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

NCT05386316 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540000

Last updated 2025-03-21

No results posted yet for this study

Summary

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).

Conditions

  • Maternal Morbidity and Mortality
  • Health Disparities

Interventions

OTHER

Multilevel intervention for racial disparities in severe maternal morbidity and mortality

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.

OTHER

Standard Enhanced Prenatal Care (EPC) services

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.

Sponsors & Collaborators

  • Spectrum Health Hospitals

    collaborator OTHER
  • Hurley Medical Center

    collaborator OTHER
  • Ascension Health

    collaborator INDUSTRY
  • Michigan State University

    lead OTHER

Principal Investigators

  • Jennifer E Johnson, PhD · Michigan State University

  • Cristian Meghea, PhD · Michigan State University

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05386316 on ClinicalTrials.gov