Homeless Overdose Prevention- Expansion (HOPE)

Homeless Overdose Prevention- Expansion (HOPE) (QUE 25-014)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Substance Use Disorder; Homelessness; Opioid Education and Naloxone Distribution (OEND)
• Intervention / Treatment: Behavioral: Homeless Overdose Prevention- Expansion (HOPE) - Low Intensity; Behavioral: Homeless Overdose Prevention- Expansion (HOPE) - High Intensity

Detailed Description

The proposed HOPE project builds on the Phase 1 implementation trial at 6 Veterans Health Administration health care systems (part of the current Bridge QUERI). This trial evaluated a 6-month implementation approach that was tailored based on the determinants identified for each of the Housing and Urban Development-VA Supportive Housing (HUD-VASH) teams as part of pre-implementation formative evaluations at each site. During the Phase 1 HOPE trial, HUD-VASH case managers reached more than 1700 HUD-VASH Veterans at risk for opioid overdose, providing education about their risk and naloxone to those who accepted the prescription. The implementation trial was conducted with 33 HUD-VASH teams at 6 low performing VISN 21 sites selected in partnership with regional HUD-VASH leadership. Approximately 300 HUD-VASH social workers were trained on OEND. Five of the 6 healthcare systems also became high performers (i.e., above the national average for naloxone receipt across all VA healthcare systems).

Phase 2 of the HOPE trial will rely on the core evidence-based practice (EBP) of OEND, including identifying community-based naloxone resources, but the investigators will also provide each HUD-VASH team education and training regarding xylazine (including how it may increase opioid-overdose mortality risk) and fentanyl test strips. The latter is particularly important given that the investigators will identify community partnerships for receipt of confidential OEND since many non-VA harm reduction services do offer drug test strips. Also, drug test strips are prohibited in certain states that identify them as illegal drug paraphernalia. States are regularly revisiting these laws, and the investigators will update each implementation site about the current status of laws regarding drug test strips as part of implementation.

In Phase 2 of the HOPE trial, the investigators will evaluate the use of an Implementation Playbook developed during HOPE's Phase 1 implementation trial. The Low Intensity (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. The investigators will begin with an initial training session with each site, and investigators will lead a monthly learning collaborative for 6 months. The LI phase will allow investigators to evaluate the effect of a comprehensive playbook on uptake of OEND. The High Intensity (HI) approach, led by investigators, 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 MS Teams; (3) monthly audit and feedback for each HUD-VASH team on progress toward providing OEND; and (4) technical assistance.

• Study Type: Interventional
• Enrollment (Estimated): 1200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda M Midboe, PhD; Phone Number: 27829 (650) 493-5000; Email: Amanda.Midboe@va.gov
• Study Contact Backup: Name: Madeleine C Golding, MPH BA; Phone Number: 27422 (650) 614-9997; Email: madeleine.golding@va.gov

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304-1207
      • VA Palo Alto Health Care System, Palo Alto, CA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Not flagged by existing HOPE algorithms
• Not currently enrolled in HUD-VASH
• Is not a patient at a participating site of the implementation trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-Intensity (LI); 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; 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.
Active Comparator: High-Intensity (HI); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	Among Veterans who received overdose education and/or naloxone, the number of Veterans at-risk of opioid overdose who were hospitalized for an opioid overdose or visited a VA emergency department for an opioid overdose, as measured by VA administrative data.	12 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Amanda M. Midboe, PhD, VA Palo Alto Health Care System, Palo Alto, CA

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): July 31, 2030
• Study Completion (Estimated): September 30, 2030

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Veterans; Implementation Science; Social Work; Unstably Housed; Risk Mitigation
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: QUX 26-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No