Meeting Women Where They Are: The Maternal Health Multilevel Intervention for Racial Equity (MIRACLE) Project
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 540,000
- 试验地点
- 2
- 主要终点
- severe maternal morbidity
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Data include Medicaid claims and birth and death records.
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Resided in intervention county at time of delivery. -
排除标准
- 未提供
结局指标
主要结局
severe maternal morbidity
时间窗: Pregnancy through 12 months postpartum
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.
severe maternal morbidity + pregnancy-related mortality
时间窗: Pregnancy through 12 months postpartum
An indicator representing yes/no any SMM and/or pregnancy-related mortality
次要结局
- enrollment in enhanced prenatal care(pregnancy through 12 months postpartum)
- non-severe maternal morbidity(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)
研究者
Jennifer E. Johnson
C. S. Mott Endowed Professor of Public Health
Michigan State University
