Randomized controlled trial of a novel digital health solution to enable remote fetal monitoring in high risk pregnancies

项目摘要 怀有高危妊娠的妇女需要经常进行面对面的胎儿监测，以减少 他们的死产风险。然而，突发公共卫生事件，如新冠肺炎大流行，导致 获得护理的机会和感染风险的增加，对这些妇女产生了截然不同的影响。这些 对于得不到充分服务和处境不利的妇女来说，次要影响甚至更具挑战性，对她们来说 事实证明，多次访问的经济和后勤障碍可能是不可逾越的。例如，黑人女性面对 死产风险增加以及新冠肺炎并发症的风险增加，同时面临更显著的 护理方面的障碍，如交通费、育儿和就业缺乏灵活性。远程医疗解决方案拥有 事实证明，在减少种族差异的同时，改善了获得产前护理的机会。不幸的是，没有数字 已经成功地实施了一项解决方案，以便能够对高危妊娠进行远程胎儿监测。 在过去的3年里，我们对一款名为Invu的小说、设备和数字平台进行了验证试验， 它使用生物电位和声学传感器通过可穿戴设备被动检测母婴心率， 自助式腰带。该平台最近刚刚被FDA批准用于检测胎儿心率 一次虚拟的产前探视。然而，我们最近验证了一种新的检测子宫的算法 宫缩使用INVU，使用母体信号的幅度调制。子宫活动的增加 监控为Invu提供远程执行非压力测试(NST)的所有组件，其中之一 最常见的胎儿监护测试用于降低死产风险。然而，以前的设备未能实现 实现广泛的普及。因此，采取深思熟虑的、战略性的和多方面的方法至关重要 实施NST远程监测解决方案，以最大限度地扩大其广泛传播。 我们聚集了一支多学科的调查团队，他们在行为和社区方面经验丰富 干预措施、健康差距、创新方法、孕产妇胎儿医学、临床试验设计和 实施科学。我们将从患者、提供者和临床团队收集强有力的利益相关者反馈 成员，并利用有价值的观点来通知使用快速循环的工作流优化过程 创新技术。这将使我们能够先发制人地识别和解决潜在的障碍 实施。然后我们将进行一项严格的混合随机对照试验，首先将重点放在 演示远程NST计划在提高患者依从性方面的有效性，并特别注意 以确保黑人妇女面临的障碍得到解决。同时，我们将使用混合的 方法策略，通过验证性调查和结构化访谈，研究流行的关键因素 实施和部署。在美国，每年有100万名高危孕妇分娩，这是一个有效的 远程NST监测可以对美国的高危产科保健提供产生深远的积极影响。

Project Summary Women carrying high risk pregnancies require frequent, in-person fetal monitoring appointments to reduce their risk of stillbirth. However, public health emergencies, such as the COVID-19 pandemic, lead to reduced access to care access and elevated risk of infectious exposures, that disparately impact these women. These secondary effects are even more challenging for underserved and disadvantaged women, for whom the economic and logistic barriers to multiple visits can prove insurmountable. For example, Black women face increased risk of stillbirth as well as of COVID-19 complications, while simultaneously facing more significant barriers to care such as transportation costs, childcare and employment inflexibility. Telehealth solutions have been shown to improve access to prenatal care while reducing racial disparities. Unfortunately, no digital solution has been successfully implemented to enable remote fetal monitoring for high risk pregnancies. Over the past 3 years, we have conducted validation trials of a novel, device and digital platform, called Invu, which uses bio-potential and acoustic sensors to passively detect maternal and fetal heart rate via a wearable, self-administered belt. This platform was just recently approved by the FDA for detecting fetal heart rate as part of a virtual prenatal care visit. However, we recently validated a novel algorithm for detecting uterine contractions using Invu, using the amplitude modulation of maternal signals. The addition of uterine activity monitoring provides Invu with all of the components to remotely conduct a non-stress test (NST), one of the most common fetal surveillance tests used to reduce the risk of stillbirth. However, prior devices have failed to achieve widespread uptake. Thus, it is critical to deploy a deliberate, strategic and multi-faceted approach to implementing a remote NST monitoring solution to maximize its widespread dissemination. We have gathered a multi-disciplinary team of investigators experienced in behavioral and communal interventions, health disparities, innovation methodologies, maternal fetal medicine, clinical trial design and implementation science. We will gather robust stakeholder feedback from patients, providers and clinical team members and utilize the valuable perspective to inform a workflow optimization process using rapid-cycle innovation techniques. This will allow us to preemptively identify and address potential barriers to implementation. We will then conduct a rigorous hybrid, randomized controlled trial that will first focus on demonstrating the effectiveness of a remote NST program to improve patient adherence, with specific attention to ensure that barriers faced by Black women are being addressed. At the same time, we will use a mixed methods strategy, via validated surveys and structured interviews, to study the key factors to widespread implementation and deployment. With 1 million high risk pregnancies delivering annually in the US, an effective remote NST monitoring can have profound positive impact on high risk obstetric health care delivery in the US.