N/A
N=253
Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program
Opioid Overdose
Bottom Line
View on ClinicalTrials.gov: NCT04317053 ↗Enrolled (actual)
253
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Number of Opioid-related Adverse Events — 4.15; 3.24 Events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- RELAY (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Opioid-related Adverse Events |
4.15; 3.24 | — |
| SECONDARY Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD) |
14.4; 16.1 | — |
| SECONDARY Overdose Risk Behavior Questionnaire Score |
3.77; 6.46 | — |
| SECONDARY Overdose Risk Behavior Questionnaire Score |
3.77; 6.46 | — |
| SECONDARY Overdose Risk Behavior Questionnaire Score |
3.77; 6.46 | — |
| SECONDARY Overdose Risk Behavior Questionnaire Score |
3.77; 6.46 | — |
| SECONDARY Time to Next Opioid-Involved Overdose |
68.0; 57.8 | — |
| SECONDARY Number of Emergency Deparment (ED) Visits for Any Cause |
6.73; 6.28 | — |
| SECONDARY Number of ED Visits for Other (Non-OD) Substance Use Reasons |
2.98; 2.26 | — |
| SECONDARY Number of Opioid Overdose-Related ED Visits |
0.402; 0.376 | — |
| SECONDARY Percentage of Participants Who Self-Report Opioid-Involved Overdose |
30.3; 37.8 | — |
| SECONDARY Percentage of Participants Who Self-Report Opioid-Involved Overdose |
30.3; 37.8 | — |
| SECONDARY Percentage of Participants Who Self-Report Opioid-Involved Overdose |
30.3; 37.8 | — |
Summary
The New York City (NYC) Department of Health and Mental Hygiene (DOHMH) has implemented Relay, a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. The proposed randomized controlled trial will evaluate the impact of Relay on preventing subsequent opioid-related adverse events. A total of 350 eligible individuals with nonfatal opioid OD presenting to one of four participating EDs will be enrolled and randomized to one of two arms: 1) site-directed care (SDC) or 2) Relay-peer-delivered OD education and treatment linkage, including 90 days of peer navigation. Outcomes will be measured for 12 months through interviews and administrative health data.
Eligibility Criteria
Inclusion Criteria
- Adults (≥18 years)
- English- or Spanish-speaking
- Patient at a participating ED with nonfatal opioid OD.
- Currently residing in NYC
Exclusion Criteria
- Unable to provide informed consent
- Currently incarcerated, currently living in another controlled environment prohibiting research contacts, or currently in police custody
- Known to be currently pregnant
- Already participating in the study (patients will only be enrolled into the study once)
- Already actively engaged in the Relay program (within the 90-day program window)
- Speaks only Spanish, at a site and time period when no Spanish-speaking RA is available
Data sourced from ClinicalTrials.gov (NCT04317053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.