Clinical trial NCT03397524: Tailored Drug Titration Through Artificial Intelligence
Official title: Tailored Drug Titration Through Artificial Intelligence: an Interventional Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypertension
Lead sponsor: Optima Integrated Health
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2018-01-12
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional arm outcomes will be compared to the control.
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in systolic BP [SBP] (mmHg) measure in the office
timeFrame: 12 months
Secondary outcomes:
measure: Reduction in systolic BP [SBP] (mmHg) measure remotely [home monitoring]
timeFrame: 12 months
measure: Incidence of Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: Optima Integrated Health
name: Gabriela Voskerician
role: PRINCIPAL_INVESTIGATOR
References: