An observational study in Uncontrolled Hypertension, sponsored by Madigan Army Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Madigan Army Medical Center · Observational
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.
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.
Credentialed providers with prescriptive authority and patients with uncontrolled hypertension practicing at or enrolled in a military treatment facility in the Pacific Northwest.
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Exclusion Criteria:
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Consented providers with prescriptive privileges will use the clinical decision software - provider portal to manage study patients with uncontrolled hypertension for 6 months. Participants will conduct a baseline face-to-face visit with study patients, access the program daily to check for patient high blood pressure alerts and lab results, conduct virtual visits as needed every 7 - 10 days, track the time and number of patients managed using the program and complete two questionnaires.
Other: Clinical Decision Software - provider portal
All consented participants provider or self-referred with uncontrolled HTN, completed a demographic questionnaire and received instruction on proper technique for checking home BPs using a study-provided, digital BP monitor with an appropriate-sized arm cuff. Readings were taken three days per week at a consistent time of day of their choosing between 8 AM and noon and 4PM and 8 PM (morning surge and chronotherapy trough). Baseline readings, the first 10 home readings taken over 10 days, were used to determine phase 2 eligibility. If 4 or more baseline readings were above recommended individualized JNC 8 BP goals set by their primary care provider, patients met criteria for rHTN and advanced to phase 2. Phase 1 patients advancing to phase 2 (met criteria for rHTN) acted as their own controls. Patients were not screened for secondary causes of HTN prior to entering phase 2.
Other: Clinical Decision Software - patient portal
Phase 2 patients continued checking BPs as in phase 1, had morning renin and aldosterone levels drawn while on their current medications, and were systematically screened by study providers for secondary causes of HTN using the CDST's diagnostic matrix. If aldosterone was significantly elevated (\> 20 ng/dl) and/or the aldosterone/renin ratio (ARR) was over 25, a 3-week drug wash out interval and repeat labs were recommended in the matrix for the work up of primary aldosteronism (PA). Due to institutional review board (IRB) stipulations, the actual workup for PA or other secondary causes of rHTN was managed by patients' PCP. Electrolytes were drawn as clinically indicated.
Other: Clinical Decision Software - patient portal
As noted in Arms
As noted in Arms
Patients with controlled hypertension
Percent of systolic and diastolic blood pressure readings within patient-specific target goals averaged in 10-day cycles at least 70% of the time.
Time frame: 6 months
Provider Satisfaction
Provider satisfaction with efficacy, feasibility and usability of the clinical decision software program
Time frame: 6 months
Patient Satisfaction
Patient satisfaction with efficacy, feasibility and usability of the clinical decision software program
Time frame: 6 months
Provider time
Time in minutes each provider spends per patient managing uncontrolled hypertension.
Time frame: 6 months
Medication costs
Costs of medications per patient to achieve controlled hypertension using a published relative value scale
Time frame: 6 months
Time to reach blood pressure goals
Number of days from enrollment patients are not at target (70% control rate)
Time frame: 6 months
Patients with controlled hypertension by provider
Number of patients per provider level (MD, DO, Nurse Practitioner, Physician Assistant) with controlled hypertension
Time frame: 6 months
Plan to share: No
This study is terminated, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Madigan Army Medical Center