多病症协作药物审查与决策制定（MyComrade）研究：一项跨境试点整群随机对照试验方案
The MultimorbiditY COllaborative Medication Review And DEcision Making (MyComrade) study: a protocol for a cross-border pilot cluster randomised controlled trial.
作者信息
Hynes Lisa, Murphy Andrew W, Hart Nigel, Kirwan Collette, Mulligan Sarah, Leathem Claire, McQuillan Laura, Maxwell Marina, Carr Emma, Walkin Scott, McCarthy Caroline, Bradley Colin, Byrne Molly, Smith Susan M, Hughes Carmel, Corry Maura, Kearney Patricia M, McCarthy Geraldine, Cupples Margaret, Gillespie Paddy, Newell John, Glynn Liam, Alvarez-Iglesias Alberto, Sinnott Carol
机构信息
Health Research Board Primary Care Clinical Trials Network Ireland, National University of Ireland, Galway, Ireland.
School of Medicine, Dentistry & Biomedical Sciences, Queen's University, Belfast, Northern Ireland.
出版信息
Pilot Feasibility Stud. 2022 Mar 28;8(1):73. doi: 10.1186/s40814-022-01018-y.
BACKGROUND
While 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 MultimorbiditY Collaborative Medication Review And Decision Making (MyComrade) 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)).
METHODS
A 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 based on pre-defined progression criteria. 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 general practitioners (GPs) in ROI, and a GP and practice-based pharmacist (PBP) in NI. The GPs/GP and PBP will schedule the time to review the 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.
DISCUSSION
The 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 REGISTRATION
ISRCTN Registry, ISRCTN80017020 . Date of confirmation is 4/11/2019.
背景
虽然国际指南推荐将药物审查作为多重疾病管理的一部分，但在初级保健实践中如何实施审查的证据仍然不足。多重疾病协作药物审查与决策（MyComrade）干预措施是一种基于证据、理论完善的新型干预措施，旨在支持在初级保健中对多重疾病患者进行药物审查。我们在这项试点研究中的目的是评估对该干预措施进行试验的可行性，该试验有独特的调整，考虑到两个相邻卫生系统（爱尔兰共和国（ROI）和北爱尔兰（NI））的背景差异。
方法
将进行一项试点整群随机对照试验，采用混合方法进行过程评估，根据预先确定的进展标准调查MyComrade干预措施试验的可行性。总共将招募16家医疗机构（ROI地区8家；NI地区8家），每个管辖区的4家医疗机构将被随机分配到干预组或对照组。在医疗机构随机分组之前，将从每家医疗机构招募20名患有多重疾病且开具了≥10种重复用药处方的患者。在干预组医疗机构中，ROI地区由一对全科医生（GP）实施MyComrade干预措施，NI地区由一名全科医生和一名驻点药剂师（PBP）实施。全科医生/全科医生和驻点药剂师将使用检查表安排共同审查药物的时间。对照组医疗机构将继续常规护理。将通过电子健康记录和邮政问卷在招募时以及随机分组后4个月和8个月收集数据。将对干预组和对照组的全科医生、驻点药剂师、医疗机构管理人员和患者进行有目的抽样的定性访谈，以评估干预措施的可行性和可接受性，并探索与多重疾病管理相关的经验。将评估作为未来确定性试验一部分进行卫生经济评估的可行性。
讨论
这项试点研究的结果将评估在两个不同卫生系统中对MyComrade干预措施进行试验的可行性。对进展标准的评估将指导是否推进到确定性试验的决策，并为试验设计提供信息。研究结果还将为与干预措施开发和可行性研究相关的不断增长的证据库做出贡献。
试验注册
ISRCTN注册库，ISRCTN80017020。确认日期为2019年11月4日。
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