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

NYU Langone Health

Status: Completed

Conditions: Opioid Overdose

Treatments: Behavioral: RELAY

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04317053

19-01547

Details and patient eligibility

About

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.

Full 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.

Enrollment: 253 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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253 participants in 2 patient groups

Site-Directed Care (SDC)

No Intervention group

Description:

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 group

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.

Treatment:

Behavioral: RELAY