Uncontrolled Hypertension Management (TEAM-HTN)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Technology Assisted Management of Uncontrolled Hypertension (TEAM-HTN): a Pilot Study

Conditions
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Uncontrolled Hypertension

Intervention / Treatment
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* Other: Clinical Decision Software - provider portal
* Other: Clinical Decision Software - patient portal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Providers with prescriptive authority practicing in outpatient clinics at a military treatment facility in the Northwest. Patients 18 years or older with uncontrolled hypertension receiving care in an outpatient setting that can give a valid consent (over age 18 years, the ability to read and understand English, and cognitively intact). Active duty service members who will not be deployed or due to change duty station for the duration of the study. - Exclusion Criteria: 1. Credentialed providers without prescribing privileges in good standing. 2. Age less than 18 years, night shift workers, anyone who cannot give a valid informed consent, pregnant or breast feeding women, prisoners, patients on renal dialysis, transplant recipients, life expectancy less than 1 year, and those disqualified during screening procedures. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Provider<br>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<br>* As noted in Arms<br>|
| Patients<br>In a 6 month period, participants with uncontrolled hypertension will attend an initial face-to-face visit with a study provider, monitor their blood pressures 3x/week at home, enter their blood pressure readings manually or digitally into the clinical decision software - patient portal, get up to 4 blood draws, participate into up to 3 virtual visits monthly, and complete a questionnaire. | Other: Clinical Decision Software - patient portal<br>* As noted in Arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Provider Satisfaction | Provider satisfaction with efficacy, feasibility and usability of the clinical decision software program | 6 months | 
| Patient Satisfaction | Patient satisfaction with efficacy, feasibility and usability of the clinical decision software program | 6 months | 
| Provider time | Time in minutes each provider spends per patient managing uncontrolled hypertension. | 6 months | 
| Medication costs | Costs of medications per patient to achieve controlled hypertension using a published relative value scale | 6 months | 
| Time to reach blood pressure goals | Number of days from enrollment patients are not at target (70% control rate) | 6 months | 
| Patients with controlled hypertension by provider | Number of patients per provider level (MD, DO, Nurse Practitioner, Physician Assistant) with controlled hypertension | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, clinical decision support software, renin, aldosterone