Enhancing Mental and Physical Health of Women Veterans

NCT05050266 | Active Not Recruiting

• 1 other identifier: QUX 21-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Access to virtual care for preventive services

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

  12 months

• Engagement in virtual care for preventive services

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

  12 months

Secondary Outcomes (7)

• Participation and engagement: DPP

  6 and 12 months

• Participation and engagement: DPP

  6 and 12 months

• Participation and engagement: DPP

  6 and 12 months

• Participation and engagement: TLC

  6 months

• Participation and engagement: TLC

  6 months

Study Arms (2)

REP

ACTIVE COMPARATOR

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

Behavioral: REP

EBQI

EXPERIMENTAL

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

Behavioral: EBQI

Interventions

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).

EBQI

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).

REP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

West Los Angeles, California, 90073-1003, United States

Location

Related Publications (4)

• Finley EP, Hamilton AB, Canelo I, Jackson SS, Lesser R, Oberman RS, Yosef J, Chrystal JG, Fletcher EH, Bean-Mayberry B, Moin T, Farmer MM, Lang AJ. Collaborative tailoring of the Reach Out, Stay Strong Essentials (ROSE) program for pregnant veterans in the U.S. Veterans Health Administration: a qualitative case study of contextual conditions and adaptations. BMC Health Serv Res. 2025 May 23;25(1):746. doi: 10.1186/s12913-025-12871-x.

  PMID: 40410822 DERIVED

• Malone A, Clair K, Chanfreau C, Bean-Mayberry B, Oberman R, Lesser R, Knight C, Finley E, Hamilton A, Farmer MM, Moin T. Predictors of enrollment in a virtual diabetes prevention program among women veterans: a retrospective analysis. BMC Womens Health. 2024 Aug 24;24(1):465. doi: 10.1186/s12905-024-03314-6.

  PMID: 39180036 DERIVED

• Finley EP, Chrystal JG, Gable AR, Fletcher EH, Palma A, Canelo I, Oberman RS, Jackson SS, Lesser R, Moin T, Bean-Mayberry B, Farmer MM, Hamilton A. The Rapid Implementation Feedback (RIF) report: real-time synthesis of qualitative data for proactive implementation planning and tailoring. Implement Sci Commun. 2024 Jun 21;5(1):69. doi: 10.1186/s43058-024-00605-9.

  PMID: 38907331 DERIVED

• Hamilton AB, Finley EP, Bean-Mayberry B, Lang A, Haskell SG, Moin T, Farmer MM; EMPOWER QUERI Team. 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. Implement Sci Commun. 2023 Mar 8;4(1):23. doi: 10.1186/s43058-022-00389-w.

  PMID: 36890587 DERIVED

Related Links

• project executive summary

MeSH Terms

Conditions

Cardiovascular Diseases; Overweight; Obesity; Smoking; Hypertension; Diabetes Mellitus; Prediabetic State; Depression, Postpartum; Depression; Psychological Well-Being; Patient Participation; Patient Satisfaction; Patient Preference; Health Behavior

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Personal Satisfaction; Patient Acceptance of Health Care; Treatment Adherence and Compliance

Study Officials

• Alison B Hamilton, PhD MPH

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Cluster randomized type 3 hybrid implementation-effectiveness trial

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 20, 2021
• Study Start: October 21, 2021
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)