Tailored Drug Titration Through Artificial Intelligence
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 12/21/2018 |
| Start Date: | October 1, 2018 |
| End Date: | March 31, 2020 |
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.
artificial intelligence in improving the management of anti-hypertensive medication
treatment.
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).
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).
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
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