A study protocol for a site-randomized trial of a multi-level digital intervention to reduce maternal morbidity & mortality

IntroductionCompared to other high-income countries, the United States continues to have the highest rates of pregnancy-related and associated mortality and morbidity (PRAMM), particularly in rural areas and among non-Hispanic Black pregnancies. Over 80% of pregnancy- related deaths are preventable; however, the intensity of existing interventions has proven difficult to broadly disseminate. Technology offers the potential to address such barriers. This study will develop a multi-level digital intervention to reduce PRAMM and evaluate its effects using a site-randomized trial. Methods and analysisThe Michigan Healthy Mom (MI MOM) intervention will be developed using a community-partnered approach and will seek to address PRAMM risks at four distinct levels: individual, support system, provider, and community. Pregnant participants and up to three members of their personal support system will receive an initial brief interactive session through a mobile web app and will thereafter receive a series of text messages with links to extended content. Healthcare providers will receive biweekly text messages and/or flyers distributed in clinic staff areas, and community health workers (CHWs)-- who can facilitate access to local services--will be available via secure live chat text access. MI MOM effects will be evaluated using a cluster randomized trial in 10 antenatal care clinics throughout Michigan (N = 500 pregnant participants age 18+ receiving Medicaid). We will compare intervention and control arms on two co-primary outcomes: total PRAMM through 1 year postpartum as measured using a universally collected linked dataset of Medicaid claims and vital records and an index of PRAMM risk factors directly targeted by MI MOM. Ethics and disseminationThe Michigan State University (MSU) Institutional Review Board (IRB) has provided ethical approval (STUDY00011005). Results will be disseminated via presentations at academic conferences and community forums, as well as publications in peer-reviewed journals. Trial registration numberClinicalTrials.gov Registry (NCT07213284). STRENGTHS AND LIMITATIONS OF THIS STUDYO_LI* Community co-creation of the intervention content ensures MI MOM reflects the best available evidence-based practices while also being deeply rooted in the preferences and needs of the intended users. C_LIO_LI* The technology-driven approach provides a unique level of scalability for the developed intervention, enabling MI MOM to be readily implemented in practice with high fidelity and minimal training across contexts. C_LIO_LI* Integrating technology-delivered services with CHW live chat text access allows on-demand connection to helping professionals to facilitate warm handoffs to locally available services. C_LIO_LI* Digital approaches can elicit concerns around offering a minimally intensive approach to addressing the complexity of PRAMM; the ideal public health response would include person-delivered approaches used in concert with highly scalable, low-barrier technology- driven programs. C_LI