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This study was dependent on an IT interoperability component requiring additional development.
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| Name | Class |
|---|---|
| University of California, San Francisco | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| optima4BP | Experimental | 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. |
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| Standard of Care | No Intervention | The participants randomized to the Standard of Care will follow usual care, as currently followed at the University of California San Francisco. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| optima4BP | Other | optima4BP will provide the treating physician with a treatment action recommendation for consideration. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriela Voskerician | Optima Integrated Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | San Francisco | California | 94123 | United States |
The patient data will not be shared with other researchers. However, study outcomes will be published in peer-reviewed journals.
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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The interventional arm outcomes will be compared to the control.
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The patient participant will be unaware of randomization.
Frequency and severity of adverse events (AEs) between baseline and the end of the study.
| 12 months |