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

Not Applicable

Completed

• Conditions: Opioid Overdose
• Interventions: Behavioral: RELAY

• Registration Number: NCT04317053
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Study Start: 2020-10-08
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Results First Submitted: 2024-06-19
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-07
• Last Update Submitted: 2024-10-07
• Results First Posted: 2024-11-25
• Last Update Posted: 2024-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 253

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Relay program (peer navigation)	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.

Primary Outcome Measures

Name	Time	Method
Number of Opioid-related Adverse Events	Up to Month 12	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD)	Up to Month 3	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.
Overdose Risk Behavior Questionnaire Score	Month 6	13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 0 (never) to 4 (very often). The total score is the sum of responses and ranges from 0 to 52; higher scores indicate more prevalent overdose risk behaviors.
Time to Next Opioid-Involved Overdose	Up to Month 6	Time to next opioid-involved overdose from the time of baseline, by self-report.
Number of Emergency Deparment (ED) Visits for Any Cause	Up to Month 12	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.
Number of ED Visits for Other (Non-OD) Substance Use Reasons	Up to Month 12	Frequency of ED visits for other (non-OD) substance use will be measured, using administrative data.
Number of Opioid Overdose-Related ED Visits	Up to Month 12	Frequency of ED visits for opioid overdose will be measured, using administrative data
Percentage of Participants Who Self-Report Opioid-Involved Overdose	Month 6	Includes non-fatal overdose that did or did not result in an ED visit, by self report.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States