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Recovery Initiation and Management After Overdose (RIMO) Experiment (RIMO)

Primary Purpose

Opioid-use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Recovery Initiation and Management after Overdose (RIMO)
Passive Referral to Treatment Control
Sponsored by
Chestnut Health Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Opioid-use Disorder focused on measuring Opioid Overdose, First responders, Medication Assisted Treatment, Treatment linkage

Eligibility Criteria

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

Inclusion Criteria:

  • experienced an opioid overdose reversed with naloxone administered by first responders on a participating team within the past week
  • not in treatment during the past 30 days
  • screen positive for an OUD

Exclusion Criteria:

  • under age 18
  • unable to speak and understand English
  • not residing in Chicago
  • cognitively unable to provide informed consent

Sites / Locations

  • Chestnut Health SystemsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Passive Referral Control

Recovery Initiation and Management after Overdose (RIMO)

Arm Description

Participants will be given information on recently expanded and publicly-funded MAT treatment in their community.

Participants assigned to the RIMO arm will meet with Linkage Managers (LM), who will use motivational interviewing (MI) techniques to: 1) identify the need for treatment and barriers to going, 2) discuss with patients the benefits of their decision to go to treatment, including activities they might enjoy as well as things they do not like about their alcohol/substance use, 3) provide personalized feedback to participants about the status of their condition based on responses to the assessment instruments, 4) help participants resolve ambivalence about their use and move them toward a commitment to change by accessing additional care, 5) address existing barriers to treatment (e.g., childcare, transportation), 6) schedule a treatment appointment, and 7) facilitate medication assisted treatment re-entry and engagement.

Outcomes

Primary Outcome Measures

MAT Time to Initiation
Days from index naloxone administration to the initiation of any kind of MAT, from treatment records.
Length of Staying on Medication
Days between MAT initiation and discharge, from treatment records.
MAT Days
Total days of MAT over 9 months from Global Appraisal of Individual Needs Quick (GAIN) and treatment records.

Secondary Outcome Measures

Time to Relapse
Days from randomization to next subsequent use of opioids or heroin based on GAIN follow-up interviews and urine tests.
Opioid Days of Use
Days of opioids and/or heroin use summed over the GAIN follow-up interviews.
Opioid Overdose
Number of opioid-related overdose[s] summed over the GAIN follow-up interviews.
Opioid-Related Fatality
Any International Classification of Diseases version 10 (ICD-10) cause of death related to opioid overdose (T40.1, T40.2, T40.3, T40.4, T40.6, X42, X44, X62, X64, Y12, Y14) in Centers for Disease Control (CDC) death records.
Opioid Use Disorder symptoms
The Opioid Use Disorder Scale; scores range form 0 to 11 based on a count of self reported symptoms from the Diagnostic and Statistical Manual 5 criteria for opioid use disorder symptoms from the GAIN follow-up interviews. The scale score is interpreted as subclinical (0-1 symptoms), low (2-3 symptoms), moderate (4-5 symptoms) or high (6-11 symptoms) severity.
Physical Health
The average of 5 past 90-day items on the Health Problem Screener (worried about health, pain, health kept participant from meeting responsibilities) from GAIN follow-up interviews.
Mental Health: Internalizing Symptoms
The GAIN's Internalizing Disorder Screener; ranging from 0 to 6, the screener includes symptoms of depression, anxiety, trauma, suicide and are interpreted as low (0 symptoms), moderate (1-2 symptoms) or high (3-6 symptoms)
Mental Health: Externalizing Symptoms
The GAIN's Externalizing Disorder Screener; ranging from 0 to 6, the screener includes symptoms of attention deficit, hyperactivity, conduct, gambling disorders and are interpreted as low (0 symptoms), moderate (1-2 symptoms) or high (3-6 symptoms)
Cost of Health Care Utilization
Sum of the quarterly costs of health care from the GAIN-Q3 follow-up interviews; based on the frequency of health, mental health or substance-related emergency department visits, hospitalizations, residential treatment, outpatient surgery, MAT, intensive outpatient, outpatient treatment days/times multiplied by their respective costs using published estimates by health economists, adjusted for inflation using the consumer price index.

Full Information

First Posted
March 26, 2019
Last Updated
July 18, 2022
Sponsor
Chestnut Health Systems
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03895827
Brief Title
Recovery Initiation and Management After Overdose (RIMO) Experiment
Acronym
RIMO
Official Title
Recovery Initiation and Management After Overdose (RIMO) Experiment: Phase 2 Main Clinical Trial (R33)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chestnut Health Systems
Collaborators
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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study targets individuals in Chicago who have received naloxone administered by first responders within the past week to reverse an overdose, but who have not entered into MAT. Study participants will be recruited through partnerships with the Chicago Fire Department (CFD) and/or Police Department (CPD); first responders will be trained to seek consent from individuals who are alert and oriented after receiving naloxone for future contacts by research staff as part of the naloxone standard protocol. Those who consent will be contacted and screened for study eligibility ideally within one week of naloxone administration; eligible participants will be randomly assigned either to the control group, i.e., referral to MAT as usual, or to Recovery Initiation and Management after Overdose (RIMO), an assertive linkage and recovery support intervention. This intervention builds on an evidence-based intervention for treatment linkage, monitoring, and recovery support evaluated in 3 prior clinical trials by the study team.
Detailed Description
Research staff will work with the Chicago Fire Department's Emergency Medical Services division and the Chicago Police Department to identify people who have just had an opioid overdose reversed with naloxone, recruit them into the trial, randomize them to a passive referral (via a brochure) vs. the RIMO experimental group. Using the study recruitment and RIMO procedures refined in Phase 1, a total of 350 individuals will be recruited and randomly assigned to the "referral to MAT" control or to "RIMO". All participants will receive standardized assessments at baseline and 3, 6, and 9 months post-randomization. The study's aims and their associated hypotheses are: Aim 1: Evaluate RIMO's direct effect on linkage to MAT, length of time on MAT, dropout, and total days of MAT. H1: Relative to the control group, RIMO will have a direct effect on: a) initiating MAT sooner, b) staying on medication longer, c) reducing dropout, and d) receiving more total days of MAT. Aim 2: Evaluate RIMO's direct and indirect (via MAT) effects on time to relapse, opioid use, and opioid-related overdose. H2: RIMO will have direct and indirect (via days of MAT treatment) effects on: a) time to relapse, b) days of opioid use, and c) number of overdoses. Aim 3: RIMO's direct and indirect (via MAT and opioid use) effects on opioid-related fatalities, opioid use disorder (OUD) symptoms, physical health, mental health and the cost of health care utilization. H3: RIMO will have direct and indirect (via days of MAT treatment and days of opioid use) effects on: a) opioid-related fatalities, b) opioid use disorders symptoms, c) physical health, d) mental health, and e) cost of health care utilization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
Opioid Overdose, First responders, Medication Assisted Treatment, Treatment linkage

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants randomly assigned to experiment group getting Recovery Initiation and Management after Overdose (RIMO) intervention or control group getting a passive referral to medication assisted treatment.
Masking
Outcomes Assessor
Masking Description
The outcome assessor is blind to the condition of the participant.
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Passive Referral Control
Arm Type
Active Comparator
Arm Description
Participants will be given information on recently expanded and publicly-funded MAT treatment in their community.
Arm Title
Recovery Initiation and Management after Overdose (RIMO)
Arm Type
Experimental
Arm Description
Participants assigned to the RIMO arm will meet with Linkage Managers (LM), who will use motivational interviewing (MI) techniques to: 1) identify the need for treatment and barriers to going, 2) discuss with patients the benefits of their decision to go to treatment, including activities they might enjoy as well as things they do not like about their alcohol/substance use, 3) provide personalized feedback to participants about the status of their condition based on responses to the assessment instruments, 4) help participants resolve ambivalence about their use and move them toward a commitment to change by accessing additional care, 5) address existing barriers to treatment (e.g., childcare, transportation), 6) schedule a treatment appointment, and 7) facilitate medication assisted treatment re-entry and engagement.
Intervention Type
Behavioral
Intervention Name(s)
Recovery Initiation and Management after Overdose (RIMO)
Intervention Description
RIMO uses motivational interviewing and linkage assistance techniques to get people who have had a recent opioid overdose reversal to go to medication-assisted treatment (MAT), stay in MAT, and, if they drop out, go back to MAT treatment.
Intervention Type
Other
Intervention Name(s)
Passive Referral to Treatment Control
Intervention Description
Currently neither first responders or emergency department staff regularly refer people to any kind of substance use after an opioid overdose reversal. In the passive referral condition they will at least get a brochure with information on recently expanded and publicly-funded medication-assisted treatment in their community.
Primary Outcome Measure Information:
Title
MAT Time to Initiation
Description
Days from index naloxone administration to the initiation of any kind of MAT, from treatment records.
Time Frame
9 months
Title
Length of Staying on Medication
Description
Days between MAT initiation and discharge, from treatment records.
Time Frame
9 months
Title
MAT Days
Description
Total days of MAT over 9 months from Global Appraisal of Individual Needs Quick (GAIN) and treatment records.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Time to Relapse
Description
Days from randomization to next subsequent use of opioids or heroin based on GAIN follow-up interviews and urine tests.
Time Frame
9 months
Title
Opioid Days of Use
Description
Days of opioids and/or heroin use summed over the GAIN follow-up interviews.
Time Frame
9 months
Title
Opioid Overdose
Description
Number of opioid-related overdose[s] summed over the GAIN follow-up interviews.
Time Frame
9 months
Title
Opioid-Related Fatality
Description
Any International Classification of Diseases version 10 (ICD-10) cause of death related to opioid overdose (T40.1, T40.2, T40.3, T40.4, T40.6, X42, X44, X62, X64, Y12, Y14) in Centers for Disease Control (CDC) death records.
Time Frame
9 months
Title
Opioid Use Disorder symptoms
Description
The Opioid Use Disorder Scale; scores range form 0 to 11 based on a count of self reported symptoms from the Diagnostic and Statistical Manual 5 criteria for opioid use disorder symptoms from the GAIN follow-up interviews. The scale score is interpreted as subclinical (0-1 symptoms), low (2-3 symptoms), moderate (4-5 symptoms) or high (6-11 symptoms) severity.
Time Frame
9 months
Title
Physical Health
Description
The average of 5 past 90-day items on the Health Problem Screener (worried about health, pain, health kept participant from meeting responsibilities) from GAIN follow-up interviews.
Time Frame
9 months
Title
Mental Health: Internalizing Symptoms
Description
The GAIN's Internalizing Disorder Screener; ranging from 0 to 6, the screener includes symptoms of depression, anxiety, trauma, suicide and are interpreted as low (0 symptoms), moderate (1-2 symptoms) or high (3-6 symptoms)
Time Frame
9 months
Title
Mental Health: Externalizing Symptoms
Description
The GAIN's Externalizing Disorder Screener; ranging from 0 to 6, the screener includes symptoms of attention deficit, hyperactivity, conduct, gambling disorders and are interpreted as low (0 symptoms), moderate (1-2 symptoms) or high (3-6 symptoms)
Time Frame
9 months
Title
Cost of Health Care Utilization
Description
Sum of the quarterly costs of health care from the GAIN-Q3 follow-up interviews; based on the frequency of health, mental health or substance-related emergency department visits, hospitalizations, residential treatment, outpatient surgery, MAT, intensive outpatient, outpatient treatment days/times multiplied by their respective costs using published estimates by health economists, adjusted for inflation using the consumer price index.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: experienced an opioid overdose reversed with naloxone administered by first responders on a participating team within the past week not in treatment during the past 30 days screen positive for an OUD Exclusion Criteria: under age 18 unable to speak and understand English not residing in Chicago cognitively unable to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christy K Scott, Ph.D.
Phone
312-274-5306
Email
cscott@chestnut.org
First Name & Middle Initial & Last Name or Official Title & Degree
Michael L Dennis, Ph.D.
Phone
309-451-7801
Email
mdennis@chestnut.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christy K Scott, Ph.D.
Organizational Affiliation
Chestnut Health Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chestnut Health Systems
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christy K Scott, Ph.D.
Phone
312-274-5306
Email
cscott@chestnut.org
First Name & Middle Initial & Last Name & Degree
Michael L Dennis, Ph.D.
Phone
309-451-7801
Email
mdennis@chestnut.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Recovery Initiation and Management After Overdose (RIMO) Experiment

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