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NCT Number: NCT05786222

Permanent Supportive Housing Overdose Prevention

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Overdose Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CSH-Delivered Overdose Prevention Support

Behavioral

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 outcomes

  1. Fidelity Checklist Score

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Intervention Appropriateness Measure (IAM) Score

    Time frame: Month 1

    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).

  2. Intervention Appropriateness Measure (IAM) Score

    Time frame: Month 8

    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).

  3. Intervention Appropriateness Measure (IAM) Score

    Time frame: Month 15

    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).

  4. Intervention Appropriateness Measure (IAM) Score

    Time frame: Month 22

    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).

  5. Intervention Appropriateness Measure (IAM) Score

    Time frame: Month 29

    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).

  6. Feasibility of Intervention Measure (FIM) Score

    Time frame: Month 1

    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).

  7. Feasibility of Intervention Measure (FIM) Score

    Time frame: Month 8

    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).

  8. Feasibility of Intervention Measure (FIM) Score

    Time frame: Month 15

    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).

  9. Feasibility of Intervention Measure (FIM) Score

    Time frame: Month 22

    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).

  10. Feasibility of Intervention Measure (FIM) Score

    Time frame: Month 29

    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).

  11. Brief Opioid Overdose Knowledge (BOOK) Survey Score

    Time frame: Month 1

    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.

  12. Brief Opioid Overdose Knowledge (BOOK) Survey Score

    Time frame: Month 8

    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.

  13. Brief Opioid Overdose Knowledge (BOOK) Survey Score

    Time frame: Month 15

    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.

  14. Brief Opioid Overdose Knowledge (BOOK) Survey Score

    Time frame: Month 22

    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.

  15. Brief Opioid Overdose Knowledge (BOOK) Survey Score

    Time frame: Month 29

    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.

  16. Perceived Stigma Toward Substance Users Scale Score

    Time frame: Month 1

    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.

  17. Perceived Stigma Toward Substance Users Scale Score

    Time frame: Month 8

    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.

  18. Perceived Stigma Toward Substance Users Scale Score

    Time frame: Month 15

    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.

  19. Perceived Stigma Toward Substance Users Scale Score

    Time frame: Month 22

    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.

  20. Perceived Stigma Toward Substance Users Scale Score

    Time frame: Month 29

    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.

  21. Tenant Substance-Use-Related Emergency Department Visits

    Time frame: Month 1

    Data derived from NY Medicaid data.

  22. Tenant Substance-Use-Related Emergency Department Visits

    Time frame: Month 8

    Data derived from NY Medicaid data.

  23. Tenant Substance-Use-Related Emergency Department Visits

    Time frame: Month 15

    Data derived from NY Medicaid data.

  24. Tenant Substance-Use-Related Emergency Department Visits

    Time frame: Month 22

    Data derived from NY Medicaid data.

  25. Tenant Substance-Use-Related Emergency Department Visits

    Time frame: Month 29

    Data derived from NY Medicaid data.

  26. Tenant Substance-Use-Related Emergency Department Visits

    Time frame: Month 35

    Data derived from NY Medicaid data.

  27. Tenant Receipt of Medication for Opioid Use Disorder (MOUD)

    Time frame: Month 1

    Data derived from NY Medicaid data.

  28. Tenant Receipt of Medication for Opioid Use Disorder (MOUD)

    Time frame: Month 8

    Data derived from NY Medicaid data.

  29. Tenant Receipt of Medication for Opioid Use Disorder (MOUD)

    Time frame: Month 15

    Data derived from NY Medicaid data.

  30. Tenant Receipt of Medication for Opioid Use Disorder (MOUD)

    Time frame: Month 22

    Data derived from NY Medicaid data.

  31. Tenant Receipt of Medication for Opioid Use Disorder (MOUD)

    Time frame: Month 29

    Data derived from NY Medicaid data.

  32. Tenant Receipt of Medication for Opioid Use Disorder (MOUD)

    Time frame: Month 35

    Data derived from NY Medicaid data.

  33. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment

    Time frame: Month 1

    Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.

  34. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment

    Time frame: Month 8

    Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.

  35. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment

    Time frame: Month 15

    Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.

  36. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment

    Time frame: Month 22

    Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.

  37. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment

    Time frame: Month 29

    Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.

  38. Tenant Receipt of Specialty Substance Use Disorder (SUD) Treatment

    Time frame: Month 35

    Data derived from NY Medicaid data. Specialty SUD treatment includes outpatient, inpatient, and detoxification.

  39. Adoption Checklist Score

    Time frame: Month 1

    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.

  40. Adoption Checklist Score

    Time frame: Month 8

    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.

  41. Adoption Checklist Score

    Time frame: Month 15

    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.

  42. Adoption Checklist Score

    Time frame: Month 22

    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.

  43. Adoption Checklist Score

    Time frame: Month 29

    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.

  44. Acceptability of Intervention Measure (AIM) Score

    Time frame: Month 1

    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).

  45. Acceptability of Intervention Measure (AIM) Score

    Time frame: Month 8

    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).

  46. Acceptability of Intervention Measure (AIM) Score

    Time frame: Month 15

    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).

  47. Acceptability of Intervention Measure (AIM) Score

    Time frame: Month 22

    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).

  48. Acceptability of Intervention Measure (AIM) Score

    Time frame: Month 29

    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).

  49. Organizational Priority Measure Score

    Time frame: Month 1

    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.

  50. Organizational Priority Measure Score

    Time frame: Month 8

    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.

  51. Organizational Priority Measure Score

    Time frame: Month 15

    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.

  52. Organizational Priority Measure Score

    Time frame: Month 22

    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.

  53. Organizational Priority Measure Score

    Time frame: Month 29

    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.

  54. Sustainment based on Fidelity Checklist Score

    Time frame: Month 15

    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.

  55. Sustainment based on Fidelity Checklist Score

    Time frame: Month 22

    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.

  56. Sustainment based on Fidelity Checklist Score

    Time frame: Month 29

    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.

  57. Sustainment based on Fidelity Checklist Score

    Time frame: Month 36

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Acronym: POP

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Mar 27, 2023
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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