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：近一半（3400万）的高血压（HTN）患者的血压（BP） 不受控制尽管有药物治疗和生活方式管理，HTN相关住院治疗的费用仍然很高。 1130亿美元，占所有医院成本的15%。HTN是中风、心力衰竭（HF）和心肌梗塞的主要原因。 梗死（MI）住院治疗。临床试验表明，积极的药物治疗管理 HTN对BP目标的降低使卒中的发生率降低35- 40%，MI降低15- 25%，HF降低高达64%。 解决方案：为了应对全国不受控制的HTN“流行病”，Optima Integrated Health 开发了Optima 4 BP。optima 4 BP是一种人工智能（AI），它可以将情景和反应 将不受控制的BP药物治疗管理的性质转化为一个连续的，主动的， 和个性化。该创新是通过模拟诊所内的临床 推理处理决策过程。optima 4 BP是一个医生决策支持辅助工具， 需要优化HTN的药理学治疗。optima 4 BP可与 Epicardium电子健康记录（EHR），不断评估患者当前治疗的疗效， 优化的要求。当需要治疗优化时，optima 4 BP直接与 通过在EHR In-Basket中提供可以接受或拒绝的建议，治疗医生。 直接进入第二阶段的目标：动脉结局[通过人工智能定制药物滴定：一个 干预性研究]是一项为期12个月的随访、随机临床试验（n=300），评价optima 4 BP 改善HTN控制的安全性和有效性[目标1]，以及确保数据系统维护[目标2]。 目标1.评估optima 4 BP在改善HTN控制方面的安全性和有效性。我们建议进行一项 在加州大学旧金山弗朗西斯科医学中心（UCSF MC）进行的随机临床试验（动脉结局）。我们将 研究与标准治疗（SoC）相比，optima 4 BP在改善BP控制方面的安全性和有效性。 主要终点将检查诊室开始和结束之间收缩压（SBP）的降低。 study.里程碑：Optima 4 BP比SoC降低SBP>6 mmHg。使用Optima 4 BP的安全性将 在报告的不良事件（AE）背景下作为次要结局进行研究。 目标二。确保数据系统维护（DSM）。DSM是一项关键活动，包括优化， 纠错、删除丢弃的特征和增强现有特征。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 流程;以及（2）监督管理，解决系统错误，并对 资料储存库〔资料仓库〕。里程碑：确保收集-处理-分析数据的有效性。 商业应用：随着对基于价值的护理需求的不断增长，optima 4 BP处于有利地位， 支持这一具体的护理协调模式。