Institute of Health Research, University of Exeter College of Medicine and Health, St Luke's Campus, Heavitree Road, Exeter, Devon, EX1 2LU, UK.
Primary Care Research Group, University of Exeter College of Medicine and Health, Exeter, Devon, EX1 2LU, UK.
BMC Med Res Methodol. 2020 Jul 6;20(1):181. doi: 10.1186/s12874-020-01060-5.
Although there is trial evidence that complex interventions are effective for the self-management of heart failure, little evidence supports their effectiveness in routine practice. We used Social Practice Theory to guide a Type 1 Hybrid Trial: a mixed methods process evaluation of a complex intervention for heart failure. The objective of this paper is to explore the value of Social Practice Theory for implementation science.
Social Practice Theory informed a mixed methods process evaluation of a multi-centre randomised controlled trial of a 12 week home-based intervention to optimise self-care support for people with heart failure and their caregivers - Rehabilitation EnAblement in Chronic Heart Failure (REACH-HF). Interviews were conducted with 19 people with heart failure and 17 caregivers at 4 months and 12 months after recruitment into the trial. Cases were constructed at the level of the individual, couple, facilitator and centre; and included multi-modal process and outcome data. Evaluative coding and subsequent within- and cross-case analyses enabled the development of a typology of relationships linking fidelity of intervention delivery and tailoring of content to individual needs and concerns. Social Practice Theory was used to interrogate the relationships between elements of the intervention and their implementation.
Of 216 trial participants, 107 were randomised to the intervention (REACH-HF plus usual care). The intervention was most effective when fidelity was high and delivery was tailored to the individual's needs, but less effective when both tailoring and fidelity were low. Theory-based analysis enabled us to model complex relationships between intervention elements (competencies, materials and meanings) and social context. The findings illustrate how intervention fidelity and tailoring are contextual and how the effectiveness of the REACH-HF intervention depended on both optimal alignment and implementation of these elements.
The study demonstrates the utility of theory-based analysis which integrates data from multiple sources to highlight contexts and circumstances in which interventions work best. Social Practice Theory provides a framework for guiding and analysing the processes by which a complex intervention is evaluated in a clinical trial, and has the potential to guide context-specific implementation strategies for clinical practice.
ISRCTN, IISRCTN86234930 . Registered 13th November 2014.
尽管有试验证据表明，复杂干预措施对于心力衰竭的自我管理是有效的，但很少有证据支持其在常规实践中的有效性。我们使用社会实践理论来指导 1 型混合试验：对心力衰竭复杂干预措施的混合方法过程评估。本文的目的是探讨社会实践理论在实施科学中的价值。
社会实践理论为一项多中心随机对照试验的混合方法过程评估提供了信息，该试验对一项为期 12 周的家庭干预措施进行了评估，旨在优化心力衰竭患者及其照顾者的自我护理支持 - 慢性心力衰竭康复赋能（REACH-HF）。在试验招募后 4 个月和 12 个月，对 19 名心力衰竭患者和 17 名照顾者进行了访谈。案例在个人、夫妻、促进者和中心层面构建；并包括多模式的过程和结果数据。评估性编码和随后的案例内和跨案例分析使我们能够开发一种类型学，将干预交付的保真度和内容定制与个人需求和关注点联系起来。社会实践理论被用于探究干预措施要素与其实施之间的关系。
在 216 名试验参与者中，有 107 人被随机分配到干预组（REACH-HF 加常规护理）。当保真度高且交付符合个人需求时，干预效果最佳，但当定制和保真度都低时，效果较差。基于理论的分析使我们能够模拟干预措施要素（能力、材料和意义）与社会背景之间的复杂关系。研究结果说明了干预保真度和定制如何具有情境性，以及 REACH-HF 干预措施的有效性取决于这些要素的最佳对齐和实施。
该研究证明了基于理论的分析具有实用性，这种分析将来自多个来源的数据整合在一起，突出了干预措施效果最佳的背景和情况。社会实践理论为指导和分析复杂干预措施在临床试验中的评估过程提供了框架，并有可能为临床实践中的特定情境实施策略提供指导。
ISRCTN，IISRCTN86234930。于 2014 年 11 月 13 日注册。
