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CompletedNCT05050266ClinicalTrials.gov record

Enhancing Mental and Physical Health of Women Veterans

Cardiovascular Diseases · Overweight · Obesity · Smoking · Hypertension · Cholesterol · Diabetes Mellitus · Prediabetic State · Pregnancy · Depression, Postpartum · Prevention · Implementation Science · Quality Improvement · Virtual Care

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
Not specified - Not specified
Sex eligible
All sexes
Healthy volunteers
Not accepted
Participants
20 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

Women Veterans are the fastest growing segment of VA users. 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. The EMPOWER QUERI 2.0 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 20 VA facilities from 4 regions.

Read the full description

Women Veterans are the fastest-growing segment of users in the Veterans Health Administration (VA). Their numbers are projected to increase by 73%, from 9.3% to 16.4%, between 2015 and 2043. Despite VA investment in improving care for women Veterans, gender disparities persist in cardiovascular (CV) and diabetes risk factor control. Also, the rate of perinatal depression among women Veterans is higher than that among civilian women, which is of particular concern given the association between perinatal depression and suicidality. Barriers to care for women Veterans include distance to VA care, rurality, competing work and caregiving responsibilities, comorbid mental health issues, and harassment on VA grounds. Improvements are still needed to increase women Veterans' access to and engagement in convenient, safe, evidence-based, patient-centered care that achieves the VA "lane of effort" of Veterans' "lifelong health, well-being, and resilience."

Since its inception in 2015, the Enhancing Mental and Physical health of Women through Engagement and Retention (EMPOWER) QUERI 1.0 team has focused on implementing gender-tailored care models for women Veteran patients. In EMPOWER 1.0 studies, women expressed preferences for gender-specific (women only) care and for virtual care options. Therefore, the EMPOWER 2.0 Impact Goal is to expand access to virtual, evidence-based, preventive lifestyle and mental health services for women Veterans with high-priority health conditions in rural and urban-isolation areas. This cluster randomized type 3 hybrid implementation-effectiveness trial randomized 20 VA sites to one of two implementation strategies, the Replicating Effective Practices (REP) or Evidence-Based Quality Improvement (EBQI), to support implementation and sustainment of evidence-based practices (EBPs). The EBPs focus on preventive lifestyle and mental health care for women Veterans across VA facilities, several of which are rural, low-performing in women's health care, and/or lead sites for high reliability organization. The study team will conduct a mixed methods implementation evaluation to compare the effectiveness of REP and EBQI in terms of: (a) improved access to and rates of engagement in virtual preventive lifestyle and mental health services and improved VA performance metrics for virtual and telehealth care delivery and related clinical outcomes for women Veterans; (b) progression along the Stages of Implementation Completion; (c) adaptation, sense-making, and experiences of EBP implementation among multilevel stakeholders; and (d) cost and return on investment.

On 8/15/23, as part of our 12 month registration update corrected the primary outcomes to accurately reflect the randomized trial and analyses design. The cluster randomized trial will evaluate the effectiveness of two implementation strategies (REP and EBQI) in implementing evidence-based practices (EBPs) for preventive services. Although we are implementing three evidence-based practices (DPP, TLC and ROSE), the EBPs are combined for each of the trial's two primary outcomes (access and engagement).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
No masking
REP

Replicating Effective Practices (REP) is a lower-intensity implementation strategy with explicit process framework for local tailoring

Behavioral: REP

EBQI

Evidence-Based Quality Improvement (EBQI) is a higher-intensity implementation strategy that entails external facilitation and formal training in quality improvement.

Behavioral: EBQI

EBQI BEHAVIORAL

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. Sites randomized to EBQI will meet monthly with the implementation support team (i.e., high-intensity).

REP BEHAVIORAL

The REP framework consists of 4 phases: pre-conditions, pre-implementation, implementation and maintenance/evolution. REP has a strong evidence-base and application in VHA health services research in promoting uptake of EBPs. Sites randomized to REP will meet quarterly with the implementation support team (i.e., low-intensity).

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Access to virtual care for preventive services

Time frame: 12 months

Proportion of eligible women Veterans who enroll in virtual DPP, TLC, or ROSE at each site

Engagement in virtual care for preventive services

Time frame: 12 months

Proportion of eligible women Veterans who attend 1 or more virtual DPP, TLC, or ROSE sessions at each site

Secondary measures

Participation and engagement: DPP

Time frame: 6 and 12 months

average # of sessions attended by women Veterans who enrolled in DPP at each site

Participation and engagement: DPP

Time frame: 6 and 12 months

proportion who completed \>9 and \>16 sessions among women Veterans who enrolled in DPP at each site

Participation and engagement: DPP

Time frame: 6 and 12 months

% weight change among women Veterans who enrolled in DPP at each site

Participation and engagement: TLC

Time frame: 6 months

average # of TLC sessions completed among women Veterans who enrolled in TLC at each site

Participation and engagement: TLC

Time frame: 6 months

% with health behavioral goal among women Veterans who enrolled in TLC at each site

Participation and engagement: TLC

Time frame: 6 months

% with behavioral change (physical activity, diet: fruit, vegetable and sugary beverage intake, stress and coping, and weight) at each site

Participation and engagement: ROSE

Time frame: 6 months

average # of ROSE sessions completed at each site

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

1 locations

VA Greater Los Angeles Healthcare System, West Los Angeles, CAWest Los Angeles, California, United StatesStatus unknown

Study team and timeline

Lead sponsor
VA Office of Research and Development
Study start
Oct 21, 2021 Actual
Primary completion
Oct 30, 2026 Actual
Study completion
Oct 30, 2026 Actual
First posted
Sep 20, 2021 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

Enhancing Mental and Physical Health of Women Through Engagement and Retention (EMPOWER) QUERI 2.0 (QUE 20-028)

A HUMAN NEXT STEP

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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.

Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026