Enhance Trial-Enriched Holistic Care to Eradicate Maternal Morbidity

项目摘要 这项随机对照试验 (SMM) 人民 解决社会和结构性不平等问题，以减少严重的孕产妇发病率 以及高危患者的孕产妇死亡率--那些自认为是黑人、土著和 颜色(BIPOC)。具体地说，我们的干预将实施和评估一个综合的、多层次的 产假护理之家模式(MCHM)，集成了产假护理导航、福利导航、社交 工作、助产士和心理健康资源都在一个护理提供模式中。而当 评估 这些 之前的研究已经 单一的社会决定因素(例如教育和保险)或单一的解决方案(例如护理导航器)， 方法缺乏一种全面、综合的方法来回应所有患者的需求。 D 我们的研究将检验我们的核心假设，即以患者为中心的医疗保健将解决社会、结构、 以及造成我们最脆弱的BIPOC患者差异的卫生系统因素，从而减少 SMM。为了测试这种MCHM的有效性，并确保及时理解结果，我们提出了类型1混合 有效性--实施试验，以评估综合医委会的有效性和实施情况 通过将统一的社会和结构服务交付模式与 在费城两家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，我们将确定综合的MCHM在减少BIPOC之间的SMM方面的有效性 患者(目标1)。患者将被随机(n=2300)到MCHM(基于办公室的综合产前护理) 在母婴健康院内提供社会服务)或标准护理(以办公室为基础，个别外判的产前护理 社会服务转介)，并在整个怀孕期间和产后一年内进行跟踪。要确定 这一综合的医疗卫生管理影响SMM的机制(次级目标1a)，我们将评估许多因素， 可以看似合理地减轻卫生系统故障、提供者偏见和不利社会条件(例如 改善卫生系统的可及性、护理协调)。我们还将确定患者、提供者和组织的特征 与综合卫生与健康管理相关的实施决定因素，并找出障碍和促进者 执行和可持续性(目标2)以及确定资源利用率和总成本/成本节约 通过与商业和医疗补助支付者结成伙伴关系，与医保委员会(次级目标2a)建立联系。 重要的是 送货 产程中 拟议的研究结果将为支持有效的产妇保健提供可行的证据。 这将产生最优和公平的结果，从而彻底改变产前、 产后护理是提供的，也是有经验的。此外，即使试验结果是否定的 减少SMM，集成的MCHM仍有许多其他潜在好处(包括许多 我们正在评估次要结果)，因此我们将收集有价值的信息，以告知 将这一模式应用于临床实践。

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.