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

Sponsor
University of Pittsburgh (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05678699
Collaborator
National Institute of Nursing Research (NINR) (NIH)
10,000,000
1
4
53
188818.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Medicaid healthcare quality interventions (equity payment and obstetric bundled payment)
  • Behavioral: Doula
  • Behavioral: Standard Care
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10000000 participants
Allocation:
Non-Randomized
Intervention Model:
Factorial Assignment
Intervention Model Description:
Evaluation of policy interventions at the state level comparing within state and across states over time.Evaluation of policy interventions at the state level comparing within state and across states over time.
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
The Effects of Medicaid Policy Interventions on Racial Equity in Severe Maternal Morbidity
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2027
Anticipated Study Completion Date :
Jun 1, 2027

Arms and Interventions

Arm Intervention/Treatment
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: 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.

Behavioral: Standard Care
Participants receive standard care without quality interventions or doula care

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: 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.

Behavioral: Standard Care
Participants receive standard care without quality interventions or doula care

No Intervention: Standard Care

Outcome Measures

Primary Outcome Measures

  1. Severe maternal morbidity (SMM) [20 weeks gestation through 42 days postpartum]

    SMM rate based on the Centers for Disease Control algorithm

Secondary Outcome Measures

  1. All cause mortality [Delivery date through one year after delivery]

    Binary indicator of mortality based on Social Security Administration records

  2. Follow up for chronic conditions [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 [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 [Year 3]

    Qualitative self report of perspectives

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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:

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pittsburgh School of Public Health Pittsburgh Pennsylvania United States 15261

Sponsors and Collaborators

  • University of Pittsburgh
  • National Institute of Nursing Research (NINR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dara Mendez, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT05678699
Other Study ID Numbers:
  • STUDY22080184
  • 1R01NR020670-01
First Posted:
Jan 10, 2023
Last Update Posted:
Jan 10, 2023
Last Verified:
Dec 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2023