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）患者的血压（BP）近一半（3400万） 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，占医院费用的15％。 梗塞（MI）住院治疗。 HTN至BP目标的速度可将中风的刺激降低35-40％，MI和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 开发的Optima4bp。 不受控制的BP药理治疗管理的性质，该过程是连续，主动的， Ando个性化。 推理治疗决策过程。 需要优化HTN的药理学处理。 Epicò电子健康记录（EHR），评估患者当前信任和您的功效 需要优化的优化要求，Optima4bp直接与 信任医生通过在ehehr内提供或拒绝的basket中提供建议。 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），该试验：iSTOUME4BP 改善HTN控制的安全性和功效[AIM 1]，并确保数据系统维护[AIM 2]。 目标1。评估Optima4bp的安全性和改善HTN控制的功效。 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） 与标准护理（SOC）相比，研究Optima4BP在改善BP控制方面的安全性和功效。 主要的终点将检查系统BP（SBP）的系统的修复，在办公室内开始和 研究。 在报告的副本副本事件（AES）的背景下，被作为次要结果进行调查。 目标2。确保数据系统维护（DSM）。 错误校正，丢弃功能的划分和UCSF MC和Optima的增强。 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 流程和（2）监视管理系统错误，并在 数据存储库[数据仓库]。 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。