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Sample records for care dicision randomised

  1. Careful science? Bodywork and care practices in randomised clinical trials

    DEFF Research Database (Denmark)

    Jespersen, Astrid Pernille; Bønnelycke, Julie; Eriksen, Hanne Hellerup

    2013-01-01

    Concern about obesity has prompted numerous public health campaigns that urge people to be more physically active. The campaigns often include normative statements and attempt to impose restrictions on individuals' lives without considering the complexities of daily life. We suggest that broadening...... into different exercise groups. In this article we analyse the scientific work of the trial as representing entangled processes of bodywork, where data are extracted and objectified bodies are manipulated and care practices address the emotional, social and mundane aspects of the participants' everyday lives....... Care practices are an inherent part of producing scientific facts but they are removed from the recognised results of scientific practice and thus from common public health recommendations. However, knowledge about the strategic use of care practices in lifestyle interventions is important for public...

  2. 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

  3. Multifaceted shared care intervention for late life depression in residential care: randomised controlled trial.

    Science.gov (United States)

    Llewellyn-Jones, R H; Baikie, K A; Smithers, H; Cohen, J; Snowdon, J; Tennant, C C

    1999-09-11

    To evaluate the effectiveness of a population based, multifaceted shared care intervention for late life depression in residential care. Randomised controlled trial, with control and intervention groups studied one after the other and blind follow up after 9.5 months. Population of residential facility in Sydney living in self care units and hostels. 220 depressed residents aged >/=65 without severe cognitive impairment. The shared care intervention included: (a) multidisciplinary consultation and collaboration, (b) training of general practitioners and carers in detection and management of depression, and (c) depression related health education and activity programmes for residents. The control group received routine care. Geriatric depression scale. Intention to treat analysis was used. There was significantly more movement to "less depressed" levels of depression at follow up in the intervention than control group (Mantel-Haenszel stratification test, P=0.0125). Multiple linear regression analysis found a significant intervention effect after controlling for possible confounders, with the intervention group showing an average improvement of 1.87 points on the geriatric depression scale compared with the control group (95% confidence interval 0.76 to 2.97, P=0.0011). The outcome of depression among elderly people in residential care can be improved by multidisciplinary collaboration, by enhancing the clinical skills of general practitioners and care staff, and by providing depression related health education and activity programmes for residents.

  4. Does hospital at home for palliative care facilitate death at home? Randomised controlled trial

    Science.gov (United States)

    Grande, Gunn E; Todd, Chris J; Barclay, Stephen I G; Farquhar, Morag C

    1999-01-01

    Objective To evaluate the impact on place of death of a hospital at home service for palliative care. Design Pragmatic randomised controlled trial. Setting Former Cambridge health district. Participants 229 patients referred to the hospital at home service; 43 randomised to control group (standard care), 186 randomised to hospital at home. Intervention Hospital at home versus standard care. Main outcome measures Place of death. Results Twenty five (58%) control patients died at home compared with 124 (67%) patients allocated to hospital at home. This difference was not significant; intention to treat analysis did not show that hospital at home increased the number of deaths at home. Seventy three patients randomised to hospital at home were not admitted to the service. Patients admitted to hospital at home were significantly more likely to die at home (88/113; 78%) than control patients. It is not possible to determine whether this was due to hospital at home itself or other characteristics of the patients admitted to the service. The study attained less statistical power than initially planned. Conclusion In a locality with good provision of standard community care we could not show that hospital at home allowed more patients to die at home, although neither does the study refute this. Problems relating to recruitment, attrition, and the vulnerability of the patient group make randomised controlled trials in palliative care difficult. While these difficulties have to be recognised they are not insurmountable with the appropriate resourcing and setting. Key messagesTerminally ill patients allocated to hospital at home were no more likely to die at home than patients receiving standard careAlthough the subsample of patients actually admitted to hospital at home did show a significant increase in likelihood of dying at home, whether this was due to the service itself or the characteristics of patients admitted to hospital at home could not be determinedThe need to

  5. 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.

  6. Transitional care for the highest risk patients: findings of a randomised control study

    Directory of Open Access Journals (Sweden)

    Kheng Hock Lee

    2015-10-01

    Full Text Available Background: Interventions to prevent readmissions of patients at highest risk have not been rigorously evaluated. We conducted a randomised controlled trial to determine if a post-discharge transitional care programme can reduce readmissions of such patients in Singapore. Methods: We randomised 840 patients with two or more unscheduled readmissions in the prior 90 days and Length of stay, Acuity of admission, Comorbidity of patient, Emergency department utilisation score ≥10 to the intervention programme (n = 419 or control (n = 421. Patients allocated to the intervention group received post-discharge surveillance by a multidisciplinary integrated care team and early review in the clinic. The primary outcome was the proportion of patients with at least one unscheduled readmission within 30 days after discharge. Results: We found no statistically significant reduction in readmissions or emergency department visits in patients on the intervention group compared to usual care. However, patients in the intervention group reported greater patient satisfaction (p < 0.001. Conclusion: Any beneficial effect of interventions initiated after discharge is small for high-risk patients with multiple comorbidity and complex care needs. Future transitional care interventions should focus on providing the entire cycle of care for such patients starting from time of admission to final transition to the primary care setting. Trial Registration: Clinicaltrials.gov, no NCT02325752

  7. Transitional care for the highest risk patients: findings of a randomised control study

    Directory of Open Access Journals (Sweden)

    Kheng Hock Lee

    2015-10-01

    Full Text Available Background: Interventions to prevent readmissions of patients at highest risk have not been rigorously evaluated. We conducted a randomised controlled trial to determine if a post-discharge transitional care programme can reduce readmissions of such patients in Singapore.Methods: We randomised 840 patients with two or more unscheduled readmissions in the prior 90 days and Length of stay, Acuity of admission, Comorbidity of patient, Emergency department utilisation score ≥10 to the intervention programme (n = 419 or control (n = 421. Patients allocated to the intervention group received post-discharge surveillance by a multidisciplinary integrated care team and early review in the clinic. The primary outcome was the proportion of patients with at least one unscheduled readmission within 30 days after discharge.Results: We found no statistically significant reduction in readmissions or emergency department visits in patients on the intervention group compared to usual care. However, patients in the intervention group reported greater patient satisfaction (p < 0.001.Conclusion: Any beneficial effect of interventions initiated after discharge is small for high-risk patients with multiple comorbidity and complex care needs. Future transitional care interventions should focus on providing the entire cycle of care for such patients starting from time of admission to final transition to the primary care setting.Trial Registration: Clinicaltrials.gov, no NCT02325752

  8. Podiatry intervention versus usual care to prevent falls in care homes: pilot randomised controlled trial (the PIRFECT study).

    Science.gov (United States)

    Wylie, Gavin; Menz, Hylton B; McFarlane, Sarah; Ogston, Simon; Sullivan, Frank; Williams, Brian; Young, Zoe; Morris, Jacqui

    2017-07-12

    Common foot problems are independent risk factors for falls in older people. There is evidence that podiatry can prevent falls in community-dwelling populations. The feasibility of implementing a podiatry intervention and trial in the care home population is unknown. To inform a potential future definitive trial, we performed a pilot randomised controlled trial to assess: (i) the feasibility of a trial of a podiatry intervention to reduce care home falls, and (ii) the potential direction and magnitude of the effect of the intervention in terms of number of falls in care home residents. Informed by Medical Research Council guidance on developing and evaluating complex interventions, we conducted a single blind, pilot randomised controlled trial in six care homes in the East of Scotland. Participants were randomised to either: (i) a three month podiatry intervention comprising core podiatry care, foot and ankle exercises, orthoses and footwear provision or (ii) usual care. Falls-related outcomes (number of falls, time to first fall) and feasibility-related outcomes (recruitment, retention, adherence, data collection rates) were collected. Secondary outcomes included: generic health status, balance, mobility, falls efficacy, and ankle joint strength. 474 care home residents were screened. 43 (9.1%) participants were recruited: 23 to the intervention, 20 to control. Nine (21%) participants were lost to follow-up due to declining health or death. It was feasible to deliver the trial elements in the care home setting. 35% of participants completed the exercise programme. 48% reported using the orthoses 'all or most of the time'. Completion rates of the outcome measures were between 93% and 100%. No adverse events were reported. At the nine month follow-up period, the intervention group per-person fall rate was 0.77 falls vs. 0.83 falls in the control group. A podiatry intervention to reduce falls can be delivered to care home residents within a pilot randomised

  9. Heartburn treatment in primary care: randomised, double blind study for 8 weeks

    Science.gov (United States)

    Hatlebakk, Jan G; Hyggen, Arild; Madsen, Per H; Walle, Per O; Schulz, Tom; Mowinckel, Petter; Bernklev, Tomm; Berstad, Arnold

    1999-01-01

    Objective To compare the effects and tolerability of omeprazole and cisapride with that of placebo for control of heartburn in primary care patients. Design Randomised, double blind, placebo controlled study. Setting 65 primary care practices in Norway. Participants 483 untreated patients with complaints of heartburn ⩾3 days a week, with at most grade 1 reflux oesophagitis. Interventions Omeprazole 20 mg once daily, cisapride 20 mg twice daily, or placebo for 8 weeks. Main outcome measures Adequate control of heartburn, defined as ⩽1 day of the past 7 days with no more than mild heartburn, after 4 weeks of treatment. Results In the all patients treated analysis, adequate control of heartburn was achieved in 71% of patients taking omeprazole, 22% taking cisapride, and 18% taking placebo after 4 weeks of treatment (omeprazole v cisapride and placebo, Pheartburn whereas cisapride 20 mg twice daily was not significantly more effective than placebo. Key messagesIn primary care patients, heartburn is commonly treated empiricallyMost randomised clinical trials of treatment for heartburn have been conducted in specialist care, and documentation for empirical treatment is limitedOmeprazole was significantly more effective than cisapride or placebo in controlling heartburn and other symptoms of gastro-oesophageal reflux after 2, 4, and 8 weeks, whereas cisapride did not differ significantly from placeboOmeprazole should be considered as a first choice for empirical treatment of heartburn in primary care PMID:10463897

  10. Supported Discharge Teams for older people in hospital acute care: a randomised controlled trial.

    Science.gov (United States)

    Parsons, Matthew; Parsons, John; Rouse, Paul; Pillai, Avinesh; Mathieson, Sean; Parsons, Rochelle; Smith, Christine; Kenealy, Tim

    2018-03-01

    Supported Discharge Teams aim to help with the transition from hospital to home, whilst reducing hospital length-of-stay. Despite their obvious attraction, the evidence remains mixed, ranging from strong support for disease-specific interventions to less favourable results for generic services. To determine whether older people referred to a Supported Discharge Team have: (i) reduced length-of-stay in hospital; (ii) reduced risk of hospital readmission; and (iii) reduced healthcare costs. Randomised controlled trial with follow-up to 6 months; 103 older women and 80 men (n = 183) (mean age 79), in hospital, were randomised to receive either Supported Discharge Team or usual care. Home-based rehabilitation was delivered by trained Health Care Assistants up to four times a day, 7 days a week, under the guidance of registered nurses, allied health and geriatricians for up to 6 weeks. Participants randomised to the Supported Discharge Team spent less time in hospital during the index admission (mean 15.7 days) in comparison to usual care (mean 21.6 days) (mean difference 5.9: 95% CI 0.6, 11.3 days: P = 0.03) and spent less time in hospital in the 6 months following discharge home. Supported discharge group costs were calculated at mean NZ$10,836 (SD NZ$12,087) compared to NZ$16,943 (SD NZ$22,303) in usual care. A Supported Discharge Team can provide an effective means of discharging older people home early from hospital and can make a cost-effective contribution to managing increasing demand for hospital beds. © The Author 2017. Published by Oxford University Press on behalf of the British Geriatrics Society.All rights reserved. For permissions, please email: journals.permissions@oup.com

  11. Continuity of care by a midwife team versus routine care during pregnancy and birth: a randomised trial.

    Science.gov (United States)

    Rowley, M J; Hensley, M J; Brinsmead, M W; Wlodarczyk, J H

    1995-09-18

    To compare continuity of care from a midwife team with routine care from a variety of doctors and midwives. A stratified, randomised controlled trial. 814 women attending the antenatal clinic of a tertiary referral, university hospital. Women were randomly allocated to team care from a team of six midwives, or routine care from a variety of doctors and midwives. Antenatal, intrapartum and neonatal events; maternal satisfaction; and cost of treatment. 405 women were randomly allocated to team care and 409 to routine care; they delivered 385 and 386 babies, respectively. Team care women were more likely to attend antenatal classes (OR, 1.73; 95% CI, 1.23-2.42); less likely to use pethidine during labour (OR, 0.32; 95% CI, 0.22-0.46); and more likely to labour and deliver without intervention (OR, 1.73; 95% CI, 1.28-2.34). Babies of team care mothers received less neonatal resuscitation (OR, 0.59; 95% CI, 0.41-0.86), although there was no difference in Apgar scores at five minutes (OR, 0.86; 95% CI, 0.29-2.57). The stillbirth and neonatal death rate was the same for both groups of mothers with a singleton pregnancy (three deaths), but there were three deaths (birthweights of 600 g, 660 g, 1340 g) in twin pregnancies in the group receiving team care. Team care was rated better than routine care for all measures of maternal satisfaction. Team care meant a cost reduction of 4.5%. Continuity of care provided by a small team of midwives resulted in a more satisfying birth experience at less cost than routine care and fewer adverse maternal and neonatal outcomes. Although a much larger study would be required to provide adequate power to detect rare outcomes, our study found that continuity of care by a midwife team was as safe as routine care.

  12. Cost effectiveness of physiotherapy, manual therapy, and general practitioner care for neck pain: economic evaluation alongside a randomised controlled trial

    NARCIS (Netherlands)

    Korthals-de Bos, Ingeborg B. C.; Hoving, Jan L.; van Tulder, Maurits W.; Rutten-van Mölken, Maureen P. M. H.; Adèr, Herman J.; de Vet, Henrica C. W.; Koes, Bart W.; Vondeling, Hindrik; Bouter, Lex M.

    2003-01-01

    OBJECTIVE: To evaluate the cost effectiveness of physiotherapy, manual therapy, and care by a general practitioner for patients with neck pain. DESIGN: Economic evaluation alongside a randomised controlled trial. SETTING: Primary care. PARTICIPANTS: 183 patients with neck pain for at least two weeks

  13. Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial.

    Science.gov (United States)

    Prestmo, Anders; Hagen, Gunhild; Sletvold, Olav; Helbostad, Jorunn L; Thingstad, Pernille; Taraldsen, Kristin; Lydersen, Stian; Halsteinli, Vidar; Saltnes, Turi; Lamb, Sarah E; Johnsen, Lars G; Saltvedt, Ingvild

    2015-04-25

    Most patients with hip fractures are characterised by older age (>70 years), frailty, and functional deterioration, and their long-term outcomes are poor with increased costs. We compared the effectiveness and cost-effectiveness of giving these patients comprehensive geriatric care in a dedicated geriatric ward versus the usual orthopaedic care. We did a prospective, single-centre, randomised, parallel-group, controlled trial. Between April 18, 2008, and Dec 30, 2010, we randomly assigned home-dwelling patients with hip-fractures aged 70 years or older who were able to walk 10 m before their fracture, to either comprehensive geriatric care or orthopaedic care in the emergency department, to achieve the required sample of 400 patients. Randomisation was achieved via a web-based, computer-generated, block method with unknown block sizes. The primary outcome, analysed by intention to treat, was mobility measured with the Short Physical Performance Battery (SPPB) 4 months after surgery for the fracture. The type of treatment was not concealed from the patients or staff delivering the care, and assessors were only partly masked to the treatment during follow-up. This trial is registered with ClinicalTrials.gov, number NCT00667914. We assessed 1077 patients for eligibility, and excluded 680, mainly for not meeting the inclusion criteria such as living in a nursing home or being aged less than 70 years. Of the remaining patients, we randomly assigned 198 to comprehensive geriatric care and 199 to orthopaedic care. At 4 months, 174 patients remained in the comprehensive geriatric care group and 170 in the orthopaedic care group; the main reason for dropout was death. Mean SPPB scores at 4 months were 5·12 (SE 0·20) for comprehensive geriatric care and 4·38 (SE 0·20) for orthopaedic care (between-group difference 0·74, 95% CI 0·18-1·30, p=0·010). Immediate admission of patients aged 70 years or more with a hip fracture to comprehensive geriatric care in a dedicated

  14. Effect of integrated care for sick listed patients with chronic low back pain: economic evaluation alongside a randomised controlled trial

    OpenAIRE

    Lambeek, Ludeke C; Bosmans, Judith E; Van Royen, Barend J; Van Tulder, Maurits W; Van Mechelen, Willem; Anema, Johannes R

    2010-01-01

    Objective To evaluate the cost effectiveness, cost utility, and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain. Design Economic evaluation alongside a randomised controlled trial with 12 months? follow-up. Setting Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals) in the Netherlands, 2005-9. Participants 134 adults aged 18-65...

  15. Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial.

    Science.gov (United States)

    Wentworth, John M; Playfair, Julie; Laurie, Cheryl; Ritchie, Matthew E; Brown, Wendy A; Burton, Paul; Shaw, Jonathan E; O'Brien, Paul E

    2014-07-01

    Bariatric surgery improves glycaemia in obese people with type 2 diabetes, but its effects are uncertain in overweight people with this disease. We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese. We did an open-label, parallel-group, randomised controlled trial between Nov 1, 2009, and June 30, 2013, at one centre in Melbourne, Australia. Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned (1:1), by computer-generated random sequence, to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone. The primary outcome was diabetes remission 2 years after randomisation, defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose, at least two days after stopping glucose-lowering drugs. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000286246. 51 patients were randomised to the multidisciplinary care plus gastric band group (n=25) or the multidisciplinary care only group (n=26), of whom 23 participants and 25 participants, respectively, completed follow-up to 2 years. 12 (52%) participants in the multidisciplinary care plus gastric band group and two (8%) participants in the multidisciplinary care only group achieved diabetes remission (difference in proportions 0.44, 95% CI 0.17-0.71; p=0.0012). One (4%) participant in the gastric band group needed revisional surgery and four others (17%) had a total of five episodes of food intolerance due to excessive adjustment of the band. When added to multidisciplinary care, laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile

  16. Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life

    OpenAIRE

    Lambeek, L.C.; van Mechelen, W.; Knol, D.L.; Loisel, P.; Anema, J.R.

    2010-01-01

    Objective To evaluate the effectiveness of an integrated care programme, combining a patient directed and a workplace directed intervention, for patients with chronic low back pain. Design Population based randomised controlled trial. Setting Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals). Participants 134 adults aged 18-65 sick listed for at least 12 weeks owing to low back pain. Intervention P...

  17. Impact of a deferred recruitment model in a randomised controlled trial in primary care (CREAM study).

    Science.gov (United States)

    Shepherd, Victoria; Thomas-Jones, Emma; Ridd, Matthew J; Hood, Kerenza; Addison, Katy; Francis, Nick A

    2017-11-10

    Recruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely. Eligible children were identified by participating general practitioners (GPs) and referred to a study research nurse, who then visited them at home. This allowed the consent and recruitment processes to take place outside the general practice setting. Information was recorded about patients who were referred and recruited, or if not, the reasons for non-recruitment. Data on recruitment challenges were collected through semi-structured interviews and questionnaires with a sample of participating GPs. Data were thematically analysed to identify key themes. Of the children referred to the study 34% (58/171) were not recruited - 48% (28/58) because of difficulties arranging a baseline visit within the defined time frame, 31% (18/58) did not meet the study inclusion criteria at the time of nurse assessment, and 21% (12/58) declined participation. GPs had positive views about the recruitment process, reporting that parents valued and benefitted from additional contact with a nurse. GPs felt that the deferred recruitment model did not negatively impact on the study. GPs and parents recognised the benefits of deferred recruitment, but these did not translate into enhanced recruitment of participants. The model resulted in the loss of a third of children who were identified by the GP as eligible, but not subsequently recruited to the study. If the potential for improving outcomes in primary care

  18. Maternal note-taking and infant care: a pilot randomised controlled trial.

    Science.gov (United States)

    Kistin, Caroline J; Barrero-Castillero, Alejandra; Lewis, Sheilajane; Hoch, Rachel; Philipp, Barbara L; Bauchner, Howard; Wang, C Jason

    2012-10-01

    A pilot randomised controlled trial was conducted with postpartum mothers to assess the feasibility and impact of note-taking during newborn teaching. Controls received standard teaching; the intervention group received pen and paper to take notes. Subjects were called 2 days post-discharge to assess infant sleep position, breastfeeding, car seat use, satisfaction and information recall. 126 mothers were randomised. There was a consistent trend that intervention subjects were more likely to report infant supine sleep position (88% vs 78%, relative risks (RR) 1.13; 95% CI 0.95 to 1.34), breastfeeding (96% vs 86%, RR 1.11; 95% CI 0.99 to 1.25) and correct car seat use (98% vs 87%, RR 1.12; 95% CI 1.00 to 1.25). Satisfaction and information recall did not differ. Among first-time mothers, intervention subjects were significantly more likely to report infant supine sleep position (95% vs 65%, RR 1.46; 95% CI 1.06 to 2.00). Maternal note-taking is feasible and potentially efficacious in promoting desirable infant care.

  19. 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

  20. Collaborative care for patients with bipolar disorder: a randomised controlled trial.

    Science.gov (United States)

    van der Voort, Trijntje Y G; van Meijel, Berno; Goossens, Peter J J; Renes, Janwillem; Beekman, Aartjan T F; Kupka, Ralph W

    2011-08-17

    Bipolar disorder is a severe mental illness with serious consequences for daily living of patients and their caregivers. Care as usual primarily consists of pharmacotherapy and supportive treatment. However, a substantial number of patients show a suboptimal response to treatment and still suffer from frequent episodes, persistent interepisodic symptoms and poor social functioning. Both psychiatric and somatic comorbid disorders are frequent, especially personality disorders, substance abuse, cardiovascular diseases and diabetes. Multidisciplinary collaboration of professionals is needed to combine all expertise in order to achieve high-quality integrated treatment. 'Collaborative Care' is a treatment method that could meet these needs. Several studies have shown promising effects of these integrated treatment programs for patients with bipolar disorder. In this article we describe a research protocol concerning a study on the effects of Collaborative Care for patients with bipolar disorder in the Netherlands. The study concerns a two-armed cluster randomised clinical trial to evaluate the effectiveness of Collaborative Care (CC) in comparison with Care as usual (CAU) in outpatient clinics for bipolar disorder or mood disorders in general. Collaborative Care includes individually tailored interventions, aimed at personal goals set by the patient. The patient, his caregiver, the nurse and the psychiatrist all are part of the Collaborative Care team. Elements of the program are: contracting and shared decision making; psycho education; problem solving treatment; systematic relapse prevention; monitoring of outcomes and pharmacotherapy. Nurses coordinate the program. Nurses and psychiatrists in the intervention group will be trained in the intervention. The effects will be measured at baseline, 6 months and 12 months. Primary outcomes are psychosocial functioning, psychiatric symptoms, and quality of life. Caregiver outcomes are burden and satisfaction with care

  1. Continuity of midwifery care and gestational weight gain in obese women: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Patterson Denise

    2011-03-01

    Full Text Available Abstract Background The increased prevalence of obesity in pregnant women in Australia and other developed countries is a significant public health concern. Obese women are at increased risk of serious perinatal complications and guidelines recommend weight gain restriction and additional care. There is limited evidence to support the effectiveness of dietary and physical activity lifestyle interventions in preventing adverse perinatal outcomes and new strategies need to be evaluated. The primary aim of this project is to evaluate the effect of continuity of midwifery care on restricting gestational weight gain in obese women to the recommended range. The secondary aims of the study are to assess the impact of continuity of midwifery care on: women's experience of pregnancy care; women's satisfaction with care and a range of psychological factors. Methods/Design A two arm randomised controlled trial (RCT will be conducted with primigravid women recruited from maternity services in Victoria, Australia. Participants will be primigravid women, with a BMI≥30 who are less than 17 weeks gestation. Women allocated to the intervention arm will be cared for in a midwifery continuity of care model and receive an informational leaflet on managing weight gain in pregnancy. Women allocated to the control group will receive routine care in addition to the same informational leaflet. Weight gain during pregnancy, standards of care, medical and obstetric information will be extracted from medical records. Data collected at recruitment (self administered survey and at 36 weeks by postal survey will include socio-demographic information and the use of validated scales to measure secondary outcomes. Discussion Continuity of midwifery care models are well aligned with current Victorian, Australian and many international government policies on maternity care. Increasingly, midwifery continuity models of care are being introduced in low risk maternity care, and

  2. Cost effectiveness of interventions for lateral epicondylitis - Results from a randomised controlled trial in primary care

    DEFF Research Database (Denmark)

    Korthals-de Bos, I.B.C.; Smidt, N.; van Tulder, M.W.

    2004-01-01

    Objective: Lateral epicondylitis is a common complaint, with an annual incidence between 1% and 3% in the general population. The Dutch College of General Practitioners in The Netherlands has issued guidelines that recommend a wait- and-see policy. However, these guidelines are not evidence based....... Design and setting: This paper presents the results of an economic evaluation in conjunction with a randomised controlled trial to evaluate the effects of three interventions in primary care for patients with lateral epicondylitis. Patients and interventions: Patients with pain at the lateral side...... versus the wait- and-see policy. Conclusions: The results of this economic evaluation provided no reason to update or amend the Dutch guidelines for GPs, which recommend a wait-and-see policy for patients with lateral epicondylitis....

  3. 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...

  4. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    OpenAIRE

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-01-01

    Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Method...

  5. A randomised controlled trial of caseload midwifery care: M@NGO (Midwives @ New Group practice Options

    Directory of Open Access Journals (Sweden)

    Tracy Sally K

    2011-10-01

    Full Text Available Abstract Background Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant. Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice. We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial. Methods/design A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs. Discussion Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05 to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive

  6. A randomised controlled trial of caseload midwifery care: M@NGO (Midwives @ New Group practice Options).

    Science.gov (United States)

    Tracy, Sally K; Hartz, Donna; Hall, Bev; Allen, Jyai; Forti, Amanda; Lainchbury, Anne; White, Jan; Welsh, Alec; Tracy, Mark; Kildea, Sue

    2011-10-26

    Australia has an enviable record of safety for women in childbirth. There is nevertheless growing concern at the increasing level of intervention and consequent morbidity amongst childbearing women. Not only do interventions impact on the cost of services, they carry with them the potential for serious morbidities for mother and infant.Models of midwifery have proliferated in an attempt to offer women less fragmented hospital care. One of these models that is gaining widespread consumer, disciplinary and political support is caseload midwifery care. Caseload midwives manage the care of approximately 35-40 a year within a small Midwifery Group Practice (usually 4-6 midwives who plan their on call and leave within the Group Practice.) We propose to compare the outcomes and costs of caseload midwifery care compared to standard or routine hospital care through a randomised controlled trial. A two-arm RCT design will be used. Women will be recruited from tertiary women's hospitals in Sydney and Brisbane, Australia. Women allocated to the caseload intervention will receive care from a named caseload midwife within a Midwifery Group Practice. Control women will be allocated to standard or routine hospital care. Women allocated to standard care will receive their care from hospital rostered midwives, public hospital obstetric care and community based general medical practitioner care. All midwives will collaborate with obstetricians and other health professionals as necessary according to the woman's needs. Data will be collected at recruitment, 36 weeks antenatally, six weeks and six months postpartum by web based or postal survey. With 750 women or more in each of the intervention and control arms the study is powered (based on 80% power; alpha 0.05) to detect a difference in caesarean section rates of 29.4 to 22.9%; instrumental birth rates from 11.0% to 6.8%; and rates of admission to neonatal intensive care of all neonates from 9.9% to 5.8% (requires 721 in each arm

  7. Hospital at Home care for older patients with cognitive impairment: a protocol for a randomised controlled feasibility trial.

    Science.gov (United States)

    Pouw, Maaike A; Calf, Agneta H; van Munster, Barbara C; Ter Maaten, Jan C; Smidt, Nynke; de Rooij, Sophia E

    2018-03-27

    An acute hospital admission is a stressful life event for older people, particularly for those with cognitive impairment. The hospitalisation is often complicated by hospital-associated geriatric syndromes, including delirium and functional loss, leading to functional decline and nursing home admission. Hospital at Home care aims to avoid hospitalisation-associated adverse outcomes in older patients with cognitive impairment by providing hospital care in the patient's own environment. This randomised, non-blinded feasibility trial aims to assess the feasibility of conducting a randomised controlled trial in terms of the recruitment, use and acceptability of Hospital at Home care for older patients with cognitive impairment. The quality of care will be evaluated and the advantages and disadvantages of the Hospital at Home care programme compared with usual hospital care. Eligible patients will be randomised either to Hospital at Home care in their own environment or usual hospital care. The intervention consists of hospital level care provided at patients' homes, including visits from healthcare professionals, diagnostics (laboratory tests, blood cultures) and treatment. The control group will receive usual hospital care. Measurements will be conducted at baseline, during admission, at discharge and at 3 and 6 months after the baseline assessment. Institutional ethics approval has been granted. The findings will be disseminated through public lectures, professional and scientific conferences, as well as peer-reviewed journal articles. The study findings will contribute to knowledge on the implementation of Hospital at Home care for older patients with cognitive disorders. The results will be used to inform and support strategies to deliver eligible care to older patients with cognitive impairment. e020313; 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

  8. 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

  9. Effect of integrated care for sick listed patients with chronic low back pain: economic evaluation alongside a randomised controlled trial.

    Science.gov (United States)

    Lambeek, Ludeke C; Bosmans, Judith E; Van Royen, Barend J; Van Tulder, Maurits W; Van Mechelen, Willem; Anema, Johannes R

    2010-11-30

    To evaluate the cost effectiveness, cost utility, and cost-benefit of an integrated care programme compared with usual care for sick listed patients with chronic low back pain. Economic evaluation alongside a randomised controlled trial with 12 months' follow-up. Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals) in the Netherlands, 2005-9. 134 adults aged 18-65 sick listed because of chronic low back pain: 66 were randomised to integrated care and 68 to usual care. Integrated care consisted of a workplace intervention based on participatory ergonomics, with involvement of a supervisor, and a graded activity programme based on cognitive behavioural principles. Usual care was provided by general practitioners and occupational physicians according to Dutch guidelines. The primary outcome was duration until sustainable return to work. The secondary outcome was quality adjusted life years (QALYs), measured using EuroQol. Total costs in the integrated care group (£13 165, SD £13 600) were significantly lower than in the usual care group (£18 475, SD £13 616). Cost effectiveness planes and acceptability curves showed that integrated care was cost effective compared with usual care for return to work and QALYs gained. The cost-benefit analyses showed that every £1 invested in integrated care would return an estimated £26. The net societal benefit of integrated care compared with usual care was £5744. Implementation of an integrated care programme for patients sick listed with chronic low back pain has a large potential to significantly reduce societal costs, increase effectiveness of care, improve quality of life, and improve function on a broad scale. Integrated care therefore has large gains for patients and society as well as for employers.

  10. Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Evelyn Korkor Ansah

    2009-01-01

    Full Text Available Delays in accessing care for malaria and other diseases can lead to disease progression, and user fees are a known barrier to accessing health care. Governments are introducing free health care to improve health outcomes. Free health care affects treatment seeking, and it is therefore assumed to lead to improved health outcomes, but there is no direct trial evidence of the impact of removing out-of-pocket payments on health outcomes in developing countries. This trial was designed to test the impact of free health care on health outcomes directly.2,194 households containing 2,592 Ghanaian children under 5 y old were randomised into a prepayment scheme allowing free primary care including drugs, or to a control group whose families paid user fees for health care (normal practice; 165 children whose families had previously paid to enrol in the prepayment scheme formed an observational arm. The primary outcome was moderate anaemia (haemoglobin [Hb] < 8 g/dl; major secondary outcomes were health care utilisation, severe anaemia, and mortality. At baseline the randomised groups were similar. Introducing free primary health care altered the health care seeking behaviour of households; those randomised to the intervention arm used formal health care more and nonformal care less than the control group. Introducing free primary health care did not lead to any measurable difference in any health outcome. The primary outcome of moderate anaemia was detected in 37 (3.1% children in the control and 36 children (3.2% in the intervention arm (adjusted odds ratio 1.05, 95% confidence interval 0.66-1.67. There were four deaths in the control and five in the intervention group. Mean Hb concentration, severe anaemia, parasite prevalence, and anthropometric measurements were similar in each group. Families who previously self-enrolled in the prepayment scheme were significantly less poor, had better health measures, and used services more frequently than those in

  11. PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Mathieson, Stephanie; Maher, Christopher G; McLachlan, Andrew J; Latimer, Jane; Koes, Bart W; Hancock, Mark J; Harris, Ian; Day, Richard O; Pik, Justin; Jan, Stephen; Billot, Laurent; Lin, Chung-Wei Christine

    2013-07-11

    Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica. PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant's optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives. This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life

  12. 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.

  13. Parental presence on neonatal intensive care unit clinical bedside rounds: randomised trial and focus group discussion

    Science.gov (United States)

    Boswell, Danette; Broom, Margaret; Smith, Judith; Davis, Deborah

    2015-01-01

    Background There are limited data to inform the choice between parental presence at clinical bedside rounds (PPCBR) and non-PPCBR in neonatal intensive care units (NICUs). Methods We performed a single-centre, survey-based, crossed-over randomised trial involving parents of all infants who were admitted to NICU and anticipated to stay >11 days. Parents were randomly assigned using a computer-generated stratified block randomisation protocol to start with PPCBR or non-PPCBR and then crossed over to the other arm after a wash-out period. At the conclusion of each arm, parents completed the ‘NICU Parental Stressor Scale’ (a validated tool) and a satisfaction survey. After completion of the trial, we surveyed all healthcare providers who participated at least in one PPCBR rounding episode. We also offered all participating parents and healthcare providers the opportunity to partake in a focus group discussion regarding PPCBR. Results A total of 72 parents were enrolled in this study, with 63 parents (87%) partially or fully completing the trial. Of the parents who completed the trial, 95% agreed that parents should be allowed to attend clinical bedside rounds. A total of 39 healthcare providers’ surveys were returned and 35 (90%) agreed that parents should be allowed to attend rounds. Nine healthcare providers and 8 parents participated in an interview or focus group, augmenting our understanding of the ways in which PPCBR was beneficial. Conclusions Parents and healthcare providers strongly support PPCBR. NICUs should develop policies allowing PPCBR while mitigating the downsides and concerns of parents and healthcare providers such as decreased education opportunity and confidentiality concerns. Trial registration number Australia and New Zealand Clinical Trials Register number, ACTRN12612000506897. PMID:25711125

  14. Exercise therapy for Stress-related mental disorder, a randomised controlled trial in primary care

    Directory of Open Access Journals (Sweden)

    Donker Marieke

    2011-07-01

    Full Text Available Abstract Background to investigate whether a structured physical exercise programme (PEP improves the recovery of general health in patients suffering from Stress-related Mental Disorder (SMD. Method Study design: randomised open trial in general practice. Patients from two regions in the Netherlands were included between September 2003 and December 2005, and followed up for 12 weeks. Intervention: the patients were referred to a physical therapist for instruction in and monitoring of physical exercise of an intermediate intensity. Following the Dutch Guidelines for Healthy Physical Exercise, the patients were instructed to exercise at least five times a week, for at least 30 minutes per day. Control group: usual care from the GP Outcome Primary: improvement of general health after 6 weeks according to the 'general health' dimension of the Short-Form 36. Secondary: total days off work, percentage that resumed work after 6 and 12 weeks, change in distress score and change in remaining SF36 dimensions after 6 and 12 weeks. Results out of 102 randomised patients (mean age 43, 60 (59% female, 70 (68% completed the trial, of whom 31 were in the intervention group. After 6 weeks, the mean (SD general health score was 54.6 (22.1 for the intervention group and 57.5 (19.2 for the controls. The corresponding effect size (Cohen's d with 95% confidence interval from analysis of covariance was -0.06 (-0.41, 0.30 indicating no effect on general health. No significant effects of the intervention were detected for any secondary outcome parameter either. Conclusion Notwithstanding the relatively high drop-out rate, our results suggest that referral to a physical therapist for structured physical exercise is not likely to be very effective in improving recovery from SMD. Trial registry Current Controlled Trials ISRCTN15609105

  15. The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.

    Science.gov (United States)

    Thompson, E A; Shaw, A; Nichol, J; Hollinghurst, S; Henderson, A J; Thompson, T; Sharp, D

    2011-07-01

    To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial. In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences. 226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process. A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  16. Collaborative care for patients with bipolar disorder: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2011-08-01

    Full Text Available Abstract Background Bipolar disorder is a severe mental illness with serious consequences for daily living of patients and their caregivers. Care as usual primarily consists of pharmacotherapy and supportive treatment. However, a substantial number of patients show a suboptimal response to treatment and still suffer from frequent episodes, persistent interepisodic symptoms and poor social functioning. Both psychiatric and somatic comorbid disorders are frequent, especially personality disorders, substance abuse, cardiovascular diseases and diabetes. Multidisciplinary collaboration of professionals is needed to combine all expertise in order to achieve high-quality integrated treatment. 'Collaborative Care' is a treatment method that could meet these needs. Several studies have shown promising effects of these integrated treatment programs for patients with bipolar disorder. In this article we describe a research protocol concerning a study on the effects of Collaborative Care for patients with bipolar disorder in the Netherlands. Methods/design The study concerns a two-armed cluster randomised clinical trial to evaluate the effectiveness of Collaborative Care (CC in comparison with Care as usual (CAU in outpatient clinics for bipolar disorder or mood disorders in general. Collaborative Care includes individually tailored interventions, aimed at personal goals set by the patient. The patient, his caregiver, the nurse and the psychiatrist all are part of the Collaborative Care team. Elements of the program are: contracting and shared decision making; psycho education; problem solving treatment; systematic relapse prevention; monitoring of outcomes and pharmacotherapy. Nurses coordinate the program. Nurses and psychiatrists in the intervention group will be trained in the intervention. The effects will be measured at baseline, 6 months and 12 months. Primary outcomes are psychosocial functioning, psychiatric symptoms, and quality of life. Caregiver

  17. A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study

    Science.gov (United States)

    Salisbury, Lisa G; Boyd, Julia; Ramsay, Pamela; Merriweather, Judith; Huby, Guro; Forbes, John; Rattray, Janice Z; Griffith, David M; Mackenzie, Simon J; Hull, Alastair; Lewis, Steff; Murray, Gordon D

    2012-01-01

    Introduction Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life. Methods and analysis The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers. Ethics and dissemination Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according

  18. Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    van Vuuren Cloete

    2008-04-01

    Full Text Available Abstract Background A major barrier to accessing free government-provided antiretroviral treatment (ART in South Africa is the shortage of suitably skilled health professionals. Current South African guidelines recommend that only doctors should prescribe ART, even though most primary care is provided by nurses. We have developed an effective method of educational outreach to primary care nurses in South Africa. Evidence is needed as to whether primary care nurses, with suitable training and managerial support, can initiate and continue to prescribe and monitor ART in the majority of ART-eligible adults. Methods/design This is a protocol for a pragmatic cluster randomised trial to evaluate the effectiveness of a complex intervention based on and supporting nurse-led antiretroviral treatment (ART for South African patients with HIV/AIDS, compared to current practice in which doctors are responsible for initiating ART and continuing prescribing. We will randomly allocate 31 primary care clinics in the Free State province to nurse-led or doctor-led ART. Two groups of patients aged 16 years and over will be included: a 7400 registering with the programme with CD4 counts of ≤ 350 cells/mL (mainly to evaluate treatment initiation and b 4900 already receiving ART (to evaluate ongoing treatment and monitoring. The primary outcomes will be time to death (in the first group and viral suppression (in the second group. Patients' survival, viral load and health status indicators will be measured at least 6-monthly for at least one year and up to 2 years, using an existing province-wide clinical database linked to the national death register. Trial registration Controlled Clinical Trials ISRCTN46836853

  19. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial

    Directory of Open Access Journals (Sweden)

    Helliwell Philip S

    2007-11-01

    Full Text Available Abstract Background Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Methods Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF and activity limitation/participation restriction (LFISAP subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS, Health Assessment Questionnaire (HAQ score and walking speed (m/s were also recorded. Results Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores, there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF but not activity/participation (LFISAP or function (walking speed over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits and 3 self-withdrew (lost to follow-up. Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3, foot orthoses (n = 9, footwear referral to the orthotist (n = 5, and ultrasound

  20. Methodological considerations for a randomised controlled trial of podiatry care in rheumatoid arthritis: lessons from an exploratory trial.

    Science.gov (United States)

    Turner, Deborah E; Helliwell, Philip S; Woodburn, James

    2007-11-06

    Whilst evidence exists to support the use of single treatments such as orthoses and footwear, the effectiveness of podiatry-led care as a complex intervention for patients with rheumatoid arthritis (RA) related foot problems is unknown. The aim of this study was to undertake an exploratory randomised controlled parallel arm clinical trial (RheumAFooT) to inform the design and implementation of a definitive trial and to understand the potential benefits of this care. Patients with a definite diagnosis of RA, stable drug management 3 months prior to entry, and a current history of foot problems (pain, deformity, stiffness, skin or nail lesions, or footwear problems) were recruited from a hospital outpatient rheumatology clinic and randomised to receive 12 months of podiatry treatment or no care. The primary outcome was change in foot health status using the impairment/footwear (LFISIF) and activity limitation/participation restriction (LFISAP) subscales of the Leeds Foot Impact Scale. Disease Activity Score (DAS), Health Assessment Questionnaire (HAQ) score and walking speed (m/s) were also recorded. Of the 80 patients identified, 64 patients were eligible to participate in the pilot and 34 were recruited. 16 patients were randomised to receive podiatry led foot care and 18 received no care. Against a backdrop of stable disease (DAS and HAQ scores), there was a statistically significant between group difference in the change in foot health status for foot impairment (LFISIF) but not activity/participation (LFISAP) or function (walking speed) over 12 months. In the podiatry arm, 1 patient declined treatment following randomisation (did not want additional hospital visits) and 3 self-withdrew (lost to follow-up). Patients received an average of 3 consultations for assessment and treatment comprising routine care for skin and nail lesions (n = 3), foot orthoses (n = 9), footwear referral to the orthotist (n = 5), and ultrasound guided intra-articular steroid injection

  1. 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

  2. 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

  3. Reduction of missed appointments at an urban primary care clinic: a randomised controlled study

    Directory of Open Access Journals (Sweden)

    Calmy Alexandra

    2010-10-01

    Full Text Available Abstract Background Missed appointments are known to interfere with appropriate care and to misspend medical and administrative resources. The aim of this study was to test the effectiveness of a sequential intervention reminding patients of their upcoming appointment and to identify the profile of patients missing their appointments. Methods We conducted a randomised controlled study in an urban primary care clinic at the Geneva University Hospitals serving a majority of vulnerable patients. All patients booked in a primary care or HIV clinic at the Geneva University Hospitals were sent a reminder 48 hrs prior to their appointment according to the following sequential intervention: 1. Phone call (fixed or mobile reminder; 2. If no phone response: a Short Message Service (SMS reminder; 3. If no available mobile phone number: a postal reminder. The rate of missed appointment, the cost of the intervention, and the profile of patients missing their appointment were recorded. Results 2123 patients were included: 1052 in the intervention group, 1071 in the control group. Only 61.7% patients had a mobile phone recorded at the clinic. The sequential intervention significantly reduced the rate of missed appointments: 11.4% (n = 122 in the control group and 7.8% (n = 82 in the intervention group (p 1year (OR 2.2; CI: 1.15-4.2, substance abuse (2.09, CI 1.21-3.61, and being an asylum seeker (OR 2.73: CI 1.22-6.09. Conclusion A practical reminder system can significantly increase patient attendance at medical outpatient clinics. An intervention focused on specific patient characteristics could further increase the effectiveness of appointment reminders.

  4. The effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care (AESOPS – A randomised control trial protocol

    Directory of Open Access Journals (Sweden)

    Morton Veronica

    2008-06-01

    Full Text Available Abstract Background There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption. In older populations excessive alcohol consumption is associated with increased risk of coronary heart disease, hypertension, stroke and a range of cancers. Alcohol consumption is also associated with an increased risk of falls, early onset of dementia and other cognitive deficits. Physiological changes that occur as part of the ageing process mean that older people experience alcohol related problems at lower consumption levels. There is a strong evidence base for the effectiveness of brief psychosocial interventions in reducing alcohol consumption in populations identified opportunistically in primary care settings. Stepped care interventions involve the delivery of more intensive interventions only to those in the population who fail to respond to less intensive interventions and provide a potentially resource efficient means of meeting the needs of this population. Methods/design The study design is a pragmatic prospective multi-centre two arm randomised controlled trial. The primary hypothesis is that stepped care interventions for older hazardous alcohol users reduce alcohol consumption compared with a minimal intervention at 12 months post randomisation. Potential participants are identified using the AUDIT questionnaire. Eligible and consenting participants are randomised with equal probability to either a minimal intervention or a three step treatment approach. The step treatment approach incorporates as step 1 behavioural change counselling, step 2 three sessions of motivational enhancement therapy and step 3 referral to specialist services. The primary outcome is measured using average standard drinks per day and secondary outcome measures include the Drinking Problems Index, health related quality of life and health utility. The study incorporates a comprehensive economic analysis to assess the relative cost

  5. Communication partner training for health care professionals in an inpatient rehabilitation setting: A parallel randomised trial.

    Science.gov (United States)

    Heard, Renee; O'Halloran, Robyn; McKinley, Kathryn

    2017-06-01

    The purpose of this study is to determine if the E-Learning Plus communication partner training (CPT) programme is as effective as the Supported Conversation for Adults with Aphasia (SCA TM ) CPT programme in improving healthcare professionals' confidence and knowledge communicating with patients with aphasia. Forty-eight healthcare professionals working in inpatient rehabilitation participated. Participants were randomised to one of the CPT programmes. The three outcome measures were self-rating of confidence, self-rating of knowledge and a test of knowledge of aphasia. Measures were taken pre-, immediately post- and 3-4 months post-training. Data were analysed using mixed between within ANOVAs. Homogeneity of variance was adequate for self-rating of confidence and test of knowledge of aphasia data to continue analysis. There was a statistically significant difference in self-rating of confidence and knowledge of aphasia for both interventions across time. No statistically significant difference was found between the two interventions. Both CPT interventions were associated with an increase in health care professionals' confidence and knowledge of aphasia, but neither programme was superior. As the E-Learning Plus CPT programme is more accessible and sustainable in the Australian healthcare context, further work will continue on this CPT programme.

  6. [Telephone support for breastfeeding by primary care: a randomised multicentre trial].

    Science.gov (United States)

    Balaguer Martínez, Josep Vicent; Valcarce Pérez, Inmaculada; Esquivel Ojeda, Jessica Noelia; Hernández Gil, Alicia; Martín Jiménez, María Del Pilar; Bernad Albareda, Mercè

    2018-03-22

    To evaluate a telephone support programme for mothers who breastfeed for the first 6 months. A randomised unmasked clinical trial was conducted in 5 urban Primary Care centres that included mothers with healthy newborns who were breastfeeding exclusively (EBF) or partially (PBF). The control group received the usual care. The intervention group also received telephone support for breastfeeding on a weekly basis for the first 2months and then every 2weeks until the sixth month. The type of breastfeeding was recorded in the usual check-up visit (1, 2, 4 and 6 months). The study included 193 patients in the intervention group, and 187 in a control group. The greatest increase in the percentage of EBF was observed at 6 months: 21.4% in the control group compared to 30.1% in the intervention group. However, in the adjusted odds ratios analysis, confidence intervals did not show statistical significance. The odds ratio at 1 month, 2 months, 4 months, and 6 months for EBF were 1.45 (0.91-2.31), 1.35 (0.87-2.08), 1.21 (0.80-1.81), and 1.58 (0.99-2.53), respectively. The odds ratio in the same age groups for any type of breastfeeding (EBF + PBF) were 1.65 (0.39-7.00), 2.08 (0.94-4.61), 1.37 (0.79-2.38), and 1.60 (0.98-2.61), respectively. Telephone intervention was not effective enough to generalise it. Copyright © 2018. Publicado por Elsevier España, S.L.U.

  7. A randomised controlled trial of three very brief interventions for physical activity in primary care

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    Sally Pears

    2016-09-01

    Full Text Available Abstract Background Very brief interventions (VBIs for physical activity are promising, but there is uncertainty about their potential effectiveness and cost. We assessed potential efficacy, feasibility, acceptability, and cost of three VBIs in primary care, in order to select the most promising intervention for evaluation in a subsequent large-scale RCT. Methods Three hundred and ninety four adults aged 40–74 years were randomised to a Motivational (n = 83, Pedometer (n = 74, or Combined (n = 80 intervention, delivered immediately after a preventative health check in primary care, or control (Health Check only; n = 157. Potential efficacy was measured as the probability of a positive difference between an intervention arm and the control arm in mean physical activity, measured by accelerometry at 4 weeks. Results For the primary outcome the estimated effect sizes (95 % CI relative to the Control arm for the Motivational, Pedometer and Combined arms were respectively: +20.3 (−45.0, +85.7, +23.5 (−51.3, +98.3, and −3.1 (−69.3, +63.1 counts per minute. There was a73% probability of a positive effect on physical activity for each of the Motivational and Pedometer VBIs relative to control, but only 46 % for the Combined VBI. Only the Pedometer VBI was deliverable within 5 min. All VBIs were acceptable and low cost. Conclusions Based on the four criteria, the Pedometer VBI was selected for evaluation in a large-scale trial. Trial registration Current Controlled Trials ISRCTN02863077 . Retrospectively registered 05/10/2012.

  8. Randomised controlled trial of integrated care to reduce disability from chronic low back pain in working and private life.

    Science.gov (United States)

    Lambeek, Ludeke C; van Mechelen, Willem; Knol, Dirk L; Loisel, Patrick; Anema, Johannes R

    2010-03-16

    To evaluate the effectiveness of an integrated care programme, combining a patient directed and a workplace directed intervention, for patients with chronic low back pain. Population based randomised controlled trial. Primary care (10 physiotherapy practices, one occupational health service, one occupational therapy practice) and secondary care (five hospitals). 134 adults aged 18-65 sick listed for at least 12 weeks owing to low back pain. Patients were randomly assigned to usual care (n=68) or integrated care (n=66). Integrated care consisted of a workplace intervention based on participatory ergonomics, involving a supervisor, and a graded activity programme based on cognitive behavioural principles. The primary outcome was the duration of time off work (work disability) due to low back pain until full sustainable return to work. Secondary outcome measures were intensity of pain and functional status. The median duration until sustainable return to work was 88 days in the integrated care group compared with 208 days in the usual care group (P=0.003). Integrated care was effective on return to work (hazard ratio 1.9, 95% confidence interval 1.2 to 2.8, P=0.004). After 12 months, patients in the integrated care group improved significantly more on functional status compared with patients in the usual care group (P=0.01). Improvement of pain between the groups did not differ significantly. The integrated care programme substantially reduced disability due to chronic low back pain in private and working life. Trial registration Current Controlled Trials ISRCTN28478651.

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

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    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

  10. 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.

  11. 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 ...

  12. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

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    Vester-Andersen Morten

    2013-02-01

    Full Text Available Abstract Background Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. Methods and design The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. Discussion This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. Trial registration Clinicaltrials.gov identifier: NCT01209663

  13. Evaluating holistic needs assessment in outpatient cancer care--a randomised controlled trial: the study protocol.

    Science.gov (United States)

    Snowden, Austyn; Young, Jenny; White, Craig; Murray, Esther; Richard, Claude; Lussier, Marie-Therese; MacArthur, Ewan; Storey, Dawn; Schipani, Stefano; Wheatley, Duncan; McMahon, Jeremy; Ross, Elaine

    2015-05-11

    People living with and beyond cancer are vulnerable to a number of physical, functional and psychological issues. Undertaking a holistic needs assessment (HNA) is one way to support a structured discussion of patients' needs within a clinical consultation. However, there is little evidence on how HNA impacts on the dynamics of the clinical consultation. This study aims to establish (1) how HNA affects the type of conversation that goes on during a clinical consultation and (2) how these putative changes impact on shared decision-making and self-efficacy. The study is hosted by 10 outpatient oncology clinics in the West of Scotland and South West England. Participants are patients with a diagnosis of head and neck, breast, urological, gynaecological and colorectal cancer who have received treatment for their cancer. Patients are randomised to an intervention or control group. The control group entails standard care--routine consultation between the patient and clinician. In the intervention group, the patient completes a holistic needs assessment prior to consultation. The completed assessment is then given to the clinician where it informs a discussion based on the patient's needs and concerns as identified by them. The primary outcome measure is patient participation, as determined by dialogue ratio (DR) and preponderance of initiative (PI) within the consultation. The secondary outcome measures are shared decision-making and self-efficacy. It is hypothesised that HNA will be associated with greater patient participation within the consultation, and that shared decision-making and feelings of self-efficacy will increase as a function of the intervention. This study has been given a favourable opinion by the West of Scotland Research Ethics Committee and NHS Research & Development. Study findings will be disseminated through peer-reviewed publications and conference attendance. Clinical Trials.gov NCT02274701. Published by the BMJ Publishing Group Limited. For

  14. A randomised controlled trial to assess the effectiveness of a nurse-led palliative care intervention for HIV positive patients on antiretroviral therapy: recruitment, refusal, randomisation and missing data.

    Science.gov (United States)

    Lowther, Keira; Higginson, Irene J; Simms, Victoria; Gikaara, Nancy; Ahmed, Aabid; Ali, Zipporah; Afuande, Gaudencia; Kariuki, Hellen; Sherr, Lorraine; Jenkins, Rachel; Selman, Lucy; Harding, Richard

    2014-09-03

    Despite the life threatening nature of an HIV diagnosis and the multidimensional problems experienced by this patient population during antiretroviral therapy, the effectiveness of a palliative care approach for HIV positive patients on ART is as yet unknown. A randomised controlled trial (RCT) was conducted in a sample of 120 HIV positive patients on ART in an urban clinic in Mombasa, Kenya. The intervention was a minimum of seven sessions of multidimensional, person-centred care, given by HIV nurses trained in the palliative care approach over a period of 5 months. Rates of recruitment and refusal, the effectiveness of the randomisation procedure, trial follow-up and attrition and extent of missing data are reported.120 patients (60 randomised to control arm, 60 randomised to intervention arm) were recruited over 5.5 months, with a refusal rate of 55.7%. During the study period, three participants died from cancer, three withdrew (two moved away and one withdrew due to time constraints). All of these patients were in the intervention arm: details are reported. There were five additional missing monthly interviews in both the control and intervention study arm, bringing the total of missing data to 26 data points (4.3%). The quality and implications of these data are discussed extensively and openly, including the effect of full and ethical consent procedures, respondent burden, HIV stigma, accurate randomisation, patient safety and the impact of the intervention. Data on recruitment randomisation, attrition and missing data in clinical trials should be routinely reported, in conjunction with the now established practice of publishing study protocols to enhance research integrity, transparency and quality. Transparency is especially important in cross cultural settings, in which the sources of funding and trial design are often not based in the country of data collection. Findings reported can be used to inform future RCTs in this area. Clinicaltrials.gov NCT

  15. 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.

  16. Paediatric asthma outpatient care by asthma nurse, paediatrician or general practitioner: randomised controlled trial with two-year follow-up

    NARCIS (Netherlands)

    Kuethe, Maarten; Vaessen-Verberne, Anja; Mulder, Paul; Bindels, Patrick; van Aalderen, Wim

    2011-01-01

    For children with stable asthma, to test non-inferiority of care provided by a hospital-based specialised asthma nurse versus a general practitioner (GP) or paediatrician. Randomised controlled trial evaluating standard care by a GP, paediatrician or an asthma nurse, with two-year follow-up. 107

  17. Paediatric asthma outpatient care by asthma nurse, paediatrician or general practitioner: Randomised controlled trial with two-year follow-up

    NARCIS (Netherlands)

    M.C. Kuethe (Maarten ); A.A.P.H. Vaessen-Verberne (Anja); P.G.H. Mulder (Paul); P.J.E. Bindels (Patrick); W.M.C. van Aalderen (Willem)

    2011-01-01

    textabstractAims: For children with stable asthma, to test non-inferiority of care provided by a hospital-based specialised asthma nurse versus a general practitioner (GP) or paediatrician. Methods: Randomised controlled trial evaluating standard care by a GP, paediatrician or an asthma nurse, with

  18. Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse : randomised controlled trial in primary care

    NARCIS (Netherlands)

    Wiegersma, Marian; Panman, Chantal M. C. R.; Kollen, Boudewijn J.; Berger, Marjolein Y.; Lisman-Van Leeuwen, Yvonne; Dekker, Janny H.

    2014-01-01

    Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse. Design Randomised controlled trial. Setting Dutch primary care. Participants Women

  19. 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

  20. 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

  1. Impact of the demand for 'proxy assent' on recruitment to a randomised controlled trial of vaccination testing in care homes.

    Science.gov (United States)

    Whelan, Paul James; Walwyn, Rebecca; Gaughran, Fiona; Macdonald, Alastair

    2013-01-01

    Legal frameworks are in place to protect those who lack the capacity to consent to research, such as the Mental Capacity Act in the UK. Assent is sought instead from a proxy, usually a relative. However, the same legislation may, perversely, affect the welfare of those who lack capacity and of others by hindering the process of recruitment into otherwise potentially beneficial research. In addition, the onus of responsibility is moved from those who know most about the study (ie, the scientific community) to those who know less (the proxies). In this paper, we describe the characteristics of a sample at different stages of the recruitment process of an influenza vaccine-based randomised control trial in elderly care home residents (the FEVER study). 62% (602/968) of potential subjects lacked capacity but only 29% (80/277) of those actually randomised. Older age, being female and living in an Elderly Mentally Ill care home were the only variables associated with lacking capacity. Considering this was a study based in a care home setting where the prevalence of dementia approximates 80%, the trial, like many others, was thus significantly biased. We believe that difficulties seeking proxy assent contributed significantly to this problem. Further thought should be given to how assent to enter research for those who lack capacity should be provided, and we suggest avenues for further discussion such as independent risk/benefit expert panels.

  2. Stepped care for depression and anxiety: from primary care to specialized mental health care: a randomised controlled trial testing the effectiveness of a stepped care program among primary care patients with mood or anxiety disorders

    Directory of Open Access Journals (Sweden)

    Seekles Wike

    2009-06-01

    Full Text Available Abstract Background Mood and anxiety disorders are highly prevalent and have a large impact on the lives of the affected individuals. Therefore, optimal treatment of these disorders is highly important. In this study we will examine the effectiveness of a stepped care program for primary care patients with mood and anxiety disorders. A stepped care program is characterized by different treatment steps that are arranged in order of increasing intensity. Methods This study is a randomised controlled trial with two conditions: stepped care and care as usual, whereby the latter forms the control group. The stepped care program consists of four evidence based interventions: (1 Watchful waiting, (2 Guided self-help, (3 Problem Solving Treatment and (4 Medication and/or specialized mental health care. The study population consists of primary care attendees aged 18–65 years. Screeners are sent to all patients of the participating general practitioners. Individuals with a Diagnostic and Statistical Manual of mental disorders (DSM diagnosis of major depression, dysthymia, panic disorder (with or without agoraphobia, generalized anxiety disorder, or social phobia are included as well as individuals with minor depression and anxiety disorders. Primary focus is the reduction of depressive and anxiety symptoms. Both conditions are monitored at 8, 16 and 24 weeks. Discussion This study evaluates the effectiveness of a stepped care program for patients with depressive and anxiety disorder. If effective, a stepped care program can form a worthwhile alternative for care as usual. Strengths and limitations of this study are discussed. Trial Registration Current Controlled Trails: ISRCTN17831610.

  3. Individual versus interprofessional team performance in formulating care transition plans: A randomised study of trainees from five professional groups.

    Science.gov (United States)

    Farrell, Timothy W; Supiano, Katherine P; Wong, Bob; Luptak, Marilyn K; Luther, Brenda; Andersen, Troy C; Wilson, Rebecca; Wilby, Frances; Yang, Rumei; Pepper, Ginette A; Brunker, Cherie P

    2018-05-01

    Health professions trainees' performance in teams is rarely evaluated, but increasingly important as the healthcare delivery systems in which they will practice move towards team-based care. Effective management of care transitions is an important aspect of interprofessional teamwork. This mixed-methods study used a crossover design to randomise health professions trainees to work as individuals and as teams to formulate written care transition plans. Experienced external raters assessed the quality of the written care transition plans as well as both the quality of team process and overall team performance. Written care transition plan quality did not vary between individuals and teams (21.8 vs. 24.4, respectively, p = 0.42). The quality of team process did not correlate with the quality of the team-generated written care transition plans (r = -0.172, p = 0.659). However, there was a significant correlation between the quality of team process and overall team performance (r = 0.692, p = 0.039). Teams with highly engaged recorders, performing an internal team debrief, had higher-quality care transition plans. These results suggest that high-quality interprofessional care transition plans may require advance instruction as well as teamwork in finalising the plan.

  4. Collaborative care for depression in general practice: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Brinck-Claussen, Ursula Ødum; Curth, Nadja Kehler; Davidsen, Annette Sofie; Mikkelsen, John Hagel; Lau, Marianne Engelbrecht; Lundsteen, Merete; Csillag, Claudio; Christensen, Kaj Sparle; Hjorthøj, Carsten; Nordentoft, Merete; Eplov, Lene Falgaard

    2017-07-21

    Depression is a common illness with great human costs and a significant burden on the public economy. Previous studies have indicated that collaborative care (CC) has a positive effect on symptoms when provided to people with depression, but CC has not yet been applied in a Danish context. We therefore developed a model for CC (the Collabri model) to treat people with depression in general practice in Denmark. Since systematic identification of patients is an "active ingredient" in CC and some literature suggests case finding as the best alternative to standard detection, the two detection methods are examined as part of the study. The aim is to investigate if treatment according to the Collabri model has an effect on depression symptoms when provided to people with depression in general practice in Denmark, and to examine if case finding is a better method to detect depression in general practice than standard detection. The trial is a cluster-randomised, clinical superiority trial investigating the effect of treatment according to the Collabri model for CC, compared to treatment as usual for 480 participants diagnosed with depression in general practice in the Capital Region of Denmark. The primary outcome is depression symptoms (Beck's Depression Inventory (BDI-II)) after 6 months. Secondary outcomes include depression symptoms (BDI-II) after 15 months, anxiety symptoms (Beck's Anxiety Inventory (BAI)), level of functioning (Global Assessment of Function (GAF)) and psychological stress (Symptom Checklist-90-Revised (SCL-90-R)). In addition, case finding (with the recommended screening tool Major Depression Inventory (MDI)) and standard detection of depression is examined in a cluster-randomized controlled design. Here, the primary outcome is the positive predictive value of referral diagnosis. If the Collabri model is shown to be superior to treatment as usual, the study will contribute with important knowledge on how to improve treatment of depression in

  5. Multicentre randomised study of the effect and experience of an early inhome programme (PreHomeCare) for preterm infants using video consultation and smartphone applications compared with inhospital consultations

    DEFF Research Database (Denmark)

    Hägi-Pedersen, Mai-Britt; Norlyk, Annelise; Dessau, Ram B

    2017-01-01

    ) in Denmark. Parents of hospitalised premature infants who fulfil the inclusion criteria for PreHomeCare will be randomised during hospitalisation to either the intervention (n=80) or control group (n=80) using 1:1 block randomisation. During PreHomeCare, the intervention group will receive a smartphone...

  6. Organising health care services for people with an acquired brain injury: an overview of systematic reviews and randomised controlled trials.

    Science.gov (United States)

    Laver, Kate; Lannin, Natasha A; Bragge, Peter; Hunter, Peter; Holland, Anne E; Tavender, Emma; O'Connor, Denise; Khan, Fary; Teasell, Robert; Gruen, Russell

    2014-09-17

    Acquired brain injury (ABI) is the leading cause of disability worldwide yet there is little information regarding the most effective way to organise ABI health care services. The aim of this review was to identify the most up-to-date high quality evidence to answer specific questions regarding the organisation of health care services for people with an ABI. We conducted a systematic review of English papers using MEDLINE, EMBASE, PsycINFO, CINAHL and the Cochrane Library. We included the most recently published high quality systematic reviews and any randomised controlled trials, non-randomised controlled trials, controlled before after studies or interrupted time series studies published subsequent to the systematic review. We searched for papers that evaluated pre-defined organisational interventions for adults with an ABI. Organisational interventions of interest included fee-for-service care, integrated care, integrated care pathways, continuity of care, consumer engagement in governance and quality monitoring interventions. Data extraction and appraisal of included reviews and studies was completed independently by two reviewers. A total of five systematic reviews and 21 studies were included in the review; eight of the papers (31%) included people with a traumatic brain injury (TBI) or ABI and the remaining papers (69%) included only participants with a diagnosis of stroke. We found evidence supporting the use of integrated care to improve functional outcome and reduce length of stay and evidence supporting early supported discharge teams for reducing morbidity and mortality and reducing length of stay for stroke survivors. There was little evidence to support case management or the use of integrated care pathways for people with ABI. We found evidence that a quality monitoring intervention can lead to improvements in process outcomes in acute and rehabilitation settings. We were unable to find any studies meeting our inclusion criteria regarding fee

  7. 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

  8. 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

  9. Efficacy of 'Tailored Physical Activity' on reducing sickness absence among health care workers: A 3-months randomised controlled trial.

    Science.gov (United States)

    Andersen, Lotte Nygaard; Juul-Kristensen, Birgit; Roessler, Kirsten Kaya; Herborg, Lene Gram; Sørensen, Thomas Lund; Søgaard, Karen

    2015-10-01

    The aim was to evaluate efficacy of "Tailored Physical Activity" (TPA) versus a reference group (REF) in reducing the number of self-reported days of sickness absence for health care workers in the Sonderborg Municipality. In this randomised controlled trial, all participants (n = 54) received health guidance for 1.5 h and were randomised to TPA or REF. The primary aim was to make a comparison of participants' self-reported sickness absence due to musculoskeletal troubles measured three months after baseline. Secondary outcomes included anthropometric, health-related and physical capacity measures. A TPA intervention was not significantly more effective than REF in reducing sickness absence caused by musculoskeletal troubles. However, there were significant improvements for TPA participants compared to REF in reducing pain intensity from 47.9 mm to 21.8 mm (p health care workers since participants achieved a substantial effect on their experience of pain, on their work ability and on their fear of physical movement relating to pain. Moreover, a difference in aerobic capacity was apparent between the sample groups. TPA however, had no significant effect in reducing sickness absence days. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. 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.

  11. 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

  12. Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial.

    Science.gov (United States)

    Clark, Lucy V; Pesola, Francesca; Thomas, Janice M; Vergara-Williamson, Mario; Beynon, Michelle; White, Peter D

    2017-07-22

    Graded exercise therapy is an effective and safe treatment for chronic fatigue syndrome, but it is therapist intensive and availability is limited. We aimed to test the efficacy and safety of graded exercise delivered as guided self-help. In this pragmatic randomised controlled trial, we recruited adult patients (18 years and older) who met the UK National Institute for Health and Care Excellence criteria for chronic fatigue syndrome from two secondary-care clinics in the UK. Patients were randomly assigned to receive specialist medical care (SMC) alone (control group) or SMC with additional guided graded exercise self-help (GES). Block randomisation (randomly varying block sizes) was done at the level of the individual with a computer-generated sequence and was stratified by centre, depression score, and severity of physical disability. Patients and physiotherapists were necessarily unmasked from intervention assignment; the statistician was masked from intervention assignment. SMC was delivered by specialist doctors but was not standardised; GES consisted of a self-help booklet describing a six-step graded exercise programme that would take roughly 12 weeks to complete, and up to four guidance sessions with a physiotherapist over 8 weeks (maximum 90 min in total). Primary outcomes were fatigue (measured by the Chalder Fatigue Questionnaire) and physical function (assessed by the Short Form-36 physical function subscale); both were self-rated by patients at 12 weeks after randomisation and analysed in all randomised patients with outcome data at follow-up (ie, by modified intention to treat). We recorded adverse events, including serious adverse reactions to trial interventions. We used multiple linear regression analysis to compare SMC with GES, adjusting for baseline and stratification factors. This trial is registered at ISRCTN, number ISRCTN22975026. Between May 15, 2012, and Dec 24, 2014, we recruited 211 eligible patients, of whom 107 were assigned to the

  13. 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

  14. PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cameron, Jan; Rendell, Peter G; Ski, Chantal F; Kure, Christina E; McLennan, Skye N; Rose, Nathan S; Prior, David L; Thompson, David R

    2015-04-29

    Cognitive impairment is seen in up to three quarters of heart failure (HF) patients and has a significant negative impact on patients' health outcomes. Prospective memory, which is defined as memory to carry out future intentions, is important for functional independence in older adults and involves application of multiple cognitive processes that are often impaired in HF patients. The objective of this study is to examine the effects of prospective memory training on patients' engagement in HF self-care and health outcomes, carer strain and quality of life. The proposed study is a randomised, controlled trial in which 200 patients diagnosed with HF, and their carers will be recruited from 3 major hospitals across Melbourne. Eligible patients with HF will be randomised to receive either: 1) The Virtual Week Training Program - a computerised prospective memory (PM) training program (intervention) or 2) non-adaptive computer-based word puzzles (active control). HF patients' baseline cognitive function will be compared to a healthy control group (n = 60) living independently in the community. Patients will undergo a comprehensive assessment of PM, neuropsychological functioning, self-care, physical, and emotional functioning. Assessments will take place at baseline, 4 weeks and 12 months following intervention. Carers will complete measures assessing quality of life, strain, perceived control in the management of the patients' HF symptoms, and ratings of the patients' level of engagement in HF self-care behaviours. If the Virtual Week Training Program is effective in improving: 1) prospective memory; 2) self-care behaviours, and 3) wellbeing in HF patients, this study will enhance our understanding of impaired cognitive processes in HF and potentially is a mechanism to reduce healthcare costs. Australian New Zealand Clinical Trials Registry #366376; 27 May 2014. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366376&isClinicalTrial=False .

  15. Effectiveness of osteopathic manipulative treatment in neonatal intensive care units: protocol for a multicentre randomised clinical trial

    Science.gov (United States)

    Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; D'Incecco, Carmine; Fusilli, Paola; Perri, Paolo Francesco; Tubaldi, Lucia; Barlafante, Gina

    2013-01-01

    Introduction Neonatal care has been considered as one of the first priorities for improving quality of life in children. In 2010, 10% of babies were born prematurely influencing national healthcare policies, economic action plans and political decisions. The use of complementary medicine has been applied to the care of newborns. One previous study documented the positive effect of osteopathic manipulative treatment (OMT) in reducing newborns’ length of stay (LOS). Aim of this multicentre randomised controlled trial is to examine the association between OMT and LOS across three neonatal intensive care units (NICUs). Methods and analysis 690 preterm infants will be recruited from three secondary and tertiary NICUs from north and central Italy and allocated into two groups, using permuted-block randomisation. The two groups will receive standard medical care and OMT will be applied, twice a week, to the experimental group only. Outcome assessors will be blinded of study design and group allocation. The primary outcome is the mean difference in days between discharge and entry. Secondary outcomes are difference in daily weight gain, number of episodes of vomit, regurgitation, stooling, use of enema, time to full enteral feeding and NICU costs. Statistical analyses will take into account the intention-to-treat method. Missing data will be handled using last observation carried forward (LOCF) imputation technique. Ethics and dissemination Written informed consent will be obtained from parents or legal guardians at study enrolment. The trial has been approved by the ethical committee of Macerata hospital (n°22/int./CEI/27239) and it is under review by the other regional ethics committees. Results Dissemination of results from this trial will be through scientific medical journals and conferences. Trial registration This trial has been registered at http://www.clinicaltrials.org (identifier NCT01645137). PMID:23430598

  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. 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

  18. 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

  19. 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

  20. Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Nordgren Lise

    2012-02-01

    Full Text Available Abstract Background Internet-administered cognitive behavioural therapy (ICBT has been found to be effective for a range of anxiety disorders. However, most studies have focused on one specific primary diagnosis and co-morbidity has not been considered. In primary care settings, patients with anxiety often suffer from more than one psychiatric condition, making it difficult to disseminate ICBT for specific conditions. The aim of this study will be to investigate if ICBT tailored according to symptom profile can be a feasible treatment for primary care patients with anxiety disorders. It is a randomised controlled trial aimed to evaluate the treatment against an active control group. Methods Participants with anxiety disorders and co-morbid conditions (N = 128, will be recruited from a primary care population. The Clinical Outcome in Routine Evaluation (CORE-OM will serve as the primary outcome measure. Secondary measures include self-reported depression, anxiety, quality of life and loss of production and the use of health care. All assessments will be collected via the Internet and measure points will be baseline, post treatment and 12 months post treatment. Discussion This trial will add to the body of knowledge on the effectiveness of ICBT for anxiety disorders in primary care. The trial will also add knowledge on the long term effects of ICBT when delivered for regular clinic patients Trial Registration ClinicalTrials.gov: NCT01390168

  1. 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.

  2. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation : two year results of a randomised controlled trial

    NARCIS (Netherlands)

    Peul, W.C.; Hout, van den W.B.; Brand, R.; Thomeer, R.T.W.M.; Koes, B.W.

    2008-01-01

    Objectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica.

  3. Once a week not enough, twice a week not feasible? A randomised controlled exercise trial in long-term care facilities

    NARCIS (Netherlands)

    Chin A Paw, M.J.M.; M.N. Poppel, van; Twisk, J.W.; van Mechelen, W.

    2006-01-01

    Objective: To evaluate the effectiveness of three different training protocols on physical function of older adults living in long-term care facilities. Emphasis was placed on feasibility in real-life situations. Methods: Subjects (N = 224) were randomised to 6 months of twice weekly (1) resistance

  4. 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

  5. Cost-effectiveness of collaborative care including PST and an antidepressant treatment algorithm for the treatment of major depressive disorder in primary care; a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2007-03-01

    Full Text Available Abstract Background Depressive disorder is currently one of the most burdensome disorders worldwide. Evidence-based treatments for depressive disorder are already available, but these are used insufficiently, and with less positive results than possible. Earlier research in the USA has shown good results in the treatment of depressive disorder based on a collaborative care approach with Problem Solving Treatment and an antidepressant treatment algorithm, and research in the UK has also shown good results with Problem Solving Treatment. These treatment strategies may also work very well in the Netherlands too, even though health care systems differ between countries. Methods/design This study is a two-armed randomised clinical trial, with randomization on patient-level. The aim of the trial is to evaluate the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework, including contracting and adherence-improving strategies, combined with Problem Solving Treatment and antidepressant medication according to a treatment algorithm. Forty general practices will be randomised to either the intervention group or the control group. Included will be patients who are diagnosed with moderate to severe depression, based on DSM-IV criteria, and stratified according to comorbid chronic physical illness. Patients in the intervention group will receive treatment based on the collaborative care approach, and patients in the control group will receive care as usual. Baseline measurements and follow up measures (3, 6, 9 and 12 months are assessed using questionnaires and an interview. The primary outcome measure is severity of depressive symptoms, according to the PHQ9. Secondary outcome measures are remission as measured with the PHQ9 and the IDS-SR, and cost-effectiveness measured with the TiC-P, the EQ-5D and the SF-36. Discussion In this study, an American model to enhance care for patients with a

  6. Utilising advance care planning videos to empower perioperative cancer patients and families: a study protocol of a randomised controlled trial.

    Science.gov (United States)

    Aslakson, Rebecca A; Isenberg, Sarina R; Crossnohere, Norah L; Conca-Cheng, Alison M; Yang, Ting; Weiss, Matthew; Volandes, Angelo E; Bridges, John F P; Roter, Debra L

    2017-06-06

    Despite positive health outcomes associated with advance care planning (ACP), little research has investigated the impact of ACP in surgical populations. Our goal is to evaluate how an ACP intervention video impacts the patient centredness and ACP of the patient-surgeon conversation during the presurgical consent visit. We hypothesise that patients who view the intervention will engage in a more patient-centred communication with their surgeons compared with patients who view a control video. Randomised controlled superiority trial of an ACP video with two study arms (intervention ACP video and control video) and four visits (baseline, presurgical consent, postoperative 1 week and postoperative 1 month). Surgeons, patients, principal investigator and analysts are blinded to the randomisation assignment. Single, academic, inner city and tertiary care hospital. Data collection began July 16, 2015 and continues to March 2017. Patients recruited from nine surgical oncology clinics who are undergoing major cancer surgery. In the intervention arm, patients view a patient preparedness video developed through extensive engagement with patients, surgeons and other stakeholders. Patients randomised to the control arm viewed an informational video about the hospital surgical programme. Primary Outcome: Patient centredness and ACP of patient-surgeon conversations during the presurgical consent visit as measured through the Roter Interaction Analysis System. patient Hospital Anxiety and Depression Scale score; patient goals of care; patient, companion and surgeon satisfaction; video helpfulness; medical decision maker designation; and the frequency patients watch the video. Intent-to-treat analysis will be used to assess the impact of video assignment on outcomes. Sensitivity analyses will assess whether there are differential effects contingent on patient or surgeon characteristics. This study has been approved by the Johns Hopkins School of Medicine institutional review

  7. Comprehensive and subacute care interventions improve health-related quality of life for older patients after surgery for hip fracture: a randomised controlled trial.

    Science.gov (United States)

    Shyu, Yea-Ing L; Liang, Jersey; Tseng, Ming-Yueh; Li, Hsiao-Juan; Wu, Chi-Chuan; Cheng, Huey-Shinn; Chou, Shih-Wei; Chen, Ching-Yen; Yang, Ching-Tzu

    2013-08-01

    Elderly patients with hip fracture have been found to benefit from subacute care interventions that usually comprise usual care with added geriatric intervention, early rehabilitation, and supported discharge. However, no studies were found on the effects of combining subacute care and health-maintenance interventions on health outcomes for elders with hip fracture. To compare the effects of an interdisciplinary comprehensive care programme with those of subacute care and usual care programmes on health-related quality of life (HRQoL) for elderly patients with hip fracture. Randomised controlled trial. A 3000-bed medical centre in northern Taiwan. Patients with hip fracture (N=299) were randomised into three groups: subacute care (n=101), comprehensive care (n=99), and usual care (n=99). Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning. Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls. Usual care included only 1-2 in-hospital rehabilitation sessions, discharge planning without environmental assessment, no geriatric consultation, and no in-home rehabilitation. HRQoL was measured using the Medical Outcomes Study Short-Form 36 Taiwan version at 1, 3, 6, and 12 months after discharge. Participants in the comprehensive care group improved more in physical function, role physical, general health and mental health than those in the usual care group. The subacute care group had greater improvement in physical function, role physical, vitality, and social function than the usual care group. The intervention effects for both comprehensive and subacute care increased over time, specifically from 6 months after hip fracture onward, and reached a maximum at 12 months following discharge. Both comprehensive care and subacute care programmes may improve health outcomes of elders with hip fracture. Our results may provide a

  8. The effect of group-based exercise on cognitive performance and mood in seniors residing in intermediate care and self-care retirement facilities: a randomised controlled trial.

    Science.gov (United States)

    Brown, A K; Liu-Ambrose, T; Tate, R; Lord, S R

    2009-08-01

    To determine the effect of a general group-based exercise programme on cognitive performance and mood among seniors without dementia living in retirement villages. Randomised controlled trial. Four intermediate care and four self-care retirement village sites in Sydney, Australia. 154 seniors (19 men, 135 women; age range 62 to 95 years), who were residents of intermediate care and self-care retirement facilities. Participants were randomised to one of three experimental groups: (1) a general group-based exercise (GE) programme composed of resistance training and balance training exercises; (2) a flexibility exercise and relaxation technique (FR) programme; or (3) no-exercise control (NEC). The intervention groups (GE and FR) participated in 1-hour exercise classes twice a week for a total period of 6 months. Using standard neuropsychological tests, we assessed cognitive performance at baseline and at 6-month re-test in three domains: (1) fluid intelligence; (2) visual, verbal and working memory; and (3) executive functioning. We also assessed mood using the Geriatric Depression Scale (GDS) and the Positive and Negative Affect Schedule (PANAS). The GE programme significantly improved cognitive performance of fluid intelligence compared with FR or NEC. There were also significant improvements in the positive PANAS scale within both the GE and FR groups and an indication that the two exercise programmes reduced depression in those with initially high GDS scores. Our GE programme significantly improved cognitive performance of fluid intelligence in seniors residing in retirement villages compared with our FR programme and the NEC group. Furthermore, both group-based exercise programmes were beneficial for certain aspects of mood within the 6-month intervention period.

  9. 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

  10. Paediatric asthma outpatient care by asthma nurse, paediatrician or general practitioner: Randomised controlled trial with two-year follow-up

    OpenAIRE

    Kuethe, Maarten; Vaessen-Verberne, Anja; Mulder, Paul; Bindels, Patrick; Aalderen, Willem

    2011-01-01

    textabstractAims: For children with stable asthma, to test non-inferiority of care provided by a hospital-based specialised asthma nurse versus a general practitioner (GP) or paediatrician. Methods: Randomised controlled trial evaluating standard care by a GP, paediatrician or an asthma nurse, with two-year follow-up. Results: 107 children were recruited, 45 from general practice and 62 from hospital. After two years, no significant differences between groups were found for airway responsiven...

  11. Skin care education and individual counselling versus treatment as usual in healthcare workers with hand eczema: randomised clinical trial.

    Science.gov (United States)

    Ibler, Kristina Sophie; Jemec, Gregor B E; Diepgen, Thomas L; Gluud, Christian; Lindschou Hansen, Jane; Winkel, Per; Thomsen, Simon Francis; Agner, Tove

    2012-12-12

    To evaluate the effect of a secondary prevention programme with education on skin care and individual counselling versus treatment as usual in healthcare workers with hand eczema. Randomised, observer blinded parallel group superiority clinical trial. Three hospitals in Denmark. 255 healthcare workers with self reported hand eczema within the past year randomised centrally and stratified by profession, severity of eczema, and hospital. 123 were allocated to the intervention group and 132 to the control group. Education in skin care and individual counselling based on patch and prick testing and assessment of work and domestic related exposures. The control was treatment as usual. The primary outcome was clinical severity of disease at five month follow-up measured by scores on the hand eczema severity index. The secondary outcomes were scores on the dermatology life quality index, self evaluated severity of hand eczema, skin protective behaviours, and knowledge of hand eczema from onset to follow-up. Follow-up data were available for 247 of 255 participants (97%). At follow-up, the mean score on the hand eczema severity index was significantly lower (improved) in the intervention group than control group: difference of means, unadjusted -3.56 (95% confidence interval -4.92 to -2.14); adjusted -3.47 (-4.80 to -2.14), both Pgroup at follow-up: difference of means: unadjusted -0.78, non-parametric test P=0.003; adjusted -0.92, -1.48 to -0.37). Self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves were also statistically significantly better in the intervention group, whereas this was not the case for knowledge of hand eczema. A secondary prevention programme for hand eczema improved severity and quality of life and had a positive effect on self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves. ClinicalTrials.gov NCT01012453.

  12. 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

  13. Point of care testing for urinary tract infection in primary care (POETIC): protocol for a randomised controlled trial of the clinical and cost effectiveness of FLEXICULT™ informed management of uncomplicated UTI in primary care.

    Science.gov (United States)

    Bates, Janine; Thomas-Jones, Emma; Pickles, Timothy; Kirby, Nigel; Gal, Micaela; Bongard, Emily; Hood, Kerenza; Francis, Nicolas; Little, Paul; Moore, Michael; Rumsby, Kate; Llor, Carlos; Burgman, Curt; Verheij, Theo; Cohen, David; Wootton, Mandy; Howe, Robin; Butler, Christopher C

    2014-11-25

    Urinary tract infections (UTI) are the most frequent bacterial infection affecting women and account for about 15% of antibiotics prescribed in primary care. However, some women with a UTI are not prescribed antibiotics or are prescribed the wrong antibiotics, while many women who do not have a microbiologically confirmed UTI are prescribed antibiotics. Inappropriate antibiotic prescribing unnecessarily increases the risk of side effects and the development of antibiotic resistance, and wastes resources. 614 adult female patients will be recruited from four primary care research networks (Wales, England, Spain, the Netherlands) and individually randomised to either POCT guided care or the guideline-informed 'standard care' arm. Urine and stool samples (where possible) will be obtained at presentation (day 1) and two weeks later for microbiological analysis. All participants will be followed up on the course of their illness and their quality of life, using a 2 week self-completed symptom diary. At 3 months, a primary care notes review will be conducted for evidence of further evidence of treatment failures, recurrence, complications, hospitalisations and health service costs. Although the Flexicult™ POCT is used in some countries in routine primary care, it's clinical and cost effectiveness has never been evaluated in a randomised clinical trial. If shown to be effective, the use of this POCT could benefit individual sufferers and provide evidence for health care authorities to develop evidence based policies to combat the spread and impact of the unprecedented rise of infections caused by antibiotic resistant bacteria in Europe. ISRCTN65200697 (Registered 10 September 2013).

  14. Tailored educational supportive care programme on sleep quality and psychological distress in patients with heart failure: A randomised controlled trial.

    Science.gov (United States)

    Chang, Yia-Ling; Chiou, Ai-Fu; Cheng, Shu-Meng; Lin, Kuan-Chia

    2016-09-01

    Up to 74% of patients with heart failure report poor sleep in Taiwan. Poor symptom management or sleep hygiene may affect patients' sleep quality. An effective educational programme was important to improve patients' sleep quality and psychological distress. However, research related to sleep disturbance in patients with heart failure is limited in Taiwan. To examine the effects of a tailored educational supportive care programme on sleep disturbance and psychological distress in patients with heart failure. randomised controlled trial. Eighty-four patients with heart failure were recruited from an outpatient department of a medical centre in Taipei, Taiwan. Patients were randomly assigned to the intervention group (n=43) or the control group (n=41). Patients in the intervention group received a 12-week tailored educational supportive care programme including individualised education on sleep hygiene, self-care, emotional support through a monthly nursing visit at home, and telephone follow-up counselling every 2 weeks. The control group received routine nursing care. Data were collected at baseline, the 4th, 8th, and 12th weeks after patients' enrollment. Outcome measures included sleep quality, daytime sleepiness, anxiety, and depression. The intervention group exhibited significant improvement in the level of sleep quality and daytime sleepiness after 12 weeks of the supportive nursing care programme, whereas the control group exhibited no significant differences. Anxiety and depression scores were increased significantly in the control group at the 12th week (p.05). Compared with the control group, the intervention group had significantly greater improvement in sleep quality (β=-2.22, pquality and psychological distress in patients with heart failure. We suggested that this supportive nursing care programme should be applied to clinical practice in cardiovascular nursing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  15. Interdisciplinary model of care (RADICALS) for early detection and management of chronic obstructive pulmonary disease (COPD) in Australian primary care: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Liang, Jenifer; Abramson, Michael J; Zwar, Nicholas; Russell, Grant; Holland, Anne E; Bonevski, Billie; Mahal, Ajay; Hecke, Benjamin van; Phillips, Kirsten; Eustace, Paula; Paul, Eldho; Petrie, Kate; Wilson, Sally; George, Johnson

    2017-09-18

    Up to half of all smokers develop clinically significant chronic obstructive pulmonary disease (COPD). Gaps exist in the implementation and uptake of evidence-based guidelines for managing COPD in primary care. We describe the methodology of a cluster randomised controlled trial (cRCT) evaluating the efficacy and cost-effectiveness of an interdisciplinary model of care aimed at reducing the burden of smoking and COPD in Australian primary care settings. A cRCT is being undertaken to evaluate an interdisciplinary model of care (RADICALS - Review of Airway Dysfunction and Interdisciplinary Community-based care of Adult Long-term Smokers). General practice clinics across Melbourne, Australia, are identified and randomised to the intervention group (RADICALS) or usual care. Patients who are current or ex-smokers, of at least 10 pack years, including those with an existing diagnosis of COPD, are being recruited to identify 280 participants with a spirometry-confirmed diagnosis of COPD. Handheld lung function devices are being used to facilitate case-finding. RADICALS includes individualised smoking cessation support, home-based pulmonary rehabilitation and home medicines review. Patients at control group sites receive usual care and Quitline referral, as appropriate. Follow-ups occur at 6 and 12 months from baseline to assess changes in quality of life, abstinence rates, health resource utilisation, symptom severity and lung function. The primary outcome is change in St George's Respiratory Questionnaire score of patients with COPD at 6 months from baseline. This project has been approved by the Monash University Human Research Ethics Committee and La Trobe University Human Ethics Committee (CF14/1018 - 2014000433). Results of the study will be disseminated in peer-reviewed journals and research conferences. If the intervention is successful, the RADICALS programme could potentially be integrated into general practices across Australia and sustained over time. ACTRN

  16. 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

  17. Using the 'Social Marketing Mix Framework' to explore recruitment barriers and facilitators in palliative care randomised controlled trials? A narrative synthesis review.

    Science.gov (United States)

    Dunleavy, Lesley; Walshe, Catherine; Oriani, Anna; Preston, Nancy

    2018-05-01

    Effective recruitment to randomised controlled trials is critically important for a robust, trustworthy evidence base in palliative care. Many trials fail to achieve recruitment targets, but the reasons for this are poorly understood. Understanding barriers and facilitators is a critical step in designing optimal recruitment strategies. To identify, explore and synthesise knowledge about recruitment barriers and facilitators in palliative care trials using the '6 Ps' of the 'Social Marketing Mix Framework'. A systematic review with narrative synthesis. Medline, CINAHL, PsycINFO and Embase databases (from January 1990 to early October 2016) were searched. Papers included the following: interventional and qualitative studies addressing recruitment, palliative care randomised controlled trial papers or reports containing narrative observations about the barriers, facilitators or strategies to increase recruitment. A total of 48 papers met the inclusion criteria. Uninterested participants (Product), burden of illness (Price) and 'identifying eligible participants' were barriers. Careful messaging and the use of scripts/role play (Promotion) were recommended. The need for intensive resources and gatekeeping by professionals were barriers while having research staff on-site and lead clinician support (Working with Partners) was advocated. Most evidence is based on researchers' own reports of experiences of recruiting to trials rather than independent evaluation. The 'Social Marketing Mix Framework' can help guide researchers when planning and implementing their recruitment strategy but suggested strategies need to be tested within embedded clinical trials. The findings of this review are applicable to all palliative care research and not just randomised controlled trials.

  18. 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.

  19. Clinician-led improvement in cancer care (CLICC) - testing a multifaceted implementation strategy to increase evidence-based prostate cancer care: phased randomised controlled trial - study protocol

    Science.gov (United States)

    2014-01-01

    Background Clinical practice guidelines have been widely developed and disseminated with the aim of improving healthcare processes and patient outcomes but the uptake of evidence-based practice remains haphazard. There is a need to develop effective implementation methods to achieve large-scale adoption of proven innovations and recommended care. Clinical networks are increasingly being viewed as a vehicle through which evidence-based care can be embedded into healthcare systems using a collegial approach to agree on and implement a range of strategies within hospitals. In Australia, the provision of evidence-based care for men with prostate cancer has been identified as a high priority. Clinical audits have shown that fewer than 10% of patients in New South Wales (NSW) Australia at high risk of recurrence after radical prostatectomy receive guideline recommended radiation treatment following surgery. This trial will test a clinical network-based intervention to improve uptake of guideline recommended care for men with high-risk prostate cancer. Methods/Design In Phase I, a phased randomised cluster trial will test a multifaceted intervention that harnesses the NSW Agency for Clinical Innovation (ACI) Urology Clinical Network to increase evidence-based care for men with high-risk prostate cancer following surgery. The intervention will be introduced in nine NSW hospitals over 10 months using a stepped wedge design. Outcome data (referral to radiation oncology for discussion of adjuvant radiotherapy in line with guideline recommended care or referral to a clinical trial of adjuvant versus salvage radiotherapy) will be collected through review of patient medical records. In Phase II, mixed methods will be used to identify mechanisms of provider and organisational change. Clinicians’ knowledge and attitudes will be assessed through surveys. Process outcome measures will be assessed through document review. Semi-structured interviews will be conducted to elucidate

  20. 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

  1. The effect of blinding on estimates of mortality in randomised clinical trials of intensive care interventions

    DEFF Research Database (Denmark)

    Anthon, Carl Thomas; Granholm, Anders; Perner, Anders

    2017-01-01

    INTRODUCTION: Evidence exists that unblinded randomised clinical trials (RCTs) overestimate intervention effects compared with blinded RCTs. It has been suggested that this is less pronounced for objective (ie, not subject to interpretation) outcome measures, including mortality. This may not apply......(s). For each intervention, we will compare summary mortality effect estimates in blinded versus unblinded trials. ETHICS AND DISSEMINATION: This research does not require ethical approval as we will use summary data from trials already approved by relevant ethical institutions. We will report the results...... in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) statement and submit the final paper to an international peer-reviewed journal. TRIAL REGISTRATION NUMBER: PROSPERO, registration number: CRD42017056212....

  2. Evaluation of a blood conservation strategy in the intensive care unit: a prospective, randomised study.

    LENUS (Irish Health Repository)

    Mahdy, Saad

    2009-06-01

    Anemia is a common problem in the ICU population. Most patients are anemic at admission, their hemoglobin concentrations declining further thereafter. The aim of the present study was to evaluate the effect of a combination strategy, involving closed arterial blood gas sampling and the use of pediatric vials for phlebotomy (Group A), on the sampling-induced blood loss and the rate of decline in hemoglobin in adult ICU patients. Combination (Group A) was compared to the current standard technique of arterial line sampling and adult vial phlebotomy (Group B) in a prospective, randomised, ethically-approved trial for the first 72 hours of their ICU stay. Peri-operative, oncology, coagulopathic and uremic patients were excluded. All other ICU patients with arterial cannulae and predicted to stay beyond 3 days, were enrolled.

  3. The effectiveness of birth plans in increasing use of skilled care at delivery and postnatal care in rural Tanzania: a cluster randomised trial.

    Science.gov (United States)

    Magoma, Moke; Requejo, Jennifer; Campbell, Oona; Cousens, Simon; Merialdi, Mario; Filippi, Veronique

    2013-04-01

    To determine the effectiveness of birth plans in increasing use of skilled care at delivery and in the postnatal period among antenatal care (ANC) attendees in a rural district with low occupancy of health units for delivery but high antenatal care uptake in northern Tanzania. Cluster randomised trial in Ngorongoro district, Arusha region, involving 16 health units (8 per arm). Nine hundred and five pregnant women at 24 weeks of gestation and above (404 in the intervention arm) were recruited and followed up to at least 1 month postpartum. Skilled delivery care uptake was 16.8% higher in the intervention units than in the control [95% CI 2.6-31.0; P = 0.02]. Postnatal care utilisation in the first month of delivery was higher (difference in proportions: 30.0% [95% CI 1.3-47.7; P < 0.01]) and also initiated earlier (mean duration 6.6 ± 1.7 days vs. 20.9 ± 4.4 days, P < 0.01) in the intervention than in the control arm. Women's and providers' reports of care satisfaction (received or provided) did not differ greatly between the two arms of the study (difference in proportion: 12.1% [95% CI -6.3-30.5] P = 0.17 and 6.9% [95% CI -3.2-17.1] P = 0.15, respectively). Implementation of birth plans during ANC can increase the uptake of skilled delivery and post delivery care in the study district without negatively affecting women's and providers' satisfaction with available ANC services. Birth plans should be considered along with the range of other recommended interventions as a strategy to improve the uptake of maternal health services. © 2013 Blackwell Publishing Ltd.

  4. Multistrategy childcare-based intervention to improve compliance with nutrition guidelines versus usual care in long day care services: a study protocol for a randomised controlled trial

    Science.gov (United States)

    Seward, Kirsty; Finch, Meghan; Wiggers, John; Wyse, Rebecca; Jones, Jannah; Gillham, Karen; Yoong, Sze Lin

    2016-01-01

    Introduction Interventions to improve child diet are recommended as dietary patterns developed in childhood track into adulthood and influence the risk of chronic disease. For child health, childcare services are required to provide foods to children consistent with nutrition guidelines. Research suggests that foods and beverages provided by services to children are often inconsistent with nutrition guidelines. The primary aim of this study is to assess, relative to a usual care control group, the effectiveness of a multistrategy childcare-based intervention in improving compliance with nutrition guidelines in long day care services. Methods and analysis The study will employ a parallel group randomised controlled trial design. A sample of 58 long day care services that provide all meals (typically includes 1 main and 2 mid-meals) to children while they are in care, in the Hunter New England region of New South Wales, Australia, will be randomly allocated to a 6-month intervention to support implementation of nutrition guidelines or a usual care control group in a 1:1 ratio. The intervention was designed to overcome barriers to the implementation of nutrition guidelines assessed using the theoretical domains framework. Intervention strategies will include the provision of staff training and resources, audit and feedback, ongoing support and securing executive support. The primary outcome of the trial will be the change in the proportion of long day care services that have a 2-week menu compliant with childcare nutrition guidelines, measured by comprehensive menu assessments. As a secondary outcome, child dietary intake while in care will also be assessed. To assess the effectiveness of the intervention, the measures will be undertaken at baseline and ∼6 months postbaseline. Ethics and dissemination The study was approved by the Hunter New England Human Research Ethics Committee. Study findings will be disseminated widely through peer-reviewed publications. PMID

  5. Brief Cognitive Behavioural Therapy compared to optimised general practitioners’ care for depression : A randomised trial

    NARCIS (Netherlands)

    Schene, A.H.; Baas, K.D.; Koeter, M.W.J.; Lucassen, P.; Bockting, C.L.H.; Wittkampf, K.A.; Huyser, J.; van Weert, H.C.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and

  6. Brief Cognitive Behavioural Therapy Compared to Optimised General Practitioners? Care for Depression: A Randomised Trial

    NARCIS (Netherlands)

    Schene, A. H.; Baas, K. D.; Koeter, M.; Lucassen, P.; Bockting, C. L. H.|info:eu-repo/dai/nl/258267992; Wittkampf, K. F.; van Weert, H. C.; Huyser, J.

    2014-01-01

    Background: How to treat Major Depressive Disorder (MDD) in primary care? Studies that compared (brief) Cognitive Behavioural Therapy (CBT) with care as usual by the General Practitioner (GP) found the first to be more effective. However, to make a fair comparison GP care should be optimised and

  7. Somatisation in primary care: experiences of primary care physicians involved in a training program and in a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Salazar Agustín

    2009-11-01

    Full Text Available Abstract Background A new intervention aimed at managing patients with medically unexplained symptoms (MUS based on a specific set of communication techniques was developed, and tested in a cluster randomised clinical trial. Due to the modest results obtained and in order to improve our intervention we need to know the GPs' attitudes towards patients with MUS, their experience, expectations and the utility of the communication techniques we proposed and the feasibility of implementing them. Physicians who took part in 2 different training programs and in a randomised controlled trial (RCT for patients with MUS were questioned to ascertain the reasons for the doctors' participation in the trial and the attitudes, experiences and expectations of GPs about the intervention. Methods A qualitative study based on four focus groups with GPs who took part in a RCT. A content analysis was carried out. Results Following the RCT patients are perceived as true suffering persons, and the relationship with them has improved in GPs of both groups. GPs mostly valued the fact that it is highly structured, that it made possible a more comfortable relationship and that it could be applied to a broad spectrum of patients with psychosocial problems. Nevertheless, all participants consider that change in patients is necessary; GPs in the intervention group remarked that that is extremely difficult to achieve. Conclusion GPs positively evaluate the communication techniques and the interventions that help in understanding patient suffering, and express the enormous difficulties in handling change in patients. These findings provide information on the direction in which efforts for improving intervention should be directed. Trial registration US ClinicalTrials.gov NCT00130988

  8. Study protocol for the Flooring for Injury Prevention (FLIP) Study: a randomised controlled trial in long-term care.

    Science.gov (United States)

    Lachance, Chantelle C; Feldman, Fabio; Laing, Andrew C; Leung, Pet Ming; Robinovitch, Stephen N; Mackey, Dawn C

    2016-12-01

    A promising strategy for reducing the incidence and severity of fall-related injuries in long-term care (LTC) is to decrease the ground surface stiffness, and the subsequent forces applied to the body parts at impact, through installation of compliant flooring that does not substantially affect balance or mobility. Definitive evidence of the effects of compliant flooring on fall-related injuries in LTC is lacking. The Flooring for Injury Prevention (FLIP) Study is designed to address this gap. The FLIP Study is a 4-year, parallel-group, 2-arm, randomised controlled superiority trial of flooring in 150 resident rooms at a LTC site. The primary objective is to determine whether compliant flooring reduces serious fall-related injuries relative to control flooring. Intervention (2.54 cm SmartCells compliant; 74 rooms) and control (2.54 cm plywood; 76 rooms) floorings were installed over the top of existing concrete floors and covered with identical 2.00 mm vinyl. The primary outcome is serious fall-related injury, defined as any impact-related injury due to a fall in a study room that results in Emergency Department visit or hospital admission. Secondary outcomes include minor fall-related injury, any fall-related injury, falls, number of fallers, fractures, and healthcare utilisation and costs for serious fall-related injuries. Randomisation of study rooms, and residents in rooms, was stratified by residential unit, and flooring assignments were concealed. Outcome ascertainment began September 2013. Results from the FLIP Study will provide evidence about the effects of compliant flooring on fall-related injuries in LTC and will guide development of safer environments for vulnerable older adults. NCT01618786. 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/.

  9. Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial.

    Directory of Open Access Journals (Sweden)

    Kim S Thomas

    2017-04-01

    Full Text Available The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care for the management of eczema in children with moderate to severe disease.This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1 to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI, which was log-transformed for analysis (intention-to-treat analysis. A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015: 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94% children (n = 141 in each group. The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]. Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43. This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25% and 39/141 (28% of children in the silk clothing and standard care groups

  10. Clinical and cost-effectiveness of computerised cognitive behavioural therapy for depression in primary care: Design of a randomised trial

    Directory of Open Access Journals (Sweden)

    Severens Johan L

    2008-06-01

    Full Text Available Abstract Background Major depression is a common mental health problem in the general population, associated with a substantial impact on quality of life and societal costs. However, many depressed patients in primary care do not receive the care they need. Reason for this is that pharmacotherapy is only effective in severely depressed patients and psychological treatments in primary care are scarce and costly. A more feasible treatment in primary care might be computerised cognitive behavioural therapy. This can be a self-help computer program based on the principles of cognitive behavioural therapy. Although previous studies suggest that computerised cognitive behavioural therapy is effective, more research is necessary. Therefore, the objective of the current study is to evaluate the (cost- effectiveness of online computerised cognitive behavioural therapy for depression in primary care. Methods/Design In a randomised trial we will compare (a computerised cognitive behavioural therapy with (b treatment as usual by a GP, and (c computerised cognitive behavioural therapy in combination with usual GP care. Three hundred mild to moderately depressed patients (aged 18–65 will be recruited in the general population by means of a large-scale Internet-based screening (N = 200,000. Patients will be randomly allocated to one of the three treatment groups. Primary outcome measure of the clinical evaluation is the severity of depression. Other outcomes include psychological distress, social functioning, and dysfunctional beliefs. The economic evaluation will be performed from a societal perspective, in which all costs will be related to clinical effectiveness and health-related quality of life. All outcome assessments will take place on the Internet at baseline, two, three, six, nine, and twelve months. Costs are measured on a monthly basis. A time horizon of one year will be used without long-term extrapolation of either costs or quality of life

  11. Randomised active programs on healthcare workers' flu vaccination in geriatric health care settings in France: the VESTA study.

    Science.gov (United States)

    Rothan-Tondeur, M; Filali-Zegzouti, Y; Golmard, J-L; De Wazieres, B; Piette, F; Carrat, F; Lejeune, B; Gavazzi, G

    2011-02-01

    Because of a lack of efficacy of influenza vaccination in elderly population, there are still numerous outbreaks in geriatric health care settings. The health care workers (HCW) flu vaccination is known to get herd immunity and decrease the impact of influenza in elderly population living in geriatric health care settings. However, the rates of vaccinated HCWs are still low in France. The French Geriatric Infection Risk Institute (ORIG) performed the VESTA study, a three-phase multicentre to identify factors limiting vaccination in HCWs, and to develop and implement active programs promoting HCWs influenza vaccination. To implement multicenter programs to enhance HCW influenza vaccination. It was a cluster randomised interventional studies. 43 geriatric health care settings (GHCSs), long term care and rehabilitation care settings in France. 1814 Health care workers from 20 GHCSs in the interventional group and 2,435 health care workers in 23 GHCSs in the control group. After the failure of a first educational program giving scientific information and. tested during the 2005-06 flu season in 43 HCSs, a second program was designed with the help of marketing experts, one year after Program 1. The objectives were to involve HCWs in the creation of "safety zones", and to give personal satisfaction. Program 2 was tested during the 2006-07 season. 20 of the 24 HCSs from the Program 1 cluster were included in the Program 2 cluster (1,814 HCWs), and 16 of the 19 HCSs from the Control 1 cluster, plus 7 new HCSs with interest in participating, were included in the Control 2 cluster (23 HCSs; 2,435 HCWs). The efficacy of each program was assessed by calculating and comparing the percentage of vaccinated HCWs, from all HCSs taken together, in the program and control clusters. Program 1 failed to increase the HCW vaccination coverage rate (VCR) (Program 1: 34%; Control 1: 32%; p > 0.05),). Program 2 increased the VCR in HCWs (Program 2: 44%; Control 2: 27%; Chi2 test, p active

  12. Randomised controlled trial of tailored interventions to improve the management of anxiety and depressive disorders in primary care

    Directory of Open Access Journals (Sweden)

    Terluin Berend

    2011-07-01

    Full Text Available Abstract Background Anxiety and depressive disorders are highly prevalent disorders and are mostly treated in primary care. The management of these disorders by general practitioners is not always consistent with prevailing guidelines because of a variety of factors. Designing implementation strategies tailored to prospectively identified barriers could lead to more guideline-recommended care. Although tailoring of implementation strategies is promoted in practice, little is known about the effect on improving the quality of care for the early recognition, diagnosis, and stepped care treatment allocation in patients with anxiety or depressive disorders in general practice. This study examines whether the tailored strategy supplemented with training and feedback is more effective than providing training and feedback alone. Methods In this cluster randomised controlled trial, a total of 22 general practices will be assigned to one of two conditions: (1 training, feedback, and tailored interventions and (2 training and feedback. The primary outcome measure is the proportion of patients who have been recognised to have anxiety and/or depressive disorder. The secondary outcome measures in patients are severity of anxiety and depressive symptoms, level of functioning, expectation towards and experience with care, quality of life, and economic costs. Measures are taken after the start of the intervention at baseline and at three- and six-month follow-ups. Secondary outcome measures in general practitioners are adherence to guideline-recommended care in care that has been delivered, the proportion of antidepressant prescriptions, and number of referrals to specialised mental healthcare facilities. Data will be gathered from the electronic medical patient records from the patients included in the study. In a process evaluation, the identification of barriers to change and the relations between prospectively identified barriers and improvement

  13. Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial.

    Science.gov (United States)

    Chatterjee, Sudipto; Leese, Morven; Koschorke, Mirja; McCrone, Paul; Naik, Smita; John, Sujit; Dabholkar, Hamid; Goldsmith, Kimberley; Balaji, Madhumitha; Varghese, Mathew; Thara, Rangaswamy; Patel, Vikram; Thornicroft, Graham

    2011-01-13

    There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR), involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC) intervention, combined with usual Facility Based Care (FBC), is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. This trial is a multi-site, parallel group randomised controlled trial design in India.The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs) working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. The trial is registered with the International Society for the Registration of Clinical Trials and the allocated unique ID number is ISRCTN

  14. Collaborative community based care for people and their families living with schizophrenia in India: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Dabholkar Hamid

    2011-01-01

    Full Text Available Abstract Background There is a large treatment gap with few community services for people with schizophrenia in low income countries largely due to the shortage of specialist mental healthcare human resources. Community based rehabilitation (CBR, involving lay health workers, has been shown to be feasible, acceptable and more effective than routine care for people with schizophrenia in observational studies. The aim of this study is to evaluate whether a lay health worker led, Collaborative Community Based Care (CCBC intervention, combined with usual Facility Based Care (FBC, is superior to FBC alone in improving outcomes for people with schizophrenia and their caregivers in India. Methods/Design This trial is a multi-site, parallel group randomised controlled trial design in India. The trial will be conducted concurrently at three sites in India where persons with schizophrenia will be screened for eligibility and recruited after providing informed consent. Trial participants will be randomly allocated in a 2:1 ratio to the CCBC+FBC and FBC arms respectively using an allocation sequence pre-prepared through the use of permuted blocks, stratified within site. The structured CCBC intervention will be delivered by trained lay community health workers (CHWs working together with the treating Psychiatrist. We aim to recruit 282 persons with schizophrenia. The primary outcomes are reduction in severity of symptoms of schizophrenia and disability at 12 months. The study will be conducted according to good ethical practice, data analysis and reporting guidelines. Discussion If the additional CCBC intervention delivered by front line CHWs is demonstrated to be effective and cost-effective in comparison to usually available care, this intervention can be scaled up to expand coverage and improve outcomes for persons with schizophrenia and their caregivers in low income countries. Trial registration The trial is registered with the International Society

  15. SCORE: Shared care of Colorectal cancer survivors: protocol for a randomised controlled trial

    OpenAIRE

    Jefford, Michael; Emery, Jon; Grunfeld, Eva; Martin, Andrew; Rodger, Paula; Murray, Alexandra M.; De Abreu Lourenco, Richard; Heriot, Alexander; Phipps-Nelson, Jo; Guccione, Lisa; King, Dorothy; Lisy, Karolina; Tebbutt, Niall; Burgess, Adele; Faragher, Ian

    2017-01-01

    Background Colorectal cancer (CRC) is the most common cancer affecting both men and women. Survivors of CRC often experience various physical and psychological effects arising from CRC and its treatment. These effects may last for many years and adversely affect QoL, and they may not be adequately addressed by standard specialist-based follow-up. Optimal management of these effects should harness the expertise of both primary care and specialist care. Shared models of care (involving both the...

  16. Stepped care for depression and anxiety in visually impaired older adults: multicentre randomised controlled trial

    NARCIS (Netherlands)

    van der Aa, H.P.A.; van Rens, G.H.M.B.; Comijs, H.C.; Margrain, T.H.; Galindo Garre, F.; Twisk, J.W.R.; van Nispen, R.M.A.

    2015-01-01

    Study question Is stepped care compared with usual care effective in preventing the onset of major depressive, dysthymic, and anxiety disorders in older people with visual impairment (caused mainly by age related eye disease) and subthreshold depression and/or anxiety? Methods 265 people aged ?50

  17. Advance care planning - a multi-centre cluster randomised clinical trial

    DEFF Research Database (Denmark)

    Rietjens, Judith A C; Korfage, Ida J; Dunleavy, Lesley

    2016-01-01

    patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control......BACKGROUND: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between...... Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. DISCUSSION: Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part...

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

    Directory of Open Access Journals (Sweden)

    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

  19. No firm evidence that lack of blinding affects estimates of mortality in randomised clinical trials of intensive care interventions: a systematic review and meta-analysis.

    Science.gov (United States)

    Anthon, Carl Thomas; Granholm, Anders; Perner, Anders; Laake, Jon Henrik; Møller, Morten Hylander

    2018-04-26

    To evaluate the effect of blinding on mortality effect estimates in randomised clinical trials (RCTs) in adult intensive care unit (ICU) patients. A systematic review and meta-analysis of RCTs reporting mortality effect estimates of ICU interventions in adult ICU patients. We assessed differences in summarised risk ratios (RRs) with 95% confidence intervals (CIs) between blinded and unblinded RCTs. P firm evidence that lack of blinding affects estimates of mortality in RCTs of ICU interventions. Copyright © 2018. Published by Elsevier Inc.

  20. Person-centred care after acute coronary syndrome, from hospital to primary care - A randomised controlled trial.

    Science.gov (United States)

    Fors, Andreas; Ekman, Inger; Taft, Charles; Björkelund, Cecilia; Frid, Kerstin; Larsson, Maria Eh; Thorn, Jörgen; Ulin, Kerstin; Wolf, Axel; Swedberg, Karl

    2015-01-01

    To evaluate if person-centred care can improve self-efficacy and facilitate return to work or prior activity level in patients after an event of acute coronary syndrome. 199 patients with acute coronary syndrome < 75 years were randomly assigned to person-centred care intervention or treatment as usual and followed for 6 months. In the intervention group a person-centred care process was added to treatment as usual, emphasising the patient as a partner in care. Care was co-created in collaboration between patients, physicians, registered nurses and other health care professionals and documented in a health plan. A team-based partnership across three health care levels included transparent knowledge about the disease and medical state to achieve agreed goals during recovery. Main outcome measure was a composite score of changes in general self-efficacy ≥ 5 units, return to work or prior activity level and re-hospitalisation or death. The composite score showed that more patients (22.3%, n=21) improved in the intervention group at 6 months compared to the control group (9.5%, n=10) (odds ratio, 2.7; 95% confidence interval: 1.2-6.2; P=0.015). The effect was driven by improved self-efficacy ≥ 5 units in the intervention group. Overall general self-efficacy improved significantly more in the intervention group compared with the control group (P=0.026). There was no difference between groups on re-hospitalisation or death, return to work or prior activity level. A person-centred care approach emphasising the partnership between patients and health care professionals throughout the care chain improves general self-efficacy without causing worsening clinical events. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  1. 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

  2. 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.

  3. Enoxaparin, effective dosage for intensive care patients: double-blinded, randomised clinical trial

    DEFF Research Database (Denmark)

    Robinson, Sian; Zincuk, Aleksander; Strøm, Thomas

    2010-01-01

    ABSTRACT: INTRODUCTION: Intensive care unit (ICU) patients are predisposed to thromboembolism. Routine prophylactic anticoagulation is widely recommended. Low-molecular-weight heparins, such as enoxaparin, are increasingly used because of predictable pharmacokinetics. This study aims to determine...

  4. Evaluation of a blood conservation strategy in the intensive care unit: a prospective, randomised study.

    LENUS (Irish Health Repository)

    Mahdy, Saad

    2012-02-01

    OBJECTIVE AND METHODS: Anemia is a common problem in the ICU population. Most patients are anemic at admission, their hemoglobin concentrations declining further thereafter. The aim of the present study was to evaluate the effect of a combination strategy, involving closed arterial blood gas sampling and the use of pediatric vials for phlebotomy (Group A), on the sampling-induced blood loss and the rate of decline in hemoglobin in adult ICU patients. Combination (Group A) was compared to the current standard technique of arterial line sampling and adult vial phlebotomy (Group B) in a prospective, randomised, ethically-approved trial for the first 72 hours of their ICU stay. Peri-operative, oncology, coagulopathic and uremic patients were excluded. All other ICU patients with arterial cannulae and predicted to stay beyond 3 days, were enrolled. RESULTS: 39 patients entered the study, 20 in Group A, and 19 in Group B. Data collection was complete for all. There was a statistically significant difference in sampling-induced blood loss between the groups over the first 72 hours of treatment (mean +\\/- standard deviation: 15.16 +\\/- 5.3 ml Group A vs 45.11 +\\/- 14 ml Group B, p<0.001). There was a smaller decline in mean hemoglobin level, which was not statistically significant (0.79 +\\/- 0.6 g\\/dL vs 1.30 +\\/- 1.13, p = 0.09). CONCLUSIONS: Overall, this strategy reduced measurable blood losses from phlebotomy. In larger trials it might also preserve hemoglobin levels.

  5. 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

  6. 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

  7. Impact of improved recording of work-relatedness in primary care visits at occupational health services on sickness absences: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Atkins, Salla; Ojajärvi, Ulla; Talola, Nina; Viljamaa, Mervi; Nevalainen, Jaakko; Uitti, Jukka

    2017-07-26

    Employment protects and fosters health. Occupational health services, particularly in Finland, have a central role in protecting employee health and preventing work ability problems. However, primary care within occupational health services is currently underused in informing preventive activities. This study was designed to assess whether the recording of work ability problems and improvement of follow-up of work-related primary care visits can reduce sickness absences and work disability pensions after 1 year. A pragmatic trial will be conducted using patient electronic registers and registers of the central pensions agency in Finland. Twenty-two occupational health centres will be randomised to intervention and control groups. Intervention units will receive training to improve recording of work ability illnesses in the primary care setting and improved follow-up procedures. The intervention impact will be assessed through examining rates of sickness absence across intervention and control clinics as well as before and after the intervention. The trial will develop knowledge of the intervention potential of primary care for preventing work disability pensions and sickness absence. The use of routine patient registers and pensions registers to assess the outcomes of a randomised controlled trial will bring forward trial methodology, particularly when using register-based data. If successful, the intervention will improve the quality of occupational health care primary care and contribute to reducing work disability. ISRCTN Registry reference number ISRCTN45728263 . Registered on 18 April 2016.

  8. Pilot randomised controlled trial of the ENGAGER collaborative care intervention for prisoners with common mental health problems, near to and after release.

    Science.gov (United States)

    Lennox, Charlotte; Kirkpatrick, Tim; Taylor, Rod S; Todd, Roxanne; Greenwood, Clare; Haddad, Mark; Stevenson, Caroline; Stewart, Amy; Shenton, Deborah; Carroll, Lauren; Brand, Sarah L; Quinn, Cath; Anderson, Rob; Maguire, Mike; Harris, Tirril; Shaw, Jennifer; Byng, Richard

    2018-01-01

    Rates of common mental health problems are much higher in prison populations, but access to primary care mental health support falls short of community equivalence. Discontinuity of care on release is the norm and is further complicated by substance use and a range of social problems, e.g. homelessness. To address these problems, we worked with criminal justice, third sector social inclusion services, health services and people with lived experiences (peer researchers), to develop a complex collaborative care intervention aimed at supporting men with common mental health problems near to and following release from prison. This paper describes an external pilot trial to test the feasibility of a full randomised controlled trial. Eligible individuals with 4 to 16 weeks left to serve were screened to assess for common mental health problems. Participants were then randomised at a ratio of 2:1 allocation to ENGAGER plus standard care (intervention) or standard care alone (treatment as usual). Participants were followed up at 1 and 3 months' post release. Success criteria for this pilot trial were to meet the recruitment target sample size of 60 participants, to follow up at least 50% of participants at 3 months' post release from prison, and to deliver the ENGAGER intervention. Estimates of recruitment and retention rates and 95% confidence intervals (CIs) are reported. Descriptive analyses included summaries (percentages or means) for participant demographics, and baseline characteristics are reported. Recruitment target was met with 60 participants randomised in 9 months. The average retention rates were 73% at 1 month [95% CI 61 to 83] and 47% at 3 months follow-up [95% CI 35 to 59]. Ninety percent of participants allocated to the intervention successfully engaged with a practitioner before release and 70% engaged following release. This pilot confirms the feasibility of conducting a randomised trial for prison leavers with common mental health problems. Based

  9. Collaborative care for sick-listed workers with major depressive disorder: a randomised controlled trial from the Netherlands Depression Initiative aimed at return to work and depressive symptoms.

    Science.gov (United States)

    Vlasveld, Moniek C; van der Feltz-Cornelis, Christina M; Adèr, Herman J; Anema, Johannes R; Hoedeman, Rob; van Mechelen, Willem; Beekman, Aartjan T F

    2013-04-01

    Major depressive disorder (MDD) is associated with absenteeism. In this study, the effectiveness of collaborative care, with a focus on return to work (RTW), was evaluated in its effect on depressive symptoms and the duration until RTW in sick-listed workers with MDD in the occupational health setting. In this randomised controlled trial, 126 sick-listed workers with MDD were randomised to usual care (N=61) or collaborative care (N=65). Collaborative care was applied by the occupational physician care manager, supported by a web-based tracking system and a consultant psychiatrist. Primary outcome measure was time to response. Secondary outcome measures were time to remission, depressive symptoms as continuous measure and the duration until full RTW. Collaborative care participants had a shorter time to response, with a difference of 2.8 months. However, no difference was found on time to remission or depressive symptoms as continuous measure. With a mean of 190 days in the collaborative care group, and 210 days in the usual care group, the groups did not differ significantly from each other in the duration until full RTW. Adherence to the collaborative care intervention was low. These results do not justify a widespread implementation of collaborative care in occupational healthcare, as it was operationalised in this study. However, since the study might have been underpowered for RTW and because treatment integrity was low, further research, with larger sample sizes, is needed to develop the best fitting (collaborative care) model for addressing RTW in depressed sick-listed workers. : ISRCTN78462860.

  10. Ibuprofen, paracetamol, and steam for patients with respiratory tract infections in primary care: pragmatic randomised factorial trial.

    Science.gov (United States)

    Little, Paul; Moore, Michael; Kelly, Joanne; Williamson, Ian; Leydon, Geraldine; McDermott, Lisa; Mullee, Mark; Stuart, Beth

    2013-10-25

    To assess strategies for advice on analgesia and steam inhalation for respiratory tract infections. Open pragmatic parallel group factorial randomised controlled trial. Primary care in United Kingdom. Patients aged ≥ 3 with acute respiratory tract infections. 889 patients were randomised with computer generated random numbers in pre-prepared sealed numbered envelopes to components of advice or comparator advice: advice on analgesia (take paracetamol, ibuprofen, or both), dosing of analgesia (take as required v regularly), and steam inhalation (no inhalation v steam inhalation). Primary: mean symptom severity on days 2-4; symptoms rated 0 (no problem) to 7 (as bad as it can be). Secondary: temperature, antibiotic use, reconsultations. Neither advice on dosing nor on steam inhalation was significantly associated with changes in outcomes. Compared with paracetamol, symptom severity was little different with ibuprofen (adjusted difference 0.04, 95% confidence interval -0.11 to 0.19) or the combination of ibuprofen and paracetamol (0.11, -0.04 to 0.26). There was no evidence for selective benefit with ibuprofen among most subgroups defined before analysis (presence of otalgia; previous duration of symptoms; temperature >37.5 °C; severe symptoms), but there was evidence of reduced symptoms severity benefit in the subgroup with chest infections (ibuprofen -0.40, -0.78 to -0.01; combination -0.47; -0.84 to -0.10), equivalent to almost one in two symptoms rated as a slight rather than a moderately bad problem. Children might also benefit from treatment with ibuprofen (ibuprofen: -0.47, -0.76 to -0.18; combination: -0.04, -0.31 to 0.23). Reconsultations with new/unresolved symptoms or complications were documented in 12% of those advised to take paracetamol, 20% of those advised to take ibuprofen (adjusted risk ratio 1.67, 1.12 to 2.38), and 17% of those advised to take the combination (1.49, 0.98 to 2.18). Mild thermal injury with steam was documented for four patients

  11. Primary care randomised controlled trial of a tailored interactive website for the self-management of respiratory infections (Internet Doctor).

    Science.gov (United States)

    Little, Paul; Stuart, Beth; Andreou, Panayiota; McDermott, Lisa; Joseph, Judith; Mullee, Mark; Moore, Mike; Broomfield, Sue; Thomas, Tammy; Yardley, Lucy

    2016-04-20

    To assess an internet-delivered intervention providing advice to manage respiratory tract infections (RTIs). Open pragmatic parallel group randomised controlled trial. Primary care in UK. Adults (aged ≥18) registered with general practitioners, recruited by postal invitation. Patients were randomised with computer-generated random numbers to access the intervention website (intervention) or not (control). The intervention tailored advice about the diagnosis, natural history, symptom management (particularly paracetamol/ibuprofen use) and when to seek further help. Primary: National Health Service (NHS) contacts for those reporting RTIs from monthly online questionnaires for 20 weeks. Secondary: hospitalisations; symptom duration/severity. Results 3044 participants were recruited. 852 in the intervention group and 920 in the control group reported one or more RTIs, among whom there a modest increase in NHS Direct contacts in the intervention group (intervention 44/1734 (2.5%) versus control 24/1842 (1.3%); multivariate Risk Ratio (RR) 2.53 (95% CI 1.10 to 5.82, p=0.029)). Conversely reduced contact with doctors occurred (283/1734 (16.3%) vs 368/1845 (20.0%); risk ratio 0.71, 0.53 to 0.95, p=0.019). Reduction in contacts occurred despite slightly longer illness duration (11.3 days versus 10.9 days respectively; multivariateestimate 0.48 days longer (-0.16 to 1.12, p=0.141) and more days of illness rated moderately bad or worse illness (0.53 days; 0.12 to 0.94, p=0.012). The estimate of slower symptom resolution in the intervention group was attenuated when controlling for whether individuals had used webpages which advocated ibuprofen use (length of illness 0.22 days, −0.51 to 0.95, p=0.551; moderately bad or worse symptoms 0.36 days, −0.08 to 0.80, p=0.105). There was no evidence of increased hospitalisations (risk ratio 0.13; 0.02 to 1.01; p=0.051). An internet-delivered intervention for the self-management of RTIs modifies help-seeking behaviour, and does

  12. The acceptability and impact of a randomised controlled trial of welfare rights advice accessed via primary health care: qualitative study

    Directory of Open Access Journals (Sweden)

    Howel Denise

    2006-06-01

    Full Text Available Abstract Background Qualitative research is increasingly used alongside randomised controlled trials (RCTs to study a range of factors including participants' experiences of a trial. The need for a sound evidence base within public health will increase the need for RCTs of non-clinical interventions. Welfare rights advice has been proposed as an intervention with potential to reduce health inequalities. This qualitative study, nested within an RCT of the impact of welfare rights advice, examined the acceptability of the intervention, the acceptability of the research process and the perceived impact of the intervention. Methods 25 men and women aged 60 years or over were recruited from four general practices in Newcastle upon Tyne (UK, a sub-sample of those who consented to be contacted (n = 96 during the RCT baseline interview. Semi-structured interviews were undertaken and analysed using the Framework Method. Results Participants viewed the trial positively although, despite agreeing that the information leaflet was clear, some had agreed to participate without being fully aware of what was involved. Some participants were unaware of the implications of randomisation. Most thought it fair, but a few concerns were raised about the control condition. The intervention was acceptable and made participants feel confident about applying for benefit entitlements. 14 out of 25 participants received some financial award; median weekly income gain was £57 (€84, $101. The perceived impact of additional finances was considerable and included: increased affordability of necessities and occasional expenses; increased capacity to deal with emergencies; and a reduction in stress related to financial worries. Overall, perceived independence and ability to participate in society increased. Most participants perceived benefits to their mental well-being, but no-one reported an improvement in physical health. The RCT showed little or no effect on a wide range

  13. Pharmacist-led management of chronic pain in primary care: costs and benefits in a pilot randomised controlled trial.

    Science.gov (United States)

    Neilson, Aileen R; Bruhn, Hanne; Bond, Christine M; Elliott, Alison M; Smith, Blair H; Hannaford, Philip C; Holland, Richard; Lee, Amanda J; Watson, Margaret; Wright, David; McNamee, Paul

    2015-04-01

    To explore differences in mean costs (from a UK National Health Service perspective) and effects of pharmacist-led management of chronic pain in primary care evaluated in a pilot randomised controlled trial (RCT), and to estimate optimal sample size for a definitive RCT. Regression analysis of costs and effects, using intention-to-treat and expected value of sample information analysis (EVSI). Six general practices: Grampian (3); East Anglia (3). 125 patients with complete resource use and short form-six-dimension questionnaire (SF-6D) data at baseline, 3 months and 6 months. Patients were randomised to either pharmacist medication review with face-to-face pharmacist prescribing or pharmacist medication review with feedback to general practitioner or treatment as usual (TAU). Differences in mean total costs and effects measured as quality-adjusted life years (QALYs) at 6 months and EVSI for sample size calculation. Unadjusted total mean costs per patient were £452 for prescribing (SD: £466), £570 for review (SD: £527) and £668 for TAU (SD: £1333). After controlling for baseline costs, the adjusted mean cost differences per patient relative to TAU were £77 for prescribing (95% CI -82 to 237) and £54 for review (95% CI -103 to 212). Unadjusted mean QALYs were 0.3213 for prescribing (SD: 0.0659), 0.3161 for review (SD: 0.0684) and 0.3079 for TAU (SD: 0.0606). Relative to TAU, the adjusted mean differences were 0.0069 for prescribing (95% CI -0.0091 to 0.0229) and 0.0097 for review (95% CI -0.0054 to 0.0248). The EVSI suggested the optimal future trial size was between 460 and 690, and between 540 and 780 patients per arm using a threshold of £30,000 and £20,000 per QALY gained, respectively. Compared with TAU, pharmacist-led interventions for chronic pain appear more costly and provide similar QALYs. However, these estimates are imprecise due to the small size of the pilot trial. The EVSI indicates that a larger trial is necessary to obtain more

  14. Advance care planning - a multi-centre cluster randomised clinical trial

    DEFF Research Database (Denmark)

    Rietjens, Judith A C; Korfage, Ida J; Dunleavy, Lesley

    2016-01-01

    patients, relatives and professional caregivers about patients' values and care preferences. It raises awareness of the need to anticipate possible future deterioration of health. ACP has the potential to improve current and future healthcare decision-making, provide patients with a sense of control...... Choices program from the perspectives of patients, their Personal Representatives, healthcare providers and facilitators. DISCUSSION: Transferring the concept of ACP from care of the elderly to patients with advanced cancer, who on average are younger and retain their mental capacity for a larger part...

  15. Guided self-help cognitive behavioural therapy for depression in primary care: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Christopher Williams

    Full Text Available BACKGROUND: Access to Cognitive behavioural therapy (CBT for depression is limited. One solution is CBT self-help books. Trial Objectives: To assess the impact of a guided self-help CBT book (GSH-CBT on mood, compared to treatment as usual (TAU. HYPOTHESES: GSH-CBT will have improved mood and knowledge of the causes and treatment of depression compared to the control receiving TAUGuided self-help will be acceptable to patients and staff. METHODS AND FINDINGS: PARTICIPANTS: Adults attending seven general practices in Glasgow, UK with a BDI-II score of ≥14. 141 randomised to GSH-CBT and 140 to TAU. INTERVENTIONS: RCT comparing 'Overcoming Depression: A Five Areas Approach' book plus 3-4 short face to face support appointments totalling up to 2 hours of guided support, compared with general practitioner TAU. PRIMARY OUTCOME: The BDI (II score at 4 months. Numbers analysed: 281 at baseline, 203 at 4 months (primary outcome, 117 at 12 months. OUTCOME: Mean BDI-II scores were lower in the GSH-CBT group at 4 months by 5.3 points (2.6 to 7.9, p<0.001. At 4 and 12 months there were also significantly higher proportions of participants achieving a 50% reduction in BDI-II in the GSH-CBT arm. The mean support was 2 sessions with 42.7 minutes for session 1, 41.4 minutes for session 2 and 40.2 minutes of support for session 3. Adverse effects/Harms: Significantly less deterioration in mood in GSH-CBT (2.0% compared to 9.8% in the TAU group for BDI-II category change. LIMITATIONS: Weaknesses: Our follow-up rate of 72.2% at 4 months is better than predicted but is poorer at 12 months (41.6%. In the GSH-CBT arm, around 50% of people attended 2 or fewer sessions. 22% failed to take up treatment. CONCLUSIONS: GSH-CBT is substantially more effective than TAU. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN13475030.

  16. Care staff training in detection of depression in residential homes for the elderly - Randomised trial

    NARCIS (Netherlands)

    Eisses, AMH; Kluiter, H; Jongenelis, K; Beekman, ATF; Ormel, J

    Background. Many people with depression in residential care homes for the elderly do not receive treatment because their depression remains undetected. Aims. To determine the effects of staff training on the detection, treatment and outcome of depression in residents often homes. Method. We

  17. Minimal contact psychotherapy for sub-threshold depression in primary care: a randomised trial.

    NARCIS (Netherlands)

    Willemse, G.R.W.M.; Smit, F.; Cuijpers, W.J.M.J.; Tiemens, B.G.

    2004-01-01

    Background: Sub-threshold depression is a prognostic variable for major depression. Interventions in sub-threshold depression may prevent the onset of new cases of major depression. Aims: To examine the effects of minimal-contact psychotherapy in primary care patients with sub-threshold depression

  18. Care staff training in detection of depression in residential homes for the elderly: randomised trial

    NARCIS (Netherlands)

    Eisses, A.M.H.; Kluiter, H.; Jongenelis, K.; Pot, A.M.; Beekman, A.T.F.; Ormel, J.

    2005-01-01

    Background: Many people with depression in residential care homes for the elderly do not receive treatment because their depression remains undetected. Aims: To determine the effects of staff training on the detection, treatment and outcome of depression in residents of ten homes. Method: We

  19. Adherence to a Depression Self-Care Intervention among Primary Care Patients with Chronic Physical Conditions: A Randomised Controlled Trial

    Science.gov (United States)

    McCusker, Jane; Cole, Martin G.; Yaffe, Mark; Strumpf, Erin; Sewitch, Maida; Sussman, Tamara; Ciampi, Antonio; Lavoie, Kim; Belzile, Eric

    2016-01-01

    Objective: Among primary care patients with chronic physical conditions and comorbid depressive symptoms, to assess (1) the effect of lay telephone coaching on adherence to a psycho-educational intervention for depression, (2) demographic characteristics that predict adherence and (3) the association between adherence and 6-month outcomes. Design:…

  20. Extra Physiotherapy in Critical Care (EPICC) Trial Protocol: a randomised controlled trial of intensive versus standard physical rehabilitation therapy in the critically ill.

    Science.gov (United States)

    Thomas, Kirsty; Wright, Stephen E; Watson, Gillian; Baker, Catherine; Stafford, Victoria; Wade, Clare; Chadwick, Thomas J; Mansfield, Leigh; Wilkinson, Jennifer; Shen, Jing; Deverill, Mark; Bonner, Stephen; Hugill, Keith; Howard, Philip; Henderson, Andrea; Roy, Alistair; Furneval, Julie; Baudouin, Simon V

    2015-05-25

    Patients discharged from Critical Care suffer from excessive longer term morbidity and mortality. Physical and mental health measures of quality of life show a marked and immediate fall after admission to Critical Care with some recovery over time. However, physical function is still significantly reduced at 6 months. The National Institute for Health and Care Excellence clinical guideline on rehabilitation after critical illness, identified the need for high-quality randomised controlled trials to determine the most effective rehabilitation strategy for critically ill patients at risk of critical illness-associated physical morbidity. In response to this, we will conduct a randomised controlled trial, comparing physiotherapy aimed at early and intensive patient mobilisation with routine care. We hypothesise that this intervention will improve physical outcomes and the mental health and functional well-being of survivors of critical illness. 308 adult patients who have received more than 48 h of non-invasive or invasive ventilation in Critical Care will be recruited to a patient-randomised, parallel group, controlled trial, comparing two intensities of physiotherapy. Participants will be randomised to receive either standard or intensive physiotherapy for the duration of their Critical Care admission. Outcomes will be recorded on Critical Care discharge, at 3 and 6 months following initial recruitment to the study. The primary outcome measure is physical health at 6 months, as measured by the SF-36 Physical Component Summary. Secondary outcomes include assessment of mental health, activities of daily living, delirium and ventilator-free days. We will also include a health economic analysis. The trial has ethical approval from Newcastle and North Tyneside 2 Research Ethics Committee (11/NE/0206). There is a Trial Oversight Committee including an independent chair. The results of the study will be submitted for publication in peer-reviewed journals and

  1. Joining psychiatric care and faith healing in a prayer camp in Ghana: randomised trial.

    Science.gov (United States)

    Ofori-Atta, A; Attafuah, J; Jack, H; Baning, F; Rosenheck, R

    2018-01-01

    Care of people with serious mental illness in prayer camps in low-income countries generates human rights concerns and ethical challenges for outcome researchers. Aims To ethically evaluate joining traditional faith healing with psychiatric care including medications (Clinical trials.gov identifier NCT02593734). Residents of a Ghana prayer camp were randomly assigned to receive either indicated medication for schizophrenia or mood disorders along with usual prayer camp activities (prayers, chain restraints and fasting) (n = 71); or the prayer camp activities alone (n = 68). Masked psychologists assessed Brief Psychiatric Rating Scale (BPRS) outcomes at 2, 4 and 6 weeks. Researchers discouraged use of chaining, but chaining decisions remained under the control of prayer camp staff. Total BPRS symptoms were significantly lower in the experimental group (P = 0.003, effect size -0.48). There was no significant difference in days in chains. Joining psychiatric and prayer camp care brought symptom benefits but, in the short-run, did not significantly reduce days spent in chains. Declaration of interest None.

  2. Developing and testing accelerated partner therapy for partner notification for people with genital Chlamydia trachomatis diagnosed in primary care: a pilot randomised controlled trial.

    Science.gov (United States)

    Estcourt, Claudia S; Sutcliffe, Lorna J; Copas, Andrew; Mercer, Catherine H; Roberts, Tracy E; Jackson, Louise J; Symonds, Merle; Tickle, Laura; Muniina, Pamela; Rait, Greta; Johnson, Anne M; Aderogba, Kazeem; Creighton, Sarah; Cassell, Jackie A

    2015-12-01

    Accelerated partner therapy (APT) is a promising partner notification (PN) intervention in specialist sexual health clinic attenders. To address its applicability in primary care, we undertook a pilot randomised controlled trial (RCT) of two APT models in community settings. Three-arm pilot RCT of two adjunct APT interventions: APTHotline (telephone assessment of partner(s) plus standard PN) and APTPharmacy (community pharmacist assessment of partner(s) plus routine PN), versus standard PN alone (patient referral). Index patients were women diagnosed with genital chlamydia in 12 general practices and three community contraception and sexual health (CASH) services in London and south coast of England, randomised between 1 September 2011 and 31 July 2013. 199 women described 339 male partners, of whom 313 were reported by the index as contactable. The proportions of contactable partners considered treated within 6 weeks of index diagnosis were APTHotline 39/111 (35%), APTPharmacy 46/100 (46%), standard patient referral 46/102 (45%). Among treated partners, 8/39 (21%) in APTHotline arm were treated via hotline and 14/46 (30%) in APTPharmacy arm were treated via pharmacy. The two novel primary care APT models were acceptable, feasible, compliant with regulations and capable of achieving acceptable outcomes within a pilot RCT but intervention uptake was low. Although addition of these interventions to standard PN did not result in a difference between arms, overall PN uptake was higher than previously reported in similar settings, probably as a result of introducing a formal evaluation. Recruitment to an individually randomised trial proved challenging and full evaluation will likely require service-level randomisation. Registered UK Clinical Research Network Study Portfolio id number 10123. 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. Randomised clinical trial: yoga vs written self-care advice for ulcerative colitis.

    Science.gov (United States)

    Cramer, H; Schäfer, M; Schöls, M; Köcke, J; Elsenbruch, S; Lauche, R; Engler, H; Dobos, G; Langhorst, J

    2017-06-01

    Perceived stress seems to be a risk factor for exacerbation of ulcerative colitis. Yoga has been shown to reduce perceived stress. To assess the efficacy and safety of yoga for improving quality of life in patients with ulcerative colitis. A total of 77 patients (75% women; 45.5 ± 11.9 years) with ulcerative colitis in clinical remission but impaired quality of life were randomly assigned to yoga (12 supervised weekly sessions of 90 min; n = 39) or written self-care advice (n = 38). Primary outcome was disease-specific quality of life (Inflammatory Bowel Disease Questionnaire). Secondary outcomes included disease activity (Rachmilewitz clinical activity index) and safety. Outcomes were assessed at weeks 12 and 24 by blinded outcome assessors. The yoga group had significantly higher disease-specific quality of life compared to the self-care group after 12 weeks (Δ = 14.6; 95% confidence interval=2.6-26.7; P = 0.018) and after 24 weeks (Δ = 16.4; 95% confidence interval=2.5-30.3; P = 0.022). Twenty-one and 12 patients in the yoga group and in the self-care group, respectively, reached a clinical relevant increase in quality of life at week 12 (P = 0.048); and 27 and 17 patients at week 24 (P = 0.030). Disease activity was lower in the yoga group compared to the self-care group after 24 weeks (Δ = -1.2; 95% confidence interval=-0.1-[-2.3]; P = 0.029). Three and one patient in the yoga group and in the self-care group, respectively, experienced serious adverse events (P = 0.317); and seven and eight patients experienced nonserious adverse events (P = 0.731). Yoga can be considered as a safe and effective ancillary intervention for patients with ulcerative colitis and impaired quality of life. ClinicalTrials.gov identifier: NCT02043600. © 2017 John Wiley & Sons Ltd.

  4. AESOPS: a randomised controlled trial of the clinical effectiveness and cost-effectiveness of opportunistic screening and stepped care interventions for older hazardous alcohol users in primary care.

    Science.gov (United States)

    Watson, J M; Crosby, H; Dale, V M; Tober, G; Wu, Q; Lang, J; McGovern, R; Newbury-Birch, D; Parrott, S; Bland, J M; Drummond, C; Godfrey, C; Kaner, E; Coulton, S

    2013-06-01

    There is clear evidence of the detrimental impact of hazardous alcohol consumption on the physical and mental health of the population. Estimates suggest that hazardous alcohol consumption annually accounts for 150,000 hospital admissions and between 15,000 and 22,000 deaths in the UK. In the older population, hazardous alcohol consumption is associated with a wide range of physical, psychological and social problems. There is evidence of an association between increased alcohol consumption and increased risk of coronary heart disease, hypertension and haemorrhagic and ischaemic stroke, increased rates of alcohol-related liver disease and increased risk of a range of cancers. Alcohol is identified as one of the three main risk factors for falls. Excessive alcohol consumption in older age can also contribute to the onset of dementia and other age-related cognitive deficits and is implicated in one-third of all suicides in the older population. To compare the clinical effectiveness and cost-effectiveness of a stepped care intervention against a minimal intervention in the treatment of older hazardous alcohol users in primary care. A multicentre, pragmatic, two-armed randomised controlled trial with an economic evaluation. General practices in primary care in England and Scotland between April 2008 and October 2010. Adults aged ≥ 55 years scoring ≥ 8 on the Alcohol Use Disorders Identification Test (10-item) (AUDIT) were eligible. In total, 529 patients were randomised in the study. The minimal intervention group received a 5-minute brief advice intervention with the practice or research nurse involving feedback of the screening results and discussion regarding the health consequences of continued hazardous alcohol consumption. Those in the stepped care arm initially received a 20-minute session of behavioural change counselling, with referral to step 2 (motivational enhancement therapy) and step 3 (local specialist alcohol services) if indicated. Sessions were

  5. CollAborative care for Screen-Positive EldeRs with major depression (CASPER plus): a multicentred randomised controlled trial of clinical effectiveness and cost-effectiveness.

    Science.gov (United States)

    Bosanquet, Katharine; Adamson, Joy; Atherton, Katie; Bailey, Della; Baxter, Catherine; Beresford-Dent, Jules; Birtwistle, Jacqueline; Chew-Graham, Carolyn; Clare, Emily; Delgadillo, Jaime; Ekers, David; Foster, Deborah; Gabe, Rhian; Gascoyne, Samantha; Haley, Lesley; Hamilton, Jahnese; Hargate, Rebecca; Hewitt, Catherine; Holmes, John; Keding, Ada; Lewis, Helen; McMillan, Dean; Meer, Shaista; Mitchell, Natasha; Nutbrown, Sarah; Overend, Karen; Parrott, Steve; Pervin, Jodi; Richards, David A; Spilsbury, Karen; Torgerson, David; Traviss-Turner, Gemma; Trépel, Dominic; Woodhouse, Rebecca; Gilbody, Simon

    2017-11-01

    Depression in older adults is common and is associated with poor quality of life, increased morbidity and early mortality, and increased health and social care use. Collaborative care, a low-intensity intervention for depression that is shown to be effective in working-age adults, has not yet been evaluated in older people with depression who are managed in UK primary care. The CollAborative care for Screen-Positive EldeRs (CASPER) plus trial fills the evidence gap identified by the most recent guidelines on depression management. To establish the clinical effectiveness and cost-effectiveness of collaborative care for older adults with major depressive disorder in primary care. A pragmatic, multicentred, two-arm, parallel, individually randomised controlled trial with embedded qualitative study. Participants were automatically randomised by computer, by the York Trials Unit Randomisation Service, on a 1 : 1 basis using simple unstratified randomisation after informed consent and baseline measures were collected. Blinding was not possible. Sixty-nine general practices in the north of England. A total of 485 participants aged ≥ 65 years with major depressive disorder. A low-intensity intervention of collaborative care, including behavioural activation, delivered by a case manager for an average of six sessions over 7-8 weeks, alongside usual general practitioner (GP) care. The control arm received only usual GP care. The primary outcome measure was Patient Health Questionnaire-9 items score at 4 months post randomisation. Secondary outcome measures included depression severity and caseness at 12 and 18 months, the EuroQol-5 Dimensions, Short Form questionnaire-12 items, Patient Health Questionnaire-15 items, Generalised Anxiety Disorder-7 items, Connor-Davidson Resilience Scale-2 items, a medication questionnaire, objective data and adverse events. Participants were followed up at 12 and 18 months. In total, 485 participants were randomised (collaborative

  6. Evaluation of the effectiveness of music therapy in improving the quality of life of palliative care patients: a randomised controlled pilot and feasibility study.

    Science.gov (United States)

    McConnell, Tracey; Graham-Wisener, Lisa; Regan, Joan; McKeown, Miriam; Kirkwood, Jenny; Hughes, Naomi; Clarke, Mike; Leitch, Janet; McGrillen, Kerry; Porter, Sam

    2016-01-01

    Music therapy is frequently used as a palliative therapy. In consonance with the goals of palliative care, the primary aim of music therapy is to improve people's quality of life by addressing their psychological needs and facilitating communication. To date, primarily because of a paucity of robust research, the evidence for music therapy's effectiveness on patient reported outcomes is positive but weak. This pilot and feasibility study will test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a phase III randomised trial to evaluate the effectiveness of music therapy in improving the quality of life of palliative care patients. A pilot randomised controlled trial supplemented with qualitative methods. The quantitative data collection will involve recruitment of >52 patients from an inpatient Marie Curie hospice setting over a 12-month period. Eligibility criteria include all patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 03- indicating they are medically fit to engage with music therapy and an Abbreviated Mental Test (AMT) score of ≥7 indicating they are capable of providing meaningful informed consent and accurate responses to outcome measures. Baseline data collection will include the McGill Quality of Life Questionnaire (MQOL); medical and socio-demographic data will be undertaken before randomisation to an intervention or control group. Participants in the intervention arm will be offered two 30-45 min sessions of music therapy per week for three consecutive weeks, in addition to care as usual. Participants in the control arm will receive care as usual. Follow-up measures will be administered in 1, 3 and 5 weeks. Qualitative data collection will involve focus group and individual interviews with HCPs and carers. This study will ensure a firm methodological grounding for the development of a robust phase III randomised trial of music therapy for

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

    Directory of Open Access Journals (Sweden)

    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

  8. Immediate interruption of sedation compared with usual sedation care in critically ill postoperative patients (SOS-Ventilation): a randomised, parallel-group clinical trial.

    Science.gov (United States)

    Chanques, Gerald; Conseil, Matthieu; Roger, Claire; Constantin, Jean-Michel; Prades, Albert; Carr, Julie; Muller, Laurent; Jung, Boris; Belafia, Fouad; Cissé, Moussa; Delay, Jean-Marc; de Jong, Audrey; Lefrant, Jean-Yves; Futier, Emmanuel; Mercier, Grégoire; Molinari, Nicolas; Jaber, Samir

    2017-10-01

    Avoidance of excessive sedation and subsequent prolonged mechanical ventilation in intensive care units (ICUs) is recommended, but no data are available for critically ill postoperative patients. We hypothesised that in such patients stopping sedation immediately after admission to the ICU could reduce unnecessary sedation and improve patient outcomes. We did a randomised, parallel-group, clinical trial at three ICUs in France. Stratified randomisation with minimisation (1:1 via a restricted web platform) was used to assign eligible patients (aged ≥18 years, admitted to an ICU after abdominal surgery, and expected to require at least 12 h of mechanical ventilation because of a critical illness defined by a Sequential Organ Failure Assessment score >1 for any organ, but without severe acute respiratory distress syndrome or brain injury) to usual sedation care provided according to recommended practices (control group) or to immediate interruption of sedation (intervention group). The primary outcome was the time to successful extubation (defined as the time from randomisation to the time of extubation [or tracheotomy mask] for at least 48 h). All patients who underwent randomisation (except for those who were excluded after randomisation) were included in the intention-to-treat analysis. This study is registered with ClinicalTrials.gov, number NCT01486121. Between Dec 2, 2011, and Feb 27, 2014, 137 patients were randomly assigned to the control (n=68) or intervention groups (n=69). In the intention-to-treat analysis, time to successful extubation was significantly lower in the intervention group than in the control group (median 8 h [IQR 4-36] vs 50 h [29-93], group difference -33·6 h [95% CI -44·9 to -22·4]; p<0·0001). The adjusted hazard ratio was 5·2 (95% CI 3·1-8·8, p<0·0001). Immediate interruption of sedation in critically ill postoperative patients with organ dysfunction who were admitted to the ICU after abdominal surgery improved outcomes compared

  9. Waste the waist: a pilot randomised controlled trial of a primary care based intervention to support lifestyle change in people with high cardiovascular risk.

    Science.gov (United States)

    Greaves, Colin; Gillison, Fiona; Stathi, Afroditi; Bennett, Paul; Reddy, Prasuna; Dunbar, James; Perry, Rachel; Messom, Daniel; Chandler, Roger; Francis, Margaret; Davis, Mark; Green, Colin; Evans, Philip; Taylor, Gordon

    2015-01-16

    In the UK, thousands of people with high cardiovascular risk are being identified by a national risk-assessment programme (NHS Health Checks). Waste the Waist is an evidence-informed, theory-driven (modified Health Action Process Approach), group-based intervention designed to promote healthy eating and physical activity for people with high cardiovascular risk. This pilot randomised controlled trial aimed to assess the feasibility of delivering the Waste the Waist intervention in UK primary care and of conducting a full-scale randomised controlled trial. We also conducted exploratory analyses of changes in weight. Patients aged 40-74 with a Body Mass Index of 28 or more and high cardiovascular risk were identified from risk-assessment data or from practice database searches. Participants were randomised, using an online computerised randomisation algorithm, to receive usual care and standardised information on cardiovascular risk and lifestyle (Controls) or nine sessions of the Waste the Waist programme (Intervention). Group allocation was concealed until the point of randomisation. Thereafter, the statistician, but not participants or data collectors were blinded to group allocation. Weight, physical activity (accelerometry) and cardiovascular risk markers (blood tests) were measured at 0, 4 and 12 months. 108 participants (22% of those approached) were recruited (55 intervention, 53 controls) from 6 practices and 89% provided data at both 4 and 12 months. Participants had a mean age of 65 and 70% were male. Intervention participants attended 72% of group sessions. Based on last observations carried forward, the intervention group did not lose significantly more weight than controls at 12 months, although the difference was significant when co-interventions and co-morbidities that could affect weight were taken into account (Mean Diff 2.6Kg. 95%CI: -4.8 to -0.3, p = 0.025). No significant differences were found in physical activity. The Waste the Waist

  10. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention

    Science.gov (United States)

    Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John

    2016-01-01

    Introduction Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. Methods and analysis 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethics and dissemination Ethical approval has been obtained from the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. Trial registration number ChiCTR-IOR-15006971. PMID:27334883

  11. Patient and family satisfaction levels in the intensive care unit after elective cardiac surgery: study protocol for a randomised controlled trial of a preoperative patient education intervention.

    Science.gov (United States)

    Lai, Veronica Ka Wai; Lee, Anna; Leung, Patricia; Chiu, Chun Hung; Ho, Ka Man; Gomersall, Charles David; Underwood, Malcolm John; Joynt, Gavin Matthew

    2016-06-22

    Patients and their families are understandably anxious about the risk of complications and unfamiliar experiences following cardiac surgery. Providing information about postoperative care in the intensive care unit (ICU) to patients and families may lead to lower anxiety levels, and increased satisfaction with healthcare. The objectives of this study are to evaluate the effectiveness of preoperative patient education provided for patients undergoing elective cardiac surgery. 100 patients undergoing elective coronary artery bypass graft, with or without valve replacement surgery, will be recruited into a 2-group, parallel, superiority, double-blinded randomised controlled trial. Participants will be randomised to either preoperative patient education comprising of a video and ICU tour with standard care (intervention) or standard education (control). The primary outcome measures are the satisfaction levels of patients and family members with ICU care and decision-making in the ICU. The secondary outcome measures are patient anxiety and depression levels before and after surgery. Ethical approval has been obtained from the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (reference number CREC 2015.308). The findings will be presented at conferences and published in peer-reviewed journals. Study participants will receive a 1-page plain language summary of results. ChiCTR-IOR-15006971. 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/

  12. Cost-effectiveness of counselling, graded-exercise and usual care for chronic fatigue: evidence from a randomised trial in primary care

    Directory of Open Access Journals (Sweden)

    Sabes-Figuera Ramon

    2012-08-01

    Full Text Available Abstract Background Fatigue is common and has been shown to result in high economic costs to society. The aim of this study is to compare the cost-effectiveness of two active therapies, graded-exercise (GET and counselling (COUN with usual care plus a self-help booklet (BUC for people presenting with chronic fatigue. Methods A randomised controlled trial was conducted with participants consulting for fatigue of over three months’ duration recruited from 31 general practices in South East England and allocated to one of three arms. Outcomes and use of services were assessed at 6-month follow-up. The main outcome measure used in the economic evaluation was clinically significant improvements in fatigue, measured using the Chalder fatigue scale. Cost-effectiveness was assessed using the net-benefit approach and cost-effectiveness acceptability curves. Results Full economic and outcome data at six months were available for 163 participants; GET = 51, COUN = 58 and BUC = 54. Those receiving the active therapies (GET and COUN had more contacts with care professionals and therefore higher costs, these differences being statistically significant. COUN was more expensive and less effective than the other two therapies. The incremental cost-effectiveness ratio of GET compared to BUC was equal to £987 per unit of clinically significant improvement. However, there was much uncertainty around this result. Conclusion This study does not provide a clear recommendation about which therapeutic option to adopt, based on efficiency, for patients with chronic fatigue. It suggests that COUN is not cost-effective, but it is unclear whether GET represents value for money compared to BUC. Clinical Trial Registration number at ISRCTN register: 72136156

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

    Directory of Open Access Journals (Sweden)

    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

  14. Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial.

    Science.gov (United States)

    Wylde, Vikki; Bertram, Wendy; Beswick, Andrew D; Blom, Ashley W; Bruce, Julie; Burston, Amanda; Dennis, Jane; Garfield, Kirsty; Howells, Nicholas; Lane, Athene; McCabe, Candy; Moore, Andrew J; Noble, Sian; Peters, Tim J; Price, Andrew; Sanderson, Emily; Toms, Andrew D; Walsh, David A; White, Simon; Gooberman-Hill, Rachael

    2018-02-21

    Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability

  15. Protocol for the Foot in Juvenile Idiopathic Arthritis trial (FiJIA: a randomised controlled trial of an integrated foot care programme for foot problems in JIA

    Directory of Open Access Journals (Sweden)

    Hendry Gordon J

    2009-06-01

    Full Text Available Abstract Background Foot and ankle problems are a common but relatively neglected manifestation of juvenile idiopathic arthritis. Studies of medical and non-medical interventions have shown that clinical outcome measures can be improved. However existing data has been drawn from small non-randomised clinical studies of single interventions that appear to under-represent the adult population suffering from juvenile idiopathic arthritis. To date, no evidence of combined therapies or integrated care for juvenile idiopathic arthritis patients with foot and ankle problems exists. Methods/design An exploratory phase II non-pharmacological randomised controlled trial where patients including young children, adolescents and adults with juvenile idiopathic arthritis and associated foot/ankle problems will be randomised to receive integrated podiatric care via a new foot care programme, or to receive standard podiatry care. Sixty patients (30 in each arm including children, adolescents and adults diagnosed with juvenile idiopathic arthritis who satisfy the inclusion and exclusion criteria will be recruited from 2 outpatient centres of paediatric and adult rheumatology respectively. Participants will be randomised by process of minimisation using the Minim software package. The primary outcome measure is the foot related impairment measured by the Juvenile Arthritis Disability Index questionnaire's impairment domain at 6 and 12 months, with secondary outcomes including disease activity score, foot deformity score, active/limited foot joint counts, spatio-temporal and plantar-pressure gait parameters, health related quality of life and semi-quantitative ultrasonography score for inflammatory foot lesions. The new foot care programme will comprise rapid assessment and investigation, targeted treatment, with detailed outcome assessment and follow-up at minimum intervals of 3 months. Data will be collected at baseline, 6 months and 12 months from baseline

  16. Making co-enrolment feasible for randomised controlled trials in paediatric intensive care.

    Directory of Open Access Journals (Sweden)

    Katie Harron

    Full Text Available Enrolling children into several trials could increase recruitment and lead to quicker delivery of optimal care in paediatric intensive care units (PICU. We evaluated decisions taken by clinicians and parents in PICU on co-enrolment for two large pragmatic trials: the CATCH trial (CATheters in CHildren comparing impregnated with standard central venous catheters (CVCs for reducing bloodstream infection in PICU and the CHIP trial comparing tight versus standard control of hyperglycaemia.We recorded the period of trial overlap for all PICUs taking part in both CATCH and CHiP and reasons why clinicians decided to co-enrol children or not into both studies. We examined parental decisions on co-enrolment by measuring recruitment rates and reasons for declining consent.Five PICUs recruited for CATCH and CHiP during the same period (an additional four opened CATCH after having closed CHiP. Of these five, three declined co-enrolment (one of which delayed recruiting elective patients for CATCH whilst CHiP was running, due to concerns about jeopardising CHiP recruitment, asking too much of parents, overwhelming amounts of information to explain to parents for two trials and a policy against co-enrolment. Two units co-enrolled in order to maximise recruitment to both trials. At the first unit, 35 parents were approached for both trials. 17/35 consented to both; 13/35 consented to one trial only; 5/35 declined both. Consent rates during co-enrolment were 29/35 (82% and 18/35 (51% for CATCH and CHiP respectively compared with 78% and 51% respectively for those approached for a single trial within this PICU. The second unit did not record data on approaches or refusals, but successfully co-enrolled one child.Co-enrolment did not appear to jeopardise recruitment or overwhelm parents. Strategies for seeking consent for multiple trials need to be developed and should include how to combine information for parents and patients.

  17. Cost-effectiveness of collaborative care for chronically ill patients with comorbid depressive disorder in the general hospital setting, a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2007-02-01

    Full Text Available Abstract Background Depressive disorder is one of the most common disorders, and is highly prevalent in chronically ill patients. The presence of comorbid depression has a negative influence on quality of life, health care costs, self-care, morbidity, and mortality. Early diagnosis and well-organized treatment of depression has a positive influence on these aspects. Earlier research in the USA has reported good results with regard to the treatment of depression with a collaborative care approach and an antidepressant algorithm. In the UK 'Problem Solving Treatment' has proved to be feasible. However, in the general hospital setting this approach has not yet been evaluated. Methods/Design CC: DIM (Collaborative Care: Depression Initiative in the Medical setting is a two-armed randomised controlled trial with randomisation at patient level. The aim of the trial is to evaluate the treatment of depressive disorder in general hospitals in the Netherlands based on a collaborative care framework, including contracting, 'Problem Solving Treatment', antidepressant algorithm, and manual-guided self-help. 126 outpatients with diabetes mellitus, chronic obstructive pulmonary disease, or cardiovascular diseases will be randomised to either the intervention group or the control group. Patients will be included if they have been diagnosed with moderate to severe depression, based on the DSM-IV criteria in a two-step screening method. The intervention group will receive treatment based on the collaborative care approach; the control group will receive 'care as usual'. Baseline and follow-up measurements (after 3, 6, 9, and 12 months will be performed by means of questionnaires. The primary outcome measure is severity of depressive symptoms, as measured with the PHQ-9. The secondary outcome measure is the cost-effectiveness of these treatments according to the TiC-P, the EuroQol and the SF-36. Discussion Earlier research has indicated that depressive disorder is

  18. 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

  19. Screening uptake rates and the clinical and cost effectiveness of screening for gestational diabetes mellitus in primary versus secondary care: study protocol for a randomised controlled trial.

    LENUS (Irish Health Repository)

    O Dea, Angela

    2014-01-17

    The risks associated with gestational diabetes mellitus (GDM) are well recognized, and there is increasing evidence to support treatment of the condition. However, clear guidance on the ideal approach to screening for GDM is lacking. Professional groups continue to debate whether selective screening (based on risk factors) or universal screening is the most appropriate approach. Additionally, there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment. Furthermore, the implications of possible screening options on health care costs are not well established. In response to this uncertainty there have been repeated calls for well-designed, randomised trials to determine the efficacy of screening, diagnosis, and management plans for GDM. We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings. The objective of this study is to assess screening uptake rates, and the clinical and cost effectiveness of screening for GDM in primary versus secondary care.

  20. The clinical and cost-effectiveness of stratified care for patients with sciatica: the SCOPiC randomised controlled trial protocol (ISRCTN75449581).

    Science.gov (United States)

    Foster, Nadine E; Konstantinou, Kika; Lewis, Martyn; Ogollah, Reuben; Dunn, Kate M; van der Windt, Danielle; Beardmore, Ruth; Artus, Majid; Bartlam, Bernadette; Hill, Jonathan C; Jowett, Sue; Kigozi, Jesse; Mallen, Christian; Saunders, Benjamin; Hay, Elaine M

    2017-04-26

    Sciatica has a substantial impact on patients, and is associated with high healthcare and societal costs. Although there is variation in the clinical management of sciatica, the current model of care usually involves an initial period of 'wait and see' for most patients, with simple measures of advice and analgesia, followed by conservative and/or more invasive interventions if symptoms fail to resolve. A model of care is needed that does not over-treat those with a good prognosis yet identifies patients who do need more intensive treatment to help with symptoms, and return to everyday function including work. The aim of the SCOPiC trial (SCiatica Outcomes in Primary Care) is to establish whether stratified care based on subgrouping using a combination of prognostic and clinical information, with matched care pathways, is more effective than non-stratified care, for improving time to symptom resolution in patients consulting with sciatica in primary care. We will also assess the impact of stratified care on service delivery and evaluate its cost-effectiveness compared to non-stratified care. Multicentre, pragmatic, parallel arm randomised trial, with internal pilot, cost-effectiveness analysis and embedded qualitative study. We will recruit 470 adult patients with sciatica from general practices in England and Wales, over 24 months. Patients will be randomised to stratified care or non-stratified care, and treated in physiotherapy and spinal specialist services, in participating NHS services. The primary outcome is time to first resolution of sciatica symptoms, measured on a 6-point ordered categorical scale, collected using text messaging. Secondary outcomes include physical function, pain intensity, quality of life, work loss, healthcare use and satisfaction with treatment, and will be collected using postal questionnaires at 4 and 12-month follow-up. Semi-structured qualitative interviews with a subsample of participants and clinicians will explore the

  1. Mediating the effect of self-care management intervention in type 2 diabetes: A meta-analysis of 47 randomised controlled trials

    DEFF Research Database (Denmark)

    Minet, Lisbeth; Møller, Sine; Vach, Werner

    2010-01-01

    OBJECTIVE: To perform a meta-analysis assessing the effects of self-care management interventions in improving glycaemic control in type 2 diabetes by analysing the impact of different study characteristics on the effect size. METHODS: A literature search in eight scientific databases up...... to November 2007 included original studies of randomised controlled trials involving adult patients diagnosed with type 2 diabetes and evaluating a self-care management intervention. RESULTS: The 47 included studies yielded 7677 participants. The analysis showed a 0.36% (95% CI 0.21-0.51) improvement...... in glycaemic control in people who received self-care management treatment. In the univariate meta-regression sample size (effect size 0.42%, p=0.007) and follow-up period (effect size 0.49%, p=0.017) were identified to have significant effect on the effect size in favour of small studies and short follow...

  2. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3: a randomised trial to determine the efficacy of adding a complex intervention for major depressive disorder (Depression Care for People with Lung Cancer to usual care, compared to usual care alone in patients with lung cancer

    Directory of Open Access Journals (Sweden)

    Sharpe Michael

    2009-09-01

    Full Text Available Abstract Background Depression Care for People with Lung Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. The third Symptom Management Research Trial in Oncology (SMaRT Oncology-3 Trial will test its efficacy when compared to usual care alone. Design A two arm parallel group multi-centre randomised controlled trial. 200 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of lung cancer; an estimated life expectancy of three months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Lung Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is average depression severity. This will be assessed using scores on the 20-item Symptom Hopkins Checklist (SCL-20D, collected every four weeks over 32 weeks. Secondary outcomes include severity of anxiety, pain and fatigue; self-rated improvement of depression; quality of life and satisfaction with depression care. Trial Registration Current controlled trials ISRCTN75905964

  3. Effects and meanings of a person-centred and health-promoting intervention in home care services - a study protocol of a non-randomised controlled trial.

    Science.gov (United States)

    Bölenius, Karin; Lämås, Kristina; Sandman, Per-Olof; Edvardsson, David

    2017-02-16

    The literature indicates that current home care service are largely task oriented with limited focus on the involvement of the older people themselves, and studies show that lack of involvement might reduce older people's quality of life. Person-centred care has been shown to improve the satisfaction with care and quality of life in older people cared for in hospitals and nursing homes, with limited published evidence about the effects and meanings of person-centred interventions in home care services for older people. This study protocol outlines a study aiming to evaluate such effects and meanings of a person-centred and health-promoting intervention in home aged care services. The study will take the form of a non-randomised controlled trial with a before/after approach. It will include 270 older people >65 years receiving home care services, 270 relatives and 65 staff, as well as a matched control group of equal size. All participants will be recruited from a municipality in northern Sweden. The intervention is based on the theoretical concepts of person-centredness and health-promotion, and builds on the four pedagogical phases of: theory apprehension, experimental learning, operationalization, and clinical supervision. Outcome assessments will focus on: a) health and quality of life (primary outcomes), thriving and satisfaction with care for older people; b) caregiver strain, informal caregiving engagement and relatives' satisfaction with care: c) job satisfaction and stress of conscience among care staff (secondary outcomes). Evaluation will be conducted by means of self-reported questionnaires and qualitative research interviews. Person-centred home care services have the potential to improve the recurrently reported sub-standard experiences of home care services, and the results can point the way to establishing a more person-centred and health-promoting model for home care services for older people. NCT02846246 .

  4. Prehospital fast track care for patients with hip fracture: Impact on time to surgery, hospital stay, post-operative complications and mortality a randomised, controlled trial.

    Science.gov (United States)

    Larsson, Glenn; Strömberg, Rn Ulf; Rogmark, Cecilia; Nilsdotter, Anna

    2016-04-01

    Ambulance organisations in Sweden have introduced prehospital fast track care (PFTC) for patients with suspected hip fracture. This means that the ambulance nurse starts the pre-operative procedure otherwise implemented at the accident & emergency ward (A&E) and transports the patient directly to the radiology department instead of A&E. If the diagnosis is confirmed, the patient is transported directly to the orthopaedic ward. No previous randomised, controlled studies have analysed PFTC to describe its possible advantages. The aim of this study is to examine whether PFTC has any impact on outcomes such as time to surgery, length of stay, post-operative complications and mortality. The design of this study is a prehospital randomised, controlled study, powered to include 400 patients. The patients were randomised into PFTC or the traditional care pathway (A&E group). Time from arrival to start for X-ray was faster for PFTC (mean, 28 vs. 145 min; pstart of X-ray to start of surgery (mean 18.40 h in both groups). No significant differences between the groups were observed with regard to: time from arrival to start of surgery (p=0.07); proportion operated within 24h (79% PFTC, 75% A&E; p=0.34); length of stay (p=0.34); post-operative complications (p=0.75); and 4 month mortality (18% PFTC, 15% A&E p=0.58). PFTC improved time to X-ray and admission to a ward, as expected, but did not significantly affect time to start of surgery, length of stay, post-operative complications or mortality. These outcomes were probably affected by other factors at the hospital. Patients with either possible life-threatening conditions or life-threatening conditions prehospital were excluded. Copyright © 2016 Elsevier Ltd. All rights reserved.

  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.

    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

  6. 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

  7. A mobile phone application for the assessment and management of youth mental health problems in primary care: health service outcomes from a randomised controlled trial of mobiletype.

    Science.gov (United States)

    Reid, Sophie C; Kauer, Sylvia D; Hearps, Stephen J C; Crooke, Alexander H D; Khor, Angela S; Sanci, Lena A; Patton, George C

    2013-06-19

    GPs detect at best 50c of mental health problems in young people. Barriers to detecting mental health problems include lack of screening tools, limited appointment times and young people's reluctance to report mental health symptoms to GPs. The mobiletype program is a mobile phone mental health assessment and management application which monitors mood, stress and everyday activities then transmits this information to general practitioners (GPs) via a secure website in summary format for medical review. The current aims were to examine: (i) mobiletype as a clinical assistance tool, ii) doctor-patient rapport and, iii) pathways to care. We conducted a randomised controlled trial in primary care with patients aged 14 to 24 years recruited from rural and metropolitan general practices. GPs identified and referred eligible participants (those with mild or more mental health concerns) who were randomly assigned to either the intervention group (where mood, stress and daily activities were monitored) or the attention-comparison group (where only daily activities were monitored). Both groups self-monitored for 2 to 4 weeks and reviewed the monitoring data with their GP. GPs, participants and researchers were blind to group allocation at randomisation. GPs assessed the mobiletype program as a clinical assistant tool. Doctor-patient rapport was assessed using the General Practice Assessment Questionnaire Communication and Enablement subscales, and the Trust in Physician Scale (TPS). Pathways to care was measured using The Party Project's Exit Interview. Of the 163 participants assessed for eligibility, 118 were randomised and 114 participants were included in analyses (intervention n = 68, attention-comparison n = 46). T-tests showed that the intervention program increased understanding of patient mental health, assisted in decisions about medication/referral and helped in diagnosis when compared to the attention-comparison program. Mixed model analysis showed no

  8. 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

  9. 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

  10. Comparison between treatment effects in a randomised controlled trial and an observational study using propensity scores in primary care

    NARCIS (Netherlands)

    Stuart, Beth L.; Grebel, Louise E.N.; Butler, Christopher C.; Hood, Kerenza; Verheij, Theo J.M.; Little, Paul

    2017-01-01

    Background  Although randomised controlled trials (RCTs) are considered 'gold standard' evidence, they are not always feasible or appropriate, and may represent a select population. Observational studies provide a useful alternative to enhance applicability, but results can be biased due to

  11. Protocol for the Northern Manhattan Diabetes Community Outreach Project. A randomised trial of a community health worker intervention to improve diabetes care in Hispanic adults.

    Science.gov (United States)

    Palmas, Walter; Teresi, Jeanne A; Findley, Sally; Mejia, Miriam; Batista, Milagros; Kong, Jian; Silver, Stephanie; Luchsinger, Jose A; Carrasquillo, Olveen

    2012-01-01

    Hispanics in the USA are affected by the diabetes epidemic disproportionately, and they consistently have lower access to care, poorer control of the disease and higher risk of complications. This study evaluates whether a community health worker (CHW) intervention may improve clinically relevant markers of diabetes care in adult underserved Hispanics. The Northern Manhattan Diabetes Community Outreach Project (NOCHOP) is a two-armed randomised controlled trial to be performed as a community-based participatory research study performed in a Primary Care Setting in Northern Manhattan (New York City). 360 Hispanic adults with poorly controlled type 2 diabetes mellitus (haemoglobin A1c >8%), aged 35-70 years, will be randomised at a 1:1 ratio, within Primary Care Provider clusters. The two study arms are (1) a 12-month CHW intervention and (2) enhanced usual care (educational materials mailed at 4-month intervals, preceded by phone calls). The end points, assessed after 12 months, are primary = haemoglobin A1c and secondary = blood pressure and low-density lipoprotein-cholesterol levels. In addition, the study will describe the CHW intervention in terms of components and intensity and will assess its effects on (1) medication adherence, (2) medication intensification, (3) diet and (4) physical activity. All participants will provide informed consent; the study protocol has been approved by the Institutional Review Board of Columbia University Medical Center. CHW interventions hold great promise in improving the well-being of minority populations who suffer from diabetes mellitus. The NOCHOP study will provide valuable information about the efficacy of those interventions vis-à-vis clinically relevant end points and will inform policy makers through a detailed characterisation of the programme and its effects. NCT00787475 at clinicaltrials.gov.

  12. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2): a randomised trial to determine the effectiveness and cost-effectiveness of adding a complex intervention for major depressive disorder to usual care for cancer patients.

    Science.gov (United States)

    Walker, Jane; Cassidy, Jim; Sharpe, Michael

    2009-03-30

    Depression Care for People with Cancer is a complex intervention delivered by specially trained cancer nurses, under the supervision of a psychiatrist. It is given as a supplement to the usual care for depression, which patients receive from their general practitioner and cancer service. In a 'proof of concept' trial (Symptom Management Research Trials in Oncology-1) Depression Care for People with Cancer improved depression more than usual care alone. The second Symptom Management Research Trial in Oncology (SMaRT Oncology-2 Trial) will test its effectiveness and cost-effectiveness in a 'real world' setting. A two arm parallel group multi-centre randomised controlled trial. TRIAL PROCEDURES: 500 patients will be recruited through established systematic Symptom Monitoring Services, which screen patients for depression. Patients will have: a diagnosis of cancer (of various types); an estimated life expectancy of twelve months or more and a diagnosis of Major Depressive Disorder. Patients will be randomised to usual care or usual care plus Depression Care for People with Cancer. Randomisation will be carried out by telephoning a secure computerised central randomisation system or by using a secure web interface. The primary outcome measure is 'treatment response' measured at 24 week outcome data collection. 'Treatment response' will be defined as a reduction of 50% or more in the patient's baseline depression score, measured using the 20-item Symptom Checklist (SCL-20D). Secondary outcomes include remission of major depressive disorder, depression severity and patients' self-rated improvement of depression. Current controlled trials ISRCTN40568538 TRIAL HYPOTHESES: (1) Depression Care for People with Cancer as a supplement to usual care will be more effective than usual care alone in achieving a 50% reduction in baseline SCL-20D score at 24 weeks. (2) Depression Care for People with Cancer as a supplement to usual care will cost more than usual care alone but will be

  13. Manual acupuncture plus usual care versus usual care alone in the treatment of endometriosis-related chronic pelvic pain: study protocol for a randomised controlled feasibility study.

    Science.gov (United States)

    Armour, Mike; Smith, Caroline A; Schabrun, Siobhan; Steiner, Genevieve Z; Zhu, Xiaoshu; Lawson, Kenny; Song, Jing

    2018-01-01

    Endometriosis is the most common cause of chronic pelvic pain worldwide. Non-surgical treatments are effective for only 30-50% of women and have a significant side effect burden that leads to high discontinuation rates. Surgery can be effective but is expensive and invasive, and symptoms tend to recur within 5 years. There is early evidence that acupuncture may be effective in treating endometriosis-related chronic pelvic pain, showing clinically significant analgesia. Both levels of inflammation and pain processing have been shown to be altered in women with chronic pelvic pain. Acupuncture has been shown to reduce inflammation and change central pain processing in other conditions, but research on women with endometriosis is currently lacking. The aim of this feasibility study is to provide data on recruitment rates, retention, appropriateness of outcome measures, minimal clinically important difference in numeric rated scales for pain and the potential effect of acupuncture on pain processing and markers of inflammation in endometriosis-related CPP. We will include women aged 18-45 years with a diagnosis of endometriosis via laparoscopy in the past 5 years. A total of 30 participants will be recruited and randomly allocated in a 1:1 ratio to receive acupuncture or usual care. Women in the acupuncture group will receive two 45-min treatment sessions per week for 8 weeks (total of 16 sessions). Women in the usual care group will continue with their current treatment regimen. The primary feasibility outcomes are recruitment rates, retention rates and the safety and acceptability of the intervention; secondary patient-centred outcomes include a change in 0-10 daily pelvic pain ratings, the Endometriosis Health Profile 30 (EHP-30) and changes in conditioned pain modulation, resting and task-related EEG activity and inflammatory markers. Analyses will be performed blind to group allocation. This is a two-armed, assessor blind, randomised controlled feasibility

  14. Kangaroo mother method: randomised controlled trial of an alternative method of care for stabilised low-birthweight infants. Maternidad Isidro Ayora Study Team.

    Science.gov (United States)

    Sloan, N L; Camacho, L W; Rojas, E P; Stern, C

    1994-09-17

    Because resources for care of low-birthweight (LBW) infants in developing countries are scarce, the Kangaroo mother method (KMM) was developed. The infant is kept upright in skin-to-skin contact with the mother's breast. Previous studies reported several benefits with the KMM but interpretation of their findings is limited by small size and design weaknesses. We have done a longitudinal, randomised, controlled trial at the Isidro Ayora Maternity Hospital in Quito, Ecuador. Infants with LBW (groups (n = 128 and 147, respectively). During 6 months of follow-up the KMM group had a significantly lower rate than the control group of serious illness (lower-respiratory-tract disorders, apnoea, aspiration, pneumonia, septicaemia, general infections; 7 [5%] vs 27 [18%], p groups in less severe morbidity were not significant. There was no significant difference in growth or in the proportion of women breastfeeding, perhaps because the proportion breastfeeding was high in both groups owing to strong promotion. Mortality was the same in both groups; most deaths occurred during the stabilisation period before randomisation. KMM mothers made more unscheduled clinic visits than control mothers but their infants had fewer re-admissions and so the cost of care was lower with the KMM. Since the eligibility criteria excluded nearly 50% of LBW infants from the study, the KMM is not universally applicable to these infants. The benefits might be greater in populations where breastfeeding is not so common.

  15. Study rationale and design of OPTIMISE, a randomised controlled trial on the effect of benchmarking on quality of care in type 2 diabetes mellitus

    Science.gov (United States)

    2011-01-01

    Background To investigate the effect of physician- and patient-specific feedback with benchmarking on the quality of care in adults with type 2 diabetes mellitus (T2DM). Methods Study centres in six European countries were randomised to either a benchmarking or control group. Physicians in both groups received feedback on modifiable outcome indicators (glycated haemoglobin [HbA1c], glycaemia, total cholesterol, high density lipoprotein-cholesterol, low density lipoprotein [LDL]-cholesterol and triglycerides) for each patient at 0, 4, 8 and 12 months, based on the four times yearly control visits recommended by international guidelines. The benchmarking group also received comparative results on three critical quality indicators of vascular risk (HbA1c, LDL-cholesterol and systolic blood pressure [SBP]), checked against the results of their colleagues from the same country, and versus pre-set targets. After 12 months of follow up, the percentage of patients achieving the pre-determined targets for the three critical quality indicators will be assessed in the two groups. Results Recruitment was completed in December 2008 with 3994 evaluable patients. Conclusions This paper discusses the study rationale and design of OPTIMISE, a randomised controlled study, that will help assess whether benchmarking is a useful clinical tool for improving outcomes in T2DM in primary care. Trial registration NCT00681850 PMID:21939502

  16. 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

  17. CASPER plus (CollAborative care in Screen-Positive EldeRs with major depressive disorder): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Overend, Karen; Lewis, Helen; Bailey, Della; Bosanquet, Kate; Chew-Graham, Carolyn; Ekers, David; Gascoyne, Samantha; Hems, Deborah; Holmes, John; Keding, Ada; McMillan, Dean; Meer, Shaista; Meredith, Jodi; Mitchell, Natasha; Nutbrown, Sarah; Parrott, Steve; Richards, David; Traviss, Gemma; Trépel, Dominic; Woodhouse, Rebecca; Gilbody, Simon

    2014-11-19

    Depression accounts for the greatest disease burden of all mental health disorders, contributes heavily to healthcare costs, and by 2020 is set to become the second largest cause of global disability. Although 10% to 16% of people aged 65 years and over are likely to experience depressive symptoms, the condition is under-diagnosed and often inadequately treated in primary care. Later-life depression is associated with chronic illness and disability, cognitive impairment and social isolation. With a progressively ageing population it becomes increasingly important to refine strategies to identity and manage depression in older people. Currently, management may be limited to the prescription of antidepressants where there may be poor concordance; older people may lack awareness of psychosocial interventions and general practitioners may neglect to offer this treatment option. CASPER Plus is a multi-centre, randomised controlled trial of a collaborative care intervention for individuals aged 65 years and over experiencing moderate to severe depression. Selected practices in the North of England identify potentially eligible patients and invite them to participate in the study. A diagnostic interview is carried out and participants with major depressive disorder are randomised to either collaborative care or usual care. The recruitment target is 450 participants. The intervention, behavioural activation and medication management in a collaborative care framework, has been adapted to meet the complex needs of older people. It is delivered over eight to 10 weekly sessions by a case manager liaising with general practitioners. The trial aims to evaluate the clinical and cost effectiveness of collaborative care in addition to usual GP care versus usual GP care alone. The primary clinical outcome, depression severity, will be measured with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 4, 12 and 18 months. Cost effectiveness analysis will assess health

  18. 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

  19. Prophylactic platelet transfusion plus supportive care versus supportive care alone in adults with dengue and thrombocytopenia: a multicentre, open-label, randomised, superiority trial.

    Science.gov (United States)

    Lye, David C; Archuleta, Sophia; Syed-Omar, Sharifah F; Low, Jenny G; Oh, Helen M; Wei, Yuan; Fisher, Dale; Ponnampalavanar, Sasheela S L; Wijaya, Limin; Lee, Linda K; Ooi, Eng-Eong; Kamarulzaman, Adeeba; Lum, Lucy C; Tambyah, Paul A; Leo, Yee-Sin

    2017-04-22

    Dengue is the commonest vector-borne infection worldwide. It is often associated with thrombocytopenia, and prophylactic platelet transfusion is widely used despite the dearth of robust evidence. We aimed to assess the efficacy and safety of prophylactic platelet transfusion in the prevention of bleeding in adults with dengue and thrombocytopenia. We did an open-label, randomised, superiority trial in five hospitals in Singapore and Malaysia. We recruited patients aged at least 21 years who had laboratory-confirmed dengue (confirmed or probable) and thrombocytopenia (≤20 000 platelets per μL), without persistent mild bleeding or any severe bleeding. Patients were assigned (1:1), with randomly permuted block sizes of four or six and stratified by centre, to receive prophylactic platelet transfusion in addition to supportive care (transfusion group) or supportive care alone (control group). In the transfusion group, 4 units of pooled platelets were given each day when platelet count was 20 000 per μL or lower; supportive care consisted of bed rest, fluid therapy, and fever and pain medications. The primary endpoint was clinical bleeding (excluding petechiae) by study day 7 or hospital discharge (whichever was earlier), analysed by intention to treat. Safety outcomes were analysed according to the actual treatment received. This study was registered with ClinicalTrials.gov, number NCT01030211, and is completed. Between April 29, 2010, and Dec 9, 2014, we randomly assigned 372 patients to the transfusion group (n=188) or the control group (n=184). The intention-to-treat analysis included 187 patients in the transfusion group (one patient was withdrawn immediately) and 182 in the control group (one was withdrawn immediately and one did not have confirmed or probable dengue). Clinical bleeding by day 7 or hospital discharge occurred in 40 (21%) patients in the transfusion group and 48 (26%) patients in the control group (risk difference -4·98% [95% CI -15·08 to

  20. RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final

  1. RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

    2013-07-02

    People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the

  2. Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study.

    Science.gov (United States)

    Dorward, Jienchi; Garrett, Nigel; Quame-Amaglo, Justice; Samsunder, Natasha; Ngobese, Hope; Ngomane, Noluthando; Moodley, Pravikrishnen; Mlisana, Koleka; Schaafsma, Torin; Donnell, Deborah; Barnabas, Ruanne; Naidoo, Kogieleum; Abdool Karim, Salim; Celum, Connie; Drain, Paul K

    2017-09-27

    Achieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shifting to enrolled nurses is non-inferior and cost-effective compared with laboratory-based VL monitoring and standard HIV care. The STREAM (Simplifying HIV TREAtment and Monitoring) study is an open-label, non-inferiority, randomised controlled implementation trial. HIV-positive adults, clinically stable at 6 months after ART initiation, will be recruited in a large urban clinic in South Africa. Approximately 396 participants will be randomised 1:1 to receive POC HIV VL monitoring and potential task shifting to enrolled nurses, versus laboratory VL monitoring and standard South African HIV care. Initial clinic follow-up will be 2-monthly in both arms, with VL testing at enrolment, 6 months and 12 months. At 6 months (1 year after ART initiation), stable participants in both arms will qualify for a differentiated care model involving decentralised ART pickup at community-based pharmacies. The primary outcome is retention in care and virological suppression at 12 months from enrolment. Secondary outcomes include time to appropriate entry into the decentralised ART delivery programme, costs per virologically suppressed patient and cost-effectiveness of the intervention compared with standard care. Findings will inform the scale up of VL testing and differentiated care in HIV-endemic resource-limited settings. Ethical approval has been granted by the University of KwaZulu-Natal Biomedical Research Ethics Committee (BFC296/16) and University of Washington Institutional Review Board (STUDY

  3. Building the capacity of family day care educators to promote children's social and emotional wellbeing: an exploratory cluster randomised controlled trial

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    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

  4. 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.

  5. The European quality of care pathways (EQCP study on the impact of care pathways on interprofessional teamwork in an acute hospital setting: study protocol: for a cluster randomised controlled trial and evaluation of implementation processes

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    Deneckere Svin

    2012-05-01

    Full Text Available Abstract Background Although care pathways are often said to promote teamwork, high-level evidence that supports this statement is lacking. Furthermore, knowledge on conditions and facilitators for successful pathway implementation is scarce. The objective of the European Quality of Care Pathway (EQCP study is therefore to study the impact of care pathways on interprofessional teamwork and to build up understanding on the implementation process. Methods/design An international post-test-only cluster Randomised Controlled Trial (cRCT, combined with process evaluations, will be performed in Belgium, Ireland, Italy, and Portugal. Teams caring for proximal femur fracture (PFF patients and patients hospitalized with an exacerbation of chronic obstructive pulmonary disease (COPD will be randomised into an intervention and control group. The intervention group will implement a care pathway for PFF or COPD containing three active components: a formative evaluation of the actual teams’ performance, a set of evidence-based key interventions, and a training in care pathway-development. The control group will provide usual care. A set of team input, process and output indicators will be used as effect measures. The main outcome indicator will be relational coordination. Next to these, process measures during and after pathway development will be used to evaluate the implementation processes. In total, 132 teams have agreed to participate, of which 68 were randomly assigned to the intervention group and 64 to the control group. Based on power analysis, a sample of 475 team members per arm is required. To analyze results, multilevel analysis will be performed. Discussion Results from our study will enhance understanding on the active components of care pathways. Through this, preferred implementation strategies can be defined. Trail registration NCT01435538

  6. A mobile phone application for the assessment and management of youth mental health problems in primary care: a randomised controlled trial.

    Science.gov (United States)

    Reid, Sophie C; Kauer, Sylvia D; Hearps, Stephen J C; Crooke, Alexander H D; Khor, Angela S; Sanci, Lena A; Patton, George C

    2011-11-29

    Over 75% of mental health problems begin in adolescence and primary care has been identified as the target setting for mental health intervention by the World Health Organisation. The mobiletype program is a mental health assessment and management mobile phone application which monitors mood, stress, coping strategies, activities, eating, sleeping, exercise patterns, and alcohol and cannabis use at least daily, and transmits this information to general practitioners (GPs) via a secure website in summary format for medical review. We conducted a randomised controlled trial in primary care to examine the mental health benefits of the mobiletype program. Patients aged 14 to 24 years were recruited from rural and metropolitan general practices. GPs identified and referred eligible participants (those with mild or more mental health concerns) who were randomly assigned to either the intervention group (where mood, stress, and daily activities were monitored) or the attention comparison group (where only daily activities were monitored). Both groups self-monitored for 2 to 4 weeks and reviewed the monitoring data with their GP. GPs, participants, and researchers were blind to group allocation at randomisation. Participants completed pre-, post-, and 6-week post-test measures of the Depression, Anxiety, Stress Scale and an Emotional Self Awareness (ESA) Scale. Of the 163 participants assessed for eligibility, 118 were randomised and 114 participants were included in analyses (intervention group n = 68, comparison group n = 46). Mixed model analyses revealed a significant group by time interaction on ESA with a medium size of effect suggesting that the mobiletype program significantly increases ESA compared to an attention comparison. There was no significant group by time interaction for depression, anxiety, or stress, but a medium to large significant main effect for time for each of these mental health measures. Post-hoc analyses suggested that participation in the RCT

  7. A mobile phone application for the assessment and management of youth mental health problems in primary care: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Reid Sophie C

    2011-11-01

    Full Text Available Abstract Background Over 75% of mental health problems begin in adolescence and primary care has been identified as the target setting for mental health intervention by the World Health Organisation. The mobiletype program is a mental health assessment and management mobile phone application which monitors mood, stress, coping strategies, activities, eating, sleeping, exercise patterns, and alcohol and cannabis use at least daily, and transmits this information to general practitioners (GPs via a secure website in summary format for medical review. Methods We conducted a randomised controlled trial in primary care to examine the mental health benefits of the mobiletype program. Patients aged 14 to 24 years were recruited from rural and metropolitan general practices. GPs identified and referred eligible participants (those with mild or more mental health concerns who were randomly assigned to either the intervention group (where mood, stress, and daily activities were monitored or the attention comparison group (where only daily activities were monitored. Both groups self-monitored for 2 to 4 weeks and reviewed the monitoring data with their GP. GPs, participants, and researchers were blind to group allocation at randomisation. Participants completed pre-, post-, and 6-week post-test measures of the Depression, Anxiety, Stress Scale and an Emotional Self Awareness (ESA Scale. Results Of the 163 participants assessed for eligibility, 118 were randomised and 114 participants were included in analyses (intervention group n = 68, comparison group n = 46. Mixed model analyses revealed a significant group by time interaction on ESA with a medium size of effect suggesting that the mobiletype program significantly increases ESA compared to an attention comparison. There was no significant group by time interaction for depression, anxiety, or stress, but a medium to large significant main effect for time for each of these mental health measures. Post

  8. 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

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    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

  9. A randomised, feasibility trial of a tele-health intervention for Acute Coronary Syndrome patients with depression ('MoodCare': Study protocol

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    Hare David L

    2011-02-01

    Full Text Available Abstract Background Coronary heart disease (CHD and depression are leading causes of disease burden globally and the two often co-exist. Depression is common after Myocardial Infarction (MI and it has been estimated that 15-35% of patients experience depressive symptoms. Co-morbid depression can impair health related quality of life (HRQOL, decrease medication adherence and appropriate utilisation of health services, lead to increased morbidity and suicide risk, and is associated with poorer CHD risk factor profiles and reduced survival. We aim to determine the feasibility of conducting a randomised, multi-centre trial designed to compare a tele-health program (MoodCare for depression and CHD secondary prevention, with Usual Care (UC. Methods Over 1600 patients admitted after index admission for Acute Coronary Syndrome (ACS are being screened for depression at six metropolitan hospitals in the Australian states of Victoria and Queensland. Consenting participants are then contacted at two weeks post-discharge for baseline assessment. One hundred eligible participants are to be randomised to an intervention or a usual medical care control group (50 per group. The intervention consists of up to 10 × 30-40 minute structured telephone sessions, delivered by registered psychologists, commencing within two weeks of baseline screening. The intervention focuses on depression management, lifestyle factors (physical activity, healthy eating, smoking cessation, alcohol intake, medication adherence and managing co-morbidities. Data collection occurs at baseline (Time 1, 6 months (post-intervention (Time 2, 12 months (Time 3 and 24 months follow-up for longer term effects (Time 4. We are comparing depression (Cardiac Depression Scale [CDS] and HRQOL (Short Form-12 [SF-12] scores between treatment and UC groups, assessing the feasibility of the program through patient acceptability and exploring long term maintenance effects. A cost-effectiveness analysis of

  10. Multicentre randomised study of the effect and experience of an early inhome programme (PreHomeCare) for preterm infants using video consultation and smartphone applications compared with inhospital consultations: protocol of the PreHomeCare study.

    Science.gov (United States)

    Hägi-Pedersen, Mai-Britt; Norlyk, Annelise; Dessau, Ram; Stanchev, Hristo; Kronborg, Hanne

    2017-03-09

    Although premature infants and their parents are discharged earlier to inhomecare programmes, how to optimally support parents during this transition remains unknown. The aim of this study is to compare the effects of early inhomecare (PreHomeCare) including video consultations and mobile applications with those of inhospital consultations regarding breast feeding, parental confidence and parent-infant interactions. A randomised controlled intervention study will be conducted in four neonatal departments offering PreHomeCare (ie, premature infant inhomecare) in Denmark. Parents of hospitalised premature infants who fulfil the inclusion criteria for PreHomeCare will be randomised during hospitalisation to either the intervention (n=80) or control group (n=80) using 1:1 block randomisation. During PreHomeCare, the intervention group will receive a smartphone application with a video system and an infant scale, and the control group will receive usual care (ie, hospital consultations). Additionally, both groups will have planned nurse consultations two to three times a week: the intervention group through video consultations and the control group through inhospital consultations. Data collection will occur at inclusion/baseline, at the end of PreHomeCare and 1 month after discharge using questionnaires and hospital records. The primary outcome is the proportion of exclusively breastfed infants 1 month after discharge/end of PreHomeCare, the secondary outcomes are parent-infant interactions measured by the Mother and baby interaction scale and family confidence in caring for infants measured by the Karitane Parenting Confidence Scale. The process evaluation will consist of two qualitative studies: a field study and an interview study. Data collection will initially involve field observations of three scheduled video consultations with six families from the intervention group. These families will also be interviewed 1 month after PreHomeCare has ended. The project

  11. 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.

  12. Ballistic strength training compared with usual care for improving mobility following traumatic brain injury: protocol for a randomised, controlled trial.

    Science.gov (United States)

    Williams, Gavin; Ada, Louise; Hassett, Leanne; Morris, Meg E; Clark, Ross; Bryant, Adam L; Olver, John

    2016-07-01

    Traumatic brain injury is the leading cause of disability in young adults aged 15 to 45 years. Mobility limitations are prevalent, and range in severity from interfering with basic day-to-day tasks to restricting participation in higher level social, leisure, employment and sporting activities. Despite the prevalence and severity of physical impairments, such as poor balance and spasticity, the main contributor to mobility limitations following traumatic brain injury is low muscle power generation. Strengthening exercises that are performed quickly are termed 'ballistic' as they are aimed at improving the rate of force production and, hence, muscle power. This is compared with conventional strength training, which is performed slowly and aims to improve maximum force production, yet has limited impact on mobility. In people recovering from traumatic brain injury: (1) is a 12-week ballistic strength-training program targeting the three muscle groups critical for walking more effective than usual care at improving mobility, strength and balance; and (2) does improved mobility translate to better health-related quality of life? A prospective, multi-centre, randomised, single-blind trial with concealed allocation will be conducted. Participants will be patients with a neurologically based movement disorder affecting mobility as a result of traumatic brain injury. Patients will be recruited during the acute phase of rehabilitation (n=166), from brain injury units in large metropolitan hospitals in Melbourne and Sydney, Australia. For 12 weeks, participants in the experimental group will have three 60-minute sessions of usual physiotherapy intervention replaced by three 60-minute sessions of strength training (ballistic strength, gait). The three key muscle groups responsible for forward propulsion will be targeted: ankle plantarflexors, hip flexors and the hip extensors. Initial loads will be low, to facilitate high contraction velocities. Progression to higher loads

  13. Enhanced interdisciplinary care improves self-care ability and decreases emergency department visits for older Taiwanese patients over 2 years after hip-fracture surgery: A randomised controlled trial.

    Science.gov (United States)

    Shyu, Yea-Ing L; Liang, Jersey; Tseng, Ming-Yueh; Li, Hsiao-Juan; Wu, Chi-Chuan; Cheng, Huey-Shinn; Chou, Shih-Wei; Chen, Ching-Yen; Yang, Ching-Tzu

    2016-04-01

    Little evidence is available on the longer-term effects (beyond 12 months) of intervention models consisting of hip fracture-specific care in conjunction with management of malnutrition, depression, and falls. To compare the relative effects of an interdisciplinary care, and a comprehensive care programme with those of usual care for elderly patients with a hip fracture on self-care ability, health care use, and mortality. Randomised experimental trial. A 3000-bed medical centre in northern Taiwan. Patients with hip fracture aged 60 years or older (N=299). Patients were randomly assigned to three groups: comprehensive care (n=99), interdisciplinary care (n=101), and usual care (control) (n=99). Usual care entailed only one or two in-hospital rehabilitation sessions. Interdisciplinary care included not only hospital rehabilitation, but also geriatric consultation, discharge planning, and 4-month in-home rehabilitation. Building upon interdisciplinary care, comprehensive care extended in-home rehabilitation to 12 months and added management of malnutrition and depressive symptoms, and fall prevention. Patients' self-care ability was measured by activities of daily living and instrumental activities of daily living using the Chinese Barthel Index and Chinese version Instrumental Activities of Daily Living scale, respectively. Outcomes were assessed before discharge, and 1, 3, 6, 12, 18, 24 months following hip fracture. Hierarchical linear models were used to analyse health outcomes and health care utilisation, including emergency department visit and hospital re-admission. The comprehensive care group had better performance trajectories for both measures of activities of daily living and fewer emergency department visits than the usual care group, but no difference in hospital readmissions. The interdisciplinary care and usual care groups did not differ in trajectories of self-care ability and service utilisation. The three groups did not differ in mortality during

  14. Protocol for Past BP: a randomised controlled trial of different blood pressure targets for people with a history of stroke of transient ischaemic attack (TIA in primary care

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    Greenfield Sheila

    2010-08-01

    Full Text Available Abstract Background Blood pressure (BP lowering in people who have had a stroke or transient ischaemic attack (TIA leads to reduced risk of further stroke. However, it is not clear what the target BP should be, since intensification of therapy may lead to additional adverse effects. PAST BP will determine whether more intensive BP targets can be achieved in a primary care setting, and whether more intensive therapy is associated with adverse effects on quality of life. Methods/Design This is a randomised controlled trial (RCT in patients with a past history of stroke or TIA. Patients will be randomised to two groups and will either have their blood pressure (BP lowered intensively to a target of 130 mmHg systolic, (or by 10 mmHg if the baseline systolic pressure is between 125 and 140 mmHg compared to a standard group where the BP will be reduced to a target of 140 mmHg systolic. Patients will be managed by their practice at 1-3 month intervals depending on level of BP and followed-up by the research team at six monthly intervals for 12 months. 610 patients will be recruited from approximately 50 general practices. The following exclusion criteria will be applied: systolic BP The primary outcome will be change in systolic BP over twelve months. Secondary outcomes include quality of life, adverse events and cardiovascular events. In-depth interviews with 30 patients and 20 health care practitioners will be undertaken to investigate patient and healthcare professionals understanding and views of BP management. Discussion The results of this trial will inform whether intensive blood pressure targets can be achieved in people who have had a stroke or TIA in primary care, and help determine whether or not further research is required before recommending such targets for this population. Trial Registration ISRCTN29062286

  15. Protocol for the melatools skin self-monitoring trial: a phase II randomised controlled trial of an intervention for primary care patients at higher risk of melanoma.

    Science.gov (United States)

    Mills, Katie; Emery, Jon; Lantaff, Rebecca; Radford, Michael; Pannebakker, Merel; Hall, Per; Burrows, Nigel; Williams, Kate; Saunders, Catherine L; Murchie, Peter; Walter, Fiona M

    2017-11-28

    Melanoma is the fifth most common cancer in the UK. Incidence rates have quadrupled over the last 30 years and continue to rise, especially among younger people. As routine screening of the general population is not currently recommended in the UK, a focus on secondary prevention through early detection and prompt treatment in individuals at increased risk of melanoma could make an important contribution to improve melanoma outcomes. This paper describes the protocol for a phase II, multisite, randomised controlled trial, in the primary care setting, for patients at increased risk of melanoma. A skin self-monitoring (SSM) smartphone 'App' was used to improve symptom appraisal and encourage help seeking in primary care, thereby promoting early presentation with skin changes suspicious of melanoma. We aim to recruit 200 participants from general practice waiting rooms in the East of England. Eligible patients are those identified at higher melanoma risk (using a real-time risk assessment tool), without a personal history of melanoma, aged 18 to 75 years. Participants will be invited to a primary care nurse consultation, and randomised to the intervention group (standard written advice on skin cancer detection and sun protection, loading of an SSM 'App' onto the participant's smartphone and instructions on use including self-monitoring reminders) or control group (standard written advice alone). The primary outcomes are consultation rates for changes to a pigmented skin lesion, and the patient interval (time from first noticing a skin change to consultation). Secondary outcomes include patient sun protection behaviours, psychosocial outcomes, and measures of trial feasibility and acceptability. NHS ethical approval has been obtained from Cambridgeshire and Hertfordshire research ethics committee (REC reference 16/EE/0248). The findings from the MelaTools SSM Trial will be disseminated widely through peer-reviewed publications and scientific conferences. ISCTRN16061621

  16. Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence.

    Science.gov (United States)

    Lamb, S E; Pepper, J; Lall, R; Jørstad-Stein, E C; Clark, M D; Hill, L; Fereday-Smith, J

    2009-09-14

    The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. The majority of women expressed no preference (55%) or preference for individual treatment (36%). Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference 52.91 pounds 95%, confidence interval ( 25.82 pounds- 80.00 pounds)). Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. ISRCTN 16772662.

  17. ParaMED Home: A protocol for a randomised controlled trial of paramedic assessment and referral to access medical care at home

    Directory of Open Access Journals (Sweden)

    Johnston Steven

    2011-06-01

    Full Text Available Abstract Background In Australia approximately 25% of Emergency Department (ED attendances are via ambulance. ED overcrowding in Australia, as in many countries, is common. Measures to reduce overcrowding include the provision of enhanced timely primary care in the community for appropriate low risk injury and illness. Therefore paramedic assessment and referral to a community home hospital service, in preference to transfer to ED, may confer clinical and cost benefit. Methods/Design A randomised controlled trial. Consenting adult patients that call an ambulance and are assessed by paramedics as having an eligible low risk problem will be randomised to referral to ED via ambulance transfer or referral to a rapid response service that will assess and treat the patient in their own residence. The primary outcome measure is requirement for unplanned medical attention (in or out of hospital in the first 48 hours. Secondary outcomes will include a number of other clinical endpoints. A cost effectiveness analysis will be conducted. Discussion If this trial demonstrates clinical non-inferiority and cost savings associated with the primary assessment service, it will provide one means to safely address ED overcrowding. Trial Registration Australian and New Zealand Clinical Trials Registry Number 12610001064099

  18. 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

  19. 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

  20. A Pragmatic Randomised, Controlled Trial of Intensive Care follow up programmes in improving Longer-term outcomes from critical illness. The PRACTICAL study

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    Ramsey Craig

    2007-07-01

    Full Text Available Abstract Background A number of intensive care (ICU patients experience significant problems with physical, psychological, and social functioning for some time after discharge from ICU. These problems have implications not just for patients, but impose a continuing financial burden for the National Health Service. To support recovery, a number of hospitals across the UK have developed Intensive Care follow-up clinics. However, there is a lack of evidence base to support these, and this study aims to test the hypothesis that intensive care follow up programmes are effective and cost-effective at improving physical and psychological quality of life in the year after intensive care discharge. Methods/Design This is a multi-centre, pragmatic, randomised controlled trial. Patients (n = 270 will be recruited prior to hospital discharge from three intensive care units in the UK, and randomised to one of two groups. The control group will receive standard in-hospital follow-up and the intervention group will participate in an ICU follow-up programme with clinic appointments 2–3 and 9 months after ICU discharge. The primary outcome measure is Health-related Quality of Life (HRQoL 12 months after ICU discharge as measured by the Short Form-36. Secondary measures include: HRQoL at six months; Quality-adjusted life years using EQ-5D; posttraumatic psychopathology as measured by Davidson Trauma Scale; and anxiety and depression using the Hospital Anxiety and Depression Scale at both six and twelve months after ICU discharge. Contacts with health services in the twelve months after ICU discharge will be measured as part of the economic analysis. Discussion The provision of intensive care follow-up clinics within the UK has developed in an ad hoc manner, is inconsistent in both the number of hospitals offering such a service or in the type of service offered. This study provides the opportunity to evaluate such services both in terms of patient benefit and

  1. 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

  2. Delivering early care in diabetes evaluation (DECIDE: a protocol for a randomised controlled trial to assess hospital versus home management at diagnosis in childhood diabetes

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    Robling Michael

    2011-01-01

    Full Text Available Abstract Background There is increased incidence of new cases of type 1 diabetes in children younger than 15 years. The debate concerning where best to manage newly diagnosed children continues. Some units routinely admit children to hospital whilst others routinely manage children at home. A Cochrane review identified the need for a large well-designed randomised controlled trial to investigate any significant differences in comprehensive short and long-term outcomes between the two approaches. The DECIDE study will address these knowledge gaps, providing high quality evidence to inform national and international policy and practice. Methods/Design This is a multi-centre randomised controlled trial across eight UK paediatric diabetes centres. The study aims to recruit 240 children newly diagnosed with type 1 diabetes and their parents/carers. Eligible patients (aged 0-17 years will be remotely randomised to either 'hospital' or 'home' management. Parents/carers of patients will also be recruited. Nursing management of participants and data collection will be co-ordinated by a project nurse at each centre. Data will be collected for 24 months after diagnosis; at follow up appointments at 3, 12 and 24 months and every 3-4 months at routine clinic visits. The primary outcome measure is patients' glycosylated haemoglobin (HbA1c at 24 months after diagnosis. Additional measurements of HbA1c will be made at diagnosis and 3 and 12 months later. HbA1c concentrations will be analysed at a central laboratory. Secondary outcome measures include length of stay at diagnosis, growth, adverse events, quality of life, anxiety, coping with diabetes, diabetes knowledge, home/clinic visits, self-care activity, satisfaction and time off school/work. Questionnaires will be sent to participants at 1, 12 and 24 months and will include a questionnaire, developed and validated to measure impact of the diagnosis on social activity and independence. Additional

  3. 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

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    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

  4. Coaching Older Adults and Carers to have their preferences Heard (COACH): A randomised controlled trial in an intermediate care setting (study protocol).

    Science.gov (United States)

    Masters, Stacey; Gordon, Jason; Whitehead, Craig; Davies, Owen; Giles, Lynne C; Ratcliffe, Julie

    2012-01-01

    Frail older people who are considering movement into residential aged care or returning home following a hospital admission often face complex and difficult decisions.Despite research interest in this area, a recent Cochrane review was unable to identify any studies of interventions to support decision-making in this group that met the experimental or quasi-experimental study design criteria. This study tests the impact of a multi-component coaching intervention on the quality of preparation for care transitions, targeted to older adults and informal carers. In addition, the study assesses the impact of investing specialist geriatric resources into consultations with families in an intermediate care setting where decisions about future care needs are being made. This study was a randomised controlled trial of 230 older adults admitted to intermediate care in Australia. Masked assessment at 3 and 12 months examined physical functioning, health-related quality of life and utilisation of health and aged care resources. A geriatrician and specialist nurse delivered a coaching intervention to both the older person and their carer/family. Components of the intervention included provision of a Question Prompt List prior to meeting with a geriatrician (to clarify medical conditions and treatments, medications, 'red flags', end of life decisions and options for future health care) and a follow-up meeting with a nurse who remained in telephone contact. Participants received a printed summary and an audio recording of the meeting with the geriatrician. The costs and outcomes of the intervention are compared with usual care. Australian New Zealand Clinical Trials Registry (ACTRN12607000638437).

  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.

    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.

  6. 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.

  7. The effect of a supportive educational intervention developed based on the Orem's self-care theory on the self-care ability of patients with myocardial infarction: a randomised controlled trial.

    Science.gov (United States)

    Mohammadpour, Ali; Rahmati Sharghi, Narjes; Khosravan, Shahla; Alami, Ali; Akhond, Majid

    2015-06-01

    The aim of this study was to assess the effect of a supportive educational intervention developed based on the Orem's self-care theory on the self-care ability of patients with myocardial infarction. Patients with cardiovascular disease suffer from the lack of knowledge about the disease and consequently are not able to fulfil their own self-care needs. This was a randomised controlled trial conducted in 2012. We recruited a random sample of 66 patients with myocardial infarction who had been recently discharged from coronary care unit. The study setting was two university hospitals located in Khorasan, Iran. Patients were randomly allocated to either the experimental or the control groups. Patients in the experimental group received education, support, and counselling while patients in the control group received no intervention. We employed a demographic questionnaire and the Myocardial Infarction Self-Care Ability Questionnaire for data collection and spss version 16.00 for data analysis. After the study, patients in the experimental group had higher levels of self-care knowledge, motivation and skills compared to the prestudy readings and the control group. The supportive educational intervention developed based on the Orem's self-care theory can improve nonhospitalised patients' self-care ability and positively affect public health outcomes. Consequently, using the developed programme for providing follow-up care to nonhospitalised patients is recommended. Having the ability to develop caring systems based on the nursing theories is a prerequisite to standard nursing practice. Identifying patients' educational needs is a fundamental prerequisite to patient education. Our findings revealed that the supportive educational intervention developed based on the Orem's self-care theory can help health care providers identify and fulfil patients' self-care needs. © 2015 John Wiley & Sons Ltd.

  8. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial.

    Science.gov (United States)

    Do, Nga T T; Ta, Ngan T D; Tran, Ninh T H; Than, Hung M; Vu, Bich T N; Hoang, Long B; van Doorn, H Rogier; Vu, Dung T V; Cals, Jochen W L; Chandna, Arjun; Lubell, Yoel; Nadjm, Behzad; Thwaites, Guy; Wolbers, Marcel; Nguyen, Kinh V; Wertheim, Heiman F L

    2016-09-01

    Inappropriate antibiotic use for acute respiratory tract infections is common in primary health care, but distinguishing serious from self-limiting infections is difficult, particularly in low-resource settings. We assessed whether C-reactive protein point-of-care testing can safely reduce antibiotic use in patients with non-severe acute respiratory tract infections in Vietnam. We did a multicentre open-label randomised controlled trial in ten primary health-care centres in northern Vietnam. Patients aged 1-65 years with at least one focal and one systemic symptom of acute respiratory tract infection were assigned 1:1 to receive either C-reactive protein point-of-care testing or routine care, following which antibiotic prescribing decisions were made. Patients with severe acute respiratory tract infection were excluded. Enrolled patients were reassessed on day 3, 4, or 5, and on day 14 a structured telephone interview was done blind to the intervention. Randomised assignments were concealed from prescribers and patients but not masked as the test result was used to assist treatment decisions. The primary outcome was antibiotic use within 14 days of follow-up. All analyses were prespecified in the protocol and the statistical analysis plan. All analyses were done on the intention-to-treat population and the analysis of the primary endpoint was repeated in the per-protocol population. This trial is registered under number NCT01918579. Between March 17, 2014, and July 3, 2015, 2037 patients (1028 children and 1009 adults) were enrolled and randomised. One adult patient withdrew immediately after randomisation. 1017 patients were assigned to receive C-reactive protein point-of-care testing, and 1019 patients were assigned to receive routine care. 115 patients in the C-reactive protein point-of-care group and 72 patients in the routine care group were excluded in the intention-to-treat analysis due to missing primary endpoint. The number of patients who used antibiotics

  9. Evaluating the impact of a 'virtual clinic' on patient experience, personal and provider costs of care in urinary incontinence: A randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Georgina Jones

    Full Text Available To evaluate the impact of using a 'virtual clinic' on patient experience and cost in the care of women with urinary incontinence.Women, aged > 18 years referred to a urogynaecology unit were randomised to either (1 A Standard Clinic or (2 A Virtual Clinic. Both groups completed a validated, web-based interactive, patient-reported outome measure (ePAQ-Pelvic Floor, in advance of their appointment followed by either a telephone consultation (Virtual Clinic or face-to-face consultation (Standard Care. The primary outcome was the mean 'short-term outcome scale' score on the Patient Experience Questionnaire (PEQ. Secondary Outcome Measures included the other domains of the PEQ (Communications, Emotions and Barriers, Client Satisfaction Questionnaire (CSQ, Short-Form 12 (SF-12, personal, societal and NHS costs.195 women were randomised: 98 received the intervention and 97 received standard care. The primary outcome showed a non-significant difference between the two study arms. No significant differences were also observed on the CSQ and SF-12. However, the intervention group showed significantly higher PEQ domain scores for Communications, Emotions and Barriers (including following adjustment for age and parity. Whilst standard care was overall more cost-effective, this was minimal (£38.04. The virtual clinic also significantly reduced consultation time (10.94 minutes, compared with a mean duration of 25.9 minutes respectively and consultation costs compared to usual care (£31.75 versus £72.17 respectively, thus presenting potential cost-savings in out-patient management.The virtual clinical had no impact on the short-term dimension of the PEQ and overall was not as cost-effective as standard care, due to greater clinic re-attendances in this group. In the virtual clinic group, consultation times were briefer, communication experience was enhanced and personal costs lower. For medical conditions of a sensitive or intimate nature, a virtual clinic

  10. Task shifting of antiretroviral treatment from doctors to primary-care nurses in South Africa (STRETCH): a pragmatic, parallel, cluster-randomised trial.

    Science.gov (United States)

    Fairall, Lara; Bachmann, Max O; Lombard, Carl; Timmerman, Venessa; Uebel, Kerry; Zwarenstein, Merrick; Boulle, Andrew; Georgeu, Daniella; Colvin, Christopher J; Lewin, Simon; Faris, Gill; Cornick, Ruth; Draper, Beverly; Tshabalala, Mvula; Kotze, Eduan; van Vuuren, Cloete; Steyn, Dewald; Chapman, Ronald; Bateman, Eric

    2012-09-08

    Robust evidence of the effectiveness of task shifting of antiretroviral therapy (ART) from doctors to other health workers is scarce. We aimed to assess the effects on mortality, viral suppression, and other health outcomes and quality indicators of the Streamlining Tasks and Roles to Expand Treatment and Care for HIV (STRETCH) programme, which provides educational outreach training of nurses to initiate and represcribe ART, and to decentralise care. We undertook a pragmatic, parallel, cluster-randomised trial in South Africa between Jan 28, 2008, and June 30, 2010. We randomly assigned 31 primary-care ART clinics to implement the STRETCH programme (intervention group) or to continue with standard care (control group). The ratio of randomisation depended on how many clinics were in each of nine strata. Two cohorts were enrolled: eligible patients in cohort 1 were adults (aged ≥16 years) with CD4 counts of 350 cells per μL or less who were not receiving ART; those in cohort 2 were adults who had already received ART for at least 6 months and were being treated at enrolment. The primary outcome in cohort 1 was time to death (superiority analysis). The primary outcome in cohort 2 was the proportion with undetectable viral loads (baseline CD4 counts of 201-350 cells per μL, mortality was slightly lower in the intervention group than in the control group (0·73, 0·54-1.00; p=0·052), but it did not differ between groups in patients with baseline CD4 of 200 cells per μL or less (0·94, 0·76-1·15; p=0·577). In cohort 2, viral load suppression 12 months after enrolment was equivalent in intervention (2156 [71%] of 3029 patients) and control groups (2230 [70%] of 3202; risk difference 1·1%, 95% CI -2·4 to 4·6). Expansion of primary-care nurses' roles to include ART initiation and represcription can be done safely, and improve health outcomes and quality of care, but might not reduce time to ART or mortality. UK Medical Research Council, Development Cooperation

  11. 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.

  12. Effectiveness and cost-effectiveness of a proactive, goal-oriented, integrated care model in general practice for older people. A cluster randomised controlled trial: Integrated Systematic Care for older People--the ISCOPE study.

    Science.gov (United States)

    Blom, Jeanet; den Elzen, Wendy; van Houwelingen, Anne H; Heijmans, Margot; Stijnen, Theo; Van den Hout, Wilbert; Gussekloo, Jacobijn

    2016-01-01

    older people often experience complex problems. Because of multiple problems, care for older people in general practice needs to shift from a 'problem-based, disease-oriented' care aiming at improvement of outcomes per disease to a 'goal-oriented care', aiming at improvement of functioning and personal quality of life, integrating all healthcare providers. Feasibility and cost-effectiveness of this proactive and integrated way of working are not yet established. cluster randomised trial. all persons aged ≥75 in 59 general practices (30 intervention, 29 control), with a combination of problems, as identified with a structured postal questionnaire with 21 questions on four health domains. for participants with problems on ≥3 domains, general practitioners (GPs) made an integrated care plan using a functional geriatric approach. Control practices: care as usual. (i) quality of life (QoL), (ii) activities of daily living, (iii) satisfaction with delivered health care and (iv) cost-effectiveness of the intervention at 1-year follow-up. Netherlands trial register, NTR1946. of the 11,476 registered eligible older persons, 7,285 (63%) participated in the screening. One thousand nine hundred and twenty-one (26%) had problems on ≥3 health domains. For 225 randomly chosen persons, a care plan was made. No beneficial effects were found on QoL, patients' functioning or healthcare use/costs. GPs experienced better overview of the care and stability, e.g. less unexpected demands, in the care. GPs prefer proactive integrated care. 'Horizontal' care using care plans for older people with complex problems can be a valuable tool in general practice. However, no direct beneficial effect was found for older persons. © The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society.

  13. Effectiveness of manual therapy compared to usual care by the general practitioner for chronic tension-type headache: design of a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Dekker Joost

    2009-02-01

    Full Text Available Abstract Background Patients with Chronic Tension Type Headache (CTTH report functional and emotional impairments (loss of workdays, sleep disturbances, emotional well-being and are at risk for overuse of medication. Manual therapy may improve symptoms through mobilisation of the spine, correction of posture, and training of cervical muscles. We present the design of a randomised clinical trial (RCT evaluating the effectiveness of manual therapy (MT compared to usual care by the general practitioner (GP in patients with CTTH. Methods and design Patients are eligible for participation if they present in general practice with CTTH according to the classification of the International Headache Society (IHS. Participants are randomised to either usual GP care according to the national Dutch general practice guidelines for headache, or manual therapy, consisting of mobilisations (high- and low velocity techniques, exercise therapy for the cervical and thoracic spine and postural correction. The primary outcome measures are the number of headache days and use of medication. Secondary outcome measures are severity of headache, functional status, sickness absence, use of other healthcare resources, active cervical range of motion, algometry, endurance of the neckflexor muscles and head posture. Follow-up assessments are conducted after 8 and 26 weeks. Discussion This is a pragmatic trial in which interventions are offered as they are carried out in everyday practice. This increases generalisability of results, but blinding of patients, GPs and therapists is not possible. The results of this trial will contribute to clinical decision making of the GP regarding referral to manual therapy in patients with chronic tension headache.

  14. 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.

  15. Effects of communication training with the MAAS-Global-D instrument on the antibiotic prescribing for respiratory infections in primary care: study protocol of a randomised controlled trial.

    Science.gov (United States)

    Hammersen, Friederike; Goetz, Katja; Soennichsen, Andreas; Emcke, Timo; Steinhaeuser, Jost

    2016-04-02

    Primary care physicians account for the majority of antibiotic prescribing in ambulatory care in Germany. Respiratory diseases are, regardless of effectiveness, often treated with antibiotics. Research has found this use without indication to be caused largely by communication problems (e.g. expectations on the patient's part or false assumptions about them by the physician). The present randomised controlled trial (RCT) study evaluates whether communication training for primary care physicians can reduce the antibiotic prescribing rate for respiratory tract infections. The study consists of three groups: group A will receive communication training; group B will be given the same, plus additional, access to an evidence-based point-of-care tool; and group C will function as the control group. The primary endpoint is the difference between intervention and control groups regarding the antibiotic prescribing rate before and after the intervention assessed through routine data. The communication skills are captured with the help of the communication instrument MAAS-Global-D, as well as individual videos of physician-patient consultations recorded by the primary care physicians. These skills will also be regarded with respect to the antibiotic prescribing rate. A process evaluation using qualitative as well as quantitative methods should provide information about barriers and enablers to implementing the communication training. The trial contributes to an insight into the effectiveness of the different components to reduce antibiotic prescribing, which will also be supported by an extensive evaluation. Communication training could be an effective method of reducing antibiotic prescribing in primary care. DRKS00009566 DATE REGISTRATION: 5 November 2015.

  16. Effectiveness of a lifestyle exercise program for older people receiving a restorative home care service: study protocol for a pragmatic randomised controlled trial.

    Science.gov (United States)

    Burton, Elissa; Lewin, Gill; Clemson, Lindy; Boldy, Duncan

    2013-10-18

    Restorative home care services help older people maximise their independence using a multi-dimensional approach. They usually include an exercise program designed to improve the older person's strength, balance and function. The types of programs currently offered require allocation of time during the day to complete specific exercises. This is not how the majority of home care clients prefer to be active and may be one of the reasons that few older people do the exercises regularly and continue the exercises post discharge.This paper describes the study protocol to test whether a Lifestyle Functional Exercise (LiFE) program: 1) is undertaken more often; 2) is more likely to be continued over the longer term; and, 3) will result in greater functional gains compared to a standard exercise program for older people receiving a restorative home care service. A pragmatic randomised controlled trial (RCT) design was employed with two study arms: LiFE program (intervention) and the current exercise program (control). Silver Chain, a health and community care organisation in Perth, Western Australia. One hundred and fifty restorative home care clients, aged 65 years and older. The primary outcome is a composite measure incorporating balance, strength and mobility. Other outcome measures include: physical functioning, falls efficacy, and levels of disability and functioning. If LiFE is more effective than the current exercise program, the evidence will be presented to the service management accompanied by the recommendation that it be adopted as the generic exercise program to be used within the restorative home care service. Australian and New Zealand Clinical Trials Registry ACTRN12611000788976.

  17. Multi-professional clinical medication reviews in care homes for the elderly: study protocol for a randomised controlled trial with cost effectiveness analysis

    Directory of Open Access Journals (Sweden)

    Sach Tracey

    2011-10-01

    Full Text Available Abstract Background Evidence demonstrates that measures are needed to optimise therapy and improve administration of medicines in care homes for older people. The aim of this study is to determine the clinical and cost effectiveness of a novel model of multi-professional medication review. Methods A cluster randomised controlled trial design, involving thirty care homes. In line with current practice in medication reviews, recruitment and consent will be sought from general practitioners and care homes, rather than individual residents. Care homes will be segmented according to size and resident mix and allocated to the intervention arm (15 homes or control arm (15 homes sequentially using minimisation. Intervention homes will receive a multi-professional medication review at baseline and at 6 months, with follow-up at 12 months. Control homes will receive usual care (support they currently receive from the National Health Service, with data collection at baseline and 12 months. The novelty of the intervention is a review of medications by a multi-disciplinary team. Primary outcome measures are number of falls and potentially inappropriate prescribing. Secondary outcome measures include medication costs, health care resource use, hospitalisations and mortality. The null hypothesis proposes no difference in primary outcomes between intervention and control patients. The primary outcome variable (number of falls will be analysed using a linear mixed model, with the intervention specified as a fixed effect and care homes included as a random effect. Analyses will be at the level of the care home. The economic evaluation will estimate the cost-effectiveness of the intervention compared to usual care from a National Health Service and personal social services perspective. The study is not measuring the impact of the intervention on professional working relationships, the medicines culture in care homes or the generic health-related quality of life of

  18. Improving advance care planning for English-speaking and Spanish-speaking older adults: study protocol for the PREPARE randomised controlled trial

    Science.gov (United States)

    Sudore, Rebecca L; Barnes, Deborah E; Le, Gem M; Ramos, Roberto; Osua, Stacy J; Richardson, Sarah A; Boscardin, John; Schillinger, Dean

    2016-01-01

    Introduction Advance care planning (ACP) is a process that allows patients to identify their goals for medical care. Traditionally, ACP has focused on completing advance directives; however, we have expanded the ACP paradigm to also prepare patients to communicate their wishes and make informed decisions. To this end, we created an ACP website called PREPARE (http://www.prepareforyourcare.org) to prepare diverse English-speaking and Spanish-speaking older adults for medical decision-making. Here, we describe the study protocol for a randomised controlled efficacy trial of PREPARE in a safety-net setting. The goal is to determine the efficacy of PREPARE to engage diverse English-speaking and Spanish-speaking older adults in a full spectrum of ACP behaviours. Methods and analysis We include English-speaking and Spanish-speaking adults from an urban public hospital who are ≥55 years old, have ≥2 chronic medical conditions and have seen a primary care physician ≥2 times in the last year. Participants are randomised to the PREPARE intervention (review PREPARE and an easy-to-read advance directive) or the control arm (only the easy-to-read advance directive). The primary outcome is documentation of an advance directive and/or ACP discussion. Secondary outcomes include ACP behaviour change processes measured with validated surveys (eg, self-efficacy, readiness) and a broad range of ACP actions (eg, choosing a surrogate, identifying goals for care, discussing ACP with clinicians and/or surrogates). Using blinded outcome ascertainment, outcomes will be measured at 1 week and at 3, 6 and 12 months, and compared between study arms using mixed-effects logistic regression and mixed-effects linear, Poisson or negative binomial regression. Ethics and dissemination This study has been approved by the appropriate Institutional Review Boards and is guided by input from patient and clinical advisory boards and a data safety monitoring board. The results of this study will

  19. Point-of-care genetic testing for personalisation of antiplatelet treatment (RAPID GENE): a prospective, randomised, proof-of-concept trial.

    Science.gov (United States)

    Roberts, Jason D; Wells, George A; Le May, Michel R; Labinaz, Marino; Glover, Chris; Froeschl, Michael; Dick, Alexander; Marquis, Jean-Francois; O'Brien, Edward; Goncalves, Sandro; Druce, Irena; Stewart, Alexandre; Gollob, Michael H; So, Derek Y F

    2012-05-05

    Prospective assessment of pharmacogenetic strategies has been limited by an inability to undertake bedside genetic testing. The CYP2C19*2 allele is a common genetic variant associated with increased rates of major adverse events in individuals given clopidogrel after percutaneous coronary intervention (PCI). We used a novel point-of-care genetic test to identify carriers of the CYP2C19*2 allele and aimed to assess a pharmacogenetic approach to dual antiplatelet treatment after PCI. Between Aug 26, 2010, and July 7, 2011, 200 patients were enrolled into our prospective, randomised, proof-of-concept study. Patients undergoing PCI for acute coronary syndrome or stable angina were randomly assigned to rapid point-of-care genotyping or to standard treatment. Individuals in the rapid genotyping group were screened for the CYP2C19*2 allele. Carriers were given 10 mg prasugrel daily, and non-carriers and patients in the standard treatment group were given 75 mg clopidogrel daily. The primary endpoint was the proportion of CYP2C19*2 carriers with high on-treatment platelet reactivity (P2Y12 reactivity unit [PRU] value of more than 234) after 1 week of dual antiplatelet treatment, which is a marker associated with increased adverse cardiovascular events. Interventional cardiologists and data analysts were masked to genetic status and treatment. Patients were not masked to treatment allocation. All analyses were by intention to treat. This study is registered with ClinicalTrials.gov, NCT01184300. After randomisation, 187 patients completed follow-up (91 rapid genotyping group, 96 standard treatment). 23 individuals in each group carried at least one CYP2C19*2 allele. None of the 23 carriers in the rapid genotyping group had a PRU value of more than 234 at day 7, compared with seven (30%) given standard treatment (p=0·0092). The point-of-care genetic test had a sensitivity of 100% (95% CI 92·3-100) and a specificity of 99·3% (96·3-100). Point-of-care genetic testing after

  20. Comparison of midwife-led and consultant-led care of healthy women at low risk of childbirth complications in the Republic of Ireland: a randomised trial.

    LENUS (Irish Health Repository)

    Begley, Cecily

    2011-10-29

    ABSTRACT: BACKGROUND: No midwifery-led units existed in Ireland before 2004. The aim of this study was to compare midwife-led (MLU) versus consultant-led (CLU) care for healthy, pregnant women without risk factors for labour and delivery. METHODS: An unblinded, pragmatic randomised trial was designed, funded by the Health Service Executive (Dublin North-East). Following ethical approval, all women booking prior to 24 weeks of pregnancy at two maternity hospitals with 1,300-3,200 births annually in Ireland were assessed for trial eligibility.1,653 consenting women were centrally randomised on a 2:1 ratio to MLU or CLU care, (1101:552). \\'Intention-to-treat\\' analysis was used to compare 9 key neonatal and maternal outcomes. RESULTS: No statistically significant difference was found between MLU and CLU in the seven key outcomes: caesarean birth (163 [14.8%] vs 84 [15.2%]; relative risk (RR) 0.97 [95% CI 0.76 to 1.24]), induction (248 [22.5%] vs 138 [25.0%]; RR 0.90 [0.75 to 1.08]), episiotomy (126 [11.4%] vs 68 [12.3%]; RR 0.93 [0.70 to 1.23]), instrumental birth (139 [12.6%] vs 79 [14.3%]; RR 0.88 [0.68 to 1.14]), Apgar scores <8 (10 [0.9%] vs 9 [1.6%]; RR 0.56 [0.23 to 1.36]), postpartum haemorrhage (144 [13.1%] vs 75 [13.6%]; RR 0.96 [0.74 to 1.25]); breastfeeding initiation (616 [55.9%] vs 317 [57.4%]; RR 0.97 [0.89 to 1.06]). MLU women were significantly less likely to have continuous electronic fetal monitoring (397 [36.1%] vs 313 [56.7%]; RR 0.64 [0.57 to 0.71]), or augmentation of labour (436 [39.6%] vs 314 [56.9%]; RR 0.50 [0.40 to 0.61]). CONCLUSIONS: Midwife-led care, as practised in this study, is as safe as consultant-led care and is associated with less intervention during labour and delivery. Trial registration: Current Controlled Trials ISRCTN14973283.

  1. The prevention and reduction of weight loss in an acute tertiary care setting: protocol for a pragmatic stepped wedge randomised cluster trial (the PRoWL project)

    Science.gov (United States)

    2013-01-01

    Background Malnutrition, with accompanying weight loss, is an unnecessary risk in hospitalised persons and often remains poorly recognised and managed. The study aims to evaluate a hospital-wide multifaceted intervention co-facilitated by clinical nurses and dietitians addressing the nutritional care of patients, particularly those at risk of malnutrition. Using the best available evidence on reducing and preventing unplanned weight loss, the intervention (introducing universal nutritional screening; the provision of oral nutritional supplements; and providing red trays and additional support for patients in need of feeding) will be introduced by local ward teams in a phased way in a large tertiary acute care hospital. Methods/Design A pragmatic stepped wedge randomised cluster trial with repeated cross section design will be conducted. The unit of randomisation is the ward, with allocation by a random numbers table. Four groups of wards (n = 6 for three groups, n = 7 for one group) will be randomly allocated to each intervention time point over the trial. Two trained local facilitators (a nurse and dietitian for each group) will introduce the intervention. The primary outcome measure is change in patient’s body weight, secondary patient outcomes are: length of stay, all-cause mortality, discharge destinations, readmission rates and ED presentations. Patient outcomes will be measured on one ward per group, with 20 patients measured per ward per time period by an unblinded researcher. Including baseline, measurements will be conducted at five time periods. Staff perspectives on the context of care will be measured with the Alberta Context Tool. Discussion Unplanned and unwanted weight loss in hospital is common. Despite the evidence and growing concern about hospital nutrition there are very few evaluations of system-wide nutritional implementation programs. This project will test the implementation of a nutritional intervention across one hospital system using a

  2. Effects of a supportive educational nursing care programme on fatigue and quality of life in patients with heart failure: a randomised controlled trial.

    Science.gov (United States)

    Wang, Tzu-Chieh; Huang, Jin-Long; Ho, Wen-Chao; Chiou, Ai-Fu

    2016-04-01

    Fatigue is a common symptom in patients with heart failure that is easy to ignore. In addition, fatigue may affect patients' physical function and psychosocial conditions that can impair their quality of life. An effective nursing care programme is required to alleviate patients' fatigue and improve their quality of life. To investigate the effects of a supportive educational nursing care programme on fatigue and quality of life in patients with heart failure. A randomised controlled trial design was used. Ninety-two patients with heart failure were randomly assigned to an intervention group (n=47) or a control group (n=45). The patients in the intervention group participated in 12 weeks of a supportive educational nursing care programme including fatigue assessment, education, coaching self-care and evaluation. The intervention was conducted by a cardiac nurse during four face-to-face interviews and three follow-up telephone interviews. Fatigue and quality of life were assessed at the baseline and 4 weeks, 8 weeks and 12 weeks after enrollment in both groups. The participants in the intervention group exhibited a significant decrease in the level of fatigue after 12 weeks, whereas those in the control group exhibited no significant changes. Compared with the control group, the intervention group exhibited a significantly greater decrease in the level of fatigue and significantly greater improvement in quality of life after 12 weeks of intervention. The supportive educational nursing care programme was recommended to alleviate fatigue and improve quality of life in patients with heart failure. © The European Society of Cardiology 2015.

  3. COgnitive behavioural therapy vs standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): a multicentre randomised controlled trial protocol.

    Science.gov (United States)

    Goldstein, Laura H; Mellers, John D C; Landau, Sabine; Stone, Jon; Carson, Alan; Medford, Nick; Reuber, Markus; Richardson, Mark; McCrone, Paul; Murray, Joanna; Chalder, Trudie

    2015-06-27

    The evidence base for the effectiveness of psychological interventions for patients with dissociative non-epileptic seizures (DS) is currently extremely limited, although data from two small pilot randomised controlled trials (RCTs), including from our group, suggest that Cognitive Behavioural Therapy (CBT) may be effective in reducing DS occurrence and may improve aspects of psychological status and psychosocial functioning. The study is a multicentre, pragmatic parallel group RCT to evaluate the clinical and cost-effectiveness of specifically-tailored CBT plus standardised medical care (SMC) vs SMC alone in reducing DS frequency and improving psychological and health-related outcomes. In the initial screening phase, patients with DS will receive their diagnosis from a neurologist/epilepsy specialist. If patients are eligible and interested following the provision of study information and a booklet about DS, they will consent to provide demographic information and fortnightly data about their seizures, and agree to see a psychiatrist three months later. We aim to recruit ~500 patients to this screening stage. After a review three months later by a psychiatrist, those patients who have continued to have DS in the previous eight weeks and who meet further eligibility criteria will be told about the trial comparing CBT + SMC vs SMC alone. If they are interested in participating, they will be given a further booklet on DS and study information. A research worker will see them to obtain their informed consent to take part in the RCT. We aim to randomise 298 people (149 to each arm). In addition to a baseline assessment, data will be collected at 6 and 12 months post randomisation. Our primary outcome is monthly seizure frequency in the preceding month. Secondary outcomes include seizure severity, measures of seizure freedom and reduction, psychological distress and psychosocial functioning, quality of life, health service use, cost effectiveness and adverse

  4. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial.

    Science.gov (United States)

    Azizi, Michel; Sapoval, Marc; Gosse, Philippe; Monge, Matthieu; Bobrie, Guillaume; Delsart, Pascal; Midulla, Marco; Mounier-Véhier, Claire; Courand, Pierre-Yves; Lantelme, Pierre; Denolle, Thierry; Dourmap-Collas, Caroline; Trillaud, Hervé; Pereira, Helena; Plouin, Pierre-François; Chatellier, Gilles

    2015-05-16

    Conflicting blood pressure-lowering effects of catheter-based renal artery denervation have been reported in patients with resistant hypertension. We compared the ambulatory blood pressure-lowering efficacy and safety of radiofrequency-based renal denervation added to a standardised stepped-care antihypertensive treatment (SSAHT) with the same SSAHT alone in patients with resistant hypertension. The Renal Denervation for Hypertension (DENERHTN) trial was a prospective, open-label randomised controlled trial with blinded endpoint evaluation in patients with resistant hypertension, done in 15 French tertiary care centres specialised in hypertension management. Eligible patients aged 18-75 years received indapamide 1·5 mg, ramipril 10 mg (or irbesartan 300 mg), and amlodipine 10 mg daily for 4 weeks to confirm treatment resistance by ambulatory blood pressure monitoring before randomisation. Patients were then randomly assigned (1:1) to receive either renal denervation plus an SSAHT regimen (renal denervation group) or the same SSAHT alone (control group). The randomisation sequence was generated by computer, and stratified by centres. For SSAHT, after randomisation, spironolactone 25 mg per day, bisoprolol 10 mg per day, prazosin 5 mg per day, and rilmenidine 1 mg per day were sequentially added from months two to five in both groups if home blood pressure was more than or equal to 135/85 mm Hg. The primary endpoint was the mean change in daytime systolic blood pressure from baseline to 6 months as assessed by ambulatory blood pressure monitoring. The primary endpoint was analysed blindly. The safety outcomes were the incidence of acute adverse events of the renal denervation procedure and the change in estimated glomerular filtration rate from baseline to 6 months. This trial is registered with ClinicalTrials.gov, number NCT01570777. Between May 22, 2012, and Oct 14, 2013, 1416 patients were screened for eligibility, 106 of those were randomly assigned to treatment

  5. Advance care planning - a multi-centre cluster randomised clinical trial: The research protocol of the ACTION study

    NARCIS (Netherlands)

    J.A.C. Rietjens (Judith); I.J. Korfage (Ida); L. Dunleavy (Lesley); N.J. Preston (Nancy J.); L.J. Jabbarian (Lea J.); C.A. Christensen (Caroline Arnfeldt); M. de Brito (Maja); F. Bulli (Francesco); G. Caswell (Glenys); B. Červ (Branka); J.J.M. van Delden (Hans); L. Deliens (Luc); G. Gorini (Giuseppe); M. Groenvold (M.); D. Houttekier (Dirk); F. Ingravallo (Francesca); M.C. Kars (Marijke); U. Lunder (Urska); G. Miccinesi (Guido); A. Mimić (Alenka); E. Paci (Eugenio); S. Payne (S.); S. Polinder (Suzanne); K. Pollock (Kristian); J. Seymour (Jane); A. Simonič (Anja); A.T. Johnsen (Anna Thit); M.N. Verkissen (Mariëtte N.); E.G.E. de Vries (Elisabeth); A. Wilcock (Andrew); M. Zwakman (Marieke); A. van der Heide (Agnes)

    2016-01-01

    textabstractBackground: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of

  6. Advance care planning - a multi-centre cluster randomised clinical trial : The research protocol of the ACTION study

    NARCIS (Netherlands)

    Rietjens, Judith A C; Korfage, Ida J.; Dunleavy, Lesley; Preston, Nancy J.; Jabbarian, Lea J.; Christensen, Caroline Arnfeldt; de Brito, Maja; Bulli, Francesco; Caswell, Glenys; Červ, Branka; van Delden, Johannes; Deliens, Luc; Gorini, Giuseppe; Groenvold, Mogens; Houttekier, Dirk; Ingravallo, Francesca; Kars, Marijke C.; Lunder, Urška; Miccinesi, Guido; Mimić, Alenka; Paci, Eugenio; Payne, Sheila; Polinder, Suzanne; Pollock, Kristian; Seymour, Jane; Simonič, Anja; Johnsen, Anna Thit; Verkissen, Mariëtte N.; de Vries, Esther; Wilcock, Andrew; Zwakman, Marieke; van der Heide (Pl), Agnes

    2016-01-01

    Background: Awareness of preferences regarding medical care should be a central component of the care of patients with advanced cancer. Open communication can facilitate this but can occur in an ad hoc or variable manner. Advance care planning (ACP) is a formalized process of communication between

  7. Multidisciplinary Collaborative Care for Depressive Disorder in the Occupational Health Setting: design of a randomised controlled trial and cost-effectiveness study

    Directory of Open Access Journals (Sweden)

    Beekman Aartjan TF

    2008-05-01

    Full Text Available Abstract Background Major depressive disorder (MDD has major consequences for both patients and society, particularly in terms of needlessly long sick leave and reduced functioning. Although evidence-based treatments for MDD are available, they show disappointing results when implemented in daily practice. A focus on work is also lacking in the treatment of depressive disorder as well as communication of general practitioners (GPs and other health care professionals with occupational physicians (OPs. The OP may play a more important role in the recovery of patients with MDD. Purpose of the present study is to tackle these obstacles by applying a collaborative care model, which has proven to be effective in the USA, with a focus on return to work (RTW. From a societal perspective, the (costeffectiveness of this collaborative care treatment, as a way of transmural care, will be evaluated in depressed patients on sick leave in the occupational health setting. Methods/Design A randomised controlled trial in which the treatment of MDD in the occupational health setting will be evaluated in the Netherlands. A transmural collaborative care model, including Problem Solving Treatment (PST, a workplace intervention, antidepressant medication and manual guided self-help will be compared with care as usual (CAU. 126 Patients with MDD on sick leave between 4 and 12 weeks will be included in the study. Care in the intervention group will be provided by a multidisciplinary team of a trained OP-care manager and a consultant psychiatrist. The treatment is separated from the sickness certification. Data will be collected by means of questionnaires at baseline and at 3, 6, 9 and 12 months after baseline. Primary outcome measure is reduction of depressive symptoms, secondary outcome measure is time to RTW, tertiary outcome measure is the cost effectiveness. Discussion The high burden of MDD and the high level of sickness absence among people with MDD contribute to

  8. 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

  9. Group treatments for sensitive health care problems: a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

    Directory of Open Access Journals (Sweden)

    Clark MD

    2009-09-01

    Full Text Available Abstract Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in a group or individual setting over three weekly sessions. Outcome were measured as Symptom Severity Index; Incontinence-related Quality of Life questionnaire; National Health Service costs, and out of pocket expenses. Results The majority of women expressed no preference (55% or preference for individual treatment (36%. Treatment attendance was good, with similar attendance with both service delivery models. Overall, there were no statistically significant differences in symptom severity or quality of life outcomes between the models. Over 85% of women reported a subjective benefit of treatment, with a slightly higher rating in the individual compared with the group setting. When all health care costs were considered, average cost per patient was lower for group sessions (Mean cost difference £52.91 95%, confidence interval (£25.82 - £80.00. Conclusion Indications are that whilst some women may have an initial preference for individual treatment, there are no substantial differences in the symptom, quality of life outcomes or non-attendance. Because of the significant difference in mean cost, group treatment is recommended. Trial Registration Trial Registration number: ISRCTN 16772662

  10. The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial.

    Science.gov (United States)

    Neubert, Antje; Baarslag, Manuel Alberto; Dijk, Monique van; Rosmalen, Joost van; Standing, Joseph F; Sheng, Yucheng; Rascher, Wolfgang; Roberts, Deborah; Winslade, Jackie; Rawcliffe, Louise; Hanning, Sara M; Metsvaht, Tuuli; Giannuzzi, Viviana; Larsson, Peter; Pokorná, Pavla; Simonetti, Alessandra; Tibboel, Dick

    2017-06-21

    Sedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation. The CLOSED study is a multicentre, double-blind, randomised, active-controlled non-inferiority trial with a 1:1 randomisation between clonidine and midazolam. Both treatment groups are stratified according to age in three groups with the same size: <28 days (n=100), 28 days to <2 years (n=100) and 2-18 years (n=100). The primary end point is defined as the occurrence of sedation failure within the study period. Secondary end points include a pharmacokinetic/pharmacodynamic relationship, pharmacogenetics, occurrence of delirium and withdrawal syndrome, opioid consumption and neurodevelopment in the neonatal age group. Logistic regression will be used for the primary end point, appropriate statistics will be used for the secondary end points. Written informed consent will be obtained from the parents/caregivers. Verbal or deferred consent will be used in the sites where national legislation allows. The study has institutional review board approval at recruiting sites. The results will be published in a peer-reviewed journal and shared with the worldwide medical community. EudraCT: 2014-003582-24; Clinicaltrials.gov: NCT02509273; 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.

  11. Explaining the effects of an intervention designed to promote evidence-based diabetes care: a theory-based process evaluation of a pragmatic cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Kaner Eileen FS

    2008-11-01

    Full Text Available Abstract Background The results of randomised controlled trials can be usefully illuminated by studies of the processes by which they achieve their effects. The Theory of Planned Behaviour (TPB offers a framework for conducting such studies. This study used TPB to explore the observed effects in a pragmatic cluster randomised controlled trial of a structured recall and prompting intervention to increase evidence-based diabetes care that was conducted in three Primary Care Trusts in England. Methods All general practitioners and nurses in practices involved in the trial were sent a postal questionnaire at the end of the intervention period, based on the TPB (predictor variables: attitude; subjective norm; perceived behavioural control, or PBC. It focussed on three clinical behaviours recommended in diabetes care: measuring blood pressure; inspecting feet; and prescribing statins. Multivariate analyses of variance and multiple regression analyses were used to explore changes in cognitions and thereby better understand trial effects. Results Fifty-nine general medical practitioners and 53 practice nurses (intervention: n = 55, 41.98% of trial participants; control: n = 57, 38.26% of trial participants completed the questionnaire. There were no differences between groups in mean scores for attitudes, subjective norms, PBC or intentions. Control group clinicians had 'normatively-driven' intentions (i.e., related to subjective norm scores, whereas intervention group clinicians had 'attitudinally-driven' intentions (i.e., related to attitude scores for foot inspection and statin prescription. After controlling for effects of the three predictor variables, this group difference was significant for foot inspection behaviour (trial group × attitude interaction, beta = 0.72, p Conclusion Attitudinally-driven intentions are proposed to be more consistently translated into action than normatively-driven intentions. This proposition was supported by the

  12. Developing and piloting a peer mentoring intervention to reduce teenage pregnancy in looked-after children and care leavers: an exploratory randomised controlled trial.

    Science.gov (United States)

    Mezey, Gillian; Meyer, Deborah; Robinson, Fiona; Bonell, Chris; Campbell, Rona; Gillard, Steve; Jordan, Peter; Mantovani, Nadia; Wellings, Kaye; White, Sarah

    2015-10-01

    Looked-after children (LAC) are at greater risk of teenage pregnancy than non-LAC, which is associated with adverse health and social consequences. Existing interventions have failed to reduce rates of teenage pregnancy in LAC. Peer mentoring is proposed as a means of addressing many of the factors associated with the increased risk of teenage pregnancy in this group. To develop a peer mentoring intervention to reduce teenage pregnancy in LAC. Phase I and II randomised controlled trial of a peer mentoring intervention for LAC; scoping exercise and literature search; national surveys of social care professionals and LAC; and focus groups and interviews with social care professionals, mentors and mentees. Three local authorities (LAs) in England. LAC aged 14-18 years (mentees/care as usual) and 19-25 years (mentors). Recruitment and training of mentors; randomisation and matching of mentors to mentees; and 1-year individual peer mentoring. pregnancy in LAC aged 14-18 years. sexual attitudes, behaviour and knowledge; psychological health; help-seeking behaviour; locus of control; and attachment style. A health economic evaluation was also carried out. In total, 54% of target recruitment was reached for the exploratory trial and 13 out of 20 mentors (65%) and 19 out of 30 LAC aged 14-18 years (63%) (recruited during Phases I and II) were retained in the research. The training programme was acceptable and could be manualised and replicated. Recruitment and retention difficulties were attributed to systemic problems and LA lack of research infrastructure and lack of additional funding to support and sustain such an intervention. Mentees appeared to value the intervention but had difficulty in meeting weekly as required. Only one in four of the relationships continued for the full year. A future Phase III trial would require the intervention to be modified to include provision of group and individual peer mentoring; internal management of the project, with support from an

  13. Protocol for a multi-centre randomised controlled trial comparing arthroscopic hip surgery to physiotherapy-led care for femoroacetabular impingement (FAI): the Australian FASHIoN trial.

    Science.gov (United States)

    Murphy, Nicholas J; Eyles, Jillian; Bennell, Kim L; Bohensky, Megan; Burns, Alexander; Callaghan, Fraser M; Dickenson, Edward; Fary, Camdon; Grieve, Stuart M; Griffin, Damian R; Hall, Michelle; Hobson, Rachel; Kim, Young Jo; Linklater, James M; Lloyd, David G; Molnar, Robert; O'Connell, Rachel L; O'Donnell, John; O'Sullivan, Michael; Randhawa, Sunny; Reichenbach, Stephan; Saxby, David J; Singh, Parminder; Spiers, Libby; Tran, Phong; Wrigley, Tim V; Hunter, David J

    2017-09-26

    Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and

  14. Modified Pilates as an adjunct to standard physiotherapy care for urinary incontinence: a mixed methods pilot for a randomised controlled trial.

    Science.gov (United States)

    Lausen, Adi; Marsland, Louise; Head, Samantha; Jackson, Joanna; Lausen, Berthold

    2018-01-12

    Urinary incontinence (UI) is a distressing condition affecting at least 5 million women in England and Wales. Traditionally, physiotherapy for UI comprises pelvic floor muscle training, but although evidence suggests this can be effective it is also recognised that benefits are often compromised by patient motivation and commitment. In addition, there is increasing recognition that physical symptoms alone are poor indicators of the impact of incontinence on individuals' lives. Consequently, more holistic approaches to the treatment of UI, such as Modified Pilates (MP) have been recommended. This study aimed to provide preliminary findings about the effectiveness of a 6-week course of MP classes as an adjunct to standard physiotherapy care for UI, and to test the feasibility of a randomised controlled trial (RCT) design. The study design was a single centre pilot RCT, plus qualitative interviews. 73 women referred to Women's Health Physiotherapy Services for UI at Colchester Hospital University NHS Foundation Trust were randomly assigned to two groups: a 6-week course of MP classes in addition to standard physiotherapy care (intervention) or standard physiotherapy care only (control). Main outcome measures were self-reported UI, quality of life and self-esteem at baseline (T1), completion of treatment (T2), and 5 months after randomisation (T3). Qualitative interviews were conducted with a subgroup at T2 and T3. Due to the nature of the intervention blinding of participants, physiotherapists and researchers was not feasible. Post-intervention data revealed a range of benefits for women who attended MP classes and who had lower symptom severity at baseline: improved self-esteem (p = 0.032), decreased social embarrassment (p = 0.026) and lower impact on normal daily activities (p = 0.025). In contrast, women with higher symptom severity showed improvement in their personal relationships (p = 0.017). Qualitative analysis supported these findings and

  15. West End Walkers 65+: A randomised controlled trial of a primary care-based walking intervention for older adults: Study rationale and design

    Directory of Open Access Journals (Sweden)

    Rowe David A

    2011-02-01

    Full Text Available Abstract Background In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged ≥65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. Methods/Design The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group or a 12-week waiting list control group (delayed group who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor, mood (Positive and Negative Affect Schedule, functional ability (Perceived Motor-Efficacy Scale for Older Adults, quality of life (Short-Form (36 Health Survey version 2 and loneliness (UCLA Loneliness Scale were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. Discussion West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged ≥65 years. The study will also

  16. The effectiveness of a semi-tailored facilitator-based intervention to optimise chronic care management in general practice: a stepped-wedge randomised controlled trial.

    Science.gov (United States)

    Due, Tina Drud; Thorsen, Thorkil; Kousgaard, Marius Brostrøm; Siersma, Volkert Dirk; Waldorff, Frans Boch

    2014-04-09

    The Danish health care sector is reorganising based on disease management programmes designed to secure integrated and high quality chronic care across hospitals, general practitioners and municipalities. The disease management programmes assign a central role to general practice; and in the Capital Region of Denmark a facilitator-based intervention was undertaken to support the implementation of the programmes in general practice. The purpose of the study was to assess the effectiveness of this semi-tailored facilitator-based intervention. The study was a stepped-wedge, randomised, controlled trial among general practices in the Capital Region of Denmark. The intervention group was offered three one-hour visits by a facilitator. The intervention was semi-tailored to the perceived needs as defined by each general practice, and the practices could choose from a list of possible topics. The control group was a delayed intervention group. The primary outcome was change in the number of annual chronic disease check-ups. Secondary outcomes were: changes in the number of annual check-ups for type 2 diabetes (DM2) and chronic obstructive pulmonary disease (COPD); changes in the number of spirometry tests, changes in the use of ICPC diagnosis coding and patient stratification; sign-up for a software program for patient overview; and reduction in number of practices with few annual chronic disease check-ups. We randomised 189 general practices: 96 practices were allocated to the intervention group and 93 to the delayed intervention group. For the primary outcome, 94 and 89 practices were analysed. Almost every outcome improved from baseline to follow-up in both allocation groups. At follow-up there was no difference between allocation groups for the primary outcome (p = 0.1639). However, some secondary outcomes favoured the intervention: a higher reported use of ICPC diagnosis coding for DM2 and COPD (p = 0.0050, p = 0.0243 respectively), stratification for COPD (p = 0

  17. Integrated collaborative care teams to enhance service delivery to youth with mental health and substance use challenges: protocol for a pragmatic randomised controlled trial.

    Science.gov (United States)

    Henderson, Joanna L; Cheung, Amy; Cleverley, Kristin; Chaim, Gloria; Moretti, Myla E; de Oliveira, Claire; Hawke, Lisa D; Willan, Andrew R; O'Brien, David; Heffernan, Olivia; Herzog, Tyson; Courey, Lynn; McDonald, Heather; Grant, Enid; Szatmari, Peter

    2017-02-06

    Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%, yet youth are challenged to access evidence-based services in a timely fashion. To address MHA system gaps, this study tests the benefits of an Integrated Collaborative Care Team (ICCT) model for youth with MHA challenges. A rapid, stepped-care approach geared to need in a youth-friendly environment is expected to result in better youth MHA outcomes. Moreover, the ICCT approach is expected to decrease service wait-times, be more youth-friendly and family-friendly, and be more cost-effective, providing substantial public health benefits. In partnership with four community agencies, four adolescent psychiatry hospital departments, youth and family members with lived experience of MHA service use, and other stakeholders, we have developed an innovative model of collaborative, community-based service provision involving rapid access to needs-based MHA services. A total of 500 youth presenting for hospital-based, outpatient psychiatric service will be randomised to ICCT services or hospital-based treatment as usual, following a pragmatic randomised controlled trial design. The primary outcome variable will be the youth's functioning, assessed at intake, 6 months and 12 months. Secondary outcomes will include clinical change, youth/family satisfaction and perception of care, empowerment, engagement and the incremental cost-effectiveness ratio (ICER). Intent-to-treat analyses will be used on repeated-measures data, along with cost-effectiveness and cost-utility analyses, to determine intervention effectiveness. Research Ethics Board approval has been received from the Centre for Addiction and Mental Health, as well as institutional ethical approval from participating community sites. This study will be conducted according to Good Clinical Practice guidelines. Participants will provide informed consent prior to study participation and data confidentiality will be ensured. A data

  18. The effect of postal questionnaire burden on response rate and answer patterns following admission to intensive care: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Robert Hatch

    2017-03-01

    Full Text Available Abstract Background The effects of postal questionnaire burden on return rates and answers given are unclear following treatment on an intensive care unit (ICU. We aimed to establish the effects of different postal questionnaire burdens on return rates and answers given. Methods Design: A parallel group randomised controlled trial. We assigned patients by computer-based randomisation to one of two questionnaire packs (Group A and Group B. Setting: Patients from 26 ICUs in the United Kingdom. Inclusion criteria: Patients who had received at least 24 h of level 3 care and were 16 years of age or older. Patients did not know that there were different questionnaire burdens. The study included 18,490 patients. 12,170 were eligible to be sent a questionnaire pack at 3 months. We sent 12,105 questionnaires (6112 to group A and 5993 to group B. Interventions: The Group A pack contained demographic and EuroQol group 5 Dimensions 3 level (EQ-5D-3 L questionnaires, making four questionnaire pages. The Group B pack also contained the Hospital Anxiety and Depression Score (HADS and the Post-Traumatic Stress Disorder Check List-Civilian (PCL-C questionnaires, making eight questionnaire pages in total. Main outcome measure: Questionnaire return rate 3 months after ICU discharge by group. Results In group A, 2466/6112 (40.3% participants responded at 3 months. In group B 2315/ 5993 (38.6% participants responded (difference 1.7% CI for difference 0–3.5% p = 0.053. Group A reported better functionality than group B in the EQ-5D-3 L mobility (41% versus 37% reporting no problems p = 0.003 and anxiety/depression (59% versus 55% reporting no problems p = 0.017 domains. Conclusions In survivors of intensive care, questionnaire burden had no effect on return rates. However, questionnaire burden affected answers to the same questionnaire (EQ-5D-3 L. Trial registration ISRCTN69112866 (assigned 02/05/2006.

  19. Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial.

    Science.gov (United States)

    Edbrooke, Lara; Aranda, Sanchia; Granger, Catherine L; McDonald, Christine F; Krishnasamy, Mei; Mileshkin, Linda; Irving, Louis; Braat, Sabine; Clark, Ross A; Gordon, Ian; Denehy, Linda

    2017-09-29

    Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference. There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly

  20. Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) in primary care using total diet replacement products: a protocol for a randomised controlled trial.

    Science.gov (United States)

    Jebb, Susan A; Astbury, Nerys M; Tearne, Sarah; Nickless, Alecia; Aveyard, Paul

    2017-08-04

    The global prevalence of obesity has risen significantly in recent decades. There is a pressing need to identify effective interventions to treat established obesity that can be delivered at scale. The aim of the Doctor Referral of Overweight People to a Low-Energy Treatment (DROPLET) study is to determine the clinical effectiveness, feasibility and acceptability of referral to a low-energy total diet replacement programme compared with usual weight management interventions in primary care. The DROPLET trial is a randomised controlled trial comparing a low-energy total diet replacement programme with usual weight management interventions delivered in primary care. Eligible patients will be recruited through primary care registers and randomised to receive a behavioural support programme delivered by their practice nurse or a referral to a commercial provider offering an initial 810 kcal/d low-energy total diet replacement programme for 8 weeks, followed by gradual food reintroduction, along with weekly behavioural support for 24 weeks. The primary outcome is weight change at 12 months. The secondary outcomes are weight change at 3 and 6 months, the proportion of participants achieving 5% and 10% weight loss at 12 months, and change in fat mass, haemoglobin A1c, low-density lipoprotein cholesterol and systolic and diastolic blood pressure at 12 months. Data will be analysed on the basis of intention to treat. Qualitative interviews on a subsample of patients and healthcare providers will assess their experiences of the weight loss programmes and identify factors affecting acceptability and adherence. This study has been reviewed and approved by the National Health ServiceHealth Research Authority (HRA)Research Ethics Committee (Ref: SC/15/0337). The trial findings will be disseminated to academic and health professionals through presentations at meetings and peer-reviewed journals and to the public through the media. If the intervention is effective, the results

  1. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).

    Science.gov (United States)

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-08-31

    Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology

  2. A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: Study protocol

    Directory of Open Access Journals (Sweden)

    Richardson Alison

    2009-03-01

    Full Text Available Abstract Background Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT. Methods/design A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i Intervention (Dignity Therapy offered in addition to any standard care, and (ii Control group (standard care. Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group. The primary outcome is residents' sense of dignity (potential effectiveness assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method. Discussion Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if

  3. A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of dignity therapy for older people in care homes: study protocol.

    Science.gov (United States)

    Hall, Sue; Chochinov, Harvey; Harding, Richard; Murray, Scott; Richardson, Alison; Higginson, Irene J

    2009-03-24

    Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT. A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method. Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of

  4. A pilot randomised controlled trial in intensive care patients comparing 7 days' treatment with empirical antibiotics with 2 days' treatment for hospital-acquired infection of unknown origin.

    Science.gov (United States)

    Scawn, N; Saul, D; Pathak, D; Matata, B; Kemp, I; Stables, R; Lane, S; Haycox, A; Houten, R

    2012-09-01

    Management of cardiac intensive care unit (ICU) sepsis is complicated by the high incidence of systemic inflammatory response syndrome, which mimics sepsis but without an infective cause. This pilot randomised trial investigated whether or not, in the ICU, 48 hours of broad-spectrum antibiotic treatment was adequate to safely treat suspected sepsis of unknown and unproven origin and also the predictive power of newer biomarkers of sepsis. The main objective of this pilot study was to provide preliminary data on the likely safety and efficacy of a reduced course of antibiotics for the treatment of ICU infections of unknown origin. A pilot, single-centre, open-label randomised trial. This study was carried out in the ICU of a tertiary heart and chest hospital. Patients being treated within the ICU were recruited into the trial if the intensivist was planning to commence antibiotics because of evidence of systemic inflammatory response syndrome and a strong suspicion of infection but there was no actual known source for that infection. Broad-spectrum antibiotic treatment administered for 48 hours (experimental) compared with treatment for 7 days (control). The primary outcome was a composite outcome of the rate of death or initiation of antibiotic therapy after the completion of the treatment schedule allocated at randomisation. Secondary outcomes included the duration of mechanical ventilation and ICU and hospital stay; the incidence of infection with Clostridium difficile (B. S. Weeks & E. Alcamo) Jones & Bartlett International Publishers, 2008, or methicillin-resistant Staphylococcus aureus (MRSA) (B. S. Weeks & E. Alcamo) Jones & Bartlett International Publishers, 2008; resource utilisation and costs associated with each of the two pilot arms; the ratio of patients screened to patients eligible to patients randomised; the incidence of crossover between groups; and the significance of newer biomarkers for sepsis for predicting patients' need for further antibiotics

  5. Can an e-learning course improve nursing care for older people at risk of delirium: a stepped wedge cluster randomised trial.

    Science.gov (United States)

    van de Steeg, Lotte; IJkema, Roelie; Langelaan, Maaike; Wagner, Cordula

    2014-05-27

    Delirium occurs frequently in older hospitalised patients and is associated with several adverse outcomes. Ignorance among healthcare professionals and a failure to recognise patients suffering from delirium have been identified as the possible causes of poor care. The objective of the study was to determine whether e-learning can be an effective means of improving implementation of a quality improvement project in delirium care. This project aims primarily at improving the early recognition of older patients who are at risk of delirium. In a stepped wedge cluster randomised trial an e-learning course on delirium was introduced, aimed at nursing staff. The trial was conducted on general medical and surgical wards from 18 Dutch hospitals. The primary outcome measure was the delirium risk screening conducted by nursing staff, measured through monthly patient record reviews. Patient records from patients aged 70 and over admitted onto wards participating in the study were used for data collection. Data was also collected on the level of delirium knowledge of these wards' nursing staff. Records from 1,862 older patients were included during the control phase and from 1,411 patients during the intervention phase. The e-learning course on delirium had a significant positive effect on the risk screening of older patients by nursing staff (OR 1.8, p-value e-learning course also showed a significant positive effect on nurses' knowledge of delirium. Nurses who undertook a delirium e-learning course showed a greater adherence to the quality improvement project in delirium care. This improved the recognition of patients at risk and demonstrated that e-learning can be a valuable instrument for hospitals when implementing improvements in delirium care. The Netherlands National Trial Register (NTR). NTR2885.

  6. A qualitative analysis of trainer/coach experiences of changing care home practice in the Well-being and Health in Dementia randomised control trial.

    Science.gov (United States)

    Fossey, Jane; Garrod, Lucy; Guzman, Azucena; Testad, Ingelin

    2018-01-01

    Objectives This study explored the experiences of a range of health and social care professionals employed in the role of trainer/coaches to support care home staff to implement a psychosocial intervention for residents living with dementia. It aimed to identify the factors which are pertinent to these roles, in the context of a cascade model of training. Method A focus group was convened involving dementia trainer/coaches and supervisors who had worked on Well-being and Health for people with Dementia randomised control trial. Twelve participants explored their preparedness for and experiences of their role as 'Well-being and Health for people with Dementia therapists'. They reflected on their perceptions of the resources and support required. The data were transcribed verbatim and subjected to inductive thematic analysis. Results Three main themes emerged from the data. Within the theme of 'skills in relationship building' were two subthemes of developing trust and getting to know individual staff and each care home. In the second main theme of 'making use of tangible resources' two subthemes relating to using the Well-being and Health for people with Dementia manuals and the supervision of the therapists arose. The third theme, 'being an agent for change' contained three subthemes: effective training methods, creating opportunities for Dementia Champions to reflect and therapists' perceived rewards of their role. Conclusion The findings provide new insights into the trainer/coach role applicable to the practices of services recruiting, training and providing ongoing professional support to practitioners in-reaching into care homes.

  7. Can an e-learning course improve nursing care for older people at risk of delirium: a stepped wedge cluster randomised trial

    Science.gov (United States)

    2014-01-01

    Background Delirium occurs frequently in older hospitalised patients and is associated with several adverse outcomes. Ignorance among healthcare professionals and a failure to recognise patients suffering from delirium have been identified as the possible causes of poor care. The objective of the study was to determine whether e-learning can be an effective means of improving implementation of a quality improvement project in delirium care. This project aims primarily at improving the early recognition of older patients who are at risk of delirium. Methods In a stepped wedge cluster randomised trial an e-learning course on delirium was introduced, aimed at nursing staff. The trial was conducted on general medical and surgical wards from 18 Dutch hospitals. The primary outcome measure was the delirium risk screening conducted by nursing staff, measured through monthly patient record reviews. Patient records from patients aged 70 and over admitted onto wards participating in the study were used for data collection. Data was also collected on the level of delirium knowledge of these wards’ nursing staff. Results Records from 1,862 older patients were included during the control phase and from 1,411 patients during the intervention phase. The e-learning course on delirium had a significant positive effect on the risk screening of older patients by nursing staff (OR 1.8, p-value e-learning course also showed a significant positive effect on nurses’ knowledge of delirium. Conclusions Nurses who undertook a delirium e-learning course showed a greater adherence to the quality improvement project in delirium care. This improved the recognition of patients at risk and demonstrated that e-learning can be a valuable instrument for hospitals when implementing improvements in delirium care. Trial registration The Netherlands National Trial Register (NTR). Trial number: NTR2885. PMID:24884739

  8. Characteristics of effective collaborative care for treatment of depression: a systematic review and meta-regression of 74 randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Peter A Coventry

    Full Text Available Collaborative care is a complex intervention based on chronic disease management models and is effective in the management of depression. However, there is still uncertainty about which components of collaborative care are effective. We used meta-regression to identify factors in collaborative care associated with improvement in patient outcomes (depressive symptoms and the process of care (use of anti-depressant medication.Systematic review with meta-regression. The Cochrane Collaboration Depression, Anxiety and Neurosis Group trials registers were searched from inception to 9th February 2012. An update was run in the CENTRAL trials database on 29th December 2013. Inclusion criteria were: randomised controlled trials of collaborative care for adults ≥18 years with a primary diagnosis of depression or mixed anxiety and depressive disorder. Random effects meta-regression was used to estimate regression coefficients with 95% confidence intervals (CIs between study level covariates and depressive symptoms and relative risk (95% CI and anti-depressant use. The association between anti-depressant use and improvement in depression was also explored. Seventy four trials were identified (85 comparisons, across 21,345 participants. Collaborative care that included psychological interventions predicted improvement in depression (β coefficient -0.11, 95% CI -0.20 to -0.01, p = 0.03. Systematic identification of patients (relative risk 1.43, 95% CI 1.12 to 1.81, p = 0.004 and the presence of a chronic physical condition (relative risk 1.32, 95% CI 1.05 to 1.65, p = 0.02 predicted use of anti-depressant medication.Trials of collaborative care that included psychological treatment, with or without anti-depressant medication, appeared to improve depression more than those without psychological treatment. Trials that used systematic methods to identify patients with depression and also trials that included patients with a chronic physical

  9. Mindfulness as a complementary intervention in the treatment of overweight and obesity in primary health care: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Salvo, Vera; Kristeller, Jean; Marin, Jesus Montero; Sanudo, Adriana; Lourenço, Bárbara Hatzlhoffer; Schveitzer, Mariana Cabral; D'Almeida, Vania; Morillo, Héctor; Gimeno, Suely Godoy Agostinho; Garcia-Campayo, Javier; Demarzo, Marcelo

    2018-05-11

    Mindfulness has been applied in the United States and Europe to improve physical and psychological health; however, little is known about its feasibility and efficacy in a Brazilian population. Mindfulness may also be relevant in tackling obesity and eating disorders by decreasing binge eating episodes-partly responsible for weight regain for a large number of people-and increasing awareness of emotional and other triggers for overeating. The aim of the present study protocol is to evaluate and compare the feasibility and efficacy of two mindfulness-based interventions (MBIs) addressing overweight and obesity in primary care patients: a general programme called Mindfulness-Based Health Promotion and a targeted mindful eating protocol called Mindfulness-Based Eating Awareness Training. A randomised controlled trial will be conducted to compare treatment as usual separately in primary care with both programmes (health promotion and mindful eating) added to treatment as usual. Two hundred forty adult women with overweight and obesity will be enrolled. The primary outcome will be an assessment of improvement in eating behaviour. Secondary outcomes will be (1) biochemical control; (2) anthropometric parameters, body composition, dietary intake and basal metabolism; and (3) levels of mindfulness, stress, depression, self-compassion and anxiety. At the end of each intervention, a focus group will be held to assess the programme's impact on the participants' lives, diet and health. A feasibility study on access to benefits from and importance of MBIs at primary care facilities will be conducted among primary care health care professionals and participants. Monthly maintenance sessions lasting at least 1 hour will be offered, according to each protocol, during the 3-month follow-up periods. This clinical trial will result in more effective mindfulness-based interventions as a complementary treatment in primary care for people with overweight and obesity. If the findings of

  10. Tailored care for somatoform vertigo/dizziness: study protocol for a randomised controlled trial evaluating integrative group psychotherapy.

    Science.gov (United States)

    Lahmann, Claas; Henningsen, P; Dieterich, M; Radziej, K; Schmid, G

    2015-08-01

    Vertigo/dizziness (VD) ranks high in lifetime prevalence and clinical relevance. Nearly half of the complex VD disorders presenting at specialised units for vertigo or otoneurological disorders are not fully explained by an identifiable medical illness, but instead are related to anxiety, depressive, or somatoform disorders. Although there is some evidence that psychotherapy may be effective for these patients, therapeutic options remain unsatisfactory. This report describes the objectives, design and methods of a randomised, controlled clinical trial, evaluating the efficacy of manualised, multimodal group psychotherapy, based on integrative psychotherapy (IPT) and tailored to subgroups of mental disorders in medically unexplained VD. This psychotherapeutic approach will be compared to self-help groups (n = 172; n = 86 per study arm). Improvements with regard to handicap due to VD at 12 months follow-up will serve as primary outcome. Additionally, measures of generic quality of life, severity of vertigo, depression, anxiety, somatisation as well as Head Impulse Test and Computerized Static Posturography will be applied. We will also analyse the cost-effectiveness of this trial. The study aims to improve treatment of this therapeutically underserved population who are often severely impaired in their working and daily lives. ClinicalTrials.gov Identifier: NCT02320851. This is an on-going study; recruitment for the study is about to start.

  11. Can an alert in primary care electronic medical records increase participation in a population-based screening programme for colorectal cancer? COLO-ALERT, a randomised clinical trial

    International Nuclear Information System (INIS)

    Guiriguet-Capdevila, Carolina; Fuentes-Peláez, Antonio; Reina-Rodríguez, Dolores; De León-Gallo, Rosa; Mendez-Boo, Leonardo; Torán-Monserrat, Pere; Muñoz-Ortiz, Laura; Rivero-Franco, Irene; Vela-Vallespín, Carme; Vilarrubí-Estrella, Mercedes; Torres-Salinas, Miquel; Grau-Cano, Jaume; Burón-Pust, Andrea; Hernández-Rodríguez, Cristina

    2014-01-01

    Colorectal cancer is an important public health problem in Spain. Over the last decade, several regions have carried out screening programmes, but population participation rates remain below recommended European goals. Reminders on electronic medical records have been identified as a low-cost and high-reach strategy to increase participation. Further knowledge is needed about their effect in a population-based screening programme. The main aim of this study is to evaluate the effectiveness of an electronic reminder to promote the participation in a population-based colorectal cancer screening programme. Secondary aims are to learn population’s reasons for refusing to take part in the screening programme and to find out the health professionals’ opinion about the official programme implementation and on the new computerised tool. This is a parallel randomised trial with a cross-sectional second stage. Participants: all the invited subjects to participate in the public colorectal cancer screening programme that includes men and women aged between 50–69, allocated to the eleven primary care centres of the study and all their health professionals. The randomisation unit will be the primary care physician. The intervention will consist of activating an electronic reminder, in the patient’s electronic medical record, in order to promote colorectal cancer screening, during a synchronous medical appointment, throughout the year that the intervention takes place. A comparison of the screening rates will then take place, using the faecal occult blood test of the patients from the control and the intervention groups. We will also take a questionnaire to know the opinions of the health professionals. The main outcome is the screening status at the end of the study. Data will be analysed with an intention-to-treat approach. We expect that the introduction of specific reminders in electronic medical records, as a tool to facilitate and encourage direct referral by

  12. Shared Decision Making in mental health care using Routine Outcome Monitoring as a source of information: a cluster randomised controlled trial.

    Science.gov (United States)

    Metz, Margot J; Franx, Gerdien C; Veerbeek, Marjolein A; de Beurs, Edwin; van der Feltz-Cornelis, Christina M; Beekman, Aartjan T F

    2015-12-15

    Shared Decision Making (SDM) is a way to empower patients when decisions are made about treatment. In order to be effective agents in this process, patients need access to information of good quality. Routine Outcome Monitoring (ROM) may provide such information and therefore may be a key element in SDM. This trial tests the effectiveness of SDM using ROM, primarily aiming to diminish decisional conflict of the patient while making decisions about treatment. The degree of decisional conflict, the primary outcome of this study, encompasses personal certainty about choosing an appropriate treatment, information about options, clarification of patient values, support from others and patients experience of an effective decision making process. Secondary outcomes of the study focus on the working alliance between patient and clinician, adherence to treatment, and clinical outcome and quality of life. This article presents the study protocol of a multi-centre two-arm cluster randomised controlled trial (RCT). The research is conducted in Dutch specialised mental health care teams participating in the ROM Quality Improvement Collaborative (QIC), which aims to implement ROM in daily clinical practice. In the intervention teams, ROM is used as a source of information during the SDM process between the patient and clinician. Control teams receive no specific SDM or ROM instructions and apply decision making as usual. Randomisation is conducted at the level of the participating teams within the mental health organisations. A total of 12 teams from 4 organisations and 364 patients participate in the study. Prior to data collection, the intervention teams are trained to use ROM during the SDM process. Data collection will be at baseline, and at 3 and 6 months after inclusion of the patient. Control teams will implement the SDM and ROM model after completion of the study. This study will provide useful information about the effectiveness of ROM within a SDM framework

  13. The QICKD study protocol: a cluster randomised trial to compare quality improvement interventions to lower systolic BP in chronic kidney disease (CKD in primary care

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    du Bois Elizabeth

    2009-07-01

    Full Text Available Abstract Background Chronic kidney disease (CKD is a relatively newly recognised but common long-term condition affecting 5 to 10% of the population. Effective management of CKD, with emphasis on strict blood pressure (BP control, reduces cardiovascular risk and slows the progression of CKD. There is currently an unprecedented rise in referral to specialist renal services, which are often located in tertiary centres, inconvenient for patients, and wasteful of resources. National and international CKD guidelines include quality targets for primary care. However, there have been no rigorous evaluations of strategies to implement these guidelines. This study aims to test whether quality improvement interventions improve primary care management of elevated BP in CKD, reduce cardiovascular risk, and slow renal disease progression Design Cluster randomised controlled trial (CRT Methods This three-armed CRT compares two well-established quality improvement interventions with usual practice. The two interventions comprise: provision of clinical practice guidelines with prompts and audit-based education. The study population will be all individuals with CKD from general practices in eight localities across England. Randomisation will take place at the level of the general practices. The intended sample (three arms of 25 practices powers the study to detect a 3 mmHg difference in systolic BP between the different quality improvement interventions. An additional 10 practices per arm will receive a questionnaire to measure any change in confidence in managing CKD. Follow up will take place over two years. Outcomes will be measured using anonymised routinely collected data extracted from practice computer systems. Our primary outcome measure will be reduction of systolic BP in people with CKD and hypertension at two years. Secondary outcomes will include biomedical outcomes and markers of quality, including practitioner confidence in managing CKD. A small

  14. 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

  15. Day care bipolar transurethral resection vs photoselective vaporisation under sedoanalgesia: A prospective, randomised study of the management of benign prostatic hyperplasia

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    Rajeev Sood

    2017-12-01

    Full Text Available Objective: To conduct a prospective randomised study comparing the safety, effectiveness and treatment outcomes in patients undergoing bipolar transurethral resection of the prostate (bTURP and photoselective vaporisation of the prostate (PVP under sedoanalgesia, as sedoanalgesia is a safe and effective technique suitable for minimally invasive endourological procedures and although studies have confirmed that both TURP and PVP are feasible under sedoanalgesia there are none comparing the two. Patients and methods: Between November 2014 and April 2016, all patients satisfying the eligibility criteria underwent either bTURP or PVP under sedoanalgesia after randomisation. The groups were compared for functional outcomes, visual analogue scale (VAS pain scores (range 0–10, perioperative variables and complications, with a follow-up of 3 months. Results: In all, 42 and 36 patients underwent bTURP and PVP under sedoanalgesia, respectively. The mean VAS pain score was <2 at any time during the procedure, with no conversions to general anaesthesia. PVP patients had a shorter operating time [mean (SD 55.64 (12.8 vs 61.79 (14.2 min, P = 0.035], shorter duration of hospitalisation [mean (SD 14.58 (2.81 vs 19.21 (2.82 h, P < 0.001] and a higher dysuria rate when compared to bTURP patients. However, the catheterisation time was similar and both intraoperative and postoperative complications were minimal and comparable. Improvements in the International Prostate Symptom Score, quality of life, prostate volume, maximum urinary flow rate and post-void residual urine volume at 3 months were similar in both groups. None of our patients required re-admission or re-operation. Conclusion: Both PVP and bTURP can be carried out safely under sedoanalgesia with excellent treatment outcomes. Keywords: Photoselective vaporisation of prostate (PVP, Bipolar TURP, Day care bTURP, Day care PVP, Sedoanalgesia

  16. Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial.

    NARCIS (Netherlands)

    Ven, G. van de; Draskovic, I.; Adang, E.M.M.; Donders, R.; Post, A.; Zuidema, S.U.; Koopmans, R.T.C.M.; Vernooij-Dassen, M.J.F.J.

    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

  17. Examining the effects of enhanced provider-patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care.

    Science.gov (United States)

    van Vliet, Liesbeth M; van Dulmen, Sandra; Thiel, Bram; van Deelen, Gerard W; Immerzeel, Stephanie; Godfried, Marc B; Bensing, Jozien M

    2017-11-03

    Placebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider's communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients' outcomes. Using a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse-patient interactions. Although communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication. NTR5994; 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.

  18. Efficacy of a global supportive skin care programme with hydrotherapy after non-metastatic breast cancer treatment: A randomised, controlled study.

    Science.gov (United States)

    Dalenc, F; Ribet, V; Rossi, A B; Guyonnaud, J; Bernard-Marty, C; de Lafontan, B; Salas, S; Ranc Royo, A-L; Sarda, C; Levasseur, N; Massabeau, C; Levecq, J-M; Dulguerova, P; Guerrero, D; Sibaud, V

    2018-01-01

    This study investigated the efficacy of post-treatment hydrotherapy as supportive care for management of persistent/long-lasting dermatologic adverse events (dAEs) induced in breast cancer survivors by adjuvant therapy, and its impact on quality of life (QoL). Patients in complete remission after standardised (neo)adjuvant chemotherapy, surgery and radiotherapy combination treatment for infiltrating HR+/HER2-breast carcinoma were enrolled in this randomised, multicentre controlled study 1-5 weeks after completing radiotherapy. The control group (CG, n = 33) received best supportive care and the treatment group (HG, n = 35) received 3-weeks of specific hydrotherapy. The primary criterion was change in QoL (QLQ-BR23) after hydrotherapy. Clinical grading of dAEs, cancer-related QoL (QLQ-C30), dermatologic QoL (DLQI) and general psychological well-being (PGWBI) were assessed. Significant dAEs were found at inclusion in both groups (n = 261). Most items showed significantly greater improvement in the HG versus CG group: QLQ-BR23 (breast [p = .0001] and arm symptoms [p = .0015], systemic therapy side effects [p = .0044], body image [p = .0139]), some dAE grading, DLQI (p = .0002) and PGWBI (p = .0028). Xerosis (88% of patients at inclusion) completely healed in all HG patients. Specific hydrotherapy is an effective supportive care for highly prevalent and long-lasting dAEs occurring after early breast cancer treatment, including chemotherapy, and leads to improved QoL and dermatologic toxicities. © 2017 John Wiley & Sons Ltd.

  19. The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS project: An open-label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for primary care detoxification from either street heroin or methadone [ISRCTN07752728

    Directory of Open Access Journals (Sweden)

    Sheard Laura

    2004-04-01

    Full Text Available Abstract Background Heroin is a synthetic opioid with an extensive illicit market leading to large numbers of people becoming addicted. Heroin users often present to community treatment services requesting detoxification and in the UK various agents are used to control symptoms of withdrawal. Dissatisfaction with methadone detoxification 8 has lead to the use of clonidine, lofexidine, buprenorphine and dihydrocodeine; however, there remains limited evaluative research. In Leeds, a city of 700,000 people in the North of England, dihydrocodeine is the detoxification agent of choice. Sublingual buprenorphine, however, is being introduced. The comparative value of these two drugs for helping people successfully and comfortably withdraw from heroin has never been compared in a randomised trial. Additionally, there is a paucity of research evaluating interventions among drug users in the primary care setting. This study seeks to address this by randomising drug users presenting in primary care to receive either dihydrocodeine or buprenorphine. Methods/design The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS project is a pragmatic randomised trial which will compare the open use of buprenorphine with dihydrocodeine for illicit opiate detoxification, in the UK primary care setting. The LEEDS project will involve consenting adults and will be run in specialist general practice surgeries throughout Leeds. The primary outcome will be the results of a urine opiate screening at the end of the detoxification regimen. Adverse effects and limited data to three and six months will be acquired.

  20. Efficacy and cost-effectiveness of a specialist depression service versus usual specialist mental health care to manage persistent depression: a randomised controlled trial.

    Science.gov (United States)

    Morriss, Richard; Garland, Anne; Nixon, Neil; Guo, Boliang; James, Marilyn; Kaylor-Hughes, Catherine; Moore, Richard; Ramana, Rajini; Sampson, Christopher; Sweeney, Timothy; Dalgleish, Tim

    2016-09-01

    Persistent moderate or severe unipolar depression is common and expensive to treat. Clinical guidelines recommend combined pharmacotherapy and psychotherapy. Such treatments can take up to 1 year to show an effect, but no trials of suitable duration have been done. We investigated the efficacy and cost-effectiveness of outpatient-based, specialist depression services (SDS) versus treatment as usual (TAU) on depression symptoms and function. We did a multicentre, single-blind, patient-level, parallel, randomised controlled trial (RCT), as part of the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) study, in three mental health outpatient settings in England. Eligible participants were in secondary care, were older than 18 years, had unipolar depression (with a current major depressive episode, a 17-item Hamilton Depression Rating Scale [HDRS17] score of ≥16, and a Global Assessment of Function [GAF] score of ≤60), and had not responded to 6 months or more of treatment for depression. Randomisation was stratified by site with allocation conveyed to a trial administrator, with research assessors masked to outcome. Patients were randomised (1:1) using a computer-generated pseudo-random code with random permuted blocks of varying sizes of two, four, or six to either SDS (collaborative care approach between psychiatrists and cognitive behavioural therapists for 12 months, followed by graduated transfer of care up to 15 months) or to the TAU group. Intention-to-treat primary outcome measures were changes in HDRS17 and GAF scores between baseline and 6, 12, and 18 months' follow-up. We will separately publish follow-up outcomes for months 24 and 36. Clinical efficacy and cost-effectiveness were examined from health and social care persp ectives at 18 months, as recommended by the National Institute for Health and Care Excellence. This trial is registered at ClinicalTrials.gov (NCT01047124) and the

  1. A digital intake approach in specialized mental health care : Study protocol of a cluster randomised controlled trial

    NARCIS (Netherlands)

    Metz, M.J.; Elfeddali, I.; Krol, D.G.H.; Veerbeek, M.A.; De Beurs, E.; Beekman, A.T.F.; van der Feltz-Cornelis, C.M.

    2017-01-01

    Background Enhancing patient participation is becoming increasingly important in mental health care as patients use to have a dependent, inactive role and nonadherence to treatment is a regular problem. Research shows promising results of initiatives stimulating patient participation in partnership

  2. A randomised crossover trial of minimising medical terminology in secondary care correspondence in patients with chronic health conditions: impact on understanding and patient reported outcomes.

    Science.gov (United States)

    Wernick, M; Hale, P; Anticich, N; Busch, S; Merriman, L; King, B; Pegg, T

    2016-05-01

    There is little existing research on the role that secondary care letters have in ensuring patient understanding of chronic health conditions. To determine whether minimising the use of medical terminology in medical correspondence improved patient understanding and anxiety/depression scores. A single-centre, non-blinded, randomised crossover design assessed health literacy, EQ-5D scores and the impact of the 'translated' letter on the doctor's professionalism, the patient's relationship with their general practitioner (GP) and their perceived impact on chronic disease management. Patients were crossed over between their 'translated' and original letter. Sixty patients were recruited. Use of a 'translated' letter reduced mean terms not understood from 7.78 to 1.76 (t(58) = 4.706, P medical terminology in medical correspondence significantly improved patient understanding and perception of their ability to manage their chronic health condition. Although there was no impact on EQ-5D depression/anxiety scores, overwhelming patient preference for the 'translated' letter indicates a need for minimisation of medical terminology in medical correspondence for patients with chronic health conditions. © 2016 Royal Australasian College of Physicians.

  3. Randomised study showed that recorded maternal voices reduced pain in preterm infants undergoing heel lance procedures in a neonatal intensive care unit.

    Science.gov (United States)

    Chirico, G; Cabano, R; Villa, G; Bigogno, A; Ardesi, M; Dioni, E

    2017-10-01

    Alleviating pain in neonates should be the goal of all caregivers. We evaluated whether recorded maternal voices were safe and effective in limiting pain in preterm infants undergoing heel lance procedures in the neonatal intensive care unit of an Italian children's hospital. This prospective, controlled study took place from December 2013 to December 2015. We enrolled 40 preterm infants, born at a 26-34 weeks of gestation, at a corrected gestational age 29-36 weeks and randomised them to listen or not listen to a recording of their mother's voice during a painful, routine heel lance for blood collection. Changes in the infants' Premature Infant Pain Profile, heart rate, oxygen saturation and blood pressure during the procedure were compared by analysis of variance. Possible side effects, of apnoea, bradycardia, seizures and vomiting, were also recorded. Both groups showed a marked increase in PIPP scores and decrease in oxygen saturation during the procedure, but infants in the treatment group had significantly lower PIPP scores (p = 0.00002) and lower decreases in oxygen saturation (p = 0.0283). No significant side effects were observed. Using recorded maternal voices to limit pain in preterm infants undergoing heel lance procedures appeared safe and effective. ©2017 Foundation Acta Paediatrica. Published by John Wiley & Sons Ltd.

  4. The effectiveness of adding cognitive behavioural therapy aimed at changing lifestyle to managed diabetes care for patients with type 2 diabetes: design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Oppen Patricia

    2007-05-01

    Full Text Available Abstract Background In patients with type 2 diabetes, the risk for cardiovascular disease is substantial. To achieve a more favourable risk profile, lifestyle changes on diet, physical activity and smoking status are needed. This will involve changes in behaviour, which is difficult to achieve. Cognitive behavioural therapies focussing on self-management have been shown to be effective. We have developed an intervention combining techniques of Motivational Interviewing (MI and Problem Solving Treatment (PST. The aim of our study is to investigate if adding a combined behavioural intervention to managed care, is effective in achieving changes in lifestyle and cardiovascular risk profile. Methods Patients with type 2 diabetes will be selected from general practices (n = 13, who are participating in a managed diabetes care system. Patients will be randomised into an intervention group receiving cognitive behaviour therapy (CBT in addition to managed care, and a control group that will receive managed care only. The CBT consists of three to six individual sessions of 30 minutes to increase the patient's motivation, by using principles of MI, and ability to change their lifestyle, by using PST. The first session will start with a risk assessment of diabetes complications that will be used to focus the intervention. The primary outcome measure is the difference between intervention and control group in change in cardiovascular risk score. For this purpose blood pressure, HbA1c, total and HDL-cholesterol and smoking status will be assessed. Secondary outcome measures are quality of life, patient satisfaction, physical activity, eating behaviour, smoking status, depression and determinants of behaviour change. Differences between changes in the two groups will be analysed according to the intention-to-treat principle, with 95% confidence intervals. The power calculation is based on the risk for cardiovascular disease and we calculated that 97 patients

  5. Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial

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    Schellberg Dieter

    2009-08-01

    Full Text Available Abstract Background Chronic (systolic heart failure (CHF is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs (Train the trainer = TTT on patient and performance outcomes. Methods This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ, total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9, behavioural change (European Heart Failure Self-Care Behaviour Scale, patient-perceived quality of care (EUROPEP and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. Results There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30. The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2–13; p = 0.02. Conclusion The intervention did not change the primary outcome or most secondary outcomes

  6. Primary care-based multifaceted, interdisciplinary medical educational intervention for patients with systolic heart failure: lessons learned from a cluster randomised controlled trial.

    Science.gov (United States)

    Peters-Klimm, Frank; Campbell, Stephen; Müller-Tasch, Thomas; Schellberg, Dieter; Gelbrich, Goetz; Herzog, Wolfgang; Szecsenyi, Joachim

    2009-08-13

    Chronic (systolic) heart failure (CHF) is a common and disabling condition. Adherence to evidence-based guidelines in primary care has been shown to improve health outcomes. The aim was to explore the impact of a multidisciplinary educational intervention for general practitioners (GPs) (Train the trainer = TTT) on patient and performance outcomes. This paper presents the key findings from the trial and discusses the lessons learned during the implementation of the TTT trial. Primary care practices were randomly assigned to the TTT intervention or to the control group. 37 GPs (18 TTT, 19 control) were randomised and 168 patients diagnosed with ascertained CHF (91 TTT, 77 control) were enrolled. GPs in the intervention group attended four meetings addressing clinical practice guidelines and pharmacotherapy feedback. The primary outcome was patient self-reported quality of life at seven months, using the SF-36 Physical Functioning scale. Secondary outcomes included other SF-36 scales, the Kansas City Cardiomyopathy Questionnaire (KCCQ), total mortality, heart failure hospital admissions, prescribing, depressive disorders (PHQ-9), behavioural change (European Heart Failure Self-Care Behaviour Scale), patient-perceived quality of care (EUROPEP) and improvement of heart failure using NT-proBNP-levels. Because recruitment targets were not achieved an exploratory analysis was conducted. There was high baseline achievement in both groups for many outcomes. At seven months, there were no significant mean difference between groups for the primary outcome measure (-3.3, 95%CI -9.7 to 3.1, p = 0.30). The only difference in secondary outcomes related to the prescribing of aldosterone antagonists by GPs in the intervention group, with significant between group differences at follow-up (42 vs. 24%, adjusted OR = 4.0, 95%CI 1.2-13; p = 0.02). The intervention did not change the primary outcome or most secondary outcomes. Recruitment targets were not achieved and the under

  7. A randomised trial of a psychosocial intervention for cancer patients integrated into routine care: the PROMPT study (promoting optimal outcomes in mood through tailored psychosocial therapies

    Directory of Open Access Journals (Sweden)

    Jolley Damien

    2011-02-01

    Full Text Available Abstract Background Despite evidence that up to 35% of patients with cancer experience significant distress, access to effective psychosocial care is limited by lack of systematic approaches to assessment, a paucity of psychosocial services, and patient reluctance to accept treatment either because of perceived stigma or difficulties with access to specialist psycho-oncology services due to isolation or disease burden. This paper presents an overview of a randomised study to evaluate the effectiveness of a brief tailored psychosocial Intervention delivered by health professionals in cancer care who undergo focused training and participate in clinical supervision. Methods/design Health professionals from the disciplines of nursing, occupational therapy, speech pathology, dietetics, physiotherapy or radiation therapy will participate in training to deliver the psychosocial Intervention focusing on core concepts of supportive-expressive, cognitive and dignity-conserving care. Health professional training will consist of completion of a self-directed manual and participation in a skills development session. Participating health professionals will be supported through structured clinical supervision whilst delivering the Intervention. In the stepped wedge design each of the 5 participating clinical sites will be allocated in random order from Control condition to Training then delivery of the Intervention. A total of 600 patients will be recruited across all sites. Based on level of distress or risk factors eligible patients will receive up to 4 sessions, each of up to 30 minutes in length, delivered face-to-face or by telephone. Participants will be assessed at baseline and 10-week follow-up. Patient outcome measures include anxiety and depression, quality of life, unmet psychological and supportive care needs. Health professional measures include psychological morbidity, stress and burnout. Process evaluation will be conducted to assess perceptions

  8. A comparison of the home-care and healthcare service use and costs of older Australians randomised to receive a restorative or a conventional home-care service.

    Science.gov (United States)

    Lewin, Gill; Allan, Janine; Patterson, Candice; Knuiman, Matthew; Boldy, Duncan; Hendrie, Delia

    2014-05-01

    Restorative home-care services, or re-ablement home-care services as they are now known in the UK, aim to assist older individuals who are experiencing difficulties in everyday living to optimise their functioning and reduce their need for ongoing home care. Until recently, the effectiveness of restorative home-care services had only been investigated in terms of singular outcomes such as length of home-care episode, admission to hospital and quality of life. This paper reports on a more complex and perhaps more significant measure--the use and cost of the home-care and healthcare services received over the 2-year period following service commencement. Seven hundred and fifty older individuals referred for government-funded home care were randomly assigned to a restorative or standard service between June 2005 and August 2007. Health and aged care service data were sourced and linked via the Western Australian Data Linkage System. Restorative clients used fewer home-care hours (mean [SD], 117.3 [129.4] vs. 191.2 [230.4]), had lower total home-care costs (AU$5570 vs. AU$8541) and were less likely to be approved for a higher level of aged care (N [%], 171 [55.2] vs. 249 [63.0]) during follow-up. They were also less likely to have presented at an emergency department (OR = 0.69, 95% CI = 0.50-0.94) or have had an unplanned hospital admission [OR (95% CI), 0.69 (0.50-0.95)]. Additionally, the aggregated health and home-care costs of the restorative clients were lower by a factor of 0.83 (95% CI 0.72-0.96) over the 2-year follow-up (AU$19,090 vs. AU$23,428). These results indicate that at a time when Australia is facing the challenges of population ageing and an expected increase in demand for health and aged care services, the provision of a restorative service when an older person is referred for home care is potentially a more cost-effective option than providing conventional home care. © 2014 The Authors. Health and Social Care in the Community published by John

  9. PIRATE project: point-of-care, informatics-based randomised controlled trial for decreasing overuse of antibiotic therapy in Gram-negative bacteraemia.

    Science.gov (United States)

    Huttner, Angela; Albrich, Werner C; Bochud, Pierre-Yves; Gayet-Ageron, Angèle; Rossel, Anne; Dach, Elodie von; Harbarth, Stephan; Kaiser, Laurent

    2017-07-13

    Antibiotic overuse drives antibiotic resistance. The optimal duration of antibiotic therapy for Gram-negative bacteraemia (GNB), a common community and hospital-associated infection, remains unknown and unstudied via randomised controlled trials (RCTs). This investigator-initiated, multicentre, non-inferiority, informatics-based point-of-care RCT will randomly assign adult hospitalised patients receiving microbiologically efficacious antibiotic(s) for GNB to (1) 14 days of antibiotic therapy, (2) 7 days of therapy or (3) an individualised duration determined by clinical response and 75% reduction in peak C reactive protein (CRP) values. The randomisation will occur in equal proportions (1:1:1) on day 5 (±1) of efficacious antibiotic therapy as determined by antibiogram; patients, their physicians and study investigators will be blind to treatment duration allocation until the day of antibiotic discontinuation. Immunosuppressed patients and those with GNB due to complicated infections (endocarditis, osteomyelitis, etc) and/or non-fermenting bacilli ( Acinetobacter spp, Burkholderia spp, Pseudomonas spp) Brucella spp, Fusobacterium spp or polymicrobial growth with Gram-positive organisms will be ineligible. The primary outcome is incidence of clinical failure at day 30; secondary outcomes include clinical failure, all-cause mortality and incidence of Clostridiumdifficile infection in the 90-day study period. An interim safety analysis will be performed after the first 150 patients have been followed for ≤30 days. Given a chosen margin of 10%, the required sample size to determine non-inferiority is roughly 500 patients. Analyses will be performed on both intention-to-treat and per-protocol populations. Ethics approval was obtained from the cantonal ethics committees of all three participating sites. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal. This trial is registered at www

  10. Lay health supporters aided by a mobile phone messaging system to improve care of villagers with schizophrenia in Liuyang, China: protocol for a randomised control trial.

    Science.gov (United States)

    Xu, Dong Roman; Gong, Wenjie; Caine, Eric D; Xiao, Shuiyuan; Hughes, James P; Ng, Marie; Simoni, Jane; He, Hua; Smith, Kirk L; Brown, Henry Shelton; Gloyd, Stephen

    2016-01-20

    Schizophrenia is a severe, chronic and disabling mental illness. Non-adherence to medication and relapse may lead to poorer patient function. This randomised controlled study, under the acronym LEAN (Lay health supporter, e-platform, award, and iNtegration), is designed to improve medication adherence and high relapse among people with schizophrenia in resource poor settings. The community-based LEAN has four parts: (1) Lay health supporters (LHSs), mostly family members who will help supervise patient medication, monitor relapse and side effects, and facilitate access to care, (2) an E-platform to support two-way mobile text and voice messaging to remind patients to take medication; and alert LHSs when patients are non-adherent, (3) an Award system to motivate patients and strengthen LHS support, and (4) iNtegration of the efforts of patients and LHSs with those of village doctors, township mental health administrators and psychiatrists via the e-platform. A random sample of 258 villagers with schizophrenia will be drawn from the schizophrenic '686' Program registry for the 9 Xiang dialect towns of the Liuyang municipality in China. The sample will be further randomised into a control group and a treatment group of equal sizes, and each group will be followed for 6 months after launch of the intervention. The primary outcome will be medication adherence as measured by pill counts and supplemented by pharmacy records. Other outcomes include symptoms and level of function. Outcomes will be assessed primarily when patients present for medication refill visits scheduled every 2 months over the 6-month follow-up period. Data from the study will be analysed using analysis of covariance for the programme effect and an intent-to-treat approach. University of Washington: 49464 G; Central South University: CTXY-150002-6. Results will be published in peer-reviewed journals with deidentified data made available on FigShare. ChiCTR-ICR-15006053; Pre-results. Published by the

  11. Clinical score and rapid antigen detection test to guide antibiotic use for sore throats: randomised controlled trial of PRISM (primary care streptococcal management).

    Science.gov (United States)

    Little, Paul; Hobbs, F D Richard; Moore, Michael; Mant, David; Williamson, Ian; McNulty, Cliodna; Cheng, Ying Edith; Leydon, Geraldine; McManus, Richard; Kelly, Joanne; Barnett, Jane; Glasziou, Paul; Mullee, Mark

    2013-10-10

    To determine the effect of clinical scores that predict streptococcal infection or rapid streptococcal antigen detection tests compared with delayed antibiotic prescribing. Open adaptive pragmatic parallel group randomised controlled trial. Primary care in United Kingdom. Patients aged ≥ 3 with acute sore throat. An internet programme randomised patients to targeted antibiotic use according to: delayed antibiotics (the comparator group for analyses), clinical score, or antigen test used according to clinical score. During the trial a preliminary streptococcal score (score 1, n=1129) was replaced by a more consistent score (score 2, n=631; features: fever during previous 24 hours; purulence; attends rapidly (within three days after onset of symptoms); inflamed tonsils; no cough/coryza (acronym FeverPAIN). Symptom severity reported by patients on a 7 point Likert scale (mean severity of sore throat/difficulty swallowing for days two to four after the consultation (primary outcome)), duration of symptoms, use of antibiotics. For score 1 there were no significant differences between groups. For score 2, symptom severity was documented in 80% (168/207 (81%) in delayed antibiotics group; 168/211 (80%) in clinical score group; 166/213 (78%) in antigen test group). Reported severity of symptoms was lower in the clinical score group (-0.33, 95% confidence interval -0.64 to -0.02; P=0.04), equivalent to one in three rating sore throat a slight versus moderate problem, with a similar reduction for the antigen test group (-0.30, -0.61 to -0.00; P=0.05). Symptoms rated moderately bad or worse resolved significantly faster in the clinical score group (hazard ratio 1.30, 95% confidence interval 1.03 to 1.63) but not the antigen test group (1.11, 0.88 to 1.40). In the delayed antibiotics group, 75/164 (46%) used antibiotics. Use of antibiotics in the clinical score group (60/161) was 29% lower (adjusted risk ratio 0.71, 95% confidence interval 0.50 to 0.95; P=0.02) and in the

  12. Lay health supporters aided by a mobile phone messaging system to improve care of villagers with schizophrenia in Liuyang, China: protocol for a randomised control trial

    Science.gov (United States)

    Gong, Wenjie; Caine, Eric D; Xiao, Shuiyuan; Hughes, James P; Ng, Marie; Simoni, Jane; He, Hua; Smith, Kirk L; Brown, Henry Shelton; Gloyd, Stephen

    2016-01-01

    Introduction Schizophrenia is a severe, chronic and disabling mental illness. Non-adherence to medication and relapse may lead to poorer patient function. This randomised controlled study, under the acronym LEAN (Lay health supporter, e-platform, award, and iNtegration), is designed to improve medication adherence and high relapse among people with schizophrenia in resource poor settings. Methods/analysis The community-based LEAN has four parts: (1) Lay health supporters (LHSs), mostly family members who will help supervise patient medication, monitor relapse and side effects, and facilitate access to care, (2) an E-platform to support two-way mobile text and voice messaging to remind patients to take medication; and alert LHSs when patients are non-adherent, (3) an Award system to motivate patients and strengthen LHS support, and (4) iNtegration of the efforts of patients and LHSs with those of village doctors, township mental health administrators and psychiatrists via the e-platform. A random sample of 258 villagers with schizophrenia will be drawn from the schizophrenic ‘686’ Program registry for the 9 Xiang dialect towns of the Liuyang municipality in China. The sample will be further randomised into a control group and a treatment group of equal sizes, and each group will be followed for 6 months after launch of the intervention. The primary outcome will be medication adherence as measured by pill counts and supplemented by pharmacy records. Other outcomes include symptoms and level of function. Outcomes will be assessed primarily when patients present for medication refill visits scheduled every 2 months over the 6-month follow-up period. Data from the study will be analysed using analysis of covariance for the programme effect and an intent-to-treat approach. Ethics and dissemination University of Washington: 49464 G; Central South University: CTXY-150002-6. Results will be published in peer-reviewed journals with deidentified data made available on

  13. Personalised long-term follow-up of cochlear implant patients using remote care, compared with those on the standard care pathway: study protocol for a feasibility randomised controlled trial.

    Science.gov (United States)

    Cullington, Helen; Kitterick, Padraig; DeBold, Lisa; Weal, Mark; Clarke, Nicholas; Newberry, Eva; Aubert, Lisa

    2016-05-13

    Many resources are required to provide postoperative care to patients who receive a cochlear implant. The implant service commits to lifetime follow-up. The patient commits to regular adjustment and rehabilitation appointments in the first year and annual follow-up appointments thereafter. Offering remote follow-up may result in more stable hearing, reduced patient travel expense, time and disruption, more empowered patients, greater equality in service delivery and more freedom to optimise the allocation of clinic resources. This will be a two-arm feasibility randomised controlled trial (RCT) involving 60 adults using cochlear implants with at least 6 months device experience in a 6-month clinical trial of remote care. This project will design, implement and evaluate a person-centred long-term follow-up pathway for people using cochlear implants offering a triple approach of remote and self-monitoring, self-adjustment of device and a personalised online support tool for home speech recognition testing, information, self-rehabilitation, advice, equipment training and troubleshooting. The main outcome measure is patient activation. Secondary outcomes are stability and quality of hearing, stability of quality of life, clinic resources, patient and clinician experience, and any adverse events associated with remote care. We will examine the acceptability of remote care to service users and clinicians, the willingness of participants to be randomised, and attrition rates. We will estimate numbers required to plan a fully powered RCT. Ethical approval was received from North West-Greater Manchester South Research Ethics Committee (15/NW/0860) and the University of Southampton Research Governance Office (ERGO 15329). Results will be disseminated in the clinical and scientific communities and also to the patient population via peer-reviewed research publications both online and in print, conference and meeting presentations, posters, newsletter articles, website reports

  14. Challenges in demonstrating the effectiveness of multidisciplinary treatment on quality of life, participation and health care utilisation in patients with fibromyalgia: a randomised controlled trial.

    Science.gov (United States)

    van Eijk-Hustings, Yvonne; Kroese, Mariëlle; Tan, Frans; Boonen, Annelies; Bessems-Beks, Monique; Landewé, Robert

    2013-02-01

    This study aimed to examine the effectiveness of a multidisciplinary intervention with aftercare (MD) compared to aerobic exercise (AE) and usual care (UC) in recently diagnosed patients with fibromyalgia (FM). In a Zelen-like design, eligible patients from the outpatient rheumatology clinics of three medical centres in the South of the Netherlands were consecutively recruited and pre-randomised to MD (n = 108), AE (n = 47) or UC (n = 48). MD consisted of a 12-week course of sociotherapy, physiotherapy, psychotherapy and creative arts therapy (three half days per week), followed by five aftercare meetings in 9 months. AE was given twice a week in a 12-week course. UC varied but incorporated at least education and lifestyle advice. Primary outcomes were health-related quality of life (HR-Qol), participation and health care utilisation. Secondary outcome was the Fibromyalgia Impact Questionnaire (FIQ). Total follow-up duration of the study was 21-24 months. As willingness to participate in AE was limited, this group has been analysed but interpretation of the data is considered arguable. Within the MD group, a statistically significantly improved HR-Qol and a statistically significant reduction in number of hours sick leave, number of contacts with general practitioners and number of contacts with medical specialists was found. Moreover, statistically significant improvements were found on the FIQ, which increased after the intervention. However, no statistically significant between-group differences were found at the endpoint of the study. MD seemed to yield positive effects, but firm conclusions with regard to effectiveness cannot be formulated due to small between-group differences and limitations of the study.

  15. COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES): statistical and economic analysis plan for a randomised controlled trial.

    Science.gov (United States)

    Robinson, Emily J; Goldstein, Laura H; McCrone, Paul; Perdue, Iain; Chalder, Trudie; Mellers, John D C; Richardson, Mark P; Murray, Joanna; Reuber, Markus; Medford, Nick; Stone, Jon; Carson, Alan; Landau, Sabine

    2017-06-06

    Dissociative seizures (DSs), also called psychogenic non-epileptic seizures, are a distressing and disabling problem for many patients in neurological settings with high and often unnecessary economic costs. The COgnitive behavioural therapy versus standardised medical care for adults with Dissociative non-Epileptic Seizures (CODES) trial is an evaluation of a specifically tailored psychological intervention with the aims of reducing seizure frequency and severity and improving psychological well-being in adults with DS. The aim of this paper is to report in detail the quantitative and economic analysis plan for the CODES trial, as agreed by the trial steering committee. The CODES trial is a multicentre, pragmatic, parallel group, randomised controlled trial performed to evaluate the clinical effectiveness and cost-effectiveness of 13 sessions of cognitive behavioural therapy (CBT) plus standardised medical care (SMC) compared with SMC alone for adult outpatients with DS. The objectives and design of the trial are summarised, and the aims and procedures of the planned analyses are illustrated. The proposed analysis plan addresses statistical considerations such as maintaining blinding, monitoring adherence with the protocol, describing aspects of treatment and dealing with missing data. The formal analysis approach for the primary and secondary outcomes is described, as are the descriptive statistics that will be reported. This paper provides transparency to the planned inferential analyses for the CODES trial prior to the extraction of outcome data. It also provides an update to the previously published trial protocol and guidance to those conducting similar trials. ISRCTN registry ISRCTN05681227 (registered on 5 March 2014); ClinicalTrials.gov NCT02325544 (registered on 15 December 2014).

  16. Preventing disease through opportunistic, rapid engagement by primary care teams using behaviour change counselling (PRE-EMPT): protocol for a general practice-based cluster randomised trial.

    Science.gov (United States)

    Spanou, Clio; Simpson, Sharon A; Hood, Kerry; Edwards, Adrian; Cohen, David; Rollnick, Stephen; Carter, Ben; McCambridge, Jim; Moore, Laurence; Randell, Elizabeth; Pickles, Timothy; Smith, Christine; Lane, Claire; Wood, Fiona; Thornton, Hazel; Butler, Chris C

    2010-09-21

    Smoking, excessive alcohol consumption, lack of exercise and an unhealthy diet are the key modifiable factors contributing to premature morbidity and mortality in the developed world. Brief interventions in health care consultations can be effective in changing single health behaviours. General Practice holds considerable potential for primary prevention through modifying patients' multiple risk behaviours, but feasible, acceptable and effective interventions are poorly developed, and uptake by practitioners is low. Through a process of theoretical development, modeling and exploratory trials, we have developed an intervention called Behaviour Change Counselling (BCC) derived from Motivational Interviewing (MI). This paper describes the protocol for an evaluation of a training intervention (the Talking Lifestyles Programme) which will enable practitioners to routinely use BCC during consultations for the above four risk behaviours. This cluster randomised controlled efficacy trial (RCT) will evaluate the outcomes and costs of this training intervention for General Practitioners (GPs) and nurses. Training methods will include: a practice-based seminar, online self-directed learning, and reflecting on video recorded and simulated consultations. The intervention will be evaluated in 29 practices in Wales, UK; two clinicians will take part (one GP and one nurse) from each practice. In intervention practices both clinicians will receive training. The aim is to recruit 2000 patients into the study with an expected 30% drop out. The primary outcome will be the proportion of patients making changes in one or more of the four behaviours at three months. Results will be compared for patients seeing clinicians trained in BCC with patients seeing non-BCC trained clinicians. Economic and process evaluations will also be conducted. Opportunistic engagement by health professionals potentially represents a cost effective medical intervention. This study integrates an existing

  17. A randomised translational trial of lifestyle intervention using a 3-tier shared care approach on pregnancy outcomes in Chinese women with gestational diabetes mellitus but without diabetes.

    Science.gov (United States)

    Yang, Xilin; Tian, Huiguang; Zhang, Fuxia; Zhang, Cuiping; Li, Yi; Leng, Junhong; Wang, Leishen; Liu, Gongshu; Liu, Gongsu; Dong, Ling; Yu, Zhijie; Hu, Gang; Chan, Juliana Cn

    2014-10-28

    There are no randomised controlled trials to demonstrate whether lifestyle modifications can improve pregnancy outcomes of gestational diabetes mellitus (GDM) diagnosed by the International Association of Diabetes and Pregnancy Study Group's (IADPSG) criteria. We tested the effectiveness of lifestyle modifications implemented in a 3-tier's shared care (SC) on pregnancy outcomes of GDM. Between December 2010 and October 2012, we randomly assigned 700 women with IADPSG-defined GDM but without diabetes at 26.3 (interquartile range: 25.4-27.3) gestational weeks in Tianjin, China, to receive SC or usual care (UC). The SC group received individual consultations and group sessions and performed regular self-monitoring of blood glucose compared to one hospital-based education session in the UC group. The outcomes were macrosomia defined as birth weight ≥ 4.0 kg and the pregnancy-induced hypertension (PIH). Women in the SC (n = 339) and UC (n = 361) groups delivered their infants at similar gestational weeks. Birth weight of infants in the SC group was lower than that in the UC group (3469 vs. 3371 grams, P = 0.021). The rate of macrosomia was 11.2% (38/339) in the SC group compared to 17.5% (63/361) in the UC group with relative risk (RR) of 0.64 (95% CI: 0.44-0.93). The rate of PIH was 8.0% (27/339) in the SC compared to 4.4% (16/361) in the UC with RR of 1.80 (0.99-3.28). Apgar score at 1 min Lifestyle modifications using a SC system improved pregnancy outcomes in Chinese women with GDM. Clinicaltrials.gov; NCT01565564.

  18. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema

    DEFF Research Database (Denmark)

    Ibler, Kristina Sophie; Agner, Tove; Hansen, Jane L.

    2010-01-01

    . The experimental group undergoes patch and prick testing; classification of the hand eczema; demonstration of hand washing and appliance of emollients; individual counselling, and a skin-care programme. The control group receives no intervention. All participants are reassessed after six months. The primary...... strategies are needed to reduce occupational hand eczema. METHODS/DESIGN: We describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified...

  19. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema

    DEFF Research Database (Denmark)

    Ibler, Kristina Sophie; Agner, Tove; Hansen, Jane L.

    2010-01-01

    strategies are needed to reduce occupational hand eczema. METHODS/DESIGN: We describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified...... from a self-administered questionnaire delivered to 3181 health-care workers in three Danish hospitals. The questionnaire identifies the prevalence of hand eczema, knowledge of skin-protection, and exposures that can lead to hand eczema. At entry, all participants are assessed regarding: disease...

  20. An internet-based intervention with brief nurse support to manage obesity in primary care (POWeR+): a pragmatic, parallel-group, randomised controlled trial.

    Science.gov (United States)

    Little, Paul; Stuart, Beth; Hobbs, Fd Richard; Kelly, Jo; Smith, Emily R; Bradbury, Katherine J; Hughes, Stephanie; Smith, Peter W F; Moore, Michael V; Lean, Mike E J; Margetts, Barrie M; Byrne, Chris D; Griffin, Simon; Davoudianfar, Mina; Hooper, Julie; Yao, Guiqing; Zhu, Shihua; Raftery, James; Yardley, Lucy

    2016-10-01

    The obesity epidemic has major public health consequences. Expert dietetic and behavioural counselling with intensive follow-up is effective, but resource requirements severely restrict widespread implementation in primary care, where most patients are managed. We aimed to estimate the effectiveness and cost-effectiveness of an internet-based behavioural intervention (POWeR+) combined with brief practice nurse support in primary care. We did this pragmatic, parallel-group, randomised controlled trial at 56 primary care practices in central and south England. Eligible adults aged 18 years or older with a BMI of 30 kg/m(2) or more (or ≥28 kg/m(2) with hypertension, hypercholesterolaemia, or diabetes) registered online with POWeR+-a 24 session, web-based, weight management intervention lasting 6 months. After registration, the website automatically randomly assigned patients (1:1:1), via computer-generated random numbers, to receive evidence-based dietetic advice to swap foods for similar, but healthier, choices and increase fruit and vegetable intake, in addition to 6 monthly nurse follow-up (control group); web-based intervention and face-to-face nurse support (POWeR+Face-to-face [POWeR+F]; up to seven nurse contacts over 6 months); or web-based intervention and remote nurse support (POWeR+Remote [POWeR+R]; up to five emails or brief phone calls over 6 months). Participants and investigators were masked to group allocation at the point of randomisation; masking of participants was not possible after randomisation. The primary outcome was weight loss averaged over 12 months. We did a secondary analysis of weight to measure maintenance of 5% weight loss at months 6 and 12. We modelled the cost-effectiveness of each intervention. We did analysis by intention to treat, with multiple imputation for missing data. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN21244703. Between Jan 30, 2013, and March 20, 2014, 818

  1. A non-clinical randomised controlled trial to assess the impact of pharmaceutical care intervention on satisfaction level of newly diagnosed diabetes mellitus patients in a tertiary care teaching hospital in Nepal.

    Science.gov (United States)

    Upadhyay, Dinesh Kumar; Mohamed Ibrahim, Mohamed Izham; Mishra, Pranaya; Alurkar, Vijay M

    2015-02-12

    Patient satisfaction is the ultimate goal of healthcare system which can be achieved from good patient-healthcare professional relationship and quality of healthcare services provided. Study was conducted to determine the baseline satisfaction level of newly diagnosed diabetics and to explore the impact of pharmaceutical care intervention on patients' satisfaction during their follow-ups in a tertiary care teaching hospital in Nepal. An interventional, pre-post non-clinical randomised controlled study was designed among randomly distributed 162 [control group (n = 54), test 1 group (n = 54) and test 2 group (n = 54)] newly diagnosed diabetes mellitus patients by consecutive sampling method for 18 months. Diabetes Patient Satisfaction Questionnaire was used to evaluate patient's satisfaction scores at baseline, three, six, nine and, twelve months' follow-ups. Test groups patients were provided pharmaceutical care whereas control group patients only received their usual care from physician/nurses. The responses were entered in SPSS version 16. Data distribution was not normal on Kolmogorov-Smirnov test. Non-parametric tests i.e. Friedman test, Mann-Whitney U test and Wilcoxon signed rank test were used to find the differences among the groups before and after the intervention (p ≤0.05). There were significant (p patients' satisfaction scores in the test groups on Friedman test. Mann-Whitney U test identified the significant differences in satisfaction scores between test 1 and test 2 groups, control and test 1 groups and, control and test 2 groups at 3-months (p = 0.008), (p satisfaction level of diabetics in the test groups compare to the control group. Diabetic kit demonstration strengthened the satisfaction level among the test 2 group patients. Therefore, pharmacist can act as a counsellor through pharmaceutical care program and assist the patients in managing their disease. This will not only modify the patients' related outcomes and their

  2. Clinical effectiveness of online computerised cognitive-behavioural therapy without support for depression in primary care: randomised trial

    NARCIS (Netherlands)

    de Graaf, L.E.; Gerhards, S.A.H.; Arntz, A.; Riper, H.; Metsemakers, J.F.M.; Evers, S.M.; Severens, J.L.; Widdershoven, G.A.M.; Huibers, M.J.H.

    2009-01-01

    BACKGROUND: Computerised cognitive-behavioural therapy (CCBT) might offer a solution to the current undertreatment of depression. AIMS: To determine the clinical effectiveness of online, unsupported CCBT for depression in primary care. METHOD: Three hundred and three people with depression were

  3. Early motion and directed exercise (EMADE) versus usual care post ankle fracture fixation: study protocol for a pragmatic randomised controlled trial.

    Science.gov (United States)

    Matthews, Paul A; Scammell, Brigitte E; Ali, Arfan; Coughlin, Timothy; Nightingale, Jessica; Khan, Tanvir; Ollivere, Ben J

    2018-05-31

    Following surgical fixation of ankle fractures, the traditional management has included immobilisation for 6 weeks in a below-knee cast. However, this can lead to disuse atrophy of the affected leg and joint stiffness. While early rehabilitation from 2 weeks post surgery is viewed as safe, controversy remains regarding its benefits. We will compare the effectiveness of early motion and directed exercise (EMADE) ankle rehabilitation, against usual care, i.e. 6 weeks' immobilisation in a below-knee cast. We have designed a pragmatic randomised controlled trial (p-RCT) to compare the EMADE intervention against usual care. We will recruit 144 independently living adult participants, absent of tissue-healing comorbidities, who have undergone surgical stabilisation of isolated Weber B ankle fractures. The EMADE intervention consists of a non-weight-bearing progressive home exercise programme, complemented with manual therapy and education. Usual care consists of immobilisation in a non-weight-bearing below-knee cast. The intervention period is between week 2 and week 6 post surgery. The primary outcome is the Olerud and Molander Ankle Score (OMAS) patient-reported outcome measure (PROM) at 12 weeks post surgery. Secondary PROMs include the EQ-5D-5 L questionnaire, return to work and return to driving, with objective outcomes including ankle range of motion. Analysis will be on an intention-to-treat basis. An economic evaluation will be included. The EMADE intervention is a package of care designed to address the detrimental effects of disuse atrophy and joint stiffness. An advantage of the OMAS is the potential of meta-analysis with other designs. Within the economic evaluation, the cost-utility analysis, may be used by commissioners, while the use of patient-relevant outcomes, such as return to work and driving, will ensure that the study remains pertinent to patients and their families. As it is being conducted in the clinical environment, this p-RCT has high external

  4. A health dialogue intervention reduces cardiovascular risk factor levels: a population based randomised controlled trial in Swedish primary care setting with 1-year follow-up

    Directory of Open Access Journals (Sweden)

    Mats Hellstrand

    2017-08-01

    Full Text Available Abstract Background The total number of cardiovascular (CVD deaths accounted for almost a third of all deaths globally in 2013. Population based randomised controlled trials, managed within primary care, on CVD risk factor interventions are scarce. The aim of the study was to evaluate the effects of a health dialogue intervention in a primary care setting offered to a population at the age of 55 years, focusing on CVD risk factors. Methods The study was performed in five primary health care centres in the county of Västmanland, Sweden between April 2011 and December 2012. Men and women were randomly assigned to intervention (n = 440 and control groups (n = 440. At baseline, both groups filled in a health questionnaire and serum cholesterol, fasting plasma glucose, glycated haemoglobin (HbA1c, weight, height, waist (WC and hip circumference, waist hip ratio (WHR and systolic/diastolic blood pressure were measured. Intervention group attended a health dialogue, supported by a visualised health profile, with a possibility for further activities. Participation rates at baseline were 53% and 52% respectively. A 1-year follow-up was carried out. Results The intervention group (n = 165 showed reductions compared to the control group (n = 177 concerning body mass index (BMI (0.3 kg/m2, p = .031, WC (2.1 cm, p ≤ .001 and WHR (.002, p ≤ .001 at the 1-year follow-up. No differences between the intervention and control groups were found in other variables. Intervention group, compared to baseline, had reduced weight, BMI, WC, WHR, HbA1c, and diet, while the men in the control group had reduced their alcohol consumption. Conclusions A health dialogue intervention at the age of 55 years, conducted in ordinary primary care, showed a moderate effect on CVD risk factor levels, in terms of BMI, WC and WHR. Trial registration number BioMed Central, ISRCTN22586871 , date assigned; 10/12/2015

  5. Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials.

    Science.gov (United States)

    Curth, Nadja Kehler; Brinck-Claussen, Ursula Ødum; Davidsen, Annette Sofie; Lau, Marianne Engelbrecht; Lundsteen, Merete; Mikkelsen, John Hagel; Csillag, Claudio; Hjorthøj, Carsten; Nordentoft, Merete; Eplov, Lene Falgaard

    2017-08-16

    People with anxiety disorders represent a significant part of a general practitioner's patient population. However, there are organisational obstacles for optimal treatment, such as a lack of coordination of illness management and limited access to evidence-based treatment such as cognitive behavioral therapy. A limited number of studies suggest that collaborative care has a positive effect on symptoms for people with anxiety disorders. However, most studies are carried out in the USA and none have reported results for social phobia or generalised anxiety disorder separately. Thus, there is a need for studies carried out in different settings for specific anxiety populations. A Danish model for collaborative care (the Collabri model) has been developed for people diagnosed with depression or anxiety disorders. The model is evaluated through four trials, of which three will be outlined in this protocol and focus on panic disorder, generalised anxiety disorder and social phobia. The aim is to investigate whether treatment according to the Collabri model has a better effect than usual treatment on symptoms when provided to people with anxiety disorders. Three cluster-randomised, clinical superiority trials are set up to investigate treatment according to the Collabri model for collaborative care compared to treatment-as-usual for 364 patients diagnosed with panic disorder, generalised anxiety disorder and social phobia, respectively (total n = 1092). Patients are recruited from general practices located in the Capital Region of Denmark. For all trials, the primary outcome is anxiety symptoms (Beck Anxiety Inventory (BAI)) 6 months after baseline. Secondary outcomes include BAI after 15 months, depression symptoms (Beck Depression Inventory) after 6 months, level of psychosocial functioning (Global Assessment of Functioning) and general psychological symptoms (Symptom Checklist-90-R) after 6 and 15 months. Results will add to the limited pool of information about

  6. Can an EASYcare based dementia training programme improve diagnostic assessment and management of dementia by general practitioners and primary care nurses? The design of a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Lucassen PL

    2008-04-01

    Full Text Available Abstract Background Early diagnosis of dementia benefits both patient and caregiver. Nevertheless, dementia in primary care is currently under-diagnosed. Some educational interventions developed to improve dementia diagnosis and management were successful in increasing the number of dementia diagnoses and in changing attitudes and knowledge of health care staff. However, none of these interventions focussed on collaboration between GPs and nurses in dementia care. We developed an EASYcare-based Dementia Training Program (DTP aimed at stimulating collaboration in dementia primary care. We expect this program to increase the number of cognitive assessments and dementia diagnoses and to improve attitudes and knowledge of GPs and nurses. Methods The DTP is a complex educational intervention that consists of two workshops, a coaching program, access to an internet forum, and a Computerized Clinical Decision Support System on dementia diagnostics. One hundred duos of GPs and nurses will be recruited, from which 2/3 will be allocated to the intervention group and 1/3 to the control group. The effects of implementation of the DTP will be studied in a cluster-randomised controlled trial. Primary outcomes will be the number of cognitive assessments and dementia diagnoses in a period of 9 months following workshop participation. Secondary outcomes are measured on GP and nurse level: adherence to national guidelines for dementia, attitude, confidence and knowledge regarding dementia diagnosis and management; on patient level: number of emergency calls, visits and consultations and patient satisfaction; and on caregiver level: informal caregiver burden and satisfaction. Data will be collected from GPs' electronic medical records, self-registration forms and questionnaires. Statistical analysis will be performed using the MANOVA-method. Also, exploratory analyses will be performed, in order to gain insight into barriers and facilitators for implementation and

  7. The Melanoma care study: protocol of a randomised controlled trial of a psycho-educational intervention for melanoma survivors at high risk of developing new primary disease.

    Science.gov (United States)

    Dieng, Mbathio; Kasparian, Nadine A; Morton, Rachael L; Mann, Graham J; Butow, Phyllis; Menzies, Scott; Costa, Daniel S J; Cust, Anne E

    2015-01-01

    Despite a good prognosis for most melanoma survivors, many experience substantial fear of new or recurrent melanoma, worry and anxiety about the future, and unmet healthcare needs. In this protocol, we outline the design and methods of the Melanoma Care Study for melanoma survivors at high risk of developing new primary disease. The objective of this study is to evaluate the efficacy and cost-effectiveness of a psycho-educational intervention for improving psychological and behavioural adjustment to melanoma risk. The study design is a two-arm randomised controlled trial comparing a psycho-educational intervention to usual care. The intervention is comprised of a newly-developed psycho-educational booklet and three telephone sessions delivered by a trained psychologist. A total of 154 melanoma survivors at high risk of developing new primary disease who are attending one of three melanoma high risk clinics in New South Wales, Australia, will be recruited. Participants will be assessed at baseline (6 weeks before their high risk clinic dermatological appointment), and then 4 weeks and 6 months after their appointment. If effectiveness of the intervention is demonstrated at 6 months, an additional assessment at 12 months is planned. The primary outcome is fear of new or recurrent melanoma, as assessed by the Fear of Cancer Recurrence Inventory (FCRI). Secondary outcomes include anxiety, depression, unmet supportive care needs, satisfaction with clinical care, knowledge, behavioural adjustment to melanoma risk, quality of life, and cost-effectiveness of the intervention from a health system perspective. Following the intention-to-treat principle, linear mixed models will be used to analyse the data to account for repeated measures. A process evaluation will also be carried out to inform and facilitate potential translation and implementation into clinical practice. This study will provide high quality evidence on the efficacy and cost-effectiveness of a psycho

  8. The Healthy Activity Program (HAP), a lay counsellor-delivered brief psychological treatment for severe depression, in primary care in India: a randomised controlled trial.

    Science.gov (United States)

    Patel, Vikram; Weobong, Benedict; Weiss, Helen A; Anand, Arpita; Bhat, Bhargav; Katti, Basavraj; Dimidjian, Sona; Araya, Ricardo; Hollon, Steve D; King, Michael; Vijayakumar, Lakshmi; Park, A-La; McDaid, David; Wilson, Terry; Velleman, Richard; Kirkwood, Betty R; Fairburn, Christopher G

    2017-01-14

    Although structured psychological treatments are recommended as first-line interventions for depression, only a small fraction of people globally receive these treatments because of poor access in routine primary care. We assessed the effectiveness and cost-effectiveness of a brief psychological treatment (Healthy Activity Program [HAP]) for delivery by lay counsellors to patients with moderately severe to severe depression in primary health-care settings. In this randomised controlled trial, we recruited participants aged 18-65 years scoring more than 14 on the Patient Health Questionnaire 9 (PHQ-9) indicating moderately severe to severe depression from ten primary health centres in Goa, India. Pregnant women or patients who needed urgent medical attention or were unable to communicate clearly were not eligible. Participants were randomly allocated (1:1) to enhanced usual care (EUC) alone or EUC combined with HAP in randomly sized blocks (block size four to six [two to four for men]), stratified by primary health centre and sex, and allocation was concealed with use of sequential numbered opaque envelopes. Physicians providing EUC were masked. Primary outcomes were depression symptom severity on the Beck Depression Inventory version II and remission from depression (PHQ-9 score of better results than did EUC alone for the secondary outcomes of disability (adjusted mean difference -2·73 [-4·39 to -1·06]; p=0·001), days out of work (-2·29 [-3·84 to -0·73]; p=0·004), intimate partner physical violence in women (0·53 [0·29-0·96]; p=0·04), behavioural activation (2·17 [1·34-3·00]; pbetter than EUC alone was for patients with moderately severe to severe depression in routine primary care in Goa, India. HAP was readily accepted by this previously untreated population and was cost-effective in this setting. HAP could be a key strategy to reduce the treatment gap for depressive disorders, the leading mental health disorder worldwide. Wellcome Trust

  9. Early workplace dialogue in physiotherapy practice improved work ability at 1-year follow-up-WorkUp, a randomised controlled trial in primary care.

    Science.gov (United States)

    Sennehed, Charlotte P; Holmberg, Sara; Axén, Iben; Stigmar, Kjerstin; Forsbrand, Malin; Petersson, Ingemar F; Grahn, Birgitta

    2018-03-15

    Workplace involvement in rehabilitation for patients with musculoskeletal pain may improve work ability. Convergence Dialogue Meeting (CDM) is a model aimed at helping the patient, the care giver, and the employer to support work ability and return-to-work. Our aim was to study the effect on work ability when adding a workplace dialogue according to CDM in physiotherapy practice for patients with pain in ordinary primary care. We conducted a prospective pairwise cluster randomised controlled trial (ClinicalTrials.gov ID: NCT02609750) in primary care involving 20 primary care rehabilitation units with 1-year follow-up. Adult patients with acute/subacute neck and back pain, worked ≥4 weeks past year and not currently on sick leave or no more than 60 days of sick leave and considered at-risk of sick leave were included (n = 352). All patients received structured physiotherapy and the intervention was the addition of CDM, delivered by the treating physiotherapist. The main confirmatory outcome, work ability (defined as working at least 4 consecutive weeks at follow-up), was assessed by a weekly short text message question on number of sick leave days past week. Work ability was reached by significantly more patients in the intervention group (108/127, 85%) compared with the reference group (127/171, 74%) (P = 0.02). The intervention increased the odds of having work ability at 1-year follow-up, also after adjustment for baseline health-related quality of life (odds ratio 1.85, confidence interval 1.01-3.38). We conclude that an early workplace dialogue in addition to structured physiotherapy improved work ability significantly.This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

  10. 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

  11. Nursing home care educational intervention for family caregivers of older adults post stroke (SHARE): study protocol for a randomised trial.

    Science.gov (United States)

    Day, Carolina Baltar; Bierhals, Carla Cristiane Becker Kottwitz; Santos, Naiana Oliveira Dos; Mocellin, Duane; Predebon, Mariane Lurdes; Dal Pizzol, Fernanda Laís Fengler; Paskulin, Lisiane Manganelli Girardi

    2018-02-09

    Family caregivers of aged stroke survivors face challenging difficulties such as the lack of support and the knowledge and skills to practice home care. These aspects negatively influence the caregivers' burden and quality of life, the use of health services, and hospital readmissions of the stroke survivor. The aim of this research is to describe an educational intervention focused on family caregivers of stroke survivors for the development of home care in the south of Brazil. A randomized clinical trial with 48 family caregivers of stroke survivors will be recruited and divided into two groups: 24 in the intervention group and 24 in the control group. The intervention will consist of the systematic follow-up by nurses who will perform three home visits over a period of 1 month. The control group will not receive the visits and will have the usual care guidelines of the health services. Primary outcomes: burden and quality of life of the caregiver. functional capacity and readmissions of the stroke survivors; the use of health services of the stroke survivors and their family caregivers. Outcomes will be measured 2 months after discharge. The project was approved in April 2016. This research offers information for conducting educational intervention with family caregivers of stroke survivors, presenting knowledge so that nurses can structure and plan the actions aimed at the education of the family caregiver. It is expected that the educational intervention will contribute to reducing caregiver burden and improving their quality of life, as well as avoiding readmissions and inadequate use of health services by stroke survivors. ClinicalTrials.gov, ID: NCT02807012 . Registered on 3 June 2016. Name: Nursing Home Care Intervention Post Stroke (SHARE).

  12. The effectiveness of Stepping stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

    Science.gov (United States)

    2011-01-01

    Background Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual) disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. Methods/Design The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14) will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P) or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. Discussion This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community-based population of

  13. Protocol for Birmingham Atrial Fibrillation Treatment of the Aged study (BAFTA: a randomised controlled trial of warfarin versus aspirin for stroke prevention in the management of atrial fibrillation in an elderly primary care population [ISRCTN89345269

    Directory of Open Access Journals (Sweden)

    Fletcher Kate

    2003-08-01

    Full Text Available Abstract Background Atrial fibrillation (AF is an important independent risk factor for stroke. Randomised controlled trials have shown that this risk can be reduced substantially by treatment with warfarin or more modestly by treatment with aspirin. Existing trial data for the effectiveness of warfarin are drawn largely from studies in selected secondary care populations that under-represent the elderly. The Birmingham Atrial Fibrillation Treatment of the Aged (BAFTA study will provide evidence of the risks and benefits of warfarin versus aspirin for the prevention of stroke for older people with AF in a primary care setting. Study design A randomised controlled trial where older patients with AF are randomised to receive adjusted dose warfarin or aspirin. Patients will be followed up at three months post-randomisation, then at six monthly intervals there after for an average of three years by their general practitioner. Patients will also receive an annual health questionnaire. 1240 patients will be recruited from over 200 practices in England. Patients must be aged 75 years or over and have AF. Patients will be excluded if they have a history of any of the following conditions: rheumatic heart disease; major non-traumatic haemorrhage; intra-cranial haemorrhage; oesophageal varices; active endoscopically proven peptic ulcer disease; allergic hypersensitivity to warfarin or aspirin; or terminal illness. Patients will also be excluded if the GP considers that there are clinical reasons to treat a patient with warfarin in preference to aspirin (or vice versa. The primary end-point is fatal or non-fatal disabling stroke (ischaemic or haemorrhagic or significant arterial embolism. Secondary outcomes include major extra-cranial haemorrhage, death (all cause, vascular, hospital admissions (all cause, vascular, cognition, quality of life, disability and compliance with study medication.

  14. The effectiveness of Stepping Stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual.

    Science.gov (United States)

    Kleefman, Marijke; Jansen, Daniëlle E M C; Reijneveld, Sijmen A

    2011-08-30

    Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual) disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14) will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P) or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community-based population of children with a mild intellectual

  15. The effectiveness of Stepping stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

    Directory of Open Access Journals (Sweden)

    Jansen Daniëlle EMC

    2011-08-01

    Full Text Available Abstract Background Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. Methods/Design The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14 will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. Discussion This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community

  16. 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

  17. Group treatments for sensitive health care problems : a randomised controlled trial of group versus individual physiotherapy sessions for female urinary incontinence

    OpenAIRE

    Lamb, S. E. (Sallie E.); Pepper, Jo; Lall, Ranjit; Jørstad-Stein , Ellen C.; Clark, M. D. (Michael D.); Hill, Lesley; Fereday Smith, Jan

    2009-01-01

    Abstract Background The aim was to compare effectiveness of group versus individual sessions of physiotherapy in terms of symptoms, quality of life, and costs, and to investigate the effect of patient preference on uptake and outcome of treatment. Methods A pragmatic, multi-centre randomised controlled trial in five British National Health Service physiotherapy departments. 174 women with stress and/or urge incontinence were randomised to receive treatment from a physiotherapist delivered in ...

  18. A randomised controlled trial of a self-management education program for osteoarthritis of the knee delivered by health care professionals.

    Science.gov (United States)

    Coleman, Sophie; Briffa, N Kathryn; Carroll, Graeme; Inderjeeth, Charles; Cook, Nicola; McQuade, Jean

    2012-01-27

    Our aim in the present study was to determine whether a disease-specific self-management program for primary care patients with osteoarthritis (OA) of the knee (the Osteoarthritis of the Knee Self-Management Program (OAK)) implemented by health care professionals would achieve and maintain clinically meaningful improvements in health-related outcomes compared with a control group. Medical practitioners referred 146 primary care patients with OA of the knee. Volunteers with coexistent inflammatory joint disease or serious comorbidities were excluded. Randomisation was to either a control group or the OAK group. The OAK group completed a 6-week self-management program. The control group had a 6-month waiting period before entering the OAK program. Assessments were taken at baseline, 8 weeks and 6 months. The primary outcomes were the results measured using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) Pain and Function subscales on the Short Form 36 version 1 questionnaire (SF-36) Secondary outcomes were Visual Analogue Scale (VAS) pain, Timed Up & Go Test (TUG), knee range of motion and quadriceps and hamstring strength-isometric contraction. Responses to treatment (responders) and minimal clinically important improvements (MCIIs) were determined. In the OAK group, VAS pain improved from baseline to week 8 from mean (SEM) 5.21 (0.30) to 3.65 (0.29) (P ≤ 0.001). During this period, improvements in the OAK group compared with the control group and responses to treatment were demonstrated according to the following outcomes: WOMAC Pain, Physical Function and Total dimensions, as well as SF-36 Physical Function, Role Physical, Body Pain, Vitality and Social Functioning domains. In addition, from baseline to week 8, the proportion of MCIIs was greater among the OAK group than the control group for all outcomes. For the period between baseline and month 6, WOMAC Pain, Physical Function and Total dimensions significantly improved in the OAK group

  19. The impact of a disease management program (COACH on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Selvaraj Francis Jude

    2012-10-01

    Full Text Available Abstract Background To evaluate the efficacy of Counselling and Advisory Care for Health (COACH programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm and primary care physicians assisted by nurse educators (PCP-NE arm. Methods This was a multi-centre, open label, randomised trial of a disease management programme (COACH among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE and 148 to care provided by primary care physicians (PCP alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio, Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Results Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS mean change from baseline LDL-C were −30.09% and −27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288, with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had

  20. The impact of a disease management program (COACH) on the attainment of better cardiovascular risk control in dyslipidaemic patients at primary care centres (The DISSEMINATE Study): a randomised controlled trial.

    Science.gov (United States)

    Selvaraj, Francis Jude; Mohamed, Mafauzy; Omar, Khairani; Nanthan, Sudha; Kusiar, Zainab; Subramaniam, Selvaraj Y; Ali, Norsiah; Karanakaran, Kamalakaran; Ahmad, Fauziah; Low, Wilson H H

    2012-10-10

    To evaluate the efficacy of Counselling and Advisory Care for Health (COACH) programme in managing dyslipidaemia among primary care practices in Malaysia. This open-label, parallel, randomised controlled trial compared the COACH programme delivered by primary care physicians alone (PCP arm) and primary care physicians assisted by nurse educators (PCP-NE arm). This was a multi-centre, open label, randomised trial of a disease management programme (COACH) among dyslipidaemic patients in 21 Malaysia primary care practices. The participating centres enrolled 297 treatment naïve subjects who had the primary diagnosis of dyslipidaemia; 149 were randomised to the COACH programme delivered by primary care physicians assisted by nurse educators (PCP-NE) and 148 to care provided by primary care physicians (PCP) alone. The primary efficacy endpoint was the mean percentage change from baseline LDL-C at week 24 between the 2 study arms. Secondary endpoints included mean percentage change from baseline of lipid profile (TC, LDL-C, HDL-C, TG, TC: HDL ratio), Framingham Cardiovascular Health Risk Score and absolute risk change from baseline in blood pressure parameters at week 24. The study also assessed the sustainability of programme efficacy at week 36. Both study arms demonstrated improvement in LDL-C from baseline. The least squares (LS) mean change from baseline LDL-C were -30.09% and -27.54% for PCP-NE and PCP respectively. The difference in mean change between groups was 2.55% (p=0.288), with a greater change seen in the PCP-NE arm. Similar observations were made between the study groups in relation to total cholesterol change at week 24. Significant difference in percentage change from baseline of HDL-C were observed between the PCP-NE and PCP groups, 3.01%, 95% CI 0.12-5.90, p=0.041, at week 24. There was no significant difference in lipid outcomes between 2 study groups at week 36 (12 weeks after the programme had ended). Patients who received coaching and advice from

  1. Randomised controlled trial of counseling sessions, antidepressant medication, and combined treatment for major depression in primary care setting

    International Nuclear Information System (INIS)

    Mossa, Samir Y.; Al-Sayed, H.; Malik, Mariam A.; Al-Hageri, S.; Al-Shaar, I.

    2006-01-01

    The study was made to determine whether counseling sessions using Egan's model combined with antidepressant medication is more effective than either treatment alone in the management of major depression in primary care. Patient aged 18 years and above with major depression on the research diagnostic criteria - a score of 13 or more on the 17 items. Hamilton rating scale for depression and a minimum duration of 4 weeks. Counseling sessions based on Egan's Model by research family physician or antidepressant medication or combination of both was performed. Hamilton rating scale for depression, Beck depression inventory, clinical interview schedule, and modified social adjustment schedule were used and assessed at 6 , 12 and 52 weeks. Patients in all groups showed a clear improvement after 12 weeks. The combination of counseling sessions and antidepressant medication is more effective than either treatment alone. Counseling sessions used by a trained family physician is an effective treatment for depressive disorders in primary care. The combination of this treatment with antidepressant medication is more effective than either treatment alone. (author)

  2. Cost-effectiveness of an intensive group training protocol compared to physiotherapy guideline care for sub-acute and chronic low back pain: design of a randomised controlled trial with an economic evaluation. [ISRCTN45641649

    Directory of Open Access Journals (Sweden)

    Franken Willemien K

    2004-11-01

    Full Text Available Abstract Background Low back pain is a common disorder in western industrialised countries and the type of treatments for low back pain vary considerably. Methods In a randomised controlled trial the cost-effectiveness and cost-utility of an intensive group training protocol versus physiotherapy guideline care for sub-acute and chronic low back pain patients is evaluated. Patients with back pain for longer than 6 weeks who are referred to physiotherapy care by their general practitioner or medical specialist are included in the study. The intensive group training protocol combines exercise therapy with principles of behavioural therapy ("graded activity" and back school. This training protocol is compared to physiotherapy care according to the recently published Low Back Pain Guidelines of the Royal Dutch College for Physiotherapy. Primary outcome measures are general improvement, pain intensity, functional status, work absenteeism and quality of life. The direct and indirect costs will be assessed using cost diaries. Patients will complete questionnaires at baseline and 6, 13, 26 and 52 weeks after randomisation. Discussion No trials are yet available that have evaluated the effect of an intensive group training protocol including behavioural principles and back school in a primary physiotherapy care setting and no data on cost-effectiveness and cost-utility are available.

  3. Involving older people in a multi-centre randomised trial of a complex intervention in pre-hospital emergency care: implementation of a collaborative model.

    Science.gov (United States)

    Koniotou, Marina; Evans, Bridie Angela; Chatters, Robin; Fothergill, Rachael; Garnsworthy, Christopher; Gaze, Sarah; Halter, Mary; Mason, Suzanne; Peconi, Julie; Porter, Alison; Siriwardena, A Niroshan; Toghill, Alun; Snooks, Helen

    2015-07-10

    Health services research is expected to involve service users as active partners in the research process, but few examples report how this has been achieved in practice in trials. We implemented a model to involve service users in a multi-centre randomised controlled trial in pre-hospital emergency care. We used the generic Standard Operating Procedure (SOP) from our Clinical Trials Unit (CTU) as the basis for creating a model to fit the context and population of the SAFER 2 trial. In our model, we planned to involve service users at all stages in the trial through decision-making forums at 3 levels: 1) strategic; 2) site (e.g. Wales; London; East Midlands); 3) local. We linked with charities and community groups to recruit people with experience of our study population. We collected notes of meetings alongside other documentary evidence such as attendance records and study documentation to track how we implemented our model. We involved service users at strategic, site and local level. We also added additional strategic level forums (Task and Finish Groups and Writing Days) where we included service users. Service user involvement varied in frequency and type across meetings, research stages and locations but stabilised and increased as the trial progressed. Involving service users in the SAFER 2 trial showed how it is feasible and achievable for patients, carers and potential patients sharing the demographic characteristics of our study population to collaborate in a multi-centre trial at the level which suited their health, location, skills and expertise. A standard model of involvement can be tailored by adopting a flexible approach to take account of the context and complexities of a multi-site trial. Current Controlled Trials ISRCTN60481756. Registered: 13 March 2009.

  4. The effects of implementing a point-of-care electronic template to prompt routine anxiety and depression screening in patients consulting for osteoarthritis (the Primary Care Osteoarthritis Trial: A cluster randomised trial in primary care.

    Directory of Open Access Journals (Sweden)

    Christian D Mallen

    2017-04-01

    Full Text Available This study aimed to evaluate whether prompting general practitioners (GPs to routinely assess and manage anxiety and depression in patients consulting with osteoarthritis (OA improves pain outcomes.We conducted a cluster randomised controlled trial involving 45 English general practices. In intervention practices, patients aged ≥45 y consulting with OA received point-of-care anxiety and depression screening by the GP, prompted by an automated electronic template comprising five questions (a two-item Patient Health Questionnaire-2 for depression, a two-item Generalized Anxiety Disorder-2 questionnaire for anxiety, and a question about current pain intensity [0-10 numerical rating scale]. The template signposted GPs to follow National Institute for Health and Care Excellence clinical guidelines for anxiety, depression, and OA and was supported by a brief training package. The template in control practices prompted GPs to ask the pain intensity question only. The primary outcome was patient-reported current pain intensity post-consultation and at 3-, 6-, and 12-mo follow-up. Secondary outcomes included pain-related disability, anxiety, depression, and general health. During the trial period, 7,279 patients aged ≥45 y consulted with a relevant OA-related code, and 4,240 patients were deemed potentially eligible by participating GPs. Templates were completed for 2,042 patients (1,339 [31.6%] in the control arm and 703 [23.1%] in the intervention arm. Of these 2,042 patients, 1,412 returned questionnaires (501 [71.3%] from 20 intervention practices, 911 [68.0%] from 24 control practices. Follow-up rates were similar in both arms, totalling 1,093 (77.4% at 3 mo, 1,064 (75.4% at 6 mo, and 1,017 (72.0% at 12 mo. For the primary endpoint, multilevel modelling yielded significantly higher average pain intensity across follow-up to 12 mo in the intervention group than the control group (adjusted mean difference 0.31; 95% CI 0.04, 0.59. Secondary

  5. The effects of implementing a point-of-care electronic template to prompt routine anxiety and depression screening in patients consulting for osteoarthritis (the Primary Care Osteoarthritis Trial): A cluster randomised trial in primary care.

    Science.gov (United States)

    Mallen, Christian D; Nicholl, Barbara I; Lewis, Martyn; Bartlam, Bernadette; Green, Daniel; Jowett, Sue; Kigozi, Jesse; Belcher, John; Clarkson, Kris; Lingard, Zoe; Pope, Christopher; Chew-Graham, Carolyn A; Croft, Peter; Hay, Elaine M; Peat, George

    2017-04-01

    This study aimed to evaluate whether prompting general practitioners (GPs) to routinely assess and manage anxiety and depression in patients consulting with osteoarthritis (OA) improves pain outcomes. We conducted a cluster randomised controlled trial involving 45 English general practices. In intervention practices, patients aged ≥45 y consulting with OA received point-of-care anxiety and depression screening by the GP, prompted by an automated electronic template comprising five questions (a two-item Patient Health Questionnaire-2 for depression, a two-item Generalized Anxiety Disorder-2 questionnaire for anxiety, and a question about current pain intensity [0-10 numerical rating scale]). The template signposted GPs to follow National Institute for Health and Care Excellence clinical guidelines for anxiety, depression, and OA and was supported by a brief training package. The template in control practices prompted GPs to ask the pain intensity question only. The primary outcome was patient-reported current pain intensity post-consultation and at 3-, 6-, and 12-mo follow-up. Secondary outcomes included pain-related disability, anxiety, depression, and general health. During the trial period, 7,279 patients aged ≥45 y consulted with a relevant OA-related code, and 4,240 patients were deemed potentially eligible by participating GPs. Templates were completed for 2,042 patients (1,339 [31.6%] in the control arm and 703 [23.1%] in the intervention arm). Of these 2,042 patients, 1,412 returned questionnaires (501 [71.3%] from 20 intervention practices, 911 [68.0%] from 24 control practices). Follow-up rates were similar in both arms, totalling 1,093 (77.4%) at 3 mo, 1,064 (75.4%) at 6 mo, and 1,017 (72.0%) at 12 mo. For the primary endpoint, multilevel modelling yielded significantly higher average pain intensity across follow-up to 12 mo in the intervention group than the control group (adjusted mean difference 0.31; 95% CI 0.04, 0.59). Secondary outcomes were

  6. A cluster randomised pragmatic trial applying Self-determination theory to type 2 diabetes care in general practice

    DEFF Research Database (Denmark)

    Juul, Lise; Maindal, Helle T; Zoffmann, Vibeke

    2011-01-01

    BACKGROUND: Treatment recommendations for prevention of type 2 diabetes complications often require radical and life-long health behaviour changes. Observational studies based on Self-determination theory (SDT) propose substantial factors for the maintenance of behaviour changes and concomitant...... well-being, but experimental research is needed to develop and evaluate SDT-based interventions. The aims of this paper were to describe 1) the design of a trial assessing the effectiveness of a training course for practice-nurses in autonomy support on patient-perceived motivation, HbA1, cholesterol...... will be assessed on the diabetes populations with regard to well-being (PAID, SF-12), HbA1c- and cholesterol-levels, perceived autonomy support (HCCQ), type of motivation (TSRQ), and perceived competence for diabetes care (PCD) 15-21 months after the core course; the completion of the second course afternoon. Data...

  7. Receiving care for intimate partner violence in primary care: Barriers and enablers for women participating in the weave randomised controlled trial.

    Science.gov (United States)

    O'Doherty, Lorna; Taket, Ann; Valpied, Jodie; Hegarty, Kelsey

    2016-07-01

    Interventions in health settings for intimate partner violence (IPV) are being increasingly recognised as part of a response to addressing this global public health problem. However, interventions targeting this sensitive social phenomenon are complex and highly susceptible to context. This study aimed to elucidate factors involved in women's uptake of a counselling intervention delivered by family doctors in the weave primary care trial (Victoria, Australia). We analysed associations between women's and doctors' baseline characteristics and uptake of the intervention. We interviewed a random selection of 20 women from an intervention group women to explore cognitions relating to intervention uptake. Interviews were audio-recorded, transcribed, coded in NVivo 10 and analysed using the theory of planned behaviour (TPB). Abuse severity and socio-demographic characteristics (apart from current relationship status) were unrelated to uptake of counselling (67/137 attended sessions). Favourable doctor communication was strongly associated with attendance. Eight themes emerged, including four sets of beliefs that influenced attitudes to uptake: (i) awareness of the abuse and readiness for help; (ii) weave as an avenue to help; (iii) doctor's communication; and (iv) role in providing care for IPV; and four sets of beliefs regarding women's control over uptake: (v) emotional health, (vi) doctors' time, (vii) managing the disclosure process and (viii) viewing primary care as a safe option. This study has identified factors that can promote the implementation and evaluation of primary care-based IPV interventions, which are relevant across health research settings, for example, ensuring fit between implementation strategies and characteristics of the target group (such as range in readiness for intervention). On practice implications, providers' communication remains a key issue for engaging women. A key message arising from this work concerns the critical role of primary

  8. Effectiveness of a tailored intervention to improve cardiovascular risk management in primary care: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Huntink, Elke; Heijmans, Naomi; Wensing, Michel; van Lieshout, Jan

    2013-12-17

    Cardiovascular disease (CVD) is an important worldwide cause of mortality. In The Netherlands, CVD is the leading cause of death for women and the second cause of death for men. Recommendations for diagnosis and treatment of CVD are not well implemented in primary care. In this study, we aim to examine the effectiveness of a tailored implementation program targeted at practice nurses to improve healthcare for patients with (high risk for) CVD. A two-arm cluster randomized trial is planned. We offer practice nurses a tailored program to improve adherence to six specific recommendations related to blood pressure and cholesterol target values, risk profiling and lifestyle advice. Practice nurses are offered training and feedback on their motivational interviewing technique and an e-learning program on cardiovascular risk management (CVRM). They are also advised to screen for the presence and severity of depressive symptoms in patients. We also advise practice nurses to use selected E-health options (selected websites and Twitter-consult) in patients without symptoms of depression. Patients with mild depressive symptoms are referred to a physical exercise group. We recommend referring patients with major depressive symptoms for assessment and treatment of depressive symptoms if appropriate before starting CVRM. Data from 900 patients at high risk of CVD or with established CVD will be collected in 30 general practices in several geographical areas in The Netherlands. The primary outcome measure is performance of practice nurses in CVRM and reflects application of recommendations for personalized counselling and education of CVRM patients. Patients' health-related lifestyles (physical exercise, diet and smoking status) will be measured with validated questionnaires and medical record audit will be performed to document estimated CVD risk. Additionally, we will survey and interview participating healthcare professionals for exploration of processes of change. The control

  9. Interventions to improve executive functioning and working memory in school-aged children with AD(H)D: a randomised controlled trial and stepped-care approach.

    Science.gov (United States)

    van der Donk, Marthe L A; Hiemstra-Beernink, Anne-Claire; Tjeenk-Kalff, Ariane C; van der Leij, Aryan V; Lindauer, Ramón J L

    2013-01-11

    Deficits in executive functioning are of great significance in attention-deficit/hyperactivity disorder (ADHD). One of these executive functions, working memory, plays an important role in academic performance and is often seen as the core deficit of this disorder. There are indications that working memory problems and academic performance can be improved by school-oriented interventions but this has not yet been studied systematically. In this study we will determine the short- and long-term effects of a working memory--and an executive function training applied in a school situation for children with AD(H)D, taking individual characteristics, the level of impairment and costs (stepped-care approach) into account. The study consists of two parts: the first part is a randomised controlled trial with school-aged children (8-12 yrs) with AD(H)D. Two groups (each n = 50) will be randomly assigned to a well studied computerized working memory training 'Cogmed', or to the 'Paying attention in class' intervention which is an experimental school-based executive function training. Children will be selected from regular -and special education primary schools in the region of Amsterdam, the Netherlands. The second part of the study will determine which specific characteristics are related to non-response of the 'Paying attention in class' intervention. School-aged children (8-12 yrs) with AD(H)D will follow the experimental school-based executive function training 'Paying attention in class' (n = 175). Academic performance and neurocognitive functioning (primary outcomes) are assessed before, directly after and 6 months after training. Secondary outcome measures are: behaviour in class, behaviour problems and quality of life. So far, there is limited but promising evidence that working memory - and other executive function interventions can improve academic performance. Little is know about the applicability and generalization effects of these interventions in a classroom

  10. Interventions to improve executive functioning and working memory in school-aged children with AD(HD: a randomised controlled trial and stepped-care approach

    Directory of Open Access Journals (Sweden)

    van der Donk Marthe LA

    2013-01-01

    Full Text Available Abstract Background Deficits in executive functioning are of great significance in attention-deficit/hyperactivity disorder (ADHD. One of these executive functions, working memory, plays an important role in academic performance and is often seen as the core deficit of this disorder. There are indications that working memory problems and academic performance can be improved by school-oriented interventions but this has not yet been studied systematically. In this study we will determine the short- and long-term effects of a working memory - and an executive function training applied in a school situation for children with AD(HD, taking individual characteristics, the level of impairment and costs (stepped-care approach into account. Methods/design The study consists of two parts: the first part is a randomised controlled trial with school-aged children (8–12 yrs with AD(HD. Two groups (each n = 50 will be randomly assigned to a well studied computerized working memory training ‘Cogmed’, or to the ‘Paying attention in class’ intervention which is an experimental school-based executive function training. Children will be selected from regular -and special education primary schools in the region of Amsterdam, the Netherlands. The second part of the study will determine which specific characteristics are related to non-response of the ‘Paying attention in class’ intervention. School-aged children (8–12 yrs with AD(HD will follow the experimental school-based executive function training ‘Paying attention in class’ (n = 175. Academic performance and neurocognitive functioning (primary outcomes are assessed before, directly after and 6 months after training. Secondary outcome measures are: behaviour in class, behaviour problems and quality of life. Discussion So far, there is limited but promising evidence that working memory – and other executive function interventions can improve academic performance. Little is know about the

  11. Cost-effectiveness of a national exercise referral programme for primary care patients in Wales: results of a randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background A recent HTA review concluded that there was a need for RCTs of exercise referral schemes (ERS) for people with a medical diagnosis who might benefit from exercise. Overall, there is still uncertainty as to the cost-effectiveness of ERS. Evaluation of public health interventions places challenges on conventional health economics approaches. This economic evaluation of a national public health intervention addresses this issue of where ERS may be most cost effective through subgroup analysis, particularly important at a time of financial constraint. Method This economic analysis included 798 individuals aged 16 and over (55% of the randomised controlled trial (RCT) sample) with coronary heart disease risk factors and/or mild to moderate anxiety, depression or stress. Individuals were referred by health professionals in a primary care setting to a 16 week national exercise referral scheme (NERS) delivered by qualified exercise professionals in local leisure centres in Wales, UK. Health-related quality of life, health care services use, costs per participant in NERS, and willingness to pay for NERS were measured at 6 and 12 months. Results The base case analysis assumed a participation cost of £385 per person per year, with a mean difference in QALYs between the two groups of 0.027. The incremental cost-effectiveness ratio was £12,111 per QALY gained. Probabilistic sensitivity analysis demonstrated an 89% probability of NERS being cost-effective at a payer threshold of £30,000 per QALY. When participant payments of £1 and £2 per session were considered, the cost per QALY fell from £12,111 (base case) to £10,926 and £9,741, respectively. Participants with a mental health risk factor alone or in combination with a risk of chronic heart disease generated a lower ICER (£10,276) compared to participants at risk of chronic heart disease only (£13,060). Conclusions Results of cost-effectiveness analyses suggest that NERS is cost saving in fully

  12. The cost-effectiveness of a structured education pulmonary rehabilitation programme for chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial.

    Science.gov (United States)

    Gillespie, Paddy; O'Shea, Eamon; Casey, Dympna; Murphy, Kathy; Devane, Declan; Cooney, Adeline; Mee, Lorraine; Kirwan, Collette; McCarthy, Bernard; Newell, John

    2013-11-25

    To assess the cost-effectiveness of a structured education pulmonary rehabilitation programme (SEPRP) for chronic obstructive pulmonary disease (COPD) relative to usual practice in primary care. The programme consisted of group-based sessions delivered jointly by practice nurses and physiotherapists over 8 weeks. Cost-effectiveness and cost-utility analysis alongside a cluster randomised controlled trial. 32 general practices in Ireland. 350 adults with COPD, 69% of whom were moderately affected. Intervention arm (n=178) received a 2 h group-based SEPRP session per week over 8 weeks delivered jointly by a practice nurse and physiotherapist at the practice surgery or nearby venue. The control arm (n=172) received the usual practice in primary care. Incremental costs, Chronic Respiratory Questionnaire (CRQ) scores, quality-adjusted life years (QALYs) gained estimated using the generic EQ5D instrument, and expected cost-effectiveness at 22 weeks trial follow-up. The intervention was associated with an increase of €944 (95% CIs 489 to 1400) in mean healthcare cost and €261 (95% CIs 226 to 296) in mean patient cost. The intervention was associated with a mean improvement of 1.11 (95% CIs 0.35 to 1.87) in CRQ Total score and 0.002 (95% CIs -0.006 to 0.011) in QALYs gained. These translated into incremental cost-effectiveness ratios of €850 per unit increase in CRQ Total score and €472 000 per additional QALY gained. The probability of the intervention being cost-effective at respective threshold values of €5000, €15 000, €25 000, €35 000 and €45 000 was 0.980, 0.992, 0.994, 0.994 and 0.994 in the CRQ Total score analysis compared to 0.000, 0.001, 0.001, 0.003 and 0.007 in the QALYs gained analysis. While analysis suggests that SEPRP was cost-effective if society is willing to pay at least €850 per one-point increase in disease-specific CRQ, no evidence exists when effectiveness was measured in QALYS gained. Current Controlled Trials ISRCTN52 403 063.

  13. Effectiveness of a multifactorial falls prevention program in community-dwelling older people when compared to usual care: study protocol for a randomised controlled trial (Prevquedas Brazil).

    Science.gov (United States)

    de Negreiros Cabral, Kelem; Perracini, Monica Rodrigues; Soares, Aline Thomaz; de Cristo Stein, Francine; Sera, Celisa Tiemi Nakagawa; Tiedemann, Anne; Sherrington, Cathie; Filho, Wilson Jacob; Paschoal, Sérgio Márcio Pacheco

    2013-03-15

    Falling in older age is a major public health concern due to its costly and disabling consequences. However very few randomised controlled trials (RCTs) have been conducted in developing countries, in which population ageing is expected to be particularly substantial in coming years. This article describes the design of an RCT to evaluate the effectiveness of a multifactorial falls prevention program in reducing the rate of falls in community-dwelling older people. Multicentre parallel-group RCT involving 612 community-dwelling men and women aged 60 years and over, who have fallen at least once in the previous year. Participants will be recruited in multiple settings in Sao Paulo, Brazil and will be randomly allocated to a control group or an intervention group. The usual care control group will undergo a fall risk factor assessment and be referred to their clinicians with the risk assessment report so that individual modifiable risk factors can be managed without any specific guidance. The intervention group will receive a 12-week Multifactorial Falls Prevention Program consisting of: an individualised medical management of modifiable risk factors, a group-based, supervised balance training exercise program plus an unsupervised home-based exercise program, an educational/behavioral intervention. Both groups will receive a leaflet containing general information about fall prevention strategies. Primary outcome measures will be the rate of falls and the proportion of fallers recorded by monthly falls diaries and telephone calls over a 12 month period. Secondary outcomes measures will include risk of falling, fall-related self-efficacy score, measures of balance, mobility and strength, fall-related health services use and independence with daily tasks. Data will be analysed using the intention-to-treat principle.The incidence of falls in the intervention and control groups will be calculated and compared using negative binomial regression analysis. This study is the

  14. Regorafenib plus best supportive care versus placebo plus best supportive care in Asian patients with previously treated metastatic colorectal cancer (CONCUR): a randomised, double-blind, placebo-controlled, phase 3 trial.

    Science.gov (United States)

    Li, Jin; Qin, Shukui; Xu, Ruihua; Yau, Thomas C C; Ma, Brigette; Pan, Hongming; Xu, Jianming; Bai, Yuxian; Chi, Yihebali; Wang, Liwei; Yeh, Kun-Huei; Bi, Feng; Cheng, Ying; Le, Anh Tuan; Lin, Jen-Kou; Liu, Tianshu; Ma, Dong; Kappeler, Christian; Kalmus, Joachim; Kim, Tae Won

    2015-06-01

    In the international randomised phase 3 CORRECT trial (NCT01103323), regorafenib significantly improved overall survival versus placebo in patients with treatment-refractory metastatic colorectal cancer. Of the 760 patients in CORRECT, 111 were Asian (mostly Japanese). This phase 3 trial was done to assess regorafenib in a broader population of Asian patients with refractory metastatic colorectal cancer than was studied in CORRECT. In this randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done in 25 hospitals in mainland China, Hong Kong, South Korea, Taiwan, and Vietnam, we recruited Asian patients aged 18 years or older with progressive metastatic colorectal cancer who had received at least two previous treatment lines or were unable to tolerate standard treatments. Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 3 months, and adequate bone marrow, liver, and renal function, without other uncontrolled medical disorders. We randomly allocated patients (2:1; with a computer-generated unicentric randomisation list [prepared by the study funder] and interactive voice response system; block size of six; stratified by metastatic site [single vs multiple organs] and time from diagnosis of metastatic disease [regorafenib 160 mg once daily or placebo on days 1-21 of each 28 day cycle; patients in both groups were also to receive best supportive care. Participants, investigators, and the study funder were masked to treatment assignment. The primary endpoint was overall survival, and we analysed data on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT01584830. Between April 29, 2012, and Feb 6, 2013, we screened 243 patients and randomly assigned 204 patients to receive either regorafenib (136 [67%]) or placebo (68 [33%]). After a median follow-up of 7·4 months (IQR 4·3-12·2), overall survival was significantly better with regorafenib

  15. Effectiveness of a Home-Based Counselling Strategy on Neonatal Care and Survival: A Cluster-Randomised Trial in Six Districts of Rural Southern Tanzania.

    Directory of Open Access Journals (Sweden)

    Claudia Hanson

    2015-09-01

    Full Text Available We report a cluster-randomised trial of a home-based counselling strategy, designed for large-scale implementation, in a population of 1.2 million people in rural southern Tanzania. We hypothesised that the strategy would improve neonatal survival by around 15%.In 2010 we trained 824 female volunteers to make three home visits to women and their families during pregnancy and two visits to them in the first few days of the infant's life in 65 wards, selected randomly from all 132 wards in six districts in Mtwara and Lindi regions, constituting typical rural areas in Southern Tanzania. The remaining wards were comparison areas. Participants were not blinded to the intervention. The primary analysis was an intention-to-treat analysis comparing the neonatal mortality (day 0-27 per 1,000 live births in intervention and comparison wards based on a representative survey in 185,000 households in 2013 with a response rate of 90%. We included 24,381 and 23,307 live births between July 2010 and June 2013 and 7,823 and 7,555 live births in the last year in intervention and comparison wards, respectively. We also compared changes in neonatal mortality and newborn care practices in intervention and comparison wards using baseline census data from 2007 including 225,000 households and 22,243 births in five of the six intervention districts. Amongst the 7,823 women with a live birth in the year prior to survey in intervention wards, 59% and 41% received at least one volunteer visit during pregnancy and postpartum, respectively. Neonatal mortality reduced from 35.0 to 30.5 deaths per 1,000 live births between 2007 and 2013 in the five districts, respectively. There was no evidence of an impact of the intervention on neonatal survival (odds ratio [OR] 1.1, 95% confidence interval [CI] 0.9-1.2, p = 0.339. Newborn care practices reported by mothers were better in intervention than in comparison wards, including immediate breastfeeding (42% of 7,287 versus 35% of 7

  16. IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care.

    Science.gov (United States)

    Clarkson, Jan E; Ramsay, Craig R; Averley, Paul; Bonetti, Debbie; Boyers, Dwayne; Campbell, Louise; Chadwick, Graham R; Duncan, Anne; Elders, Andrew; Gouick, Jill; Hall, Andrew F; Heasman, Lynne; Heasman, Peter A; Hodge, Penny J; Jones, Clare; Laird, Marilyn; Lamont, Thomas J; Lovelock, Laura A; Madden, Isobel; McCombes, Wendy; McCracken, Giles I; McDonald, Alison M; McPherson, Gladys; Macpherson, Lorna E; Mitchell, Fiona E; Norrie, John Dt; Pitts, Nigel B; van der Pol, Marjon; Ricketts, David Nj; Ross, Margaret K; Steele, James G; Swan, Moira; Tickle, Martin; Watt, Pauline D; Worthington, Helen V; Young, Linda

    2013-10-26

    Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0-3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI.Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases.The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the gingival margin; oral hygiene self

  17. Evaluation of community-level interventions to increase early initiation of antenatal care in pregnancy: protocol for the Community REACH study, a cluster randomised controlled trial with integrated process and economic evaluations.

    Science.gov (United States)

    Sawtell, Mary; Sweeney, Lorna; Wiggins, Meg; Salisbury, Cathryn; Eldridge, Sandra; Greenberg, Lauren; Hunter, Rachael; Kaur, Inderjeet; McCourt, Christine; Hatherall, Bethan; Findlay, Gail; Morris, Joanne; Reading, Sandra; Renton, Adrian; Adekoya, Ruth; Green, Belinda; Harvey, Belinda; Latham, Sarah; Patel, Kanta; Vanlessen, Logan; Harden, Angela

    2018-03-05

    The provision of high-quality maternity services is a priority for reducing inequalities in health outcomes for mothers and infants. Best practice includes women having their initial antenatal appointment within the first trimester of pregnancy in order to provide screening and support for healthy lifestyles, well-being and self-care in pregnancy. Previous research has identified inequalities in access to antenatal care, yet there is little evidence on interventions to improve early initiation of antenatal care. The Community REACH trial will assess the effectiveness and cost-effectiveness of engaging communities in the co-production and delivery of an intervention that addresses this issue. The study design is a matched cluster randomised controlled trial with integrated process and economic evaluations. The unit of randomisation is electoral ward. The intervention will be delivered in 10 wards; 10 comparator wards will have normal practice. The primary outcome is the proportion of pregnant women attending their antenatal booking appointment by the 12th completed week of pregnancy. This and a number of secondary outcomes will be assessed for cohorts of women (n = approximately 1450 per arm) who give birth 2-7 and 8-13 months after intervention delivery completion in the included wards, using routinely collected maternity data. Eight hospitals commissioned to provide maternity services in six NHS trusts in north and east London and Essex have been recruited to the study. These trusts will provide anonymised routine data for randomisation and outcomes analysis. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will use a cost-consequences analysis and decision model to evaluate the intervention. Targeted community engagement in the research process was a priority. Community REACH aims to increase early initiation of antenatal care using an intervention that is co-produced and

  18. IQuaD dental trial; improving the quality of dentistry: a multicentre randomised controlled trial comparing oral hygiene advice and periodontal instrumentation for the prevention and management of periodontal disease in dentate adults attending dental primary care

    Science.gov (United States)

    2013-01-01

    Background Periodontal disease is the most common oral disease affecting adults, and although it is largely preventable it remains the major cause of poor oral health worldwide. Accumulation of microbial dental plaque is the primary aetiological factor for both periodontal disease and caries. Effective self-care (tooth brushing and interdental aids) for plaque control and removal of risk factors such as calculus, which can only be removed by periodontal instrumentation (PI), are considered necessary to prevent and treat periodontal disease thereby maintaining periodontal health. Despite evidence of an association between sustained, good oral hygiene and a low incidence of periodontal disease and caries in adults there is a lack of strong and reliable evidence to inform clinicians of the relative effectiveness (if any) of different types of Oral Hygiene Advice (OHA). The evidence to inform clinicians of the effectiveness and optimal frequency of PI is also mixed. There is therefore an urgent need to assess the relative effectiveness of OHA and PI in a robust, sufficiently powered randomised controlled trial (RCT) in primary dental care. Methods/Design This is a 5 year multi-centre, randomised, open trial with blinded outcome evaluation based in dental primary care in Scotland and the North East of England. Practitioners will recruit 1860 adult patients, with periodontal health, gingivitis or moderate periodontitis (Basic Periodontal Examination Score 0–3). Dental practices will be cluster randomised to provide routine OHA or Personalised OHA. To test the effects of PI each individual patient participant will be randomised to one of three groups: no PI, 6 monthly PI (current practice), or 12 monthly PI. Baseline measures and outcome data (during a three year follow-up) will be assessed through clinical examination, patient questionnaires and NHS databases. The primary outcome measures at 3 year follow up are gingival inflammation/bleeding on probing at the

  19. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial.

    Science.gov (United States)

    Lean, Michael Ej; Leslie, Wilma S; Barnes, Alison C; Brosnahan, Naomi; Thom, George; McCombie, Louise; Peters, Carl; Zhyzhneuskaya, Sviatlana; Al-Mrabeh, Ahmad; Hollingsworth, Kieren G; Rodrigues, Angela M; Rehackova, Lucia; Adamson, Ashley J; Sniehotta, Falko F; Mathers, John C; Ross, Hazel M; McIlvenna, Yvonne; Stefanetti, Renae; Trenell, Michael; Welsh, Paul; Kean, Sharon; Ford, Ian; McConnachie, Alex; Sattar, Naveed; Taylor, Roy

    2018-02-10

    Type 2 diabetes is a chronic disorder that requires lifelong treatment. We aimed to assess whether intensive weight management within routine primary care would achieve remission of type 2 diabetes. We did this open-label, cluster-randomised trial (DiRECT) at 49 primary care practices in Scotland and the Tyneside region of England. Practices were randomly assigned (1:1), via a computer-generated list, to provide either a weight management programme (intervention) or best-practice care by guidelines (control), with stratification for study site (Tyneside or Scotland) and practice list size (>5700 or ≤5700). Participants, carers, and research assistants who collected outcome data were aware of group allocation; however, allocation was concealed from the study statistician. We recruited individuals aged 20-65 years who had been diagnosed with type 2 diabetes within the past 6 years, had a body-mass index of 27-45 kg/m 2 , and were not receiving insulin. The intervention comprised withdrawal of antidiabetic and antihypertensive drugs, total diet replacement (825-853 kcal/day formula diet for 3-5 months), stepped food reintroduction (2-8 weeks), and structured support for long-term weight loss maintenance. Co-primary outcomes were weight loss of 15 kg or more, and remission of diabetes, defined as glycated haemoglobin (HbA 1c ) of less than 6·5% (<48 mmol/mol) after at least 2 months off all antidiabetic medications, from baseline to 12 months. These outcomes were analysed hierarchically. This trial is registered with the ISRCTN registry, number 03267836. Between July 25, 2014, and Aug 5, 2017, we recruited 306 individuals from 49 intervention (n=23) and control (n=26) general practices; 149 participants per group comprised the intention-to-treat population. At 12 months, we recorded weight loss of 15 kg or more in 36 (24%) participants in the intervention group and no participants in the control group (p<0·0001). Diabetes remission was achieved in 68 (46

  20. Rationale, design and methods of the Study of Work and Pain (SWAP): a cluster randomised controlled trial testing the addition of a vocational advice service to best current primary care for patients with musculoskeletal pain (ISRCTN 52269669).

    Science.gov (United States)

    Bishop, Annette; Wynne-Jones, Gwenllian; Lawton, Sarah A; van der Windt, Danielle; Main, Chris; Sowden, Gail; Burton, A Kim; Lewis, Martyn; Jowett, Sue; Sanders, Tom; Hay, Elaine M; Foster, Nadine E

    2014-07-10

    Musculoskeletal pain is a major contributor to short and long term work absence. Patients seek care from their general practitioner (GP) and yet GPs often feel ill-equipped to deal with work issues. Providing a vocational case management service in primary care, to support patients with musculoskeletal problems to remain at or return to work, is one potential solution but requires robust evaluation to test clinical and cost-effectiveness. This protocol describes a cluster randomised controlled trial, with linked qualitative interviews, to investigate the effect of introducing a vocational advice service into general practice, to provide a structured approach to managing work related issues in primary care patients with musculoskeletal pain who are absent from work or struggling to remain in work. General practices (n = 6) will be randomised to offer best current care or best current care plus a vocational advice service. Adults of working age who are absent from or struggling to remain in work due to a musculoskeletal pain problem will be invited to participate and 330 participants will be recruited. Data collection will be through patient completed questionnaires at baseline, 4 and 12 months. The primary outcome is self-reported work absence at 4 months. Incremental cost-utility analysis will be undertaken to calculate the cost per additional QALY gained and incremental net benefits. A linked interview study will explore the experiences of the vocational advice service from the perspectives of GPs, nurse practitioners (NPs), patients and vocational advisors. This paper presents the rationale, design, and methods of the Study of Work And Pain (SWAP) trial. The results of this trial will provide evidence to inform primary care practice and guide the development of services to provide support for musculoskeletal pain patients with work-related issues. Current Controlled Trials ISRCTN52269669.

  1. Enhanced maternal and child health nurse care for women experiencing intimate partner/family violence: protocol for MOVE, a cluster randomised trial of screening and referral in primary health care.

    Science.gov (United States)

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

    2012-09-20

    Intimate partner violence (IPV) can result in significant harm to women and families and is especially prevalent when women are pregnant or recent mothers. Maternal and child health nurses (MCHN) in Victoria, Australia are community-based nurse/midwives who see over 95% of all mothers with newborns. MCHN are in an ideal position to identify and support women experiencing IPV, or refer them to specialist family violence services. Evidence for IPV screening in primary health care is inconclusive to date. The Victorian government recently required nurses to screen all mothers when babies are four weeks old, offering an opportunity to examine the effectiveness of MCHN IPV screening practices. This protocol describes the development and design of MOVE, a study to examine IPV screening effectiveness and the sustainability of screening practice. MOVE is a cluster randomised trial of a good practice model of MCHN IPV screening involving eight maternal and child health nurse teams in Melbourne, Victoria. Normalisation Process Theory (NPT) was incorporated into the design, implementation and evaluation of the MOVE trial to enhance and evaluate sustainability. Using NPT, the development stage combined participatory action research with intervention nurse teams and a systematic review of nurse IPV studies to develop an intervention model incorporating consensus guidelines, clinical pathway and strategies for individual nurses, their teams and family violence services. Following twelve months' implementation, primary outcomes assessed include IPV inquiry, IPV disclosure by women and referral using data from MCHN routine data collection and a survey to all women giving birth in the previous eight months. IPV will be measured using the Composite Abuse Scale. Process and impact evaluation data (online surveys and key stakeholders interviews) will highlight NPT concepts to enhance sustainability of IPV identification and referral. Data will be collected again in two years. MOVE

  2. Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management).

    Science.gov (United States)

    Peters-Klimm, Frank; Müller-Tasch, Thomas; Schellberg, Dieter; Gensichen, Jochen; Muth, Christiane; Herzog, Wolfgang; Szecsenyi, Joachim

    2007-08-23

    Chronic congestive heart failure (CHF) is a complex disease with rising prevalence, compromised quality of life (QoL), unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP) can improve patients' QoL. HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific self-management, (non)pharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation). Patients from control group receive usual care by their GPs, who were introduced to guideline-oriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ), depression and anxiety disorders (PHQ-9, GAD-7), adherence (EHFScBS and SANA), quality of care measured by an adapted version of the Patient Chronic Illness

  3. Rationale, design and conduct of a randomised controlled trial evaluating a primary care-based complex intervention to improve the quality of life of heart failure patients: HICMan (Heidelberg Integrated Case Management

    Directory of Open Access Journals (Sweden)

    Muth Christiane

    2007-08-01

    Full Text Available Abstract Background Chronic congestive heart failure (CHF is a complex disease with rising prevalence, compromised quality of life (QoL, unplanned hospital admissions, high mortality and therefore high burden of illness. The delivery of care for these patients has been criticized and new strategies addressing crucial domains of care have been shown to be effective on patients' health outcomes, although these trials were conducted in secondary care or in highly organised Health Maintenance Organisations. It remains unclear whether a comprehensive primary care-based case management for the treating general practitioner (GP can improve patients' QoL. Methods/Design HICMan is a randomised controlled trial with patients as the unit of randomisation. Aim is to evaluate a structured, standardized and comprehensive complex intervention for patients with CHF in a 12-months follow-up trial. Patients from intervention group receive specific patient leaflets and documentation booklets as well as regular monitoring and screening by a prior trained practice nurse, who gives feedback to the GP upon urgency. Monitoring and screening address aspects of disease-specific self-management, (nonpharmacological adherence and psychosomatic and geriatric comorbidity. GPs are invited to provide a tailored structured counselling 4 times during the trial and receive an additional feedback on pharmacotherapy relevant to prognosis (data of baseline documentation. Patients from control group receive usual care by their GPs, who were introduced to guideline-oriented management and a tailored health counselling concept. Main outcome measurement for patients' QoL is the scale physical functioning of the SF-36 health questionnaire in a 12-month follow-up. Secondary outcomes are the disease specific QoL measured by the Kansas City Cardiomyopathy questionnaire (KCCQ, depression and anxiety disorders (PHQ-9, GAD-7, adherence (EHFScBS and SANA, quality of care measured by an adapted

  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. Effectiveness of a training course for general practice nurses in motivation support in type 2 diabetes care: a cluster-randomised trial.

    Science.gov (United States)

    Juul, Lise; Maindal, Helle T; Zoffmann, Vibeke; Frydenberg, Morten; Sandbaek, Annelli

    2014-01-01

    Type 2 diabetes is a common metabolic disease with the potential for prevention of complications. The prevention requires a high level of lasting actions from the patients, which may be burdensome. The aim of this trial was to evaluate the effectiveness of a training course for general practice nurses in motivation support at 18 months follow-up in the affiliated type 2 diabetes population. Forty general practices with nurse-led diabetes consultations from the area of Aarhus, Denmark were randomised 1∶1 to either intervention or usual practice. Intervention practices were offered a 16-hour Self-determination theory-based course including communication training for general practice nurses delivered over 10 months. The affiliated diabetes populations (aged 40-74 years) were identified from registers (intervention n = 2,005; usual n = 2,029). Primary outcomes were register-based glycated haemoglobin (HbA1c) -, total cholesterol levels, and well-being measured by the Problem Areas In Diabetes scale (PAID) and the mental component summary score, SF12 (SF12, mcs). Intention-to-treat analyses were performed. Predefined subgroups analyses were performed. The differences between the intervention- and the control practices' mean HbA1c and total cholesterol at follow-up adjusted for baseline values and clustering were respectively: -0.02%-points (95% CI: -0.11 to 0.07; p: 0.67); 0.08 mmol/l (95% CI: 0.01 to 0.15; p: 0.02). Differences in median scores adjusted for clustering were for PAID: 1.25; p = 0.31 and SF12, mcs: 0.99; p = 0.15. Women in intervention practices differed from women in usual practices on mean HbA1c: -0.12%-points (-0.23 to -0.02; p = 0.02) and SF12, mcs: 2.6; p = 0.01. Offering a training course for general practice nurses in applying the Self-determination theory in current type 2 diabetes care had no effect compared with usual practice measured by HbA1c and total cholesterol levels and the well-being at 18 months of follow-up in

  6. 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

  7. A pilot randomised controlled trial of personalised care for depressed patients with symptomatic coronary heart disease in South London general practices: the UPBEAT-UK RCT protocol and recruitment

    Directory of Open Access Journals (Sweden)

    Tylee André

    2012-06-01

    Full Text Available Abstract Background Community studies reveal people with coronary heart disease (CHD are twice as likely to be depressed as the general population and that this co-morbidity negatively affects the course and outcome of both conditions. There is evidence for the efficacy of collaborative care and case management for depression treatment, and whilst NICE guidelines recommend these approaches only where depression has not responded to psychological, pharmacological, or combined treatments, these care approaches may be particularly relevant to the needs of people with CHD and depression in the earlier stages of stepped care in primary care settings. Methods This pilot randomised controlled trial will evaluate whether a simple intervention involving a personalised care plan, elements of case management and regular telephone review is a feasible and acceptable intervention that leads to better mental and physical health outcomes for these patients. The comparator group will be usual general practitioner (GP care. 81 participants have been recruited from CHD registers of 15 South London general practices. Eligible participants have probable major depression identified by a score of ≥8 on the Hospital Anxiety and Depression Scale depression subscale (HADS-D together with symptomatic CHD identified using the Modified Rose Angina Questionnaire. Consenting participants are randomly allocated to usual care or the personalised care intervention which involves a comprehensive assessment of each participant’s physical and mental health needs which are documented in a care plan, followed by regular telephone reviews by the case manager over a 6-month period. At each review, the intervention participant’s mood, function and identified problems are reviewed and the case manager uses evidence based behaviour change techniques to facilitate achievement of goals specified by the patient with the aim of increasing the patient’s self efficacy to solve their

  8. Clinical effectiveness and cost-effectiveness of cognitive behavioural therapy as an adjunct to pharmacotherapy for treatment-resistant depression in primary care: the CoBalT randomised controlled trial.

    Science.gov (United States)

    Wiles, Nicola; Thomas, Laura; Abel, Anna; Barnes, Maria; Carroll, Fran; Ridgway, Nicola; Sherlock, Sofie; Turner, Nicholas; Button, Katherine; Odondi, Lang'o; Metcalfe, Chris; Owen-Smith, Amanda; Campbell, John; Garland, Anne; Hollinghurst, Sandra; Jerrom, Bill; Kessler, David; Kuyken, Willem; Morrison, Jill; Turner, Katrina; Williams, Chris; Peters, Tim; Lewis, Glyn

    2014-05-01

    Only one-third of patients with depression respond fully to treatment with antidepressant medication. However, there is little robust evidence to guide the management of those whose symptoms are 'treatment resistant'. The CoBalT trial examined the clinical effectiveness and cost-effectiveness of cognitive behavioural therapy (CBT) as an adjunct to usual care (including pharmacotherapy) for primary care patients with treatment-resistant depression (TRD) compared with usual care alone. Pragmatic, multicentre individually randomised controlled trial with follow-up at 3, 6, 9 and 12 months. A subset took part in a qualitative study investigating views and experiences of CBT, reasons for completing/not completing therapy, and usual care for TRD. General practices in Bristol, Exeter and Glasgow, and surrounding areas. Patients aged 18-75 years who had TRD [on antidepressants for ≥ 6 weeks, had adhered to medication, Beck Depression Inventory, 2nd version (BDI-II) score of ≥ 14 and fulfilled the International Classification of Diseases and Related Health Problems, Tenth edition criteria for depression]. Individuals were excluded who (1) had bipolar disorder/psychosis or major alcohol/substance abuse problems; (2) were unable to complete the questionnaires; or (3) were pregnant, as were those currently receiving CBT/other psychotherapy/secondary care for depression, or who had received CBT in the past 3 years. Participants were randomised, using a computer-generated code, to usual care or CBT (12-18 sessions) in addition to usual care. The primary outcome was 'response', defined as ≥ 50% reduction in depressive symptoms (BDI-II score) at 6 months compared with baseline. Secondary outcomes included BDI-II score as a continuous variable, remission of symptoms (BDI-II score of social care use, personal costs, and time off work were collected at 6 and 12 months. Costs from these three perspectives were reported using a cost-consequence analysis. A cost-utility analysis

  9. 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

  10. Two-year effects and cost-effectiveness of pelvic floor muscle training in mild pelvic organ prolapse : a randomised controlled trial in primary care

    NARCIS (Netherlands)

    Panman, Chantal M.C.R.; Wiegersma, M; Kollen, B J; Berger, M Y; Lisman-Van Leeuwen, Y; Vermeulen, K M; Dekker, J H

    OBJECTIVE: To compare effects and cost-effectiveness of pelvic floor muscle training (PFMT) and watchful waiting in women with pelvic organ prolapse. DESIGN: Randomised controlled trial. SETTING: Dutch general practice. POPULATION: Women (≥55 years) with symptomatic mild prolapse, identified by

  11. 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),

  12. The feasibility of a randomised controlled trial to compare the cost-effectiveness of palliative cardiology or usual care in people with advanced heart failure: Two exploratory prospective cohorts.

    Science.gov (United States)

    Johnson, Miriam J; McSkimming, Paula; McConnachie, Alex; Geue, Claudia; Millerick, Yvonne; Briggs, Andrew; Hogg, Karen

    2018-06-01

    The effectiveness of cardiology-led palliative care is unknown; we have insufficient information to conduct a full trial. To assess the feasibility (recruitment/retention, data quality, variability/sample size estimation, safety) of a clinical trial of palliative cardiology effectiveness. Non-randomised feasibility. Unmatched symptomatic heart failure patients on optimal cardiac treatment from (1) cardiology-led palliative service (caring together group) and (2) heart failure liaison service (usual care group). Outcomes/safety: Symptoms (Edmonton Symptom Assessment Scale), Kansas City Cardiomyopathy Questionnaire, performance, understanding of disease, anticipatory care planning, cost-effectiveness, survival and carer burden. A total of 77 participants (caring together group = 43; usual care group = 34) were enrolled (53% men; mean age 77 years (33-100)). The caring together group scored worse in Edmonton Symptom Assessment Scale (43.5 vs 35.2) and Kansas City Cardiomyopathy Questionnaire (35.4 vs 39.9). The caring together group had a lower consent/screen ratio (1:1.7 vs 1: 2.8) and few died before approach (0.08% vs 16%) or declined invitation (17% vs 37%). Data quality: At 4 months, 74% in the caring together group and 71% in the usual care group provided data. Most attrition was due to death or deterioration. Data quality in self-report measures was otherwise good. There was no difference in survival. Symptoms and quality of life improved in both groups. A future trial requires 141 (202 allowing 30% attrition) to detect a minimal clinical difference (1 point) in Edmonton Symptom Assessment Scale score for breathlessness (80% power). More participants (176; 252 allowing 30% attrition) are needed to detect a 10.5 change in Kansas City Cardiomyopathy Questionnaire score (80% power; minimum clinical difference = 5). A trial to test the clinical effectiveness (improvement in breathlessness) of cardiology-led palliative care is feasible.

  13. Coming to grips with challenging behaviour: a cluster randomised controlled trial on the effects of a new care programme for challenging behaviour on burnout, job satisfaction and job demands of care staff on dementia special care units

    NARCIS (Netherlands)

    Zwijsen, S.A.; Gerritsen, D.L.; Eefsting, J.A.; Smalbrugge, M.; Hertogh, C.M.P.M.; Pot, A.M.

    2015-01-01

    Background: Caring for people with dementia in dementia special care units is a demanding job. Challenging behaviour is one of the factors influencing the job satisfaction and burnout of care staff. A care programme for the challenging behaviour of nursing home residents with dementia might, next to

  14. Coming to grips with challenging behaviour: a cluster randomised controlled trial on the effects of a new care programme for challenging behaviour on burnout, job satisfaction and job demands of care staff on dementia special care units

    NARCIS (Netherlands)

    Zwijsen, S.A.; Gerritsen, D.L.; Eefsting, J.A.; Smalbrugge, M.; Hertogh, C.M.; Pot, A.M.

    2015-01-01

    BACKGROUND: Caring for people with dementia in dementia special care units is a demanding job. Challenging behaviour is one of the factors influencing the job satisfaction and burnout of care staff. A care programme for the challenging behaviour of nursing home residents with dementia might, next to

  15. A new primary dental care service compared with standard care for child and family to reduce the re-occurrence of childhood dental caries (Dental RECUR): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Pine, Cynthia; Adair, Pauline; Burnside, Girvan; Robinson, Louise; Edwards, Rhiannon Tudor; Albadri, Sondos; Curnow, Morag; Ghahreman, Marjan; Henderson, Mary; Malies, Clare; Wong, Ferranti; Muirhead, Vanessa; Weston-Price, Sally; Whitehead, Hilary

    2015-11-04

    In England and Scotland, dental extraction is the single highest cause of planned admission to the hospital for children under 11 years. Traditional dental services have had limited success in reducing this disease burden. Interventions based on motivational interviewing have been shown to impact positively dental health behaviours and could facilitate the prevention of re-occurrence of dental caries in this high-risk population. The objective of the study is to evaluate whether a new, dental nurse-led service, delivered using a brief negotiated interview based on motivational interviewing, is a more cost-effective service than treatment as usual, in reducing the re-occurrence of dental decay in young children with previous dental extractions. This 2-year, two-arm, multicentre, randomised controlled trial will include 224 child participants, initially aged 5 to 7 years, who are scheduled to have one or more primary teeth extracted for dental caries under general anaesthesia (GA), relative analgesia (RA: inhalation sedation) or local anaesthesia (LA). The trial will be conducted in University Dental Hospitals, Secondary Care Centres or other providers of dental extraction services across the United Kingdom. The intervention will include a brief negotiated interview (based on the principles of motivational interviewing) delivered between enrollment and 6 weeks post-extraction, followed by directed prevention in primary dental care. Participants will be followed up for 2 years. The main outcome measure will be the dental caries experienced by 2 years post-enrollment at the level of dentine involvement on any tooth in either dentition, which had been caries-free at the baseline assessment. The participants are a hard-to-reach group in which secondary prevention is a challenge. Lack of engagement with dental care makes the children and their families scheduled for extraction particularly difficult to recruit to an RCT. Variations in service delivery between sites have

  16. Effectiveness of the HuCare Quality Improvement Strategy on health-related quality of life in patients with cancer: study protocol of a stepped-wedge cluster randomised controlled trial (HuCare2 study).

    Science.gov (United States)

    Caminiti, Caterina; Iezzi, Elisa; Passalacqua, Rodolfo

    2017-10-06

    Our group previously demonstrated the feasibility of the HuCare Quality Improvement Strategy (HQIS), aimed at integrating into practice six psychosocial interventions recommended by international guidelines. This trial will assess whether the introduction of the strategy in oncology wards improves patient's health-related quality of life (HRQoL). Multicentre, incomplete stepped-wedge cluster randomised controlled trial, conducted in three clusters of five centres each, in three equally spaced time epochs. The study also includes an initial epoch when none of the centres are exposed to the intervention, and a final epoch when all centres will have implemented the strategy. The intervention is applied at a cluster level, and assessed at an individual level with cross-sectional model. A total of 720 patients who received a cancer diagnosis in the previous 2 months and about to start medical treatment will be enrolled. The primary aim is to evaluate the effectiveness of the HQIS versus standard care in terms of improvement of at least one of two domains (emotional and social functions) of HRQoL using the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items) questionnaire, at baseline and at 3 months. This outcome was chosen because patients with cancer generally exhibit low HRQoL, particularly at certain stages of care, and because it allows to assess the strategy's impact as perceived by patients themselves. The HQIS comprises three phases: (1) clinician training-to improve communication-relational skills and instruct on the project; (2) centre support-four on-site visits by experts of the project team, aimed to boost motivation, help with context analysis and identification of solutions; (3) implementation of Evidence-Based Medicine (EBM) recommendations at the centre. Ethics committee review approval has been obtained from the Ethics Committee of Parma. Results will be disseminated at conferences, and

  17. Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE).

    OpenAIRE

    Crawford, MJ; Killaspy, H; Barnes, TR; Barrett, B; Byford, S; Clayton, K; Dinsmore, J; Floyd, S; Hoadley, A; Johnson, T; Kalaitzaki, E; King, M; Leurent, B; Maratos, A; O'Neill, FA

    2012-01-01

    OBJECTIVE To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING Study partic...

  18. Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS).

    Science.gov (United States)

    Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

    2016-01-21

    International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. This feasibility trial protocol was approved by the UCD Human Research Ethics-Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in

  19. Tight intra-operative blood pressure control versus standard care for patients undergoing hip fracture repair - Hip Fracture Intervention Study for Prevention of Hypotension (HIP-HOP) trial: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Moppett, Iain Keith; White, Stuart; Griffiths, Richard; Buggy, Donal

    2017-07-25

    Hypotension during anaesthesia for hip fracture surgery is common. Recent data suggest that there is an association between the lowest intra-operative blood pressure and mortality, even when adjusted for co-morbidities. This is consistent with data derived from the wider surgical population, where magnitude and duration of hypotension are associated with mortality and peri-operative complications. However, there are no trial to data to support more aggressive blood pressure control. We are conducting a three-centre, randomised, double-blinded pilot study in three hospitals in the United Kingdom. The sample size will be 75 patients (25 from each centre). Randomisation will be done using computer-generated concealed tables. Both participants and investigators will be blinded to group allocation. Participants will be aged >70 years, cognitively intact (Abbreviated Mental Test Score 7 or greater), able to give informed consent and admitted directly through the emergency department with a fractured neck of the femur requiring operative repair. Patients randomised to tight blood pressure control or avoidance of intra-operative hypotension will receive active treatment as required to maintain both of the following: systolic arterial blood pressure >80% of baseline pre-operative value and mean arterial pressure >75 mmHg throughout. All participants will receive standard hospital care, including spinal or general anaesthesia, at the discretion of the clinical team. The primary outcome is a composite of the presence or absence of defined cardiovascular, renal and delirium morbidity within 7 days of surgery (myocardial injury, stroke, acute kidney injury, delirium). Secondary endpoints will include the defined individual morbidities, mortality, early mobility and discharge to usual residence. This is a small-scale pilot study investigating the feasibility of a trial of tight intra-operative blood pressure control in a frail elderly patient group with known high morbidity

  20. Coming to grips with challenging behaviour: a cluster randomised controlled trial on the effects of a new care programme for challenging behaviour on burnout, job satisfaction and job demands of care staff on dementia special care units.

    Science.gov (United States)

    Zwijsen, S A; Gerritsen, D L; Eefsting, J A; Smalbrugge, M; Hertogh, C M P M; Pot, A M

    2015-01-01

    Caring for people with dementia in dementia special care units is a demanding job. Challenging behaviour is one of the factors influencing the job satisfaction and burnout of care staff. A care programme for the challenging behaviour of nursing home residents with dementia might, next to diminishing the challenging behaviour of residents, improve job satisfaction and reduce the care staff's feelings of burnout. To determine the effects of a care programme for the challenging behaviour of nursing home residents with dementia on the burnout, job satisfaction and job demands of care staff. The care programme was implemented according to a stepped wedge design in which care units were randomly divided over five groups with different time points of starting with implementation. 17 Dutch dementia special care units. Care staff members of the 17 units. The care programme consists of an education package and of various structured assessment tools that guide professionals through the multidisciplinary detection, analysis, treatment and evaluation of treatment of challenging behaviour. Burnout, job satisfaction and job demands were measured before implementation, halfway through the implementation process and after all the care units had implemented the care programme. Burnout was measured with the Dutch version of the Maslach burnout inventory (UBOS-C, three subscales); job satisfaction and job demands were measured with subscales of the Leiden Quality of Work Questionnaire. Mixed model analyses were used to determine effects. Care staff could not be blinded for the intervention. Of the 1441 questionnaires, 645 were returned (response 45%, 318 control measurements, 327 intervention measurements) by 380 unique care staff members. Significant effects were found on job satisfaction (0.93, 95% CI 0.48-1.38). On the other outcomes, no significant changes in the scores were found. Positive effects of using the Grip on Challenging behaviour care programme were found on job

  1. The Hand Eczema Trial (HET): Design of a randomised clinical trial of the effect of classification and individual counselling versus no intervention among health-care workers with hand eczema.

    Science.gov (United States)

    Ibler, Kristina Sophie; Agner, Tove; Hansen, Jane Lindschou; Gluud, Christian

    2010-08-31

    Hand eczema is the most frequently recognized occupational disease in Denmark with an incidence of approximately 0.32 per 1000 person-years. Consequences of hand eczema include chronic severe eczema, prolonged sick leave, unemployment, and impaired quality of life. New preventive strategies are needed to reduce occupational hand eczema. We describe the design of a randomised clinical trial to investigate the effects of classification of hand eczema plus individual counselling versus no intervention. The trial includes health-care workers with hand eczema identified from a self-administered questionnaire delivered to 3181 health-care workers in three Danish hospitals. The questionnaire identifies the prevalence of hand eczema, knowledge of skin-protection, and exposures that can lead to hand eczema. At entry, all participants are assessed regarding: disease severity (Hand Eczema Severity Index); self-evaluated disease severity; number of eruptions; quality of life; skin protective behaviour, and knowledge of skin protection. The patients are centrally randomised to intervention versus no intervention 1:1 stratified for hospital, profession, and severity score. The experimental group undergoes patch and prick testing; classification of the hand eczema; demonstration of hand washing and appliance of emollients; individual counselling, and a skin-care programme. The control group receives no intervention. All participants are reassessed after six months. The primary outcome is observer-blinded assessment of disease severity and the secondary outcomes are unblinded assessments of disease severity; number of eruptions; knowledge of skin protection; skin-protective behaviour, and quality of life. The trial is registered in ClinicalTrials.Gov, NCT01012453.

  2. Effectiveness of a diabetes education and self management programme (DESMOND) for people with newly diagnosed type 2 diabetes mellitus: three year follow-up of a cluster randomised controlled trial in primary care.

    Science.gov (United States)

    Khunti, Kamlesh; Gray, Laura J; Skinner, Timothy; Carey, Marian E; Realf, Kathryn; Dallosso, Helen; Fisher, Harriet; Campbell, Michael; Heller, Simon; Davies, Melanie J

    2012-04-26

    To measure whether the benefits of a single education and self management structured programme for people with newly diagnosed type 2 diabetes mellitus are sustained at three years. Three year follow-up of a multicentre cluster randomised controlled trial in primary care, with randomisation at practice level. 207 general practices in 13 primary care sites in the United Kingdom. 731 of the 824 participants included in the original trial were eligible for follow-up. Biomedical data were collected on 604 (82.6%) and questionnaire data on 513 (70.1%) participants. A structured group education programme for six hours delivered in the community by two trained healthcare professional educators compared with usual care. The primary outcome was glycated haemoglobin (HbA(1c)) levels. The secondary outcomes were blood pressure, weight, blood lipid levels, smoking status, physical activity, quality of life, beliefs about illness, depression, emotional impact of diabetes, and drug use at three years. HbA(1c) levels at three years had decreased in both groups. After adjusting for baseline and cluster the difference was not significant (difference -0.02, 95% confidence interval -0.22 to 0.17). The groups did not differ for the other biomedical and lifestyle outcomes and drug use. The significant benefits in the intervention group across four out of five health beliefs seen at 12 months were sustained at three years (Pdiabetes mellitus showed no difference in biomedical or lifestyle outcomes at three years although there were sustained improvements in some illness beliefs. Current Controlled Trials ISRCTN17844016.

  3. The effect of changing movement and posture using motion-sensor biofeedback, versus guidelines-based care, on the clinical outcomes of people with sub-acute or chronic low back pain-a multicentre, cluster-randomised, placebo-controlled, pilot trial

    DEFF Research Database (Denmark)

    Kent, Peter; Laird, Robert; Haines, Terry

    2015-01-01

    sample size calculations for a fully powered trial. METHODS: A multicentre (8 clinics), cluster-randomised, placebo-controlled pilot trial compared two groups of patients seeking medical or physiotherapy primary care for sub-acute and chronic back pain. It was powered for longitudinal analysis...

  4. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services.

    Science.gov (United States)

    Tickle, Martin; Milsom, Keith M; Donaldson, Michael; Killough, Seamus; O'Neill, Ciaran; Crealey, Grainne; Sutton, Matthew; Noble, Solveig; Greer, Margaret; Worthington, Helen V

    2011-10-10

    Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group.The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will be obtained from parental

  5. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    Directory of Open Access Journals (Sweden)

    Noble Solveig

    2011-10-01

    Full Text Available Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education with dental health education alone in young children. Methods/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years, fluoride toothpaste (1,450 ppm F (supplied twice per year, a toothbrush (supplied twice a year or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit. 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs

  6. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    LENUS (Irish Health Repository)

    Tickle, Martin

    2011-10-10

    Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. Methods\\/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will

  7. Study protocol of EMPOWER participatory action research (EMPOWER-PAR): a pragmatic cluster randomised controlled trial of multifaceted chronic disease management strategies to improve diabetes and hypertension outcomes in primary care.

    Science.gov (United States)

    Ramli, Anis S; Lakshmanan, Sharmila; Haniff, Jamaiyah; Selvarajah, Sharmini; Tong, Seng F; Bujang, Mohamad-Adam; Abdul-Razak, Suraya; Shafie, Asrul A; Lee, Verna K M; Abdul-Rahman, Thuhairah H; Daud, Maryam H; Ng, Kien K; Ariffin, Farnaza; Abdul-Hamid, Hasidah; Mazapuspavina, Md-Yasin; Mat-Nasir, Nafiza; Miskan, Maizatullifah; Stanley-Ponniah, Jaya P; Ismail, Mastura; Chan, Chun W; Abdul-Rahman, Yong R; Chew, Boon-How; Low, Wilson H H

    2014-09-13

    Chronic disease management presents enormous challenges to the primary care workforce because of the rising epidemic of cardiovascular risk factors. The chronic care model was proven effective in improving chronic disease outcomes in developed countries, but there is little evidence of its effectiveness in developing countries. The aim of this study was to evaluate the effectiveness of the EMPOWER-PAR intervention (multifaceted chronic disease management strategies based on the chronic care model) in improving outcomes for type 2 diabetes mellitus and hypertension using readily available resources in the Malaysian public primary care setting. This paper presents the study protocol. A pragmatic cluster randomised controlled trial using participatory action research is underway in 10 public primary care clinics in Selangor and Kuala Lumpur, Malaysia. Five clinics were randomly selected to provide the EMPOWER-PAR intervention for 1 year and another five clinics continued with usual care. Each clinic consecutively recruits type 2 diabetes mellitus and hypertension patients fulfilling the inclusion and exclusion criteria over a 2-week period. The EMPOWER-PAR intervention consists of creating/strengthening a multidisciplinary chronic disease management team, training the team to use the Global Cardiovascular Risks Self-Management Booklet to support patient care and reinforcing the use of relevant clinical practice guidelines for management and prescribing. For type 2 diabetes mellitus, the primary outcome is the change in the proportion of patients achieving HbA1c diabetes mellitus, the primary outcome is the change in the proportion of patients achieving blood pressure care and prescribing patterns. Patients' assessment of their chronic disease care and providers' perceptions, attitudes and perceived barriers in care delivery and cost-effectiveness of the intervention are also evaluated. Results from this study will provide objective evidence of the effectiveness and

  8. Shared care or nursing consultations as an alternative to rheumatologist follow-up for rheumatoid arthritis outpatients with low disease activity--patient outcomes from a 2-year, randomised controlled trial

    DEFF Research Database (Denmark)

    Primdahl, Jette; Sørensen, Jan; Horn, Hans Christian

    2014-01-01

    were randomised to 2-year follow-up by either: (1) planned rheumatologist consultations, (2) shared care without planned consultations or (3) planned nursing consultations. The primary outcome was change in disease activity. DAS28-CRP, Health Assessment Questionnaire, visual analogue scale (VAS......)-pain, fatigue, global health, confidence and satisfaction, quality-of-life by the Short Form 12 and self-efficacy measured by the RA Self-Efficacy questionnaire and the Arthritis Self-Efficacy Scale, were recorded annually and safety measures were recorded. x-Rays of hands and feet were taken at baseline...... and at 2-year follow-up. Mixed effect models were used to explore differences between the three groups over time. RESULTS: At 2-year follow-up, the group allocated to nursing consultations had lower disease activity than the group that underwent rheumatologist consultations (DAS28-CRP -0.3, p=0...

  9. Improving glycaemic control and life skills in adolescents with type 1 diabetes: A randomised, controlled intervention study using the Guided Self-Determination-Young method in triads of adolescents, parents and health care providers integrated into routine paediatric outpatient clinics

    DEFF Research Database (Denmark)

    Husted, Gitte; Thorsteinsson, Birger; Esbensen, Bente Appel

    2011-01-01

    visits will reduce haemoglobin A1c (HbA1c) concentrations and improve adolescents' life skills compared with a control group. METHODS: Using a mixed methods design comprising a randomised controlled trial and a nested qualitative evaluation, we will recruit 68 adolescents age 13 - 18 years with type 1......ABSTRACT: BACKGROUND: Adolescents with type 1 diabetes face demanding challenges due to conflicting priorities between psychosocial needs and diabetes management. This conflict often results in poor glycaemic control and discord between adolescents and parents. Adolescent-parent conflicts are thus...... are lacking. The Guided Self-Determination method is proven effective in adult care and has been adapted to adolescents and parents (Guided Self-Determination-Young (GSD-Y)) for use in paediatric diabetes outpatient clinics. Our objective is to test whether GSD-Y used in routine paediatric outpatient clinic...

  10. A randomised, multicentre clinical trial of specialised palliative care plus standard treatment versus standard treatment alone for cancer patients with palliative care needs: the Danish palliative care trial (DanPaCT) protocol

    DEFF Research Database (Denmark)

    Johnsen, Anna Thit; Damkier, Anette; Vejlgaard, Tove Bahn

    2013-01-01

    Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialised palliative care (SPC) could improve their symptoms and problems.The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer, who report...... palliative needs in a screening, will benefit from being referred to 'early SPC'....

  11. Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients. Protocol Version 9, 19 February 2007 known as SIGNET (Scottish Intensive care Glutamine or seleNium Evaluative Trial

    Directory of Open Access Journals (Sweden)

    Vale Luke D

    2007-09-01

    Full Text Available Abstract Background Mortality rates in the Intensive Care Unit and subsequent hospital mortality rates in the UK remain high. Infections in Intensive Care are associated with a 2–3 times increased risk of death. It is thought that under conditions of severe metabolic stress glutamine becomes "conditionally essential". Selenium is an essential trace element that has antioxidant and anti-inflammatory properties. Approximately 23% of patients in Intensive Care require parenteral nutrition and glutamine and selenium are either absent or present in low amounts. Both glutamine and selenium have the potential to influence the immune system through independent biochemical pathways. Systematic reviews suggest that supplementing parenteral nutrition in critical illness with glutamine or selenium may reduce infections and mortality. Pilot data has shown that more than 50% of participants developed infections, typically resistant organisms. We are powered to show definitively whether supplementation of PN with either glutamine or selenium is effective at reducing new infections in critically ill patients. Methods/design 2 × 2 factorial, pragmatic, multicentre, double-blind, randomised controlled trial. The trial has an enrolment target of 500 patients. Inclusion criteria include: expected to be in critical care for at least 48 hours, aged 16 years or over, patients who require parenteral nutrition and are expected to have at least half their daily nutritional requirements given by that route. Allocation is to one of four iso-caloric, iso-nitrogenous groups: glutamine, selenium, both glutamine & selenium or no additional glutamine or selenium. Trial supplementation is given for up to seven days on the Intensive Care Unit and subsequent wards if practicable. The primary outcomes are episodes of infection in the 14 days after starting trial nutrition and mortality. Secondary outcomes include antibiotic usage, length of hospital stay, quality of life and

  12. Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Holm, Charlotte; Thomsen, Lars Lykke; Norgaard, Astrid; Langhoff-Roos, Jens

    2015-01-14

    Postpartum haemorrhage can lead to iron deficiency with and without anaemia, the clinical consequences of which include physical fatigue. Although oral iron is the standard treatment, it is often associated with gastrointestinal side effects and poor compliance. To date, no published randomised controlled studies have compared the clinical efficacy and safety of standard medical care with intravenous administration of iron supplementation after postpartum haemorrhage.The primary objective of this study is to compare the efficacy of an intravenous high single-dose of iron isomaltoside 1000 with standard medical care on physical fatigue in women with postpartum haemorrhage. In a single centre, open-labelled, randomised trial, women with postpartum haemorrhage exceeding 700 mL will be allocated to either a single dose of 1,200 mg of iron isomaltoside 1000 or standard medical care. Healthy parturients with a singleton pregnancy will be included within 48 hours after delivery.Participants will complete structured questionnaires that focus on several dimensions of fatigue and mental health (Multidimensional Fatigue Inventory, Edinburgh Postnatal Depression Scale and the Postpartum Questionnaire), at inclusion and at follow-up visits after three days, one week, three weeks, eight weeks, and 12 weeks postpartum. The primary endpoint is the aggregated change in physical fatigue score within 12 weeks postpartum, as measured by a subscale of the Multidimensional Fatigue Inventory. The primary objective will be considered to have been met if an intravenous high single dose of iron isomaltoside 1000 is shown to be superior to standard medical care in women after postpartum haemorrhage regarding physical fatigue.For claiming superiority, we set the minimal clinically relevant difference between the mean scores at 1.8, and the assumed standard deviation at 4.2. Hence, 87 participants per treatment group are needed in order to demonstrate superiority; to provide an extra margin

  13. Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care

    Directory of Open Access Journals (Sweden)

    Fanshawe Tom

    2011-04-01

    Full Text Available Abstract Background The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year. Methods/Design ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i intensive treatment alone (n = 239, or (ii intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239. Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking, including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing, change in objectively measured dietary intake (plasma vitamin C, medication adherence (plasma drug levels, and smoking status (plasma cotinine levels at

  14. Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients. Protocol Version 9, 19 February 2007 known as SIGNET (Scottish Intensive care Glutamine or seleNium Evaluative Trial).

    Science.gov (United States)

    Andrews, Peter J D; Avenell, Alison; Noble, David W; Campbell, Marion K; Battison, Claire G; Croal, Bernard L; Simpson, William G; Norrie, John; Vale, Luke D; Cook, Jonathon; de Verteuil, Robyn; Milne, Anne C

    2007-09-20

    Mortality rates in the Intensive Care Unit and subsequent hospital mortality rates in the UK remain high. Infections in Intensive Care are associated with a 2-3 times increased risk of death. It is thought that under conditions of severe metabolic stress glutamine becomes "conditionally essential". Selenium is an essential trace element that has antioxidant and anti-inflammatory properties. Approximately 23% of patients in Intensive Care require parenteral nutrition and glutamine and selenium are either absent or present in low amounts. Both glutamine and selenium have the potential to influence the immune system through independent biochemical pathways. Systematic reviews suggest that supplementing parenteral nutrition in critical illness with glutamine or selenium may reduce infections and mortality. Pilot data has shown that more than 50% of participants developed infections, typically resistant organisms. We are powered to show definitively whether supplementation of PN with either glutamine or selenium is effective at reducing new infections in critically ill patients. 2 x 2 factorial, pragmatic, multicentre, double-blind, randomised controlled trial. The trial has an enrollment target of 500 patients. Inclusion criteria include: expected to be in critical care for at least 48 hours, aged 16 years or over, patients who require parenteral nutrition and are expected to have at least half their daily nutritional requirements given by that route. Allocation is to one of four iso-caloric, iso-nitrogenous groups: glutamine, selenium, both glutamine & selenium or no additional glutamine or selenium. Trial supplementation is given for up to seven days on the Intensive Care Unit and subsequent wards if practicable. The primary outcomes are episodes of infection in the 14 days after starting trial nutrition and mortality. Secondary outcomes include antibiotic usage, length of hospital stay, quality of life and cost-effectiveness. To date more than 285 patients have been

  15. Protocol for the ADDITION-Plus study: a randomised controlled trial of an individually-tailored behaviour change intervention among people with recently diagnosed type 2 diabetes under intensive UK general practice care.

    Science.gov (United States)

    Griffin, Simon J; Simmons, Rebecca K; Williams, Kate M; Prevost, A Toby; Hardeman, Wendy; Grant, Julie; Whittle, Fiona; Boase, Sue; Hobbis, Imogen; Brage, Soren; Westgate, Kate; Fanshawe, Tom; Sutton, Stephen; Wareham, Nicholas J; Kinmonth, Ann Louise

    2011-04-04

    The increasing prevalence of type 2 diabetes poses both clinical and public health challenges. Cost-effective approaches to prevent progression of the disease in primary care are needed. Evidence suggests that intensive multifactorial interventions including medication and behaviour change can significantly reduce cardiovascular morbidity and mortality among patients with established type 2 diabetes, and that patient education in self-management can improve short-term outcomes. However, existing studies cannot isolate the effects of behavioural interventions promoting self-care from other aspects of intensive primary care management. The ADDITION-Plus trial was designed to address these issues among recently diagnosed patients in primary care over one year. ADDITION-Plus is an explanatory randomised controlled trial of a facilitator-led, theory-based behaviour change intervention tailored to individuals with recently diagnosed type 2 diabetes. 34 practices in the East Anglia region participated. 478 patients with diabetes were individually randomised to receive (i) intensive treatment alone (n = 239), or (ii) intensive treatment plus the facilitator-led individual behaviour change intervention (n = 239). Facilitators taught patients key skills to facilitate change and maintenance of key behaviours (physical activity, dietary change, medication adherence and smoking), including goal setting, action planning, self-monitoring and building habits. The intervention was delivered over one year at the participant's surgery and included a one-hour introductory meeting followed by six 30-minute meetings and four brief telephone calls. Primary endpoints are physical activity energy expenditure (assessed by individually calibrated heart rate monitoring and movement sensing), change in objectively measured dietary intake (plasma vitamin C), medication adherence (plasma drug levels), and smoking status (plasma cotinine levels) at one year. We will undertake an intention

  16. Day care bipolar transurethral resection vs photoselective vaporisation under sedoanalgesia: A prospective, randomised study of the management of benign prostatic hyperplasia.

    Science.gov (United States)

    Sood, Rajeev; Manasa, T; Goel, Hemant; Singh, Ritesh Kumar; Singh, Rajpal; Khattar, Nikhil; Pandey, Praveen

    2017-12-01

    To conduct a prospective randomised study comparing the safety, effectiveness and treatment outcomes in patients undergoing bipolar transurethral resection of the prostate (bTURP) and photoselective vaporisation of the prostate (PVP) under sedoanalgesia, as sedoanalgesia is a safe and effective technique suitable for minimally invasive endourological procedures and although studies have confirmed that both TURP and PVP are feasible under sedoanalgesia there are none comparing the two. Between November 2014 and April 2016, all patients satisfying the eligibility criteria underwent either bTURP or PVP under sedoanalgesia after randomisation. The groups were compared for functional outcomes, visual analogue scale (VAS) pain scores (range 0-10), perioperative variables and complications, with a follow-up of 3 months. In all, 42 and 36 patients underwent bTURP and PVP under sedoanalgesia, respectively. The mean VAS pain score was operating time [mean (SD) 55.64 (12.8) vs 61.79 (14.2) min, P  = 0.035], shorter duration of hospitalisation [mean (SD) 14.58 (2.81) vs 19.21 (2.82) h, P  post-void residual urine volume at 3 months were similar in both groups. None of our patients required re-admission or re-operation. Both PVP and bTURP can be carried out safely under sedoanalgesia with excellent treatment outcomes.

  17. Effectiveness of the Assessment of Burden of COPD (ABC) tool on health-related quality of life in patients with COPD: a cluster randomised controlled trial in primary and hospital care

    Science.gov (United States)

    Slok, Annerika H M; Kotz, Daniel; van Breukelen, Gerard; Chavannes, Niels H; Rutten-van Mölken, Maureen P M H; Kerstjens, Huib A M; van der Molen, Thys; Asijee, Guus M; Dekhuijzen, P N Richard; Holverda, Sebastiaan; Salomé, Philippe L; Goossens, Lucas M A; Twellaar, Mascha; in ‘t Veen, Johannes C C M; van Schayck, Onno C P

    2016-01-01

    Objective Assessing the effectiveness of the Assessment of Burden of COPD (ABC) tool on disease-specific quality of life in patients with chronic obstructive pulmonary disease (COPD) measured with the St. George's Respiratory Questionnaire (SGRQ), compared with usual care. Methods A pragmatic cluster randomised controlled trial, in 39 Dutch primary care practices and 17 hospitals, with 357 patients with COPD (postbronchodilator FEV1/FVC ratio <0.7) aged ≥40 years, who could understand and read the Dutch language. Healthcare providers were randomly assigned to the intervention or control group. The intervention group applied the ABC tool, which consists of a short validated questionnaire assessing the experienced burden of COPD, objective COPD parameter (eg, lung function) and a treatment algorithm including a visual display and treatment advice. The control group provided usual care. Researchers were blinded to group allocation during analyses. Primary outcome was the number of patients with a clinically relevant improvement in SGRQ score between baseline and 18-month follow-up. Secondary outcomes were the COPD Assessment Test (CAT) and the Patient Assessment of Chronic Illness Care (PACIC; a measurement of perceived quality of care). Results At 18-month follow-up, 34% of the 146 patients from 27 healthcare providers in the intervention group showed a clinically relevant improvement in the SGRQ, compared with 22% of the 148 patients from 29 healthcare providers in the control group (OR 1.85, 95% CI 1.08 to 3.16). No difference was found on the CAT (−0.26 points (scores ranging from 0 to 40); 95% CI −1.52 to 0.99). The PACIC showed a higher improvement in the intervention group (0.32 points (scores ranging from 1 to 5); 95% CI 0.14 to 0.50). Conclusions This study showed that use of the ABC tool may increase quality of life and perceived quality of care. Trial registration number NTR3788; Results. PMID:27401361

  18. Holistic needs assessment and care plans for women with gynaecological cancer: do they improve cancer-specific health-related quality of life? A randomised controlled trial using mixed methods.

    Science.gov (United States)

    Sandsund, Catherine; Towers, Richard; Thomas, Karen; Tigue, Ruth; Lalji, Amyn; Fernandes, Andreia; Doyle, Natalie; Jordan, Jake; Gage, Heather; Shaw, Clare

    2017-08-28

    Holistic needs assessment (HNA) and care planning are proposed to address unmet needs of people treated for cancer. We tested whether HNA and care planning by an allied health professional improved cancer-specific quality of life for women following curative treatment for stage I-III gynaecological cancer. Consecutive women were invited to participate in a randomised controlled study (HNA and care planning vs usual care) at a UK cancer centre. Data were collected by questionnaire at baseline, 3 and 6 months. The outcomes were 6-month change in European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (version 3), global score (primary) and, in EORTC subscales, generic quality of life and self-efficacy (secondary). The study was blinded for data management and analysis. Differences in outcomes were compared between groups. Health service utilisation and quality-adjusted life years (QALY) (from Short Form-6) were gathered for a cost-effectiveness analysis. Thematic analysis was used to interpret data from an exit interview. 150 women consented (75 per group); 10 undertook interviews. For 124 participants (61 intervention, 63 controls) with complete data, no statistically significant differences were seen between groups in the primary endpoint. The majority of those interviewed reported important personal gains they attributed to the intervention, which reflected trends to improvement seen in EORTC functional and symptom scales. Economic analysis suggests a 62% probability of cost-effectiveness at a £30 000/QALY threshold. Care plan development with an allied health professional is cost-effective, acceptable and useful for some women treated for stage I-III gynaecological cancer. We recommend its introduction early in the pathway to support person-centred care. © 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

  19. A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services: the Northern Ireland Caries Prevention In Practice (NIC-PIP) trial.

    Science.gov (United States)

    Tickle, Martin; O'Neill, Ciaran; Donaldson, Michael; Birch, Stephen; Noble, Solveig; Killough, Seamus; Murphy, Lynn; Greer, Margaret; Brodison, Julie; Verghis, Rejina; Worthington, Helen V

    2016-09-01

    Dental caries is the most common disease of childhood. The NHS guidelines promote preventative care in dental practices, particularly for young children. However, the cost-effectiveness of this policy has not been established. To measure the effects and costs of a composite fluoride intervention designed to prevent caries in young children attending dental services. The study was a two-arm, parallel-group, randomised controlled trial, with an allocation ratio of 1 : 1. Randomisation was by clinical trials unit, using randomised permuted blocks. Children/families were not blinded; however, outcome assessment was blinded to group assessment. The study took place in 22 NHS dental practices in Northern Ireland, UK. The study participants were children aged 2-3 years, who were caries free at baseline. The intervention was composite in nature, comprising a varnish containing 22,600 parts per million (p.p.m.) fluoride, a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m. fluoride; plus standardised, evidence-based prevention advice provided at 6-monthly intervals over 3 years. The control group received the prevention advice alone. The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were the number of decayed, missing or filled tooth surfaces in primary dentition (dmfs) in caries-active children, the number of episodes of pain, the number of extracted teeth and the costs of care. Adverse reactions (ARs) were recorded. A total of 1248 children (624 randomised to each group) were recruited and 1096 (549 in the intervention group and 547 in the control group) were included in the final analyses. A total of 87% of the intervention children and 85% of control children attended every 6-month visit (p = 0.77). In total, 187 (34%) children in the intervention group converted to caries active, compared with 213 (39%) in the control group [odds ratio (OR) 0.81, 95% confidence interval (CI) 0.64 to

  20. Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Clive Ballard

    2018-02-01

    Full Text Available Agitation is a common, challenging symptom affecting large numbers of people with dementia and impacting on quality of life (QoL. There is an urgent need for evidence-based, cost-effective psychosocial interventions to improve these outcomes, particularly in the absence of safe, effective pharmacological therapies. This study aimed to evaluate the efficacy of a person-centred care and psychosocial intervention incorporating an antipsychotic review, WHELD, on QoL, agitation, and antipsychotic use in people with dementia living in nursing homes, and to determine its cost.This was a randomised controlled cluster trial conducted between 1 January 2013 and 30 September 2015 that compared the WHELD intervention with treatment as usual (TAU in people with dementia living in 69 UK nursing homes, using an intention to treat analysis. All nursing homes allocated to the intervention received staff training in person-centred care and social interaction and education regarding antipsychotic medications (antipsychotic review, followed by ongoing delivery through a care staff champion model. The primary outcome measure was QoL (DEMQOL-Proxy. Secondary outcomes were agitation (Cohen-Mansfield Agitation Inventory [CMAI], neuropsychiatric symptoms (Neuropsychiatric Inventory-Nursing Home Version [NPI-NH], antipsychotic use, global deterioration (Clinical Dementia Rating, mood (Cornell Scale for Depression in Dementia, unmet needs (Camberwell Assessment of Need for the Elderly, mortality, quality of interactions (Quality of Interactions Scale [QUIS], pain (Abbey Pain Scale, and cost. Costs were calculated using cost function figures compared with usual costs. In all, 847 people were randomised to WHELD or TAU, of whom 553 completed the 9-month randomised controlled trial. The intervention conferred a statistically significant improvement in QoL (DEMQOL-Proxy Z score 2.82, p = 0.0042; mean difference 2.54, SEM 0.88; 95% CI 0.81, 4.28; Cohen's D effect size 0

  1. Effect of a Primary Care Walking Intervention with and without Nurse Support on Physical Activity Levels in 45- to 75-Year-Olds: The Pedometer And Consultation Evaluation (PACE-UP Cluster Randomised Clinical Trial.

    Directory of Open Access Journals (Sweden)

    Tess Harris

    2017-01-01

    Full Text Available Pedometers can increase walking and moderate-to-vigorous physical activity (MVPA levels, but their effectiveness with or without support has not been rigorously evaluated. We assessed the effectiveness of a pedometer-based walking intervention in predominantly inactive adults, delivered by post or through primary care nurse-supported physical activity (PA consultations.A parallel three-arm cluster randomised trial was randomised by household, with 12-mo follow-up, in seven London, United Kingdom, primary care practices. Eleven thousand fifteen randomly selected patients aged 45-75 y without PA contraindications were invited. Five hundred forty-eight self-reporting achieving PA guidelines were excluded. One thousand twenty-three people from 922 households were randomised between 2012-2013 to one of the following groups: usual care (n = 338; postal pedometer intervention (n = 339; and nurse-supported pedometer intervention (n = 346. Of these, 956 participants (93% provided outcome data (usual care n = 323, postal n = 312, nurse-supported n = 321. Both intervention groups received pedometers, 12-wk walking programmes, and PA diaries. The nurse group was offered three PA consultations. Primary and main secondary outcomes were changes from baseline to 12 mo in average daily step-counts and time in MVPA (in ≥10-min bouts, respectively, measured objectively by accelerometry. Only statisticians were masked to group. Analysis was by intention-to-treat. Average baseline daily step-count was 7,479 (standard deviation [s.d.] 2,671, and average time in MVPA bouts was 94 (s.d. 102 min/wk. At 12 mo, mean steps/d, with s.d. in parentheses, were as follows: control 7,246 (2,671; postal 8,010 (2,922; and nurse support 8,131 (3,228. PA increased in both intervention groups compared with the control group; additional steps/d were 642 for postal (95% CI 329-955 and 677 for nurse support (95% CI 365-989; additional MVPA in bouts (min/wk were 33 for postal (95% CI

  2. 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

  3. MENOS4 trial: a multicentre randomised controlled trial (RCT) of a breast care nurse delivered cognitive behavioural therapy (CBT) intervention to reduce the impact of hot flushes in women with breast cancer: Study Protocol.

    Science.gov (United States)

    Fenlon, Deborah; Nuttall, Jacqueline; May, Carl; Raftery, James; Fields, Jo; Kirkpatrick, Emma; Abab, Julia; Ellis, Mary; Rose, Taylor; Khambhaita, Priya; Galanopoulou, Angeliki; Maishman, Tom; Haviland, Jo; Griffiths, Gareth; Turner, Lesley; Hunter, Myra

    2018-05-08

    Women who have been treated for breast cancer may identify vasomotor symptoms, such as hot flushes and night sweats (HFNS), as a serious problem. HFNS are unpleasant to experience and can have a significant impact on daily life, potentially leading to reduced adherence to life saving adjuvant hormonal therapy. It is known that Cognitive Behavioural Therapy (CBT) is effective for the alleviation of hot flushes in both well women and women who have had breast cancer. Most women with breast cancer will see a breast care nurse and there is evidence that nurses can be trained to deliver psychological treatments to a satisfactory level, whilst also maintaining treatment fidelity. The research team will assess whether breast care nurses can effectively deliver a CBT intervention to alleviate hot flushes in women with breast cancer. This study is a multi-centre phase III individually randomised controlled trial of group CBT versus usual care to reduce the impact of hot flushes in women with breast cancer. 120-160 women with primary breast cancer experiencing seven or more problematic HFNS a week will be randomised to receive either treatment as usual (TAU) or participation in the group CBT intervention plus TAU (CBT Group). A process evaluation using May's Normalisation Process Theory will be conducted, as well as practical and organisational issues relating to the implementation of the intervention. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost effectiveness of the intervention will also be assessed. There is a need for studies that enable effective interventions to be implemented in practice. There is good evidence that CBT is helpful for women with breast cancer who experience HFNS, yet it is not widely available. It is not yet known whether the intervention can be effectively delivered by breast care nurses or implemented in practice. This study will provide information on both whether the intervention can effectively

  4. A pilot randomised controlled trial of personalised care after treatment for prostate cancer (TOPCAT-P): nurse-led holistic-needs assessment and individualised psychoeducational intervention: study protocol

    Science.gov (United States)

    Stanciu, Marian Andrei; Morris, Caroline; Makin, Matt; Watson, Eila; Bulger, Jenna; Evans, Richard; Hiscock, Julia; Hoare, Zoë; Edwards, Rhiannon Tudor; Neal, Richard David; Wilkinson, Clare

    2015-01-01

    Introduction Prostate cancer is common and the incidence is increasing, but more men are living longer after diagnosis, and die with their disease rather than of it. Nonetheless, specific and substantial physical, sexual, emotional and mental health problems often lead to a poor quality of life. Urology services increasingly struggle to cope with the demands of follow-up care, and primary care is likely to play the central role in long-term follow-up. The present phase II trial will evaluate the feasibility and acceptability of a nurse-led, person-centred psychoeducational intervention, delivered in community or primary care settings. Methods and analysis Prostate cancer survivors diagnosed in the past 9–48 months and currently biochemically stable will be identified from hospital records by their treating clinician. Eligible men would have either completed radical treatment, or would be followed up with prostate specific antigen monitoring and symptom reporting. We will recruit 120 patients who will be randomised to receive either an augmented form of usual care, or an additional nurse-led intervention for a period of 36 weeks. Following the health policy in Wales, the intervention is offered by a key worker, is promoting prudent healthcare and is using a holistic needs assessment. Outcome measures will assess physical symptoms, psychological well-being, confidence in managing own health and quality of life. Healthcare service use will be measured over 36 weeks. Feedback interviews with patients and clinicians will further inform the acceptability of the intervention. Recruitment, attrition, questionnaire completion rates and outcome measures variability will be assessed, and results will inform the design of a future phase III trial and accompanying economic evaluation. Ethics and dissemination Ethics approval was granted by Bangor University and North Wales REC (13/WA/0291). Results will be reported in peer-reviewed publications, at scientific

  5. Effectiveness of a PLISSIT model intervention in patients with type 2 diabetes mellitus in primary care: design of a cluster-randomised controlled trial

    NARCIS (Netherlands)

    Rutte, A.; van Oppen, P.C.; Nijpels, G.; Snoek, F.J.; Enzlin, P.; Leusink, P.; Elders, P.J.M.

    2015-01-01

    Background: Sexual dysfunction is prevalent in patients with type 2 diabetes mellitus, but remains one of the most frequently neglected complications in diabetes care. Both patients and care providers appear to have difficulty with discussing sexual problems in diabetes care. A sexual counselling

  6. Effectiveness of involving a nurse specialist for patients with urinary incontinence in primary care: results of a pragmatic multicentre randomised controlled trial.

    NARCIS (Netherlands)

    Albers-Heitner, P.C.; Lagro-Janssen, A.L.M.; Joore, M.M.; Berghmans, B.L.; Nieman, F.F.; Venema, P.P.; Severens, J.J.; Winkens, R.R.

    2011-01-01

    BACKGROUND: Urinary incontinence (UI) primary care management is substandard, offering care rather than cure despite the existence of guidelines that help to improve cure. Involving nurse specialists on incontinence in general practice could be a way to improve care for UI patients. AIMS: We studied

  7. Rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study : a cluster randomised controlled trial

    NARCIS (Netherlands)

    Valk, Mark J.; Hoes, Arno W.; Mosterd, Arend; Landman, Marcel A.; Broekhuizen, Berna D L; Rutten, Frans H.

    2015-01-01

    BACKGROUND: Heart failure (HF) is mainly detected and managed in primary care, but the care is considered suboptimal. We present the rationale, design and baseline results of the Treatment Optimisation in Primary care of Heart failure in the Utrecht region (TOPHU) study. In this study we assess the

  8. Study protocol to assess the effectiveness and safety of a flexible family visitation model for delirium prevention in adult intensive care units: a cluster-randomised, crossover trial (The ICU Visits Study).

    Science.gov (United States)

    Rosa, Regis Goulart; Falavigna, Maicon; Robinson, Caroline Cabral; da Silva, Daiana Barbosa; Kochhann, Renata; de Moura, Rafaela Moraes; Santos, Mariana Martins Siqueira; Sganzerla, Daniel; Giordani, Natalia Elis; Eugênio, Cláudia; Ribeiro, Tarissa; Cavalcanti, Alexandre Biasi; Bozza, Fernando; Azevedo, Luciano Cesar Pontes; Machado, Flávia Ribeiro; Salluh, Jorge Ibrain Figueira; Pellegrini, José Augusto Santos; Moraes, Rafael Barberena; Hochegger, Taís; Amaral, Alexandre; Teles, José Mario Meira; da Luz, Lucas Gobetti; Barbosa, Mirceli Goulart; Birriel, Daniella Cunha; Ferraz, Iris de Lima; Nobre, Vandack; Valentim, Helen Martins; Corrêa E Castro, Livia; Duarte, Péricles Almeida Delfino; Tregnago, Rogério; Barilli, Sofia Louise Santin; Brandão, Nilton; Giannini, Alberto; Teixeira, Cassiano

    2018-04-13

    Flexible intensive care unit (ICU) visiting hours have been proposed as a means to improve patient-centred and family-centred care. However, randomised trials evaluating the effects of flexible family visitation models (FFVMs) are scarce. This study aims to compare the effectiveness and safety of an FFVM versus a restrictive family visitation model (RFVM) on delirium prevention among ICU patients, as well as to analyse its potential effects on family members and ICU professionals. A cluster-randomised crossover trial involving adult ICU patients, family members and ICU professionals will be conducted. Forty medical-surgical Brazilian ICUs with RFVMs (<4.5 hours/day) will be randomly assigned to either an RFVM (visits according to local policies) or an FFVM (visitation during 12 consecutive hours per day) group at a 1:1 ratio. After enrolment and follow-up of 25 patients, each ICU will be switched over to the other visitation model, until 25 more patients per site are enrolled and followed. The primary outcome will be the cumulative incidence of delirium among ICU patients, measured twice a day using the Confusion Assessment Method for the ICU. Secondary outcome measures will include daily hazard of delirium, ventilator-free days, any ICU-acquired infections, ICU length of stay and hospital mortality among the patients; symptoms of anxiety and depression and satisfaction among the family members; and prevalence of burnout symptoms among the ICU professionals. Tertiary outcomes will include need for antipsychotic agents and/or mechanical restraints, coma-free days, unplanned loss of invasive devices and ICU-acquired pneumonia, urinary tract infection or bloodstream infection among the patients; self-perception of involvement in patient care among the family members; and satisfaction among the ICU professionals. The study protocol has been approved by the research ethics committee of all participant institutions. We aim to disseminate the findings through

  9. The SPHERE Study. Secondary prevention of heart disease in general practice: protocol of a randomised controlled trial of tailored practice and patient care plans with parallel qualitative, economic and policy analyses. [ISRCTN24081411].

    LENUS (Irish Health Repository)

    Murphy, Andrew W

    2005-07-29

    BACKGROUND: The aim of the SPHERE study is to design, implement and evaluate tailored practice and personal care plans to improve the process of care and objective clinical outcomes for patients with established coronary heart disease (CHD) in general practice across two different health systems on the island of Ireland. CHD is a common cause of death and a significant cause of morbidity in Ireland. Secondary prevention has been recommended as a key strategy for reducing levels of CHD mortality and general practice has been highlighted as an ideal setting for secondary prevention initiatives. Current indications suggest that there is considerable room for improvement in the provision of secondary prevention for patients with established heart disease on the island of Ireland. The review literature recommends structured programmes with continued support and follow-up of patients; the provision of training, tailored to practice needs of access to evidence of effectiveness of secondary prevention; structured recall programmes that also take account of individual practice needs; and patient-centred consultations accompanied by attention to disease management guidelines. METHODS: SPHERE is a cluster randomised controlled trial, with practice-level randomisation to intervention and control groups, recruiting 960 patients from 48 practices in three study centres (Belfast, Dublin and Galway). Primary outcomes are blood pressure, total cholesterol, physical and mental health status (SF-12) and hospital re-admissions. The intervention takes place over two years and data is collected at baseline, one-year and two-year follow-up. Data is obtained from medical charts, consultations with practitioners, and patient postal questionnaires. The SPHERE intervention involves the implementation of a structured systematic programme of care for patients with CHD attending general practice. It is a multi-faceted intervention that has been developed to respond to barriers and solutions to

  10. An evaluation of Croí MyAction community lifestyle modification programme compared to standard care to reduce progression to diabetes/pre-diabetes in women with prior gestational diabetes mellitus (GDM): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Infanti, Jennifer J; Dunne, Fidelma P; O'Dea, Angela; Gillespie, Paddy; Gibson, Irene; Glynn, Liam G; Noctor, Eoin; Newell, John; McGuire, Brian E

    2013-05-02

    Universal screening using the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria has identified a prevalence of gestational diabetes mellitus (GDM) of 12.4% in women living in Ireland. Women with prior GDM are at increased risk of developing type 2 diabetes later in life. A number of risk factors linked to the development of type 2 diabetes are potentially modifiable through lifestyle and behaviour changes, and medical management. No previous Irish studies have adequately investigated the efficacy of lifestyle intervention programmes in reducing these risk factors in women with prior GDM. Through a two-group, parallel randomised controlled trial (RCT), this study aims to assess the clinical impact, cost-effectiveness and psychological experience of the Croí MyAction intensive lifestyle modification programme for women with prior GDM. A total of 54 women with a history of GDM and persistent post-partum glucose dysfunction (impaired glucose tolerance (IGT) or impaired fasting glucose (IFG)), are randomly assigned to a control arm (n=27) or to the Croí MyAction intervention group (n=27). The control arm receives usual health care advice--written information on diet and lifestyle changes for reducing diabetes risks and visits with general practitioners as required. The intervention group receives usual health care as per the control group in addition to attending a 12-week intensive lifestyle modification programme known as Croí MyAction. Croí MyAction involves 2.5 hour sessions once per week (for 12 weeks) comprising a group exercise programme, group health promotion or education seminars, and one-to-one meetings with a multidisciplinary health care team to personalise risk factor reductions. Randomisation and allocation to the intervention arms is carried out by an independent researcher, ensuring that the allocation sequence is concealed from study researchers until the interventions are assigned. The primary analysis is based on

  11. Educational Outreach with an Integrated Clinical Tool for Nurse-Led Non-communicable Chronic Disease Management in Primary Care in South Africa: A Pragmatic Cluster Randomised Controlled Trial.

    Science.gov (United States)

    Fairall, Lara R; Folb, Naomi; Timmerman, Venessa; Lombard, Carl; Steyn, Krisela; Bachmann, Max O; Bateman, Eric D; Lund, Crick; Cornick, Ruth; Faris, Gill; Gaziano, Thomas; Georgeu-Pepper, Daniella; Zwarenstein, Merrick; Levitt, Naomi S

    2016-11-01

    In many low-income countries, care for patients with non-communicable diseases (NCDs) and mental health conditions is provided by nurses. The benefits of nurse substitution and supplementation in NCD care in high-income settings are well recognised, but evidence from low- and middle-income countries is limited. Primary Care 101 (PC101) is a programme designed to support and expand nurses' role in NCD care, comprising educational outreach to nurses and a clinical management tool with enhanced prescribing provisions. We evaluated the effect of the programme on primary care nurses' capacity to manage NCDs. In a cluster randomised controlled trial design, 38 public sector primary care clinics in the Western Cape Province, South Africa, were randomised. Nurses in the intervention clinics were trained to use the PC101 management tool during educational outreach sessions delivered by health department trainers and were authorised to prescribe an expanded range of drugs for several NCDs. Control clinics continued use of the Practical Approach to Lung Health and HIV/AIDS in South Africa (PALSA PLUS) management tool and usual training. Patients attending these clinics with one or more of hypertension (3,227), diabetes (1,842), chronic respiratory disease (1,157) or who screened positive for depression (2,466), totalling 4,393 patients, were enrolled between 28 March 2011 and 10 November 2011. Primary outcomes were treatment intensification in the hypertension, diabetes, and chronic respiratory disease cohorts, defined as the proportion of patients in whom treatment was escalated during follow-up over 14 mo, and case detection in the depression cohort. Primary outcome data were analysed for 2,110 (97%) intervention and 2,170 (97%) control group patients. Treatment intensification rates in intervention clinics were not superior to those in the control clinics (hypertension: 44% in the intervention group versus 40% in the control group, risk ratio [RR] 1.08 [95% CI 0.94 to 1

  12. The effectiveness of a structured education pulmonary rehabilitation programme for improving the health status of people with moderate and severe chronic obstructive pulmonary disease in primary care: the PRINCE cluster randomised trial.

    Science.gov (United States)

    Casey, Dympna; Murphy, Kathy; Devane, Declan; Cooney, Adeline; McCarthy, Bernard; Mee, Lorraine; Newell, John; O'Shea, Eamon; Scarrott, Carl; Gillespie, Paddy; Kirwan, Collette; Murphy, Andrew W

    2013-10-01

    To evaluate the effectiveness of a structured education pulmonary rehabilitation programme on the health status of people with chronic obstructive pulmonary disease (COPD). Two-arm, cluster randomised controlled trial. 32 general practices in the Republic of Ireland. 350 participants with a diagnosis of moderate or severe COPD. Experimental group received a structured education pulmonary rehabilitation programme, delivered by the practice nurse and physiotherapist. Control group received usual care. Health status as measured by the Chronic Respiratory Questionnaire (CRQ) at baseline and at 12-14 weeks postcompletion of the programme. Participants allocated to the intervention group had statistically significant higher mean change total CRQ scores (adjusted mean difference (MD) 1.11, 95% CI 0.35 to 1.87). However, the CI does not exclude a smaller difference than the one that was prespecified as clinically important. Participants allocated to the intervention group also had statistically significant higher mean CRQ Dyspnoea scores after intervention (adjusted MD 0.49, 95% CI 0.20 to 0.78) and CRQ Physical scores (adjusted MD 0.37, 95% CI 0.14 to 0.60). However, CIs for both the CRQ Dyspnoea and CRQ Physical subscales do not exclude smaller differences as prespecified as clinically important. No other statistically significant differences between groups were seen. A primary care based structured education pulmonary rehabilitation programme is feasible and may increase local accessibility to people with moderate and severe COPD. ISRCTN52403063.

  13. Evaluating the clinical and cost effectiveness of a behaviour change intervention for lowering cardiovascular disease risk for people with severe mental illnesses in primary care (PRIMROSE study): study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Osborn, David; Burton, Alexandra; Walters, Kate; Nazareth, Irwin; Heinkel, Samira; Atkins, Lou; Blackburn, Ruth; Holt, Richard; Hunter, Racheal; King, Michael; Marston, Louise; Michie, Susan; Morris, Richard; Morris, Steve; Omar, Rumana; Peveler, Robert; Pinfold, Vanessa; Zomer, Ella; Barnes, Thomas; Craig, Tom; Gilbert, Hazel; Grey, Ben; Johnston, Claire; Leibowitz, Judy; Petersen, Irene; Stevenson, Fiona; Hardy, Sheila; Robinson, Vanessa

    2016-02-12

    People with severe mental illnesses die up to 20 years earlier than the general population, with cardiovascular disease being the leading cause of death. National guidelines recommend that the physical care of people with severe mental illnesses should be the responsibility of primary care; however, little is known about effective interventions to lower cardiovascular disease risk in this population and setting. Following extensive peer review, funding was secured from the United Kingdom National Institute for Health Research (NIHR) to deliver the proposed study. The aim of the trial is to test the effectiveness of a behavioural intervention to lower cardiovascular disease risk in people with severe mental illnesses in United Kingdom General Practices. The study is a cluster randomised controlled trial in 70 GP practices for people with severe mental illnesses, aged 30 to 75 years old, with elevated cardiovascular disease risk factors. The trial will compare the effectiveness of a behavioural intervention designed to lower cardiovascular disease risk and delivered by a practice nurse or healthcare assistant, with standard care offered in General Practice. A total of 350 people will be recruited and followed up at 6 and 12 months. The primary outcome is total cholesterol level at the 12-month follow-up and secondary outcomes include blood pressure, body mass index, waist circumference, smoking status, quality of life, adherence to treatments and services and behavioural measures for diet, physical activity and alcohol use. An economic evaluation will be carried out to determine the cost effectiveness of the intervention compared with standard care. The results of this pragmatic trial will provide evidence on the clinical and cost effectiveness of the intervention on lowering total cholesterol and addressing multiple cardiovascular disease risk factors in people with severe mental illnesses in GP Practices. Current Controlled Trials ISRCTN13762819. Date of

  14. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting:A randomised, open-label, blinded-endpoint, controlled trial in a health-care setting

    OpenAIRE

    Caterina, Breitenstein; Grewe, Tanja; Flöel, Agnes; Ziegler, Wolfram; Springer, Luise; Martus, Peter; Huber, Walter; Willmes, Klaus; Ringelstein, E. Bernd; Haeusler, Karl Georg; Abel, Steffie; Glindemann, Ralf; Domahs, Frank; Regenbrecht, Frank; Schlenck, Klaus-Jürgen

    2017-01-01

    BackgroundTreatment guidelines for aphasia recommend intensive speech and language therapy for chronic (≥6 months) aphasia after stroke, but large-scale, class 1 randomised controlled trials on treatment effectiveness are scarce. We aimed to examine whether 3 weeks of intensive speech and language therapy under routine clinical conditions improved verbal communication in daily-life situations in people with chronic aphasia after stroke.MethodsIn this multicentre, parallel group, superiority, ...

  15. Protocol for a randomised controlled implementation trial of point-of-care viral load testing and task shifting: the Simplifying HIV TREAtment and Monitoring (STREAM) study

    OpenAIRE

    Dorward, Jienchi; Garrett, Nigel; Quame-Amaglo, Justice; Samsunder, Natasha; Ngobese, Hope; Ngomane, Noluthando; Moodley, Pravikrishnen; Mlisana, Koleka; Schaafsma, Torin; Donnell, Deborah; Barnabas, Ruanne; Naidoo, Kogieleum; Abdool Karim, Salim; Celum, Connie; Drain, Paul K

    2017-01-01

    Introduction Achieving the Joint United Nations Programme on HIV and AIDS 90-90-90 targets requires models of HIV care that expand antiretroviral therapy (ART) coverage without overburdening health systems. Point-of-care (POC) viral load (VL) testing has the potential to efficiently monitor ART treatment, while enrolled nurses may be able to provide safe and cost-effective chronic care for stable patients with HIV. This study aims to demonstrate whether POC VL testing combined with task shift...

  16. Intensive speech and language therapy in patients with chronic aphasia after stroke: a randomised, open-label, blinded-endpoint, controlled trial in a health-care setting.

    Science.gov (United States)

    Breitenstein, Caterina; Grewe, Tanja; Flöel, Agnes; Ziegler, Wolfram; Springer, Luise; Martus, Peter; Huber, Walter; Willmes, Klaus; Ringelstein, E Bernd; Haeusler, Karl Georg; Abel, Stefanie; Glindemann, Ralf; Domahs, Frank; Regenbrecht, Frank; Schlenck, Klaus-Jürgen; Thomas, Marion; Obrig, Hellmuth; de Langen, Ernst; Rocker, Roman; Wigbers, Franziska; Rühmkorf, Christina; Hempen, Indra; List, Jonathan; Baumgaertner, Annette

    2017-04-15

    Treatment guidelines for aphasia recommend intensive speech and language therapy for chronic (≥6 months) aphasia after stroke, but large-scale, class 1 randomised controlled trials on treatment effectiveness are scarce. We aimed to examine whether 3 weeks of intensive speech and language therapy under routine clinical conditions improved verbal communication in daily-life situations in people with chronic aphasia after stroke. In this multicentre, parallel group, superiority, open-label, blinded-endpoint, randomised controlled trial, patients aged 70 years or younger with aphasia after stroke lasting for 6 months or more were recruited from 19 inpatient or outpatient rehabilitation centres in Germany. An external biostatistician used a computer-generated permuted block randomisation method, stratified by treatment centre, to randomly assign participants to either 3 weeks or more of intensive speech and language therapy (≥10 h per week) or 3 weeks deferral of intensive speech and language therapy. The primary endpoint was between-group difference in the change in verbal communication effectiveness in everyday life scenarios (Amsterdam-Nijmegen Everyday Language Test A-scale) from baseline to immediately after 3 weeks of treatment or treatment deferral. All analyses were done using the modified intention-to-treat population (those who received 1 day or more of intensive treatment or treatment deferral). This study is registered with ClinicalTrials.gov, number NCT01540383. We randomly assigned 158 patients between April 1, 2012, and May 31, 2014. The modified intention-to-treat population comprised 156 patients (78 per group). Verbal communication was significantly improved from baseline to after intensive speech and language treatment (mean difference 2·61 points [SD 4·94]; 95% CI 1·49 to 3·72), but not from baseline to after treatment deferral (-0·03 points [4·04]; -0·94 to 0·88; between-group difference Cohen's d 0·58; p=0·0004). Eight patients had

  17. Effect of an interactive text-messaging service on patient retention during the first year of HIV care in Kenya (WelTel Retain): an open-label, randomised parallel-group study.

    Science.gov (United States)

    van der Kop, Mia Liisa; Muhula, Samuel; Nagide, Patrick I; Thabane, Lehana; Gelmon, Lawrence; Awiti, Patricia Opondo; Abunah, Bonface; Kyomuhangi, Lennie Bazira; Budd, Matthew A; Marra, Carlo; Patel, Anik; Karanja, Sarah; Ojakaa, David I; Mills, Edward J; Ekström, Anna Mia; Lester, Richard Todd

    2018-03-01

    Retention of patients in HIV care is crucial to ensure timely treatment