Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2025-04-05 DOI:10.1016/j.conctc.2025.101478

Nancy A. Hodgson , Miranda V. McPhillips , Karen B. Hirschman , Emily Summerhayes , Catherine Verrier Piersol , Laura N. Gitlin

{"title":"Training to Move an Evidence-based Dementia Caregiver Support Program into Practice: A pragmatic, randomized, non-inferiority trial protocol","authors":"Nancy A. Hodgson , Miranda V. McPhillips , Karen B. Hirschman , Emily Summerhayes , Catherine Verrier Piersol , Laura N. Gitlin","doi":"10.1016/j.conctc.2025.101478","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>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.</div></div><div><h3>Objective</h3><div>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.</div><div>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).</div></div><div><h3>Discussion</h3><div>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.</div></div><div><h3>Clinical trial registration</h3><div>NCT04165213.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"45 ","pages":"Article 101478"},"PeriodicalIF":1.4000,"publicationDate":"2025-04-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contemporary Clinical Trials Communications","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2451865425000523","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}

引用次数: 0

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.

查看原文本刊更多论文

将以证据为基础的痴呆症护理人员支持计划付诸实践的培训：一项实用的、随机的、非劣效性的试验方案

尽管有200多个基于证据的痴呆症护理项目，但我们对在日常服务环境中优化这些项目的最佳方法知之甚少，我们也不完全了解确保成功实施的最有效方法。因此，在美国的许多痴呆症患者及其护理人员中，只有一小部分人能够获得基于证据的项目。在长期护理环境中实施以证据为基础的痴呆症护理人员支持规划的主要障碍是缺乏精简、可扩展、用户友好和经过测试的培训模式。目的描述一项评估老年人全包照护计划（PACE）实施环境中人照护（COPE）的研究方案。PACE中的COPE研究旨在确定基于证据的痴呆护理项目COPE中自定进度的在线培训是否优于传统的、面对面的、有指导的培训，以提高临床医生的知识和能力、患者的症状、功能、护理人员的信心和负担，以及临床医生和护理人员之间的治疗联盟。方法/设计：采用实用的多地点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，其次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。“COPE in PACE”研究是一项正在美国10个PACE机构进行的正在进行的试验（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，以增强循证项目的可扩展性。临床试验注册号：nct04165213。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.