Opioid Overdose
Conditions
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.
Interventions
BEHAVIORALRELAY
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.
Sponsors
Centers for Disease Control and Prevention
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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. |
| 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 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 1 | Includes non-fatal overdose that did or did not result in an ED visit, by self report. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 122 |
| 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. | 125 |
| Total | 247 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawn (screen failure) | 4 | 2 |
Baseline characteristics
| Characteristic | Site-Directed Care (SDC) | Total | Relay Program (Peer Navigation) |
|---|---|---|---|
| Age, Continuous | 50.4 years STANDARD_DEVIATION 14.5 | 49.5 years STANDARD_DEVIATION 14.2 | 48.7 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 70 Participants | 126 Participants | 56 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants | 121 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 43 Participants | 80 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 11 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 34 Participants | 72 Participants | 38 Participants |
| Race (NIH/OMB) White | 34 Participants | 76 Participants | 42 Participants |
| Region of Enrollment United States | 122 participants | 247 participants | 125 participants |
| Sex/Gender, Customized Female | 31 Participants | 55 Participants | 24 Participants |
| Sex/Gender, Customized Male | 91 Participants | 190 Participants | 99 Participants |
| Sex/Gender, Customized Unknown/Not Reported | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 23 / 122 | 21 / 125 |
| other Total, other adverse events | 0 / 122 | 0 / 125 |
| serious Total, serious adverse events | 0 / 122 | 0 / 125 |
Outcome results
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.
Time frame: Up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site-Directed Care (SDC) | Number of Opioid-related Adverse Events | 4.15 Events | Standard Deviation 9.58 |
| Relay Program (Peer Navigation) | Number of Opioid-related Adverse Events | 3.24 Events | Standard Deviation 4.76 |
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.
Time frame: Up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site-Directed Care (SDC) | Number of ED Visits for Other (Non-OD) Substance Use Reasons | 2.98 Visits | Standard Deviation 8.62 |
| Relay Program (Peer Navigation) | Number of ED Visits for Other (Non-OD) Substance Use Reasons | 2.26 Visits | Standard Deviation 4.03 |
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.
Time frame: Up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site-Directed Care (SDC) | Number of Emergency Deparment (ED) Visits for Any Cause | 6.73 Visits | Standard Deviation 12.9 |
| Relay Program (Peer Navigation) | Number of Emergency Deparment (ED) Visits for Any Cause | 6.28 Visits | Standard Deviation 8.85 |
Secondary
Number of Opioid Overdose-Related ED Visits
Frequency of ED visits for opioid overdose will be measured, using administrative data
Time frame: Up to Month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site-Directed Care (SDC) | Number of Opioid Overdose-Related ED Visits | 0.402 Visits | Standard Deviation 1.28 |
| Relay Program (Peer Navigation) | Number of Opioid Overdose-Related ED Visits | 0.376 Visits | Standard Deviation 0.964 |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Site-Directed Care (SDC) | Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD) | 14.4 Percentage of participants |
| Relay Program (Peer Navigation) | Number of Participants Who Initiate Medication for Opioid Use Disorder (MOUD) | 16.1 Percentage of participants |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site-Directed Care (SDC) | Overdose Risk Behavior Questionnaire Score | 3.77 score on a scale | Standard Deviation 6.14 |
| Relay Program (Peer Navigation) | Overdose Risk Behavior Questionnaire Score | 6.46 score on a scale | Standard Deviation 8.13 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site-Directed Care (SDC) | Overdose Risk Behavior Questionnaire Score | 8.22 score on a scale | Standard Deviation 6.35 |
| Relay Program (Peer Navigation) | Overdose Risk Behavior Questionnaire Score | 8.9 score on a scale | Standard Deviation 8.13 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site-Directed Care (SDC) | Overdose Risk Behavior Questionnaire Score | 4.39 score on a scale | Standard Deviation 6.51 |
| Relay Program (Peer Navigation) | Overdose Risk Behavior Questionnaire Score | 6.52 score on a scale | Standard Deviation 6.6 |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site-Directed Care (SDC) | Overdose Risk Behavior Questionnaire Score | 4.49 score on a scale | Standard Deviation 6.61 |
| Relay Program (Peer Navigation) | Overdose Risk Behavior Questionnaire Score | 6.6 score on a scale | Standard Deviation 7.01 |
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Site-Directed Care (SDC) | Percentage of Participants Who Self-Report Opioid-Involved Overdose | 11.3 Percentage of participants |
| Relay Program (Peer Navigation) | Percentage of Participants Who Self-Report Opioid-Involved Overdose | 16.7 Percentage of participants |
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.
Time frame: Month 6
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Site-Directed Care (SDC) | Percentage of Participants Who Self-Report Opioid-Involved Overdose | 30.3 Percentage of participants |
| Relay Program (Peer Navigation) | Percentage of Participants Who Self-Report Opioid-Involved Overdose | 37.8 Percentage of participants |
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.
Time frame: Month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Site-Directed Care (SDC) | Percentage of Participants Who Self-Report Opioid-Involved Overdose | 24.3 Percentage of participants |
| Relay Program (Peer Navigation) | Percentage of Participants Who Self-Report Opioid-Involved Overdose | 31.6 Percentage of participants |
Secondary
Time to Next Opioid-Involved Overdose
Time to next opioid-involved overdose from the time of baseline, by self-report.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Site-Directed Care (SDC) | Time to Next Opioid-Involved Overdose | 68.0 days | Standard Deviation 49.3 |
| Relay Program (Peer Navigation) | Time to Next Opioid-Involved Overdose | 57.8 days | Standard Deviation 51.4 |