The OPTIMIZE Study: Optimizing Patient Navigation for Perinatal Care

OPTIMIZE 研究：优化围产期护理患者导航

基本信息

批准号：
10132748
负责人：
MELISSA A. SIMON
金额：
$ 57.8万
依托单位：
NORTHWESTERN UNIVERSITY AT CHICAGO
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-07 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10132748
关键词：
Address Adherence African American Age-Years American College of Obstetricians and Gynecologists Anxiety Area Attention Bandage Birth Breast Feeding Caring Chicago Child Clinic Communities Consolidated Framework for Implementation Research Contraceptive methods Data Depression screen Economics Effectiveness Effectiveness of Interventions Enrollment Evaluation First Pregnancy Trimester Focus Groups Frequencies Guidelines Health Personnel Healthcare Systems Human Papilloma Virus Vaccine Human Papillomavirus Hybrids Individual Infant Influenza Intervention Interview Learning Low Birth Weight Infant Low income Medical Records Methods Modeling Neighborhood Health Center Not Hispanic or Latino Patient-Focused Outcomes Patients Perinatal Perinatal Care Persons Postpartum Depression Postpartum Period Pregnancy Complications Pregnancy Trimesters Premature Birth Prenatal care Process Prospective Studies Provider Public Health Randomized Resources Risk Scanning Second Pregnancy Trimester Services Site Surveys System Testing Vaccines Woman Women&apos s Health Work arm care coordination compare effectiveness depressive symptoms effectiveness evaluation effectiveness-implementation randomized trial experience fourth trimester group intervention health care delivery health disparity implementation barriers implementation facilitators implementation intervention improved infant outcome informant maternal outcome multilevel analysis perinatal health perinatal outcomes perinatal period postpartum care postpartum contraception pragmatic trial prenatal primary outcome programs racial and ethnic disparities randomized trial recruit secondary outcome severe maternal morbidity social social health determinants standard care treatment arm uptake vaccine acceptance

项目摘要

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.

在美国的母亲和婴儿成果中的种族和种族差异一直是紧迫的公共卫生问题。非裔美国人（AA）妇女的早产风险大约是两倍与非西班牙裔白人妇女相比，生日重量怀孕和严重的母亲发病率。由于这些差异未知，因此已重新关注围产期护理。围产期是在出生前后的几周健康和她的孩子。不幸的是，现行的围产期标准护理模型一直停滞数十年，没有满足AA妇女的需求，尤其是考虑到社会决定因素健康（SDH）和美国产科学院提出的“四个月的第四个孕期” 和妇科医生（ACOG）。患者导航（PN）已证明在改善护理一致性方面已表现出效率并在AA妇女中解决SDH。但是，传统的PN模型在经济上挑战扩展并维持，这表明需要进行PN范式转变 - 一种可以最大程度地减少对面对面的需求导航员和对诊所和系统级护理改进的关注更加关注，以整合本地和联邦计划支持SDH。在我们在PN工作十年的妇女健康和护理工作的基础上建立协调清单，我们建议为围绕的PN开发学习医疗保健提供方法优化综合而全面的围产期护理清单。优化与ACOG高度排列认可清单以增强护理和团队合作的过程。通过混合型1群随机有效性实施试验，我们将比较优化干预的有效性相对于标准护理改善患者的综合围产期护理（产前）量身定制的内容，产后内容和SDH内容）在评估时量干预实施。 n = 600名AA妇女在怀孕的第一或第二个三个月将从20开始招募诊所附属两个社区健康中心网络，可为AA提供大部分围产期护理芝加哥的妇女。诊所将被随机分配给标准护理（控制）或标准护理以及优化从初次访问开始，从12周产后开始，带有PN支持（干预）的清单。优化清单将通过支持协调和努力整合来扩展导航员的范围跨围产期护理领域，并将SDH方向整合到围产期护理。量身定制的清单每个诊所内的工作流程将为每个患者包含产前，产后和SDH含量。主要结果是患者在这三个由病历收集的内容领域中收到围产期护理组件审查。次要结局包括抑郁症状，母乳喂养，疫苗（TDAP，Imparcea，HPV）和避孕的吸收。实施研究的合并框架将指导我们的混合方法评估干预实施并确定实施促进者和障碍的方法。