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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06956352
Acronym
NEST
Enrollment
1350
Registered
2025-05-04
Start date
2025-06-24
Completion date
2031-08-31
Last updated
2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder, Postpartum Period, Pregnancy

Keywords

HEAL Inititative, HEAL, MOUD, OUD, Pregnancy, Postpartum, Substance

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.

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.

Interventions

BEHAVIORALUsual Care

Usual, referral-based, care.

BEHAVIORALAdapted Collaborative Care Model (CCM)

Person-centered, recovery supports.

Sponsors

Magee-Women's Research Institute
CollaboratorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Initiation of Medication for Opioid Use Disorder (MOUD)During pregnancy (up to 40 weeks), up to 1 year post deliveryPatient 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
Patient Duration of MOUDDuring pregnancy (up to 40 weeks), up to 1 year post deliveryPatient Duration of MOUD as measured by proportion of days' covered incorporating buprenorphine or methadone treatment in EHR and claims data
Patient OverdoseDuring pregnancy (up to 40 weeks), up to 1 year post deliveryPatient Overdose as measured by total count of nonfatal or fatal overdose events in EHR and claims data
Patient child foster care placementDelivery through 1 year postpartumPatient child foster care placement as measured by total child placements in foster care system according to child protective service data linked with Medicaid data
Patient utilization of well-child servicesDelivery through 1 year postpartumPatient utilization of well-child services as measured by total well-child visits in EHR and claims data

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026