Clayton Jordana L, Utz Rebecca L, Aruscavage Nancy, Bybee Sara G, Bigger Sharon E, Iacob Eli, Dassel Kara B
College of Social and Behavioral Sciences, University of Utah, Carolyn and Kem Gardner Commons Suite 3725, 260 S Central Campus Dr, Salt Lake City, UT, 84112, USA.
College of Nursing, University of Utah, 10 South 2000 East, Salt Lake City, UT, 84112, USA.
Contemp Clin Trials Commun. 2024 Nov 26;42:101398. doi: 10.1016/j.conctc.2024.101398. eCollection 2024 Dec.
Community engagement is increasingly considered a key component of intervention development, as it can leverage community members' knowledge, experiences, and insights to create a nuanced intervention which meets the needs, preferences, and realities of the population of interest. Community engagement exists along a spectrum from outreach to the community to partnership with community members and organizations, and all levels of community engagement can benefit from systematic documentation of community feedback and decision-making processes. This paper demonstrates how we utilized the "Framework for Reporting Adaptations and Modifications to Evidence-based Interventions" (FRAME; Wiltsey Stirman et al., 2019) model to track and report adaptations to our dementia end-of-life care planning intervention based on community engagement via a project-specific Community Advisory Board (CAB). Using FRAME, we generated a comprehensive report of the iterative changes made to our pilot intervention, including whether the change was planned, who made the decision to modify the intervention, the nature of the change, its relationship to intervention fidelity, and the reason for the change. This process ensured that we effectively integrated feedback and assistance from our CAB, increased the appropriateness of our intervention for our population of interest, established criteria to monitor intervention fidelity, and prepared our team to run a rigorous clinical trial of the revised intervention. Clinical Trial Registration Number: NCT05909189.
社区参与日益被视为干预措施开发的关键组成部分，因为它可以利用社区成员的知识、经验和见解，来创建一个细致入微的干预措施，以满足目标人群的需求、偏好和实际情况。社区参与涵盖了从向社区宣传到与社区成员及组织建立伙伴关系的一系列活动，而且所有层面的社区参与都能从对社区反馈和决策过程的系统记录中受益。本文展示了我们如何利用“基于证据的干预措施的改编与修改报告框架”（FRAME；威尔特西·斯特曼等人，2019年）模型，通过一个特定项目的社区咨询委员会（CAB），来跟踪并报告基于社区参与对我们的痴呆症临终关怀规划干预措施所做的改编。使用FRAME，我们生成了一份关于对我们的试点干预措施所做的迭代更改的综合报告，包括更改是否是计划好的、谁做出了修改干预措施的决定、更改的性质、其与干预保真度的关系以及更改的原因。这一过程确保了我们有效地整合了来自CAB的反馈和协助，提高了我们的干预措施对目标人群的适用性，建立了监测干预保真度的标准，并让我们的团队为开展修订后干预措施的严格临床试验做好了准备。临床试验注册号：NCT05909189。
