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Enhancing Mental and Physical Health of Women Veterans

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05050266
Acronym
EMPOWER
Enrollment
20
Registered
2021-09-20
Start date
2021-10-21
Completion date
2026-09-30
Last updated
2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Cardiovascular diseases, Overweight, Obesity, Smoking, Hypertension, Cholesterol, Diabetes Mellitus, Prediabetic State, Pregnancy, Depression, Postpartum, Depression, Women, Veterans, Primary Health Care, Mental Health, Patient Participation, Patient Satisfaction, Patient Preference, Physicians, Primary Care, Physicians, Women, Health Behavior, Quality Improvement, Prevention, Heart Disease Risk Factors

Brief summary

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.

Detailed 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).

Interventions

BEHAVIORALEBQI

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).

BEHAVIORALREP

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).

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Cluster randomized type 3 hybrid implementation-effectiveness trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Access to virtual care for preventive services12 monthsProportion of eligible women Veterans who enroll in virtual DPP, TLC, or ROSE at each site
Engagement in virtual care for preventive services12 monthsProportion of eligible women Veterans who attend 1 or more virtual DPP, TLC, or ROSE sessions at each site

Secondary

MeasureTime frameDescription
Participation and engagement: DPP6 and 12 monthsaverage # of sessions attended by women Veterans who enrolled in DPP at each site
Participation and engagement: TLC6 monthsaverage # of TLC sessions completed among women Veterans who enrolled in TLC at each site
Participation and engagement: ROSE6 monthsaverage # of ROSE sessions completed at each site

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAlison B Hamilton, PhD MPH

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026