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

Primary Purpose

Severe Maternal Morbidity, Maternal Death

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medicaid healthcare quality interventions (equity payment and obstetric bundled payment)
Doula
Standard Care
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Severe Maternal Morbidity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: -

Sites / Locations

  • University of Pittsburgh School of Public HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

No Intervention

Arm Label

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

Doula Only

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

Standard Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Severe maternal morbidity (SMM)
SMM rate based on the Centers for Disease Control algorithm

Secondary Outcome Measures

All cause mortality
Binary indicator of mortality based on Social Security Administration records
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
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
Medicaid managed care administrator perspectives on policy interventions
Qualitative self report of perspectives

Full Information

First Posted
October 26, 2022
Last Updated
August 4, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT05678699
Brief Title
The Effects of Medicaid Policy Interventions on Racial Equity in Severe Maternal Morbidity
Official Title
The Effects of Medicaid Policy Interventions on Racial Equity in Severe Maternal Morbidity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
June 2027 (Anticipated)
Study Completion Date
June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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: What is the effect of Medicaid healthcare quality interventions on SMM? What is the effect of Medicaid healthcare quality interventions + doula care? 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Maternal Morbidity, Maternal Death

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Evaluation of policy interventions at the state level comparing within state and across states over time.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10000000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) Only
Arm Type
Other
Arm Description
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.
Arm Title
Doula Only
Arm Type
Other
Arm Description
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.
Arm Title
Medicaid healthcare quality interventions (equity payment and obstetric bundled payment) + Doula
Arm Type
Other
Arm Title
Standard Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Medicaid healthcare quality interventions (equity payment and obstetric bundled payment)
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Doula
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
Participants receive standard care without quality interventions or doula care
Primary Outcome Measure Information:
Title
Severe maternal morbidity (SMM)
Description
SMM rate based on the Centers for Disease Control algorithm
Time Frame
20 weeks gestation through 42 days postpartum
Secondary Outcome Measure Information:
Title
All cause mortality
Description
Binary indicator of mortality based on Social Security Administration records
Time Frame
Delivery date through one year after delivery
Title
Follow up for chronic conditions
Description
Percent of persons who receive guideline concordant care for depression, substance use disorders, immunizations, and screening and referral for social determinants of health
Time Frame
43 days through 1 year after delivery
Title
Provision of evidence care in pregnancy and postpartum
Description
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
Time Frame
During pregnancy and postpartum up to 1 year
Title
Medicaid managed care administrator perspectives on policy interventions
Description
Qualitative self report of perspectives
Time Frame
Year 3
Other Pre-specified Outcome Measures:
Title
Assess the changes in effects of the Medicaid healthcare quality interventions on beneficiaries' experiences
Description
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
Time Frame
Years 2, 3, and 4

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Facility Information:
Facility Name
University of Pittsburgh School of Public Health
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dara D Mendez, PhD
Phone
412-648-5664
Email
ddm11@pitt.edu
First Name & Middle Initial & Last Name & Degree
Marquita Smalls, MPH
Phone
4123830574
Email
mns69@pitt.edu
First Name & Middle Initial & Last Name & Degree
Dara D Mendez, PhD
First Name & Middle Initial & Last Name & Degree
Marian P Jarlenski, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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