Evaluating a multi-modal maternal infant perinatal outpatient delivery system: A randomized controlled trial (MOMI PODS RCT)

评估多模式母婴围产期门诊分娩系统：一项随机对照试验 (MOMI PODS RCT)

• 批准号: 10834413
• 负责人: Seuli Moushumi Bose Brill
• 金额: $ 78.7万
• 依托单位: OHIO STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-22 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10834413
• 关键词: Address; Affect; Birth; COVID-19 pandemic; Caring; Cessation of life; Clinical; Collaborations; Country; Data; Developed Countries; Discipline of obstetrics; Discrimination; Disparity; Emergency Situation; Endocrine; Equity; Exhibits; Expectancy; Family; Goals; Healthcare; Heart; High-Risk Pregnancy; Hospitals; Hybrids; Immune; Individual; Infant; Infant Care; Life; Link; Maternal Health; Maternal Health Services; Medicaid; Mental Health; Metabolic; Minority; Modality; Modeling; Mothers; Not Hispanic or Latino; Ohio; Outcome; Outpatients; Patients; Perinatal; Postpartum Period; Precipitating Factors; Pregnancy; Pregnancy Rate; Primary Care; Provider; Psychosocial Stress; Randomized, Controlled Trials; Recording of previous events; Reporting; Risk; Risk Factors; Sampling; Services; Site; Socioeconomic Status; Stress; Supportive care; System; Testing; Time; United States; Visit; Woman; acceptability and feasibility; anxiety symptoms; biopsychosocial; cardiometabolism; care delivery; chronic care model; clinical care; depressive symptoms; design; disparity reduction; effectiveness evaluation; ethnic disparity; ethnic minority; evidence base; evidence based guidelines; health care settings; hospital readmission; improved; individual patient; low socioeconomic status; minority patient; mortality; mortality disparity; mortality risk; multimodality; novel; participant enrollment; post pregnancy; post-pandemic; postpartum care; postpartum health; primary outcome; programs; psychosocial; racial disparity; racial minority; racism; reduce symptoms; scale up; secondary outcome; socioeconomic disparity; treatment as usual; trend

PROJECT SUMMARY United States (US) pregnancy-related mortality (PRM) has more than doubled over the last two decades, with an additional 1.5-fold post-pandemic rise. There are also striking socioeconomic, racial, and ethnic disparities US PRM. It’s estimated that 80% of US PRM is preventable, yet rates remain high and disparities remain wide. Roughly half of US PRM occurs postpartum (PP) after hospital discharge. During this period, cardiometabolic and mental health conditions are precipitating factors in most deaths. Such data is particularly alarming considering that only 60% of patients receive healthcare during the PP year and few patients receive care that is adherent to evidence-based guidelines, particularly after pregnancy affected by a cardiometabolic or mental health condition. This is perhaps not surprising considering that patients consistently report that, “after you have [a] baby, it’s all about the baby and you don’t have time for yourself.” And providers consistently report that the obstetric to PP primary care hand-off is challenging. Mothers with low socioeconomic status (SES) and from minoritized backgrounds are least likely to receive PP care but most likely to exhibit a major risk factor for PRM, which is driven by structural and individual racism and discrimination, including in healthcare. In collaboration with the Ohio Department of Medicaid, we designed a novel dyadic mother-infant PP primary care program targeted toward Medicaid-insured, minoritized patients transitioning out of high-risk pregnancy – the Multi-modal Maternal Infant Perinatal Outpatient Delivery System (MOMI PODS). Dyadic care is a critical component of the model, with mothers and infants cared for in tandem throughout the PP year, and beyond. MOMI PODS was also strategically designed to 1) facilitate a coordinated obstetric to PP primary care transition, 2) promote tailored, evidence-based care informed by the obstetric history, and 3) integrate clinical and supportive care to concurrently address clinical and psychosocial needs. We have now established 7 MOMI PODS sites and delivered MOMI PODS to >150 dyads. Our compelling preliminary data shows that MOMI PODS is feasible and acceptable, with patients attending 95% of visits that systematically incorporate clinical and supportive care. In the MOMI PODS hybrid type 1 randomized controlled trial (RCT), we’ll evaluate the effectiveness of MOMI PODS in mitigating PP cardiometabolic and mental health risk, identify the biopsychosocial mechanisms linking MOMI PODS to PP health, determine if MOMI PODS reduces disparities in PP care delivery, and identify strategies to improve implementation. Our central hypothesis is that MOMI PODS will mitigate PP risk and reduce disparities in PP risk by improving biopsychosocial profiles and facilitating access to evidence-based clinical and supportive care. Thus, the MOMI PODS RCT represents a critical step toward establishing an equitable, scalable model of integrative PP clinical and supportive care that is capable of mitigating PRM risk and addressing PRM disparities. MOMI PODS has significant potential to serve as a foundational model of care appropriate for scale up and replication in diverse healthcare settings.

项目摘要 美国（US）妊娠相关死亡率（PRM）在过去二十年中翻了一番多， 在大流行后又增加了1.5倍。还有显著的社会经济、种族和民族差异 美国PRM。据估计，美国80%的PRM是可以预防的，但比率仍然很高，差距仍然很大。 大约一半的US PRM发生在出院后的产后（PP）。在此期间，心脏代谢 精神健康状况是大多数死亡的诱因。这样的数据尤其令人震惊 考虑到只有60%的患者在PP年期间接受医疗保健， 遵循循证指南，特别是在受心脏代谢或精神疾病影响的妊娠后 健康状况。这也许并不奇怪，因为患者一直报告说，“在你 生孩子，一切都是为了孩子，你没有时间给自己。“供应商一致报告 从产科到PP初级保健的交接是具有挑战性的。社会经济地位低的母亲， 来自少数民族背景的人最不可能接受PP护理，但最有可能表现出以下主要风险因素： PRM是由结构性和个人种族主义和歧视驱动的，包括在医疗保健领域。在 与俄亥俄州医疗补助部合作，我们设计了一种新型的母婴PP初级 针对医疗补助保险的少数民族患者的护理计划，这些患者正在从高风险妊娠中过渡出来， 多模式母婴围产期门诊分娩系统。双元护理是一种 该模式的关键组成部分，在整个PP年期间，母亲和婴儿得到同时照顾， 超越。MOMI PODS的战略设计还包括：1）促进产科与PP初级保健的协调 过渡，2）促进量身定制，循证护理告知产科史，和3）整合临床 和支持性护理，以同时满足临床和心理社会需求。目前，我们已经建立了7 MOMI PODS网站和交付MOMI PODS到>150 dyads。我们令人信服的初步数据显示， MOMI PODS是可行和可接受的，95%的患者参加了系统性纳入的访视 临床和支持性护理。在MOMI PODS混合1型随机对照试验（RCT）中，我们将 评价MOMI PODS在缓解PP心脏代谢和心理健康风险方面的有效性， 将MOMI PODS与PP健康联系起来的生物心理社会机制，确定MOMI PODS是否减少了差异 在PP护理提供方面，并确定改善执行情况的战略。我们的核心假设是， PODS将通过改善生物心理社会特征， 促进获得循证临床和支持性护理。因此，MOMI PODS RCT代表了 建立一个公平的，可扩展的综合PP临床和支持性护理模式的关键一步， 能够减轻PRM风险并解决PRM差异。MOMI PODS具有巨大的潜力， 作为一个基础的护理模式，适合在不同的医疗保健环境中扩大和复制。