Clinical trial NCT04276792: Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center
Official title: Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Addiction, Opioid
Lead sponsor: Texas Christian University
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: Loyola University
First posted: 2020-02-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 cluster randomized parallel design with staggered starts
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Public Health assessed by decrease in days and amount of illicit drug use, including opioids
timeFrame: 6 months and 12 months post-release
measure: Public Safety as assessed through reduction in rearrest rates
timeFrame: 6 months and 12 months post-release
measure: Increase in Access to Services
timeFrame: 6 months and 12 months post-release
measure: Increase in Retention in Services
timeFrame: 6 months and 12 months post-release
Secondary outcomes:
measure: Systems Impact as assessed through improved intervention attitudes
timeFrame: 6 and 12 months post implementation start
measure: Systems Impact as assessed through intervention cost
timeFrame: 6 and 12 months post implementation start
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Christian University
state: Texas
Study officials:
affiliation: Texas Christian University
name: Danica K Knight, PhD
role: PRINCIPAL_INVESTIGATOR
References: