Permanent Supportive Housing Overdose Prevention

Overdose Clinical Trial

— POP  

Official title:

Permanent Supportive Housing Overdose Prevention (POP) Study: A Hybrid Type 3 Stepped Wedge Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05786222
• Other study ID #: 23-00098
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 26, 2023
• Est. completion date: January 31, 2027

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1350
• Est. completion date: January 31, 2027
• Est. primary completion date: February 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Drug Overdose
• Overdose

Intervention

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).

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Intervention Appropriateness Measure (IAM) Score	1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 1
Secondary	Intervention Appropriateness Measure (IAM) Score	1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 8
Secondary	Intervention Appropriateness Measure (IAM) Score	1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 15
Secondary	Intervention Appropriateness Measure (IAM) Score	1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 22
Secondary	Intervention Appropriateness Measure (IAM) Score	1-item assessment of intervention appropriateness (adapted from Weiner, et al.) for each of three overdose prevention categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 29
Secondary	Feasibility of Intervention Measure (FIM) Score	1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 1
Secondary	Feasibility of Intervention Measure (FIM) Score	1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 8
Secondary	Feasibility of Intervention Measure (FIM) Score	1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 15
Secondary	Feasibility of Intervention Measure (FIM) Score	1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 22
Secondary	Feasibility of Intervention Measure (FIM) Score	1-item assessment of intervention feasibility (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 29
Secondary	Brief Opioid Overdose Knowledge (BOOK) Survey Score	BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.	Month 1
Secondary	Brief Opioid Overdose Knowledge (BOOK) Survey Score	BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.	Month 8
Secondary	Brief Opioid Overdose Knowledge (BOOK) Survey Score	BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.	Month 15
Secondary	Brief Opioid Overdose Knowledge (BOOK) Survey Score	BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.	Month 22
Secondary	Brief Opioid Overdose Knowledge (BOOK) Survey Score	BOOK is a 12-item assessment of opioid overdose knowledge (Dunn, et al.) administered to staff. For each item, staff select either "True" or "False." The total score ranges from 0-12; higher scores indicate greater opioid overdose knowledge.	Month 29
Secondary	Perceived Stigma Toward Substance Users Scale Score	8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.	Month 1
Secondary	Perceived Stigma Toward Substance Users Scale Score	8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.	Month 8
Secondary	Perceived Stigma Toward Substance Users Scale Score	8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.	Month 15
Secondary	Perceived Stigma Toward Substance Users Scale Score	8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.	Month 22
Secondary	Perceived Stigma Toward Substance Users Scale Score	8-item assessment of perceived stigma toward substance users (Luoma, et al.). Survey is administered to staff. Each item is ranked on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). The score is the sum of responses (with some items reverse-scored). The total score ranges from 8-32, with higher scores indicating greater perceived stigma.	Month 29
Secondary	Tenant Substance-Use-Related Emergency Department Visits	Data derived from NY Medicaid data.	Month 1
Secondary	Tenant Substance-Use-Related Emergency Department Visits	Data derived from NY Medicaid data.	Month 8
Secondary	Tenant Substance-Use-Related Emergency Department Visits	Data derived from NY Medicaid data.	Month 15
Secondary	Tenant Substance-Use-Related Emergency Department Visits	Data derived from NY Medicaid data.	Month 22
Secondary	Tenant Substance-Use-Related Emergency Department Visits	Data derived from NY Medicaid data.	Month 29
Secondary	Tenant Substance-Use-Related Emergency Department Visits	Data derived from NY Medicaid data.	Month 35
Secondary	Tenant Receipt of Medication for Opioid Use Disorder (MOUD)	Data derived from NY Medicaid data.	Month 1
Secondary	Tenant Receipt of Medication for Opioid Use Disorder (MOUD)	Data derived from NY Medicaid data.	Month 8
Secondary	Tenant Receipt of Medication for Opioid Use Disorder (MOUD)	Data derived from NY Medicaid data.	Month 15
Secondary	Tenant Receipt of Medication for Opioid Use Disorder (MOUD)	Data derived from NY Medicaid data.	Month 22
Secondary	Tenant Receipt of Medication for Opioid Use Disorder (MOUD)	Data derived from NY Medicaid data.	Month 29
Secondary	Tenant Receipt of Medication for Opioid Use Disorder (MOUD)	Data derived from NY Medicaid data.	Month 35
Secondary	Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment	Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.	Month 1
Secondary	Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment	Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.	Month 8
Secondary	Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment	Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.	Month 15
Secondary	Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment	Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.	Month 22
Secondary	Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment	Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.	Month 29
Secondary	Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment	Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.	Month 35
Secondary	Adoption Checklist Score	20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.	Month 1
Secondary	Adoption Checklist Score	20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.	Month 8
Secondary	Adoption Checklist Score	20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.	Month 15
Secondary	Adoption Checklist Score	20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.	Month 22
Secondary	Adoption Checklist Score	20-item checklist assessing building adoption of each overdose prevention practice. Checklist is included in a subset of staff surveys. Buildings will receive an adoption checklist score of 0 (not adopted) or 1 (adopted) for each of 20 overdose prevention practices. The total score is the sum of responses and ranges from 0-20, with higher scores indicating greater adoption.	Month 29
Secondary	Acceptability of Intervention Measure (AIM) Score	1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 1
Secondary	Acceptability of Intervention Measure (AIM) Score	1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 8
Secondary	Acceptability of Intervention Measure (AIM) Score	1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 15
Secondary	Acceptability of Intervention Measure (AIM) Score	1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 22
Secondary	Acceptability of Intervention Measure (AIM) Score	1-item assessment of intervention acceptability (adapted from Weiner, et al.) for each of the three overdose prevention practice categories, administered to staff and rated on a Likert scale from 1 (completely disagree) to 5 (completely agree).	Month 29
Secondary	Organizational Priority Measure Score	7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.	Month 1
Secondary	Organizational Priority Measure Score	7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.	Month 8
Secondary	Organizational Priority Measure Score	7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.	Month 15
Secondary	Organizational Priority Measure Score	7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.	Month 22
Secondary	Organizational Priority Measure Score	7-item assessment of organizational priority (adapted from Klein, et al.) administered to staff and rated on a Likert scale from 1 (not true) to 5 (definitely true). The total score is the sum of responses and ranges from 7 to 35; higher scores indicate higher organizational priority.	Month 29
Secondary	Sustainment based on Fidelity Checklist Score	Sustainment of the overdose prevention practices will be measured using fidelity checklist score results. 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
Secondary	Sustainment based on Fidelity Checklist Score	Sustainment of the overdose prevention practices will be measured using fidelity checklist score results. 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
Secondary	Sustainment based on Fidelity Checklist Score	Sustainment of the overdose prevention practices will be measured using fidelity checklist score results. 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	Sustainment based on Fidelity Checklist Score	Sustainment of the overdose prevention practices will be measured using fidelity checklist score results. 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 36