Tailored Drug Titration Using Artificial Intelligence

NCT ID: NCT04223934

Last Updated: 2023-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-18
• Study Completion Date: 2023-06-27

Brief Summary

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.

Detailed 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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

optima4BP

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.

Group Type: EXPERIMENTAL

optima4BP

Intervention Type: OTHER

optima4BP establishes a "no gaps" computational framework in determining the most effective treatment change that can optimize a patient's HTN management towards BP Target. All possible drug combination options available through the 16 anti-HTN drug classes and subclasses are quantitatively evaluated in the context of 5 actions: add a drug, remove a drug, replace a drug, increase a drug dose, and decrease a drug dose. The pharmacological intervention efficacy ranking is computed and the highest ranked treatment recommendation is selected for consideration by the treating physician.

Standard of Care (SOC)

The treating physician follows usual care practices.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

optima4BP

optima4BP establishes a "no gaps" computational framework in determining the most effective treatment change that can optimize a patient's HTN management towards BP Target. All possible drug combination options available through the 16 anti-HTN drug classes and subclasses are quantitatively evaluated in the context of 5 actions: add a drug, remove a drug, replace a drug, increase a drug dose, and decrease a drug dose. The pharmacological intervention efficacy ranking is computed and the highest ranked treatment recommendation is selected for consideration by the treating physician.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: collaborator

Optima Integrated Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriela Voskerician, PhD

Role: STUDY_DIRECTOR

Optima Integrated Health

Liviu Klein, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

O4BP-001

Identifier Type: -

Identifier Source: org_study_id