Clinical trial NCT03281772: Uncontrolled Hypertension Management (TEAM-HTN)
Official title: Technology Assisted Management of Uncontrolled Hypertension (TEAM-HTN): a Pilot Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Uncontrolled Hypertension
Keywords: hypertension
clinical decision support software
renin
aldosterone
Lead sponsor: Madigan Army Medical Center
Sponsor class: FED
Collaborators: name: Telemedicine & Advanced Technology Research Center
name: Analytics4Medicine, LLC
First posted: 2017-09-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Credentialed providers with prescriptive authority and patients with uncontrolled hypertension practicing at or enrolled in a military treatment facility in the Pacific Northwest.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Providers with prescriptive authority practicing in outpatient clinics at a military treatment facility in the Northwest.
2. 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.

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   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.

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Primary outcomes:
measure: Patients with controlled hypertension
timeFrame: 6 months
Secondary outcomes:
measure: Provider Satisfaction
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 6 months
measure: Provider time
timeFrame: 6 months
measure: Medication costs
timeFrame: 6 months
measure: Time to reach blood pressure goals
timeFrame: 6 months
measure: Patients with controlled hypertension by provider
timeFrame: 6 months
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: Madigan Army Medical Center
name: Leilani A. Siaki, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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