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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Overdose
• Intervention / Treatment: Behavioral: RELAY

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 247
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Site-Directed Care (SDC); 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); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of opioid-related adverse events	Opioid-related adverse events includes 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.	Up to Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who initiate medication for opioid use disorder (MOUD)	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.	Baseline
Number of participants who initiate medication for opioid use disorder (MOUD)	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.	Month 1
Number of participants who initiate medication for opioid use disorder (MOUD)	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.	Month 3
Number of participants who initiate medication for opioid use disorder (MOUD)	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.	Month 6
Overdose Risk Behavior Questionnaire Score	13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.	Baseline
Overdose Risk Behavior Questionnaire Score	13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.	Month 1
Overdose Risk Behavior Questionnaire Score	13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.	Month 3
Overdose Risk Behavior Questionnaire Score	13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.	Month 6
Time to Next Opioid-Involved Overdose	Time to next opioid-involved overdose from the time of baseline, by self-report.	Month 1
Time to Next Opioid-Involved Overdose	Time to next opioid-involved overdose from the time of baseline, by self-report.	Month 3
Time to Next Opioid-Involved Overdose	Time to next opioid-involved overdose from the time of baseline, by self-report.	Month 6
Number of Emergency Deparment (ED) 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.	Up to Month 12
Number of Opioid-Related ED Visits	Frequency of ED visits for opioid overdose will be measured, using administrative data.	Up to Month 12
Number of ED Visits for other (non-OD) substance use reasons	Frequency of ED visits for other (non-OD) substance use will be measured, using administrative data.	Up to Month 12
Number of Participants who Self-Report Opioid-Involved Overdose	Includes non-fatal overdose that did or did not result in an ED visit, by self report.	Month 1
Number of Participants who Self-Report Opioid-Involved Overdose	Includes non-fatal overdose that did or did not result in an ED visit, by self report.	Month 3
Number of Participants who Self-Report Opioid-Involved Overdose	Includes non-fatal overdose that did or did not result in an ED visit, by self report.	Month 6

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Kelly Doran, MD, New York University

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2020
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Drug Overdose; Opiate Overdose
• Other Study ID Numbers: 19-01547

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months following article publication and ending 6 years after any reporting, publication, or presentation.
• IPD Sharing Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Upon request, study investigators will provide the research dataset to qualified investigators under a Data Use Agreement (DUA) that will require approval of the study Principal Investigators and each of the primary research team participating agencies (NYU and NYC Department of Health and Mental Hygiene).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No