Clinical trial NCT04309565: Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support
Official title: Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Addiction
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of North Carolina
name: University of Puerto Rico
name: University of Rochester
name: University of Miami
name: University of California, San Francisco
name: University of Connecticut
name: Albert Einstein College of Medicine
name: Hennepin Healthcare Research Institute
name: National Institute on Drug Abuse (NIDA)
First posted: 2020-03-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid type I effectiveness-implementation trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: TCN PATHS will recruit an anticipated 400 participants who are prescribed MOUD who are released from detention facilities. Each individual will be randomized to either 1) standard primary care (SPC) or 2) a Transitions Clinic Network (TCN) program primary care. Participants will be followed for a year and complete surveys at baseline and at month 1, 3, 6, 9, and 12. At each of these points research staff will confirm MOUD status. Urine drug screenings will be completed at baseline, month 1, 6, and 12 if the participant is not incarcerated. When possible, research staff will collect electronic health records.

Detailed description: Purpose: The overall objective of this study is to assess whether the Transitions Clinic Network (TCN) program, which provides enhanced primary care and opioid use disorder (OUD) treatment for people recently released from incarceration, improves measures in the opioid treatment cascade compared to referral to standard primary care.

Participants: An anticipated 400 individuals currently receiving medications for OUD released from eight local jails (Durham, NC; Minneapolis, MN; Bronx, NY; Bridgeport and Niantic, CT; and Bayamón and Ponce, Puerto Rico)

Procedures: This is a hybrid type I effectiveness-implementation trial will randomize an anticipated 400 participants to one of two treatment conditions: TCN or standard primary care. People will complete the enrollment process while in jail (recruitment, screening, consent, baseline assessments, and randomization). Due to COVID-19 restrictions some jails are limiting researcher assess to people and some of our sites may enroll participants once they are released, this is referred to as a community enrollment. Post participants will meet with research assistants for a structured interview and urine toxicology screening at 1, 6, and 12 months, and a phone interview at months 3 and 9. 120 people will be selected to participate in Intensive Longitudinal Assessment (ILA) to access both the acceptability and appropriateness of the TCN intervention and the multi-level facilitators and barriers of OUD treatment engagement in the first 30 days following release from incarceration.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* English and Spanish-speaking,
* Meeting current DSM-5 criteria for OUD

Exclusion Criteria:

* acutely psychotic, suicidal or homicidal,
* require prescription opioids for acute pain, chronic pain or palliative care without OUD,
* have a planned relocation that makes it unlikely they would be able to complete the study and follow-up assessments,
* have a primary care provider that they already have established care with in the community,
* women of child-bearing age will be excluded if they are pregnant

Primary outcomes:
measure: Engagement in opioid use disorder (OUD) treatment
timeFrame: 30 days following jail release
measure: Retention in OUD treatment
timeFrame: 12 months following jail release
measure: Retention on medication for OUD (MOUD)
timeFrame: 12 months following initial jail release
measure: Percent days of illicit opioid use
timeFrame: 12 months following initial jail release
Secondary outcomes:
measure: Retention in primary care
timeFrame: 12 months following jail release
measure: Overdose
timeFrame: 12 months following initial jail release
measure: Time to Overdose
timeFrame: 12 months following initial jail release
measure: Death
timeFrame: 12 months following initial jail release
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale
state: Connecticut
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: Yale University
name: Emily Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Howell BA, Puglisi L, Clark K, Albizu-Garcia C, Ashkin E, Booth T, Brinkley-Rubinstein L, Fiellin DA, Fox AD, Maurer KF, Lin HJ, McCollister K, Murphy S, Morse DS, Shavit S, Wang K, Winkelman T, Wang EA. The Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN-PATHS): A hybrid type-1 effectiveness trial of enhanced primary care to improve opioid use disorder treatment outcomes following release from jail. J Subst Abuse Treat. 2021 Sep;128:108315. doi: 10.1016/j.jsat.2021.108315. Epub 2021 Jan 29.