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

NCT06956352 | Enrolling By Invitation

• 2 other identifiers: STUDY24030140R61DA061377
• Study Type: observational
• Target: 1,350
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy; Postpartum Period; Opioid Use Disorder

Keywords

HEAL Inititative; HEAL; MOUD; OUD; Pregnancy; Postpartum; Substance

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Adapted Collaborative Care Model (CCM)

Person-centered, recovery supports.

Behavioral: Adapted Collaborative Care Model (CCM)

Usual care

Usual, referral-based, care

Behavioral: Usual Care

Interventions

Usual Care BEHAVIORAL

Usual, referral-based, care.

Usual care

Adapted Collaborative Care Model (CCM) BEHAVIORAL

Person-centered, recovery supports.

Adapted Collaborative Care Model (CCM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• (Stakeholder Participant)
• years or older
• Providing care at participating obstetric site
• English speaking
• (Patient Participant)
• years or older
• Receiving care at participating obstetric site
• English speaking

You may not qualify if:

• \. Unwillingness to have participation audio recorded.

Sponsors & Collaborators

• University of Pittsburgh: lead
• Magee-Women's Research Institute: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Magee Womens Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elizabeth Krans, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Marian Jarlenski, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 4, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: Before publishing and/or at the end of the study period with results.
• 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.

Locations

US (1)