Aquino Maria Raisa Jessica Ryc, Mullis Ricky, Kreit Elizabeth, Johnson Vicki, Grant Julie, Lim Lisa, Sutton Stephen, Mant Jonathan
Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.
BMJ Open. 2020 Jul 8;10(7):e036879. doi: 10.1136/bmjopen-2020-036879.
Primary care interventions are often multicomponent, with several targets (eg, patients and healthcare professionals). Improving Primary Care After Stroke (IPCAS) is a novel primary care-based model of long-term stroke care involving a review of stroke-related needs, a self-management programme, a direct point of contact in general practice, enhanced communication between care services, and a directory of national and local community services, currently being evaluated in a cluster randomised controlled trial (RCT). Informed by Medical Research Council guidance for complex interventions and the Behaviour Change Consortium fidelity framework, this protocol outlines the process evaluation of IPCAS within this RCT. The process evaluation aimed to explore how the intervention was delivered in context and how participants engaged with the intervention.
Mixed methods will be used: (1) design: intervention content will be compared with 'usual care'; (2) training: intervention training sessions will be audio/video-recorded where feasible; (3) delivery: healthcare professional self-reports, audio recordings of intervention delivery and observations of My Life After Stroke course (10% of reviews and sessions) will be coded separately; semistructured interviews will be conducted with a purposive sample of healthcare professionals; (4) receipt and (5) enactment: where available, structured stroke review records will be analysed quantitatively; semistructured interviews will be conducted with a purposive sample of study participants. Self-reports, observations and audio/video recordings will be coded and scored using specifically developed checklists. Semistructured interviews will be analysed thematically. Data will be analysed iteratively, independent of primary endpoint analysis.
Favourable ethical opinion was gained from Yorkshire & The Humber-Bradford Leeds NHS Research Ethics Committee (19 December 2017, 17/YH/0441). Study results will be published in a peer-reviewed journal and presented at relevant conferences.
NCT03353519; Pre-results.
初级保健干预措施通常包含多个组成部分，有多个目标对象（例如患者和医疗保健专业人员）。卒中后改善初级保健（IPCAS）是一种新型的基于初级保健的长期卒中护理模式，包括对卒中相关需求的评估、自我管理计划、全科医疗中的直接联系点、护理服务之间加强沟通以及国家和地方社区服务目录，目前正在一项整群随机对照试验（RCT）中进行评估。本方案依据医学研究理事会关于复杂干预措施的指南以及行为改变联盟的保真度框架，概述了该RCT中IPCAS的过程评估。过程评估旨在探究干预措施在实际情境中的实施方式以及参与者对干预措施的参与情况。
将采用混合方法：（1）设计：将干预内容与“常规护理”进行比较；（2）培训：可行的情况下，对干预培训课程进行音频/视频录制；（3）实施：医疗保健专业人员的自我报告、干预实施的音频记录以及对“卒中后我的生活”课程（10%的评估和课程）的观察将分别进行编码；将对有目的抽样的医疗保健专业人员进行半结构化访谈；（4）接受情况和（5）实施情况：如有可用的结构化卒中评估记录，将进行定量分析；将对有目的抽样的研究参与者进行半结构化访谈。自我报告、观察结果以及音频/视频记录将使用专门制定的清单进行编码和评分。半结构化访谈将进行主题分析。数据将独立于主要终点分析进行迭代分析。
获得了约克郡和亨伯-布拉德福德利兹国民保健服务研究伦理委员会的有利伦理意见（2017年12月19日，17/YH/0441）。研究结果将发表在同行评审期刊上，并在相关会议上展示。
NCT03353519；预结果。
