CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 269 enrolled
Drug / intervention
Telemedicine +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03725332
NCT03725332N/ACompleted

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

Wendy F Hansen·interventional·Posted Oct 31, 2018·Updated May 1, 2025

In Brief

A clinical study evaluating Telemedicine and Group Care for Neonatal Abstinence Syndrome. Completed, enrolled 269 participants across 11 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 31, 2018
Enrollment StartMar 13, 2019
Primary CompletionApr 1, 2024
Study CompletionNov 1, 2024
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 7.7 years ago

Interventions

Telemedicinebehavioral

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.

Group Carebehavioral

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.