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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03281772
Recruitment Status : Unknown
Verified March 2018 by Madigan Army Medical Center.
Recruitment status was:  Recruiting
First Posted : September 13, 2017
Last Update Posted : March 19, 2018
Sponsor:
Collaborators:
Telemedicine & Advanced Technology Research Center
Analytics4Medicine, Inc.
Information provided by (Responsible Party):
Madigan Army Medical Center

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.

Condition or disease Intervention/treatment
Uncontrolled Hypertension 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.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Technology Assisted Management of Uncontrolled Hypertension (TEAM-HTN): a Pilot Study
Actual Study Start Date : January 24, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


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
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
As noted in Arms




Primary Outcome Measures :
  1. Patients with controlled hypertension [ Time Frame: 6 months ]
    Percent of systolic and diastolic blood pressure readings within patient-specific target goals averaged in 10-day cycles at least 70% of the time.


Secondary Outcome Measures :
  1. Provider Satisfaction [ Time Frame: 6 months ]
    Provider satisfaction with efficacy, feasibility and usability of the clinical decision software program

  2. Patient Satisfaction [ Time Frame: 6 months ]
    Patient satisfaction with efficacy, feasibility and usability of the clinical decision software program

  3. Provider time [ Time Frame: 6 months ]
    Time in minutes each provider spends per patient managing uncontrolled hypertension.

  4. Medication costs [ Time Frame: 6 months ]
    Costs of medications per patient to achieve controlled hypertension using a published relative value scale

  5. Time to reach blood pressure goals [ Time Frame: 6 months ]
    Number of days from enrollment patients are not at target (70% control rate)

  6. Patients with controlled hypertension by provider [ Time Frame: 6 months ]
    Number of patients per provider level (MD, DO, Nurse Practitioner, Physician Assistant) with controlled hypertension



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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:

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.

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281772


Contacts
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Contact: Leilani A Siaki, PhD 253-698-2289 leilani.a.siaki.mil@mail.mil
Contact: Victor S Lin, MD 253-968-1885 victor.s.lin.mil@mail.mil

Locations
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United States, Washington
Madigan Army Medical Center Recruiting
Tacoma, Washington, United States, 98431-1100
Sponsors and Collaborators
Madigan Army Medical Center
Telemedicine & Advanced Technology Research Center
Analytics4Medicine, Inc.
Investigators
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Principal Investigator: Leilani A. Siaki, PhD Madigan Army Medical Center
Publications:
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.
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/

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Responsible Party: Madigan Army Medical Center
ClinicalTrials.gov Identifier: NCT03281772    
Other Study ID Numbers: AAMTI 6422
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Madigan Army Medical Center:
hypertension
clinical decision support software
renin
aldosterone
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases