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

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).

Study Overview

• Status: Completed
• Conditions: Neonatal Abstinence Syndrome
• Intervention / Treatment: Behavioral: Telemedicine; Behavioral: Group Care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • Karen's Place Maternity Center
    • Bowling Green, Kentucky, United States, 42101
      • The Medical Center
    • Corbin, Kentucky, United States, 40701
      • Grace Health Women's Care
    • Georgetown, Kentucky, United States, 40324
      • University of Kentucky Women's Health OB-GYN
    • Georgetown, Kentucky, United States, 40324
      • BrightView
    • Hazard, Kentucky, United States, 41701
      • Primary Care Centers of Eastern Kentucky
    • Louisville, Kentucky, United States, 40202
      • OB/GYN & Women's Health University of Louisville
    • Middlesboro, Kentucky, United States, 40965
      • ARH Women's and Family Health Center - Middlesboro
    • Morehead, Kentucky, United States, 40351
      • University of Kentucky Morehead Women's Healthcare
    • Prestonsburg, Kentucky, United States, 41465
      • Frontier Behavioral Health Centers
    • S. Williamson, Kentucky, United States, 41514
      • ARH Women's and Family Health Center - Tug Valley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine Education; This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (>500 deliveries/year) and 'low volume' (<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to telemedicine will be recruited by research staff.	Behavioral: Telemedicine; Patients enrolled at sites randomized to telemedicine will receive a standardized, rotating patient education curriculum through consultations with substance use counselor or perinatal nurse facilitator. Consultations will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months postpartum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.
Active Comparator: Group Care Education; This is a stratified cluster non-inferiority randomized controlled trial with randomization of participating clusters into a 'telemedicine' or 'group care' arm. Sites will be stratified into 'high volume' (>500 deliveries/year) and 'low volume' (<500 deliveries per year). Randomization will be within each strata. Patients attending sites randomized to group care will be recruited by research staff.	Behavioral: Group Care; Patients enrolled at sites randomized to group care will receive a standardized, rotating patient education curriculum delivered in small groups led by a perinatal nurse facilitator or substance use counselor, with a peer support specialist. Small group care meetings will occur twice a month until 8 weeks post-partum and will then continue monthly until 6 months post-partum. Rotating topics include: 1) Treatment Options for Opioid Use Disorder, 2) Smoking Cessation, 3) Relapse Prevention Education, 4) NAS Reduction Education, 5) Breast Feeding Support/Education, 6) Domestic Violence Education, 7) Postpartum Depression, and 8) Birth Control/Family Planning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment	Medical records will be reviewed post-partum for treatment for NAS. Diagnosis of NAS will be made within 10 days of birth and treatment started based on standard of care. Data will be presented as the percent of infants born requiring therapy in each group.	up to 10 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Inappropriate Maternal Drug Screens at Delivery	Maternal urine drug screen (UDS) will be collected at the time of hospital admission for delivery for each participant. A urine drug screen is considered inappropriate when the presence of an illicit drug that is not prescribed for the participant is detected or the prescribed medication for opioid use disorder is not detected. The actual number of inappropriate maternal drug screens will be calculated. Results will be compared between Arms: Telemedicine and Group	Up to 10 days post-partum
Prenatal Engagement With Percent of Program Education Sessions Attended	Engagement with PATHHome is measured by the number of counseling/education sessions (groups or telemedicine) attended by each participant. Results will be compared between Arms and expressed as percent of interventions attended by participants.	Up to delivery, an average of 19 weeks
Prenatal Engagement With MAT Provider	Engagement with MAT provider is measured by the average number of visits attended by each participant with their MAT provider.	Up to delivery, an average of 19 weeks
Prenatal Engagement in Prenatal Care	Engagement with Prenatal Care is considered by gestational age of entry. The number of prenatal visits is expressed as a percentage of prenatal visits attended with a denominator of prenatal visits scheduled. The data is provided by patient report and confirmed by medical record review when possible. Results will be compared between Arms. Categories reported are no prenatal visits, 5-50%, 51-100%.	Up to delivery, an average of 19 weeks
Participants With Cigarette Dependency Over Time	Participants will complete the Fagerstrom Test for Cigarette Dependence 4 times during the course of the study: Intake, 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). This is a 7-question survey with each question scored on a scale of zero to 3 and totaled. Scores greater than 8 are considered high dependency, scores of 5-7 are considered moderately dependent, scores of 3-4 are low to moderate dependence and scores of 1-2 are low dependence. Data will be presented as the number of participants with cigarette dependency over time compared between groups.	Up to 60 weeks
Participants With Maternal Anxiety Over Time	Participants will complete the Generalized Anxiety Disorder survey at their intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 7 questions probing the participants burden of anxiety. Each question is scored from 0 to 3, with 3 representing the most severe state. A total score of 1-4 indicates minimal anxiety, 5-14 indicates moderate anxiety, and 15-21 indicates severe anxiety. Data will be presented as the number of participants with anxiety over time compared between groups.	Up to 60 weeks
Participants With Maternal Depression Over Time	Participants will complete the Edinburgh Depression Scale at 4 times during the study: Intake visit, at 28-32 weeks, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). The survey consists of 10 questions. Each question is scored between 0-3. An answer of 3 represents a more severe state. A total score of 1-8 falls within a normal range, a score is 9-10 is at risk for depression and a score of 11 or more indicates depression. In general, the higher the score, the more severe the depression. Data will be presented as the number of participants with depression over time compared between groups.	Up to 60 weeks
Participant Quality of Life	WHO-Quality of Life Survey (WHOQoL) will be administered to patients at 28-32 weeks gestation. WHOQoL is a 26 question self administered survey. Each question falls within 1 of 4 "domains": physical health, psychological health, social relationships, environment. For purposes of reporting, we are using the first question, "How would you rate your quality of life?" on a scale of 1-5, with 1 being very poor quality, 2 poor quality, 3 neither poor nor good, 4 good quality, 5 very good quality.	28-32 weeks gestation
Severity of Opioid Use Disorder	Participants will complete a Diagnostic and Statistical Manual of Mental Disorders-5-TR, Addiction Severity Scale to assess their opioid dependency at the intake visit (between 6-32 weeks). The survey asks 11 questions. Each question asks about symptoms related to opioid use disorder and are answered in a yes/no format. A mild substance use disorder is diagnosed with 2-3 symptoms, moderate with 4-5 symptoms, and severe is 6 or more symptoms. Data will be presented as the number of participants in each category.	Intake visit (between 6-32 weeks gestation)
Incidence of Hospitalization for Opioid Related Issues During the Study Period	Hospitalizations for opioid related issues were determined by two main methods. Participants were assessed for hospitalization at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, hospitalizations were determined and confirmed through medical record review when possible. Data will be presented as number of hospitalizations in each arm.	up to 60 weeks
Change in Physical Condition of Infant Post-delivery by Apgar Score	Infant physical condition at birth will be assessed using the Apgar score at 1 minute and 5 minutes after birth. The Apgar score consists of 5 criteria: Appearance (skin color), pulse, grimace (reflex irritability), activity (muscle tone), respiration. Each criteria is scored 0-2. Scores are summed to evaluate a newborns health. A score of 8-10 is considered normal. A score less than 8 requires medical support. The lower the score, the more severely affected the newborn. Data will be presented as the change in Apgar score over time compared between groups.	Up to five minutes
Incidence of Pediatric Emergency Room (ER) Visits	Pediatric emergency room visits will be determined by both in person reporting during a postpartum intervention and by medical record review. Time span starts at discharge from the hospital (after birth) to 6 months postpartum. Data will be presented as the total number of pediarric ER visits compared between groups	birth-six months
Adherence to a Vaccine Schedule	Adherence to a vaccine schedule will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; "Is your infant up to date on vaccines?". Data will be presented as the total number of infants compliant on their vaccines and compared between groups.	Infant 3 months and 6 months of age
Engagement With Pediatric Care	Engagement with pediatric care will be determined by both in person reporting during a postpartum intervention and by medical record review when possible. Participants will be asked at their 3 and 6-month postpartum visit; "Does your baby regularly see a pediatrician?". Data will be presented as the total number of infants engaged in pediatric care and compared between groups.	Infant 3 month and 6 months of life
Infant Gross Motor Development	The Ages & Stages Questionnaires®, Third Edition (ASQ®-3) was completed by the participant at the 3-month postpartum intervention. The survey collects infant milestones in five domains: communication, gross motor, fine motor, problem-solving, and personal/social. The developmental instrument is 38 items and scored by the research staff. For purposes of reporting, we are utilizing the gross motor domain subsection score only. This domain includes 6 questions. Scores are calculated at 0, 5, or 10 per question. The highest score is 60- the lowest score would be 0. The higher the score the better. For a score greater than 41 development is considered to be on schedule. If the score falls between 38-41- targeted learning activities and monitoring is recommended. If the score falls below 38, concern for lagging infant motor development and further assessment with a professional is recommended. Scores will be presented as the mean +/- standard error compared between group	Infant at 3 months of age
Infant Gross Motor Development	The Ages & Stages Questionnaires®, Third Edition (ASQ®-3) was completed by the participant at the 6-month postpartum intervention. The survey collects infant milestones in five domains: communication, gross motor, fine motor, problem-solving, and personal/social. The Ages and Stages 6-month survey instrument is 38 items and scored by the research staff. For purposes of reporting, we are utilizing the gross motor domain score only. This domain includes 6 questions, scores are calculated at 0, 5, or 10 per question and a score below 22 is concerning for lagging infant motor development. Scores will be presented as the mean +/- standard error compared between groups.	Infant at 6 months of age
Incidence of Relapse	Relapse was defined as the use of any illicit substance or misuse of prescribed medications including medication for opioid use disorder. Incidence of relapse was determined by two main methods. Participants were assessed for relapse at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, relapses were determined and confirmed through medical record review, including inappropriate urine drug screens, when possible. Data will be presented in 2 categories: Relapse with opioids and relapse with other substances. The number of relapses is not equal to the number of participants as a single participant may have more than one relapse or polysubstance relapse. Data will be presented as the total number of relapses and compared between groups.	Up to 60 weeks
Incidence of Opioid Overdose	The incidence of opioid overdose was determined by two main methods. Participants were assessed for overdose at each intervention visit. Interventions occurred every two weeks until 8 weeks postpartum, then monthly through 6 months. Secondly, overdoses were determined and confirmed through medical record review when possible. Data will be presented as number of overdoses in each arm.	Up to 60 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Employment Status	Participants will be asked about employment status during their intake visit, at 28 weeks gestational age, 3 months postpartum and 6 months postpartum (combined total time of observation is up to 60 weeks). Participants will answer "yes" or "no" regarding their employment status. Data will be presented as the change in employment status between groups.	Up to 60 weeks
Change in Household Size	Participants will be asked to indicate the total number of people sharing their living space during the intake visit, and 6 months postpartum (combined total time of observation is up to 38 weeks). Data will be presented as the change in dwelling occupancy over time compared between groups.	up to 38 weeks
Acceptance of Long-term Contraception	Participants will be offered long-acting reversible contraception. Data will be presented as the number of participants per group accepting long term contraception.	Up to 6 months postpartum

Collaborators and Investigators

• Sponsor: Wendy F Hansen
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: Wendy Hansen, MD, University of Kentucky, Department of OB-GYN, Division of Maternal Fetal Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): April 1, 2024
• Study Completion (Actual): November 1, 2024

Study Registration Dates

• First Submitted: October 29, 2018
• First Submitted That Met QC Criteria: October 29, 2018
• First Posted (Actual): October 31, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Infant, Newborn, Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Neonatal Abstinence Syndrome
• Other Study ID Numbers: 44929; MAT-2017C2-7842 (Other Identifier: Patients Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share IPD at this time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No