Clinical trial NCT05386316: The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Official title: Meeting Women Where They Are: The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Maternal Morbidity and Mortality
Health Disparities
Keywords: maternal mortality
maternal health
maternal health services
African American
health disparity
healthcare disparities
Lead sponsor: Michigan State University
Sponsor class: OTHER
Collaborators: name: Spectrum Health Hospitals
name: Hurley Medical Center
name: Ascension Health
First posted: 2022-05-23
Enrollment: 540000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 health"1), 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.

Eligibility criteria: Inclusion Criteria: Resided in intervention county at time of delivery. -

Exclusion Criteria: None.

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Primary outcomes:
measure: severe maternal morbidity
timeFrame: Pregnancy through 12 months postpartum
measure: severe maternal morbidity + pregnancy-related mortality
timeFrame: Pregnancy through 12 months postpartum
Secondary outcomes:
measure: non-severe maternal morbidity
timeFrame: pregnancy through 12 months postpartum
measure: enrollment in enhanced prenatal care
timeFrame: pregnancy through 12 months postpartum
measure: outpatient visits
timeFrame: pregnancy through 12 months postpartum
measure: emergency department visits
timeFrame: pregnancy through 12 months postpartum
measure: cost-effectiveness
timeFrame: pregnancy through 12 months postpartum
Other outcomes:
Locations:
city: Flint
country: United States
facility: Michigan State University
state: Michigan
Study officials:
affiliation: Michigan State University
name: Jennifer E Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan State University
name: Cristian Meghea, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.