Enhance Trial-Enriched Holistic Care to Eradicate Maternal Morbidity

项目摘要 该随机对照试验 （SMM） 人 解决社会和结构性不平等，以减少严重的孕产妇发病率 和孕产妇死亡率在最危险的病人-那些自我认同为黑人，土著和 颜色（BIPOC）具体而言，我们的干预措施将实施和评估一个综合的、多层次的 产妇护理之家模式（MCHM），包括产妇护理导航，福利导航，社会 工作、导乐和心理健康资源都在一个护理提供模式中。而 评价 这些 先前的研究 单一的社会决定因素（如教育和保险）或单一的解决方案（如护理导航）， 这些方法缺乏一种全面的、综合的方法来满足所有患者的需求。 D 我们的研究将测试我们的中心假设，即以患者为中心的MCHM将解决社会，结构， 和卫生系统因素，导致我们最脆弱的BIPOC患者的差异，从而减少 SMM。为了测试这种MCHM的有效性，并确保及时吸收的结果，我们提出了1型混合 有效性实施试验，以评估综合MCHM的有效性和实施情况， 提供了一个全面的方法，通过建立一个统一的社会和结构性服务提供模式， 在费城两个最大的分娩医院附属的所有产前办公室提供医疗服务。 在这项研究中，我们将确定综合MCHM在减少BIPOC中SMM的有效性 患者（目标1）。患者将随机（n=2300）接受MCHM（基于诊所的产前护理， 与MCHM内的社会服务）或护理标准（基于办公室的产前护理， 社会服务转介），并在整个怀孕期间和产后1年进行随访。以确定 这种综合MCHM影响SMM（子目标1a）的机制，我们将评估许多因素， 可以合理地减轻卫生系统失灵、提供者偏见和不利的社会条件（例如， 改善卫生系统的利用，护理协调）。我们还将描述患者，提供者和组织 与综合妇幼保健管理有关的实施决定因素，并确定障碍和促进因素， 以及确定资源利用和总费用/费用节省 通过与商业和医疗补助支付者合作，与MCHM（子目标2a）相关联。 重要的是， 递送 产时 拟议研究的结果将为支持有效的孕产妇保健提供可操作的证据 这导致了最佳和公平的结果，从而彻底改变了产前， 产后护理也能提供和体验。此外，即使试验是负面的， 减少SMM，仍然有许多其他潜在的好处，以综合MCHM（包括许多 我们正在评估的次要结果），因此，我们将收集有价值的信息， 将该模型应用于临床实践。

Project Summary This randomized controlled trial (SMM) people addresses social and structural inequities to reduce severe maternal morbidity and maternal mortality in the most at-risk patients – those that self-identify as Black, indigenous and of color (BIPOC). Specifically, our intervention will implement and evaluate an integrated, multi-level maternity care home model (MCHM) that incorporates maternity care navigation, benefits navigation, social work, doula and mental health resources all within one care-delivery model. While evaluated these previous studies have single social eterminants (e.g. education and insurance) or single solutions (e.g. care navigator), approaches lack a comprehensive, integrated approach that is responsive to all patient needs. d Our study will test our central hypothesis that a patient-centered MCHM will address the gap in social, structural, and health system factors that contribute to disparities for our most vulnerable BIPOC patients, thereby reducing SMM. Totest the effectiveness of this MCHM and ensure timely uptake of the results, we propose a type 1 hybrid effectiveness-implementation trial to evaluate the effectiveness and implementation of an integrated MCHM that provides a comprehensive approach by partnering a unified model of social and structural service delivery with medical service delivery in all prenatal offices affiliated with the two largest birthing hospitals in Philadelphia. Within this study we will determine the effectiveness of an integrated MCHM in reducing SMM among BIPOC patients (Aim 1). Patients will be randomized (n=2300) to a MCHM (office-based prenatal care that is integrated with social services within the MCHM) or standard of care (office-based prenatal care with individually outsourced social services referrals) and followed throughout pregnancy and for 1 year postpartum. To determine mechanisms by which this integrated MCHM impacts SMM (Sub-Aim 1a), we will evaluate numerous factors that could plausibly mitigate the effects of health system failures, provider bias and adverse social conditions (e.g. improved health system access, care coordination). We will also characterize patient, provider and organizational implementation determinants relevant to an integrated MCHM and identify barriers and facilitators to implementation and sustainability (Aim 2) as well as determine resource utilization and total cost/cost savings associated with the MCHM (Sub-Aim 2a) by partnering with commercial and Medicaid payers. Importantly, delivery intrapartum the results of the proposed study will provide actionable evidence to support effective maternity care that results in optimal and equitable outcomes, thereby revolutionizing the way in which prenatal, and postpartum care is delivered and experienced. Additionally, even if the trial is negative in reducing SMM, there are still numerous other potential benefits to an integrated MCHM (including many of the secondary outcomes we are evaluating) and we will have therefore collected valuable information to inform the implementation of this model into clinical practice.