Uncontrolled Hypertension Management (TEAM-HTN)

Madigan Army Medical Center

Status: Terminated

Conditions: Uncontrolled Hypertension

Treatments: Other: Clinical Decision Software - provider portal; Other: Clinical Decision Software - patient portal

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03281772

AAMTI 6422

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

   Exclusion Criteria:

3. 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.

Trial design

70 participants in 3 patient groups

Provider

Description:

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.

Treatment:

Other: Clinical Decision Software - provider portal

Patients Phase 1

Description:

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.

Treatment:

Other: Clinical Decision Software - patient portal

Patients Phase 2

Description:

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.

Treatment:

Other: Clinical Decision Software - patient portal