Uncontrolled Hypertension Management (TEAM-HTN) (TEAM-HTN)

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

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.

Study Overview

• Status: Terminated
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Other: Clinical Decision Software - provider portal; Other: Clinical Decision Software - patient portal

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.

• Study Type: Observational
• Enrollment (Actual): 70

Contacts and Locations

Study Locations

• United States
  • Washington
    • Tacoma, Washington, United States, 98431-1100
      • Madigan Army Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Provider; 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; As noted in Arms
Patients Phase 1; 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; As noted in Arms
Patients Phase 2; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Madigan Army Medical Center
• Collaborators: Telemedicine & Advanced Technology Research Center; Analytics4Medicine, LLC
• Investigators: Principal Investigator: Leilani A. Siaki, PhD, Madigan Army Medical Center

Publications and helpful links

General Publications

• James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, Lackland DT, LeFevre ML, MacKenzie TD, Ogedegbe O, Smith SC Jr, Svetkey LP, Taler SJ, Townsend RR, Wright JT Jr, Narva AS, Ortiz E. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014 Feb 5;311(5):507-20. doi: 10.1001/jama.2013.284427. Erratum In: JAMA. 2014 May 7;311(17):1809.
• Weber MA, Schiffrin EL, White WB, Mann S, Lindholm LH, Kenerson JG, Flack JM, Carter BL, Materson BJ, Ram CV, Cohen DL, Cadet JC, Jean-Charles RR, Taler S, Kountz D, Townsend R, Chalmers J, Ramirez AJ, Bakris GL, Wang J, Schutte AE, Bisognano JD, Touyz RM, Sica D, Harrap SB. Clinical practice guidelines for the management of hypertension in the community a statement by the American Society of Hypertension and the International Society of Hypertension. J Hypertens. 2014 Jan;32(1):3-15. doi: 10.1097/HJH.0000000000000065. No abstract available.
• SPRINT Research Group; Wright JT Jr, Williamson JD, Whelton PK, Snyder JK, Sink KM, Rocco MV, Reboussin DM, Rahman M, Oparil S, Lewis CE, Kimmel PL, Johnson KC, Goff DC Jr, Fine LJ, Cutler JA, Cushman WC, Cheung AK, Ambrosius WT. A Randomized Trial of Intensive versus Standard Blood-Pressure Control. N Engl J Med. 2015 Nov 26;373(22):2103-16. doi: 10.1056/NEJMoa1511939. Epub 2015 Nov 9. Erratum In: N Engl J Med. 2017 Dec 21;377(25):2506. doi: 10.1056/NEJMx170008.
• Kisaka T, Ozono R, Ishida T, Higashi Y, Oshima T, Kihara Y. Association of elevated plasma aldosterone-to-renin ratio with future cardiovascular events in patients with essential hypertension. J Hypertens. 2012 Dec;30(12):2322-30. doi: 10.1097/HJH.0b013e328359862d.
• Moran AE, Odden MC, Thanataveerat A, Tzong KY, Rasmussen PW, Guzman D, Williams L, Bibbins-Domingo K, Coxson PG, Goldman L. Cost-effectiveness of hypertension therapy according to 2014 guidelines. N Engl J Med. 2015 Jan 29;372(5):447-55. doi: 10.1056/NEJMsa1406751. Erratum In: N Engl J Med. 2015 Apr 23;372(17):1677. doi: 10.1056/NEJMx150016.
• Yoon SS, Fryar CD, Carroll MD. Hypertension prevalence and control among adults: United States, 2011-2014. Data from the National Health and Nutrition Examination Survey. http://www.cdc.gov/nchs/products/databriefs/db220.htm . Accessed March 18, 2016.
• Bochud M, Burnier M, Guessous I. Top Three Pharmacogenomics and Personalized Medicine Applications at the Nexus of Renal Pathophysiology and Cardiovascular Medicine. Curr Pharmacogenomics Person Med. 2011 Dec;9(4):299-322. doi: 10.2174/187569211798377135.
• Rosendorff C, Lackland DT, Allison M, Aronow WS, Black HR, Blumenthal RS, Cannon CP, de Lemos JA, Elliott WJ, Findeiss L, Gersh BJ, Gore JM, Levy D, Long JB, O'Connor CM, O'Gara PT, Ogedegbe G, Oparil S, White WB; American Heart Association, American College of Cardiology, and American Society of Hypertension. Treatment of hypertension in patients with coronary artery disease: a scientific statement from the American Heart Association, American College of Cardiology, and American Society of Hypertension. Hypertension. 2015 Jun;65(6):1372-407. doi: 10.1161/HYP.0000000000000018. Epub 2015 Mar 31. No abstract available. Erratum In: Hypertension. 2016 Oct;68(4):e61. doi: 10.1161/HYP.0000000000000051.
• Deal, P. (2011). Hypertension: More Soldiers die from silent killer than combat. Army News Front Page. Retrieved October 24, 2015 from: http://www.army.mil/article/59005/
• Wang G, Fang J, Ayala C. Hypertension-associated hospitalizations and costs in the United States, 1979-2006. Blood Press. 2014 Apr;23(2):126-33. doi: 10.3109/08037051.2013.814751. Epub 2013 Jul 25.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2017
• Primary Completion (Actual): July 31, 2018
• Study Completion (Actual): July 31, 2018

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): April 16, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: hypertension; aldosterone; renin; clinical decision support software
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: AAMTI 6422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No