The PATH Home Trial

Background

Perinatal opioid use disorder (OUD) is a major health concern in the United States, with significant impact on mothers, infants and communities. The Commonwealth of Kentucky and the Appalachian region of our state have been especially impacted by the current epidemic of OUD. Our team at the University of Kentucky has developed a comprehensive clinical care model for perinatal OUD, known as UK PATHways that has demonstrated success in maternal and neonatal outcomes. The UK PATHways program is directed by Agatha Critchfield, MD and is only available in Lexington, KY. 

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 Kentucky. Our 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.

Study Goals

The goals of PATH Home are to:

• Expand the reach of the current successful PATHways program to 11 sites across rural Kentucky
• Reduce the impact of perinatal OUD in underserved rural areas of Kentucky
• Compare the effectiveness of an educational intervention delivered by two different strategies (group care vs. telemedicine) 

Study Population

• Pregnant (6-32 weeks gestational age at enrollment)
• Age 18-55
• Receiving medication assisted therapy
• Receiving prenatal care at one of eleven study sites 

Study Design

•     Sites randomized to telemedicine or group-care.

•     Telemedicine (nurse facilitator/counselor led) versus group-care (nurse facilitator/peer support led)

•     Standardized rotating patient education curriculum is delivered

•     Rotating topics include:

• Treatment options for opioid use disorder
• Smoking cessation
• Relapse prevention education
• Neonatal abstinence syndrome reduction education
• Breast feeding support/education
• Domestic violence education
• Postpartum depression
• Birth control/family planning

•     Study visits every two weeks through eight weeks postpartum; after eight weeks postpartum, study visits occur monthly until 6 months post-partum

•     All patients continue to receive routine prenatal care and substance abuse treatment

•     Patients are compensated for their time; gift cards are provided at enrollment, once between 28-32 of pregnancy, delivery, 3 months postpartum, and 6 months postpartum. An optional qualitative interview at the completion of the program is also available for compensation.

Study Sites

Ashland, Bowling Green, Corbin, Georgetown, Hazard, Louisville, Maysville, Middlesboro, Morehead, South Williamson, Winchester

Study Advisory Committee

The UK PATH Home trial team collaborates with the Study Advisory Committee (SAC), a key stakeholder partner. The SAC provides guidance in study design, implementation, and dissemination efforts.

Members of the SAC include:

• community clinicians
• community advocates
• health care payers
• patient partners
• policy makers