Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program

Study Overview
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Brief Summary
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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.

Detailed Description
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Relay is 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. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education.

Official Title
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Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program

Conditions
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Opioid Overdose

Intervention / Treatment
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* Behavioral: RELAY


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Site-Directed Care (SDC)<br>Site-specific existing interventions delivered to patients with OUD as part of ED care. At a minimum SDC arm patients will receive from the study research team OD education and naloxone distribution (OEND), a list of opioid treatment programs, and an informational flyer about Relay. | |
| Experimental: Relay program (peer navigation)<br>Relay is 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. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education. | Behavioral: RELAY<br>* Relay is 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. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of opioid-related adverse events | The primary outcome is opioid-related adverse events, which will include fatal and non-fatal opioid-involved overdose as well as substance use-related emergency department (ED) visits. ED visits and fatal overdoses in the 12-month period after baseline will be captured in administrative data sources. Other non-fatal opioid-involved overdose events will be captured by self-report in follow-up interviews through six months after baseline, and estimated for the second half of the 12-month follow-up period. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of medication for opioid use disorder (MOUD) | MOUD initiation will be measured at each study visit. MOUD is defined as use of methadone, buprenorphine, or naltrexone that is prescribed by an office-based provider or provided by a treatment program as treatment for OUD. Initiation is defined as receiving MOUD within the 90 days following the index visit, for individuals who received no MOUD for at least 2 weeks prior to the index visit. | 1 month, 3 months | 
| Change in Overdose risk behaviors | Overdose risk behaviors will be measured using questions that measure the frequency in a period of 3 months at which participants engaged in a one or more of several different known risk behaviors for opioid overdose. The total risk score is an aggregation of responses to the individual questions. | 1 month, 3 months, 6 months | 
| Time to next opioid-involved overdose | Time to next opioid-involved overdose from the time of baseline, by self-report. | 1 month, 3 months, 6 months | 
| Percent of Emergency department visits for any cause | Frequency of ED visits for any cause (including visits that are not substance use-related) will be measured, using administrative data, to assess whether there are differences in overall acute care use representing potentially negative health events | 12 months | 
| Percent of Emergency department visits for opioid overdose | Frequency of ED visits for opioid overdose will be measured, using administrative data | 12 months | 
| Percent of Emergency Department visits for other (non-OD) substance use reasons. | Emergency department visits for other (non-OD) substance use reasons Frequency of ED visits for other (non-OD) substance use will be measured, using administrative data. | 12 months | 
| Percent of Self-reported opioid-involved overdose | Includes non-fatal overdose that did or did not result in an ED visit, by self report. | 1 month, 3 months, 6 months |