跳至主要内容
临床试验/NCT07356479
NCT07356479尚未招募不适用

Enhancing Mental and Physical Health of Women Through Engagement and Retention (EMPOWER) 3.0 (QUE 25-015)

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
18
试验地点
1

研究概览

简要总结

Women Veterans are the fastest growing segment of VA users, with most users in midlife. This dramatic growth has created challenges for VA to ensure that appropriate services are available to meet women Veterans' needs, and that they will want and be able to use those services. Furthermore, few VA improvement efforts have focused on women Veterans' health and health care in midlife. The EMPOWER QUERI 3.0 Program is a cluster randomized type 3 hybrid implementation-effectiveness trial testing two strategies designed to support implementation and sustainment of evidence-based practices for women Veterans in at least 18 VA facilities from 4 regions.

详细描述

Women Veterans are the fastest growing group of Veterans Health Administration (VA) users. Of the 528,424 women Veterans who used VA care in FY19, nearly half were in midlife (aged 45-64). A growing number of studies identify gaps in health care for women Veterans in this life stage, during which menopause typically occurs, 49% of women Veterans meet criteria for obesity, and the risk of chronic disease increases dramatically. Furthermore, women Veterans have a high burden of trauma and physical and mental health comorbidities, which may exacerbate menopause symptoms and chronic disease risk as well as negatively impact healthcare engagement and trust. Notably, only 40% of women in VA care report "complete trust" in their VA provider. Lack of trust in VA can drive seeking community care, which is associated with lower quality of care, higher costs, and eventual attrition from VA. While VA has invested substantially in improving health care for women Veterans, continued improvement efforts are needed to ensure accessible, effective, trustworthy, and trauma-informed care for women Veterans, with concerted efforts for women in midlife.

The EMPOWER 3.0 Impact Goal is to optimize women Veterans' access to and quality and experience of care by offering trauma-informed, evidence-based interventions that meet high-priority health needs in midlife, and thereby, to increase women Veterans' trust, well-being, and engagement in VA care. This Impact Goal is guided by input from the investigators' longstanding VA operations partners: the Offices of Women's Health (OWH), Mental Health (OMH), Patient-Centered Care and Cultural Transformation (OPCC&CT), Rural Health (ORH), and the National Center for Health Promotion and Disease Prevention (NCP). To support sites with implementation, the investigators will leverage OWH's multi-year, multi-million dollar investment in rolling out Evidence-Based Quality Improvement (EBQI) across VA women's health. EBQI has demonstrated effectiveness in VA women's health, contributing to improved care services for women Veterans. In collaboration with OWH, the investigators' team now has a unique opportunity to assess the additional supports needed to successfully launch novel EBPs in women's health clinics across four partnering Veteran Integrated Service Networks (VISNs).

Specific Aims are to:

Aim 1. Support implementation and sustainment of three EBPs for women Veterans in midlife using an EBQI Booster (EBQI/B) strategy in 18 VA facilities that have completed the OWH EBQI initiative. Half of these sites (n=9) will be randomized to also receive 12 months of external facilitation (EF): EBQI/B+EF.

Aim 2. Conduct a multi-method implementation evaluation using a type 3 hybrid implementation-effectiveness cluster randomized trial design. The investigators will compare effectiveness of EBQI/B and EBQI/B+EF in terms of: (a) improved access to trauma-informed care for women Veterans; (b) implementation strategy fidelity, speed of implementation, and sustainment; (c) recipient perspectives on and experiences of EBP implementation; and (d) costs of implementation and business case analysis to support sustained EBP use.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • This study is recruiting VA sites - not individual patients.
  • Prior to randomization, the study team will work with sites to ensure they have met the preconditions necessary to enroll in the study, which includes VISN, regional and/or facility level leadership support for participation.

排除标准

  • 未提供

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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