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Scaling up Maternal Health Equity Best Practices

Scale-up Implementation Approaches to Ending Pregnancy-related and -Associated Morbidity and Mortality (MIRACLE Center Project 3)

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06541951
Enrollment
600
Registered
2024-08-07
Start date
2024-11-01
Completion date
2030-11-30
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

Maternal Morbidity Disparities, Maternal Mortality Disparities

Keywords

health inequities, maternal health, maternal mortality, implementation science, healthcare disparities, African Americans, Hispanic

Brief summary

This study works with prenatal and postnatal care providers in 12 Michigan counties to scale up best practices for maternal health equity.

Detailed description

The project recruits prenatal and postnatal care providers in 12 Michigan counties. his project will develop and test a scale-up focused implementation approach for addressing pregnancy-related and -associated morbidity and mortality (PRAMM) disparities. Previous efforts have shown that use of hospital- focused maternal safety bundles are an important part of successful efforts to reduce PRAMM. However, overall quality of obstetric care improved in these efforts without any effect on disparities. Thus, unlike previous efforts, the proposed project will implement quality improvement bundles that: (1) focus on PRAMM disparities; and (2) focus on community care (i.e., care provided outside the hospital in outpatient and other community settings) and coordination among care settings. Given that 83% of U.S. pregnancy-related and pregnancy-associated deaths occur during pregnancy or postpartum (rather than around the time of delivery), outpatient and community efforts are vital. Bundles (the evidence-based practices to be implemented) are developed by the national Alliance for Innovation on Maternal Health Community Care Initiative (AIM-CCI), and include Community care for postpartum safety and wellness, and Community care for maternal mental health, Chronic conditions, and Intimate partner violence bundles. All bundles target PRAMM disparities. • Aim 1 of the proposed project will analyze bundle implementation experiences in 2 counties to develop a county-wide scale-up focused implementation approach for the bundles in partnership with stakeholders date to create and manualize a scale-up implementation intervention. • Aim 2 will evaluate the effectiveness and cost-effectiveness of the scale-up implementation intervention using a stepped wedge design in 12 Michigan counties with a total population of nearly 6 million people. PRAMM outcomes (individual level) will be extracted from a pre-existing statewide linked dataset. The sample for these analyses will include all Medicaid insured individuals in the 12 counties observed during pregnancy, at birth, and up to 1 year postpartum during the project period (\ 151,920 births, including \ 49,110 births to African American and/or Hispanic mothers). Implementation outcomes (provider-level) include scale-up (penetration, reach, control for delivery, and intervention effectiveness at scale) and sustainment (maintenance of fidelity to core elements, health benefits, and capacity to deliver core elements over time). This project is innovative because it: (1) is the first controlled implementation trial to test approaches to implementing quality improvement bundles that: (a) specifically target PRAMM disparities; and (b) focus on community care; (2) advances the science of scale-up (it is the first study to test scale- up or sustainment implementation approaches to addressing maternal morbidity/mortality disparities); and (3) works to improve services across many (vs. a single) health systems. The project is significant because the field needs to reach pregnant people at scale, and scale-up is an understudied aspect of implementation science.

Interventions

OTHERServices as usual

During this phase of the stepped wedge design, agencies offering prenatal and postnatal care will follow their standard procedures

OTHERScale-up implementation approach

An implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide, co-developed with partners. It may involve implementation approaches such as training, facilitation, learning collaboratives, coalitions, and other activities.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Michigan State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)

Intervention model description

Cluster-randomized stepped wedge design

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Provider Inclusion Criteria: -Be a provider or staff person at agencies offering prenatal and/or postnatal services in Wayne, Oakland, Ingham, Isabella, Macomb, Muskegon, Calhoun, Jackson, Saginaw, Kalamazoo, Barrien, or Washtenaw counties in Michigan. Provider

Exclusion criteria

* None Patient outcomes are assessed through population-level Medicaid data, without direct recruitment. Patient Inclusion criteria: -All pregnant or postpartum (up to 12 months) people receiving Medicaid in Michigan Patient

Design outcomes

Primary

MeasureTime frameDescription
African-American and Hispanic pregnancy-related and associated morbidity and mortality (PRAMM)Continuous for 6 yearsA composite variable reflecting all pregnancy-related and associated morbidity and mortality conditions from pregnancy through 12 months postpartum, assessed using Medicaid claims data. The investigators will assess overall rates for African-American/Hispanic people and their rates relative to non-Hispanic white ones.

Secondary

MeasureTime frameDescription
Scale-up: ReachAssessed annually for 6 yearsNumber of perinatal people receiving recommended practices
Scale-up: Control for deliveryAssessed annually for 6 yearsThe degree to which control for delivery shifts to local actors and the practices are embedded in local delivery systems
Scale-up: EffectivenessAssessed annually for 6 yearsEffectiveness is retained as the intervention is scaled: Operationalized using outcome 1 (PRAMM) analyses.
Sustainment: FidelityAnnually for 6 yearsFidelity to core elements at each time point as assessed through provider behavior assessed using a self-reported y/n responses to a checklist of activities
Scale-up: PenetrationAssessed annually for 6 yearsPenetration (% providers/staff using recommended maternal health equity practices)
Sustainment: CapacityAnnually for 6 yearsCapacity continues over time. Operationalized as the slope of capacity annually after the county moves into the intervention phase of the stepped wedge design
Cost of implementation approachesContinuous over 6 yearsCost via our grant accounting
Cost-effectiveness of implementation approachesContinuous over 6 yearsThe primary cost-effectiveness measure will be non-severe maternal morbidity, calculating intervention costs per point of score reduction. Secondary cost-effectiveness measures will be severe maternal morbidity and maternal mortality. Prevented severe maternal morbidity (SMM) will be also monetized using Medicaid claims data by calculating the difference between Medicaid delivery expenditures between women/birthing persons with SMM and without SMM using our own claims data and prior estimates. The value of a statistical life, currently around $10 million, will be used to monetize prevented maternal deaths.
Index (y/n) that is yes if there is any African-American and Hispanic severe maternal morbidity or pregnancy-associated mortalityContinuous for 6 yearsThese will be assessed during pregnancy and through one-year postpartum using state Medicaid claims records and death records. The investigators will assess overall rates and rates relative to non-Hispanic white people.
Sustainment: Health benefitsAnnually for 6 yearsHealth benefits continuing over time: Operationalized as the slope of PRAMM annually after the county moves into the intervention phase of the stepped wedge design

Countries

United States

Contacts

Primary ContactSimran Dhaliwal Project Coordinator
MHMiracle@Msu.edu810-600-5630

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026