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

NCT05386316 | Enrolling By Invitation

• 1 other identifier: R01MD016003
• Study Type: interventional
• Target: 540,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

maternal mortality; maternal health; maternal health services; African American; health disparity; healthcare disparities

Outcome Measures

Primary Outcomes (2)

• severe maternal morbidity

  We will assess severe maternal morbidity (SMM, as defined by CDC and ACOG)4 using CDC's list of 21 SMM indicators based on ICD-10 diagnosis and procedure codes.60 The binary overall SMM indicator will be coded 1 if any SMM will be identified during a woman's pregnancy, delivery, and up to 12 months postpartum using Medicaid claims and 0 otherwise.

  Pregnancy through 12 months postpartum

• severe maternal morbidity + pregnancy-related mortality

  An indicator representing yes/no any SMM and/or pregnancy-related mortality

  Pregnancy through 12 months postpartum

Secondary Outcomes (5)

• non-severe maternal morbidity

  pregnancy through 12 months postpartum

• enrollment in enhanced prenatal care

  pregnancy through 12 months postpartum

• outpatient visits

  pregnancy through 12 months postpartum

• emergency department visits

  pregnancy through 12 months postpartum

• cost-effectiveness

  pregnancy through 12 months postpartum

Study Arms (2)

Intervention counties

EXPERIMENTAL

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

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

Control counties

ACTIVE COMPARATOR

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

Other: Standard Enhanced Prenatal Care (EPC) services

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.

Intervention counties

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.

Control counties; Intervention counties

Eligibility Criteria

• Gender Eligibility Details: All birthing persons, regardless of self-identified gender.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Michigan State University: lead
• Corewell Health West: collaborator
• Hurley Medical Center: collaborator
• Ascension Health: collaborator

Study Sites (1)

Michigan State University

Flint, Michigan, 48502, United States

Location

Related Publications (1)

• Johnson JE, Roman L, Key KD, Meulen MV, Raffo JE, Luo Z, Margerison CE, Olomu A, Johnson-Lawrence V, White JM, Meghea C. Study protocol: The Maternal Health Multilevel Intervention for Racial Equity (Maternal Health MIRACLE) Project. Contemp Clin Trials. 2022 Sep;120:106894. doi: 10.1016/j.cct.2022.106894. Epub 2022 Aug 24.

  PMID: 36028193 DERIVED

Related Links

• Study web page
• News article

MeSH Terms

Conditions

Maternal Death

Interventions

Mortality; erucylphosphocholine

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Vital Statistics; Data Collection; Epidemiologic Methods; Investigative Techniques; Demography; Population Characteristics; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Jennifer E Johnson, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

• Cristian Meghea, PhD

  Michigan State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Data include Medicaid claims and birth and death records.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: C. S. Mott Endowed Professor of Public Health

Model Details: Individuals who live in the intervention counties at the time of birth will be assigned to the intervention condition. Individuals who live in control counties at the time of birth are assigned to the control condition.

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 23, 2022
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)