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

Study Overview
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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.

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

Conditions
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Addiction, Opioid

Intervention / Treatment
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* Behavioral: TCU Opioid-Treatment Linkage Model (O-TLM)


Participation Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Horizontal implementation approach<br>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)<br>* 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.<br>|
| Active Comparator: Vertical implementation approach<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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