Clinical trial NCT04317053: Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program
Official title: Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Overdose
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-03-20
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Opioid-related Adverse Events
timeFrame: Up to Month 12
Secondary outcomes:
measure: Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD)
timeFrame: Up to Month 3
measure: Overdose Risk Behavior Questionnaire Score
timeFrame: Baseline
measure: Overdose Risk Behavior Questionnaire Score
timeFrame: Month 1
measure: Overdose Risk Behavior Questionnaire Score
timeFrame: Month 3
measure: Overdose Risk Behavior Questionnaire Score
timeFrame: Month 6
measure: Time to Next Opioid-Involved Overdose
timeFrame: Up to Month 6
measure: Number of Emergency Deparment (ED) Visits for Any Cause
timeFrame: Up to Month 12
measure: Number of ED Visits for Other (Non-OD) Substance Use Reasons
timeFrame: Up to Month 12
measure: Number of Opioid Overdose-Related ED Visits
timeFrame: Up to Month 12
measure: Percentage of Participants Who Self-Report Opioid-Involved Overdose
timeFrame: Month 1
measure: Percentage of Participants Who Self-Report Opioid-Involved Overdose
timeFrame: Month 3
measure: Percentage of Participants Who Self-Report Opioid-Involved Overdose
timeFrame: Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York University
name: Kelly Doran, MD
role: PRINCIPAL_INVESTIGATOR
References: