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

Opioid Overdose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317053
• Other study ID #: 19-01547
• Status: Completed
• Phase: Phase 3
• Start date: October 8, 2020
• Est. completion date: July 1, 2023

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Opiate Overdose
• Opioid Overdose

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants who initiate medication for opioid use disorder (MOUD)	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.	Baseline
Secondary	Number of participants who initiate medication for opioid use disorder (MOUD)	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.	Month 1
Secondary	Number of participants who initiate medication for opioid use disorder (MOUD)	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.	Month 3
Secondary	Number of participants who initiate medication for opioid use disorder (MOUD)	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.	Month 6
Secondary	Overdose Risk Behavior Questionnaire Score	13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.	Baseline
Secondary	Overdose Risk Behavior Questionnaire Score	13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.	Month 1
Secondary	Overdose Risk Behavior Questionnaire Score	13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.	Month 3
Secondary	Overdose Risk Behavior Questionnaire Score	13-item questionnaire assessing overdose risk behaviors. Items are rated on a Likert scale from 1 (rarely) to 4 (very often). The total score is the sum of responses and ranges from 13 to 52; higher scores indicate more prevalent overdose risk behaviors.	Month 6
Secondary	Time to Next Opioid-Involved Overdose	Time to next opioid-involved overdose from the time of baseline, by self-report.	Month 1
Secondary	Time to Next Opioid-Involved Overdose	Time to next opioid-involved overdose from the time of baseline, by self-report.	Month 3
Secondary	Time to Next Opioid-Involved Overdose	Time to next opioid-involved overdose from the time of baseline, by self-report.	Month 6
Secondary	Number of Emergency Deparment (ED) visits for any cause	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.	Up to Month 12
Secondary	Number of Opioid-Related ED Visits	Frequency of ED visits for opioid overdose will be measured, using administrative data.	Up to Month 12
Secondary	Number of ED Visits for other (non-OD) substance use reasons	Frequency of ED visits for other (non-OD) substance use will be measured, using administrative data.	Up to Month 12
Secondary	Number of Participants who Self-Report Opioid-Involved Overdose	Includes non-fatal overdose that did or did not result in an ED visit, by self report.	Month 1
Secondary	Number of Participants who Self-Report Opioid-Involved Overdose	Includes non-fatal overdose that did or did not result in an ED visit, by self report.	Month 3
Secondary	Number of Participants who Self-Report Opioid-Involved Overdose	Includes non-fatal overdose that did or did not result in an ED visit, by self report.	Month 6