Stroke Early Supported Discharge (ESD) is a service innovation that facilitates discharge from hospital and delivery of specialist rehabilitation in patients’ homes. There is currently widespread implementation of ESD services in many countries, driven by robust clinical trial evidence. In England, the type of ESD service patients receive on the ground is variable, and in some regions, ESD is still not offered at all. This protocol presents a study designed to investigate the mechanisms and outcomes of implementing ESD at scale in real-world conditions. This will help to establish which models of ESD are most effective and in what context. A realist evaluation approach composed of two interlinking work packages will be adopted to investigate how and why ESD works, for whom and in what circumstances. Work package 1 (WP1) will begin with a rapid evidence synthesis to formulate preliminary realist hypotheses. Quantitative analyses of historical prospective Sentinel Stroke National Audit Programme (SSNAP) data will be performed to evaluate service outcomes based on the degree to which evidence-based ESD has been implemented. Work package 2 (WP2) will involve the qualitative investigation of purposively selected case study sites featuring in WP1 and covering different regions in England. The perspectives of clinicians, managers, commissioners, and service users will be explored qualitatively. Cost implications of ESD models will be examined using a cost-consequence analysis. Cross-case comparisons and triangulation of the data sources from both work packages will be performed to test, revise, and refine initial programme theories and address research aims. This study will investigate whether and how current large-scale implementation of ESD is achieving the outcomes suggested by the evidence base. The theory-driven evaluation approach will highlight key mechanisms and contextual conditions necessary to optimise outcomes and allow us to draw transferable lessons to inform the effective implementation and sustainability of ESD in clinical practice. In addition, the methodological framework will progress the theoretical understanding of implementation and evaluation of complex rehabilitation interventions in stroke care. ISRCTN: 15568163, registration date: 26 October 2018.

中文翻译：

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大规模实施脑卒中早期支持出院有何影响？混合方法现实主义评估研究方案


中风早期支持出院 (ESD) 是一项服务创新，有助于患者出院并在家中接受专科康复治疗。目前，在强有力的临床试验证据的推动下，许多国家广泛实施了 ESD 服务。在英格兰，患者在当地接受的 ESD 服务类型各不相同，并且在某些地区，仍然根本不提供 ESD。该协议提出了一项研究，旨在调查在现实条件下大规模实施 ESD 的机制和结果。这将有助于确定哪些 ESD 模型最有效以及在什么情况下最有效。将采用由两个相互关联的工作包组成的现实主义评估方法来研究静电放电如何以及为什么起作用，对谁以及在什么情况下起作用。工作包 1 (WP1) 将从快速证据综合开始，以制定初步的现实主义假设。将对前哨哨兵国家审计计划 (SSNAP) 的历史前瞻性数据进行定量分析，以根据基于证据的 ESD 实施程度来评估服务结果。工作包 2 (WP2) 将涉及对 WP1 中特意选择的案例研究地点进行定性调查，涵盖英格兰的不同地区。将定性地探讨临床医生、管理者、专员和服务使用者的观点。将使用成本后果分析来检查 ESD 模型的成本影响。将对两个工作包的数据源进行跨案例比较和三角测量，以测试、修改和完善初始计划理论并解决研究目标。 本研究将调查当前大规模实施的可持续发展教育是否以及如何实现证据基础建议的结果。理论驱动的评估方法将突出优化结果所需的关键机制和背景条件，并使我们能够吸取可转移的经验教训，为临床实践中 ESD 的有效实施和可持续性提供信息。此外，该方法框架将增进对中风护理中复杂康复干预措施的实施和评估的理论理解。 ISRCTN：15568163，注册日期：2018年10月26日。