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Completed

NCT Number: NCT04317053

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

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.

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Key information

Conditions

Opioid Overdose Chemically-Induced Disorders Drug Misuse Drug Overdose Mental Disorders Narcotic-Related Disorders Opiate Overdose Opioid-Related Disorders Prescription Drug Misuse Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RELAY

Behavioral

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 outcomes

  1. Number of Opioid-related Adverse Events

    Time frame: 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 outcomes

  1. Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD)

    Time frame: 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.

  2. Overdose Risk Behavior Questionnaire Score

    Time frame: Baseline

    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.

  3. Overdose Risk Behavior Questionnaire Score

    Time frame: Month 1

    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.

  4. Overdose Risk Behavior Questionnaire Score

    Time frame: Month 3

    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.

  5. Overdose Risk Behavior Questionnaire Score

    Time frame: 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.

  6. Time to Next Opioid-Involved Overdose

    Time frame: Up to Month 6

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

  7. Number of Emergency Deparment (ED) Visits for Any Cause

    Time frame: 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.

  8. Number of ED Visits for Other (Non-OD) Substance Use Reasons

    Time frame: Up to Month 12

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

  9. Number of Opioid Overdose-Related ED Visits

    Time frame: Up to Month 12

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

  10. Percentage of Participants Who Self-Report Opioid-Involved Overdose

    Time frame: Month 1

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

  11. Percentage of Participants Who Self-Report Opioid-Involved Overdose

    Time frame: Month 3

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

  12. Percentage of Participants Who Self-Report Opioid-Involved Overdose

    Time frame: Month 6

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2020
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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