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

NCT04317053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2024-11-25

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Kelly Doran, MD · New York University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2023-07-01
Completion
2023-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04317053 on ClinicalTrials.gov