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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy; Opioid Use Disorder; Postpartum Period
• Intervention / Treatment: Behavioral: Adapted Collaborative Care Model (CCM); Behavioral: Usual Care

Detailed Description

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:

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

Investigators will also:

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

Research findings will:

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

• Study Type: Observational
• Enrollment (Estimated): 1350

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Womens Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A core team of clinical providers at each obstetric site (i.e., nurse case manager, peer navigator, advanced practice provider, behavioral health provider, and lead obstetrician/gynecologist) have already committed to providing clinical care for the adapted CCM and participate in all stages of the research process. As such, they will not need to be recruited for participation.

Maternal and child outcome data will be collected retrospectively from the EHR and individual patients will not be recruited to participate in the study. A small subset of pregnant women (n=50) who meet DSM-V criteria for OUD and who receive care at obstetric sites will be recruited for a one-time, semi-structured qualitative interview.

Description

Inclusion Criteria:

(Stakeholder Participant)

1. 18 years or older
2. Providing care at participating obstetric site
3. English speaking

(Patient Participant)

1. 18 years or older
2. Receiving care at participating obstetric site
3. English speaking

Exclusion Criteria:

1. Unwillingness to have participation audio recorded.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adapted Collaborative Care Model (CCM); Person-centered, recovery supports.	Behavioral: Adapted Collaborative Care Model (CCM); Person-centered, recovery supports.
Usual care; Usual, referral-based, care	Behavioral: Usual Care; Usual, referral-based, care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Initiation of Medication for Opioid Use Disorder (MOUD)	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	During pregnancy (up to 40 weeks), up to 1 year post delivery
Patient Duration of MOUD	Patient Duration of MOUD as measured by proportion of days' covered incorporating buprenorphine or methadone treatment in EHR and claims data	During pregnancy (up to 40 weeks), up to 1 year post delivery
Patient Overdose	Patient Overdose as measured by total count of nonfatal or fatal overdose events in EHR and claims data	During pregnancy (up to 40 weeks), up to 1 year post delivery
Patient child foster care placement	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	Delivery through 1 year postpartum
Patient utilization of well-child services	Patient utilization of well-child services as measured by total well-child visits in EHR and claims data	Delivery through 1 year postpartum

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute on Drug Abuse (NIDA); Magee-Women's Research Institute
• Investigators: Principal Investigator: Marian Jarlenski, PhD, University of Pittsburgh; Principal Investigator: Elizabeth Krans, MD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: May 1, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 4, 2025

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 10, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Postpartum; OUD; MOUD; Substance; HEAL Inititative; HEAL
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders
• Other Study ID Numbers: STUDY24030140; R61DA061377 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: HEAL Data Platform (HDP01418); NAHDAP data repository.
• IPD Sharing Time Frame: Before publishing and/or at the end of the study period with results.
• IPD Sharing Access Criteria: Public Access and Data Sharing Plan: A Public Access and Data Sharing Plan describes the plan for releasing Publications and sharing the Underlying Primary Data for an NIH HEAL Initiative Research Project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No