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Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support (TCN-PATHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04309565
Recruitment Status : Not yet recruiting
First Posted : March 16, 2020
Last Update Posted : March 17, 2020
Sponsor:
Collaborators:
University of North Carolina
University of Puerto Rico
University of Rochester
University of Miami
University of California, San Francisco
University of Connecticut
Albert Einstein College of Medicine
Hennepin Healthcare Research Institute
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Brief Summary:

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: 800 individuals currently receiving medications for OUD released from six local jails (Bridgeport, CT; Bronx, NY; Caguas, PR; Durham, NC; Minneapolis, MN; Rochester, NY)

Procedures (methods): This is a hybrid type I effectiveness-implementation trial will randomize 800 people to one of two treatment conditions: TNC and referral to opioid treatment program (OTP) or standard care and referral to OTP. People will complete the recruitment process while in jail (screening, consent, baseline assessments, and randomization). Post incarceration 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 Ecological Momentary Assessment (EMA) 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.


Condition or disease Intervention/treatment Phase
Opioid Addiction Behavioral: Transitions Clinic Network Primary Care Behavioral: Standard Primary Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Hybrid type I effectiveness-implementation trial
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: 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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. Engagement in opioid use disorder (OUD) treatment [ Time Frame: 30 days following jail release ]
    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, naltrexone formulations (MOUD) to be considered engaged 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.

  2. Retention in OUD treatment [ Time Frame: 12 months following jail release ]
    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.

  3. Retention on medication for OUD (MOUD) [ Time Frame: 12 months following initial jail release ]
    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 (for those on naltrexone, it is required that their dose extend to no more than 7 days before the index date). 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.

  4. Percent days of illicit opioid use (relapse) [ Time Frame: 12 months following initial jail release ]
    Investigators will measure percent days of illicit opioid use in a month. Investigators have defined relapse as 10/28 days of illicit opioid use, recognizing that episodic use (lapse) is inherent to the diagnosis of substance use disorder, yet allows time for patients to seek and receive treatment for their substance use. Investigators will measure this using TimeLine FollowBack asking the participant how many days in the past 28 days 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 TimeLine FollowBack and urine toxicology results, percent of days of illicit opioid use will be calculated for each participant at each time point.


Secondary Outcome Measures :
  1. Retention in primary care [ Time Frame: 12 months following jail release ]
    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.

  2. Overdose [ Time Frame: 12 months following initial jail release ]
    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

  3. Time to Overdose [ Time Frame: 12 months following initial jail release ]
    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.

  4. Death [ Time Frame: 12 months following initial jail release ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • English and Spanish-speaking,
  • Meeting current DSM-5 criteria for OUD, and are on MOUD prior to release from jail.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04309565


Contacts
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Contact: Emily Wang, MD 203-737-7624 emily.wang@yale.edu

Sponsors and Collaborators
Yale University
University of North Carolina
University of Puerto Rico
University of Rochester
University of Miami
University of California, San Francisco
University of Connecticut
Albert Einstein College of Medicine
Hennepin Healthcare Research Institute
National Institute on Drug Abuse (NIDA)
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04309565    
Other Study ID Numbers: 2000027469
1UG1DA050072-01 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders