An interventional study of Employing Peer Outreach and Whole Health in Recovery (EMPOWER) in Substance Use Disorder, Mental Health Disorder and Homelessness, sponsored by VA Office of Research and Development. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-02.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research
Homelessness is a national crisis in the United States, particularly in the veteran population. Due to multiple chronic conditions, homeless individuals frequently become hospitalized or are treated in emergency departments. Care engagement can mitigate this risk. Interventions grounded in evidence-based practices of peer support and whole health are effective for increasing care engagement. However, implementation of such interventions with high-acuity patients often requires strategies that are intensive and costly. This trial will evaluate the relative impacts and costs of using a high-intensity (vs. low-intensity) strategy to implement a peer-led, whole health intervention for homeless-experienced Veterans in permanent supportive housing.
Background: Homelessness is a national crisis in the United States, particularly in the Veteran population. Due to multiple chronic conditions, homeless individuals have elevated risk for acute care service use. Engagement in primary and specialty care can mitigate this risk. Interventions grounded in evidence-based practices of peer support, patient-centered care, and whole health are effective for increasing service engagement. However, implementation of such interventions with high-acuity patients often requires multi-component strategies that are intensive and costly. This study protocol describes a hybrid type 3 effectiveness-implementation trial of Employing Peer Outreach and Whole Health in Recovery (EMPOWER) with high-need, homeless-experienced Veterans in permanent supportive housing and will evaluate the impact and cost of a high-intensity (vs. low-intensity) strategy on implementation outcomes.
Methods: (Aim 1) At 7 sites in the Veterans Health Administration (VA), a mixed methods pre-implementation evaluation will identify determinants and their potential impact on uptake of the EMPOWER and inform modifications to the intervention and implementation strategies as needed. (Aim 2) A staircase cluster randomized design will evaluate the rollout of the implementation strategies, beginning with Audit and Feedback (low-intensity) and then switching to Facilitation (high-intensity) after 6 months. Facilitation is hypothesized to have a greater impact on the reach, effectiveness, adoption, implementation (fidelity), and maintenance of EMPOWER. (Aim 3) A budget impact analysis will estimate the average cost of implementing EMPOWER at future sites and comparative costs for implementing the low- and high-intensity strategies.
Anticipated Impact: This study will provide information on the relative impacts and relative costs of strategies aimed at implementing a peer-led, patient-centered, whole health intervention for homeless-experienced Veterans in permanent supportive housing. The findings will provide guidance to VA and other healthcare systems that serve the aging population of homeless-experienced Veterans.
2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.
This study's planned enrollment of 278 is above the median of 108 across 1,840 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
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The criteria were revised on the registry on Oct 2, 2026. See what changed
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From these reports, the investigators will identify patients at each implementation site who are
Exclusion Criteria:
For the LI phase of a site's implementation, a light-touch strategy will be used to implement EMPOWER; specifically, Audit and Feedback. In Audit and Feedback, key stakeholders at sites receive summarized data about their performance relative to a standard or benchmark. Specifically, HUD-VASH peers and supervisors at each site will be emailed monthly automated reports on EMPOWER fidelity data from the EHR (e.g., % of HUD-VASH patients with a Personal Health Plan note) as well as aggregated data on treatment engagement via the Hot Spot dashboard (e.g., % of HUD-VASH Veterans with an SUD diagnosis who received SUD specialty care in the past month). The monthly reports will include tailored action item recommendations based on the local site's performance. Under the LI strategy, sites will not be provided interactive support to review these reports.
Behavioral: Employing Peer Outreach and Whole Health in Recovery (EMPOWER)
For the HI phase of a site's implementation, a higher-intensity strategy will be used to implement EMPOWER; specifically, Facilitation. Facilitation is a collaborative strategy in which trained individuals work with organizations or teams to support the adoption, implementation, and sustainment of an evidence-based practice (EBP). It is a dynamic process that involves tailored guidance, problem-solving, technical assistance, and capacity-building activities to address specific barriers and leverage facilitators of change. To this end, external facilitators often collaborate with local champions to bring expertise regarding the implementation processes and have transferable knowledge in relevant clinical and behavior change models that inform the EBP's implementation.
Behavioral: Employing Peer Outreach and Whole Health in Recovery (EMPOWER)
EMPOWER is a multicomponent intervention to facilitate homeless-experienced Veterans' (HEVs) care engagement: (DATA ANALYTICS) HUD-VASH case managers identify high-need, HUD-VASH Veterans on the Homeless Registry Hot Spot Report. Veterans' profiles are reviewed to learn about their chronic health conditions, housing status, acute care use, and engagement in supportive care. (PEER SUPPORT): HUD-VASH peers meet with identified Veterans for up to six months, averaging once-per week sessions for the first three months, with step-down in frequency as Veterans begin to engage in services and reach their goals. (WHOLE HEALTH): During sessions, peers use a Whole Health approach to collaboratively develop personal health goals that align with the Veteran's priorities and values-e.g, help Veterans completing a Personal Health Inventory and developing a Personal Health Plans. Provider communications: Peers communicate with a Veteran's care providers to share the Veteran's personal health goals.
Also known as: EMPOWER
Reach
Reach will be measured in terms of the number of patients who are willing to receive EMPOWER, out of all patients that are estimated to be eligible at potential sites.
Time frame: 18 months
Adoption
Adoption will be measured in terms of the number of peers in HUD-VASH at sites that are trained in EMPOWER and initiate the intervention with eligible patients at their site.
Time frame: 18 months
Implementation
Implementation will be measured in terms of rate of completion of peer encounters at the site level and rate of completion of the elements of EMPOWER (e.g., percentage of EMPOWER patients with a Personal Health Plan entered into the EHR; percentage of EMPOWER patients who were referred to a Whole Health service at the local facility). These rates will be measured via activity logs embedded in the EHR and electronic data capture logs to document type and length of encounters.
Time frame: 18 months
Maintenance
Maintenance will be measured by the number of patients who are continuing to engage in EMPOWER and other VA services over the duration of the implementation phase (18 months).
Time frame: 18 months
Effectiveness - Mental Health Outpatient Care
Among patients who receive EMPOWER and have a mental health diagnosis, the number of outpatient visits for mental health care they receive after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters).
Time frame: 6 months
Effectiveness - Substance Use Disorder Outpatient Care
Among patients who receive EMPOWER and have a diagnosis of a substance use disorder (SUD), the number of outpatient visits for SUD care they receive after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters).
Time frame: 6 months
Effectiveness - Primary Care
Among patients who receive EMPOWER, the number of primary care visits they attend after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters).
Time frame: 6 months
Effectiveness - Whole Health care
Among patients who receive EMPOWER, the number of outpatient visits for Whole Health-related care they receive after 6 months, as measured by VA administrative data (e.g., stop codes of outpatient encounters of health coaching and other complementary and integrative services).
Time frame: 6 months
Effectiveness - Hospitalizations
Among patients who receive EMPOWER, the number of bed days of care for ambulatory-care sensitive conditions after 6 months, as measured by VA administrative data (e.g., Bedsection codes).
Time frame: 6 months
Effectiveness - Emergency department (ED) visits
Among patients who receive EMPOWER, the number of visits to an emergency department after 6 months, as measured by VA administrative data (e.g., stop codes).
Time frame: 6 months
Plan to share: No
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