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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to prevent overdoses among people living in permanent supportive housing (PSH) in New York. The researchers will test strategies such as training staff and tenants and providing resources to implement overdose prevention practices, including CSH-Delivered Overdose Prevention Support. Tenants or staff members in participating PSH buildings who can read and respond to surveys in English or Spanish might be a good fit for the trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for overdose prevention in the community.

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 prior data suggests that this implementation strategy is safe for PSH tenants?

Research shows that the CSH-Delivered Overdose Prevention Support, part of this trial, builds on methods previously used to reduce overdoses. While specific safety data for this exact support package may not be available, the methods employed are widely recognized as safe. These include education on overdose risks and distribution of naloxone, a medication that can reverse opioid overdoses, to those at risk.

Health authorities commonly use and recommend these methods, and they are generally considered safe with few side effects. Prospective participants can take comfort in knowing that these strategies have been safely used in other settings to help prevent overdoses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CSH-Delivered Overdose Prevention Support because it offers a unique approach to tackling overdoses by focusing on community-based interventions. Unlike traditional treatments that may rely on medications or emergency responses, this support system is delivered right where people live, aiming to create a safer environment and build awareness among residents. This method emphasizes prevention through education and community involvement, which is a fresh take compared to the usual medical or emergency interventions. Overall, the goal is to empower communities to be proactive in preventing overdoses, potentially leading to more sustainable outcomes.

What evidence suggests that this trial's treatments could be effective for preventing overdoses?

Research shows that strategies to prevent overdoses can effectively reduce both fatal and non-fatal incidents. In this trial, researchers randomize buildings into different clusters to receive the CSH-Delivered Overdose Prevention Support at various times. Staff in permanent supportive housing (PSH) strongly support these strategies, with over 90% agreeing they are suitable and acceptable. The HEALing Communities Study demonstrated that these prevention methods work well in community settings. This suggests that using these strategies in PSH could lower the risk of overdoses among residents. Although this specific approach is being tested for the first time in PSH, it is based on proven methods that have succeeded elsewhere. ^{1 2 3 6 7}

Who Is on the Research Team?

Kelly Doran, MD, MHS

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10246871/

The POP (Permanent Supportive Housing Overdose ... This study will be the first controlled trial of overdose prevention implementation in PSH settings.

2. withpower.com withpower.com/trial/phase-drug-overdose-8-2023-19d13

Overdose Prevention Support for Overdoses (POP Trial) What data supports the effectiveness of the treatment CSH-Delivered Overdose Prevention Support? The HEALing Communities Study highlights the effectiveness ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12007226/

Staff views on overdose prevention in permanent ... Staff felt very positively (91.6–97.2% agreed or completely agreed) regarding the appropriateness and acceptability of implementing overdose ...

4. dhs.state.il.us dhs.state.il.us/OneNetLibrary/27896/documents/OPS.pdf

Overdose Prevention Site Community Engagement Project Since 2017, Illinois has implemented several strategies to address the opioid epidemic and reduce fatal and non-fatal opioid overdoses.

5. researchgate.net researchgate.net/publication/384781046_A_community-academic_partnership_to_develop_an_implementation_support_package_for_overdose_prevention_in_permanent_supportive_housing

A community-academic partnership to develop an ... A community-academic partnership to develop an implementation support package for overdose prevention in permanent supportive housing.

6. dhcs.ca.gov dhcs.ca.gov/Documents/BHIN-24-031-Updated-Guidance-for-the-RI-Program.pdf

August 22, 2024 Behavioral Health Information Notice No: 24 ... As a best practice overdose prevention measure, providers can prescribe opioid overdose reversal medication to all members who are ...

7. cdc.gov cdc.gov/overdose-prevention/data-research/facts-stats/index.html

Data Resources | Overdose Prevention View fatal and nonfatal overdose data dashboards, and pharmacy dispensing rate maps.