A Pragmatic Trial of Integrating Community-based Patient Navigation into the Continuum of Maternal Care for Black Women in a Safety-Net Health System: Effects on Maternal Health, Health Care, Morbidit - US maternal mortality is substantially higher than that of other developed nations, with Georgia ranking second highest among the states. Maternal mortality and severe maternal morbidity (SMM) are increasing in Georgia, with the highest rates among those who deliver in safety-net hospitals, who are Black and publicly insured or uninsured. Maternal morbidity and mortality occur along a continuum in which the accumulation and progression in severity of events can be prevented through access to and utilization of quality health care. Georgia’s Maternal Mortality Review Committee concludes that two-thirds of maternal deaths are preventable and attributes recent increases to rising rates of inadequately managed chronic health conditions, mental health disorders, substance use, and pregnancy complications in the setting of care that is often difficult to access, fragmented and of insufficient quality. Experts emphasize that health care approaches that embed transformational aspects into their design through stakeholder input and clinical models that include social support offer the most promise for improving maternal health outcomes and reducing disparities. Emerging data support that the incorporation of community-based patient navigators can enhance the quality of care while addressing barriers that low-income women face in accessing and navigating care, including unmet health and social needs. To date, however, limited research has evaluated this promising strategy in real-life settings using rigorous methods with sufficient sample size and ascertainment of morbidity and mortality endpoints critical for determining effectiveness and motivating large-scale policy and practice change. We posit that the integration of community-based patient navigators into maternal care will improve maternal health outcomes through meeting social needs, lowering stress and depressive symptoms, and improving access to and utilization of care thereby promoting better and more timely management of chronic conditions, pregnancy complications, and reducing the occurrence and progression of complications. To test this hypothesis, we will perform a pragmatic randomized controlled trial (RCT) of the integration of community-based patient navigators into the continuum of maternal care, starting prior to mid-pregnancy and continuing through one-year of birth, among 500 Black women with identified health and social needs in a safety-net hospital system to include both outcome evaluation, to discern effectiveness in reducing maternal morbidity and mortality, and process evaluation, to enhance understanding of RCT findings. We will employ the Respectful Maternity Care and the NIMHD Research Frameworks to rigorously evaluate maternal health outcomes in a hospital system that primarily serves urban, Black women with high unmet health and social needs who experience excessive rates of adverse maternal health outcomes via a multi-disciplinary team experienced in health services and community-based research and with the capacity to implement a care model intervention with high fidelity and acquire and utilize health system and patient-reported data to conduct comprehensive, high-quality evaluation.
