Multilevel Intervention for Maternal Health Equity

(MIRACLE Trial)

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Michigan State University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

540000 Participants Needed

Trial Summary

What is the purpose of this trial?

This community-partnered study will scale a community, provider, and system-level implementation intervention to reduce African American maternal morbidity and mortality disparities in two Michigan counties (Genesee and Kent). This project will test the intervention using data from Medicaid insured women who deliver in Michigan from 2016-2019 and 2022-2025 (approximately 540,000 births, including 162,000 births to African American women).

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Multilevel intervention for racial disparities in severe maternal morbidity and mortality?

Research suggests that improving the quality of healthcare from before pregnancy through postpartum care can help reduce racial disparities in maternal health outcomes. Additionally, initiatives that focus on patient safety and quality improvement, such as monitoring and addressing disparities in severe maternal morbidity, have shown promise in reducing these disparities. ^{1 2 3 4 5}

How is the Multilevel Intervention for Maternal Health Equity treatment different from other treatments for racial disparities in severe maternal morbidity and mortality?

This treatment is unique because it uses a multilevel approach that considers not just individual health factors but also community and social contexts to address racial disparities in maternal health. It aims to identify and tackle underlying community-level factors contributing to these disparities, which is different from traditional treatments that focus mainly on individual risk factors. ^{3 5 6 7 8}

Research Team

Jennifer E Johnson, PhD

Principal Investigator

Michigan State University

Cristian Meghea, PhD

Principal Investigator

Michigan State University

Eligibility Criteria

The MIRACLE Project is for African American women who gave birth in Genesee or Kent counties, Michigan during specific periods (2016-2019 and 2022-2025) and were covered by Medicaid. There are no exclusion criteria, so all women from these areas and times can participate.

Inclusion Criteria

Resided in intervention county at time of delivery

Exclusion Criteria

Not applicable.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Implementation

Implementation of multilevel interventions at community, provider, and system levels to address maternal morbidity and mortality disparities

3 years

Follow-up

Participants are monitored for outcomes such as severe maternal morbidity and pregnancy-related mortality up to 1 year postpartum

12 months

Treatment Details

Interventions

• Multilevel intervention for racial disparities in severe maternal morbidity and mortality
• Standard Enhanced Prenatal Care (EPC) services

Trial Overview This study compares a multilevel intervention aimed at reducing racial disparities in severe maternal morbidity and mortality against standard enhanced prenatal care services provided to African American mothers in the selected Michigan counties.

Participant Groups

Group I: Intervention counties Experimental Treatment 2 Interventions

Birthing persons who live in Kent County or Genesee County, Michigan, USA at the time of delivery.

Group II: Control counties Active Control 1 Intervention

Birthing persons who live in the other Michigan, USA counties at the time of delivery.

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Hurley Medical Center

Collaborator

Trials

7

Recruited

544,000+

Ascension Health

Industry Sponsor

Trials

28

Recruited

543,000+

Spectrum Health Hospitals

Collaborator

Trials

66

Recruited

553,000+

Hurley MIHP and Healthy Start

Collaborator

Trials

1

Recruited

540,000+

Ascension MIHP and Healthy Start

Collaborator

Trials

1

Recruited

540,000+

Genesee County Health Department

Collaborator

Trials

1

Recruited

540,000+

Community Based Organization Partners

Collaborator

Trials

1

Recruited

540,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Using medical expenditure panel survey data to explore the relationship between patient-centered medical homes and racial disparities in severe maternal morbidity outcomes. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Strengthening the postpartum transition of care to address racial disparities in maternal health. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Reducing Disparities in Severe Maternal Morbidity and Mortality. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Examining the effect of quality improvement initiatives on decreasing racial disparities in maternal morbidity. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Implementation and outcomes of a system-wide women's health 'team goal' to reduce maternal morbidity for black women: a prospective quality improvement study. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Changing the conversation: applying a health equity framework to maternal mortality reviews. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Study protocol: The Maternal Health Multilevel Intervention for Racial Equity (Maternal Health MIRACLE) Project. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Reduction in racial disparities in severe maternal morbidity from hemorrhage in a large-scale quality improvement collaborative. [2022]