TECTONICS (Telemedicine Control Tower for the OR: Navigating Information, Care and Safety) trial

TECTONICS（手术室远程医疗控制塔：导航信息、护理和安全）试验

• 批准号: 10586120
• 负责人: Michael Simon Avidan
• 金额: $ 50.56万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10586120
• 关键词: Address; Adherence; Affect; Air; Algorithms; Anesthesia procedures; Anesthesiology; Anesthetics; Area; Awareness; Behavior; Caring; Certified registered nurse anesthetist; Cessation of life; Clinical; Clinical Trials; Cognitive; Collaborations; Computer software; Consent; Data; Data Science; Decision Making; Delirium; Diagnosis; Effectiveness; Electronic Health Record; Enabling Factors; Engineering; Evidence based practice; Failure; Feedback; Fostering; Foundations; Funding; Funding Agency; Future; Goals; Health; Health Resources; Healthcare; Human; Informatics; Institution; Kidney Failure; Machine Learning; Measures; Motivation; Operating Rooms; Operative Surgical Procedures; Outcome; Patient risk; Patient-Focused Outcomes; Patients; Perioperative; Perioperative Care; Perioperative complication; Postoperative Period; Process; Public Health; Quality of Care; Randomized; Resources; Respiratory Failure; Risk; Risk Assessment; Safety; Science; Series; Signal Transduction; System; Technology; Telemedicine; Testing; Thinking; Time; Training; Translating; United States Agency for Healthcare Research and Quality; Update; adverse outcome; algorithm development; clinical decision support; clinically relevant; cognitive process; computer science; data integration; design; evidence base; experience; health care settings; health information technology; high risk; implementation framework; improved; improved outcome; innovation; machine learning algorithm; machine learning prediction algorithm; modifiable risk; mortality; neural network; novel; patient oriented; postoperative delirium; pragmatic randomized trial; prevent; prototype; randomized trial; remote monitoring; remote patient monitoring; risk prediction; routine care; support tools; surgery outcome; usability; user-friendly; waiver

Abstract Adverse outcomes, including death, respiratory failure and renal failure, are common after surgery, and represent a serious public health challenge. Such adverse outcomes can be mitigated through integrated, collaborative health information technology solutions that provide clinicians cognitive and computational support. The chief motivation for the TECTONICS (Telemedicine Control Tower for the OR: Navigating Information, Care and Safety) trial is that a multi-faceted telemedicine solution has the potential to facilitate the dynamic assessment of risk, diagnose negative patient trajectories, and implement evidence-based practices. The net result for patients would be improved safety and outcomes. Our telemedicine solution, called the Anesthesiology Control Tower (ACT), encompasses real-time patient data integration from the electronic health record, clinician decision support, machine learning algorithms that predict adverse outcomes, and remote monitoring for the operating room (OR). This conceptualization of sophisticated remote monitoring for the OR is somewhat analogous to an air traffic control tower for a busy airport. The innovative TECTONICS trial will build on a series of preliminary studies (funded by the Agency for Healthcare Research and Quality, and the National Science Foundation) that have (i) established the usefulness and usability of a prototype telemedicine ACT; (ii) customized and enhanced decision-support alerts for the ACT, based on clinician user feedback; (iii) designed, developed, and tested machine learning algorithms that predict adverse postoperative outcomes; and (iv) established the feasibility of conducing a real-world randomized trial of the prototype ACT. The TECTONICS trial builds logically on these preliminary studies. Aim 1 is to show that we can implement and sustain an integrated ACT system. As part of this, we will iteratively assess the accuracy of our machine learning algorithms and modify them to improve their ability to predict in real time when patients are at high risk for experiencing negative outcomes. Aim 2 is to understand how the ACT system affects clinicians’ (anesthesiologists and certified registered nurse anesthetists [CRNAs]) thinking, decision-making and behavior. This understanding will help us to enhance the ACT system, improve workflow processes in the ACT and in the OR, and improve collaborative interactions between anesthesiologists and CRNAs. Aim 3 is to conduct a rigorous clinical trial. We will evaluate the impact of the ACT system on the quality of care in the OR, and clinical outcomes such as intraoperative awareness, and postoperative delirium, renal failure, respiratory failure, and 30-day mortality. TECTONICS will be the first practical and scientifically rigorous trial of a telemedicine solution for the operating room, and will inform the usefulness of incorporating such technology in routine care of surgical patients, including under-resourced healthcare settings. With many millions undergoing surgery yearly, this feasible application of technology could signal a major shift in the safety and quality of perioperative care, and translate into substantial societal gain.

抽象的 手术后常见的不良后果包括死亡、呼吸衰竭和肾衰竭 是一个严重的公共卫生挑战。这种不利后果可以通过综合、 为临床医生提供认知和计算能力的协作健康信息技术解决方案 支持。 TECTONICS（手术室远程医疗控制塔：导航）的主要动机 信息、护理和安全）试验表明，多方面的远程医疗解决方案有可能促进 动态评估风险，诊断负面患者轨迹，并实施循证实践。 对于患者来说，最终的结果将是提高安全性和治疗结果。我们的远程医疗解决方案称为 麻醉控制塔 (ACT)，包含来自电子设备的实时患者数据集成 健康记录、临床医生决策支持、预测不良结果的机器学习算法，以及 手术室 (OR) 的远程监控。这种复杂的远程监控的概念 OR 有点类似于繁忙机场的空中交通管制塔。创新的构造 试验将建立在一系列初步研究的基础上（由医疗保健研究和质量局资助， 和国家科学基金会）已经 (i) 确定了原型的有用性和可用性 远程医疗 ACT； (ii) 根据临床医生用户定制和增强的 ACT 决策支持警报 反馈; (iii) 设计、开发和测试预测术后不良反应的机器学习算法 结果； (iv) 确定了对原型 ACT 进行现实世界随机试验的可行性。 TECTONICS 试验逻辑上建立在这些初步研究的基础上。目标 1 是表明我们可以实施 并维持一个综合的 ACT 系统。作为其中的一部分，我们将迭代评估我们机器的准确性 学习算法并对其进行修改，以提高实时预测患者何时处于高风险的能力 经历负面结果。目标 2 是了解 ACT 系统如何影响临床医生 （麻醉师和注册护士麻醉师 [CRNA]）思维、决策和行为。 这种理解将帮助我们增强 ACT 系统，改进 ACT 和 OR，并改善麻醉师和 CRNA 之间的协作互动。目标 3 是开展 严格的临床试验。我们将评估 ACT 系统对手术室护理质量的影响，以及 临床结果，如术中意识、术后谵妄、肾功能衰竭、呼吸系统疾病 失败和 30 天死亡率。 TECTONICS 将是第一个实用且科学严谨的试验 手术室的远程医疗解决方案，并将告知将此类技术纳入其中的有用性 手术患者的常规护理，包括资源不足的医疗机构。数百万人正在经历 每年进行一次手术，这种可行的技术应用可能标志着手术安全和质量的重大转变 围手术期护理，并转化为巨大的社会收益。