Permanent Supportive Housing Overdose Prevention

NCT05786222 | Active Not Recruiting DMC

• 1 other identifier: 23-00098
• Study Type: interventional
• Target: 1,350
• Locations: 1 country
• Sites: 1

Brief Summary

Permanent supportive housing (PSH), the gold standard intervention for ending chronic homelessness, has expanded rapidly across the U.S. in recent years. Due to a confluence of individual and environmental risk factors, PSH tenants face heightened risk for overdose. While evidence-based practices to prevent overdose exist, they have not been broadly implemented in PSH settings. This study will address this research to practice gap by studying the implementation of evidence-based practices to prevent overdose in 20 PSH buildings in New York. In a community-partnered stepped wedge randomized controlled trial, the investigators will study a package of implementation strategies that includes an implementation toolkit, tenant and staff implementation champions, limited practice facilitation, and learning collaboratives. Outcomes will be examined using surveys and qualitative interviews with PSH tenants and staff; observation; and analysis of Medicaid claims data.

Conditions

Overdose

Outcome Measures

Primary Outcomes (5)

• Fidelity Checklist Score

  Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.

  Month 1

• Fidelity Checklist Score

  Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.

  Month 8

• Fidelity Checklist Score

  Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.

  Month 15

• Fidelity Checklist Score

  Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.

  Month 22

• Fidelity Checklist Score

  Buildings will receive a fidelity checklist score of 0 (not implemented), 1 (partial implementation), or 2 (full implementation) for each overdose prevention practice. The primary outcome is total summed score, with higher scores indicating greater fidelity.

  Month 29

Secondary Outcomes (57)

• Intervention Appropriateness Measure (IAM) Score

  Month 1

• Intervention Appropriateness Measure (IAM) Score

  Month 8

• Intervention Appropriateness Measure (IAM) Score

  Month 15

• Intervention Appropriateness Measure (IAM) Score

  Month 22

• Intervention Appropriateness Measure (IAM) Score

  Month 29

Study Arms (4)

Cluster 1

EXPERIMENTAL

Buildings randomized to Cluster 1 will receive the CSH-delivered intervention at Months 2-7. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period. At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period.

Behavioral: CSH-Delivered Overdose Prevention Support

Cluster 2

EXPERIMENTAL

Buildings randomized to Cluster 2 will receive the CSH-delivered intervention at Months 9-14. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period. At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period.

Behavioral: CSH-Delivered Overdose Prevention Support

Cluster 3

EXPERIMENTAL

Buildings randomized to Cluster 3 will receive the CSH-delivered intervention at Months 16-21. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period. At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period.

Behavioral: CSH-Delivered Overdose Prevention Support

Cluster 4

EXPERIMENTAL

Buildings randomized to Cluster 3 will receive the CSH-delivered intervention at Months 23-28. Tenant surveys will be administered 1 month prior to and 12 months following the start of the intervention period. At all clusters, an all-staff survey will be administered at Months 1, 8, 15, 22, and 29. A sustainment survey will be administered to selected staff-leaders in the 8th month following the end of the intervention period.

Behavioral: CSH-Delivered Overdose Prevention Support

Interventions

CSH-Delivered Overdose Prevention Support BEHAVIORAL

Corporation for Supportive Housing (CSH) will deliver technical support for overdose (OD) prevention in the participating PSH buildings using a package of core implementation strategies: PSH Overdose Prevention (POP) Toolkit (an implementation manual/blueprint for overdose prevention practices); Implementation Champions (staff and tenants in each PSH building will be selected as implementation champions who support implementation and sustainment of OD prevention practices in their buildings); practice facilitation (the practice facilitator \[a trained CSH employee\] will work with the tenant and staff champions in small group workshops and coaching sessions, building their capacity and supporting their work toward implementation of building OD prevention practices); learning collaboratives (PSH buildings starting the intervention at the same time will attend learning collaborative meetings).

Cluster 1; Cluster 2; Cluster 3; Cluster 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tenant surveys: To be eligible to participate in the tenant survey part of this study, an individual must:
• Be a supportive housing tenant in a participating building
• Be at least 18 years old
• Be able to read and respond to a survey in English or Spanish
• Staff surveys: To be eligible to participate in the staff survey part of this study, an individual must work for a participating PSH building (or have worked for one in the past 6 months). All PSH building staff are at least 18 years old and are able to read and respond to a survey in English. Staff surveys will begin with a question confirming eligibility.
• Qualitative interviews: To be eligible to participate in the qualitative interview part of this study, an individual must:
• Work for or live in a participating PSH building
• Serve as staff (including leaders) or tenant implementation champion
• Be at least 18 years old
• Speak and understand English
• Medicaid data analysis: Identifying information for all tenants in participating buildings (to be provided to the study team by buildings as described in a bilaterally signed information sharing agreement) will be used to conduct a match with Medicaid administrative data.

You may not qualify if:

• Children under the age of 18 years old will be excluded, including from the Medicaid data analysis.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (2)

• Gaeta Gazzola M, Torsiglieri A, Blaufarb S, Velez L, Hernandez P, O'Grady MA, Shelley D, Frank D, Cleland CM, Doran KM. Understanding overdose risk and response in permanent supportive housing: results of focus groups with tenants, staff, and leaders. Addict Sci Clin Pract. 2025 Nov 28;20(1):91. doi: 10.1186/s13722-025-00616-4.

  PMID: 41316389 DERIVED

• Doran KM, Torsiglieri A, Blaufarb S, Hernandez P, Melnick E, Velez L, Cleland CM, Neighbors C, O'Grady MA, Shelley D. The POP (Permanent Supportive Housing Overdose Prevention) Study: protocol for a hybrid type 3 stepped-wedge cluster randomized controlled trial. Implement Sci. 2023 Jun 7;18(1):21. doi: 10.1186/s13012-023-01278-z.

  PMID: 37287026 DERIVED

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kelly Doran, MD, MHS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: September 26, 2023
• Primary Completion: March 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Qualified researchers who have a research question appropriate to the data and of potential benefit to permanent supportive housing tenants will be granted access to the data. Requests should be directed to Kelly.Doran@nyulangone.org. Deidentified data will only be provided in aggregate after completion of a data use agreement (DUA). All requests for such data will be presented to the study's Advisory Board for approval.

Locations

US (1)