NCT07356479

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
61mo left

Started Oct 2026

Longer than P75 for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 21, 2026

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2030

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2031

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

January 12, 2026

Last Update Submit

January 12, 2026

Conditions

Keywords

Cardiovascular diseasesOverweightObesityHypertensionCholesterolDiabetes MellitusPrediabetic StateMenopauseCognitive Behavioral TherapyPrimary Health CareStress Disorders, Post-TraumaticPreventionImplementation scienceQuality ImprovementWomenVeteransPatient ParticipationPatient SatisfactionPatient PreferencePhysicians, Primary CarePhysicians, WomenHealth Behavior

Outcome Measures

Primary Outcomes (3)

  • Engagement: TIC

    \# of women with shared decision-making treatment planning marker (1=WBS completed in EHR)

    12 months

  • Engagement: CBT-SM

    \# women participating in CBT-SM (1=yes for one or more sessions)

    12 months

  • Engagement: Women's MOVE!

    \# of women enrolled in Women's MOVE! (1=yes for one or more sessions)

    12 months

Study Arms (2)

EBQI Booster (EBQI/B)

ACTIVE COMPARATOR

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 Booster + External Facilitation (EBQI/B+EF)

EXPERIMENTAL

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)

Interventions

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.

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. 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.

EBQI Booster + External Facilitation (EBQI/B+EF)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Cardiovascular DiseasesOverweightObesityHypertensionDiabetes MellitusPrediabetic StateStress Disorders, Post-TraumaticPatient ParticipationPatient SatisfactionPatient PreferenceHealth Behavior

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesStress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersPatient Acceptance of Health CareTreatment Adherence and ComplianceBehavior

Study Officials

  • Alison B Hamilton, PhD MPH

    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
  • Bevanne A Bean-Mayberry, MD MHS

    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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alison B Hamilton, PhD MPH

CONTACT

Melissa M Farmer Coste, PhD MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Cluster randomized type 3 hybrid implementation-effectiveness trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2026

First Posted

January 21, 2026

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

September 30, 2031

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations