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Employing Peer Outreach and Whole Health in Recovery for Homeless-Experienced Veterans

Employing Peer Outreach and Whole Health in Recovery (EMPOWER) for Homeless-Experienced Veterans: A Hybrid Type III Implementation Trial (QUE 25-014)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07309224
Acronym
EMPOWER
Enrollment
278
Registered
2025-12-30
Start date
2026-10-01
Completion date
2030-09-30
Last updated
2026-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Homelessness, Mental Health Disorder, Substance Use Disorder

Keywords

Veterans, Homeless Persons, Peer Influence, Whole Person Health, Implementation Science

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALEmploying 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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

The investigators will conduct an adaptation of the multi-site hybrid III cluster randomized trial design to evaluate the implementation of EMPOWER through tailored low-intensity and high-intensity strategies. Specifically, the investigators will use a staircase design - an adaptation to stepped wedge designs (SWD). This design accommodates more flexible implementation (i.e., less burden to sites and clinicians) while at the same time offering robust statistical efficiency, given that statistical information is often strongest around time periods in the SWD when a strategy switches. For EMPOWER, of interest is the effect of switching from Low Intensity (LI - i.e., Audit and Feedback) to High Intensity (HI - i.e., Facilitation) implementation strategies; an imbalanced design will be employed in which sites will spend twice as long in HI than LI (12 months vs. 6 months, respectively).

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 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 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

Design outcomes

Primary

MeasureTime frameDescription
Reach18 monthsReach 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.
Adoption18 monthsAdoption 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.
Implementation18 monthsImplementation 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.
Maintenance18 monthsMaintenance 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).

Secondary

MeasureTime frameDescription
Effectiveness - Mental Health Outpatient Care6 monthsAmong 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).
Effectiveness - Substance Use Disorder Outpatient Care6 monthsAmong 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).
Effectiveness - Primary Care6 monthsAmong 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).
Effectiveness - Whole Health care6 monthsAmong 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).
Effectiveness - Hospitalizations6 monthsAmong 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).
Effectiveness - ED visits6 monthsAmong 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).

Countries

United States

Contacts

CONTACTDaniel M Blonigen, PhD MA
Daniel.Blonigen@va.gov(650) 493-5000
CONTACTJennifer S Smith, MPH
jennifer.s.smith@va.gov(650) 493-5000
PRINCIPAL_INVESTIGATORDaniel M. Blonigen, PhD MA

VA Palo Alto Health Care System, Palo Alto, CA

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 5, 2026