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

February 9, 2023 updated by: DanicaKnight, Texas Christian University
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jennifer Becan, PhD
  • Phone Number: 18172576518
  • Email: j.becan@tcu.edu

Study Locations

    • Texas
      • Fort Worth, Texas, United States, 76109
        • Recruiting
        • Texas Christian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Horizontal implementation approach
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 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.
ACTIVE_COMPARATOR: Vertical implementation approach
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Public Health assessed by decrease in days and amount of illicit drug use, including opioids
Time Frame: 6 months and 12 months post-release
decreases in days and amount of illicit drug use, including opioids assessed through client interviews using the timeline follow-back method
6 months and 12 months post-release
Public Safety as assessed through reduction in rearrest rates
Time Frame: 6 months and 12 months post-release
reductions in rearrest rates measured through justice and department of pubic safety records
6 months and 12 months post-release
Increase in Access to Services
Time Frame: 6 months and 12 months post-release
referral rate increase as self-reported through client interviews and provided through justice records
6 months and 12 months post-release
Increase in Retention in Services
Time Frame: 6 months and 12 months post-release
appointments kept as self-reported through client interviews and provided through justice and provider records
6 months and 12 months post-release

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systems Impact as assessed through improved intervention attitudes
Time Frame: 6 and 12 months post implementation start
staff attitudes of intervention acceptability as assessed through survey
6 and 12 months post implementation start
Systems Impact as assessed through intervention cost
Time Frame: 6 and 12 months post implementation start
accumulated cost of intervention
6 and 12 months post implementation start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Danica K Knight, PhD, Texas Christian University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 7, 2021

Primary Completion (ANTICIPATED)

May 31, 2023

Study Completion (ANTICIPATED)

April 30, 2024

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (ACTUAL)

February 19, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 9, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will adhere to NIH JCOIN approved plan

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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