Enhancing Mental and Physical Health of Women Veterans 3.0 (EMPOWER)

VA Office of Research and Development

Status: Begins enrollment in 7 months

Conditions: Prediabetic State; Menopause; Diabetes Mellitus; Stress Disorders, Post-Traumatic; Obesity; Cardiovascular Diseases; Quality Improvement; Implementation Science; Prevention; Hypertension; Overweight; Cholesterol; Primary Health Care; Cognitive Behavioral Therapy

Treatments: Behavioral: EBQI Booster + External Facilitation (EBQI/B+EF); Behavioral: EBQI Booster (EBQI/B)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT07356479

1I01RD000411-01A2 (Other Grant/Funding Number)

QUX 26-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

EBQI Booster (EBQI/B)

Active Comparator group

Description:

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.

Treatment:

Behavioral: EBQI Booster (EBQI/B)

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

Experimental group

Description:

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.

Treatment:

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