Multi-centre cluster randomised trial comparing a community group exercise programme with home based exercise with usual care for people aged 65 and over in primary care: protocol of the ProAct 65+ trial

BackgroundRegular physical activity (PA) reduces the risk of falls and hip fractures, and mortality from all causes. However, PA levels are low in the older population and previous intervention studies have demonstrated only modest, short-term improvements.ObjectiveTo evaluate the impact of two exercise promotion programmes on PA in people aged ≥ 65 years.DesignThe ProAct65+ study was a pragmatic, three-arm parallel design, cluster randomised controlled trial of class-based exercise [Falls Management Exercise (FaME) programme], home-based exercise [Otago Exercise Programme (OEP)] and usual care among older people (aged ≥ 65 years) in primary care.SettingForty-three UK-based general practices in London and Nottingham/Derby.ParticipantsA total of 1256 people ≥ 65 years were recruited through their general practices to take part in the trial.InterventionsThe FaME programme and OEP. FaME included weekly classes plus home exercises for 24 weeks and encouraged walking. OEP included home exercises supported by peer mentors (PMs) for 24 weeks, and encouraged walking.Main outcome measuresThe primary outcome was the proportion that reported reaching the recommended PA target of 150 minutes of moderate to vigorous physical activity (MVPA) per week, 12 months after cessation of the intervention. Secondary outcomes included functional assessments of balance and falls risk, the incidence of falls, fear of falling, quality of life, social networks and self-efficacy. An economic evaluation including participant and NHS costs was embedded in the clinical trial.ResultsIn total, 20,507 patients from 43 general practices were invited to participate. Expressions of interest were received from 2752 (13%) and 1256 (6%) consented to join the trial; 387 were allocated to the FaME arm, 411 to the OEP arm and 458 to usual care. Primary outcome data were available at 12 months after the end of the intervention period for 830 (66%) of the study participants.The proportions reporting at least 150 minutes of MVPA per week rose between baseline and 12 months after the intervention from 40% to 49% in the FaME arm, from 41% to 43% in the OEP arm and from 37.5% to 38.0% in the usual-care arm. A significantly higher proportion in the FaME arm than in the usual-care arm reported at least 150 minutes of MVPA per week at 12 months after the intervention [adjusted odds ratio (AOR) 1.78, 95% confidence interval (CI) 1.11 to 2.87;p = 0.02]. There was no significant difference in MVPA between OEP and usual care (AOR 1.17, 95% CI 0.72 to 1.92;p = 0.52). Participants in the FaME arm added around 15 minutes of MVPA per day to their baseline physical activity level. In the 12 months after the close of the intervention phase, there was a statistically significant reduction in falls rate in the FaME arm compared with the usual-care arm (incidence rate ratio 0.74, 95% CI 0.55 to 0.99;p = 0.042). Scores on the Physical Activity Scale for the Elderly showed a small but statistically significant benefit for FaME compared with usual care, as did perceptions of benefits from exercise. Balance confidence was significantly improved at 12 months post intervention in both arms compared with the usual-care arm. There were no statistically significant differences between intervention arms and the usual-care arm in other secondary outcomes, including quality-adjusted life-years. FaME is more expensive than OEP delivered with PMs (£269 vs. £88 per participant in London; £218 vs. £117 in Nottingham). The cost per extra person exercising at, or above, target was £1919.64 in London and £1560.21 in Nottingham (mean £1739.93).ConclusionThe FaME intervention increased self-reported PA levels among community-dwelling older adults 12 months after the intervention, and significantly reduced falls. Both the FaME and OEP interventions appeared to be safe, with no significant differences in adverse reactions between study arms.Trial registrationThis trial is registered as ISRCTN43453770.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 18, No. 49. See the NIHR Journals Library website for further project information.

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Cost-effectiveness of a patient-centred approach to managing multimorbidity in primary care: a pragmatic cluster randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-030110 ◽

2020 ◽

Vol 10 (1) ◽

pp. e030110 ◽

Cited By ~ 1

Author(s):

Joanna Thorn ◽

Mei-See Man ◽

Katherine Chaplin ◽

Peter Bower ◽

Sara Brookes ◽

...

Keyword(s):

Primary Care ◽

Economic Evaluation ◽

Cost Effectiveness ◽

Usual Care ◽

Randomised Trial ◽

Mean Difference ◽

Secondary Outcome ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

The Cost

ObjectivePatients with multiple chronic health conditions are often managed in a disjointed fashion in primary care, with annual review clinic appointments offered separately for each condition. This study aimed to determine the cost-effectiveness of the 3D intervention, which was developed to improve the system of care.DesignEconomic evaluation conducted alongside a pragmatic cluster-randomised trial.SettingGeneral practices in three centres in England and Scotland.Participants797 adults with three or more chronic conditions were randomised to the 3D intervention, while 749 participants were randomised to receive usual care.InterventionThe 3D approach: comprehensive 6-monthly general practitioner consultations, supported by medication reviews and nurse appointments.Primary and secondary outcome measuresThe primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the National Health Service (NHS) and personal social services (PSS). Costs were related to changes in a range of secondary outcomes (QALYs accrued by both participants and carers, and deaths) in a cost–consequences analysis from the perspectives of the NHS/PSS, patients/carers and productivity losses.ResultsVery small increases were found in both QALYs (adjusted mean difference 0.007 (−0.009 to 0.023)) and costs (adjusted mean difference £126 (£−739 to £991)) in the intervention arm compared with usual care after 15 months. The incremental cost-effectiveness ratio was £18 499, with a 50.8% chance of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY (55.8% at £30 000 per QALY).ConclusionsThe small differences in costs and outcomes were consistent with chance, and the uncertainty was substantial; therefore, the evidence for the cost-effectiveness of the 3D approach from the NHS/PSS perspective should be considered equivocal.Trial registration numberISCRTN06180958

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Impact of patient education on chronic heart failure in primary care (ETIC): a cluster randomised trial

BMC Family Practice ◽

10.1186/s12875-016-0473-4 ◽

2016 ◽

Vol 17 (1) ◽

Cited By ~ 8

Author(s):

Hélène Vaillant-Roussel ◽

Catherine Laporte ◽

Bruno Pereira ◽

Marion De Rosa ◽

Bénédicte Eschalier ◽

...

Keyword(s):

Heart Failure ◽

Primary Care ◽

Chronic Heart Failure ◽

Patient Education ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Cluster Randomised

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Electronically delivered, multicomponent intervention to reduce unnecessary antibiotic prescribing for respiratory infections in primary care: a cluster randomised trial using electronic health records—REDUCE Trial study original protocol

BMJ Open ◽

10.1136/bmjopen-2015-010892 ◽

2016 ◽

Vol 6 (8) ◽

pp. e010892 ◽

Cited By ~ 8

Author(s):

Dorota Juszczyk ◽

Judith Charlton ◽

Lisa McDermott ◽

Jamie Soames ◽

Kirin Sultana ◽

...

Keyword(s):

Primary Care ◽

Electronic Health Records ◽

Respiratory Infections ◽

Randomised Trial ◽

Cluster Randomised Trial ◽

Antibiotic Prescribing ◽

Health Records ◽

Multicomponent Intervention ◽

Cluster Randomised ◽

Electronically Delivered

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Using mHealth tools to improve access, coverage and treatment of uninsured people with high cardiovascular disease risk in Argentina: a study protocol for a pragmatic cluster randomised trial

BMJ Innovations ◽

10.1136/bmjinnov-2017-000255 ◽

2018 ◽

Vol 4 (3) ◽

pp. 135-141 ◽

Cited By ~ 2

Author(s):

Shafika Abrahams-Gessel ◽

Andrea Beratarrechea ◽

Vilma Irazola ◽

Laura Gutierrez ◽

Daniela Moyano ◽

...

Keyword(s):

Cardiovascular Disease ◽

Primary Care ◽

High Risk ◽

Randomised Trial ◽

Text Messages ◽

Cluster Randomised Trial ◽

Cvd Risk ◽

High Risk Patients ◽

Cluster Randomised ◽

Risk Patients

IntroductionCardiovascular disease (CVD) accounts for approximately one-third of Argentina’s deaths. Despite government provision of free primary care health services to the uninsured population, with a focus on non-communicable diseases, screening and management of those with high CVD risk at primary care clinics (PCCs) remain low.Methods and analysisThis pragmatic cluster randomised trial will take place in two provinces of Argentina and will recruit 740 participants. Eight PCCs will be randomised to either the intervention or current practice arm. Community health workers (CHWs) in the intervention arm will be trained to use a set of integrated mHealth tools (a validated risk screening tool mobile application; electronic scheduling system using wireless access to PCCs; and educational text messages) to screen for CVD and to schedule appointments with primary care providers for persons with high CVD risk (≥10%). The primary aims of this study are to determine if the use of mHealth tools will (1) increase attendance of first appointments scheduled by CHWs for persons determined to have high risk for CVD during screening and, (2) lead to an increase in follow-up visits at PCCs by high risk patients. Secondary outcomes include assessing the proportion of high-risk patients receiving appropriate medications and a cost-effective analysis of the intervention.Ethics and disseminationThis study has been approved by the Institutional Review Boards at Partners/Brigham and Women’s Hospital (USA) and the Hospital Italiano de Buenos Aires (Argentina). The open-source software for the mHealth tools will be made publicly available at the end of the study.Trial registration numberNCT02913339.

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Clinical effectiveness of health visitor training in psychologically informed approaches for depression in postnatal women: pragmatic cluster randomised trial in primary care

BMJ ◽

10.1136/bmj.a3045 ◽

2009 ◽

Vol 338 (jan15 2) ◽

pp. a3045-a3045 ◽

Cited By ~ 116

Author(s):

C J. Morrell ◽

P. Slade ◽

R. Warner ◽

G. Paley ◽

S. Dixon ◽

...

Keyword(s):

Primary Care ◽

Randomised Trial ◽

Clinical Effectiveness ◽

Health Visitor ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Postnatal Women

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Understanding usual care for patients with multimorbidity: baseline data from a cluster-randomised trial of the 3D intervention in primary care

BMJ Open ◽

10.1136/bmjopen-2017-019845 ◽

2018 ◽

Vol 8 (8) ◽

pp. e019845 ◽

Cited By ~ 7

Author(s):

Katherine Chaplin ◽

Peter Bower ◽

Mei-See Man ◽

Sara T Brookes ◽

Daisy Gaunt ◽

...

Keyword(s):

Primary Care ◽

Usual Care ◽

External Validity ◽

Randomised Trial ◽

Baseline Data ◽

Secondary Outcome ◽

Treatment Burden ◽

Practice Staff ◽

Illness Burden ◽

Cluster Randomised

ObjectivesRecent evidence has highlighted the high prevalence and impact of multimorbidity, but the evidence base for improving management is limited. We have tested a new complex intervention for multimorbidity (the 3D model). The paper describes the baseline characteristics of practices and patients in order to establish the external validity of trial participants. It also explores current ‘usual primary care’ for multimorbidity, against which the 3D intervention was tested.DesignAnalysis of baseline data from patients in a cluster-randomised controlled trial and additional data from practice staff.SettingPrimary care in the UK.ParticipantsPatients with multimorbidity (n=5253) and 154 practice staff.Primary and secondary outcome measuresUsing surveys and routinely available data, we compared the characteristics of participating and non-participating practices and participating and non-participating eligible patients.Baseline questionnaire data from patient participants was used to examine participant illness burden, treatment burden and perceptions of receiving patient-centred care. We obtained data about usual care preintervention from practice staff using questionnaires and a structured pro forma.ResultsParticipating practices were slightly larger, in less deprived areas, and with slightly higher scores for patient satisfaction compared with non-participating practices. Patients with dementia or learning difficulties were likely to be excluded by their general practitioners, but comparison of participants with non-participants identified only minor differences in characteristics, suggesting that the sample was otherwise representative. Patients reported substantial illness burden, and an important minority reported high treatment burden. Although patients reported relatively high levels of satisfaction with care, many reported not having received potentially important components of care.ConclusionThis trial achieved good levels of external validity. Although patients were generally satisfied with primary care services, there was significant room for improvement in important aspects of care for multimorbidity that are targeted by the 3D intervention.Trial registration numberISRCTN06180958; Post-results.

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Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Café Study)

10.21203/rs.2.328/v1 ◽

2019 ◽

Author(s):

Jeanette Trøstrup ◽

Lone Ramer Mikkelsen ◽

Poul Frost ◽

Annett Dalbøge ◽

Mette Terp Høybye ◽

...

Keyword(s):

Usual Care ◽

Mixed Model ◽

Exercise Intervention ◽

Randomised Trial ◽

Self Report ◽

Controlled Study ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

First Choice ◽

Randomised Controlled

Abstract Background: In Denmark, exercise therapy in combination with work modifications is the first choice treatment for persons with shoulder complaints and high occupational shoulder exposures. To obtain this treatment they must visit several healthcare providers, which makes usual care fragmented and uncoordinated. Therefore, we developed a new intervention which unifies the expertise that is needed. The main hypotheses are that a group-based Shoulder-Café intervention will reduce (I) shoulder complaints and (II) occupational shoulder exposures more effectively than an individual-based Shoulder-Guidance intervention (active control – enhanced usual care). Methods: A cluster-randomised trial is conducted including 120 employees with high occupational shoulder exposures. Companies (clusters) are randomised to either Shoulder-Café or Shoulder-Guidance with a 1:1 allocation ratio. Participants are 18–65 years old and have an Oxford Shoulder Score (OSS) ≤ 40. Both interventions include a home-based shoulder exercise programme, assessment of shoulder exposures by technical measurements and self-report, and general information on how to reduce shoulder exposures. The Shoulder-Café course also includes three café meetings with physiotherapist-supervised exercises, clinical shoulder evaluation, education on shoulder anatomy, workplace-oriented counselling, and an opportunity for a workplace visit by a health and safety consultant. The primary outcomes are the OSS at 6 month follow-up (hypothesis I), and the mean number of minutes/day with the arm elevated > 60° shortly after end of intervention (hypothesis II). We will use mixed model analysis that allows for company clustering, and data will be analysed according to the intention-to-treat principle. Discussion: Persons with shoulder complaints and high occupational shoulder exposures are an obvious target group for secondary prevention efforts. We developed the Shoulder-Café to reduce shoulder complaints and shoulder exposures while unifying the expertise that is needed to evaluate and treat shoulder complaints. If the intervention is effective, it would warrant widespread implementation. Trial registration: The trial was registered at Clinicaltrials.gov on 18 May 2017 (ID: NCT03159910). Keywords: Exercise, Intervention, Mechanical exposure, Occupation, Randomised controlled trial, Shoulder, Training programme.

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