elderly's functional level

  11. Effect of non-monetary incentives on uptake of couples' counselling and testing among clients attending mobile HIV services in rural Zimbabwe: a cluster-randomised trial.

    Science.gov (United States)

    Sibanda, Euphemia L; Tumushime, Mary; Mufuka, Juliet; Mavedzenge, Sue Napierala; Gudukeya, Stephano; Bautista-Arredondo, Sergio; Hatzold, Karin; Thirumurthy, Harsha; McCoy, Sandra I; Padian, Nancy; Copas, Andrew; Cowan, Frances M

    2017-09-01

    Couples' HIV testing and counselling (CHTC) is associated with greater engagement with HIV prevention and care than individual testing and is cost-effective, but uptake remains suboptimal. Initiating discussion of CHTC might result in distrust between partners. Offering incentives for CHTC could change the focus of the pre-test discussion. We aimed to determine the impact of incentives for CHTC on uptake of couples testing and HIV case diagnosis in rural Zimbabwe. In this cluster-randomised trial, 68 rural communities (the clusters) in four districts receiving mobile HIV testing services were randomly assigned (1:1) to incentives for CHTC or not. Allocation was not masked to participants and researchers. Randomisation was stratified by district and proximity to a health facility. Within each stratum random permutation was done to allocate clusters to the study groups. In intervention communities, residents were informed that couples who tested together could select one of three grocery items worth US$1·50. Standard mobilisation for testing was done in comparison communities. The primary outcome was the proportion of individuals testing with a partner. Analysis was by intention to treat. 3 months after CHTC, couple-testers from four communities per group individually completed a telephone survey to evaluate any social harms resulting from incentives or CHTC. The effect of incentives on CHTC was estimated using logistic regression with random effects adjusting for clustering. The trial was registered with the Pan African Clinical Trial Registry, number PACTR201606001630356. From May 26, 2015, to Jan 29, 2016, of 24 679 participants counselled with data recorded, 14 099 (57·1%) were in the intervention group and 10 580 (42·9%) in the comparison group. 7852 (55·7%) testers in the intervention group versus 1062 (10·0%) in the comparison group tested with a partner (adjusted odds ratio 13·5 [95% CI 10·5-17·4]). Among 427 (83·7%) of 510 eligible

  12. Effect of water quality, sanitation, hand washing, and nutritional interventions on child development in rural Bangladesh (WASH Benefits Bangladesh): a cluster-randomised controlled trial.

    Science.gov (United States)

    Tofail, Fahmida; Fernald, Lia Ch; Das, Kishor K; Rahman, Mahbubur; Ahmed, Tahmeed; Jannat, Kaniz K; Unicomb, Leanne; Arnold, Benjamin F; Ashraf, Sania; Winch, Peter J; Kariger, Patricia; Stewart, Christine P; Colford, John M; Luby, Stephen P

    2018-04-01

    Poor nutrition and hygiene make children vulnerable to delays in growth and development. We aimed to assess the effects of water quality, sanitation, handwashing, and nutritional interventions individually or in combination on the cognitive, motor, and language development of children in rural Bangladesh. In this cluster-randomised controlled trial, we enrolled pregnant women in their first or second trimester from rural villages of Gazipur, Kishoreganj, Mymensingh, and Tangail districts of central Bangladesh, with an average of eight women per cluster. Groups of eight geographically adjacent clusters were block-randomised, using a random number generator, into six intervention groups (all of which received weekly visits from a community health promoter for the first 6 months and every 2 weeks for the next 18 months) and a double-sized control group (no intervention or health promoter visit). The six intervention groups were: chlorinated drinking water; improved sanitation; handwashing with soap; combined water, sanitation, and handwashing; improved nutrition through counselling and provision of lipid-based nutrient supplements; and combined water, sanitation, handwashing, and nutrition. Here, we report on the prespecified secondary child development outcomes: gross motor milestone achievement assessed with the WHO module at age 1 year, and communication, gross motor, personal social, and combined scores measured by the Extended Ages and Stages Questionnaire (EASQ) at age 2 years. Masking of participants was not possible. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01590095. Between May 31, 2012, and July 7, 2013, 5551 pregnant women residing in 720 clusters were enrolled. Index children of 928 (17%) enrolled women were lost to follow-up in year 1 and an additional 201 (3%) in year 2. 4757 children were assessed at 1 year and 4403 at 2 years. At year 1, compared with the control group, the combined water

  13. Effects of water quality, sanitation, handwashing, and nutritional interventions on diarrhoea and child growth in rural Bangladesh: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Stephen P Luby, ProfMD

    2018-03-01

    Full Text Available Summary: Background: Diarrhoea and growth faltering in early childhood are associated with subsequent adverse outcomes. We aimed to assess whether water quality, sanitation, and handwashing interventions alone or combined with nutrition interventions reduced diarrhoea or growth faltering. Methods: The WASH Benefits Bangladesh cluster-randomised trial enrolled pregnant women from villages in rural Bangladesh and evaluated outcomes at 1-year and 2-years' follow-up. Pregnant women in geographically adjacent clusters were block-randomised to one of seven clusters: chlorinated drinking water (water; upgraded sanitation (sanitation; promotion of handwashing with soap (handwashing; combined water, sanitation, and handwashing; counselling on appropriate child nutrition plus lipid-based nutrient supplements (nutrition; combined water, sanitation, handwashing, and nutrition; and control (data collection only. Primary outcomes were caregiver-reported diarrhoea in the past 7 days among children who were in utero or younger than 3 years at enrolment and length-for-age Z score among children born to enrolled pregnant women. Masking was not possible for data collection, but analyses were masked. Analysis was by intention to treat. This trial is registered at ClinicalTrials.gov, number NCC01590095. Findings: Between May 31, 2012, and July 7, 2013, 5551 pregnant women in 720 clusters were randomly allocated to one of seven groups. 1382 women were assigned to the control group; 698 to water; 696 to sanitation; 688 to handwashing; 702 to water, sanitation, and handwashing; 699 to nutrition; and 686 to water, sanitation, handwashing, and nutrition. 331 (6% women were lost to follow-up. Data on diarrhoea at year 1 or year 2 (combined were available for 14 425 children (7331 in year 1, 7094 in year 2 and data on length-for-age Z score in year 2 were available for 4584 children (92% of living children were measured at year 2. All interventions had high adherence

  14. Comparing the behavioural impact of a nudge-based handwashing intervention to high-intensity hygiene education: a cluster-randomised trial in rural Bangladesh.

    Science.gov (United States)

    Grover, Elise; Hossain, Mohammed Kamal; Uddin, Saker; Venkatesh, Mohini; Ram, Pavani K; Dreibelbis, Robert

    2018-01-01

    To determine the impact of environmental nudges on handwashing behaviours among primary school children as compared to a high-intensity hygiene education intervention. In a cluster-randomised trial (CRT), we compared the rates of handwashing with soap (HWWS) after a toileting event among primary school students in rural Bangladesh. Eligible schools (government run, on-site sanitation and water, no hygiene interventions in last year, fewer than 450 students) were identified, and 20 schools were randomly selected and allocated without blinding to one of four interventions, five schools per group: simultaneous handwashing infrastructure and nudge construction, sequential infrastructure then nudge construction, simultaneous infrastructure and high-intensity hygiene education (HE) and sequential handwashing infrastructure and HE. The primary outcome, incidence of HWWS after a toileting event, was compared between the intervention groups at different data collection points with robust-Poisson regression analysis with generalised estimating equations, adjusting for school-level clustering of outcomes. The nudge intervention and the HE intervention were found to be equally effective at sustained impact over 5 months post-intervention (adjusted IRR 0.81, 95% CI 0.61-1.09). When comparing intervention delivery timing, the simultaneous delivery of the HE intervention significantly outperformed the sequential HE delivery (adjusted IRR 1.58 CI 1.20-2.08), whereas no significant difference was observed between sequential and simultaneous nudge intervention delivery (adjusted IRR 0.75, 95% CI 0.48-1.17). Our trial demonstrates sustained improved handwashing behaviour 5 months after the nudge intervention. The nudge intervention's comparable performance to a high-intensity hygiene education intervention is encouraging. © 2017 John Wiley & Sons Ltd.

  15. Evaluation of an Australian health literacy training program for socially disadvantaged adults attending basic education classes: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    McCaffery, Kirsten J; Morony, Suzanne; Muscat, Danielle M; Smith, Sian K; Shepherd, Heather L; Dhillon, Haryana M; Hayen, Andrew; Luxford, Karen; Meshreky, Wedyan; Comings, John; Nutbeam, Don

    2016-05-27

    People with low literacy and low health literacy have poorer health outcomes. Literacy and health literacy are distinct but overlapping constructs that impact wellbeing. Interventions that target both could improve health outcomes. This is a cluster randomised controlled trial with a qualitative component. Participants are 300 adults enrolled in basic language, literacy and numeracy programs at adult education colleges across New South Wales, Australia. Each adult education institute (regional administrative centre) contributes (at least) two classes matched for student demographics, which may be at the same or different campuses. Classes (clusters) are randomly allocated to receive either the health literacy intervention (an 18-week program with health knowledge and skills embedded in language, literacy, and numeracy training (LLN)), or the standard Language Literacy and Numeracy (LLN) program (usual LLN classes, specifically excluding health content). The primary outcome is functional health literacy skills - knowing how to use a thermometer, and read and interpret food and medicine labels. The secondary outcomes are self-reported confidence, more advanced health literacy skills; shared decision making skills, patient activation, health knowledge and self-reported health behaviour. Data is collected at baseline, and immediately and 6 months post intervention. A sample of participating teachers, students, and community health workers will be interviewed in-depth about their experiences with the program to better understand implementation issues and to strengthen the potential for scaling up the program. Outcomes will provide evidence regarding real-world implementation of a health literacy training program with health worker involvement in an Australian adult education setting. The evaluation trial will provide insight into translating and scaling up health literacy education for vulnerable populations with low literacy. Australian New Zealand Clinical Trials

  16. Effectiveness of school dental screening on dental visits and untreated caries among primary schoolchildren: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Alayadi, Haya; Sabbah, Wael; Bernabé, Eduardo

    2018-04-13

    Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. School-based dental screening could be a potential intervention that impacts uptake of dental services, and subsequently, dental caries' levels. The purpose of this study is to evaluate the effectiveness of two alternative approaches for school-based dental screening in promoting dental attendance and reducing untreated dental caries among primary schoolchildren. This is a cluster randomised controlled trial comparing referral of screened-positive children to a specific treatment facility (King Saud University Dental College) against conventional referral (information letter advising parents to take their child to a dentist). A thousand and ten children in 16 schools in Riyadh, Saudi Arabia, will be recruited for the trial. Schools (clusters) will be randomly selected and allocated to either group. Clinical assessment for dental caries will be conducted at baseline and after 12 months by dentists using the World Health Organisation (WHO) criteria. Data on sociodemographic, behavioural factors and children's dental visits will be collected through structured questionnaires at baseline and follow-up. The primary outcome is the change in number of teeth with untreated dental caries 12 months after referral. Secondary outcomes are the changes in the proportions of children having untreated caries and of those who visited the dentist over the trial period. This project should provide high level of evidence on the clinical benefits of school dental screening. The findings should potentially inform policies related to the continuation/implementation of school-based dental screening in Saudi Arabia. ClinicalTrials.gov , ID: NCT03345680 . Registered on 17 November 2017.

  17. Can patient involvement improve patient safety? A cluster randomised control trial of the Patient Reporting and Action for a Safe Environment (PRASE) intervention.

    Science.gov (United States)

    Lawton, Rebecca; O'Hara, Jane Kathryn; Sheard, Laura; Armitage, Gerry; Cocks, Kim; Buckley, Hannah; Corbacho, Belen; Reynolds, Caroline; Marsh, Claire; Moore, Sally; Watt, Ian; Wright, John

    2017-08-01

    To evaluate the efficacy of the Patient Reporting and Action for a Safe Environment intervention. A multicentre cluster randomised controlled trial. Clusters were 33 hospital wards within five hospitals in the UK. All patients able to give informed consent were eligible to take part. Wards were allocated to the intervention or control condition. The ward-level intervention comprised two tools: (1) a questionnaire that asked patients about factors contributing to safety (patient measure of safety (PMOS)) and (2) a proforma for patients to report both safety concerns and positive experiences (patient incident reporting tool). Feedback was considered in multidisciplinary action planning meetings. Primary outcomes were routinely collected ward-level harm-free care (HFC) scores and patient-level feedback on safety (PMOS). Intervention uptake and retention of wards was 100% and patient participation was high (86%). We found no significant effect of the intervention on any outcomes at 6 or 12 months. However, for new harms (ie, those for which the wards were directly accountable) intervention wards did show greater, though non-significant, improvement compared with control wards. Analyses also indicated that improvements were largest for wards that showed the greatest compliance with the intervention. Adherence to the intervention, particularly the implementation of action plans, was poor. Patient safety outcomes may represent too blunt a measure. Patients are willing to provide feedback about the safety of their care. However, we were unable to demonstrate any overall effect of this intervention on either measure of patient safety and therefore cannot recommend this intervention for wider uptake. Findings indicate promise for increasing HFC where wards implement ≥75% of the intervention components. ISRCTN07689702; pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  18. Effects of a multicomponent workplace intervention programme with environmental changes on physical activity among Japanese white collar employees: a protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Watanabe, Kazuhiro; Kawakami, Norito

    2017-10-24

    Physical activity is one of the most important health behaviours as a determinant of physical and mental health. Although intervention strategies for promoting physical activity among workers are needed, evidence for the effectiveness of multilevel workplace interventions with environmental changes on the promotion of physical activity are still limited due to lack of cluster randomised controlled trials (RCTs). The aim of this study is to investigate effects of a 3-month workplace intervention programme with environmental changes on the improvement in physical activity among Japanese white collar employees. This study will be a two-arm and parallel-group cluster (worksite) RCT. Japanese worksites and employees who are employed by the worksites will be recruited through health insurance associations and chambers of commerce. Worksites that meet the inclusion criteria will be randomly allocated to intervention or control groups. The intervention worksites will be offered the original intervention programme that consists of 13 contents with environmental changes. The control worksites will be able to get three times feedback of the assessment of the amount of physical activity and basic occupational health service in each worksite. The primary outcome will be the total amount of physical activity measured by the Global Physical Activity Questionnaire at baseline, 3 months and 6 months. Multilevel latent growth modelling will be conducted to examine the effectiveness of the intervention programme. This study was ethically approved by the research ethics committee of the Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Japan (No. 11230). Results will be submitted and published in a scientific peer-reviewed journal. UMIN000024069; Pre-results. © 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.

  19. A cluster-randomised trial of staff education to improve the quality of life of people with dementia living in residential care: the DIRECT study.

    Directory of Open Access Journals (Sweden)

    Christopher Beer

    Full Text Available BACKGROUND: The Dementia In Residential care: EduCation intervention Trial (DIRECT was conducted to determine if delivery of education designed to meet the perceived need of GPs and care staff improves the quality of life of participants with dementia living in residential care. METHODOLOGY/PRINCIPAL FINDINGS: This cluster-randomised controlled trial was conducted in 39 residential aged care facilities in the metropolitan area of Perth, Western Australia. 351 care facility residents aged 65 years and older with Mini-Mental State Examination ≤ 24, their GPs and facility staff participated. Flexible education designed to meet the perceived needs of learners was delivered to GPs and care facility staff in intervention groups. The primary outcome of the study was self-rated quality of life of participants with dementia, measured using the QOL-Alzheimer's Disease Scale (QOL-AD at 4 weeks and 6 months after the conclusion of the intervention. Analysis accounted for the effect of clustering by using multi-level regression analysis. Education of GPs or care facility staff did not affect the primary outcome at either 4 weeks or 6 months. In a post hoc analysis excluding facilities in which fewer than 50% of staff attended an education session, self-rated QOL-AD scores were 6.14 points (adjusted 95%CI 1.14, 11.15 higher at four-week follow-up among residents in facilities randomly assigned to the education intervention. CONCLUSION: The education intervention directed at care facilities or GPs did not improve the quality of life ratings of participants with dementia as a group. This may be explained by the poor adherence to the intervention programme, as participants with dementia living in facilities where staff participated at least minimally seemed to benefit. TRIAL REGISTRATION: ANZCTR.org.au ACTRN12607000417482.

  20. A cluster-randomised trial of staff education to improve the quality of life of people with dementia living in residential care: the DIRECT study.

    Science.gov (United States)

    Beer, Christopher; Horner, Barbara; Flicker, Leon; Scherer, Samuel; Lautenschlager, Nicola T; Bretland, Nick; Flett, Penelope; Schaper, Frank; Almeida, Osvaldo P

    2011-01-01

    The Dementia In Residential care: EduCation intervention Trial (DIRECT) was conducted to determine if delivery of education designed to meet the perceived need of GPs and care staff improves the quality of life of participants with dementia living in residential care. This cluster-randomised controlled trial was conducted in 39 residential aged care facilities in the metropolitan area of Perth, Western Australia. 351 care facility residents aged 65 years and older with Mini-Mental State Examination ≤ 24, their GPs and facility staff participated. Flexible education designed to meet the perceived needs of learners was delivered to GPs and care facility staff in intervention groups. The primary outcome of the study was self-rated quality of life of participants with dementia, measured using the QOL-Alzheimer's Disease Scale (QOL-AD) at 4 weeks and 6 months after the conclusion of the intervention. Analysis accounted for the effect of clustering by using multi-level regression analysis. Education of GPs or care facility staff did not affect the primary outcome at either 4 weeks or 6 months. In a post hoc analysis excluding facilities in which fewer than 50% of staff attended an education session, self-rated QOL-AD scores were 6.14 points (adjusted 95%CI 1.14, 11.15) higher at four-week follow-up among residents in facilities randomly assigned to the education intervention. The education intervention directed at care facilities or GPs did not improve the quality of life ratings of participants with dementia as a group. This may be explained by the poor adherence to the intervention programme, as participants with dementia living in facilities where staff participated at least minimally seemed to benefit. ANZCTR.org.au ACTRN12607000417482.

  1. Does the Good Schools Toolkit Reduce Physical, Sexual and Emotional Violence, and Injuries, in Girls and Boys equally? A Cluster-Randomised Controlled Trial.

    Science.gov (United States)

    Devries, Karen M; Knight, Louise; Allen, Elizabeth; Parkes, Jenny; Kyegombe, Nambusi; Naker, Dipak

    2017-10-01

    We aimed to investigate whether the Good School Toolkit reduced emotional violence, severe physical violence, sexual violence and injuries from school staff to students, as well as emotional, physical and sexual violence between peers, in Ugandan primary schools. We performed a two-arm cluster randomised controlled trial with parallel assignment. Forty-two schools in one district were allocated to intervention (n = 21) or wait-list control (n = 21) arms in 2012. We did cross-sectional baseline and endline surveys in 2012 and 2014, and the Good School Toolkit intervention was implemented for 18 months between surveys. Analyses were by intention to treat and are adjusted for clustering within schools and for baseline school-level proportions of outcomes. The Toolkit was associated with an overall reduction in any form of violence from staff and/or peers in the past week towards both male (aOR = 0.34, 95%CI 0.22-0.53) and female students (aOR = 0.55, 95%CI 0.36-0.84). Injuries as a result of violence from school staff were also lower in male (aOR = 0.36, 95%CI 0.20-0.65) and female students (aOR = 0.51, 95%CI 0.29-0.90). Although the Toolkit seems to be effective at reducing violence in both sexes, there is some suggestion that the Toolkit may have stronger effects in boys than girls. The Toolkit is a promising intervention to reduce a wide range of different forms of violence from school staff and between peers in schools, and should be urgently considered for scale-up. Further research is needed to investigate how the intervention could engage more successfully with girls.

  2. Behaviour change intervention to improve shared toilet maintenance and cleanliness in urban slums of Dhaka: a cluster-randomised controlled trial.

    Science.gov (United States)

    Alam, Mahbub-Ul; Winch, Peter J; Saxton, Ronald E; Nizame, Fosiul A; Yeasmin, Farzana; Norman, Guy; Masud, Abdullah-Al; Begum, Farzana; Rahman, Mahbubur; Hossain, Kamal; Layden, Anita; Unicomb, Leanne; Luby, Stephen P

    2017-08-01

    Shared toilets in urban slums are often unclean and poorly maintained, discouraging consistent use and thereby limiting impacts on health and quality of life. We developed behaviour change interventions to support shared toilet maintenance and improve user satisfaction. We report the intervention effectiveness on improving shared toilet cleanliness. We conducted a cluster-randomised controlled trial among users of 1226 shared toilets in 23 Dhaka slums. We assessed baseline toilet cleanliness in January 2015. The six-month intervention included provision of hardware (bin for solid waste, 4 l flushing bucket, 70 l water reservoir), and behaviour change communication (compound meetings, interpersonal household sessions, signs depicting rules for toilet use). We estimated the adjusted difference in difference (DID) to assess outcomes and accounted for clustering effects using generalised estimating equations. Compared to controls, intervention toilets were more likely to have water available inside toilet cubicles (DID: +4.7%, 95% CI: 0.2, 9.2), access to brush/broom for cleaning (DID: +8.4%, 95% CI: 2, 15) and waste bins (DID: +63%, 95% CI: 59, 66), while less likely to have visible faeces inside the pan (DID: -13%, 95% CI: -19, -5), the smell of faeces (DID: -7.6%, 95% CI: -14, -1.3) and household waste inside the cubicle (DID: -4%, 95% CI: -7, -1). In one of few efforts to promote shared toilet cleanliness, intervention compounds were significantly more likely to have cleaner toilets after six months. Future research might explore how residents can self-finance toilet maintenance, or employ mass media to reduce per-capita costs of behaviour change. © 2017 John Wiley & Sons Ltd.

  3. Relative benefit of a stage of change approach for the prevention of musculoskeletal pain and discomfort: a cluster randomised trial.

    Science.gov (United States)

    Doda, Diana; Rothmore, Paul; Pisaniello, Dino; Briggs, Nancy; Stewart, Sasha; Mahmood, Mohammed; Hiller, Janet E

    2015-11-01

    To examine the benefit of a psychological Stage of Change (SOC) approach, relative to standard ergonomics advice, for the prevention of work-related musculoskeletal pain and discomfort (MSPD). A cluster randomised trial was conducted in South Australia across a broad range of workplaces. Repeated face-to-face interviews were conducted onsite to assess MSPD, safety climate, job satisfaction and other factors. Changes in MSPD across intervention groups and time were investigated using Generalised Estimating Equation (GEE) methods. 25 workgroups (involving 242 workers) were randomly allocated to either a standard intervention or an intervention tailored according to SOC. The prevalence of MSPD increased for both groups, but was only significant for the standard group, in respect of lower back MSPD. Workers receiving tailored interventions were 60% less likely to experience lower back MSPD. After adjusting for age, gender and job satisfaction, it was found that company safety climate and length of employment were significantly correlated to the time-intervention effect. There was no correlation with workload. Compared with standard ergonomics advice to management, there was evidence of a benefit of stage-matched intervention for MSPD prevention, particularly for low back pain. Organisational safety climate should be taken into account when planning prevention programmes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  4. Mediating effects of resistance training skill competency on health-related fitness and physical activity: the ATLAS cluster randomised controlled trial.

    Science.gov (United States)

    Smith, Jordan J; Morgan, Philip J; Plotnikoff, Ronald C; Stodden, David F; Lubans, David R

    2016-01-01

    The purpose of this study was to examine the mediating effect of resistance training skill competency on percentage of body fat, muscular fitness and physical activity among a sample of adolescent boys participating in a school-based obesity prevention intervention. Participants were 361 adolescent boys taking part in the Active Teen Leaders Avoiding Screen-time (ATLAS) cluster randomised controlled trial: a school-based program targeting the health behaviours of economically disadvantaged adolescent males considered "at-risk" of obesity. Body fat percentage (bioelectrical impedance), muscular fitness (hand grip dynamometry and push-ups), physical activity (accelerometry) and resistance training skill competency were assessed at baseline and post-intervention (i.e., 8 months). Three separate multi-level mediation models were analysed to investigate the potential mediating effects of resistance training skill competency on each of the study outcomes using a product-of-coefficients test. Analyses followed the intention-to-treat principle. The intervention had a significant impact on the resistance training skill competency of the boys, and improvements in skill competency significantly mediated the effect of the intervention on percentage of body fat and the combined muscular fitness score. No significant mediated effects were found for physical activity. Improving resistance training skill competency may be an effective strategy for achieving improvements in body composition and muscular fitness in adolescent boys.

  5. Effect of the good school toolkit on school staff mental health, sense of job satisfaction and perceptions of school climate: Secondary analysis of a cluster randomised trial.

    Science.gov (United States)

    Kayiwa, Joshua; Clarke, Kelly; Knight, Louise; Allen, Elizabeth; Walakira, Eddy; Namy, Sophie; Merrill, Katherine G; Naker, Dipak; Devries, Karen

    2017-08-01

    The Good School Toolkit, a complex behavioural intervention delivered in Ugandan primary schools, has been shown to reduce school staff-perpetrated physical violence against students. We aimed to assess the effect of this intervention on staff members' mental health, sense of job satisfaction and perception of school climate. We analysed data from a cluster-randomised trial administered in 42 primary schools in Luwero district, Uganda. The trial was comprised of cross-sectional baseline (June/July 2012) and endline (June/July 2014) surveys among staff and students. Twenty-one schools were randomly selected to receive the Toolkit, whilst 21 schools constituted a wait-listed control group. We generated composite measures to assess staff members' perceptions of the school climate and job satisfaction. The trial is registered at clinicaltrials.gov (NCT01678846). No schools dropped out of the study and all 591 staff members who completed the endline survey were included in the analysis. Staff in schools receiving the Toolkit had more positive perspectives of their school climate compared to staff in control schools (difference in mean scores 2.19, 95% Confidence Interval 0.92, 3.39). We did not find any significant differences for job satisfaction and mental health. In conclusion, interventions like the Good School Toolkit that reduce physical violence by school staff against students can improve staff perceptions of the school climate, and could help to build more positive working and learning environments in Ugandan schools. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. Universal Internet-based prevention for alcohol and cannabis use reduces truancy, psychological distress and moral disengagement: a cluster randomised controlled trial.

    Science.gov (United States)

    Newton, Nicola C; Andrews, Gavin; Champion, Katrina E; Teesson, Maree

    2014-08-01

    A universal Internet-based preventive intervention has been shown to reduce alcohol and cannabis use. The aim of this study was to examine if this program could also reduce risk-factors associated with substance use in adolescents. A cluster randomised controlled trial was conducted in Sydney, Australia in 2007-2008 to assess the effectiveness of the Internet-based Climate Schools: Alcohol and Cannabis course. The evidence-based course, aimed at reducing alcohol and cannabis use, consists of two sets of six lessons delivered approximately six months apart. A total of 764 students (mean 13.1years) from 10 secondary schools were randomly allocated to receive the preventive intervention (n=397, five schools), or their usual health classes (n=367, five schools) over the year. Participants were assessed at baseline, immediately post, and six and twelve months following the intervention on their levels of truancy, psychological distress and moral disengagement. Compared to the control group, students in the intervention group showed significant reductions in truancy, psychological distress and moral disengagement up to twelve months following completion of the intervention. These intervention effects indicate that Internet-based preventive interventions designed to prevent alcohol and cannabis use can concurrently reduce risk-factors associated with substance use in adolescents. Australian Clinical Trials Registry ACTRN: 012607000312448. Copyright © 2014 Elsevier Inc. All rights reserved.

  7. "GET-UP" study rationale and protocol: a cluster randomised controlled trial to evaluate the effects of reduced sitting on toddlers' cognitive development.

    Science.gov (United States)

    Santos, Rute; Cliff, Dylan P; Howard, Steven J; Veldman, Sanne L; Wright, Ian M; Sousa-Sá, Eduarda; Pereira, João R; Okely, Anthony D

    2016-11-09

    The educational and cognitive differences associated with low socioeconomic status begin early in life and tend to persist throughout life. Coupled with the finding that levels of sedentary time are negatively associated with cognitive development, and time spent active tends to be lower in disadvantaged circumstances, this highlights the need for interventions that reduce the amount of time children spend sitting and sedentary during childcare. The proposed study aims to assess the effects of reducing sitting time during Early Childhood Education and Care (ECEC) services on cognitive development in toddlers from low socio-economic families. We will implement a 12-months 2-arm parallel group cluster randomised controlled trial (RCT) with Australian toddlers, aged 12 to 26 months at baseline. Educators from the ECEC services allocated to the intervention group will receive professional development on how to reduce sitting time while children attend ECEC. Participants' cognitive development will be assessed as a primary outcome, at baseline and post-intervention, using the cognitive sub-test from the Bayley Scales of Infant and Toddler Development. This trial has the potential to inform programs and policies designed to optimize developmental and health outcomes in toddlers, specifically in those from disadvantaged backgrounds. Australian New Zealand Clinical Trials Registry: ACTRN12616000471482 , 11/04/2016, retrospectively registered.

  8. The nutrition-based comprehensive intervention study on childhood obesity in China (NISCOC: a randomised cluster controlled trial

    Directory of Open Access Journals (Sweden)

    Xu Guifa

    2010-05-01

    Full Text Available Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. Methods/Design The study is designed