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Clinical Trial Summary

Current guideline directed medical therapies (GDMT) for hypertension (HTN) endorse a trial and error approach based on drug class. This pilot study will evaluate the efficacy of a Clinical Decision Support (CDS) program to assist providers with delivering a more personalized approach using individual renin-aldosterone levels and the mechanism of action of medications included in GDMT recommendations. The overarching goal is to achieve HTN control rates above the 2014 National Health and Nutrition Examination Survey reported rate of 53% in a timely fashion, by individualizing medication management, thereby reducing the patient risk of stroke, heart and renal disease, and other devastating HTN-related outcomes.


Clinical Trial Description

Current guideline directed medical therapies (GDMT) for hypertension (HTN) endorse a trial and error approach based on drug class. This pilot study will evaluate the efficacy of a Clinical Decision Support (CDS) program to assist providers with delivering a more personalized approach using individual renin-aldosterone levels and the mechanism of action of medications included in GDMT recommendations. Current research suggests underlying mechanisms of HTN can be categorized by renin and aldosterone levels into approximately 50 categories and sub-categories. Timely identification of a patients' category is challenging for clinicians and possibly a contributing factor to the low rates of HTN control reported in the 2014 National Health and Nutrition Examination Survey (NHANES) of 53%. The overarching goal of this study is to achieve HTN control rates above the 2014 NANES rate in a timely, cost-effective manner by individualizing medication management, thereby reducing the patient risk of stroke, heart and renal disease, and other devastating HTN-related outcomes. Specific aims are: 1) evaluate the efficacy of the CDS software program to assist providers in identifying and matching the underlying mechanisms of HTN with the mechanism of action of antihypertensive medications to achieve better HTN control rates than the 53% reported in the 2014 NHANES data, 2) assess the efficacy of the CDS program across prescribing provider levels (MD/DO, residents, and APRN/PA), and 3) Determine the impact of the CDS program on: a) medication costs, b) provider management time, c), provider and patient satisfaction with and perception of usability and efficacy of the CDS program to manage their blood pressure. This 2-phase, prospective, within-subjects, repeated measures pilot study will enroll up to 20 multi-level providers with prescriptive authority and 160 military beneficiaries with uncontrolled HTN in the Northwest to evaluate the efficacy, feasibility, and usability of a CDS program to improve blood pressure control over a six-month period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03281772
Study type Observational
Source Madigan Army Medical Center
Contact Leilani A Siaki, PhD
Phone 253-698-2289
Email leilani.a.siaki.mil@mail.mil
Status Recruiting
Phase
Start date January 24, 2017
Completion date July 1, 2018

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