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

• 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
• 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

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.

项目摘要 携带高危妊娠的妇女需要频繁的亲自胎儿监测预约，以减少 死胎的风险。然而，突发公共卫生事件，如COVID-19大流行， 获得护理的机会和感染风险的增加，这对这些妇女产生了严重影响。这些 对得不到充分服务和处境不利的妇女来说， 多次访问的经济和后勤障碍可能无法克服。例如，黑人妇女面临 死产和COVID-19并发症的风险增加，同时面临更严重的 交通费用、儿童保育和就业不灵活等护理障碍。远程医疗解决方案具有 已被证明可以改善产前护理的获得，同时减少种族差异。不幸的是，没有数码 已经成功地实施了一种解决方案，以使得能够对高危妊娠进行远程胎儿监测。 在过去的3年里，我们对一种名为Invu的新型设备和数字平台进行了验证试验， 其使用生物电位和声学传感器通过可穿戴设备被动地检测母亲和胎儿的心率， 自我管理的腰带这个平台最近刚刚被FDA批准用于检测胎儿心率， 虚拟产前检查然而，我们最近验证了一种新的算法，用于检测子宫 收缩使用Invu，使用母体信号的幅度调制。子宫活动的增加 监控为Invu提供了远程进行非压力测试（NST）的所有组件， 最常见的胎儿监测测试用于降低死胎的风险。然而，先前的装置未能 实现广泛吸收。因此，采取深思熟虑、战略性和多方面的方法至关重要， 实施远程NST监测解决方案，以最大限度地扩大其广泛传播。 我们召集了一个多学科的调查小组，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，母婴医学，临床试验设计和 执行科学。我们将从患者、医疗服务提供者和临床团队收集强大的利益相关者反馈 成员，并利用有价值的观点，通知工作流程优化过程，使用快速循环 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， 证明远程NST计划在提高患者依从性方面的有效性， 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，通过有效的调查和结构化访谈，研究关键因素，以广泛 实施和部署。在美国，每年有100万高危妊娠分娩， 远程NST监测可以对美国的高风险产科卫生保健提供产生深远的积极影响。