Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT05386316 |
| Other study ID # |
R01MD016003 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 31, 2025 |
Study information
| Verified date |
May 2022 |
| Source |
Michigan State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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).
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.
