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

March 15, 2018 updated by: Madigan Army Medical Center

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

Unknown

Conditions

Intervention / Treatment

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 (Anticipated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

    -

    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.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider Satisfaction
Time Frame: 6 months
Provider satisfaction with efficacy, feasibility and usability of the clinical decision software program
6 months
Patient Satisfaction
Time Frame: 6 months
Patient satisfaction with efficacy, feasibility and usability of the clinical decision software program
6 months
Provider time
Time Frame: 6 months
Time in minutes each provider spends per patient managing uncontrolled hypertension.
6 months
Medication costs
Time Frame: 6 months
Costs of medications per patient to achieve controlled hypertension using a published relative value scale
6 months
Time to reach blood pressure goals
Time Frame: 6 months
Number of days from enrollment patients are not at target (70% control rate)
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Madigan Army Medical Center

Collaborators

Telemedicine & Advanced Technology Research Center
Analytics4Medicine, Inc.

Investigators

  • Principal Investigator: Leilani A. Siaki, PhD, Madigan Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 24, 2017

Primary Completion (ANTICIPATED)

June 30, 2018

Study Completion (ANTICIPATED)

July 1, 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)

March 19, 2018

Last Update Submitted That Met QC Criteria

March 15, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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