Recruiting

Observational Study

Sponsor:

Texas Christian University

Code:

NCT04276792

Conditions

Addiction, Opioid

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TCU Opioid-Treatment Linkage Model (O-TLM)

Study Details

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

Study ID

NCT04276792

Start date

Oct 7, 2021

Status verified date

May, 2024

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

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 Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Public Health assessed by decrease in days and amount of illicit drug use, including opioids [ Time Frame: 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 ]
  • Increase in Access to Services [ Time Frame: 6 months and 12 months post-release ]
  • Increase in Retention in Services [ Time Frame: 6 months and 12 months post-release ]

Central Contacts and Locations

Central contacts

Jennifer Becan, PhD

18172576518j.becan@tcu.edu

Locations

Texas Christian University

Recruiting

Fort Worth, Texas, United States, 76109

Contacts

Jennifer Becan, PhD

817-257-6518j.becan@tcu.edu

More Information

Sponsor

Texas Christian University

Last update posted

May 17, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Texas Christian University on 2024-05-17.