Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Therese Chan Tack, DO, MPH
Headshot of Therese Chan Tack
Therese Chan Tack

Description

Summary

This study sets out to evaluate a UC-wide (Davis, San Francisco, and Los Angeles) quality improvement initiative to increase remote (home) blood pressure monitoring and improve blood pressure control for persons with hypertension. Participants at each site will be randomized to one of two types of remote monitoring: integrated versus manual. Participants using the integrated monitoring will have their home blood pressure readings sent directly to their participating health systems. Participants using the manual monitoring will record their own blood pressures and report them to their health care system as per usual care.

Details

Hypertension is an important modifiable risk factor for numerous adverse health outcomes including cardiovascular and kidney disease. In 2017, about 45.3% of US adults had hypertension or were taking antihypertensive medications (1). Hypertension has historically been diagnosed and treated using office-based blood pressure measurements, however blood pressure may differ when measured in the office compared to the home setting. Because of this discrepancy, and an extensive body of evidence supporting remote monitoring, national guidelines for hypertension management now recommend that all persons with hypertension participate in remote (home) monitoring. (2) This study sets out to evaluate a UC-wide (Davis, San Francisco, and Los Angeles) quality improvement initiative to increase remote (home) blood pressure monitoring and improve blood pressure control for persons with hypertension. Participants at each site will be randomized to one of two types of remote monitoring: integrated versus manual. Participants using the integrated monitoring will have their home blood pressure readings sent directly to their participating health systems. Participants using the manual monitoring will record their own blood pressures and report them to their health care system as per usual care. The investigators hypothesize that remote monitoring (both integrated and manual) will be associated with improved blood pressure control and that there will be no difference in control between type of remote monitoring. Aim 1: Evaluate whether this remote blood pressure quality improvement initiative leads to improved blood pressure control. Aim 2: Compare the impact of integrated versus manual remote monitoring on blood pressure control. The primary outcome measures will be: 1) the difference in blood pressure after six months (adjusted for baseline variables), and 2) whether participants achieved greater than or equal to 5 mmHg change in systolic blood pressure. Outcomes will be compared between participants in each arm to determine whether one type of monitoring is superior to the other. The investigators will convene bi-monthly meetings with site champions to foster communication and learning across sites and to learn about variation across sites. 1. Carey RM, Whelton PK. Prevention, detection, evaluation, and management of high blood pressure in adults: synopsis of the 2017 American College of Cardiology/American Heart Association Hypertension Guideline. Annals of internal medicine. 2018 Mar 6;168(5):351-8. 2. Shimbo D, Artinian NT, Basile JN, Krakoff LR, Margolis KL, Rakotz MK, Wozniak G; American Heart Association and the American Medical Association. Self-Measured Blood Pressure Monitoring at Home: A Joint Policy Statement From the American Heart Association and American Medical Association. Circulation. 2020 Jul 28;142(4):e42-e63. doi: 10.1161/CIR.0000000000000803. Epub 2020 Jun 22.

Keywords

Hypertension, Remote Blood Pressure Monitoring, manual monitoring and general education on use, integrated monitoring and local wrap-around hypertension program, Integrated, Manual

Eligibility

You can join if…

Open to people ages 18 years and up

  • Aged 18 years and older.
  • Participant must be willing and functionally able (with help from another person if needed) to both use the remote BP monitoring device as well as do home BP monitoring using a manual BP cuff.
  • Have access to the online healthcare portal (with help from another person if needed).
  • Have 2 or more office visits with a blood pressure recorded in the last year and still affiliated with institution.
  • Diagnosis of Hypertension.
  • Has two readings of SBP > 150 or DBP > 90 mmHg recorded in the EHR with the older reading within the last 6 months of the more recent reading.
  • The most recent reading (index blood pressure) is from the primary care physician office visit.
  • Has visit with a primary care physician within one year.
  • Takes zero or one antihypertensive medication.
  • Not currently or previously enrolled in any integrated remote BP intervention.
  • Have access to non-EMR connected BP cuff at home.
  • Must be eligible for local site wrap-around intervention.

You CAN'T join if...

  • BP > 180/110 mmHg (office) or > 175/105 mmHg (SMBP measurements)
  • Pheochromocytoma
  • Uncontrolled hypothyroidism or hyperthyroidism
  • Renal artery stenosis
  • Conn's syndrome
  • End Stage Renal Disease (ESRD)
  • Chronic Kidney Disease (CKD) Stage 3b (CrCL < 45) and above
  • Transplant patients --> used the code that if they ever had a transplant
  • Pregnancy
  • Severe aortic stenosis
  • Hospice/End-of-life or Palliative Care
  • Left Ventricular Ejection Fraction (LVEF) < 30%
  • Acute cardiac event in the last 3 months (e.g. acute MI)
  • Heart block and arrhythmia(s)
  • Recurrent or symptomatic hypotension (SBP < 100 mmHg or DBP < 60 mmHg)
  • Drug/alcohol abuse
  • Receiving HTN management from other services (home health, hospice, already enrolled in hypertension management program)
  • Already enrolled in a hypertension management study
  • Prisoners
  • Adults with cognitive impairments affecting ability to participate in site intervention or Dementia and mental degeneration
  • White Coat Hypertension

Locations

  • University of California, San Francisco
    San Francisco California 94143 United States
  • University of California, Davis
    Davis California 95616 United States

Lead Scientist at UCSF

  • Therese Chan Tack, DO, MPH
    Dr. Therese Chan Tack is an Associate Professor of Clinical Medicine and Physician Lead of Telehealth Programs for UCSF Health. She is closely involved in COVID-19 telehealth expansion across UCSF and its affiliates. She authored the Telehealth Communication Tips resource for providers, which has garnered 1000+ views and is used in residency and student training.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05390502
Study Type
Interventional
Participants
Expecting 660 study participants
Last Updated