Waste the Waist: Pilot study for a randomised controlled trial of a pragmatic, primary care based intervention to support lifestyle change in the management of high cardiovascular risk

2013 ◽  
Author(s):  
Rachel Perry
Keyword(s):  
Primary Care ◽  
Cardiovascular Risk ◽  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Lifestyle Change ◽  
High Cardiovascular Risk ◽  
Randomised Controlled

scholarly journals The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: A protocol for a cross-border pilot cluster randomised controlled trial

2021 ◽  
Author(s):  
Lisa Hynes ◽  
Andrew W Murphy ◽  
Nigel Hart ◽  
Collette Kirwan ◽  
Sarah Mulligan ◽  
...  
Keyword(s):  
Primary Care ◽  
Decision Making ◽  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Medication Reviews ◽  
Randomised Controlled

AbstractBackgroundWhile international guidelines recommend medication reviews as part of the management of multimorbidity, evidence on how to implement reviews in practice in primary care is lacking. The MyComrade (MultimorbiditY Collaborative Medication Review And Decision Making) intervention is an evidence-based, theoretically-informed novel intervention which aims to support the conduct of medication reviews for patients with multimorbidity in primary care. Our aim in this pilot study is to evaluate the feasibility of a trial of the intervention with unique modifications accounting for contextual variations in two neighbouring health systems (Republic of Ireland (ROI) and Northern Ireland (NI)).MethodsA pilot cluster randomised controlled trial will be conducted, using a mixed methods process evaluation to investigate the feasibility of a trial of the MyComrade intervention. A total of 16 practices will be recruited (eight in ROI; eight in NI) and four practices in each jurisdiction will be randomly allocated to intervention or control. Twenty people living with multimorbidity and prescribed ≥10 repeat medications will be recruited from each practice prior to practice randomisation. In intervention practices, the MyComrade intervention will be delivered by pairs of GPs in ROI, and a GP and Practice Based Pharmacist (PBP) in NI. The GPs/GP and PBP will schedule time to review medications together using a checklist. Usual care will proceed in practices in the control arm. Data will be collected via electronic health records and postal questionnaires at recruitment, and 4- and 8-months after randomisation. Qualitative interviews to assess the feasibility and acceptability of the intervention, and explore experiences related to multimorbidity management will be conducted with a purposive sample of GPs, PBPs, practice administration staff and patients in intervention and control practices. The feasibility of conducting a health economic evaluation as part of a future definitive trial will be assessed.DiscussionThe findings of this pilot study will assess the feasibility of a trial of the MyComrade intervention in two different health systems. Evaluation of the progression criteria will guide the decision to progress to a definitive trial and inform trial design. The findings will also contribute to the growing evidence-base related to intervention development and feasibility studies.Trial registrationRegistry: ISRCTN, ISRCTN80017020; Date of confirmation 4/11/2019; Retrospectively registered; http://www.isrctn.com/ISRCTN80017020.

scholarly journals Primary care-based link workers providing social prescribing to improve health and social care outcomes for people with multimorbidity in socially deprived areas (the LinkMM trial): Pilot study for a pragmatic randomised controlled trial

2021 ◽  
Vol 11 ◽  
pp. 263355652110177
Author(s):  
Bridget Kiely ◽  
Deirdre Connolly ◽  
Barbara Clyne ◽  
Fiona Boland ◽  
Patrick O’Donnell ◽  
...  
Keyword(s):  
Primary Care ◽  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Selection Process ◽  
Controlled Trial ◽  
Social Prescribing ◽  
Psychosocial Need ◽  
Randomised Controlled ◽  
Improve Health ◽  
Deprived Areas

Introduction: Individuals with multimorbidity in deprived areas experience worse health outcomes and fragmented care. Research suggests that primary care-based link workers providing social prescribing have potential to improve health and well-being. This paper reports the results of a pilot study conducted in preparation for a randomised controlled trial (RCT) that aims to test the effectiveness of primary care-based link workers providing social prescribing in improving health outcomes for people with multimorbidity who attend general practices in deprived areas in Ireland. Methods: An uncontrolled pilot study of an intervention based on the Glasgow Deep End links worker programme, in a single general practice, tested the feasibility and acceptability of planned processes for a RCT. Outcomes were recruitment and retention rates and acceptability of the trial processes and intervention to patients, general practitioners (GPs) and the link worker. Structured interviews were conducted with six patients, the link worker and two GPs within the practice and analysed using descriptive qualitative analysis. Feedback from a Public Patient Involvement group and an Implementation Advisory Group of key stakeholders was incorporated into the evaluation process. Results: Twelve out of 14 patients completed the intervention. Selection and recruitment processes were lengthier than expected. GPs recommended including psychosocial need in the selection process. Interviewed patients, the GPs and the link worker were positive about the intervention. Conclusion: A range of adaptations were identified for the main trial, mainly considering psychosocial need in the selection process to reflect normal referral pathways. This has resulted in a pragmatic RCT design.

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