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

NCT04276792 | Recruiting DMC

• 1 other identifier: 1UG1DA050074
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Addiction, Opioid

Outcome Measures

Primary Outcomes (4)

• 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

  6 months and 12 months post-release

• Public Safety as assessed through reduction in rearrest rates

  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

  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

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

  6 months and 12 months post-release

Secondary Outcomes (2)

• Systems Impact as assessed through improved intervention attitudes

  6 and 12 months post implementation start

• Systems Impact as assessed through intervention cost

  6 and 12 months post implementation start

Study Arms (2)

Horizontal implementation approach

EXPERIMENTAL

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)

Vertical implementation approach

ACTIVE COMPARATOR

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)

Interventions

TCU Opioid-Treatment Linkage Model (O-TLM) BEHAVIORAL

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.

Horizontal implementation approach; Vertical implementation approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• client level participant eligibility includes having a history of opioid use or at risk for opioid use; 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.

You may not qualify if:

• no history of opioid use or being at risk of opioid use; not being released to a participating community.

Sponsors & Collaborators

• Texas Christian University: lead
• University of New Mexico: collaborator
• Loyola University: collaborator

Study Sites (1)

Texas Christian University

Fort Worth, Texas, 76109, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Danica K Knight, PhD

  Texas Christian University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Becan, PhD

CONTACT

18172576518; j.becan@tcu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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 cluster randomized parallel design with staggered starts

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 19, 2020
• Study Start: October 7, 2021
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

US (1)