Trials / Enrolling By Invitation
Enrolling By InvitationNCT05786222
Permanent Supportive Housing Overdose Prevention
Permanent Supportive Housing Overdose Prevention (POP) Study: A Hybrid Type 3 Stepped Wedge Randomized Controlled Trial
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,350 (estimated)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | 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). |
Timeline
- Start date
- 2023-09-26
- Primary completion
- 2026-02-28
- Completion
- 2027-01-31
- First posted
- 2023-03-27
- Last updated
- 2025-06-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT05786222. Inclusion in this directory is not an endorsement.