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

NCT04317053 | Completed Results DMC

• 1 other identifier: 19-01547
• Study Type: interventional
• Target: 253
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Opioid Overdose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD)

  Up to Month 3

• Overdose Risk Behavior Questionnaire Score

  Baseline

• Overdose Risk Behavior Questionnaire Score

  Month 1

• Overdose Risk Behavior Questionnaire Score

  Month 3

• Overdose Risk Behavior Questionnaire Score

  Month 6

Study Arms (2)

Site-Directed Care (SDC)

NO INTERVENTION

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.

Relay program (peer navigation)

EXPERIMENTAL

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

Interventions

RELAY BEHAVIORAL

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.

Relay program (peer navigation)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years)
• English- or Spanish-speaking
• Patient at a participating ED with nonfatal opioid OD.
• Currently residing in NYC

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• Doran KM, Welch AE, Jeffers A, Kepler KL, Chambless D, Cowan E, Wittman I, Regina A, Chang TE, Parraga S, Tapia J, Diaz C, Gwadz M, Cleland CM, McNeely J. Study protocol for a multisite randomized controlled trial of a peer navigator intervention for emergency department patients with nonfatal opioid overdose. Contemp Clin Trials. 2023 Mar;126:107111. doi: 10.1016/j.cct.2023.107111. Epub 2023 Feb 4.

  PMID: 36746325 DERIVED

MeSH Terms

Conditions

Opiate Overdose

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Results Point of Contact

• Title: Kelly Doran, MD, MHS
• Organization: NYU Langone Health

Kelly.Doran@nyulangone.org

212-263-5850

Study Officials

• Kelly Doran, MD

  New York University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 20, 2020
• Study Start: October 8, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months following article publication and ending 6 years after any reporting, publication, or presentation.
• 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).

Locations

US (1)