Permanent Supportive Housing Overdose Prevention

NCT ID: NCT05786222

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 1350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2027-01-31

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.

Detailed Description

This single-center study is a hybrid type 3 trial with a stepped wedge cluster randomized controlled trial design, with primary objectives of studying implementation of overdose prevention practices in PSH and secondary objectives of examining effectiveness on clinically relevant outcomes and multilevel factors influencing implementation. Twenty participating PSH building sites will be randomized into four intervention clusters of five buildings each. With the stepped wedge design, all clusters of study PSH buildings will begin in the control condition. Clusters are randomly assigned to receive the intervention at different times, with all eventually receiving the six-month implementation strategy package intervention from Corporation for Supportive Housing (CSH). Study investigators will survey PSH building tenants and staff; conduct observation of building policies and procedures; analyze tenant Medicaid data; and interview staff and tenants.

Conditions

Overdose

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Cluster 1

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.

Group Type: EXPERIMENTAL

CSH-Delivered Overdose Prevention Support

Intervention Type: 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 2

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.

Group Type: EXPERIMENTAL

CSH-Delivered Overdose Prevention Support

Intervention Type: 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 3

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.

Group Type: EXPERIMENTAL

CSH-Delivered Overdose Prevention Support

Intervention Type: 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 4

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.

Group Type: EXPERIMENTAL

CSH-Delivered Overdose Prevention Support

Intervention Type: 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).

Interventions

CSH-Delivered Overdose Prevention Support

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelly Doran, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37287026 (View on PubMed)

Other Identifiers

23-00098

Identifier Type: -

Identifier Source: org_study_id