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NCT Number: NCT05678699

The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity

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.

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Key information

Conditions

Severe Maternal Morbidity Death Maternal Death Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh School of Public Health

Pittsburgh, Pennsylvania, 15261, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

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

Behavioral

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.

  • 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

Behavioral

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.

  • 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.
  • care intervention by coverage of doula services for all Medicaid beneficiaries across Pennsylvania.

Standard Care

Behavioral

Participants receive standard care without quality interventions or doula care

Primary outcomes

  1. Severe maternal morbidity (SMM)

    Time frame: 20 weeks gestation through 42 days postpartum

    SMM rate based on the Centers for Disease Control algorithm

Secondary outcomes

  1. All cause mortality

    Time frame: Delivery date through one year after delivery

    Binary indicator of mortality based on Social Security Administration records

  2. Follow up for chronic conditions

    Time frame: 43 days through 1 year after delivery

    Percent of persons who receive guideline concordant care for depression, substance use disorders, immunizations, and screening and referral for social determinants of health

  3. Provision of evidence care in pregnancy and postpartum

    Time frame: During pregnancy and postpartum up to 1 year

    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

  4. Medicaid managed care administrator perspectives on policy interventions

    Time frame: Year 3

    Qualitative self report of perspectives

Other outcomes

  1. Assess the changes in effects of the Medicaid healthcare quality interventions on beneficiaries' experiences

    Time frame: Years 2, 3, and 4

    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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jan 10, 2023
Registry last updated
Sep 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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