Impact of Collaborative Care for Pregnant Women With Opioid Use Disorder in Low-Resource Obstetric Settings
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Usual Care, Adapted Collaborative Care Model (CCM).
- Who it may be relevant to
- Registry conditions: Pregnancy, Postpartum Period, Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Usual Care
Usual, referral-based, care. - Behavioral Adapted Collaborative Care Model (CCM)
Person-centered, recovery supports.
Primary outcome measures
- Patient Initiation of Medication for Opioid Use Disorder (MOUD) [Time frame: During pregnancy (up to 40 weeks), up to 1 year post delivery]
- Patient Duration of MOUD [Time frame: During pregnancy (up to 40 weeks), up to 1 year post delivery]
- Patient Overdose [Time frame: During pregnancy (up to 40 weeks), up to 1 year post delivery]
- Patient child foster care placement [Time frame: Delivery through 1 year postpartum]
- Patient utilization of well-child services [Time frame: Delivery through 1 year postpartum]
Eligibility criteria
Inclusion criteria
(Stakeholder Participant)
- 18 years or older
- Providing care at participating obstetric site
- English speaking
(Patient Participant)
- 18 years or older
- Receiving care at participating obstetric site
- English speaking
Exclusion criteria
1\. Unwillingness to have participation audio recorded.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Magee Womens Hospital of UPMC — Pittsburgh
Identifiers
NCT: NCT06956352 · STUDY24030140 · R61DA061377