Recruiting

Medicaid Interventions

Sponsor:

University of Pittsburgh

Code:

NCT05678699

Conditions

Severe Maternal Morbidity

Maternal Death

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment)

Doula

Standard Care

Study Details

Brief summary:

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:

1. What is the effect of Medicaid healthcare quality interventions on SMM?
2. What is the effect of Medicaid healthcare quality interventions + doula care?
3. What are Medicaid beneficiaries' experiences in receiving services and the potential impact of integration of doula services?

Participants will be asked to describe experiences as a result of Medicaid policy interventions and focused Medicaid policies.

Conditions

Severe Maternal Morbidity

Maternal Death

Study ID

NCT05678699

Start date

Jan 3, 2023

Status verified date

Sep, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Pregnant and postpartum Medicaid beneficiaries across the US

Qualitative:

  • Medicaid beneficiaries who identify as being at risk for poor outcomes or live in PA Health Equity Zones
  • Doulas who provide care to Medicaid beneficiaries in Pennsylvania
  • Medicaid Managed Care Organization (MCO) administrators in Pennsylvania. Severe maternal morbidity and mortality outcomes will be assessed in healthcare records and for these quantitative outcomes, patients will not be recruited individually

Exclusion Criteria:

\-

Study Design

Enrollment

10000000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

other: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) Only

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.

other: Doula Only

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.

other: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula

no intervention: Standard Care

Interventions

Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment)

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.

Doula

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.

Standard Care

Participants receive standard care without quality interventions or doula care

Primary outcome measure

  • Severe maternal morbidity (SMM) [ Time Frame: 20 weeks gestation through 42 days postpartum ]

Central Contacts and Locations

Locations

University of Pittsburgh School of Public Health

Recruiting

Pittsburgh, Pennsylvania, United States, 15261

Contacts

Dara D Mendez, PhD

4126485664ddm11@pitt.edu

Marquita Smalls, MPH

4123830574mns69@pitt.edu

Principal Investigator:

Dara D Mendez, PhD

More Information

Sponsor

University of Pittsburgh

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-09-10. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.