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

NCT03725332 | Completed Results DMC

• 2 other identifiers: 44929MAT-2017C2-7842
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 11

Brief 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).

Conditions

Neonatal Abstinence Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Number of Inappropriate Maternal Drug Screens at Delivery

  Up to 10 days post-partum

• Prenatal Engagement With Percent of Program Education Sessions Attended

  Up to delivery, an average of 19 weeks

• Prenatal Engagement With MAT Provider

  Up to delivery, an average of 19 weeks

• Prenatal Engagement in Prenatal Care

  Up to delivery, an average of 19 weeks

• Participants With Cigarette Dependency Over Time

  Up to 60 weeks

Other Outcomes (3)

• Change in Employment Status

  Up to 60 weeks

• Change in Household Size

  up to 38 weeks

• Acceptance of Long-term Contraception

  Up to 6 months postpartum

Study Arms (2)

Telemedicine Education

EXPERIMENTAL

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

Group Care Education

ACTIVE COMPARATOR

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

Interventions

Telemedicine BEHAVIORAL

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.

Telemedicine Education

Group Care BEHAVIORAL

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.

Group Care Education

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Wendy F Hansen: lead

Study Sites (11)

Karen's Place Maternity Center

Ashland, Kentucky, 41101, United States

Location

The Medical Center

Bowling Green, Kentucky, 42101, United States

Location

Grace Health Women's Care

Corbin, Kentucky, 40701, United States

Location

BrightView

Georgetown, Kentucky, 40324, United States

Location

University of Kentucky Women's Health OB-GYN

Georgetown, Kentucky, 40324, United States

Location

Primary Care Centers of Eastern Kentucky

Hazard, Kentucky, 41701, United States

Location

OB/GYN & Women's Health University of Louisville

Louisville, Kentucky, 40202, United States

Location

ARH Women's and Family Health Center - Middlesboro

Middlesboro, Kentucky, 40965, United States

Location

University of Kentucky Morehead Women's Healthcare

Morehead, Kentucky, 40351, United States

Location

Frontier Behavioral Health Centers

Prestonsburg, Kentucky, 41465, United States

Location

ARH Women's and Family Health Center - Tug Valley

South Williamson, Kentucky, 41514, United States

Location

MeSH Terms

Conditions

Neonatal Abstinence Syndrome

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

The study is NOT powered for the primary outcome NAS, but is powered for 4 major secondary outcomes- maternal urine drug screen at delivery, and the number of education/interventions, prenatal care and MAT visits attended Protocols for NAS treatment differ greatly between hospitals and potentially effect the start and the type of medication treatment Complex data collection relying on frequent participant interviews and medical records Patients would be LTFU and then return to the study

Results Point of Contact

• Title: Wendy Hansen, MD
• Organization: University of Kentucky

wendy.hansen@uky.edu

859-218-0765

Study Officials

• Wendy Hansen, MD

  University of Kentucky, Department of OB-GYN, Division of Maternal Fetal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 29, 2018
• First Posted: October 31, 2018
• Study Start: March 13, 2019
• Primary Completion: April 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 1, 2025
• Results First Posted: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)