Uncontrolled Hypertension Management (TEAM-HTN)

NCT03281772 | Terminated

• 1 other identifier: AAMTI 6422
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Uncontrolled Hypertension

Keywords

hypertension; clinical decision support software; renin; aldosterone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Provider Satisfaction

  6 months

• Patient Satisfaction

  6 months

• Provider time

  6 months

• Medication costs

  6 months

• Time to reach blood pressure goals

  6 months

Study Arms (3)

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

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

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

Interventions

Clinical Decision Software - provider portal OTHER

As noted in Arms

Provider

Clinical Decision Software - patient portal OTHER

As noted in Arms

Patients Phase 1; Patients Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Madigan Army Medical Center: lead
• Telemedicine & Advanced Technology Research Center: collaborator
• Analytics4Medicine, LLC: collaborator

Study Sites (1)

Madigan Army Medical Center

Tacoma, Washington, 98431-1100, United States

Location

Related Publications (10)

• 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.

  PMID: 24352797 BACKGROUND

• 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.

  PMID: 23107914 BACKGROUND

• 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.

  PMID: 24270181 BACKGROUND

• 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.

  PMID: 25629742 BACKGROUND

• 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.

  PMID: 26551272 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23049672 BACKGROUND

• 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.

  PMID: 25828847 BACKGROUND

• 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/

  BACKGROUND

• 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.

  PMID: 23885763 BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Leilani A. Siaki, PhD

  Madigan Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 13, 2017
• Study Start: January 24, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)