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

  • STATUS
    Recruiting
  • End date
    Jan 25, 2023
  • participants needed
    1620
  • sponsor
    Wendy F Hansen
Updated on 25 January 2021
Investigator
Karen Fawcett, MPH
Primary Contact
OB/GYN & Women's Health University of Louisville (6.1 mi away) Contact
+11 other location
opioid
violence
buprenorphine
opioid use
methadone
prenatal

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, 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 PATHways program for rural implementation (local group-support vs. UK specialist telemedicine)

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 our 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 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 and Peer Support Specialist (GROUP arm); or, 2) Telemedicine consultation with substance abuse counselors, perinatal nurse educators, and/or Peer Health Specialists 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 PATHways program (UK-PATHways: Hub) at the University of Kentucky.

Details
Condition Drug abuse, Neonatal Abstinence Syndrome, Substance Abuse, Drug use
Treatment telemedicine, Group Care
Clinical Study IdentifierNCT03725332
SponsorWendy F Hansen
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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 and Eastern Kentucky

Exclusion Criteria

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