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

Sponsor
Texas Christian University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04276792
Collaborator
University of New Mexico (Other), Loyola University (Other)
18
1
2
30.8
0.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: TCU Opioid-Treatment Linkage Model (O-TLM)
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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 trialOur 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)
Primary Purpose:
Health Services Research
Official Title:
Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center
Actual Study Start Date :
Oct 7, 2021
Anticipated Primary Completion Date :
May 31, 2023
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

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.

Behavioral: TCU Opioid-Treatment Linkage Model (O-TLM)
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.

Behavioral: TCU Opioid-Treatment Linkage Model (O-TLM)
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.

Outcome Measures

Primary Outcome Measures

  1. Public Health assessed by decrease in days and amount of illicit drug use, including opioids [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

  2. Public Safety as assessed through reduction in rearrest rates [6 months and 12 months post-release]

    reductions in rearrest rates measured through justice and department of pubic safety records

  3. Increase in Access to Services [6 months and 12 months post-release]

    referral rate increase as self-reported through client interviews and provided through justice records

  4. Increase in Retention in Services [6 months and 12 months post-release]

    appointments kept as self-reported through client interviews and provided through justice and provider records

Secondary Outcome Measures

  1. Systems Impact as assessed through improved intervention attitudes [6 and 12 months post implementation start]

    staff attitudes of intervention acceptability as assessed through survey

  2. Systems Impact as assessed through intervention cost [6 and 12 months post implementation start]

    accumulated cost of intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Texas Christian University Fort Worth Texas United States 76109

Sponsors and Collaborators

  • Texas Christian University
  • University of New Mexico
  • Loyola University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
DanicaKnight, Associate Professor, Texas Christian University
ClinicalTrials.gov Identifier:
NCT04276792
Other Study ID Numbers:
  • 1UG1DA050074
First Posted:
Feb 19, 2020
Last Update Posted:
Mar 15, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022