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Reducing Opioid Mortality in Illinois (ROMI)

Primary Purpose

Opioid Use, Opioid-use Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Case Management and Peer Recovery
Naloxone-Only
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participants must be at least 18 years old
  • Reside in designated research site county or zip code
  • Satisfy criteria for likely OUD based upon nonmedical use of prescription opioids, heroin, or synthetic opioids.

Exclusion Criteria:

  • Participants experiencing cognitive impairments that preclude informed consent.
  • Reside out of the service area.
  • Prior enrollment in a parallel JCOIN study.

Sites / Locations

  • Cook County Department of Corrections
  • Jackson County Jail
  • LaSalle County JailRecruiting
  • Illinois Department of Corrections
  • Lake County Sheriff's Office Corrections Division

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Case Management and Peer Recovery

Naloxone-Only

Arm Description

Participants in the CM/PRC + OEND arm will receive one year of service delivery. During the initial intake interview the CM will identify primary, secondary, and tertiary barriers to treatment initiation and completion, then create an action plan tailored to each client. PRCs with lived SUD or incarceration experience will address recovery barriers, while CMs will focus on service barriers. Where beneficial and desired by the clients, PRCs will accompany clients to provider and select service appointments to promote engagement and retention. CM/PRC teams will provide OEND upon community re-entry. The teams will provide follow-up phone calls and home visits to facilitate service linkages. Contact frequency will depend on clients' individual barriers (e.g., transportation, homelessness), but will include at least weekly in-person or telephone check-ins for first six months, reduced to monthly check-ins after that.

Participants randomized to the Usual care + OEND condition will be trained on naloxone administration by research staff at the time of randomization. Upon community re-entry,they will be given a naloxone kit and information on local resources for harm reduction, SUD treatment, and additional supportive services.

Outcomes

Primary Outcome Measures

Percent of participants with two or more MOUD provider encounters
Defined as two or more MOUD provider encounters and/or filled prescription in the 30 days prior to follow up assessment.

Secondary Outcome Measures

Percent of participants enrolled in Medicaid or private insurance
Defined as Medicaid or private insurance enrollment during the intervention period.
Percent of participant utilizing mental health services
Defined as any mental health utilization within 90 days conditional on CAT-MH diagnostic.
Days of Opioid Use
A self-reported count 0 to 90 days of using any kind of opioids each quarter, as indicated by the Global Appraisal of Individual Needs (GAIN)assessment tool.
Opioid Use Disorder (OUD) Symptoms
A self-reported count of Opioid Use Disorders (OUD) symptoms, again as captured by the GAIN instrument, measuring past month, past 90 days, year, and lifetime. SUD/MH symptoms as captured by the CAT-MH/SUD.
Patient Reported Outcomes Measurement Information System
This scale of person-centered measures includes eight domains (physical function, ability to participate in social roles and activities, anxiety, depression, fatigue, sleep disturbance, cognitive function ability, pain interference, and pain intensity). These are elicited in a five point likert scale (from 1= never to 5 = always) with higher scores equaling more of the concept being measured, which may be better or worse based on the domain measured.
Health services costs
This cost measure is based on the self-reported frequency of all healthcare services use. Measured using published Medicare reimbursement rates for all pertinent medical care services. Addiction services cost as measured by DATCAP methodology.
Re-arrest and Re-incarceration
Arrest or re-incarceration based on any charge using data from Illinois Criminal Justice Information Authority (ICJIA). The investigators will examine the binary outcomes of re-arrest and reincarceration, and also count data models of the number of arrests post-enrollment during days of non-incarceration.
Self-reported rate of illegal activity
This is a self-reported count of 19 items across different types of illegal activities following the JCOIN core measures instrument.
Social cost of self reported crime
Total social cost of self-reported illegal activity, using estimates for offense-specific economic valuations of social cost per offense and a self-reported count of 19 items across different types of illegal activities.
Social cost of re-arrest and associated offenses
Total social cost of crime, using estimates for offense-specific economic valuations of social cost per offense and any charge using data from Illinois Criminal Justice Information Authority (ICJIA).

Full Information

First Posted
May 5, 2021
Last Updated
October 6, 2021
Sponsor
University of Chicago
Collaborators
Community Outreach Intervention Projects, Cook County Sheriff Office, Cook County Health & Hospitals System, Lake County Sheriff Office, LaSalle County Jail, Perfectly Flawed Foundation, Jackson County Sheriff Office, Illinois Department of Corrections
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1. Study Identification

Unique Protocol Identification Number
NCT04925427
Brief Title
Reducing Opioid Mortality in Illinois
Acronym
ROMI
Official Title
Justice Community Opioid Innovation Network (JCOIN): Reducing Opioid Mortality in Illinois
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
August 30, 2026 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Community Outreach Intervention Projects, Cook County Sheriff Office, Cook County Health & Hospitals System, Lake County Sheriff Office, LaSalle County Jail, Perfectly Flawed Foundation, Jackson County Sheriff Office, Illinois Department of Corrections

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
Reducing Opioid Mortality in Illinois (ROMI) is 5-year research study led by the University of Chicago in partnership with the University of Illinois at Chicago's (UIC) Community Outreach Intervention Projects (COIP), the Illinois Criminal Justice Information Authority (ICJIA) and the American Institutes for Research (AIR). ROMI aims to understand and test strategies for linking individuals with a history of opioid use disorder who are released from Illinois jails and prisons to substance use treatment. ROMI is one of twelve grants awarded by the National Institutes of Health (NIH) as part of the Justice Community Opioid Innovation Network (JCOIN) to support research on quality addiction treatment for opioid use disorder in criminal justice settings nationwide.
Detailed Description
This NIDA-funded multi-site randomized control trial (RCT) examines the effectiveness of an established, intensive case management model for study participants who are awaiting release from four jails and two prisons across Illinois. The investigators seek to demonstrate that a unified case management approach can improve treatment engagement and retention among individuals who face high risks of opioid use disorders, overdose, and related harms. The investigators will examine the impact of case management and peer recovery coaching on participants' engagement with treatment and harm reduction interventions. The investigators will also study secondary outcomes including insurance enrollment, re-arrest, use of mental health services, and more. ROMI will enroll at least 500 individuals with opioid disorders in the CMPR group, and at least 500 participants in the naloxone-only across five geographically distinct sites of care. All participants will receive harm reduction resources. The investigators hypothesize that the treatment group will display declines in opioid use, re-arrest, self-reported syringe sharing, and overdose risk behaviors relative to the control groups. The investigators will also examine differences between urban - rural and rural differences in treatment engagement and retention engagement, retention, and downstream outcomes across treatment arms. Aside from demonstrating these treatment impacts, the investigators will guide, document and evaluate ROMI's implementation efforts to ensure consistency across sites across sites and to inform future replication of the model in different settings or for different populations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid-use Disorder

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Case Management and Peer Recovery
Arm Type
Experimental
Arm Description
Participants in the CM/PRC + OEND arm will receive one year of service delivery. During the initial intake interview the CM will identify primary, secondary, and tertiary barriers to treatment initiation and completion, then create an action plan tailored to each client. PRCs with lived SUD or incarceration experience will address recovery barriers, while CMs will focus on service barriers. Where beneficial and desired by the clients, PRCs will accompany clients to provider and select service appointments to promote engagement and retention. CM/PRC teams will provide OEND upon community re-entry. The teams will provide follow-up phone calls and home visits to facilitate service linkages. Contact frequency will depend on clients' individual barriers (e.g., transportation, homelessness), but will include at least weekly in-person or telephone check-ins for first six months, reduced to monthly check-ins after that.
Arm Title
Naloxone-Only
Arm Type
Placebo Comparator
Arm Description
Participants randomized to the Usual care + OEND condition will be trained on naloxone administration by research staff at the time of randomization. Upon community re-entry,they will be given a naloxone kit and information on local resources for harm reduction, SUD treatment, and additional supportive services.
Intervention Type
Behavioral
Intervention Name(s)
Case Management and Peer Recovery
Intervention Description
A blend between a Critical Time Intervention (CTI) case management model and a peer recovery coaching approach. CORI will employ peer-based case management/recovery coaching and other transitional services (e.g., peer navigation) to provide support and service linkages to medication-assisted treatment (MAT) and harm reduction interventions to reduce subsequent opioid use and related harms.
Intervention Type
Behavioral
Intervention Name(s)
Naloxone-Only
Intervention Description
Participants will be trained on naloxone administration, and upon re-entry, they will be given a naloxone kit and information on local resources for harm reduction, SUD treatment, and additional supportive services.
Primary Outcome Measure Information:
Title
Percent of participants with two or more MOUD provider encounters
Description
Defined as two or more MOUD provider encounters and/or filled prescription in the 30 days prior to follow up assessment.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percent of participants enrolled in Medicaid or private insurance
Description
Defined as Medicaid or private insurance enrollment during the intervention period.
Time Frame
12 months
Title
Percent of participant utilizing mental health services
Description
Defined as any mental health utilization within 90 days conditional on CAT-MH diagnostic.
Time Frame
90 days
Title
Days of Opioid Use
Description
A self-reported count 0 to 90 days of using any kind of opioids each quarter, as indicated by the Global Appraisal of Individual Needs (GAIN)assessment tool.
Time Frame
12 months
Title
Opioid Use Disorder (OUD) Symptoms
Description
A self-reported count of Opioid Use Disorders (OUD) symptoms, again as captured by the GAIN instrument, measuring past month, past 90 days, year, and lifetime. SUD/MH symptoms as captured by the CAT-MH/SUD.
Time Frame
12 months
Title
Patient Reported Outcomes Measurement Information System
Description
This scale of person-centered measures includes eight domains (physical function, ability to participate in social roles and activities, anxiety, depression, fatigue, sleep disturbance, cognitive function ability, pain interference, and pain intensity). These are elicited in a five point likert scale (from 1= never to 5 = always) with higher scores equaling more of the concept being measured, which may be better or worse based on the domain measured.
Time Frame
12 months
Title
Health services costs
Description
This cost measure is based on the self-reported frequency of all healthcare services use. Measured using published Medicare reimbursement rates for all pertinent medical care services. Addiction services cost as measured by DATCAP methodology.
Time Frame
12 months
Title
Re-arrest and Re-incarceration
Description
Arrest or re-incarceration based on any charge using data from Illinois Criminal Justice Information Authority (ICJIA). The investigators will examine the binary outcomes of re-arrest and reincarceration, and also count data models of the number of arrests post-enrollment during days of non-incarceration.
Time Frame
12 months
Title
Self-reported rate of illegal activity
Description
This is a self-reported count of 19 items across different types of illegal activities following the JCOIN core measures instrument.
Time Frame
12 months
Title
Social cost of self reported crime
Description
Total social cost of self-reported illegal activity, using estimates for offense-specific economic valuations of social cost per offense and a self-reported count of 19 items across different types of illegal activities.
Time Frame
12 months
Title
Social cost of re-arrest and associated offenses
Description
Total social cost of crime, using estimates for offense-specific economic valuations of social cost per offense and any charge using data from Illinois Criminal Justice Information Authority (ICJIA).
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participants must be at least 18 years old Reside in designated research site county or zip code Satisfy criteria for likely OUD based upon nonmedical use of prescription opioids, heroin, or synthetic opioids. Exclusion Criteria: Participants experiencing cognitive impairments that preclude informed consent. Reside out of the service area. Prior enrollment in a parallel JCOIN study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Harold Pollack, PhD
Phone
773-834-4292
Email
haroldp@uchicago.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mai Pho, MD
Phone
773-834-3689
Email
mpho@bsd.uchicago.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold Pollack, PhD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mai Pho, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cook County Department of Corrections
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60608
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Kelly, PhD
Phone
773-674-7100
Email
Marianne.Kelly@cookcountyil.gov
Facility Name
Jackson County Jail
City
Murphysboro
State/Province
Illinois
ZIP/Postal Code
62966
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff Whitbeck
Phone
618-687-2292
Email
Jeff.Whitbeck@jacksoncounty-il.gov
Facility Name
LaSalle County Jail
City
Ottawa
State/Province
Illinois
ZIP/Postal Code
61350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Edgcomb
Phone
815-434-8383
Email
jedgcomb@lasallecounty.org
Facility Name
Illinois Department of Corrections
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Meeks, MD
Phone
312-814-3017
Facility Name
Lake County Sheriff's Office Corrections Division
City
Waukegan
State/Province
Illinois
ZIP/Postal Code
60085
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Vega
Email
AVega@lakecountyil.gov

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will adhere to NIH JCOIN approved plan
IPD Sharing Time Frame
Will adhere to NIH JCOIN approved plan
IPD Sharing Access Criteria
Will adhere to NIH JCOIN approved plan

Learn more about this trial

Reducing Opioid Mortality in Illinois

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