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Blood pressure checks for diagnosing hypertension (BP-CHECK)
Investigator (PI): Green, Beverly B
Performing Organization (PO): (Current): Kaiser Permanente, Kaiser Permanente Washington Health Research Institute / (206) 287-2900
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2021
Record Source/Award ID: PCORI/CER-1511-32979
Funding: Total Award Amount: $2,802,649
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: 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 hypertension 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-CHECKs for Hypertension Diagnosis (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. We will compare the accuracy and acceptability (i.e., comfort, convenience) of clinic, home, and kiosk BP testing to 24-hour BP ambulatory monitoring. We 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 they feel better or worse overall, worry about BP, and change health behaviors (e.g., lowering salt intake). We will talk with patients and interview health care providers and clinical leaders to understand how the recommendations from the USPSTF might fit into ongoing health care. Our study team includes patients. We also have patient and stakeholder advisors to ensure our study is conducted properly and is not a burden to patients and providers. We will share study results with patient participants and publish papers in scientific journals. We will also create a toolkit to help health care systems and providers choose accurate BP monitors, train staff on BP measurements in and out of clinics, and interpret BP readings.
MeSH Terms:
  • Adolescent
  • Adult
  • Aged
  • Blood Pressure
  • Blood Pressure Monitoring, Ambulatory /*methods
  • Diagnostic Errors
  • Humans
  • Hypertension /*diagnosis
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • Reproducibility of Results
  • Time Factors
  • United States
  • White Coat Hypertension /diagnosis
  • Young Adult
Country: United States
State: Washington
Zip Code: 98101
UI: 20164052
CTgovId: NCT03130257
Project Status: Ongoing
Record History: ('2020: Project extended to 2021. 2018: Project extended to 2020.',)