NCT06956352

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

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 1,350 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pregnancy
• Postpartum Period
• Opioid Use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Usual Care	Usual, referral-based, care.
BEHAVIORAL	Adapted Collaborative Care Model (CCM)	Person-centered, recovery supports.

Timeline

• Start date: 2025-06-24
• Primary completion: 2030-08-01
• Completion: 2031-08-01
• First posted: 2025-05-04
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States