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 optima4BPs safety and efficacy in improving HTN control [Aim 1], and Ensures Data Systems Maintenance [Aim 2]. Aim 1. Evaluate optima4BPs 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.
Public Health Relevance Statement: Our goal is to simplify the care management of high blood pressure (BP) with the goal of reaching BP control, demonstrated to reduce the incidence of stroke, heart failure, and myocardial infarction. We will investigate the benefits of optima4BP artificial intelligence that transforms the episodic and reactive nature of uncontrolled BP pharmacological treatment management into a process that is continuous, proactive, and personalized.
NIH Spending Category: Aging; Bioengineering; Brain Disorders; Cardiovascular; Cerebrovascular; Clinical Research; Clinical Trials and Supportive Activities; Comparative Effectiveness Research; Data Science; Health Services; Heart Disease; Heart Disease - Coronary Heart Disease; Hypertension; Machine Learning and Artificial Intelligence; Networking and Information Technology R&D (NITRD); Patient Safety; Prevention; Stroke; Women's Health
Project Terms: Address; Adverse event; adverse event risk; Age; Algorithms; arm; Artificial Intelligence; base; Blood Pressure; blood pressure reduction; blood pressure regulation; cardiovascular risk factor; care coordination; Caring; Clinical; Clinical Trials; commercial application; comorbidity; Confidential Information; cost; Data; data acquisition; Data Analyses; data warehouse; Diagnosis; Effectiveness; Electronic Health Record; Emergency department visit; Ensure; Epidemic; Ethnic Origin; follow-up; Gender; Generations; Goals; Health; health care delivery; Heart failure; Hospital Costs; Hospitalization; Hybrids; Hypersensitivity; Hypertension; hypertension control; hypertension treatment; improved; Information Systems; innovation; interoperability; Intervention Studies; Learning; Life Style; Maintenance; Measures; Medical center; medication compliance; Mind; Modeling; Modification; Myocardial Infarction; Nature; Outcome; Patients; Pharmaceutical Preparations; Pharmacological Treatment; Phase; Physicians; Positioning Attribute; primary endpoint; primary outcome; Procedures; Process; Randomized; Randomized Clinical Trials; randomized trial; Recommendation; Reporting; response; Safety; San Francisco; secondary outcome; Secure; Service delivery model; side effect; standard of care; Stroke; stroke incidence; System; Time; Titrations; treatment arm; treatment choice; Treatment Efficacy; treatment optimization; web services
