Clinical trial NCT05050266: Enhancing Mental and Physical Health of Women Veterans
Official title: Enhancing Mental and Physical Health of Women Through Engagement and Retention (EMPOWER) QUERI 2.0 (QUE 20-028)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Overweight
Obesity
Smoking
Hypertension
Cholesterol
Diabetes Mellitus
Prediabetic State
Pregnancy
Depression, Postpartum
Prevention
Implementation Science
Quality Improvement
Virtual Care
Keywords: Cardiovascular diseases
Overweight
Obesity
Smoking
Hypertension
Cholesterol
Diabetes Mellitus
Prediabetic State
Pregnancy
Depression, Postpartum
Depression
Women
Veterans
Primary Health Care
Mental Health
Patient Participation
Patient Satisfaction
Patient Preference
Physicians, Primary Care
Physicians, Women
Health Behavior
Quality Improvement
Prevention
Heart Disease Risk Factors
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-09-20
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized type 3 hybrid implementation-effectiveness trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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 at least 20 VA facilities from 4 regions.

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.

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).

Eligibility 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

Primary outcomes:
measure: Access to virtual care for preventive services
timeFrame: 12 months
measure: Engagement in virtual care for preventive services
timeFrame: 12 months
Secondary outcomes:
measure: Participation and engagement: DPP
timeFrame: 6 and 12 months
measure: Participation and engagement: DPP
timeFrame: 6 and 12 months
measure: Participation and engagement: DPP
timeFrame: 6 and 12 months
measure: Participation and engagement: TLC
timeFrame: 6 months
measure: Participation and engagement: TLC
timeFrame: 6 months
measure: Participation and engagement: TLC
timeFrame: 6 months
measure: Participation and engagement: ROSE
timeFrame: 6 months
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Alison B Hamilton, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: