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Homeless Overdose Prevention- Expansion

ConditionsHomelessnessOpioid Education and Naloxone Distribution (OEND)Substance Use Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Not flagged by existing HOPE algorithms

Not currently enrolled in HUD-VASH

Is not a patient at a participating site of the implementation trial

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

1,200 Participants
are divided into 2 treatment groups
Group A: Low-Intensity (LI)Active comparator 1 intervention
Group B: High-Intensity (HI)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months
4

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.

Time frame
6-12 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: