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)

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要在过去的二十年中，美国（美国）妊娠有关的死亡率（PRM）增加了一倍以上，大流行后增加1.5倍。也有惊人的社会经济，种族和种族分布美国PRM。据估计，美国PRM中有80％是可以预防的，但差异仍然很高，并且差异仍然很大。住院后，大约一半的PRM发生在产后（PP）。在此期间，心脏代谢心理健康状况是大多数死亡的促成因素。这样的数据特别令人震惊考虑到只有60％的患者在PP年内接受医疗保健，很少有患者接受护理遵守基于证据的指南，特别是在怀孕后受心脏代谢或心理影响后健康状况。考虑到患者始终报告：“在您之后，这可能并不奇怪有[一个]宝贝，这全都与婴儿有关，您没有时间为自己。”提供者始终报告 PP初级保健交接的产科受到挑战。社会经济地位低下的母亲（SES）和从少数背景中，最不可能获得PP护理，但很可能会退出主要风险因素 PRM是由结构性和个人种族主义和歧视驱动的，包括医疗保健。与俄亥俄州医疗补助部的合作，我们设计了一个新颖的二元母亲PP PRIMPR 针对医疗补助保险的，少数化患者过渡的护理计划 - 多模式的孕产妇围产期门诊系统（MOMI PODS）。二元护理是该模型的关键组成部分，在整个PP年中，母亲和婴儿在超过。 MOMI PODS也经过战略性设计，可用于1）促进PP初级保健的协调产科过渡，2）促进量身定制的基于证据的护理，以产科历史告知，3）综合临床以及同时满足临床和社会心理需求的支持性护理。我们现在已经建立了7 Momi Pods站点并将Momi Pods交付到> 150个二元组。我们引人入胜的初步数据表明 Momi Pods是可行的，可接受的，患者参加了95％的系统访问临床和支持的护理。在Momi Pods混合型1型随机对照试验（RCT）中，我们将评估MOMI POD在减轻PP心脏代谢和心理健康风险中的有效性，确定将MOMI POD与PP健康联系起来的生物心理社会机制，确定MOMI POD是否减少了分布在PP护理交付中，并确定改善实施的策略。我们的中心假设是莫米 PODS将通过改善生物心理社会概况和促进获得基于证据的临床和支持护理的机会。那，莫米豆荚RCT代表建立综合PP临床和支持性护理的相等，可扩展模型的关键步骤能够减轻PRM风险并解决PRM分布。 Momi Pods具有很大的潜力作为适合在潜水员医疗环境中扩大和复制的护理的基础模型。