Overdose Prevention Support for Overdoses

(POP Trial)

Overseen By Stephanie Blaufarb

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Children under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

1350 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on implementing overdose prevention strategies in supportive housing, so it's unlikely that stopping medications is required.

What data supports the effectiveness of the treatment CSH-Delivered Overdose Prevention Support?

The HEALing Communities Study highlights the effectiveness of community-based interventions in reducing opioid overdoses by implementing evidence-based practices, which suggests that similar community-focused approaches like CSH-Delivered Overdose Prevention Support could be effective. Additionally, the SRO Project in San Francisco showed that training and involving community members in overdose education and response can significantly reduce fatal overdoses, indicating potential benefits of community-driven overdose prevention efforts. ^{1 2 3 4 5}

Is the Overdose Prevention Support treatment safe for humans?

The available research highlights challenges in defining and reporting adverse events (unwanted side effects) in clinical trials, especially in areas like suicide prevention and substance use disorder. However, there is no specific safety data available for the Overdose Prevention Support treatment itself. ^{6 7 8 9 10}

How is the CSH-Delivered Overdose Prevention Support treatment different from other overdose prevention treatments?

CSH-Delivered Overdose Prevention Support is unique because it involves peer workers, who are people with lived experience of drug use, in providing support and supervision at overdose prevention sites. This approach enhances comfort and engagement among users, promoting harm reduction and health benefits, unlike traditional medical interventions. ^{2 5 11 12 13}

What is the purpose of this trial?

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.

Research Team

Kelly Doran, MD, MHS

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults over 18 who either live in or work at participating Permanent Supportive Housing (PSH) buildings in New York. It's focused on those who can read and respond to surveys or participate in interviews in English. Children under 18 are not eligible.

Inclusion Criteria

I live in supportive housing, am over 18, and can complete a survey in English or Spanish.

Medicaid data analysis: Identifying information for all tenants in participating buildings will be used to conduct a match with Medicaid administrative data

I work (or have worked within 6 months) at a PSH building, am over 18, and can complete an English survey.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control

All clusters begin in the control condition before receiving the intervention

Varies by cluster

Intervention

Clusters receive the CSH-delivered intervention for overdose prevention

6 months

Tenant surveys 1 month prior and 12 months following intervention start

Follow-up

Participants are monitored for effectiveness and sustainment of overdose prevention practices

12 months post-intervention

Sustainment survey administered 8 months post-intervention

Treatment Details

Interventions

• CSH-Delivered Overdose Prevention Support

Trial Overview The study tests overdose prevention strategies within PSH settings, including an implementation toolkit, champions for the cause among tenants and staff, limited practice facilitation, and learning collaboratives.

Participant Groups

Group I: Cluster 4 Experimental Treatment 1 Intervention

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.

Group II: Cluster 3 Experimental Treatment 1 Intervention

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.

Group III: Cluster 2 Experimental Treatment 1 Intervention

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.

Group IV: Cluster 1 Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

A new standardized strategy for reporting adverse events (AEs) and serious adverse events (SAEs) in substance use disorder (SUD) clinical trials was developed, which aims to reduce the reporting burden while maintaining safety monitoring.

In a review of 17 SUD trials involving 6737 participants, the new strategy showed a significant reduction in irrelevant safety event reporting, leading to a more consistent safety assessment system tailored to the risks associated with specific trial interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. Lindblad, R., Campanella, M., Styers, D., et al.[2013]

A symposium with 31 healthcare professionals highlighted that preventing adverse events in community care requires a multi-faceted approach involving policy changes at various levels, including system integration and improved communication among providers.

Key recommendations from the symposium include prioritizing education for clinicians and caregivers, enhancing organizational culture, and leveraging technology to improve patient safety and reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. Masotti, P., Green, M., McColl, MA.[2019]

A total of 11,999 Adverse Drug Events (ADEs) were identified from 244,992 hospital admissions, indicating a prevalence of 4.9 ADEs per 100 admissions, particularly affecting older adults and linked to longer hospital stays.

Clinical Coding Surveillance (CCS) proved to be a reliable method for monitoring ADEs, with 91% accuracy in classifying ADEs based on clinical documentation, suggesting it can effectively enhance patient safety in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. Ng, J., Andrew, P., Muir, P., et al.[2019]

In a study involving 303 patients at Southampton Hospitals, pharmacist-led monitoring effectively identified 21 suspected adverse drug reactions (ADRs) associated with newly marketed drugs, demonstrating the feasibility of this approach in a hospital setting.

The study highlighted that while pharmacist monitoring was effective, the lack of electronic patient records (EPRs) limited efficiency; better-designed EPR systems could enhance the identification of patients on newly marketed drugs and improve monitoring outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events monitored by hospital pharmacists. Hospital Adverse Event Monitoring Study (HAEMS) Group. Emerson, A., Martin, RM., Tomlin, M., et al.[2016]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Statewide Policy to Improve Post-Overdose Care in Emergency Departments and Subsequent Treatment Engagement. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Recent contact with health and social services by drug misusers in Glasgow who died of a fatal overdose in 1999. [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

Introduction to the special issue on the HEALing Communities Study. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Saving lives in our homes: Qualitative evaluation of a tenant overdose response program in supportive, single-room occupancy (SRO) housing. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Peer worker involvement in low-threshold supervised consumption facilities in the context of an overdose epidemic in Vancouver, Canada. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Strategies for safety reporting in substance abuse trials. [2013]

8. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: implications for practice, policy and research. [2019]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Prospective cohort study of adverse events monitored by hospital pharmacists. Hospital Adverse Event Monitoring Study (HAEMS) Group. [2016]

11. Netherlands pubmed.ncbi.nlm.nih.gov

The police paradox: A qualitative study of post-overdose outreach program implementation through public health-public safety partnerships in Massachusetts. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The implementation of overdose prevention sites as a novel and nimble response during an illegal drug overdose public health emergency. [2020]

13. Netherlands pubmed.ncbi.nlm.nih.gov

'It's our safe sanctuary': Experiences of using an unsanctioned overdose prevention site in Toronto, Ontario. [2020]