OPTIMA 4 BP DECISION-MAKING

OPTIMA 4 BP simulates the successive steps of the pharmacological intervention clinical reasoning process while engaging the provider and patient in shared HTN management.

National Heart Lung and Blood Institute, 2017. Award # R44 HL132622-02.

Need: Uncontrolled hypertension (HTN) affects 34 million Americans. The cost of HTN-associated hospitalizations is $113 billion, or 15% of all hospital costs, with >135 million Emergency Department visits. HTN is the leading cause for stroke, heart failure (HF) and myocardial infarction (MI).

Solution: Optima Integrated Health Inc. (Optima) has developed optima4BP, a decision support technology for anti-HTN medication treatment management. optima4BP is designed as a physician decision/action support aid in timely and safely optimizing medication treatment independent of in-office visits, for patients with uncontrolled hypertension (HTN).

Goal of Direct to Phase II: ARTERY [tailored drug titration through artificial intelligence: an interventional study] establishes the operational clinical trial infrastructure required, in a subsequent stage, to deploy a randomized clinical trial intended to evaluate the safety and efficacy of optima4BP in the clinic. ARTERY will: establish in clinic efficacy through pilot studies [Aim 1]; explore options for data interoperability and evaluate user [patient and physician] experience (UX) [Aim 2]; generate and validate the business model [Aim 3]; develop and validate the set-up and infrastructure needed at the clinical trial site, University of California San Francisco Medical Center (UCSF MC), to evaluate clinical safety and efficacy of optima4BP [Aim 4].

Aim 1. Establish in-clinic pilot efficacy: The efficacy validation will be structured into 3 categories, critical to establish optima4BP’s viability as a clinical decision support artificial intelligence: Is the treatment recommendation accurate; Is optima4BP saving physician time and what is the value of it; and How does optima4BP measure to a Veterans Affairs (VA) home-grown algorithms. Aim 2. Explore options for data interoperability and evaluate user [patient and physician] experience (UX). The interoperability between optima4BP and Epic® Electronic Health Record will be investigated with the intention of establishing a first-in-class Fast Healthcare Interoperability Resources (FHIR) Health Level7 (HL7) clinical data exchange. Aim 3. Generate and validate the business model. A business model will be built, in the context of the current healthcare opportunities and challenges. The efficacy validation will answer: Is the business model valid; What is the market entry strategy; and What is the regulatory strategy. Aim 4. Develop and validate the set-up and infrastructure needed at the clinical trial site to evaluate clinical safety and efficacy of optima4BP. ARTERY will deliver on the FHIR HL7 interoperability and integrate the service into the in-clinic care flow at UCSF MC. Then, optima4BP’s service will be launched and validated in a pilot study (n=21 patients).

Commercial Application: With a growing need for value-based care, optima4BP is strongly positioned to support the effort of improving HTN control, leading to reduction in the incidence of stroke, HF, MI or death.

OPTIMA 4 BP ACTION SUPPORT

In between office visits, OPTIMA 4 BP successfully optimizes pharmacological interventions leading to blood pressure Target within 6 months.

National Heart Lung and Blood Institute, 2019. Award # R44 HL149428-01.

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 Epic 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.

OPTIMA 4 HEART GDMT DECISION

OPTIMA 4 HEART provides sustained and safe treatment optimization to life-saving GDMT medications Target within 4 months.

National Heart Lung and Blood Institute, 2019. Award # R43 HL147627-01.

Need: 2,200 Americans die of cardiovascular disease (CVD) each day, while 92.1 million live with some form of CVD and stroke. Heart failure (HF) represent the primary driver of the CVD “epidemic”. The American College of Cardiology (ACC) recommends: (1) PCP/Cardiologist pharmacological interventions that drive effective treatment decisions, and (2) Standardization of Care Flows that implements cross-communication of treatment protocols and outcome measures among providers.

Solution: In response to the ACC guidance (above), Optima Integrated Health aims to create a clinician-trusted software tool (optima4heart) that recommends: (1) a pharmacological intervention and (2) needed changes in team-based transfer of care [primary care provider (PCP)  Cardiologist] for clinicians managing patients with CVD. optima4heart is clinically applicable through a patient-tailored analytic intelligence (AI) augmented by a dashboard user-interface displayed into the electronic health record (EHR). optima4heart directly addresses the current barriers to progress: (1a) manages the evolving complexity of the treatment management guidelines; (1b) unifies and harmonizes segregated patient datasets; (2a) provides an organization-integrated approach to pharmacological interventions; (2b) establishes an inter-division agreement for transfer of care.

optima4heart Aim: Reduce the incidence of HF, stroke, myocardial infarction (MI)] or death.

Goal of Phase I: Build the heart failure with reduced ejection fraction [HFrEF] pharmacological intervention and transfer of care platform. The Specific Aims are: Aim 1. Develop and Validate the Pharmacological Intervention. In particular, the optima4BP basic system architecture will be adapted to include HF pharmacologic efficacy contribution (weight) to the pharmacological intervention total score. Aim 2. Develop and Validate HF Transfer of Care. The Transfer of Care decision document has been completed. It will be integrated within the existing interoperability architecture consisting of: EHR database of patients, Fast Healthcare Interoperability Resources [FHIR] functionality, remote device platform, and patient surveys. Software Tool Validation will be performed using theoretical patient test cases. Clinical adjudication of optima4heart outcomes by a multi-disciplinary clinical team will establish validity of the software tool at all stages of development.

Future Work: Phase II will use the proof of concept of Phase I to validate the solution in a multi-center clinical trial setting.

OPTIMA 4 BP AFRICA

OPTIMA 4 BP AFRICA adapts the efficacy of optima4BP, developed by Optima for use in the US, to the needs of a low-resource setting.

National Heart Lung and Blood Institute, 2020. Award # Pending.

Need: The Global Burden of hypertension (HTN) is approaching 2 Billion people. Africa has the highest prevalence of HTN. 552 million (46%) are hypertensive, while the reported control rate is 7%. The low-resource setting in Africa challenges the deployment of HTN strategies proven successful elsewhere.

Solution: In response to the HTN “epidemic”, Optima Integrated Health (Optima) has been closely working with Yale Institute for Global Health to develop a sustainable and scalable strategy to HTN management in the Sub-Saharan Africa (SSA) region, recognized for its political stability and healthcare trend-setting. At the end of a 2-year road, optima4BP Africa emerged. optima4BP Africa adapts the efficacy of optima4BP, developed by Optima for use in the US, to the needs of a low-resource setting. optima4BP is an analytic intelligence (AI) algorithm. It transforms the episodic and reactive nature of uncontrolled HTN pharmacological treatment management into a process that is continuous, proactive, and personalized.

Goal of Phase I: Sustainable and Scalable strategy to HTN management in the SSA region. Our ongoing effort established a unified HTN treatment guideline amongst SSA partner countries, and developed the anti-HTN country-specific drug availability record. Phase I builds on this effort.

Aim 1. Build the SSA unified HTN guideline into the decision logic. Hypothesis. The unified HTN guideline can be integrated into the optima4BP decision logic. Milestone. Achieve 100% prediction accuracy. Approach. This effort will follow the same validated protocol for integrating the US HTN guidelines into the optima4BP decision logic. Test. An overall organized regression test will assess correct processing by each action. Then, patient test cases will be used to validate treatment recommendation outputs.

Aim 2. Build choice of drug treatment based on availability. Hypothesis. The existing optima4BP decision logic can address drug unavailability. Milestone. Achieve 100% prediction accuracy. Approach. A post-processing module will be built to monitor the content of the treatment recommendation based on country-specific drug availability. It will function by recommending the replacement of an unavailable drug with the next best available choice. Test. An overall organized regression test will validate correct processing. Then, patient test cases will be used to evaluate correct drug treatment replacement choices.

Aim 3. Build the Patient Registry. Hypothesis. A Patient Registry can provide HTN treatment optimization decision support & clinical education. Milestone. Achieve 100% proposed functionality. Achieve >85% overall satisfaction. Approach. A platform that supports secure data upload and HTN treatment decision support will be built. User interaction will be achieved by re-designing existing optima4BP capabilities to the needs of the SSA HTN management clinical model. Test. An overall organized regression test will assess correct processing by each action. User-Centered Metrics will be used to evaluate physician satisfaction.