Clinical trial NCT05786222: Permanent Supportive Housing Overdose Prevention
Official title: Permanent Supportive Housing Overdose Prevention (POP) Study: A Hybrid Type 3 Stepped Wedge Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Overdose
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-03-27
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Fidelity Checklist Score
timeFrame: Month 1
measure: Fidelity Checklist Score
timeFrame: Month 8
measure: Fidelity Checklist Score
timeFrame: Month 15
measure: Fidelity Checklist Score
timeFrame: Month 22
measure: Fidelity Checklist Score
timeFrame: Month 29
Secondary outcomes:
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: Month 1
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: Month 8
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: Month 15
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: Month 22
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: Month 29
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: Month 1
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: Month 8
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: Month 15
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: Month 22
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: Month 29
measure: Brief Opioid Overdose Knowledge (BOOK) Survey Score
timeFrame: Month 1
measure: Brief Opioid Overdose Knowledge (BOOK) Survey Score
timeFrame: Month 8
measure: Brief Opioid Overdose Knowledge (BOOK) Survey Score
timeFrame: Month 15
measure: Brief Opioid Overdose Knowledge (BOOK) Survey Score
timeFrame: Month 22
measure: Brief Opioid Overdose Knowledge (BOOK) Survey Score
timeFrame: Month 29
measure: Perceived Stigma Toward Substance Users Scale Score
timeFrame: Month 1
measure: Perceived Stigma Toward Substance Users Scale Score
timeFrame: Month 8
measure: Perceived Stigma Toward Substance Users Scale Score
timeFrame: Month 15
measure: Perceived Stigma Toward Substance Users Scale Score
timeFrame: Month 22
measure: Perceived Stigma Toward Substance Users Scale Score
timeFrame: Month 29
measure: Tenant Substance-Use-Related Emergency Department Visits
timeFrame: Month 1
measure: Tenant Substance-Use-Related Emergency Department Visits
timeFrame: Month 8
measure: Tenant Substance-Use-Related Emergency Department Visits
timeFrame: Month 15
measure: Tenant Substance-Use-Related Emergency Department Visits
timeFrame: Month 22
measure: Tenant Substance-Use-Related Emergency Department Visits
timeFrame: Month 29
measure: Tenant Substance-Use-Related Emergency Department Visits
timeFrame: Month 35
measure: Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
timeFrame: Month 1
measure: Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
timeFrame: Month 8
measure: Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
timeFrame: Month 15
measure: Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
timeFrame: Month 22
measure: Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
timeFrame: Month 29
measure: Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
timeFrame: Month 35
measure: Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
timeFrame: Month 1
measure: Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
timeFrame: Month 8
measure: Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
timeFrame: Month 15
measure: Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
timeFrame: Month 22
measure: Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
timeFrame: Month 29
measure: Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
timeFrame: Month 35
measure: Adoption Checklist Score
timeFrame: Month 1
measure: Adoption Checklist Score
timeFrame: Month 8
measure: Adoption Checklist Score
timeFrame: Month 15
measure: Adoption Checklist Score
timeFrame: Month 22
measure: Adoption Checklist Score
timeFrame: Month 29
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: Month 1
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: Month 8
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: Month 15
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: Month 22
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: Month 29
measure: Organizational Priority Measure Score
timeFrame: Month 1
measure: Organizational Priority Measure Score
timeFrame: Month 8
measure: Organizational Priority Measure Score
timeFrame: Month 15
measure: Organizational Priority Measure Score
timeFrame: Month 22
measure: Organizational Priority Measure Score
timeFrame: Month 29
measure: Sustainment based on Fidelity Checklist Score
timeFrame: Month 15
measure: Sustainment based on Fidelity Checklist Score
timeFrame: Month 22
measure: Sustainment based on Fidelity Checklist Score
timeFrame: Month 29
measure: Sustainment based on Fidelity Checklist Score
timeFrame: Month 36
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kelly Doran, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: