Tailored Drug Titration Using Artificial Intelligence

Optima Integrated Health

Status: Completed

Conditions: Hypertension

Treatments: Other: optima4BP

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04223934

O4BP-001

Details and patient eligibility

About

The purpose of the ARTERY Outcomes study is to compare optima-for-blood pressure (optima4BP), a clinical decision support system for hypertension (HTN) treatment optimization to standard of care in patients with essential HTN.

Full description

Nearly 34 million Americans have their blood pressure (BP) uncontrolled. Hypertension (HTN) claims 1000 deaths every day. Despite medication and life-style management, the cost of HTN associated hospitalizations had escalated to $113 billion in 2016, or 15% of all hospital costs, with >135 million Emergency Department (ED) visits.

Uncontrolled HTN for even a few weeks is associated with increased risk for acute cardiovascular (CVD) events [stroke, heart failure (HF), myocardial infarction (MI)] and death. Medication treatment optimization to BP goal reduces the incidence of stroke by 35-40%, HF by up to 64%, and MI by 15-25%.

optima-for-blood pressure [optima4BP] transforms the episodic and reactive nature of uncontrolled HTN pharmacological treatment management into a process that is continuous, proactive, and personalized. The innovation simulates the established clinical reasoning treatment decision process undertaken during a patient's visit.

Enrollment: 164 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Two or more blood pressure (BP) readings of ≥ 140/90 mmHg during UCSF primary care or cardiology office visits within the last 12 months
• Therapy with medications from at least 1 anti-HTN pharmacological agents at the time of the last office visit
• At least minimally "tech-savvy" defined as Ownership of a compatible smartphone and Ability to access the internet
• Active Electronic Health Record MyChart account

Exclusion criteria

• Home anti-HTN medication therapy doesn't match the electronic health record medication list
• Anti-HTN medication therapy changed within 30 days prior to enrollment
• Inability to operate a BP cuff
• Incompatible smartphone device (Galaxy S5 Android 5.0)
• Less than minimally "tech-savvy" defined as Inability to use the Internet
• Non-compliance with medical follow-up (>3 "no shows" in the previous 12 months)
• Planned coronary revascularization in the next 12 months
• Myocardial infarction, coronary revascularization, stroke, cardiac or aortic surgery in the previous 90 days
• GFR < 30 (CKD stage IV/ V)
• Treating physician rules out the patient due to superseding health management concerns
• Treating physician rules out the patient due to other concerns

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 2 patient groups

optima4BP

Experimental group

Description:

Treating physicians receive periodic (every 5-8 weeks) medication treatment recommendations intended to optimize the current patient treatment. The recommendations are generated based on periodic remote data collected from the patient and from the Electronic Health Record. The analysis of the data allows assessment of the patient's response to current treatment and need for a treatment optimization. If a treatment optimization is needed, one is generated and sent to the treating physician for consideration.

Treatment:

Other: optima4BP

Standard of Care (SOC)

No Intervention group

Description:

The treating physician follows usual care practices.