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

Meeting Women Where They Are: The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05386316
Acronym
MIRACLE
Enrollment
540000
Registered
2022-05-23
Start date
2022-01-01
Completion date
2025-12-31
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Disparities, Maternal Morbidity and Mortality

Keywords

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

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).

Detailed description

Maternal morbidity and mortality in the US are critical problems of public health significance. US maternal mortality rates are the highest among high-income countries. In addition, severe maternal morbidity (SMM; unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health1), affects around 60,000 US women every year. Such life-threatening complications affect mothers, children, families, and communities, and cost billions of dollars per year. These challenges disproportionately affect African American (AA) women. AA women are three to four times more likely to die of pregnancy related complications than non-Hispanic white (NHW) women and have twice the rates of SMM.2,3 Inequities occur at many levels. These include the community level, in which the built environment and working multiple jobs while managing family obligations can make it difficult for AA women to access even enhanced prenatal and postnatal care (EPC) programs designed for them. At the provider/practice level, implicit and explicit biases and the structures and practices reflecting them contribute to inadequate quality of care for AA women, reduce the acceptability of treatment, and contribute to racial disparities in maternal morbidity and mortality. At the system level, health systems serving AA women are less likely to offer high-quality care, and quality initiatives that to do not directly target disparities often have little or no effect on disparities. This proposal will test the effectiveness and cost-effectiveness of a multilevel intervention to address AA-NHW maternal morbidity and mortality disparities in two Michigan counties: Genesee County (which includes Flint) and Kent County (which includes Grand Rapids). Interventions at each level were developed or co-developed by our partners in these counties, who include AA women residents and community leaders, EPC staff (including Community Health Workers), and physician/health system representatives. Community level (improving accessibility) intervention. This project will expand access to EPC services using telehealth and flexible scheduling (e.g. outside business hours). EPC programs (such as Healthy Start and statewide home visiting programs) provide care coordination, promote healthy behaviors, provide health education and social support, and address social determinants of health. These programs, some using race-matched Community Health Workers, improve maternal and infant health, including reducing mortality, especially for AA. Despite being designed for minority women, 60% of eligible AA women in Michigan do not enroll in EPC services. The investigators found that 50% of minority women who declined EPC services said they would participate if a tele-health option was available. This project will provide this option to improve access to these important services. Provider/practice level (improving acceptability) intervention. This project will address provider and health system implicit and explicit bias and corresponding structures and practices and make this learning actionable using daylong experiential trainings. Trainings will include didactics, reflection, discussion, windshield tours, and brainstorming ways to tailor trainees' settings to better hear, respect, and meet the needs of perinatal AA women. Training will include everyone from physicians to front desk staff and will take place in small groups (10-20) with additional opportunities for the larger community to come together to brainstorm and plan responses. System level (improving quality) intervention. This project will deploy community care patient safety bundles targeting maternal health disparities throughout the intervention counties. Community care is defined as care provided by outpatient, EPC, and community-based organizations. Kent County is the lead of 5 pilot communities in the national Alliance for Innovation on Maternal Health Community Care Initiative (AIM-CCI) to develop and implement non-hospital focused maternal safety bundles. The bundles provide care guidelines to address disparities in preventable maternal mortality and SMM. As part of this project, Genesee County will implement the bundles in partnership with Kent County, providing the final level of our multilevel intervention. The study sample will include all Medicaid insured women observed during pregnancy, at birth, and/or up to 1 year postpartum, who deliver in Michigan from 2016-2019 and 2021-2024 (\ 540,000 births, including \ 162,000 births to AA women). Investigators will test the effects of the multilevel intervention using a quasi-experimental difference-in-difference with propensity scores approach to compare pre (2016-2019) to post (2022-2025) changes in outcomes among Medicaid women in the two intervention counties with similar women in other counties. Measures will be taken from a pre-existing linked dataset that includes Medicaid claims, death records, birth records, and EPC program data. The specific aims are to: 1. Assess the effectiveness of the multilevel intervention on the following outcomes: 1. AA SMM and pregnancy-related mortality (up to 1-year postpartum; overall & relative to NHW women) 2. AA non-severe maternal morbidity (overall & relative to NHW women) 2. Test improved service utilization (enrollment in EPC, more outpatient visits, fewer emergency department \[ED\] visits during pregnancy and postpartum) and non-severe maternal morbidity (overall & relative to NHW women) as mechanisms of the effect of the multilevel intervention on SMM 3. Evaluate the cost-effectiveness of the multilevel intervention AA women face addressable disparities in maternal morbidity and mortality. This trial, among the first to evaluate a multilevel intervention to address population-level AA SMM, will help build the evidence-base to address them. The study will also provide information about cost-effectiveness needed to drive policy decisions and information about mechanisms of intervention effects needed to drive the science forward. Achieving these aims will deter-mine whether this intervention could be scaled widely to reduce AA SMM and pregnancy-related mortality.

Interventions

OTHERMultilevel 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.

OTHERStandard 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

Corewell Health West
CollaboratorOTHER
Hurley Medical Center
CollaboratorOTHER
Ascension Health
CollaboratorINDUSTRY
Michigan State University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Data include Medicaid claims and birth and death records.

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

Resided in intervention county at time of delivery. -

Exclusion criteria

None. \-

Design outcomes

Primary

MeasureTime frameDescription
severe maternal morbidityPregnancy through 12 months postpartumWe 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.
severe maternal morbidity + pregnancy-related mortalityPregnancy through 12 months postpartumAn indicator representing yes/no any SMM and/or pregnancy-related mortality

Secondary

MeasureTime frameDescription
outpatient visitspregnancy through 12 months postpartumNumber of outpatient pregnancy and postpartum visits (higher is better)
non-severe maternal morbiditypregnancy through 12 months postpartumMeasurement of non-severe maternal morbidity (NSMM), is taken from the WHO's Maternal Morbidity Working Group (MMWG).61-64 Most NSMM are measurable using ICD-10 diagnostic and procedure codes63,65 To capture multimorbidity in our sample, the overall NSMM indicator will be the sum of WHO-delineated NSMM diagnoses and procedures63,65 identified in a woman's Medicaid claims during pregnancy and up to 1 year postpartum. We will also assess the following WHO-defined subcategories: (1) number of direct NSMM diagnoses and procedures (e.g., delivery complications, hypertensive disorders of pregnancy, obstetric hemorrhage, pregnancy-related infections);63 (2) number of indirect NSMM diagnoses and procedures (e.g. endocrine, nutritional, and metabolic diseases; mental disorders); and (3) number co-incidental NSMM (e.g. partner violence, sexual assault) diagnoses and procedures.63
cost-effectivenesspregnancy through 12 months postpartumThe primary outcome used for cost-effectiveness analyses will be SMM. Prevented SMM will be monetized using Medicaid claims data by calculating the difference between Medicaid delivery expenditures between women with SMM and without SMM using our own claims data and prior estimates.6 Secondary cost-effectiveness measures will be maternal mortality and NSMM. The value of a statistical life,66 currently around $10 million, will be used to monetize prevented maternal deaths. For NSMM, we will calculate intervention costs per point of NSMM score reduction.
emergency department visitspregnancy through 12 months postpartumNumber of emergency department visits (lower is better)
enrollment in enhanced prenatal carepregnancy through 12 months postpartumBinary indicator reflecting yes/no enrollment in MIHP and/or Health Start

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026