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

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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.