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

Primary Purpose

Opioid Overdose

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer
Treatment As Usual Peer
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Opioid Overdose focused on measuring overdose, peer support

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Mercy Health Youngstown
  • Prisma Health Upstate
  • Providence Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

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

Treatment As Usual Peer

Arm Description

Outcomes

Primary Outcome Measures

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 at 180 days (6 months post-randomization) compared between experimental groups.

Secondary Outcome Measures

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).

Full Information

First Posted
October 26, 2021
Last Updated
September 29, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Drug Abuse Treatment Clinical Trials Network, The Emmes Company, LLC, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT05123027
Brief Title
Peer Intervention to Link Overdose Survivors to Treatment (PILOT)
Acronym
PILOT
Official Title
NIDA CTN-0107 Peer Intervention to Link Overdose Survivors to Treatment (PILOT)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 28, 2021 (Actual)
Primary Completion Date
January 5, 2024 (Anticipated)
Study Completion Date
February 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Drug Abuse Treatment Clinical Trials Network, The Emmes Company, LLC, National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Overdose
Keywords
overdose, peer support

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer
Arm Type
Experimental
Arm Title
Treatment As Usual Peer
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Peer Intervention to Link Overdose Survivors to Treatment (PILOT) Peer
Intervention Description
Participants will meet with the PILOT Peer consistently throughout the 6 months of study participation.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual Peer
Intervention Description
Participants will receive recovery resources and standard of care procedures specific to the Emergency Department.
Primary Outcome Measure Information:
Title
Number of self-reported overdose risk behaviors at 180 days (6 months) after Index ED admission
Description
Past month total score on the modified Overdose Risk Behavior Checklist at 180 days (6 months post-randomization) compared between experimental groups.
Time Frame
180 days (6 months)
Secondary Outcome Measure Information:
Title
Number of steps achieved along a modified SUD Cascade of Care
Description
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).
Time Frame
180 days (6 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
To be included in this study participants must: Be 18 years of age or older at time of first contact by research staff (no upper age limit for inclusion). Meet one of the following non-fatal overdose involving opioids (NFOO) criteria: 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 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 Be able to provide sufficient locator information, defined as identifying at least two individual contacts other than the participant. 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. 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: Identified as having had an intentional overdose as the Index NFOO. Actively suicidal at the time of screening (defined as current intention and/or plan for suicide attempt). Unable to complete study baseline procedures due to medical or psychiatric condition. 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). Previously randomized as a participant in this study - individuals may only be enrolled and randomized once. Unwilling to follow study procedures (e.g., unable to provide sufficient locator information [defined as two contacts] or unavailable for follow-up assessments).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Barth, DO
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Health Youngstown
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44501
Country
United States
Facility Name
Prisma Health Upstate
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Providence Regional Medical Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) and the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy).

Learn more about this trial

Peer Intervention to Link Overdose Survivors to Treatment (PILOT)

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