Clinical trial NCT03725332: The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
Official title: The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Abstinence Syndrome
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 269
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: The UK-PATHways program preliminary successes during the first three years are clear: enrolled mothers (n\&gt;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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Percent of Infants Diagnosed With Neonatal Abstinence Syndrome (NAS) Requiring Medication Treatment
timeFrame: up to 10 days postpartum
Secondary outcomes:
measure: Number of Inappropriate Maternal Drug Screens at Delivery
timeFrame: Up to 10 days post-partum
measure: Prenatal Engagement With Percent of Program Education Sessions Attended
timeFrame: Up to delivery, an average of 19 weeks
measure: Prenatal Engagement With MAT Provider
timeFrame: Up to delivery, an average of 19 weeks
measure: Prenatal Engagement in Prenatal Care
timeFrame: Up to delivery, an average of 19 weeks
measure: Participants With Cigarette Dependency Over Time
timeFrame: Up to 60 weeks
measure: Participants With Maternal Anxiety Over Time
timeFrame: Up to 60 weeks
measure: Participants With Maternal Depression Over Time
timeFrame: Up to 60 weeks
measure: Participant Quality of Life
timeFrame: 28-32 weeks gestation
measure: Severity of Opioid Use Disorder
timeFrame: Intake visit (between 6-32 weeks gestation)
measure: Incidence of Hospitalization for Opioid Related Issues During the Study Period
timeFrame: up to 60 weeks
measure: Change in Physical Condition of Infant Post-delivery by Apgar Score
timeFrame: Up to five minutes
measure: Incidence of Pediatric Emergency Room (ER) Visits
timeFrame: birth-six months
measure: Adherence to a Vaccine Schedule
timeFrame: Infant 3 months and 6 months of age
measure: Engagement With Pediatric Care
timeFrame: Infant 3 month and 6 months of life
measure: Infant Gross Motor Development
timeFrame: Infant at 3 months of age
measure: Infant Gross Motor Development
timeFrame: Infant at 6 months of age
measure: Incidence of Relapse
timeFrame: Up to 60 weeks
measure: Incidence of Opioid Overdose
timeFrame: Up to 60 weeks
Other outcomes:
measure: Change in Employment Status
timeFrame: Up to 60 weeks
measure: Change in Household Size
timeFrame: up to 38 weeks
measure: Acceptance of Long-term Contraception
timeFrame: Up to 6 months postpartum
Locations:
city: Ashland
country: United States
facility: Karen's Place Maternity Center
state: Kentucky
city: Bowling Green
country: United States
facility: The Medical Center
state: Kentucky
city: Corbin
country: United States
facility: Grace Health Women's Care
state: Kentucky
city: Georgetown
country: United States
facility: BrightView
state: Kentucky
city: Georgetown
country: United States
facility: University of Kentucky Women's Health OB-GYN
state: Kentucky
city: Hazard
country: United States
facility: Primary Care Centers of Eastern Kentucky
state: Kentucky
city: Louisville
country: United States
facility: OB/GYN & Women's Health University of Louisville
state: Kentucky
city: Middlesboro
country: United States
facility: ARH Women's and Family Health Center - Middlesboro
state: Kentucky
city: Morehead
country: United States
facility: University of Kentucky Morehead Women's Healthcare
state: Kentucky
city: Prestonsburg
country: United States
facility: Frontier Behavioral Health Centers
state: Kentucky
city: S. Williamson
country: United States
facility: ARH Women's and Family Health Center - Tug Valley
state: Kentucky
Study officials:
affiliation: University of Kentucky, Department of OB-GYN, Division of Maternal Fetal Medicine
name: Wendy Hansen, MD
role: PRINCIPAL_INVESTIGATOR
References: