Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06956352

Impact of Collaborative Care for Pregnant Women With Opioid Use Disorder in Low-Resource Obstetric Settings

The investigators seek to adapt a collaborative care model (CCM) for community-based, low-resource obstetric settings and to test the effects of this adapted CCM on health outcomes among Pregnant, postpartum, and parenting person (PPPP) with Opioid use disorder (OUD) and their families. To achieve this goal, investigators will conduct a nonrandomized, Type 1 hybrid implementation-effectiveness study across 3 community-based, low-resource obstetric sites in Northwest PA, a region with rates of maternal opioid-related diagnoses 4 times higher than national averages.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Pregnancy Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid Use Disorder Opioid-Related Disorders Postpartum Period Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

Our central hypothesis is that person-centered, recovery supports, provided in the CCM will increase medication for OUD (MOUD) initiation and continuation, decrease overdose and reduce child removal rates among PPPP with OUD.

Specifically, investigators will:

  • Conduct an intervention adaptation project to adapt the Pregnancy and Women's Recovery Center (PWRC) CCM for rural and low-resource obstetric settings; and
  • Create a common data model to harmonize variables across data sources and data collection processes across study sites.

Investigators will also:

  • Evaluate the effects of the adapted PWRC CCM on outcomes among PPPP with OUD;
  • Determine if improvements in person-centered, recovery supports mediate the relationship between PWRC Community and outcomes using causal mediation methods; and
  • Identify PWRC Community adaptations that are associated with increased MOUD access, improved outcomes and that facilitate sustainability and scalability.

Research findings will:

  • provide high-quality evidence on how CCMs affect service delivery and health outcomes for PPPP with OUD,
  • inform stakeholders about ways to adapt CCMs for low-resource and rural healthcare settings, and
  • inform policymakers about the adaptations necessary to replicate these models widely.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Stakeholder Participant)

  • 18 years or older
  • Providing care at participating obstetric site
  • English speaking

(Patient Participant)

  • 18 years or older
  • Receiving care at participating obstetric site
  • English speaking

Exclusion criteria

  • Unwillingness to have participation audio recorded.

Treatment and study plan

Usual Care

Behavioral

Usual, referral-based, care.

Adapted Collaborative Care Model (CCM)

Behavioral

Person-centered, recovery supports.

Primary outcomes

  1. Patient Initiation of Medication for Opioid Use Disorder (MOUD)

    Time frame: During pregnancy (up to 40 weeks), up to 1 year post delivery

    Patient Initiation of Medication for Opioid Use Disorder (MOUD) as measured by total buprenorphine or methadone initiation in Electronic Health Record (EHR) and Medicaid claims data

  2. Patient Duration of MOUD

    Time frame: During pregnancy (up to 40 weeks), up to 1 year post delivery

    Patient Duration of MOUD as measured by proportion of days' covered incorporating buprenorphine or methadone treatment in EHR and claims data

  3. Patient Overdose

    Time frame: During pregnancy (up to 40 weeks), up to 1 year post delivery

    Patient Overdose as measured by total count of nonfatal or fatal overdose events in EHR and claims data

  4. Patient child foster care placement

    Time frame: Delivery through 1 year postpartum

    Patient child foster care placement as measured by total child placements in foster care system according to child protective service data linked with Medicaid data

  5. Patient utilization of well-child services

    Time frame: Delivery through 1 year postpartum

    Patient utilization of well-child services as measured by total well-child visits in EHR and claims data

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Magee-Women's Research Institute
  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: NEST

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
May 4, 2025
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.