A cluster randomized stepped wedge implementation trial of scale-up approaches to ending pregnancy-related and -associated morbidity and mortality disparities in 12 Michigan counties: rationale and study protocol.

Background: Hospital-focused maternal health safety and quality guidelines have been found to reduce pregnancy-related and -associated morbidity and mortality (PRAMM). Unfortunately, quality of obstetric care can improve without affecting disparities. This project is the first controlled implementation trial to test approaches to implementing safety guidelines that: (1) target PRAMM disparities; and (2) focus on community care (care provided outside hospitals in outpatient and other community settings, and coordination among care settings), where most deaths occur. It is also one of the first to test scale-up or sustainment implementation approaches to addressing maternal morbidity and mortality disparities.

Methods: This project, one of three in the federally funded Multilevel Interventions for Raci.a.l Equity (MIRACLE) Maternal Health Research Center of Excellence, will develop and evaluate an implementation approach for scaling up bundled equity-focused maternal health safety guidelines in community care settings county-wide. The scale-up approach will be co-developed with partners, and then tested using a cluster randomized stepped-wedge trial of 12 Michigan counties with a total population of nearly 6 million. Randomization occurs at the county level; birthing people and providers are clustered within counties. PRAMM outcomes (individual level; primary) will be extracted from a pre-existing statewide linked dataset that includes Medicaid claims and vital records data. The sample 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 Black and/or Hispanic mothers). Implementation outcomes (provider level) will be collected using annual provider (n = 600) surveys and will 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) of bundles and cost-effectiveness of implementation approaches.

Discussion: This implementation trial will be the first to evaluate an implementation approach to scaling community health equity-focused maternal safety guidelines, addressing an understudied aspect of implementation science (i.e., scale-up). The study will also provide information about implementation cost-effectiveness needed to drive policy decisions.

Trial registration: The study was prospectively registered on Clinicaltrials.gov (NCT06541951) on August 6, 2024. The first participant has not yet been recruited. The url for the trial registration is: https://clinicaltrials.gov/study/NCT06541951?locStr=Flint,%20MI&country=United%20States&state=Michigan&city=Flint&rank=1 .