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Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center (JCOIN_TCU)

Primary Purpose

Addiction, Opioid

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TCU Opioid-Treatment Linkage Model (O-TLM)
Sponsored by
Texas Christian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Addiction, Opioid

Eligibility Criteria

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

Inclusion Criteria:

  • client level participant eligibility includes having a history of opioid use or at risk for opioid use after release; being released to a participating community while under supervision
  • staff level participant eligibility includes being a key member of a participating community and involved in the service assessment and referral process of justice-involved individuals.

Exclusion Criteria:

  • no history of opioid use or being at risk of opioid use; not being released to a participating community.
  • staff level participant exclusion criteria include not being a key member of a participating community and not being involved in the service assessment and referral process of justice-involved individuals.

Sites / Locations

  • Texas Christian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Horizontal implementation approach

Vertical implementation approach

Arm Description

The Horizontal implementation approach of the O-TLM intervention is accompanied by facilitated collaboration between Criminal Justice and Community Behavioral Health systems. Direct involvement of stakeholders with differing perspectives and buy-in from agency leadership and policymakers are key elements. The Horizontal approach involves first developing a prototype (including how to modify existing practices, overcome implementation barriers, and manage roles and responsibilities) that are tested and refined before being rolled out systematically to other units within an agency.

The Vertical implementation approach of the O-TLM intervention relies on the traditional criminal justice system's typical use of a hierarchical structure and the use of a top-down implementation approach (i.e., administrative orders) for directing change. Top-down regulatory and policy changes are viewed as vital levers for driving system change.

Outcomes

Primary Outcome Measures

Public Health assessed by decrease in days and amount of illicit drug use, including opioids
decreases in days and amount of illicit drug use, including opioids assessed through client interviews using the timeline follow-back method
Public Safety as assessed through reduction in rearrest rates
reductions in rearrest rates measured through justice and department of pubic safety records
Increase in Access to Services
referral rate increase as self-reported through client interviews and provided through justice records
Increase in Retention in Services
appointments kept as self-reported through client interviews and provided through justice and provider records

Secondary Outcome Measures

Systems Impact as assessed through improved intervention attitudes
staff attitudes of intervention acceptability as assessed through survey
Systems Impact as assessed through intervention cost
accumulated cost of intervention

Full Information

First Posted
February 14, 2020
Last Updated
February 9, 2023
Sponsor
Texas Christian University
Collaborators
University of New Mexico, Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT04276792
Brief Title
Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center
Acronym
JCOIN_TCU
Official Title
Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Christian University
Collaborators
University of New Mexico, Loyola University

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
There are two study periods for the TCU JCOIN project. The primary aims of Study 1 (approved by the TCU IRB) are (1) to gather information from staff on the current treatment referral process within participating communities and (2) to learn about the existing interrelationships between medical and community behavioral health (CBH) providers. TCU IRB granted approval for Phase 1 on 11/07/19, approval number: 1920-60-AM1. Study 2 (under current review by the TCU IRB) includes recruitment across 18 community collaboration sites across 3 states; these communities will participate in the TCU Opioid-Treatment Linkage Model (O-TLM) protocol. The O-TLM is focused on best practices for improving screening, identifying and linking to MOUD providers, reducing stigma, and addressing other important factors that impact justice-involved individuals returning to their communities. Along with their agency records, information collected from justice-involved individuals within the target communities will be examined to assess O-TLM impact on improving public health and public safety outcomes. Furthermore, stakeholder staff across community organizations, including criminal justice and treatment agencies, will be asked to complete surveys on the O-TLM regarding its acceptability and adoption, as well as on best training strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Addiction, Opioid

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Our design is a Hybrid Type 3 design with the primary aim to compare 2 implementation strategies, and a secondary aim to assess client-level outcomes associated with the trial; the design includes a stepped wedge and cluster randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Horizontal implementation approach
Arm Type
Experimental
Arm Description
The Horizontal implementation approach of the O-TLM intervention is accompanied by facilitated collaboration between Criminal Justice and Community Behavioral Health systems. Direct involvement of stakeholders with differing perspectives and buy-in from agency leadership and policymakers are key elements. The Horizontal approach involves first developing a prototype (including how to modify existing practices, overcome implementation barriers, and manage roles and responsibilities) that are tested and refined before being rolled out systematically to other units within an agency.
Arm Title
Vertical implementation approach
Arm Type
Active Comparator
Arm Description
The Vertical implementation approach of the O-TLM intervention relies on the traditional criminal justice system's typical use of a hierarchical structure and the use of a top-down implementation approach (i.e., administrative orders) for directing change. Top-down regulatory and policy changes are viewed as vital levers for driving system change.
Intervention Type
Behavioral
Intervention Name(s)
TCU Opioid-Treatment Linkage Model (O-TLM)
Intervention Description
The O-TLM is focused on best practices for improving screening, identifying and linking to MOUD providers, reducing stigma, and addressing other important factors that impact justice-involved individuals returning to their communities.
Primary Outcome Measure Information:
Title
Public Health assessed by decrease in days and amount of illicit drug use, including opioids
Description
decreases in days and amount of illicit drug use, including opioids assessed through client interviews using the timeline follow-back method
Time Frame
6 months and 12 months post-release
Title
Public Safety as assessed through reduction in rearrest rates
Description
reductions in rearrest rates measured through justice and department of pubic safety records
Time Frame
6 months and 12 months post-release
Title
Increase in Access to Services
Description
referral rate increase as self-reported through client interviews and provided through justice records
Time Frame
6 months and 12 months post-release
Title
Increase in Retention in Services
Description
appointments kept as self-reported through client interviews and provided through justice and provider records
Time Frame
6 months and 12 months post-release
Secondary Outcome Measure Information:
Title
Systems Impact as assessed through improved intervention attitudes
Description
staff attitudes of intervention acceptability as assessed through survey
Time Frame
6 and 12 months post implementation start
Title
Systems Impact as assessed through intervention cost
Description
accumulated cost of intervention
Time Frame
6 and 12 months post implementation start

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: client level participant eligibility includes having a history of opioid use or at risk for opioid use after release; being released to a participating community while under supervision staff level participant eligibility includes being a key member of a participating community and involved in the service assessment and referral process of justice-involved individuals. Exclusion Criteria: no history of opioid use or being at risk of opioid use; not being released to a participating community. staff level participant exclusion criteria include not being a key member of a participating community and not being involved in the service assessment and referral process of justice-involved individuals.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Becan, PhD
Phone
18172576518
Email
j.becan@tcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danica K Knight, PhD
Organizational Affiliation
Texas Christian University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Christian University
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Becan, PhD
Phone
817-257-6518
Email
j.becan@tcu.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will adhere to NIH JCOIN approved plan

Learn more about this trial

Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center

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