Clinical trial NCT06956352: Impact of Collaborative Care for Pregnant Women With Opioid Use Disorder in Low-Resource Obstetric Settings
Official title: Impact of Collaborative Care for Pregnant Women With Opioid Use Disorder in Low-Resource Obstetric Settings
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pregnancy
Postpartum Period
Opioid Use Disorder
Keywords: HEAL Inititative
HEAL
MOUD
OUD
Pregnancy
Postpartum
Substance
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Magee-Women's Research Institute
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-05-04
Enrollment: 1350
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Patient Initiation of Medication for Opioid Use Disorder (MOUD)
timeFrame: During pregnancy (up to 40 weeks), up to 1 year post delivery
measure: Patient Duration of MOUD
timeFrame: During pregnancy (up to 40 weeks), up to 1 year post delivery
measure: Patient Overdose
timeFrame: During pregnancy (up to 40 weeks), up to 1 year post delivery
measure: Patient child foster care placement
timeFrame: Delivery through 1 year postpartum
measure: Patient utilization of well-child services
timeFrame: Delivery through 1 year postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Elizabeth Krans, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Marian Jarlenski, PhD
role: PRINCIPAL_INVESTIGATOR
References: