Cardiovascular DiseasesEMPOWERNCT07356479
Enhancing Mental and Physical Health of Women Veterans 3.0
A study testing EBQI Booster (EBQI/B) and EBQI Booster + External Facilitation (EBQI/B+EF) in people with Cardiovascular Diseases and Overweight, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Diseases, Overweight, Obesity
- What is being tested?
- EBQI Booster (EBQI/B) and EBQI Booster + External Facilitation (EBQI/B+EF)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073-1003
Alison B Hamilton, PhD MPH, 310-478-3711 ext. 44157, Alison.Hamilton@va.gov
Bevanne A Bean-Mayberry, MD MHS, (818) 891-7711 ext. 36009, bevanne.bean-mayberry@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Overweight, Obesity, Hypertension, Cholesterol, Diabetes Mellitus
- Being tested
- EBQI Booster (EBQI/B), EBQI Booster + External Facilitation (EBQI/B+EF)
- Keywords
- Cardiovascular diseases, Overweight, Obesity, Hypertension, Cholesterol, Diabetes Mellitus, Prediabetic State, Menopause, Cognitive Behavioral Therapy, Primary Health Care, Stress Disorders, Post-Traumatic, Prevention, Implementation science, Quality Improvement, Women, Veterans, Patient Participation, Patient Satisfaction, Patient Preference, Physicians, Primary Care
- Medical subject headings
- Cardiovascular Diseases, Overweight, Obesity, Hypertension, Diabetes Mellitus, Prediabetic State, Stress Disorders, Post-Traumatic, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBQI Booster (EBQI/B)Behavioural
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 + External Facilitation (EBQI/B+EF)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: EBQI Booster + External Facilitation (EBQI/B+EF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement: TIC
# of women with shared decision-making treatment planning marker (1=WBS completed in EHR)
Measured: 12 months
Engagement: CBT-SM
# women participating in CBT-SM (1=yes for one or more sessions)
Measured: 12 months
Engagement: Women's MOVE!
# of women enrolled in Women's MOVE! (1=yes for one or more sessions)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized type 3 hybrid implementation-effectiveness trial
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alison B Hamilton, PhD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CAMelissa M Farmer Coste, PhD MS, Principal investigator, VA Greater Los Angeles Healthcare System, Sepulveda, CABevanne A Bean-Mayberry, MD MHS, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CAErin P Finley, PhD MPH, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07356479
- Sponsor's protocol ID
- QUX 26-001
- Other IDs
- 1I01RD000411-01A2
- Acronym
- EMPOWER
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Mental and Physical Health of Women Through Engagement and Retention (EMPOWER) 3.0 (QUE 25-015)
- ClinicalTrials.gov ID
- NCT07356479
- Acronym / sponsor ID
- EMPOWER / QUX 26-001
- Conditions
- Cardiovascular Diseases, Overweight, Obesity, Hypertension, Cholesterol, Diabetes Mellitus
- Keywords
- Cardiovascular diseases, Overweight, Obesity, Hypertension, Cholesterol, Diabetes Mellitus, Prediabetic State, Menopause
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized type 3 hybrid implementation-effectiveness trial
| Arm | Type | Receives |
|---|---|---|
| EBQI Booster (EBQI/B) | Active comparator | Behavioral: 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. |
| EBQI Booster + External Facilitation (EBQI/B+EF) | Experimental | Behavioral: 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | EBQI Booster (EBQI/B) |
| 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. | Behavioural | EBQI Booster + External Facilitation (EBQI/B+EF) |
Primary outcome
Engagement: TIC
Time frame: 12 months
# of women with shared decision-making treatment planning marker (1=WBS completed in EHR)
Engagement: CBT-SM
Time frame: 12 months
# women participating in CBT-SM (1=yes for one or more sessions)
Engagement: Women's MOVE!
Time frame: 12 months
# of women enrolled in Women's MOVE! (1=yes for one or more sessions)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alison B Hamilton, PhD MPH principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Melissa M Farmer Coste, PhD MS principal investigator
VA Greater Los Angeles Healthcare System, Sepulveda, CA
Bevanne A Bean-Mayberry, MD MHS principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EBQI Booster (EBQI/B) and EBQI Booster + External Facilitation (EBQI/B+EF) in people with Cardiovascular Diseases and Overweight, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alison B Hamilton, PhD MPH ((310) 478-3711 ext. 44157, Alison.Hamilton@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement: TIC (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.