探索PRIME-帕金森病护理方案是如何实施的，以及它是否、如何以及为何会产生变化，针对哪些人群以及在何种条件下产生变化：一项在英国PRIME随机对照试验中进行嵌入式过程评估的方案。

Exploring how PRIME-Parkinson care is implemented and whether, how and why it produces change, for who and under what conditions: a protocol for an embedded process evaluation within the PRIME-UK randomised controlled trial.

作者信息

Lloyd Katherine, Tenison Emma, Smith Safi, Lithander Fiona, Kidger Judi, Brant Heather, Redwood Sabi, Ben-Shlomo Yoav, Henderson Emily J

机构信息

Ageing and Movement Research Group, Population Health Sciences, University of Bristol, Bristol, UK

Ageing and Movement Research Group, Population Health Sciences, University of Bristol, Bristol, UK.

出版信息

BMJ Open. 2025 Feb 2;15(1):e086353. doi: 10.1136/bmjopen-2024-086353.

DOI:10.1136/bmjopen-2024-086353

PMID:39894518

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11792278/

Abstract

INTRODUCTION

The PRIME-UK randomised controlled trial (RCT) aims to establish whether a model of care that seeks to be proactive, integrated and empower participants, caregivers and healthcare professionals can improve outcomes in people with parkinsonism. Given that this intervention is novel and complex, understanding whether and how the intervention will be acceptable, implementable, cost-effective and scalable across contexts are key questions beyond that of whether 'it works'. We describe an embedded process evaluation to answer these questions, which aims to support interpretation of the trial results, refinement of the intervention and support future scaling of the PRIME-Parkinson model of care.

METHODS AND ANALYSIS

A mixed-methods approach will be used to collect data across four process evaluation domains: implementation, mechanism of change, acceptability and context. Quantitative data will be collected prospectively from all participants and analysed descriptively with exploratory tests of relationships as power allows. Qualitative data will be collected through semistructured interviews with a purposively sampled subpopulation of participants, caregivers and staff members as well as case studies where relevant. Interview transcripts will be analysed thematically using interpretive qualitative analysis. Synthesis of quantitative and qualitative data will also be performed to draw conclusions.

ETHICS AND DISSEMINATION

The quantitative data will be collected as part of the main PRIME-UK RCT which was been granted NHS REC approval (21/LO/0387) on 27 July 2021. The qualitative data will be collected as part of a substudy, 'PRIME-Qual', which was granted NHS REC approval (21/LO/0388) on 14 July 2021. The mixed-methods process evaluation will be published after the conclusion of the trial in addition to the main trial findings.

TRIAL REGISTRATION NUMBER

NCT05127057.

摘要

引言

英国帕金森病主动式综合照护模式随机对照试验（PRIME-UK RCT）旨在确定一种积极主动、综合全面且能增强参与者、照料者及医疗保健专业人员能力的照护模式是否能改善帕金森综合征患者的治疗效果。鉴于此干预措施新颖且复杂，除了“是否有效”之外，了解该干预措施在不同环境下是否以及如何被接受、是否可实施、是否具有成本效益以及是否可扩展，是关键问题。我们描述了一项嵌入式过程评估以回答这些问题，其目的是支持对试验结果的解读、完善干预措施，并为未来推广PRIME-帕金森病照护模式提供支持。

方法与分析

将采用混合方法收集四个过程评估领域的数据：实施情况、变化机制、可接受性和背景情况。定量数据将前瞻性地收集自所有参与者，并在有足够统计效能时，通过探索性的关系检验进行描述性分析。定性数据将通过对有目的抽样的参与者、照料者和工作人员子群体进行半结构化访谈以及在相关情况下进行案例研究来收集。访谈记录将采用解释性定性分析进行主题分析。还将对定量和定性数据进行综合分析以得出结论。

伦理与传播

定量数据将作为主要的英国PRIME RCT的一部分进行收集，该试验于2021年7月27日获得英国国家医疗服务体系研究伦理委员会（NHS REC）批准（21/LO/0387）。定性数据将作为一项子研究“PRIME-Qual”的一部分进行收集，该子研究于2021年7月14日获得NHS REC批准（21/LO/0388）。除主要试验结果外，混合方法过程评估将在试验结束后发表。