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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Site-Directed Care (SDC) | No Intervention | 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) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Doran, MD | New York University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41649817 | Derived | Doran KM, Welch AE, Kepler KL, Jeffers A, Chambless D, Cowan E, Wittman I, Regina A, Siu K, Bailey VS, Rostam-Abadi Y, Kennedy J, Kunins HV, Gwadz M, Shelley D, Cleland CM, McNeely J. Peer Navigator Intervention and Opioid-Related Adverse Events for Emergency Department Patients: A Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2555903. doi: 10.1001/jamanetworkopen.2025.55903. | |
| 36746325 |
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Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months following article publication and ending 6 years after any reporting, publication, or presentation.
The investigator who proposed to use the data. Upon reasonable request. Upon request, study investigators will provide the research dataset to qualified investigators under a Data Use Agreement (DUA) that will require approval of the study Principal Investigators and each of the primary research team participating agencies (NYU and NYC Department of Health and Mental Hygiene).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Events | Up to Month 12 |
|
12 months
All mortality was assessed by the NYC Department of Health and Mental Hygiene by examining vital statistics records for all study participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Doran, MD, MHS | NYU Langone Health | 212-263-5850 | Kelly.Doran@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2023 | Jun 5, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 11, 2021 | Jul 6, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000083682 | Opiate Overdose |
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
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|
| Up to Month 3 |
| Overdose Risk Behavior Questionnaire Score | 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. | Baseline |
| Overdose Risk Behavior Questionnaire Score | 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. | Month 1 |
| Overdose Risk Behavior Questionnaire Score | 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. | Month 3 |
| Overdose Risk Behavior Questionnaire Score | 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. | Month 6 |
| Time to Next Opioid-Involved Overdose | Time to next opioid-involved overdose from the time of baseline, by self-report. | Up to Month 6 |
| 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 |
| 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 |
| Number of Opioid Overdose-Related ED Visits | Frequency of ED visits for opioid overdose will be measured, using administrative data | Up to Month 12 |
| Percentage 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 |
| Percentage 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 |
| Percentage 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 |
| Derived |
| Doran KM, Welch AE, Jeffers A, Kepler KL, Chambless D, Cowan E, Wittman I, Regina A, Chang TE, Parraga S, Tapia J, Diaz C, Gwadz M, Cleland CM, McNeely J. Study protocol for a multisite randomized controlled trial of a peer navigator intervention for emergency department patients with nonfatal opioid overdose. Contemp Clin Trials. 2023 Mar;126:107111. doi: 10.1016/j.cct.2023.107111. Epub 2023 Feb 4. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to Month 3 |
|
|
|
| Secondary | Overdose Risk Behavior Questionnaire Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline |
|
|
|
| Secondary | Overdose Risk Behavior Questionnaire Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 1 |
|
|
|
| Secondary | Overdose Risk Behavior Questionnaire Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 3 |
|
|
|
| Secondary | Overdose Risk Behavior Questionnaire Score | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Month 6 |
|
|
|
| Secondary | Time to Next Opioid-Involved Overdose | Time to next opioid-involved overdose from the time of baseline, by self-report. | 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. | Posted | Mean | Standard Deviation | days | Up to 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. | Posted | Mean | Standard Deviation | Visits | 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. | Posted | Mean | Standard Deviation | Visits | Up to Month 12 |
|
|
|
| Secondary | Number of Opioid Overdose-Related ED Visits | Frequency of ED visits for opioid overdose will be measured, using administrative data | Posted | Mean | Standard Deviation | Visits | Up to Month 12 |
|
|
|
| Secondary | Percentage 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. | 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. | Posted | Number | Percentage of participants | Month 1 |
|
|
|
| Secondary | Percentage 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. | Posted | Number | Percentage of participants | Month 3 |
|
|
|
| Secondary | Percentage 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. | Posted | Number | Percentage of participants | Month 6 |
|
|
|
| 23 |
| 122 |
| 0 |
| 122 |
| 0 |
| 122 |
| EG001 | 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. | 21 | 125 | 0 | 125 | 0 | 125 |
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| D064419 |
| Chemically-Induced Disorders |
| D009293 | Opioid-Related Disorders |
| D000079524 | Narcotic-Related Disorders |
| D001523 | Mental Disorders |