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.

项目概要美国 (US) 妊娠相关死亡率 (PRM) 在过去二十年中增加了一倍多，疫情后增长了 1.5 倍，社会经济、种族和民族方面也存在显着差异。据估计，美国 80% 的 PRM 是可以预防的，但比率仍然很高，而且差异仍然很大。美国大约一半的 PRM 发生在出院后的产后 (PP) 在此期间，心脏代谢发生变化。精神健康状况是大多数死亡的促成因素，此类数据尤其令人震惊。考虑到只有 60% 的患者在 PP 年期间接受医疗保健，并且很少有患者接受遵守基于证据的指南，特别是在怀孕后受到心脏代谢或精神疾病的影响考虑到患者不断报告“在您之后”，这也许并不奇怪。有了孩子，一切都与孩子有关，你没有时间陪伴自己。” 社会经济地位 (SES) 较低的母亲从产科到 PP 初级保健的交接具有挑战性。来自少数群体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。与俄亥俄州医疗补助部门合作，我们设计了一种新颖的二元母婴 PP 初级针对医疗补助保险的少数族裔患者摆脱高危妊娠的护理计划 – 多模式母婴围产期门诊分娩系统 (MOMI PODS) 是一种护理服务。该模式的关键组成部分，在整个 PP 年中对母亲和婴儿进行协同护理，以及除此之外，MOMI PODS 的战略设计还旨在 1) 促进产科与 PP 初级护理的协调。过渡，2) 促进根据产科病史进行定制、循证护理，以及 3) 整合临床和支持性护理，以同时满足临床心理和社会需求。我们现已建立 7 个项目。 MOMI PODS 站点并向超过 150 个二人组交付了 MOMI PODS 我们令人信服的初步数据表明： MOMI PODS 是可行且可接受的，95% 的患者参加了系统性整合的就诊在 MOMI PODS 混合 1 型随机对照试验 (RCT) 中，我们将评估 MOMI PODS 在减轻 PP 心脏代谢和心理健康风险方面的有效性，确定将 MOMI PODS 与 PP 健康联系起来的生物心理社会机制，确定 MOMI PODS 是否减少差异 PP 护理服务，并确定改进实施的策略。我们的中心假设是 MOMI。 PODS 将通过改善生物心理社会状况和降低 PP 风险并减少 PP 风险的差异促进获得基于证据的临床和支持性护理因此，MOMI PODS RCT 代表了一项这是建立公平、可扩展的 PP 临床和支持性护理综合模型的关键一步， MOMI PODS 能够降低 PRM 风险并解决 PRM 差异，具有巨大的潜力。作为适合在不同医疗保健环境中扩大和复制的基本护理模型。