Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support

Opioid Addiction Clinical Trial

— TCN-PATHS  

Official title:

Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04309565
• Other study ID #: 2000027469
• Secondary ID: 1UG1DA050072-01
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Yale University
• Contact: Emily Wang, MD
• Phone: 203-737-7624
• Email: emily.wang[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2025
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Opioid Addiction
• Opioid-Related Disorders

Intervention

Behavioral:
• Transitions Clinic Network Primary Care
Transitions Clinic Network (TCN)- participants in this arm will be referred to a TCN program for primary care and community Opioid Treatment Program (OTP). All TCN programs have the ability to prescribe buprenorphine and Extended-release naltrexone (XR-NTX) and assist with referrals to methadone. The primary features of the TCN include (1) primary care and onsite MOUD or referral to community treatment when indicated, (2) addressing social determinants of OUD and care coordination through a Community Health Worker (CHW), and (3) addressing the discrimination and stigma that exist based on incarceration.
• Standard Primary Care
Those randomized to the standard primary care arm will be referred to primary care and community Opioid Treatment Program (OTP). Participants may receive buprenorphine or Extended-release naltrexone (XR-NTX) through primary care or with a community addiction treatment provider.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	Albert Einstein College of Medicine	Bronx	New York
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	Hennepin Healthcare	Minneapolis	Minnesota
United States	Yale	New Haven	Connecticut
United States	University of Rochester	Rochester	New York

Sponsors (10)

Lead Sponsor	Collaborator
Yale University	Albert Einstein College of Medicine, Hennepin Healthcare Research Institute, National Institute on Drug Abuse (NIDA), University of California, San Francisco, University of Connecticut, University of Miami, University of North Carolina, University of Puerto Rico, University of Rochester

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Engagement in opioid use disorder (OUD) treatment	The primary study outcome will be engagement in OUD treatment within 30 days of jail release, defined as treatment consistent with the American Society of Addiction Medicine's levels of care (1-4), which allows for a range of treatments and clinical settings consistent with patient's needs and preference (e.g., office-based providers of buprenorphine or naltrexone, OTPs, or intensive outpatient, inpatient, or residential treatments). Patients do not need to be receiving methadone, buprenorphine, or naltrexone formulations (MOUD) to be considered engaged in OUD treatment. This will be measured based on questions about engagement in OUD treatment. These responses will be used to calculate a count of participants engaged in OUD treatment. As appropriate, this information will be confirmed in the electronic health record or with the addiction treatment facilities after obtaining a signed release.	30 days following jail release
Primary	Retention in OUD treatment	Retention in community OUD treatment will defined in accordance with the American Society of Addiction Medicine's levels of care (1-4), which allows for a range of treatments and clinical settings consistent with patient's needs and preference (e.g., office-based providers of buprenorphine or naltrexone, OTPs, or intensive outpatient, inpatient, or residential treatments). Patients do not need to be receiving MOUD to be considered retained in OUD treatment. Consistent with our prior research, this will be measured based on a Yes/No question about engagement in OUD treatment from the Treatment Services Review (TSR). These responses will be used to calculate a count of participants engaged in OUD treatment. As appropriate, this information will be confirmed in the electronic health record or with the addiction treatment facilities after obtaining a signed release. Re-incarceration (and resumption of MOUD in jail) will not count as retained in community OUD treatment.	12 months following jail release
Primary	Retention on medication for OUD (MOUD)	Retention on MOUD will be defined as receipt of any of the 3 FDA approved medications for OUD (methadone, buprenorphine, naltrexone) within 7 days of the index date (release from jail/interview date) regardless of what MOUD participants were on at baseline prior to release. This measure will be collected by using self report and as appropriate, will confirm self-report in the electronic health record or with the addiction treatment facilities after obtaining a signed release.	12 months following initial jail release
Primary	Percent days of illicit opioid use	Investigators will measure percent days of illicit opioid use during study time frames. Investigators will measure this by asking the participant how many days during the study time frame have they used illicit opioids. A urine toxicology that is positive for illicit opioids on testing will count as three days of using illicit opioids. Using the data from the	12 months following initial jail release
Secondary	Retention in primary care	Retention in primary care which is defined as 2 or more visits to primary care in twelve months. Participants will be asked to self-report the number of visits and this data will be used to count the number of participants retained in primary care.	12 months following jail release
Secondary	Overdose	Participants will be asked about overdose events using self-report, when applicable, be supplemented by data from the electronic health record which will indicate visits to the emergency department and hospitalizations for overdose. In at least four TCN program sites, investigators will have access to administrative payer data (Medicaid) where investigators will be able to examine time to overdose as a secondary outcome. This data will be used to calculate a count of participants experiencing an overdose event	12 months following initial jail release
Secondary	Time to Overdose	In at least four of the six TCN program sites, investigators will have access to administrative payer data (Medicaid) where investigators will be able to examine time to overdose as a secondary outcome. This data will be used to calculate time to overdose for each participant for each overdose event.	12 months following initial jail release
Secondary	Death	Participant death will be collected using the electronic health record. In at least four of the six TCN program sites, investigators will have access to vital statistics data where survival analyses will be conducting with mortality as a secondary outcome.	12 months following initial jail release