Enhancing Mental and Physical Health of Women Veterans 3.0 (EMPOWER)

January 12, 2026 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Aim 3. Develop a translation-to-policy (T2P)-informed scale-up and evaluation plan to support sustainment, spread, and continuous improvement of trauma-informed EBPs in VA care.

The investigators will implement three EBPs: 1) Trauma-Informed Care (TIC), a VA-mandated set of activities and approaches that support trust and safety in primary care interactions, 2) Cognitive Behavioral Therapy for Symptoms of Menopause (CBT-SM), which provides group-based therapy, education, and personalized referrals for women across the menopausal transition; and 3) Women's MOVE!, which provides lifestyle and weight management support to enhance women Veterans' health and well-being.

Study Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • West Los Angeles, California, United States, 90073-1003
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alison B Hamilton, PhD MPH
        • Principal Investigator:
          • Bevanne A Bean-Mayberry, MD MHS
        • Principal Investigator:
          • Erin P Finley, PhD MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EBQI Booster (EBQI/B)
A two-hour EBQI Booster delivered virtually to site-identified QI champions and local implementation teams for each EBP reviewing key EBQI components and providing examples grounded in the EBPs.
Behavioral: EBQI Booster (EBQI/B)
EBQI is a systematic quality improvement method for engaging frontline practices in improvement that introduces "best science" and evidence in the service of operational goals. EBQI has been tested in several VA implementation trials and the VA Office of Women's Health (OWH) recently conducted a large-scale roll out of EBQI across VA women's health. Sites randomized to EBQI/B will receive a two-hour EBQI Booster delivered virtually to site-identified QI champions and local implementation teams for each EBP reviewing key EBQI components and providing examples grounded in the EBPs.
Experimental: EBQI Booster + External Facilitation (EBQI/B+EF)
A two-hour EBQI Booster delivered virtually to site-identified QI champions and local implementation teams for each EBP reviewing key EBQI components and providing examples grounded in the EBPs, plus 12 months of external facilitation.
Behavioral: EBQI Booster + External Facilitation (EBQI/B+EF)
EBQI is a systematic quality improvement method for engaging frontline practices in improvement that introduces "best science" and evidence in the service of operational goals. EBQI has been tested in several VA implementation trials and the VA Office of Women's Health (OWH) recently conducted a large-scale roll out of EBQI across VA women's health. External facilitation (EF) delivered by an expert facilitator from outside of the local implementation site, offers a supportive coaching process in which facilitators encourage interactive problem-solving in improvement efforts. EF is one of the most-studied implementation strategies. Sites randomized to EBQI/B+EF will receive a two-hour EBQI Booster delivered virtually to site-identified QI champions and local implementation teams for each EBP reviewing key EBQI components and providing examples grounded in the EBPs, plus 12 months of EF.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement: TIC
Time Frame: 12 months
# of women with shared decision-making treatment planning marker (1=WBS completed in EHR)
12 months
Engagement: CBT-SM
Time Frame: 12 months
# women participating in CBT-SM (1=yes for one or more sessions)
12 months
Engagement: Women's MOVE!
Time Frame: 12 months
# of women enrolled in Women's MOVE! (1=yes for one or more sessions)
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Bevanne A Bean-Mayberry, MD MHS, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Principal Investigator: Melissa M Farmer Coste, PhD MS, VA Greater Los Angeles Healthcare System, Sepulveda, CA
  • Principal Investigator: Alison B Hamilton, PhD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Principal Investigator: Erin P Finley, PhD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2031

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 12, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QUX 26-001
  • 1I01RD000411-01A2 (U.S. NIH Grant/Contract: VA Office of Research & Development)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sets underlying all publications resulting from the proposed research will not be shared outside VA, except as required under the Freedom of Information Act (FOIA), because VHA policy would prohibit re-disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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