Document Type

Article

Publication Date

4-5-2025

Comments

This article is the author’s final published version in Contemporary Clinical Trials Communications, Volume 45, June 2025, Article number 101478.

The published version is available at https://doi.org/10.1016/j.conctc.2025.101478. Copyright © 2025 The Authors. Published by Elsevier Inc.

Abstract

Background

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.

Objective

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).

Discussion

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.

Clinical trial registration

NCT04165213.

Creative Commons License

Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

PubMed ID

40248174

Language

English

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