Blood Pressure Checks for Diagnosing Hypertension (BP-CHECK)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/6/2019 |
| Start Date: | May 11, 2017 |
| End Date: | September 30, 2019 |
Hypertension is usually diagnosed at a clinic or doctor's office when a patient has blood
pressure (BP) that is high for several measurements. However, about 30 percent of patients
with high BP in clinics have normal BP outside of clinics. This is called white-coat
hypertension. Correct diagnosis of hyper-tension is important to prevent strokes, heart
attacks, and heart failure but also to avoid making people worry or take medicines when they
don't need to.
To avoid misdiagnosis of hypertension, the US Preventive Services Task Force (USPSTF), which
makes national recommendations about disease screening, recommends people should have 24-hour
BP ambulatory monitoring (i.e., an arm cuff and BP monitor worn for 24 hours, with
measurements taken every 30 minutes during the day and every 60 minutes at night), with home
BP monitoring over several days as an alternative. However, most patients have never heard of
24-hour BP monitoring, and physicians rarely order it. Physicians sometimes use home BP
monitoring, but not according to recommended guidelines. BP kiosks, for example at drug
stores, offer another option. Newer models are accurate and easy to use.
BP-CHECK will identify patients, ages 18 to 85, with high BP at their last clinic visit and
invite them to a screening visit. Patients with high BP at the screening visit (510 patients)
will be randomized and assigned to 1) clinic BP, 2) home BP, or 3) kiosk BP diagnostic groups
for confirming a new diagnosis of hypertension. The clinic BP group will have BP measured at
two clinic visits. The home BP group will measure BP two times, twice a day, for five days.
The kiosk BP group will measure BP three times on three separate days at a kiosk at their
clinic or nearby drugstore. Participants will complete their diagnostic tests over three
weeks. They will then be asked to complete 24-hour BP monitoring. Participants will complete
surveys at baseline prior to randomization, after diagnostic tests, and at six months.
Hypothesis 1: Compared to the reference standard (24-hour BP), home BP and kiosk BP will be
more accurate than clinic BP. Hypothesis 2: Patients with clinic, home, or kiosk BP results
concordant with reference standard results will prefer home or kiosk to clinic and 24-hour
BP. Hypothesis 2: Patients with clinic, home, or kiosk BP results concordant with reference
standard results will prefer home or kiosk to clinic and 24-hours BP.
pressure (BP) that is high for several measurements. However, about 30 percent of patients
with high BP in clinics have normal BP outside of clinics. This is called white-coat
hypertension. Correct diagnosis of hyper-tension is important to prevent strokes, heart
attacks, and heart failure but also to avoid making people worry or take medicines when they
don't need to.
To avoid misdiagnosis of hypertension, the US Preventive Services Task Force (USPSTF), which
makes national recommendations about disease screening, recommends people should have 24-hour
BP ambulatory monitoring (i.e., an arm cuff and BP monitor worn for 24 hours, with
measurements taken every 30 minutes during the day and every 60 minutes at night), with home
BP monitoring over several days as an alternative. However, most patients have never heard of
24-hour BP monitoring, and physicians rarely order it. Physicians sometimes use home BP
monitoring, but not according to recommended guidelines. BP kiosks, for example at drug
stores, offer another option. Newer models are accurate and easy to use.
BP-CHECK will identify patients, ages 18 to 85, with high BP at their last clinic visit and
invite them to a screening visit. Patients with high BP at the screening visit (510 patients)
will be randomized and assigned to 1) clinic BP, 2) home BP, or 3) kiosk BP diagnostic groups
for confirming a new diagnosis of hypertension. The clinic BP group will have BP measured at
two clinic visits. The home BP group will measure BP two times, twice a day, for five days.
The kiosk BP group will measure BP three times on three separate days at a kiosk at their
clinic or nearby drugstore. Participants will complete their diagnostic tests over three
weeks. They will then be asked to complete 24-hour BP monitoring. Participants will complete
surveys at baseline prior to randomization, after diagnostic tests, and at six months.
Hypothesis 1: Compared to the reference standard (24-hour BP), home BP and kiosk BP will be
more accurate than clinic BP. Hypothesis 2: Patients with clinic, home, or kiosk BP results
concordant with reference standard results will prefer home or kiosk to clinic and 24-hour
BP. Hypothesis 2: Patients with clinic, home, or kiosk BP results concordant with reference
standard results will prefer home or kiosk to clinic and 24-hours BP.
The investigators will compare the accuracy and acceptability (i.e., comfort, convenience) of
clinic, home, and kiosk BP testing to 24-hour BP ambulatory monitoring. The investigators
will look at the impact of the study, up to six months after the study starts, on outcomes
that matter to patients: their BP and whether participants feel better or worse overall,
worry about BP, and change health behaviors (e.g., lowering salt intake). The investigators
will talk with patients and interview healthcare providers and clinical leaders to understand
how the recommendations from the USPSTF might fit into ongoing health care.
Our study team includes patients. The study team also has patient and stakeholder advisors to
ensure our study is conducted properly and is not a burden to patients and providers. The
investigators will share study results with patient participants and publish papers in
scientific journals. The investigators will also create a toolkit to help healthcare systems
and providers choose accurate BP monitors, train staff on BP measurements in and out of
clinics, and interpret BP readings.
clinic, home, and kiosk BP testing to 24-hour BP ambulatory monitoring. The investigators
will look at the impact of the study, up to six months after the study starts, on outcomes
that matter to patients: their BP and whether participants feel better or worse overall,
worry about BP, and change health behaviors (e.g., lowering salt intake). The investigators
will talk with patients and interview healthcare providers and clinical leaders to understand
how the recommendations from the USPSTF might fit into ongoing health care.
Our study team includes patients. The study team also has patient and stakeholder advisors to
ensure our study is conducted properly and is not a burden to patients and providers. The
investigators will share study results with patient participants and publish papers in
scientific journals. The investigators will also create a toolkit to help healthcare systems
and providers choose accurate BP monitors, train staff on BP measurements in and out of
clinics, and interpret BP readings.
Inclusion Criteria:
- enrolled in the health plan for two years, no diagnosis of hypertension in the prior 2
years or more,
- not on anti-hypertensive medications,
- a high blood pressure at their last clinic visit (systolic blood pressure > or equal
to 140 mm Hg or diastolic blood pressure > or equal to 90,
- planning to remain a Kaiser Permanente patient for the next six months,
- able to converse and read in English,
- required to have elevated blood pressure at the screening visit (BP taken 2 times,
high each time).
Exclusion Criteria:
- children and pregnant women,
- patients with end-stage renal disease,
- dementia,
- atrial fibrillation and other significant arrhythmias.
We found this trial at
1
site
301 South 320th Street
Seattle, Washington 98023
Seattle, Washington 98023
Principal Investigator: Beverly B Green, MD,MPH
Phone: 206-287-2381
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