The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project

Part of paid clinical trials in Flint, Michigan.

Sponsor
Michigan State University
Study ID
NCT05386316
Status
Enrolling By Invitation

Conditions

  • Health Disparities
  • Maternal Morbidity and Mortality

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Multilevel intervention for racial disparities in severe maternal morbidity and mortality — OTHER
    In addition to standard enhance prenatal care (EPC) services, the following will be offered. Community level. We will make EPC services (i.e., MIHP and Healthy Start) available via telehealth with flexible hours to women who are eligible for Healthy Start (primarily minority women) who decline traditional (i.e., home visiting) services. Provider/practice level. We will provide actionable maternal health-focused anti-racism training to health system administrators, physicians, residents, midwives, nurses, front desk staff, schedulers, public health officers, EPC staff, doulas, WIC staff, and lactation consultants. System level. Counties will implement equity focused community care maternal safety bundles. Community care is care provided by outpatient, EPC, community-based organizations, and linkages between hospital care and these settings.
  • Standard Enhanced Prenatal Care (EPC) services — OTHER
    Pregnant women in comparison counties will receive whatever EPC services (MIHP and/or Healthy Start) they naturalistically choose to receive. Maternal Infant Health Program (MIHP). All women in Michigan who are Medicaid insured are eligible for MIHP. MIHP offers monthly home visiting and care coordination to supplements regular care during pregnancy and up to 12 months post birth. MIHP offers care coordination; risk assessment; individual care plan; evidence-based interventions; transportation; education; and referrals. Healthy Start. Health Start is a federally funded program for minority women that offers more intensive EPC services delivered by race/ethnicity matched community health workers. Community health workers offer peer support; resilience and problem solving; risk assessment; facilitating provider-client communication; collaborative care; system navigation, including transition from prenatal care to postnatal primary care; and supportive referrals.

Study Details

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).

Key Dates

Start date
Jan 1, 2022
Status verified
Mar 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
540,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention counties
    Birthing persons who live in Kent County or Genesee County, Michigan, USA at the time of delivery.
  • Active Comparator: Control counties
    Birthing persons who live in the other Michigan, USA counties at the time of delivery.

Primary Outcome Measure

severe maternal morbidity [ Time Frame: Pregnancy through 12 months postpartum ]

Locations (1)

FacilityCityStateZIPSite coordinators
Michigan State UniversityFlintMichigan48502-

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By research site
Michigan State University· Flint, MI

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