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Homeless Overdose Prevention- Expansion (HOPE)

28 juli 2026 bijgewerkt door: VA Office of Research and Development

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

1200

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • California
      • Palo Alto, California, Verenigde Staten, 94304-1207
        • VA Palo Alto Health Care System, Palo Alto, CA

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
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.
Actieve vergelijker: 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.
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Reach - VA administrative data
Tijdsspanne: 12 months
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
Tijdsspanne: 12 months
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
Tijdsspanne: 12 months
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
Tijdsspanne: 6-12 months
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Effectiveness
Tijdsspanne: 12 months
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Amanda M. Midboe, PhD, VA Palo Alto Health Care System, Palo Alto, CA

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

31 augustus 2026

Primaire voltooiing (Geschat)

31 juli 2030

Studie voltooiing (Geschat)

30 september 2030

Studieregistratiedata

Eerst ingediend

2 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

15 juli 2026

Eerst geplaatst (Werkelijk)

21 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

28 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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