Scaling up Maternal Health Equity Best Practices
NCT Number: NCT06541951
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Maternal Mortality Disparities|Maternal Morbidity Disparities
Interventions: OTHER: Services as usual|OTHER: Scale-up implementation approach
Sponsor: Michigan State University
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 600
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: PREVENTION
Start Date: 2024-11-01
Completion Date: 2030-11
Locations: Michigan State University on behalf on 12 Michigan counties, Flint, Michigan, 48503-4684, United States

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

Primary Outcome Measures: African-American and Hispanic pregnancy-related and associated morbidity and mortality (PRAMM), A 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., Continuous for 6 years
Secondary Outcome Measures: Scale-up: Penetration, Penetration (% providers/staff using recommended maternal health equity practices), Assessed annually for 6 years|Scale-up: Reach, Number of perinatal people receiving recommended practices, Assessed annually for 6 years|Scale-up: Control for delivery, The degree to which control for delivery shifts to local actors and the practices are embedded in local delivery systems, Assessed annually for 6 years|Scale-up: Effectiveness, Effectiveness is retained as the intervention is scaled: Operationalized using outcome 1 (PRAMM) analyses., Assessed annually for 6 years|Sustainment: Fidelity, Fidelity 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, Annually for 6 years|Sustainment: Health benefits, Health benefits continuing over time: Operationalized as the slope of PRAMM annually after the county moves into the "intervention phase of the stepped wedge design, Annually for 6 years|Sustainment: Capacity, Capacity continues over time. Operationalized as the slope of capacity annually after the county moves into the "intervention" phase of the stepped wedge design, Annually for 6 years|Cost of implementation approaches, Cost via our grant accounting, Continuous over 6 years|Cost-effectiveness of implementation approaches, The 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., Continuous over 6 years|Index (y/n) that is yes if there is any African-American and Hispanic severe maternal morbidity or pregnancy-associated mortality, These 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., Continuous for 6 years