Health Services Research and Development Center of Innovation, Durham VA Health Care System, Durham, NC, USA.
Department of Population Health Sciences, Duke University School of Medicine, Durham, NC, USA.
BMC Health Serv Res. 2022 Jul 29;22(1):968. doi: 10.1186/s12913-022-08270-1.
Clinical interventions often need to be adapted from their original design when they are applied to new settings. There is a growing literature describing frameworks and approaches to deploying and documenting adaptations of evidence-based practices in healthcare. Still, intervention modifications are often limited in detail and justification, which may prevent rigorous evaluation of interventions and intervention adaptation effectiveness in new contexts. We describe our approach in a case study, combining two complementary intervention adaptation frameworks to modify CONNECT for Quality, a provider-facing team building and communication intervention designed to facilitate implementation of a new clinical program.
This process of intervention adaptation involved the use of the Planned Adaptation Framework and the Framework for Reporting Adaptations and Modifications, for systematically identifying key drivers, core and non-core components of interventions for documenting planned and unplanned changes to intervention design.
The CONNECT intervention's original context and setting is first described and then compared with its new application. This lays the groundwork for the intentional modifications to intervention design, which are developed before intervention delivery to participating providers. The unpredictable nature of implementation in real-world practice required unplanned adaptations, which were also considered and documented. Attendance and participation rates were examined and qualitative assessment of reported participant experience supported the feasibility and acceptability of adaptations of the original CONNECT intervention in a new clinical context.
This approach may serve as a useful guide for intervention implementation efforts applied in diverse clinical contexts and subsequent evaluations of intervention effectiveness.
The study was registered at ClinicalTrials.gov ( NCT03300336 ) on September 28, 2017.
临床干预措施在应用于新环境时，通常需要从原始设计进行调整。越来越多的文献描述了在医疗保健中部署和记录基于证据的实践调整的框架和方法。尽管如此，干预措施的修改通常在细节和理由上受到限制，这可能会妨碍对新环境中的干预措施和干预措施调整效果进行严格评估。我们通过案例研究描述了我们的方法，将两种互补的干预措施调整框架相结合，对 CONNECT for Quality 进行了调整，这是一种面向提供者的团队建设和沟通干预措施，旨在促进新临床项目的实施。
干预措施调整的过程涉及使用计划调整框架和调整和修改框架，以系统地确定干预措施的关键驱动因素、核心和非核心组件，用于记录干预设计的计划和非计划变更。
首先描述 CONNECT 干预措施的原始背景和环境，然后将其与新应用进行比较。这为干预设计的有意修改奠定了基础，这些修改是在向参与提供者提供干预措施之前制定的。实际实践中实施的不可预测性需要进行无计划的调整，这些调整也得到了考虑和记录。检查了出勤率和参与率，并对报告的参与者体验进行了定性评估，支持了在新临床环境中对原始 CONNECT 干预措施进行适应性调整的可行性和可接受性。
这种方法可以为在不同临床环境中应用的干预措施实施工作以及随后对干预措施效果的评估提供有用的指导。
该研究于 2017 年 9 月 28 日在 ClinicalTrials.gov（NCT03300336）注册。
