Opioid Overdose
Conditions
Keywords
overdose, peer support
Brief summary
The purpose of the Peer Intervention to Link Overdose Survivors to Treatment (PILOT) study is to improve outcomes for individuals after surviving an overdose involving opioids. This study will be comparing the enhanced peer intervention known as PILOT for overdose survivors with treatment as usual (TAU) provided in the Emergency Department.
Interventions
BEHAVIORALPeer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer
Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation.
BEHAVIORALTreatment As Usual Peer
Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.
Sponsors
National Drug Abuse Treatment Clinical Trials Network
The Emmes Company, LLC
National Institute on Drug Abuse (NIDA)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
To be included in this study participants must: 1. Be 18 years of age or older at time of first contact by research staff (no upper age limit for inclusion). 2. Meet one of the following non-fatal overdose involving opioids (NFOO) criteria: 1. Having presented to the Emergency Department for any health issue within the past 48 hours AND self-report having a known or suspected overdose involving opioids in the past 72 hours, OR 2. Having presented to the Emergency Department within the past 48 hours for any SUD-related health issue, self-report having a known or suspected overdose involving opioids in the past 30 days 3. Be able to provide sufficient locator information, defined as identifying at least two individual contacts other than the participant. 4. Be able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study as determined by research staff. 5. Be willing and able to confirm future SUD treatment receipt as evidenced by 2 out of 3 of the following: (a) signing appropriate releases to for study staff to confirm treatment with follow-up provider; (b) having technology necessary to visualize medication bottles and transmit to study team utilizing HIPAA-compliant platform; and/or (c) able and willing to undergo toxicology tests (in person or via HIPAA-compliant videoconferencing).
Exclusion criteria
include those who are: 1. Identified as having had an intentional overdose as the Index NFOO. 2. Actively suicidal at the time of screening (defined as current intention and/or plan for suicide attempt). 3. Unable to complete study baseline procedures due to medical or psychiatric condition. 4. Currently in jail, prison or in police custody at the time of the index ED visit or under current terms of civil commitment or guardianship (i.e., OHRP-defined prisoner status). 5. Previously randomized as a participant in this study - individuals may only be enrolled and randomized once. 6. Unwilling to follow study procedures (e.g., unable to provide sufficient locator information \[defined as two contacts\] or unavailable for follow-up assessments).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission | 180 days (6 months) | Past month total score on the modified Overdose Risk Behavior Checklist (OBRC) at 180 days (6 months post-randomization) compared between experimental groups. The ORBC was a 13-item scale with 11 of the items used to generate a total score (ranging from 0-44); higher scores indicate greater frequency and number of overdose risk behaviors. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Steps Achieved Along a Modified SUD Cascade of Care | 180 days (6 months) | Number of steps achieved along a modified substance use disorder (SUD) Cascade of Care (0-11 steps possible) at 180 days post-randomization (6 months). Higher scores are associated with better outcomes. |
Countries
United States
Participant flow
Recruitment details
A randomized, controlled, parallel group design was implemented across three sites within the National Drug Abuse Treatment Clinical Trials Network (CTN): Prisma Health Systems (Southern Consortium Node); Mercy Health (Ohio Valley Node), and Providence Regional Medical Center (Pacific Northwest Node). From December 2021 through February 2024, 150 participants identified in the ED as opioid overdose survivors were approached to participate in the study.
Pre-assignment details
Participants were identified and recruited from the ED at the time of ED admission (primary method of recruitment). Recruitment, approaching patients, screening, consent, and study procedures were completed in-person or remotely, utilizing HIPAA-compliant videoconferencing. Participants could be approached, screened and randomized after ED admission and could be randomized after screening had occurred in the ED.
Participants by arm
| Arm | Count |
|---|---|
| Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer: Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation.
Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department. | 72 |
| Treatment As Usual Peer Treatment As Usual Peer: Participants will receive recovery resources and standard of care procedures specific to the Emergency Department. | 78 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 2 |
| Overall Study | Incarceration | 3 | 4 |
| Overall Study | Lost to Follow-up | 17 | 22 |
| Overall Study | Other | 2 | 0 |
Baseline characteristics
| Characteristic | Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer | Treatment As Usual Peer | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants | 76 Participants | 146 Participants |
| Age, Continuous | 39.3 years STANDARD_DEVIATION 11.58 | 38.1 years STANDARD_DEVIATION 11.28 | 38.7 years STANDARD_DEVIATION 11.41 |
| Baseline ORBC score | 12.6 units on a scale STANDARD_DEVIATION 7.4 | 12 units on a scale STANDARD_DEVIATION 7.9 | 12.3 units on a scale STANDARD_DEVIATION 7.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants | 8 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 70 Participants | 136 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 12 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 6 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 5 Participants | 10 Participants |
| Race (NIH/OMB) White | 51 Participants | 53 Participants | 104 Participants |
| Sex: Female, Male Female | 21 Participants | 30 Participants | 51 Participants |
| Sex: Female, Male Male | 51 Participants | 48 Participants | 99 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 72 | 2 / 78 |
| other Total, other adverse events | 0 / 72 | 0 / 78 |
| serious Total, serious adverse events | 21 / 72 | 18 / 78 |
Outcome results
Primary
Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission
Past month total score on the modified Overdose Risk Behavior Checklist (OBRC) at 180 days (6 months post-randomization) compared between experimental groups. The ORBC was a 13-item scale with 11 of the items used to generate a total score (ranging from 0-44); higher scores indicate greater frequency and number of overdose risk behaviors.
Time frame: 180 days (6 months)
Population: Intent to treat analysis. All randomized subjects were included in the analysis. A participant contributed to the Day 180 estimate if they had all fixed effect covariates including baseline ORBC score and an ORBC score at Day 180
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PILOT Intervention Arm | Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission | 4.5 units on a scale | Standard Deviation 6.7 |
| Treatment as Usual (TAU) Arm | Number of Self-reported Overdose Risk Behaviors at 180 Days (6 Months) After Index ED Admission | 5.6 units on a scale | Standard Deviation 7.8 |
Comparison: The primary outcome was analyzed with a longitudinal mixed effects negative binomial model incorporating the total score at earlier time points as well as 180 days. Fixed effect covariates included baseline score, treatment, days, site, stratum, and an interaction between treatment and days. A random effect was included to account for correlation within each participant.p-value: 0.39995% CI: [0.3, 1.62]Mixed Models Analysis
Secondary
Number of Steps Achieved Along a Modified SUD Cascade of Care
Number of steps achieved along a modified substance use disorder (SUD) Cascade of Care (0-11 steps possible) at 180 days post-randomization (6 months). Higher scores are associated with better outcomes.
Time frame: 180 days (6 months)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PILOT Intervention Arm | Number of Steps Achieved Along a Modified SUD Cascade of Care | 4.4 units on a scale | Standard Deviation 2.6 |
| Treatment as Usual (TAU) Arm | Number of Steps Achieved Along a Modified SUD Cascade of Care | 3.9 units on a scale | Standard Deviation 2.5 |
Comparison: This was modeled similar to the primary outcome, an over dispersed Poisson regression model with fixed effect covariates for treatment arm, treatment days, site, and stratum with an interaction between treatment arm and treatment days. Note that no baseline score covariate was included as all participants will be considered to have achieved 0 steps at baseline. A random intercept was included for each subject to account for repeated measures.p-value: 0.5395% CI: [0.83, 1.45]Mixed Models Analysis