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

NCT ID: NCT04276792

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-07

Study Completion Date

2026-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Addiction, Opioid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TCU Opioid-Treatment Linkage Model (O-TLM)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

TCU Opioid-Treatment Linkage Model (O-TLM)

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of New Mexico

OTHER

Sponsor Role collaborator

Loyola University

OTHER

Sponsor Role collaborator

Texas Christian University

OTHER

Sponsor Role lead

Responsible Party

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DanicaKnight

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danica K Knight, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Christian University

Locations

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Texas Christian University

Fort Worth, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jennifer Becan, PhD

Role: CONTACT

18172576518

Facility Contacts

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Jennifer Becan, PhD

Role: primary

817-257-6518

Other Identifiers

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1UG1DA050074

Identifier Type: NIH

Identifier Source: org_study_id

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