EMPOWER: Enhancing Mental and Physical Health of Women Veterans
Study Details
Study Description
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 up to 20 VA facilities from 4 regions.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 will randomize up to 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: REP Replicating Effective Practices (REP) is a lower-intensity implementation strategy with explicit process framework for local tailoring |
Behavioral: REP
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).
|
| Experimental: EBQI Evidence-Based Quality Improvement (EBQI) is a higher-intensity implementation strategy that entails external facilitation and formal training in quality improvement. |
Behavioral: EBQI
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).
|
Outcome Measures
Primary Outcome Measures
- Access to virtual care for preventive services: DPP [12 months]
Proportion of eligible women Veterans who enroll in virtual DPP at each site
- Engagement in virtual care for preventive services: DPP [12 months]
Proportion of eligible women Veterans who attend 1 or more virtual DPP sessions at each site
- Access to virtual care for preventive services: TLC [12 months]
# of provider referrals for TLC at each site
- Engagement in virtual care for preventive services: TLC [12 months]
# of patients with TLC encounter (enrolled) at each site
- Access to virtual care for preventive services: ROSE [12 months]
# of provider referrals for ROSE at each site
- Engagement in virtual care for preventive services: ROSE [12 months]
# of eligible patients with ROSE encounter (enrolled) at each site
Secondary Outcome Measures
- Participation and engagement: DPP [6 and 12 months]
average # of sessions attended by women Veterans who enrolled in DPP at each site
- Participation and engagement: DPP [6 and 12 months]
proportion who completed >9 and >16 sessions among women Veterans who enrolled in DPP at each site
- Participation and engagement: DPP [6 and 12 months]
% weight change among women Veterans who enrolled in DPP at each site
- Participation and engagement: TLC [6 months]
average # of TLC sessions completed among women Veterans who enrolled in TLC at each site
- Participation and engagement: TLC [6 months]
% with health behavioral goal among women Veterans who enrolled in TLC at each site
- Participation and engagement: TLC [6 months]
% with behavioral change (physical activity, diet: fruit, vegetable and sugary beverage intake, stress and coping, and weight) at each site
- Participation and engagement: ROSE [6 months]
average # of ROSE sessions completed at each site
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | United States | 90073 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Principal Investigator: Alison B Hamilton, PhD MPH, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- QUX 21-006