Homeless Overdose Prevention- Expansion

NCT07716202 | Not Yet Recruiting

• 1 other identifier: QUX 26-003
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

Homeless Overdose Prevention - Expansion (HOPE), tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing. HOPE sites will receive a playbook that offers step-by-step instructions, tools, templates, and checklists tailorable to site needs; sites will also receive performance feedback about their performance relative to a standard or benchmark.

Conditions

Homelessness; Opioid Education and Naloxone Distribution (OEND); Substance Use Disorder

Keywords

Veterans; Risk Mitigation; Unstably Housed; Social Work; Implementation Science

Outcome Measures

Primary Outcomes (4)

• Reach - VA administrative data

  Reach will be measured in terms of the proportion of Veterans who receive OEND, including overdose education and/or a naloxone prescription, using VA administrative data.

  12 months

• Adoption - VA administrative data

  Adoption will be measured in terms of the proportion of VHA pharmacy and other prescriber staff who delivered OEND, using VA administrative data.

  12 months

• Implementation - Electronic Data Capture

  Implementation will be measured in terms of adherence of sites to tailored implementation. Implementation fidelity will be captured using electronic data capture.

  12 months

• Maintenance - Rapid Qualitative Interviews

  Maintenance will be assessed by the extent to which OEND has become part of routine organizational practices and policies, including clinical processes to maintain OEND. Maintenance will be assessed 6-12 months post-implementation using semi-structured interviews. Interviews will be conducted with HUD-VASH staff and measured using rapid qualitative methods and administrative data. Administrative data will be used to measure whether OEND continues to be provided in the maintenance period.

  6-12 months

Secondary Outcomes (1)

• Effectiveness

  12 months

Study Arms (2)

Low-Intensity (LI)

ACTIVE COMPARATOR

The LI implementation approach will include providing sites with the HOPE Implementation Playbook, including access to the associated resources (e.g., OEND note templates) on the HOPE SharePoint site. Investigators will begin with an initial training session with each site, and lead a monthly learning collaborative for 6 months. The LI phase will allow evaluation of the effect of a comprehensive playbook on uptake of OEND.

Behavioral: Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity

High-Intensity (HI)

ACTIVE COMPARATOR

The HI approach will include: (1) creation of a novel clinical team (i.e., prescriber and HUD-VASH team) if not created under LI; (2) monthly overdose education and training delivered synchronously via Microsoft Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance. Investigators hypothesize the HI implementation strategy will have a greater impact on RE-AIM outcomes.

Behavioral: Homeless Overdose Prevention- Expansion (HOPE) - High Intensity

Interventions

Homeless Overdose Prevention- Expansion (HOPE) - High Intensity BEHAVIORAL

Homeless Overdose Prevention - Expansion (HOPE) tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing. During pre-implementation, investigators will conduct a rapid qualitative evaluation with 5-10 key informants at each of the identified implementation sites to refine the implementation approach. Investigators will evaluate low-intensity (LI) vs high-intensity (HI) strategy. The HI approach includes: (1) creation of a novel clinical team if not created under LI; (2) monthly overdose education and training delivered synchronously via Microsoft Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance.

High-Intensity (HI)

Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity BEHAVIORAL

Homeless Overdose Prevention - Expansion (HOPE) tests implementation of overdose education and naloxone distribution (OEND), a program that targets homeless experienced Veterans at risk for overdose, including Veterans in community-based supportive housing. During pre-implementation, investigators will conduct a rapid qualitative evaluation with 5-10 key informants at each of the identified implementation sites to refine the implementation approach. Investigators will evaluate low-intensity (LI) vs high-intensity (HI) strategy. The LI implementation approach will include providing sites with the HOPE Implementation Playbook, including access to the associated resources on the HOPE SharePoint site.

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:

• Veterans enrolled in HUD-VASH at risk for opioid overdose (based on existing HOPE algorithms aligned with Pharmacy Benefit Manager data definitions), drawing from VA administrative data.

You may not qualify if:

• Not flagged by existing HOPE algorithms
• Not currently enrolled in HUD-VASH
• 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

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Amanda M. Midboe, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda M Midboe, PhD

CONTACT

(650) 493-5000; Amanda.Midboe@va.gov

Madeleine C Golding, MPH BA

CONTACT

(650) 614-9997; madeleine.golding@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: During implementation, investigators will conduct rapid qualitative evaluation with 5-10 key informants at each implementation site to refine the implementation approach (Aim1). Investigators will evaluate low intensity (LI) vs high intensity (HI) strategy. The LI implementation approach will include providing sites with the HOPE Implementation Playbook and access to the associated resources on the HOPE SharePoint site. Investigators will provide an initial training session with each site and lead a monthly learning collaborative for 6 months. The HI approach includes: (1) creation of a novel clinical team (i.e., prescriber and HUD-VASH team) if not created under LI; (2) monthly overdose education and training delivered synchronously via Microsoft Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance (Aim2). Investigators will incorporate findings from the Phase 2 implementation trial (Aim3).

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 21, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)