The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky

Last updated: January 17, 2025
Sponsor: Wendy F Hansen
Overall Status: Completed

Phase

N/A

Condition

Opioid Use Disorder

Treatment

Telemedicine

Group Care

Clinical Study ID

NCT03725332
44929
MAT-2017C2-7842
  • Ages 18-55
  • Female

Study Summary

Perinatal opioid use disorder (OUD) is a major health concern in the U.S. with significant impact on mothers, infants, and communities. Investigators at the University of Kentucky/UK HealthCare (UK) have developed a comprehensive clinical care model for perinatal OUD (known as UK-PATHways) that has demonstrated success in maternal and neonatal outcomes. The overreaching goals of the proposed project are to: 1) expand the reach of this successful clinical program to rural communities thereby improving access to integrated MAT prenatal care, 2) to reduce the impact of perinatal OUD in underserved rural areas of our state, and 3) to compare the relative effectiveness methods of delivery active elements of the UK-PATHways program for rural implementation (local group-support vs. telemedicine).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Pregnant women at 6 to 32 weeks' gestational age

  • History of Opioid Use Disorder

  • Receiving Medication Assisted Therapy (buprenorphine products or methadone)

  • Obtaining prenatal care at one of eleven study sites located throughout Central andEastern Kentucky

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 268
Treatment Group(s): 2
Primary Treatment: Telemedicine
Phase:
Study Start date:
March 13, 2019
Estimated Completion Date:
November 01, 2024

Study Description

The UK-PATHways program preliminary successes during the first three years are clear: enrolled mothers (n>200) have reduced relapse, increased treatment compliance, and improved neonatal outcomes when compared to non-enrolled OUD mothers. However, at this time, UK-PATHways is only available at the main healthcare campus in Lexington, KY. Many eligible patients reside great distances from our clinical home and some current patients travel hours to access this valuable resource. While Medication Assisted Therapy (MAT) has become increasingly available in our region, many of the components of the UK-PATHways program are not readily accessible in rural Central and Eastern Kentucky and the quality of programming with MAT treatment is not standardized in these locations. Furthermore, rural patients continue to face challenges related to stigma of their OUD and transportation difficulties if they desire more comprehensive services. The proposed study will evaluate the introduction of essential components of the UK-PATHways program into rural communities and identify the optimal intervention strategies for expansion of services and to improve the treatment of OUD for rural patients. Specific aims include the following: Aim 1) Conduct a randomized cluster trial using a 'hub and spoke' study design, comparing two delivery modes (local GROUP care vs TELEMEDICINE) for the delivery of a UK-PATHways based patient education curriculum at participating rural regional sites. Each regional site will be randomized to support one of two study arms: 1) Prenatal group care led by a perinatal nurse facilitator or substance use counselor with a peer support specialist (GROUP arm); or, 2) Telemedicine consultation with substance use counselor or perinatal nurse facilitator based at the 'hub' site (TELEMEDICINE arm); and Aim 2) Evaluate the relative effectiveness of each study arm on primary and secondary maternal and neonatal outcomes as compared to the established UK-PATHways program (UK PATHways: Hub) at the University of Kentucky.

Connect with a study center

  • Karen's Place Maternity Center

    Ashland, Kentucky 41101
    United States

    Site Not Available

  • The Medical Center

    Bowling Green, Kentucky 42101
    United States

    Site Not Available

  • Grace Health Women's Care

    Corbin, Kentucky 40701
    United States

    Site Not Available

  • BrightView

    Georgetown, Kentucky 40324
    United States

    Site Not Available

  • University of Kentucky Women's Health OB-GYN

    Georgetown, Kentucky 40324
    United States

    Site Not Available

  • Primary Care Centers of Eastern Kentucky

    Hazard, Kentucky 41701
    United States

    Site Not Available

  • University of Kentucky

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • OB/GYN & Women's Health University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Primary Plus

    Maysville, Kentucky 41056
    United States

    Site Not Available

  • ARH Women's and Family Health Center - Middlesboro

    Middlesboro, Kentucky 40965
    United States

    Site Not Available

  • University of Kentucky Morehead Women's Healthcare

    Morehead, Kentucky 40351
    United States

    Site Not Available

  • Frontier Behavioral Health Centers

    Prestonsburg, Kentucky 41465
    United States

    Site Not Available

  • ARH Women's and Family Health Center - Tug Valley

    S. Williamson, Kentucky 41514
    United States

    Site Not Available

  • ARH Women's and Family Health Center - Tug Valley

    South Williamson, Kentucky 41514
    United States

    Site Not Available

  • Sterling Health Care

    Winchester, Kentucky 40390
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.