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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

Tracking Information
First Submitted Date  ICMJE March 12, 2020
First Posted Date  ICMJE March 16, 2020
Last Update Posted Date March 17, 2020
Estimated Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2020)
  • 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.
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 12, 2020)
  • 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.
  • 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
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support
Official Title  ICMJE Transitions Clinic Network: Post Incarceration Addiction Treatment, Healthcare, and Social Support
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Hybrid type I effectiveness-implementation trial
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE Opioid Addiction
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Standard Primary Care
  • 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.
    Intervention: Behavioral: Transitions Clinic Network Primary Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 12, 2020)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emily Wang, MD 203-737-7624 emily.wang@yale.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04309565
Other Study ID Numbers  ICMJE 2000027469
1UG1DA050072-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE
  • 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)
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP