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Permanent Supportive Housing Overdose Prevention (POP)

Primary Purpose

Overdose

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CSH-Delivered Overdose Prevention Support
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Overdose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cluster 1

Cluster 2

Cluster 3

Cluster 4

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Tenant Substance-Use-Related Emergency Department Visits
Data derived from NY Medicaid data.
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Data derived from NY Medicaid data.
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 14, 2023
Last Updated
October 16, 2023
Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05786222
Brief Title
Permanent Supportive Housing Overdose Prevention
Acronym
POP
Official Title
Permanent Supportive Housing Overdose Prevention (POP) Study: A Hybrid Type 3 Stepped Wedge Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 26, 2023 (Actual)
Primary Completion Date
February 28, 2026 (Anticipated)
Study Completion Date
January 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overdose

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cluster 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cluster 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cluster 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Cluster 4
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CSH-Delivered Overdose Prevention Support
Intervention Description
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).
Primary Outcome Measure Information:
Title
Fidelity Checklist Score
Description
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.
Time Frame
Month 1
Title
Fidelity Checklist Score
Description
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.
Time Frame
Month 8
Title
Fidelity Checklist Score
Description
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.
Time Frame
Month 15
Title
Fidelity Checklist Score
Description
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.
Time Frame
Month 22
Title
Fidelity Checklist Score
Description
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.
Time Frame
Month 29
Secondary Outcome Measure Information:
Title
Intervention Appropriateness Measure (IAM) Score
Description
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).
Time Frame
Month 1
Title
Intervention Appropriateness Measure (IAM) Score
Description
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).
Time Frame
Month 8
Title
Intervention Appropriateness Measure (IAM) Score
Description
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).
Time Frame
Month 15
Title
Intervention Appropriateness Measure (IAM) Score
Description
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).
Time Frame
Month 22
Title
Intervention Appropriateness Measure (IAM) Score
Description
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).
Time Frame
Month 29
Title
Feasibility of Intervention Measure (FIM) Score
Description
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).
Time Frame
Month 1
Title
Feasibility of Intervention Measure (FIM) Score
Description
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).
Time Frame
Month 8
Title
Feasibility of Intervention Measure (FIM) Score
Description
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).
Time Frame
Month 15
Title
Feasibility of Intervention Measure (FIM) Score
Description
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).
Time Frame
Month 22
Title
Feasibility of Intervention Measure (FIM) Score
Description
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).
Time Frame
Month 29
Title
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Description
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.
Time Frame
Month 1
Title
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Description
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.
Time Frame
Month 8
Title
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Description
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.
Time Frame
Month 15
Title
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Description
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.
Time Frame
Month 22
Title
Brief Opioid Overdose Knowledge (BOOK) Survey Score
Description
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.
Time Frame
Month 29
Title
Perceived Stigma Toward Substance Users Scale Score
Description
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.
Time Frame
Month 1
Title
Perceived Stigma Toward Substance Users Scale Score
Description
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.
Time Frame
Month 8
Title
Perceived Stigma Toward Substance Users Scale Score
Description
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.
Time Frame
Month 15
Title
Perceived Stigma Toward Substance Users Scale Score
Description
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.
Time Frame
Month 22
Title
Perceived Stigma Toward Substance Users Scale Score
Description
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.
Time Frame
Month 29
Title
Tenant Substance-Use-Related Emergency Department Visits
Description
Data derived from NY Medicaid data.
Time Frame
Month 1
Title
Tenant Substance-Use-Related Emergency Department Visits
Description
Data derived from NY Medicaid data.
Time Frame
Month 8
Title
Tenant Substance-Use-Related Emergency Department Visits
Description
Data derived from NY Medicaid data.
Time Frame
Month 15
Title
Tenant Substance-Use-Related Emergency Department Visits
Description
Data derived from NY Medicaid data.
Time Frame
Month 22
Title
Tenant Substance-Use-Related Emergency Department Visits
Description
Data derived from NY Medicaid data.
Time Frame
Month 29
Title
Tenant Substance-Use-Related Emergency Department Visits
Description
Data derived from NY Medicaid data.
Time Frame
Month 35
Title
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Description
Data derived from NY Medicaid data.
Time Frame
Month 1
Title
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Description
Data derived from NY Medicaid data.
Time Frame
Month 8
Title
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Description
Data derived from NY Medicaid data.
Time Frame
Month 15
Title
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Description
Data derived from NY Medicaid data.
Time Frame
Month 22
Title
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Description
Data derived from NY Medicaid data.
Time Frame
Month 29
Title
Tenant Receipt of Medication for Opioid Use Disorder (MOUD)
Description
Data derived from NY Medicaid data.
Time Frame
Month 35
Title
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Description
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Time Frame
Month 1
Title
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Description
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Time Frame
Month 8
Title
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Description
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Time Frame
Month 15
Title
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Description
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Time Frame
Month 22
Title
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Description
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Time Frame
Month 29
Title
Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment
Description
Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.
Time Frame
Month 35
Title
Adoption Checklist Score
Description
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.
Time Frame
Month 1
Title
Adoption Checklist Score
Description
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.
Time Frame
Month 8
Title
Adoption Checklist Score
Description
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.
Time Frame
Month 15
Title
Adoption Checklist Score
Description
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.
Time Frame
Month 22
Title
Adoption Checklist Score
Description
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.
Time Frame
Month 29
Title
Acceptability of Intervention Measure (AIM) Score
Description
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).
Time Frame
Month 1
Title
Acceptability of Intervention Measure (AIM) Score
Description
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).
Time Frame
Month 8
Title
Acceptability of Intervention Measure (AIM) Score
Description
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).
Time Frame
Month 15
Title
Acceptability of Intervention Measure (AIM) Score
Description
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).
Time Frame
Month 22
Title
Acceptability of Intervention Measure (AIM) Score
Description
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).
Time Frame
Month 29
Title
Organizational Priority Measure Score
Description
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.
Time Frame
Month 1
Title
Organizational Priority Measure Score
Description
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.
Time Frame
Month 8
Title
Organizational Priority Measure Score
Description
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.
Time Frame
Month 15
Title
Organizational Priority Measure Score
Description
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.
Time Frame
Month 22
Title
Organizational Priority Measure Score
Description
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.
Time Frame
Month 29
Title
Sustainment based on Fidelity Checklist Score
Description
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.
Time Frame
Month 15
Title
Sustainment based on Fidelity Checklist Score
Description
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.
Time Frame
Month 22
Title
Sustainment based on Fidelity Checklist Score
Description
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.
Time Frame
Month 29
Title
Sustainment based on Fidelity Checklist Score
Description
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.
Time Frame
Month 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Doran, MD, MHS
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified staff and tenant questionnaire data will be shared beginning 3 months and ending 5 years following article publication with qualified researchers who have a research question appropriate to the data and of potential benefit to permanent supportive housing tenants. Deidentified data will only be provided in aggregate after completion of a data use agreement (DUA). Requests should be directed to Kelly.Doran@nyulangone.org. All requests for such data will be presented to the study's Advisory Board for approval. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing 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.

Learn more about this trial

Permanent Supportive Housing Overdose Prevention

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