Hodgson Nancy A, McPhillips Miranda V, Hirschman Karen B, Summerhayes Emily, Piersol Catherine Verrier, Gitlin Laura N
School of Nursing, University of Pennsylvania, Philadelphia, PA, USA.
M. Louise Fitzpatrick College of Nursing, Villanova University, Villanova, PA, USA.
Contemp Clin Trials Commun. 2025 Apr 5;45:101478. doi: 10.1016/j.conctc.2025.101478. eCollection 2025 Jun.
Despite over 200 evidence-based dementia caregiver programs, we know little about the best approaches for optimally scaling these programs in daily service contexts, nor do we fully understand the most effective approaches of ensuring successful implementation. As a result, a small fraction of the many individuals living with dementia and their caregivers within in the US have access to evidence-based programs. A leading barrier to implementation of evidence-based dementia caregiver support programs into long-term care settings is the lack of streamlined, scalable, user-friendly, and tested training modalities.
To describe the protocol for a study evaluating the implementation of the Care of Persons in their Environment (COPE) in Programs of All-Inclusive Care for the Elderly (PACE) setting. The COPE in PACE study aims to determine if self-paced, online training in the evidence-based dementia care program COPE is non-inferior to the traditional, in-person, instructor-led training for improving clinician knowledge and competence, patient symptoms, function, caregiver confidence and burden, and therapeutic alliance between clinicians and caregivers.Methods/Design: Pragmatic, multisite randomized controlled non-inferiority trial is being used to assess the implementation of COPE into PACE. The study utilizes a type III hybrid effectiveness design with a primary focus on measuring implementation factors and a secondary focus on measuring COPE effectiveness through caregiver and patient outcomes and therapeutic alliance. The 'COPE in PACE' study is an ongoing trial being conducted in 10 PACE settings throughout the US (NCT04165213).
This study design has potential to guide future translational efforts by providing program adaptation, fidelity monitoring and implementation details to enhance scalability of evidence-based programs.
NCT04165213.
尽管有200多种循证痴呆症护理者项目，但我们对在日常服务环境中以最佳方式扩大这些项目的最佳方法知之甚少，也不完全了解确保成功实施的最有效方法。因此，在美国众多患有痴呆症的个人及其护理者中，只有一小部分能够获得循证项目。将循证痴呆症护理者支持项目实施到长期护理环境中的一个主要障碍是缺乏精简、可扩展、用户友好且经过测试的培训模式。
描述一项评估“老年人综合照护项目（PACE）”环境下“环境中人员护理（COPE）”实施情况的研究方案。PACE环境下的COPE研究旨在确定，在循证痴呆症护理项目COPE中，自主节奏的在线培训在提高临床医生知识和能力、患者症状、功能、护理者信心和负担以及临床医生与护理者之间的治疗联盟方面，是否不劣于传统的面对面、由教师主导的培训。
方法/设计：采用务实的多中心随机对照非劣效性试验来评估COPE在PACE中的实施情况。该研究采用III型混合有效性设计，主要侧重于测量实施因素，次要侧重于通过护理者和患者的结果以及治疗联盟来测量COPE的有效性。“PACE环境下的COPE”研究是一项正在美国10个PACE机构进行的试验（NCT04165213）。
本研究设计有可能通过提供项目适应性、保真度监测和实施细节来指导未来的转化工作，以提高循证项目的可扩展性。
NCT04165213。
