Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Opioid Overdose

Treatments: Behavioral: Treatment As Usual Peer; Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer

Study type: Interventional

Funder types: Other; NETWORK; Industry; NIH

Identifiers

NCT05123027

00103441

3UG1DA013727-20S5 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer

Experimental group

Treatment:

Behavioral: Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer

Behavioral: Treatment As Usual Peer

Treatment As Usual Peer

Active Comparator group

Treatment:

Behavioral: Treatment As Usual Peer