Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for Homeless-Experienced Veterans: A Hybrid Type III Implementation Trial (QUE 25-014)
| Registry | NCT07309224, acronym EMPOWER |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; non randomized, sequential, masking: none, health services research |
| Enrollment | 278 (Estimated) |
| Sponsor | VA Office of Research and Development (Fed) |
| Conditions | Substance Use Disorder, Mental Health Disorder, Homelessness |
| Interventions | Employing Peer Outreach and Whole Health in Recovery (EMPOWER) (Behavioral) |
| Dates | start 2027-01-01 (estimated), primary completion 2030-07-01 (estimated), completion 2030-09-30 (estimated), first posted 2025-12-30, last updated 2026-10-02 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Substance Use Disorder All trials for Mental Health Disorder All trials of Employing Peer Outreach and Whole Health in Recovery (EMPOWER)
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Low-Intensity (LI) | Active comparator | Behavioral: Employing Peer Outreach and Whole Health in Recovery (EMPOWER) | 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. |
| High-Intensity (HI) | Experimental | 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. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Eligible patients will be identified from VA's Homeless Registry "Hot Spot" reports, which use real-time data on acute care service utilization to identify high-need, housing-insecure patients. * These reports identify Veterans on the VA Homeless Registry (i.e., those who had received VA housing services in the past two years) who had >1 hospital admissions and/or >2 emergency department (ED) visits in the past quarter of the fiscal year. * From these reports, the investigators will identify patients at each implementation site who are * (a) currently enrolled in HUD-VASH * (b) have a mental health and/or substance use disorder (SUD) diagnosis Exclusion Criteria: * Not flagged on the VA's Homeless Registry Hot Spot Report * Not currently enrolled in HUD-VASH * Does not have a mental health and/or substance use disorder diagnosis * Is not a patient at a participating site of the implementation trial
| Facility | City | Country | Status |
|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto, California | United States |