Tailored Drug Titration Through Artificial Intelligence (ARTERY)

Tailored Drug Titration Through Artificial Intelligence: an Interventional Study

ARTERY is a randomized clinical trial that investigates the benefit of a predictive modeling artificial intelligence in improving the management of anti-hypertensive medication treatment.

Study Overview

• Status: Withdrawn
• Conditions: Hypertension
• Intervention / Treatment: Other: optima4BP

Detailed Description

The goal of the proposed research is to test a connected medication management platform technology to address medication optimization and non-adherence in chronic disease management. Chronic diseases (such as hypertension, heart failure, diabetes, coronary disease, etc.) are the main causes of morbidity, mortality and healthcare expense in the United States. Poor medication adherence and mismatches in the treatment (due to patient's reported side effect, complexity of treatment, and suboptimal efficacy of a chosen pharmacological treatment) are a major reason of failure in the management of chronic disease. The platform tested in this award will evaluate a complex machine-learning algorithm in treatment optimization for one of the chronic conditions, namely hypertension. The results of the proposed randomized clinical trial, if successful, will lead to a change in the treatment paradigm for chronic diseases. The principal investigator has just completed a pilot study in conjunction with Optima Inrwgrated Health, Inc. (i.e. PRECISION) to successfully test the medication management platform technology and its integration with the electronic medical record (EPIC® platform).

Optima-for-Blood Pressure (O4BP) is a cloud-based artificial intelligence clinical decision support system (CDSS) that evaluates patient status updates in real-time to provide advanced decision recommendations for medication treatment changes, when needed, personalized to each patient. O4BP provides a multiparameter (age, gender, ethnicity, current treatment, comorbidities, side-effects, laboratory values, compliance) overall score computation that ranks possible treatment changes in order of % improvement over current treatment. The goal of the study is to test if blood pressure management by using the O4BP CDSS is superior to standard of care (SOC) (i.e. blood pressure management during office visits).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94123
      • University of California San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Two or more blood pressure readings of ≥ 150/95 mmHg during primary care office visits in the Department of General Medicine within the last 6 months
• Therapy with medications from at least 1 anti-hypertensive pharmacological agents at the time of the last office visit
• At least minimally "tech-savvy" defined as Ownership of a compatible smartphone Ability to access the internet

Exclusion Criteria:

• Inability to operate a blood pressure 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 (frequent "no shows")
• 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)
• Primary care provider rules out the patient due to comorbidities or other factors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: optima4BP; optima4BP will receive several types of data to personalize the participant's medication treatment. The data include: remotely measured blood pressure (BP), and information on current medication treatment as well as health updates posted in Epic Electronic Record.	Other: optima4BP; optima4BP will provide the treating physician with a treatment action recommendation for consideration.
No Intervention: Standard of Care; The participants randomized to the Standard of Care will follow usual care, as currently followed at the University of California San Francisco.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in systolic BP [SBP] (mmHg) measure in the office	optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in systolic BP [SBP] (mmHg) measure remotely [home monitoring]	optima4BP leads >6 mmHg of the BP reduction compared to Standard of Care baseline through 12 months of enrollment.	12 months
Incidence of Adverse Events	Frequency and severity of adverse events (AEs) between baseline and the end of the study.	12 months

Collaborators and Investigators

• Sponsor: Optima Integrated Health
• Collaborators: University of California, San Francisco
• Investigators: Principal Investigator: Gabriela Voskerician, Optima Integrated Health

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: January 5, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): September 20, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 17-21426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The patient data will not be shared with other researchers. However, study outcomes will be published in peer-reviewed journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No