The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

在美国，孕产妇和婴儿结局的持续和不断恶化的种族和民族差异是紧迫的 公共健康问题。非裔美国人（AA）妇女早产的风险约为两倍， 出生体重与非西班牙裔白色妇女相比， 怀孕和严重的孕产妇发病率。随着这些差距的加剧，人们重新关注 围产期护理围产期，即出生前后的几周，对妇女的健康有重要影响。 她的健康和孩子的健康。不幸的是，流行的围产期标准护理模式一直停滞不前， 几十年来，并没有满足AA妇女的需要，特别是考虑到社会决定因素， 健康（SDH）和美国产科医师学会提出的产后"第四个三个月“ 妇科医生（ACOG）已证明患者导航（PN）在提高护理一致性方面的有效性 并在AA妇女中解决SDH问题。然而，传统的PN模型在经济上难以扩展 并持续下去，这表明需要一个PN范式转变-一个最大限度地减少对亲自的需要 导航员和地方更加注重诊所和系统级护理的改善， 联邦计划支持解决SDH问题。基于我们在PN妇女健康和护理方面十年的工作 协调清单，我们建议制定一个学习卫生保健提供的方法，以PN为中心， 优化综合全面的围产期护理清单。OPTIMIZE与ACOG高度一致 核可加强护理和团队工作进程的清单。通过混合1型群集 随机有效性实施试验，我们将比较OPTIMIZE干预的有效性 与标准护理相比，在改善患者接受综合和全面围产期护理（产前 内容，产后内容，和SDH内容）量身定制的妇女的个人需求，同时评估 干预实施。将从20名女性中招募N=600名处于妊娠早期或中期的AA女性 附属于两个社区卫生中心网络的诊所，为AA提供大部分围产期护理 芝加哥的女人诊所将以1：1的比例随机分配至标准治疗（对照）或标准治疗加OPTIMIZE组 从最初的产前访视到产后12周，使用PN支持（干预）检查表。 OPTIMIZE清单将通过促进协调和整合工作来扩大导航员的范围 在围产期保健领域，并将SDH方向纳入围产期保健。该清单是根据 每个诊所内的工作流程将包含每个患者的产前、产后和SDH内容。主 结果是患者收到医疗记录收集的这3个内容领域的围产期护理内容 审查.次要结局包括抑郁症状、母乳喂养、疫苗（Tdap、流感、HPV）和 采取避孕措施。实施研究的综合框架将指导我们的混合方法 评估干预措施实施情况并确定实施促进因素和障碍的方法。

Persistent and worsening racial and ethnic disparities in maternal and infant outcomes in the US are urgent public health concerns. African American (AA) women have about twice the risk of preterm birth and low birthweight compared with non-Hispanic white women and are more likely to suffer from complications of pregnancy and severe maternal morbidity. As these disparities worsen, there has been renewed focus on perinatal care. The perinatal period, those weeks before and after birth, has important implications for a woman's health and that of her child. Unfortunately, the prevailing perinatal standard care model has been stagnant for decades and is not meeting the needs of AA women, especially with consideration to Social Determinants of Health (SDH) and the `fourth trimester' postpartum period proposed by the American College of Obstetricians and Gynecologists (ACOG). Patient navigation (PN) has demonstrated efficacy in improving consistency of care and addressing SDH among AA women. However, traditional PN models are economically challenging to scale and sustain, suggesting that a PN paradigm shift is needed – one that minimizes the need for in-person navigators and places greater focus on clinic and systems level care improvement that integrates local and federally program support addressing SDH. Building on our decade of work in PN in women's health and care coordination checklists, we propose to develop a learning health care delivery approach to PN centered around an OPTIMIZE integrated and comprehensive perinatal care checklist. OPTIMIZE is highly aligned with ACOG endorsement of checklists for enhancing processes of care and teamwork. Through a Hybrid type 1 cluster randomized effectiveness-implementation trial, we will compare the effectiveness of the OPTIMIZE intervention relative to standard care in improving patient receipt of integrated and comprehensive perinatal care (prenatal content, postpartum content, and SDH content) tailored to a woman's individual needs, while evaluating intervention implementation. N=600 AA women in their 1st or 2nd trimester of pregnancy will be recruited from 20 clinics affiliated with two community health center networks that provide the majority of perinatal care for AA women in Chicago. Clinics will be randomized 1:1 to standard care (control) or standard care plus OPTIMIZE checklist with PN support (intervention) starting from the initial prenatal visit and through 12-weeks postpartum. The OPTIMIZE checklist will scale the reach of navigators by facilitating coordination and integration of efforts across perinatal care domains and integrating a SDH orientation to perinatal care. The checklist, tailored to the workflow within each clinic, will contain prenatal, postpartum, and SDH content for each patient. The primary outcome is patient receipt of perinatal care components in these 3 content areas collected by medical records review. Secondary outcomes include depressive symptoms, breastfeeding, vaccine (Tdap, influenza, HPV) and contraception uptake. The Consolidated Framework for Implementation Research will guide our mixed-methods approach to evaluate intervention implementation and identify implementation facilitators and barriers.