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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05678699
Other study ID # STUDY22080184
Secondary ID 1R01NR020670-01
Status Recruiting
Phase N/A
First received
Last updated
Start date January 3, 2023
Est. completion date June 2027

Study information

Verified date August 2023
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000000
Est. completion date June 2027
Est. primary completion date June 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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.
Standard Care
Participants receive standard care without quality interventions or doula care

Locations

Country Name City State
United States University of Pittsburgh School of Public Health Pittsburgh Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pittsburgh National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary Severe maternal morbidity (SMM) SMM rate based on the Centers for Disease Control algorithm 20 weeks gestation through 42 days postpartum
Secondary All cause mortality Binary indicator of mortality based on Social Security Administration records Delivery date through one year after delivery
Secondary 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
Secondary 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
Secondary Medicaid managed care administrator perspectives on policy interventions Qualitative self report of perspectives Year 3
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