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

Grants and Contracts Details

Description

Background and Significance: Opioid addiction can result in significant morbidity and mortality(1,2,3) and have devastating effects on individuals, families, and communities. Opioid Use Disorder (OUD) has become a major problem in the US Appalachian region.(4) This epidemic has had enormous economic and social impact in these rural communities and prevention, treatment and intervention services for OUD in the area are limited.(2) Although Medication-Assisted Treatment (MAT) during pregnancy has been shown to improve maternal and neonatal outcomes, knowledge of the best method of delivery of prenatal MAT in rural settings is lacking(5,6) In 2014, and in response to the burgeoning OUD crisis, the University of Kentucky implemented the UK-Perinatal Assistance and Treatment Home (UK-PATHways) program. The PATHways program is a multi-specialty comprehensive prenatal and substance abuse treatment program for pregnant and early parenting women with OUD. The UK-PATHways program preliminary successes during the first three years are clear: enrolled mothers (n>150) have reduced relapse, increased treatment compliance, and improved neonatal outcomes when compared to non-enrolled OUD mothers (7, 8)However, while MAT has become increasingly available in our region, many of the components of the UK-PATHways program are not readily accessible in rural areas and the quality of programming with MAT treatment is not standardized in these locations. Furthermore, rural patients continue to face challenges related to transportation difficulties if they desire more comprehensive services. Study Aims: The long term objective of this project is to provide evidence that will fill critical gaps in knowledge regarding the optimal delivery of care to the opioid dependent pregnant women in rural settings. We hope to provide valuable insights regarding approaches to establish evidence-based MAT practice protocols to mitigate the impact of perinatal OUD and, importantly, provide evidence that guides patients and their providers in decisions regarding optimal treatment of perinatal OUD.The specific aims of the study are to: 1) conduct a randomized cluster trial using a ‘hub and spoke’ study design, comparing two active and evidence based elements of our established UK-PATHways program at participating rural regional sites and 2) evaluate the relative effectiveness of each study arm on primary and secondary maternal and neonatal outcomes as compared to the established PATHways program (UK-PATHways: Hub) at the University of Kentucky. Study Description: Overall Design: This study is a randomized comparative efficacy trial (Cluster RCT) of two active elements of the UK-PATHways Program for pregnant women with OUD on MAT at twelve participating prenatal clinics in rural Eastern and SouthEastern Kentucky. Sites will be stratified via delivery volume. Randomization will occur via proc plan SAS 9.4 (SAS Institute Inc., Cary, NC, USA). Comparators: Each cluster site will have equal odds for being randomized into one of the following study arms: 1) GROUP arm: Study participatnts will receive group care at 2 week intervals initiated at study enrollment. Group care sessions will be led by a trained local Perinatal Nurse Facilitator and a Peer Support Specialist. Group sessions follow a rotating eight week curriculum and continue until six months postpartum. 2) TELEMEDICINE arm: Study
StatusActive
Effective start/end date8/1/184/30/25

Funding

  • Patient-Centered Outcomes Research Institute: $5,316,906.00

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