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, or OUD, happens when people misuse, become addicted to, or take too many opioids at once. Rates of OUD among pregnant women have quadrupled in the past two decades. Clinicians can help pregnant women with OUD start and stay in treatment. But many clinicians at women’s health clinics aren’t trained and supported in ways to treat OUD.

In this study, the research team is comparing two ways to help women’s health clinics provide care and OUD treatment to women before and after the birth of their child. The first way is Collaborative Care, or CC, which includes

  • OUD screening for all women who visit the clinic for prenatal care
  • A clinical care coordinator who has frequent contact with the clinician and patient
  • A focus on treatment to wellness, which refers to supporting treatment goals  that aim for rare use or no recreational use of opioids among patients

The second way draws on a program called Extension for Community Healthcare Outcomes, or ECHO. ECHO uses video training and mentoring to help clinicians treat pregnant women with OUD.

Who can this research help?

Results may help clinics considering ways to improve treatment for pregnant women with OUD.

What is the research team doing?

The research team is recruiting 12 women’s health clinics to take part in the study. The team is pairing similar clinics, and then assigning one clinic per pair by chance to receive CC or ECHO. Across the clinics, the team is enrolling 480 women, half at CC clinics and half at ECHO clinics.

At CC Clinics, clinicians attend four to six support and training sessions during the first three months of the study. During these sessions, clinicians learn about OUD treatments, including medicine and counseling methods, and about resources on these treatments. At the CC clinics, a clinical care coordinator also helps women go to their prenatal visits and supports their recovery.

Clinicians in the ECHO program have bimonthly video conference calls for the first six months and monthly thereafter. An OUD treatment expert leads the 30-minute ECHO calls, which cover the same topics as the CC training.  

Patients in the study have clinic visits every one to two weeks during their pregnancy for OUD treatment and prenatal care. The research team is looking to see how many women start and stay in treatment at CC versus ECHO sites. Also, the team is surveying patients when they join the study, when they are 26 and 34 weeks pregnant, and 3 months after they have given birth. The survey asks patients about depression and anxiety, and about their confidence to

  • Control their OUD while avoiding non-prescribed opioids
  • Work with doctors and nurses to make medical decisions
  • Fulfill life roles, such as mother, daughter, or partner

At the same time points, the research team is collecting patient urine samples to see if patients have recently used opioids or other substances. The team is also looking at birth outcomes such as delivering a baby early.

Women with a history of opioid use during pregnancy are helping the research team choose outcomes and recruit and retain study participants.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 480 women ages 18 and older who have an OUD and are <34 weeks pregnant
Interventions/
Comparators
  • CC
  • ECHO
Outcomes

Primary: treatment engagement, treatment retention, patient activation

Secondary: abstinence from opioids and other substances, birth outcomes

Timeframe Up to 1-year follow-up for primary outcome

Engagement Resources

Project Information

Ariadna Forray
Yale University School of Medicine
$5,572,916
Support Models for Addiction-Related Treatment

Key Dates

April 2019
April 2025
2019

Study Registration Information

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