Specialized Post-Incarceration Care for Opioid Addiction

(TCN-PATHS Trial)

Recruiting at 4 trial locations

Overseen By Aaron Fox, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: MOUD

Disqualifiers: Psychotic, Suicidal, Homicidal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 12 months

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, since participants are required to be on MOUD (medications for opioid use disorder), it seems you may need to continue those medications.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants must be on MOUD (medications for opioid use disorder), so you may need to continue those.

What data supports the idea that Specialized Post-Incarceration Care for Opioid Addiction is an effective treatment?

The available research shows that Specialized Post-Incarceration Care for Opioid Addiction, like the Transitions Clinic Network, can be effective. For example, one study found that people released from jail who received care in a primary care setting had similar success in staying in treatment and avoiding opioid misuse as those referred from the community. Another study highlighted that early engagement in the Transitions Clinic Network led to fewer emergency visits for those referred by correctional partners. This suggests that such specialized care can help people stay healthier and avoid emergency situations. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Transitions Clinic Network Primary Care for opioid addiction?

Research shows that the Transitions Clinic Network (TCN) helps people released from prison by improving their health through better primary care. Patients referred by correctional partners had fewer emergency visits, suggesting that TCN can effectively support individuals with chronic conditions, including opioid addiction, after incarceration. ^{1 2 3 4 5}

What safety data exists for post-incarceration opioid addiction treatment in primary care?

The safety data for post-incarceration opioid addiction treatment in primary care settings includes studies on buprenorphine-naloxone maintenance. One study showed similar treatment retention and opioid abstinence rates between postrelease patients and community-referred patients in primary care. Another study evaluated a primary care-based transition clinic for patients initiated on buprenorphine in the emergency department, highlighting the role of multidisciplinary care in improving treatment linkage and retention. Additionally, nurse-sensitive indicators in office-based opioid treatment (OBOT) programs demonstrate effective care coordination and transition management, which are crucial for patient outcomes in primary care settings. ^{1 2 4 5 6}

Is the Specialized Post-Incarceration Care for Opioid Addiction safe for humans?

Research shows that primary care settings, including those with specialized programs like the Transitions Clinic, are generally safe for individuals with opioid use disorder. These programs often involve medication-assisted treatment with buprenorphine, which has been shown to be safe and effective in maintaining treatment and reducing opioid misuse. ^{1 2 4 5 6}

Is the Transitions Clinic Network Primary Care a promising treatment for opioid addiction after prison?

Yes, the Transitions Clinic Network Primary Care is promising because it helps people leaving prison connect with health services, reduces emergency visits, and supports ongoing care for opioid addiction. ^{1 3 5 7 8}

How does the Transitions Clinic Network Primary Care treatment differ from other treatments for opioid addiction?

The Transitions Clinic Network Primary Care treatment is unique because it focuses on providing specialized care for individuals recently released from incarceration, linking them to primary care and support services that address both medical and social needs. This approach includes community health workers with histories of incarceration, which helps improve care continuity and support reentry into the community, making it distinct from standard primary care options. ^{1 3 5 7 8}

Research Team

Emily Wang, MD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for adults over 18 with Opioid Use Disorder (OUD) who are on medication-assisted treatment and have been recently released from jail. Participants must speak English or Spanish, not be planning to relocate soon, and can't already have a primary care provider. Pregnant women or those needing opioids for pain management without OUD are excluded.

Inclusion Criteria

I am 18 years old or older.

I can speak English or Spanish.

Meeting current DSM-5 criteria for OUD

Exclusion Criteria

Acutely psychotic, suicidal or homicidal

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment

Participants complete the enrollment process while in jail, including recruitment, screening, consent, baseline assessments, and randomization

1-2 weeks

Treatment

Participants receive either standard primary care or Transitions Clinic Network (TCN) program primary care, with follow-up surveys and urine drug screenings at specified intervals

12 months

Visits at baseline, month 1, 3, 6, 9, and 12

Follow-up

Participants are monitored for safety and effectiveness after treatment, including engagement and retention in OUD treatment

12 months

Treatment Details

Interventions

• Standard Primary Care
• Transitions Clinic Network Primary Care

Trial Overview The study compares two types of post-incarceration care: standard primary care versus Transitions Clinic Network (TCN) program primary care. The goal is to see which better supports individuals with OUD in maintaining their treatment. Participants will be randomly assigned to one of the groups and followed for a year.

Participant Groups

Group I: Transitions Clinic Network Primary Care Experimental Treatment 1 Intervention

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.

Group II: Standard Primary Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

University of Puerto Rico

Collaborator

Trials

69

Recruited

22,300+

University of Rochester

Collaborator

Trials

883

Recruited

555,000+

University of Miami

Collaborator

Trials

976

Recruited

423,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of Connecticut

Collaborator

Trials

194

Recruited

162,000+

Albert Einstein College of Medicine

Collaborator

Trials

302

Recruited

11,690,000+

Hennepin Healthcare Research Institute

Collaborator

Trials

94

Recruited

77,100+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a study of 142 opioid-dependent adults, those released from jail and seeking buprenorphine treatment in primary care had similar treatment retention rates (37%) compared to those referred from the community (30%) over 48 weeks.

Both groups showed comparable rates of opioid misuse, indicating that primary care can effectively support opioid-dependent individuals, regardless of their incarceration status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Buprenorphine-naloxone maintenance following release from jail. Lee, JD., Grossman, E., Truncali, A., et al.[2021]

In a study analyzing 368 nursing notes from 100 patients in an office-based opioid treatment program, nurses provided significant care coordination, which is crucial for improving outcomes in patients with opioid use disorder (OUD).

The analysis identified seven key areas of care coordination, such as medication management and patient education, highlighting the important role nurses play in supporting patients through medication-assisted treatment with buprenorphine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Sensitive Indicators in the Care of Individuals With Opioid Use Disorder. Bernhardt, JM.[2023]

Among 751 patients studied, those referred to the Transitions Clinic Network (TCN) by correctional partners had fewer emergency department visits and hospitalizations in the year following their release compared to those referred by community partners, indicating the importance of coordinated care.

Early engagement in primary care after release was linked to increased acute care visits, suggesting that while timely access to health services is crucial, it may also lead to higher immediate health care utilization rather than reducing it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitions Clinic Network: Challenges And Lessons In Primary Care For People Released From Prison. Shavit, S., Aminawung, JA., Birnbaum, N., et al.[2018]

A randomized controlled trial involving 200 recently released prisoners showed that both Transitions Clinic and expedited primary care had similar rates of primary care engagement, with 37.7% and 47.1% respectively.

However, participants in the Transitions Clinic experienced significantly lower emergency department visits (25.5%) compared to those receiving expedited primary care (39.2%), indicating that a tailored care management program can effectively reduce acute care utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging individuals recently released from prison into primary care: a randomized trial. Wang, EA., Hong, CS., Shavit, S., et al.[2021]

A primary care-based transition clinic (SPARC) for patients starting buprenorphine for opioid use disorder showed significantly better treatment retention rates compared to usual primary care, with 90% retention at 1 month versus 60% in the usual care group.

Patients referred to SPARC had higher rates of attending initial visits (58% vs 38%) and received better quality care, including 100% naloxone provision and 81% infectious disease screening, indicating that multidisciplinary clinics can enhance care for those with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a Primary Care-Based Multidisciplinary Transition Clinic for Patients Newly Initiated on Buprenorphine in the Emergency Department. Incze, MA., Sehgal, SL., Hansen, A., et al.[2023]

Surgeons often transition postoperative opioid prescribing to primary care physicians passively, which can lead to patients returning to surgeons due to unresolved pain issues, highlighting a need for better coordination of care.

The study identified key areas for improvement, including establishing clear guidelines for care coordination, utilizing support staff for active transitions, and promoting multidisciplinary collaboration among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative opioid prescribing is not my job: A qualitative analysis of care transitions. Klueh, MP., Sloss, KR., Dossett, LA., et al.[2020]

The Transitions Clinic Network (TCN) program, which provides enhanced primary care for chronically ill and older individuals recently released from prison, costs $54,394 annually, or $146 per participant per month, and is associated with significantly lower criminal justice system costs compared to those not in the program.

Investing in the TCN program is financially beneficial, yielding a return of $2.55 for every dollar spent, while Medicaid costs remain similar between participants in the TCN and those who did not receive TCN care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost savings of a primary care program for individuals recently released from prison: a propensity-matched study. Harvey, TD., Busch, SH., Lin, HJ., et al.[2022]

The Transitions Clinic Network (TCN) successfully linked the California Department of Corrections and Rehabilitation with 21 primary care clinics, facilitating 8420 referrals for health care services to individuals released from prison between April 2020 and August 2022.

This initiative highlights the importance of care continuity and coordination, including data sharing and pre-release planning, as a model for improving health outcomes for formerly incarcerated individuals, especially in light of new policies like the Medicaid Reentry Act.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Reentry Health Care Hub: Creating a California-Based Referral System to Link Chronically Ill People Leaving Prison to Primary Care. Divakaran, B., Bloch, N., Sinha, M., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Buprenorphine-naloxone maintenance following release from jail. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Nurse-Sensitive Indicators in the Care of Individuals With Opioid Use Disorder. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Transitions Clinic Network: Challenges And Lessons In Primary Care For People Released From Prison. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Engaging individuals recently released from prison into primary care: a randomized trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a Primary Care-Based Multidisciplinary Transition Clinic for Patients Newly Initiated on Buprenorphine in the Emergency Department. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Postoperative opioid prescribing is not my job: A qualitative analysis of care transitions. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Cost savings of a primary care program for individuals recently released from prison: a propensity-matched study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Reentry Health Care Hub: Creating a California-Based Referral System to Link Chronically Ill People Leaving Prison to Primary Care. [2023]