Project Summary

PCORI has identified treatment for opioid use disorder among pregnant women, with a focus on maternal and neonatal outcomes, as an important research topic. To compare the effectiveness of different treatment approaches, PCORI launched an initiative in 2017 on Medication-Assisted Treatment (MAT) Delivery for Pregnant Women with Substance Use Disorders Involving Prescription Opioids and/or Heroin. The initiative funded this research project.

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Opioid use disorder is a major health problem in the United States, especially in rural areas. Pregnant women with this disorder may have babies who are born early, are underweight, and who have withdrawal from opioids.

Medical treatment can help women stop using opioids during and after pregnancy. Extra services and education can also improve health for women and babies. In this study, the research team is comparing two different ways of providing that education, called comprehensive care, to pregnant women and women who recently gave birth.

Who can this research help?

Healthcare organizations can use results from this study when considering ways to treat pregnant women in rural settings who have opioid use disorder.

What is the research team doing?

The research team is recruiting 1,620 women who receive treatment at 12 prenatal clinics in rural Kentucky. All women in the study are between weeks 6 and 32 of their pregnancy and are taking medicine to treat opioid use disorder. The team is assigning clinics to one of two groups by chance.

In the first group of clinics, a nurse and peer support specialist lead group care sessions at the clinics. Peer support specialists are women who are in long-term recovery from a substance use disorder. They help other people with these disorders learn how to care for themselves.

In the second group of clinics, specialists in substance use and in mother and child health meet with mothers online.

In both groups, the sessions cover the same topics:

  • Treating opioid use disorder
  • Quitting smoking
  • Avoiding taking opioids again
  • Keeping the baby safe from exposure to opioids
  • Breastfeeding
  • Learning about signs of domestic violence
  • Watching for signs of depression after birth
  • Learning about birth control

Women in both groups receive the education every two weeks from the time they join the study until six months after they give birth.

The research team is looking at medical records to see how often babies have symptoms of opioid withdrawal after they are born. In addition, the team is tracking mothers’ smoking, mental health, and opioid use, and whether they are breastfeeding their baby. Finally, the team is tracking how often mothers and babies use healthcare services and how often babies are placed in foster care.

Patients, clinicians, government and insurance agencies, and community members are helping plan and conduct the study.

Research methods at a glance

Design Element Description
Design Randomized controlled trial
Population Pregnant women in rural Kentucky receiving medication-assisted therapy for opioid use disorder
Interventions/
Comparators
  • Biweekly group sessions on substance use and maternal-infant health
  • Biweekly telemedicine calls on substance use and maternal-infant health
Outcomes

Primary: rate of neonatal abstinence syndrome requiring treatment

Secondary: smoking cessation, foster care placement, depression, anxiety, maternal and infant health service utilization, maternal relapse, breastfeeding

Timeframe Follow-up at delivery for primary outcome

Project Information

Wendy Hansen, MD
University of Kentucky Research Foundation
$5,316,906
The PATH Home Trial: A Comparative Effectiveness Study of Peripartum Opioid Use Disorder in Rural Kentucky

Key Dates

April 2018
November 2023
2018

Study Registration Information

^Agatha Critchfield, MD was this project's principal investigator when it was awarded.

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022