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通过参与和留存增强女性身心健康(EMPOWER)2.0质量提升研究计划:一项整群随机混合3型有效性-实施试验的研究方案

Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER) 2.0 QUERI: study protocol for a cluster-randomized hybrid type 3 effectiveness-implementation trial.

作者信息

Hamilton Alison B, Finley Erin P, Bean-Mayberry Bevanne, Lang Ariel, Haskell Sally G, Moin Tannaz, Farmer Melissa M

机构信息

Veterans Affairs Health Services Research and Development (HSR&D) Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, CA, USA.

Department of Psychiatry and Biobehavioral Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA.

出版信息

Implement Sci Commun. 2023 Mar 8;4(1):23. doi: 10.1186/s43058-022-00389-w.

DOI:10.1186/s43058-022-00389-w
PMID:36890587
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9994412/
Abstract

BACKGROUND

Women Veterans are the fastest-growing segment of Veterans Health Administration (VA) users. The VA has invested heavily in delivering care for women Veterans that is effective, comprehensive, and gender-tailored. However, gender disparities persist in cardiovascular (CV) and diabetes risk factor control, and the rate of perinatal depression among women Veterans is higher than that among civilian women. Challenges such as distance, rurality, negative perception of VA, discrimination (e.g., toward sexual and/or gender minority individuals), and harassment on VA grounds can further impede women's regular use of VA care. Enhancing Mental and Physical Health of Women through Engagement and Retention (EMPOWER) 2.0 builds on work to date by expanding access to evidence-based, telehealth preventive and mental health services for women Veterans with high-priority health conditions in rural and urban-isolation areas.

METHODS

EMPOWER 2.0 will evaluate two implementation strategies, Replicating Effective Practices (REP) and Evidence-Based Quality Improvement (EBQI), in supporting the implementation and sustainment of three evidence-based interventions (Virtual Diabetes Prevention Program; Telephone Lifestyle Coaching Program; and Reach Out, Stay Strong Essentials) focused on preventive and mental health care for women Veterans. We will conduct a mixed-methods implementation evaluation using a cluster-randomized hybrid type 3 effectiveness-implementation trial design to compare the effectiveness of REP and EBQI on improved access to and rates of engagement in telehealth preventive lifestyle and mental health services. Other outcomes of interest include (a) VA performance metrics for telehealth care delivery and related clinical outcomes; (b) progression along the Stages of Implementation Completion; (c) adaptation, sensemaking, and experiences of implementation among multilevel stakeholders; and (d) cost and return on investment. We will also generate implementation playbooks for program partners to support scale-up and spread of these and future evidence-based women's health programs and policies.

DISCUSSION

EMPOWER 2.0 provides a model for mixed-methods hybrid type 3 effectiveness-implementation trial design incorporating evaluation of performance metrics, implementation progress, stakeholder experience, and cost and return on investment, with the ultimate goal of improving access to evidence-based preventive and mental telehealth services for women Veterans with high-priority health conditions.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT05050266 . Registered on 20 September 2021.

摘要

背景

女性退伍军人是退伍军人健康管理局(VA)用户中增长最快的群体。VA已投入大量资金为女性退伍军人提供有效、全面且针对性别的护理。然而,在心血管(CV)和糖尿病风险因素控制方面,性别差异依然存在,且女性退伍军人的围产期抑郁症发病率高于普通女性。诸如距离、地处农村、对VA的负面看法、歧视(例如针对性取向和/或性别少数群体个体)以及VA场所内的骚扰等挑战,可能会进一步阻碍女性定期使用VA护理服务。通过参与和留存增强女性身心健康(EMPOWER)2.0项目在以往工作的基础上进行拓展,为农村和城市偏远地区患有高度优先健康问题的女性退伍军人扩大提供基于证据的远程医疗预防和心理健康服务。

方法

EMPOWER 2.0将评估两种实施策略,即复制有效实践(REP)和基于证据的质量改进(EBQI),以支持三项基于证据的干预措施(虚拟糖尿病预防项目;电话生活方式指导项目;以及“伸出援手,保持坚强基础版”)的实施和维持,这些干预措施聚焦于女性退伍军人的预防和心理健康护理。我们将采用整群随机混合3型有效性 - 实施试验设计进行混合方法实施评估,以比较REP和EBQI在改善远程医疗预防生活方式和心理健康服务的可及性及参与率方面的有效性。其他感兴趣的结果包括:(a)VA远程医疗服务提供的绩效指标及相关临床结果;(b)沿着实施完成阶段的进展情况;(c)多层次利益相关者在实施过程中的适应情况、理解情况及体验;(d)成本和投资回报率。我们还将为项目合作伙伴生成实施手册,以支持这些及未来基于证据的女性健康项目和政策的扩大推广。

讨论

EMPOWER 2.0提供了一个混合方法混合3型有效性 - 实施试验设计的模型,该设计纳入了对绩效指标、实施进展、利益相关者体验以及成本和投资回报率的评估,其最终目标是改善为患有高度优先健康问题的女性退伍军人提供基于证据的预防性和心理健康远程医疗服务的可及性。

试验注册

ClinicalTrials.gov,NCT05050266。于2021年9月20日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b44d/9996896/a18fd7e74131/43058_2022_389_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b44d/9996896/60c86198004c/43058_2022_389_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b44d/9996896/a18fd7e74131/43058_2022_389_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b44d/9996896/60c86198004c/43058_2022_389_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b44d/9996896/a18fd7e74131/43058_2022_389_Fig2_HTML.jpg

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