POP: Permanent Supportive Housing Overdose Prevention

Sponsor
NYU Langone Health (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05786222
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
1,350
1
4
41
32.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: CSH-Delivered Overdose Prevention Support
N/A

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 in buildings; analyze tenant Medicaid data; and interview staff and tenants.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1350 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Permanent Supportive Housing Overdose Prevention (POP) Study: A Hybrid Type 3 Stepped Wedge Randomized Controlled Trial
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2026
Anticipated Study Completion Date :
Jan 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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 12 months following the end of the intervention period.

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).

Experimental: 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 12 months following the end of the intervention period.

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).

Experimental: 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 12 months following the end of the intervention period.

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).

Experimental: 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 12 months following the end of the intervention period.

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).

Outcome Measures

Primary Outcome Measures

  1. Fidelity Checklist Score [Month 1]

    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.

  2. Fidelity Checklist Score [Month 8]

    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.

  3. Fidelity Checklist Score [Month 15]

    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.

  4. Fidelity Checklist Score [Month 22]

    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.

  5. Fidelity Checklist Score [Month 29]

    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

  1. Intervention Appropriateness Measure (IAM) Score [Month 1]

    4-item assessment of intervention appropriateness (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater appropriateness of the intervention.

  2. Intervention Appropriateness Measure (IAM) Score [Month 8]

    4-item assessment of intervention appropriateness (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater appropriateness of the intervention.

  3. Intervention Appropriateness Measure (IAM) Score [Month 15]

    4-item assessment of intervention appropriateness (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater appropriateness of the intervention.

  4. Intervention Appropriateness Measure (IAM) Score [Month 22]

    4-item assessment of intervention appropriateness (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater appropriateness of the intervention.

  5. Intervention Appropriateness Measure (IAM) Score [Month 29]

    4-item assessment of intervention appropriateness (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater appropriateness of the intervention.

  6. Feasibility of Intervention Measure (FIM) Score [Month 1]

    4-item assessment of intervention feasibility (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater feasibility of the intervention.

  7. Feasibility of Intervention Measure (FIM) Score [Month 8]

    4-item assessment of intervention feasibility (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater feasibility of the intervention.

  8. Feasibility of Intervention Measure (FIM) Score [Month 15]

    4-item assessment of intervention feasibility (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater feasibility of the intervention.

  9. Feasibility of Intervention Measure (FIM) Score [Month 22]

    4-item assessment of intervention feasibility (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater feasibility of the intervention.

  10. Feasibility of Intervention Measure (FIM) Score [Month 29]

    4-item assessment of intervention feasibility (Weiner, et al.) administered to staff. Items rated on a Likert scale from 1 (completely disagree) to 5 (completely agree). The total score is the sum of responses and ranges from 4 to 20 for each intervention; higher scores indicate greater feasibility of the intervention.

  11. Brief Opioid Overdose Knowledge (BOOK) Survey Score [Month 1]

    BOOK is a 12-item assessment of opioid overdose knowledge 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.

  12. Brief Opioid Overdose Knowledge (BOOK) Survey Score [Month 8]

    BOOK is a 12-item assessment of opioid overdose knowledge 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.

  13. Brief Opioid Overdose Knowledge (BOOK) Survey Score [Month 15]

    BOOK is a 12-item assessment of opioid overdose knowledge 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.

  14. Brief Opioid Overdose Knowledge (BOOK) Survey Score [Month 22]

    BOOK is a 12-item assessment of opioid overdose knowledge 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.

  15. Brief Opioid Overdose Knowledge (BOOK) Survey Score [Month 29]

    BOOK is a 12-item assessment of opioid overdose knowledge 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.

  16. Perceived Stigma Toward Substance Users Scale Score [Month 1]

    8-item assessment of perceived stigma toward substance users. 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.

  17. Perceived Stigma Toward Substance Users Scale Score [Month 8]

    8-item assessment of perceived stigma toward substance users. 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.

  18. Perceived Stigma Toward Substance Users Scale Score [Month 15]

    8-item assessment of perceived stigma toward substance users. 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.

  19. Perceived Stigma Toward Substance Users Scale Score [Month 22]

    8-item assessment of perceived stigma toward substance users. 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.

  20. Perceived Stigma Toward Substance Users Scale Score [Month 29]

    8-item assessment of perceived stigma toward substance users. 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.

  21. Tenant Substance-Use-Related Emergency Department Visits [Month 1]

    Data derived from NY Medicaid data.

  22. Tenant Substance-Use-Related Emergency Department Visits [Month 8]

    Data derived from NY Medicaid data.

  23. Tenant Substance-Use-Related Emergency Department Visits [Month 15]

    Data derived from NY Medicaid data.

  24. Tenant Substance-Use-Related Emergency Department Visits [Month 22]

    Data derived from NY Medicaid data.

  25. Tenant Substance-Use-Related Emergency Department Visits [Month 29]

    Data derived from NY Medicaid data.

  26. Tenant Substance-Use-Related Emergency Department Visits [Month 35]

    Data derived from NY Medicaid data.

  27. Tenant Receipt of Medication for Opioid Use Disorder (MOUD) [Month 1]

    Data derived from NY Medicaid data. Defined as tenants receiving MOUD, initiating MOUD or maintaining MOUD.

  28. Tenant Receipt of Medication for Opioid Use Disorder (MOUD) [Month 8]

    Data derived from NY Medicaid data. Defined as tenants receiving MOUD, initiating MOUD or maintaining MOUD.

  29. Tenant Receipt of Medication for Opioid Use Disorder (MOUD) [Month 15]

    Data derived from NY Medicaid data. Defined as tenants receiving MOUD, initiating MOUD or maintaining MOUD.

  30. Tenant Receipt of Medication for Opioid Use Disorder (MOUD) [Month 22]

    Data derived from NY Medicaid data. Defined as tenants receiving MOUD, initiating MOUD or maintaining MOUD.

  31. Tenant Receipt of Medication for Opioid Use Disorder (MOUD) [Month 29]

    Data derived from NY Medicaid data. Defined as tenants receiving MOUD, initiating MOUD or maintaining MOUD.

  32. Tenant Receipt of Medication for Opioid Use Disorder (MOUD) [Month 35]

    Data derived from NY Medicaid data. Defined as tenants receiving MOUD, initiating MOUD or maintaining MOUD.

  33. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment [Month 1]

    Data derived from NY Medicaid data.

  34. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment [Month 8]

    Data derived from NY Medicaid data. Specialty SUD treatment defined as outpatient, inpatient or detoxification care.

  35. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment [Month 15]

    Data derived from NY Medicaid data. Specialty SUD treatment defined as outpatient, inpatient or detoxification care.

  36. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment [Month 22]

    Data derived from NY Medicaid data. Specialty SUD treatment defined as outpatient, inpatient or detoxification care.

  37. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment [Month 29]

    Data derived from NY Medicaid data. Specialty SUD treatment defined as outpatient, inpatient or detoxification care.

  38. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment [Month 35]

    Data derived from NY Medicaid data. Specialty SUD treatment defined as outpatient, inpatient or detoxification care.

  39. Adoption Checklist Score [Month 1]

    15-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 15 overdose prevention practices. The total score is the sum of responses and ranges from 0-15, with higher scores indicating greater adoption.

  40. Adoption Checklist Score [Month 8]

    15-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 15 overdose prevention practices. The total score is the sum of responses and ranges from 0-15, with higher scores indicating greater adoption.

  41. Adoption Checklist Score [Month 15]

    15-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 15 overdose prevention practices. The total score is the sum of responses and ranges from 0-15, with higher scores indicating greater adoption.

  42. Adoption Checklist Score [Month 22]

    15-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 15 overdose prevention practices. The total score is the sum of responses and ranges from 0-15, with higher scores indicating greater adoption.

  43. Adoption Checklist Score [Month 29]

    15-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 15 overdose prevention practices. The total score is the sum of responses and ranges from 0-15, with higher scores indicating greater adoption.

  44. Fidelity Checklist Score [Month 13 Post-Intervention (Up to Month 41)]

    Sustainability of the intervention will be measured via 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Tenant surveys: To be eligible to participate in the tenant survey part of this study, an individual must:

  • Be a tenant in a participating PSH building

  • Be at least 18 years old

  • Be able to read and respond to a written survey in English

Staff surveys: To be eligible to participate in the staff survey part of this study, an individual must work for a participating PSH building. 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 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health
  • National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Kelly Doran, MD, MHS, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT05786222
Other Study ID Numbers:
  • 23-00098
First Posted:
Mar 27, 2023
Last Update Posted:
Mar 27, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 27, 2023