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

NCT07309224 | Not Yet Recruiting

• 1 other identifier: QUX 26-002
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorder; Mental Health Disorder; Homelessness

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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).

  18 months

Secondary Outcomes (6)

• Effectiveness - Mental Health Outpatient Care

  6 months

• Effectiveness - Substance Use Disorder Outpatient Care

  6 months

• Effectiveness - Primary Care

  6 months

• Effectiveness - Whole Health care

  6 months

• Effectiveness - Hospitalizations

  6 months

Study Arms (2)

Low-Intensity (LI)

ACTIVE COMPARATOR

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)

High-Intensity (HI)

EXPERIMENTAL

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)

Interventions

Employing Peer Outreach and Whole Health in Recovery (EMPOWER) BEHAVIORAL

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

High-Intensity (HI); Low-Intensity (LI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Mental Disorders

Interventions

Salvage Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Daniel M. Blonigen, PhD MA

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel M Blonigen, PhD MA

CONTACT

(650) 493-5000; Daniel.Blonigen@va.gov

Jennifer S Smith, MPH

CONTACT

(650) 493-5000; jennifer.s.smith@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 30, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)