Trial Outcomes & Findings for Multi-Center Randomized Controlled Trial of Relay- NYC's Nonfatal Overdose Response Program (NCT NCT04317053)

NCT ID: NCT04317053

Last Updated: 2024-11-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 253 participants
• Primary outcome timeframe: Up to Month 12
• Results posted on: 2024-11-25

Participant Flow

Participant milestones

Measure	Site-Directed Care (SDC) 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) 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. 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.
Overall Study STARTED	126	127
Overall Study COMPLETED	122	125
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Site-Directed Care (SDC) 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) 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. 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.
Overall Study Withdrawn (screen failure)	4	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Site-Directed Care (SDC) n=122 Participants 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) n=125 Participants 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. 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.	Total n=247 Participants Total of all reporting groups
Age, Continuous	50.4 years STANDARD_DEVIATION 14.5 • n=5 Participants	48.7 years STANDARD_DEVIATION 13.8 • n=7 Participants	49.5 years STANDARD_DEVIATION 14.2 • n=5 Participants
Sex/Gender, Customized Female	31 Participants n=5 Participants	24 Participants n=7 Participants	55 Participants n=5 Participants
Sex/Gender, Customized Male	91 Participants n=5 Participants	99 Participants n=7 Participants	190 Participants n=5 Participants
Sex/Gender, Customized Unknown/Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	70 Participants n=5 Participants	56 Participants n=7 Participants	126 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	69 Participants n=7 Participants	121 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	43 Participants n=5 Participants	37 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants	42 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) More than one race	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	34 Participants n=5 Participants	38 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment United States	122 participants n=5 Participants	125 participants n=7 Participants	247 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Site-Directed Care (SDC) n=122 Participants 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) n=125 Participants 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. 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.
Number of Opioid-related Adverse Events	4.15 Events Standard Deviation 9.58	3.24 Events Standard Deviation 4.76

SECONDARY outcome

Timeframe: Up to Month 3

Population: Not all participants involved in the study completed all outcome measure data collection visits for each individual outcome measure. Thus, not all participants who completed the study are included in the analysis.

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.

Outcome measures

Measure	Site-Directed Care (SDC) n=97 Participants 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) n=93 Participants 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. 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.
Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD)	14.4 Percentage of participants Interval 8.8 to 22.8	16.1 Percentage of participants Interval 10.0 to 24.9

SECONDARY outcome

Timeframe: Baseline

Population: Not all participants involved in the study completed all outcome measure data collection visits for each individual outcome measure. Thus, not all participants who completed the study are included in the analysis.

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.

Outcome measures

Measure	Site-Directed Care (SDC) n=122 Participants 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) n=125 Participants 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. 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.
Overdose Risk Behavior Questionnaire Score	8.22 score on a scale Standard Deviation 6.35	8.9 score on a scale Standard Deviation 8.13

SECONDARY outcome

Timeframe: Month 1

Population: Not all participants involved in the study completed all outcome measure data collection visits for each individual outcome measure. Thus, not all participants who completed the study are included in the analysis.

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.

Outcome measures

Measure	Site-Directed Care (SDC) n=62 Participants 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) n=66 Participants 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. 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.
Overdose Risk Behavior Questionnaire Score	4.39 score on a scale Standard Deviation 6.51	6.52 score on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: Month 3

Population: Not all participants involved in the study completed all outcome measure data collection visits for each individual outcome measure. Thus, not all participants who completed the study are included in the analysis.

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.

Outcome measures

Measure	Site-Directed Care (SDC) n=72 Participants 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) n=75 Participants 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. 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.
Overdose Risk Behavior Questionnaire Score	4.49 score on a scale Standard Deviation 6.61	6.6 score on a scale Standard Deviation 7.01

SECONDARY outcome

Timeframe: Month 6

Population: Not all participants involved in the study completed all outcome measure data collection visits for each individual outcome measure. Thus, not all participants who completed the study are included in the analysis.

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.

Outcome measures

Measure	Site-Directed Care (SDC) n=69 Participants 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) n=70 Participants 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. 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.
Overdose Risk Behavior Questionnaire Score	3.77 score on a scale Standard Deviation 6.14	6.46 score on a scale Standard Deviation 8.13

SECONDARY outcome

Timeframe: Up to Month 6

Population: Not all participants involved in the study completed all outcome measure data collection visits for each individual outcome measure. Thus, not all participants who completed the study are included in the analysis.

Time to next opioid-involved overdose from the time of baseline, by self-report.

Outcome measures

Measure	Site-Directed Care (SDC) n=22 Participants 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) n=27 Participants 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. 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.
Time to Next Opioid-Involved Overdose	68.0 days Standard Deviation 49.3	57.8 days Standard Deviation 51.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Site-Directed Care (SDC) n=122 Participants 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) n=125 Participants 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. 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.
Number of Emergency Deparment (ED) Visits for Any Cause	6.73 Visits Standard Deviation 12.9	6.28 Visits Standard Deviation 8.85

SECONDARY outcome

Timeframe: Up to Month 12

Frequency of ED visits for other (non-OD) substance use will be measured, using administrative data.

Outcome measures

Measure	Site-Directed Care (SDC) n=122 Participants 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) n=125 Participants 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. 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.
Number of ED Visits for Other (Non-OD) Substance Use Reasons	2.98 Visits Standard Deviation 8.62	2.26 Visits Standard Deviation 4.03

SECONDARY outcome

Timeframe: Up to Month 12

Frequency of ED visits for opioid overdose will be measured, using administrative data

Outcome measures

Measure	Site-Directed Care (SDC) n=122 Participants 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) n=125 Participants 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. 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.
Number of Opioid Overdose-Related ED Visits	0.402 Visits Standard Deviation 1.28	0.376 Visits Standard Deviation 0.964

SECONDARY outcome

Timeframe: Month 1

Population: Not all participants involved in the study completed all outcome measure data collection visits for each individual outcome measure. Thus, not all participants who completed the study are included in the analysis.

Includes non-fatal overdose that did or did not result in an ED visit, by self report.

Outcome measures

Measure	Site-Directed Care (SDC) n=62 Participants 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) n=66 Participants 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. 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.
Percentage of Participants Who Self-Report Opioid-Involved Overdose	11.3 Percentage of participants	16.7 Percentage of participants

SECONDARY outcome

Timeframe: Month 3

Includes non-fatal overdose that did or did not result in an ED visit, by self report.

Outcome measures

Measure	Site-Directed Care (SDC) n=74 Participants 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) n=76 Participants 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. 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.
Percentage of Participants Who Self-Report Opioid-Involved Overdose	24.3 Percentage of participants	31.6 Percentage of participants

SECONDARY outcome

Timeframe: Month 6

Includes non-fatal overdose that did or did not result in an ED visit, by self report.

Outcome measures

Measure	Site-Directed Care (SDC) n=76 Participants 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) n=74 Participants 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. 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.
Percentage of Participants Who Self-Report Opioid-Involved Overdose	30.3 Percentage of participants	37.8 Percentage of participants

Adverse Events

Site-Directed Care (SDC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 23 deaths

Relay Program (Peer Navigation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 21 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Kelly Doran, MD, MHS

NYU Langone Health

Phone: 212-263-5850

Email: Kelly.Doran@nyulangone.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place