The Effects of Medicaid Policy Interventions on Racial Equity in Severe Maternal Morbidity

The goal of this study is to learn about the effects of structural inventions, such as equity-focused Medicaid polices, 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 and equity practices?

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

Study Overview

• Status: Recruiting
• Conditions: Maternal Death; Severe Maternal Morbidity
• Intervention / Treatment: Behavioral: Medicaid healthcare quality interventions (equity payment and obstetric bundled payment); Behavioral: Standard Care; Behavioral: Doula

• Study Type: Interventional
• Enrollment (Estimated): 10000000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • Recruiting
      • University of Pittsburgh School of Public Health
      • Contact: Marquita Smalls, MPH; Phone Number: 4123830574; Email: mns69@pitt.edu
      • Principal Investigator: Dara D Mendez, PhD
      • Sub-Investigator: Marian P Jarlenski, PhD
      • Contact: Dara D Mendez, PhD; Phone Number: 4126485664; Email: ddm11@pitt.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Pregnant and postpartum Medicaid beneficiaries across the US

Qualitative:

• Medicaid beneficiaries who self-identify as Black and/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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care
Other: Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) Only; The investigators will employ a quasi-experimental study design to test two hypotheses: H1: SMM rates among Black people will decline after the interventions (equity payment and obstetric bundled payment), relative to people of other race groups within Pennsylvania (PA); and H2: Racial inequities in 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 (equity 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 examine in aim 2. 1) health equity incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care and well-child visits among Black beneficiaries. The equity-focused obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among Black beneficiaries; Behavioral: Standard Care; Participants receive standard care without quality interventions or doula care
Other: Doula Only; The investigators will test two hypotheses: H1: SMM rates among Black people will decline more after the addition of doula care in PA, relative to healthcare quality interventions alone. H2: Racial inequities in 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: Standard Care; Participants receive standard care without quality interventions or doula care; Behavioral: Doula; This study has two components, with the first component being examined in Aim 1 and the first and second components being examine in aim 2.; health equity incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care and well-child visits among Black beneficiaries. The equity-focused obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among Black beneficiaries.; care intervention by coverage of doula services for all Medicaid beneficiaries across Pennsylvania.
Other: Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) + Doula	Behavioral: Medicaid healthcare quality interventions (equity 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 examine in aim 2. 1) health equity incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care and well-child visits among Black beneficiaries. The equity-focused obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among Black beneficiaries; Behavioral: Standard Care; Participants receive standard care without quality interventions or doula care; Behavioral: Doula; This study has two components, with the first component being examined in Aim 1 and the first and second components being examine in aim 2.; health equity incentive payment program makes available $26 million annually in Medicaid managed care organization (MCO) payments to plans that improve access to timely prenatal care and well-child visits among Black beneficiaries. The equity-focused obstetric care bundled payment model provides incentives for clinicians to improve on a wide range of pregnancy health outcomes, and specifically incentivizes improvements among Black beneficiaries.; care intervention by coverage of doula services for all Medicaid beneficiaries across Pennsylvania.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severe maternal morbidity (SMM)	SMM rate based on the Centers for Disease Control algorithm	20 weeks gestation through 42 days postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	Binary indicator of mortality based on Social Security Administration records	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	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	During pregnancy and postpartum up to 1 year
Medicaid managed care administrator perspectives on policy interventions	Qualitative self report of perspectives	Year 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Years 2, 3, and 4

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Nursing Research (NINR)

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2023
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Death; Parental Death; Maternal Death
• Other Study ID Numbers: STUDY22080184; 1R01NR020670-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No