ARTERY Outcomes: tAilored dRug Titration through artificial intElligence: an inteRventional studY

动脉结果：通过人工智能定制药物滴定：一项干预性研究

• 批准号: 10001603
• 负责人: Gabriela Voskerician
• 金额: $ 65.48万
• 依托单位: OPTIMA INTEGRATED HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2021-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10001603
• 关键词: Address; Adverse event; Age; Algorithms; Artificial Intelligence; Blood Pressure; Caring; Clinical; Clinical Trials; Confidential Information; Data; Data Analyses; Diagnosis; Effectiveness; Electronic Health Record; Emergency department visit; Ensure; Epidemic; Ethnic Origin; Gender; Generations; Goals; Health; Heart failure; Hospital Costs; Hospitalization; Hybrids; Hypersensitivity; Hypertension; Information Systems; Intervention Studies; Learning; Life Style; Maintenance; Measures; Medical center; Mind; Modeling; Modification; Myocardial Infarction; Nature; Outcome; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Physicians; Positioning Attribute; Procedures; Process; Randomized; Randomized Clinical Trials; Recommendation; Reporting; Safety; San Francisco; Secure; Service delivery model; Stroke; System; Time; Titrations; Treatment Efficacy; adverse event risk; arm; base; blood pressure reduction; blood pressure regulation; cardiovascular risk factor; care coordination; commercial application; comorbidity; cost; data acquisition; data warehouse; follow-up; health care delivery; hypertension control; hypertension treatment; improved; innovation; interoperability; medication compliance; primary endpoint; primary outcome; randomized trial; response; secondary outcome; side effect; standard of care; stroke incidence; treatment arm; treatment choice; treatment optimization; web services

Need: Nearly half (34 million) of all hypertension (HTN) patients have their blood pressure (BP) uncontrolled. Despite medication and life-style management, the cost of HTN-associated hospitalizations is $113 billion, or 15% of all hospital costs. HTN is the leading cause for stroke, heart failure (HF) and myocardial infarction (MI) hospitalizations. Clinical trials have shown that active pharmacological treatment management of HTN to BP goal reduces the incidence of stroke by 35-40%, MI by 15-25%, and HF by up to 64%. Solution: In response to the national “epidemic” of uncontrolled HTN, Optima Integrated Health has developed optima4BP. optima4BP is an artificial intelligence (AI) that transforms the episodic and reactive nature of uncontrolled BP pharmacological treatment management into a process that is continuous, proactive, and personalized. The innovation was developed with the physician in mind by simulating the in-office clinical reasoning treatment decision process. optima4BP is a physician decision support aid that safely and when needed optimizes the pharmacological treatment for HTN. optima4BP is interoperable in real-time with the EpicÒ Electronic Health Record (EHR), constantly evaluating the efficacy of patients’ current treatment and the requirement for optimization. When a treatment optimization is needed, optima4BP communicates directly with the treating physician by providing a recommendation in the EHR In-Basket that can be accepted or declined. Goal of Direct to Phase II: ARTERY Outcomes [tailored drug titration through artificial intelligence: an interventional study] is a 12 months follow-up, randomized clinical trial (n=300) that: Evaluates optima4BP’s safety and efficacy in improving HTN control [Aim 1], and Ensures Data Systems Maintenance [Aim 2]. Aim 1. Evaluate optima4BP’s safety and efficacy in improving HTN control. We propose to conduct a randomized clinical trial (ARTERY Outcomes) at UC San Francisco Medical Center (UCSF MC). We will investigate the safety and efficacy of optima4BP in improving BP control compared to standard of care (SoC). The primary end-point will examine the reduction in systolic BP (SBP) between in-office start and end of study. Milestone: optima4BP reduces SBP by >6 mmHg than SoC. The safety of using optima4BP will be investigated as a secondary outcome in the context of reported adverse events (AEs). Aim 2. Ensure data systems maintenance (DSM). DSM is a critical activity that includes optimization, error correction, deletion of discarded features and enhancement of existing features. UCSF MC and Optima IT teams will address (1) Data Acquisition upgrades and patches of any system/component within the data flow; and (2) Surveillance management that addresses systems errors, and performs audits/upgrades on the data repository [data warehouse]. Milestone: Ensure the validity of the collected-processed-analyzed data. Commercial Application: With a growing need for value-based care, optima4BP is strongly positioned to support this specific care coordination model.

需求：所有高血压（HTN）患者的近一半（3400万）患有血压（BP） 不受控制。尽管有药物和生活方式管理，但与HTN相关的住院费用是 1,130亿美元，或所有医院费用的15％。 HTN是中风，心力衰竭（HF）和心肌的主要原因 梗塞（MI）住院。临床试验表明，主动药物治疗管理 HTN到BP目标的中风事件减少了35-40％，MI降低了15-25％，HF降低了64％。 解决方案：响应不受控制的HTN国家“流行病”，Optima Integrated Health具有 开发了Optima4bp。 Optima4bp是一种人工智能（AI），可以改变情节性和反应性 不受控制的BP药物治疗管理的性质是连续，积极主动的过程 和个性化。通过模拟办公室内临床，创新了创新的脑海。 推理治疗决策过程。 Optima4bp是安全的，是安全的，何时安全的 需要优化HTN的药物治疗。 Optima4bp与 Epicò电子健康记录（EHR），不断评估患者当前治疗的效率和 优化的要求。当需要优化治疗时，Optima4bp直接与 治疗医师通过在EHR内篮子内提供可以接受或拒绝的建议。 直接进入第二阶段的目标：动脉结果[通过人工智能量身定制的药物滴定： 介入研究]是一项12个月的随访，随机临床试验（n = 300）：评估Optima4bp的 改善HTN控制的安全性和效率[AIM 1]，并确保数据系统维护[AIM 2]。 AIM 1。评估Optima4BP在改善HTN控制方面的安全性和效率。我们建议进行 加州大学旧金山分校医疗中心（UCSF MC）的随机临床试验（动脉结果）。我们将 与标准护理标准（SOC）相比，研究Optima4bp在改善BP控制方面的安全性和效率。 主要终点将检查办公室内和结束之间的收缩BP（SBP）的减少 学习。里程碑：Optima4bp比SOC降低了SBP> 6 mmHg。使用Optima4bp的安全性 在报告的不良事件（AES）的背景下，可以作为次要结果进行调查。 目标2。确保数据系统维护（DSM）。 DSM是一个关键活动，包括优化， 误差校正，删除废弃功能以及对现有功能的增强。 UCSF MC和Optima IT团队将解决（1）数据采集升级和数据中任何系统/组件的补丁 流动; （2）解决系统错误的监视管理，并在该系统上执行审核/升级 数据存储库[数据仓库]。里程碑：确保收集到的分析数据的有效性。 商业应用：随着对价值护理的需求越来越大，Optima4bp的位置很强 支持此特定的护理协调模型。