Enhancing Mental and Physical Health of Women Veterans

Obesity Clinical Trial

— EMPOWER  

Official title:

Enhancing Mental and Physical Health of Women Through Engagement and Retention (EMPOWER) QUERI 2.0 (QUE 20-028)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050266
• Other study ID #: QUX 21-006
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2021
• Est. completion date: September 30, 2025

Study information

• Verified date: August 2023
• Source: VA Office of Research and Development
• Contact: Alison B Hamilton, PhD MPH
• Phone: (310) 478-3711
• Email: Alison.Hamilton[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

On 8/15/23, as part of our 12 month registration update we are correcting the primary outcomes to accurately reflect the randomized trial and analyses design. The cluster randomized trial will evaluate the effectiveness of two implementation strategies (REP and EBQI) in implementing evidence-based practices (EBPs) for preventive services. Although we are implementing three evidence-based practices (DPP, TLC and ROSE), the EBPs are combined for each of the trial's two primary outcomes (access and engagement).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cholesterol
• Depression
• Depression, Postpartum
• Diabetes Mellitus
• Hypertension
• Implementation Science
• Obesity
• Overweight
• Prediabetic State
• Pregnancy
• Prevention
• Quality Improvement
• Smoking

Intervention

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).
• 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).

Locations

Country	Name	City	State
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Participation and engagement: DPP	average # of sessions attended by women Veterans who enrolled in DPP at each site	6 and 12 months
Secondary	Participation and engagement: DPP	proportion who completed >9 and >16 sessions among women Veterans who enrolled in DPP at each site	6 and 12 months
Secondary	Participation and engagement: DPP	% weight change among women Veterans who enrolled in DPP at each site	6 and 12 months
Secondary	Participation and engagement: TLC	average # of TLC sessions completed among women Veterans who enrolled in TLC at each site	6 months
Secondary	Participation and engagement: TLC	% with health behavioral goal among women Veterans who enrolled in TLC at each site	6 months
Secondary	Participation and engagement: TLC	% with behavioral change (physical activity, diet: fruit, vegetable and sugary beverage intake, stress and coping, and weight) at each site	6 months
Secondary	Participation and engagement: ROSE	average # of ROSE sessions completed at each site	6 months

External Links

•   project executive summary