An interventional study of Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) and Doula in Severe Maternal Morbidity and Maternal Death, sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
The goal of this study is to learn about the effects of Medicaid policy interventions on severe maternal morbidity (SMM) and mortality and maternal health. The main questions it aims to answer are:
Participants will be asked to describe experiences as a result of Medicaid policy interventions and focused Medicaid policies.
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's planned enrollment of 10,000,000 is above the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Qualitative:
Exclusion Criteria:
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The investigators will employ a quasi-experimental study design to test two hypotheses: H1: SMM rates will decline among populations at risk after the interventions (incentive payment and obstetric bundled payment) within Pennsylvania (PA); and H2: SMM will decline among those exposed to the interventions in PA, relative to those in similar states. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare interventions on beneficiaries' experiences.
Behavioral: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) · Behavioral: Standard Care
The investigators will test two hypotheses: H1: SMM rates will decline among populations at risk after the addition of doula care in PA, relative to healthcare quality interventions alone. H2: SMM will decline more among those exposed to both healthcare quality and doula care interventions in PA, relative to states implementing doula care only. The investigators will collect qualitative data to assess the effects of the Medicaid healthcare and service interventions on beneficiaries' experiences.
Behavioral: Doula · Behavioral: Standard Care
Behavioral: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) · Behavioral: Doula · Behavioral: Standard Care
This study has two components, with the first component being examined in Aim 1 and the first and second components being examined in aim 2. 1\) incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care. The obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among beneficiaries at risk for poor outcomes.
This study has two components, with the first component being examined in Aim 1 and the first and second components being examined in aim 2. 1. Incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care. The obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among beneficiaries at risk for poor outcomes. 2. care intervention by coverage of doula services for all Medicaid beneficiaries across Pennsylvania.
Participants receive standard care without quality interventions or doula care
Severe maternal morbidity (SMM)
SMM rate based on the Centers for Disease Control algorithm
Time frame: 20 weeks gestation through 42 days postpartum
All cause mortality
Binary indicator of mortality based on Social Security Administration records
Time frame: Delivery date through one year after delivery
Follow up for chronic conditions
Percent of persons who receive guideline concordant care for depression, substance use disorders, immunizations, and screening and referral for social determinants of health
Time frame: 43 days through 1 year after delivery
Provision of evidence care in pregnancy and postpartum
Percent of Medicaid patients among each provider who receive screening and follow up for depression, treatment for substance use disorders, perinatal immunizations, and screening and referral for social determinants of health
Time frame: During pregnancy and postpartum up to 1 year
Medicaid managed care administrator perspectives on policy interventions
Qualitative self report of perspectives
Time frame: Year 3
Assess the changes in effects of the Medicaid healthcare quality interventions on beneficiaries' experiences
The investigators will collect qualitative data from three different study populations across Pennsylvania who will be affected by the Medicaid policies under study: 1) Medicaid beneficiaries (n=100; Years 2 and 4); 2) Doula care providers (n=60; Years 2 and 4); Managed Care Organization (MCO) leadership (n=10); Year 3
Time frame: Years 2, 3, and 4
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Jun 2027, 53 months after the start.
Of 35 interventional studies with no phase under Maternal Death, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 41. This study's planned 53 months is above that.
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