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

新型数字健康解决方案的随机对照试验，可在高风险妊娠中实现远程胎儿监测

基本信息

批准号：
10242470
负责人：
Nadav Schwartz
金额：
$ 76.13万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-20 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10242470
关键词：
Acoustics Address Adherence Algorithms Appointment Attention Attitude Behavioral COVID-19 COVID-19 pandemic Caring Clinic Clinical Clinical Trials Clinical Trials Design Clinical effectiveness Conduct Clinical Trials Consolidated Framework for Implementation Research Data Devices Disadvantaged Discipline of obstetrics Economics Effectiveness Emergency Situation Emergency department visit Employment Ensure FDA approved Face Feedback Fetal Heart Rate Fetal Monitoring Future Health Health Services Accessibility Healthcare High Risk Woman High-Risk Pregnancy Home Hospitals Hybrids Improve Access Infection Influenza Intervention Interview Lead Literature Logistics Maternal-fetal medicine Mediating Medical Methodology Methods Middle East Respiratory Syndrome Monitor Outcome Patient Recruitments Patients Pennsylvania Perception Persons Pilot Projects Population Pregnancy Pregnant Women Prenatal care Preparation Provider Randomized Controlled Trials Research Research Personnel Risk Self Administration Severe Acute Respiratory Syndrome Signal Transduction Social Workers Structure Surveys Techniques Testing Third Pregnancy Trimester Time Transportation Travel United States University Hospitals Uterine Contraction Uterus Validation Visit Woman Work ZIKA adverse outcome antenatal arm barrier to care base black women clinical implementation clinical research site commune compliance behavior cost cost effectiveness design digital digital health effectiveness evaluation effectiveness implementation study efficacy testing evidence base experience fetal flexibility health care delivery health disparity high risk implementation outcomes implementation science improved information gathering innovation instrument interest member monitoring device multidisciplinary novel pandemic disease process optimization programs public health emergency racial disparity remote monitoring sensor stillbirth telehealth uptake virtual wearable device

项目摘要

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.

项目概要怀有高风险妊娠的女性需要经常进行面对面的胎儿监测，以减少妊娠风险。他们死产的风险。然而，突发公共卫生事件，例如 COVID-19 大流行，导致获得护理的机会和接触传染病的风险增加，这对这些妇女产生了不同的影响。这些对于服务不足和处境不利的妇女来说，次要影响甚至更具挑战性，对她们来说多次访问的经济和后勤障碍可能是无法克服的。例如，黑人女性面临死产和 COVID-19 并发症的风险增加，同时面临更严重的风险护理障碍，例如交通费用、儿童保育和就业缺乏灵活性。远程医疗解决方案有已被证明可以改善获得产前护理的机会，同时减少种族差异。可惜没有数字该解决方案已成功实施，可对高风险妊娠进行远程胎儿监测。在过去的三年里，我们对一个名为 Invu 的小说、设备和数字平台进行了验证试验，它使用生物电势和声学传感器通过可穿戴设备被动检测母体和胎儿心率自管理腰带。该平台最近刚刚获得 FDA 批准，用于检测胎儿心率虚拟产前护理访问。然而，我们最近验证了一种用于检测子宫的新算法使用 Invu 进行宫缩，利用母体信号的幅度调制。增加子宫活动监控为 Invu 提供了远程执行非压力测试 (NST) 的所有组件，这是远程测试之一最常见的胎儿监测测试用于降低死产风险。然而，先前的设备未能实现广泛采用。因此，采取深思熟虑的、战略性的和多方面的方法来解决问题至关重要。实施远程 NST 监测解决方案，以最大限度地扩大其广泛传播。我们聚集了一个多学科的研究团队，在行为和社区方面经验丰富干预措施、健康差异、创新方法、母胎医学、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利益相关者的强有力反馈成员并利用宝贵的观点来利用快速周期为工作流程优化过程提供信息创新技术。这将使我们能够先发制人地识别并解决潜在的障碍执行。然后，我们将进行严格的混合随机对照试验，首先关注展示远程 NST 计划在提高患者依从性方面的有效性，并给予特别关注确保黑人妇女面临的障碍得到解决。同时，我们将使用混合方法策略，通过经过验证的调查和结构化访谈，研究广泛传播的关键因素实施和部署。美国每年有 100 万例高风险妊娠分娩，因此有效的远程 NST 监测可以对美国的高风险产科医疗保健服务产生深远的积极影响。