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

摘要 美国的产妇死亡率大大高于其他发达国家，格鲁吉亚位居第二 在各州中是最高的。在格鲁吉亚，孕产妇死亡率和严重孕产妇发病率(SMM)正在上升， 在黑人、公共保险或未投保并在安全网中分娩的人中，比率最高 医院。孕产妇发病率和死亡率发生在一个连续统一体中，在这个连续统一体中， 可以通过获得和利用优质卫生保健来预防事件的严重性。佐治亚州的母亲 死亡率审查委员会得出结论，三分之二的孕产妇死亡是可以预防的，并将最近 管理不善的慢性健康状况、精神健康障碍、 药物使用和妊娠并发症的护理环境往往很难获得，支离破碎 质量不够好。专家强调，以公平为中心的医疗保健方法--它嵌入了 通过利益相关者的意见和黑人主导的护理模式将各方面转变为他们的设计，包括 应对与种族主义和风化有关的压力的社会支持--为减少 不平等。新出现的数据支持，纳入种族和谐的社区患者 导航员可以提高护理的文化能力，同时解决歧视、系统性种族主义和 影响优质医疗服务的体制障碍。然而，到目前为止，只有有限的研究评估了这一有希望的战略 使用具有足够样本量和确定发病率和发病率的严格方法的真实环境 死亡率终点对于确定有效性和激励大规模的政策和做法改变至关重要。 我们假设，将基于社区的患者导航器整合到孕产妇护理中将改善孕产妇 通过满足社会需求，减轻压力和抑郁症状，改善健康状况 获得和利用护理，从而促进更好和更及时地管理条件和 减少并发症的发生和进展。为了检验这一假设，我们建议执行一个 将社区患者导航器整合到 连续的产妇护理，从怀孕中期开始，一直持续到出生一年， 500名有明确健康和社会需求的黑人妇女在安全网医院系统中，将两者都包括在内 结果评估，以确定在降低孕产妇发病率和死亡率方面的有效性，以及程序 评估，以加强对随机对照试验结果的理解。我们将采用尊重产妇护理和 NIMHD研究框架在医院系统中严格评估孕产妇健康结果 主要服务于有大量未得到满足的需求的黑人妇女，她们经历了过高的不良孕产期 通过在卫生服务和基于社区的研究方面经验丰富的多学科团队， 以公平为中心的护理，并有能力实施高保真和 获取和利用卫生系统和患者报告的数据，进行全面、高质量的评估。

ABSTRACT 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 are Black, publicly insured or uninsured, and deliver in safety-net hospitals. Maternal morbidity and mortality occur on 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 equity-centered health care approaches – which embed transformational aspects into their design through stakeholder input and Black-led models of care that include social support to counter stress related to racism and weathering – offer the most promise for reducing inequities. Emerging data support that the incorporation of racially-concordant, community-based patient navigators can enhance the cultural-competence of care while addressing discrimination, systemic racism, and institutional barriers to quality care. 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 conditions and reducing the occurrence and progression of complications. To test this hypothesis, we propose to 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 Black women with high unmet needs who experience excessive rates of adverse maternal health outcomes via a multi-disciplinary team experienced in health services and community-based research, equity-centered care, 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.