The Effects of Medicaid Policy Interventions on Severe Maternal Morbidity

NCT05678699 | Recruiting DMC

• 2 other identifiers: STUDY220801841R01NR020670-01
• Study Type: interventional
• Target: 10,000,000
• Locations: 1 country
• Sites: 1

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

Conditions

Severe Maternal Morbidity; Maternal Death

Outcome Measures

Primary Outcomes (1)

• Severe maternal morbidity (SMM)

  SMM rate based on the Centers for Disease Control algorithm

  20 weeks gestation through 42 days postpartum

Secondary Outcomes (4)

• All cause mortality

  Delivery date through one year after delivery

• Follow up for chronic conditions

  43 days through 1 year after delivery

• Provision of evidence care in pregnancy and postpartum

  During pregnancy and postpartum up to 1 year

• Medicaid managed care administrator perspectives on policy interventions

  Year 3

Other Outcomes (1)

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

  Years 2, 3, and 4

Study Arms (4)

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

OTHER

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

Doula Only

OTHER

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

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

OTHER

Behavioral: Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment); Behavioral: Doula; Behavioral: Standard Care

Standard Care

NO INTERVENTION

Interventions

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. 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.

Doula Only; Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula

Standard Care BEHAVIORAL

Participants receive standard care without quality interventions or doula care

Doula Only; Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula; Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) Only

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. 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.

Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) + Doula; Medicaid healthcare quality interventions (incentive payment and obstetric bundled payment) Only

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Pittsburgh School of Public Health

Pittsburgh, Pennsylvania, 15261, United States

RECRUITING

MeSH Terms

Conditions

Maternal Death

Interventions

Doulas; Standard of Care

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Evaluation of policy interventions at the state level comparing within state and across states over time.

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: January 10, 2023
• Study Start: January 3, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)