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.

美国孕产妇和婴儿结局方面持续存在且日益恶化的种族和民族差异刻不容缓公共健康问题非裔美国 (AA) 女性的早产风险约为两倍。与非西班牙裔白人女性相比，其出生体重较轻，并且更有可能患有以下并发症随着这些差异的加剧，人们重新开始关注怀孕和严重的孕产妇发病率。围产期护理围产期（即出生前和出生后的几周）对女性的健康具有重要影响。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 女性的需求，特别是考虑到社会决定因素健康 (SDH) 和美国妇产科学院提出的“第四个月”产后时期和妇科医生 (ACOG) 已证明患者导航 (PN) 在提高护理一致性方面有效。然而，传统的 PN 模式在经济上难以规模化。并维持，表明需要进行 PN 范式转变 — — 最大限度地减少面对面的需求导航者并更加注重诊所和系统级护理改进，将当地和以我们十年来在 PN 妇女健康和护理方面的工作为基础，提供解决 SDH 问题的联邦计划支持。协调清单，我们建议开发一种以 PN 为中心的学习型医疗保健提供方法 OPTIMIZE 综合且全面的围产期护理清单与 ACOG 高度一致。通过混合 1 类集群认可用于加强护理和团队合作流程的清单。随机有效性实施试验，我们将比较 OPTIMIZE 干预措施的有效性相对于标准护理，改善患者接受综合和全面的围产期护理（产前内容、产后内容和 SDH 内容）根据女性的个人需求量身定制，同时评估干预实施将从 20 名中招募 600 名怀孕第一或第二个月的 AA 妇女。隶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性诊所将按 1:1 的比例随机分配至标准护理（对照）或标准护理加 OPTIMIZE。从初次产前检查到产后 12 周的 PN 支持（干预）清单。优化清单将通过促进协调和整合工作来扩大导航者的影响范围涵盖围产期护理领域，并将 SDH 方向纳入围产期护理。每个诊所内的工作流程将包含每位患者的产前、产后和 SDH 内容。结果是患者接受医疗记录收集的这 3 个内容领域的围产期护理内容次要结果包括抑郁症状、母乳喂养、疫苗（Tdap、流感、HPV）和实施研究综合框架将指导我们的混合方法。评估实施干预并确定实施促进因素和障碍的方法。