Clinical trial NCT05390502: University of California Health Remote (Home) Monitoring Evaluation
Official title: Evaluation of a University of California-wide Quality Improvement Effort to Improve Blood Pressure Control Using Remote (Home) Monitoring
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Remote Blood Pressure Monitoring
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: University of California Office of the President- Quality and Population Health Management
name: University of California, Davis
name: University of California, San Francisco
First posted: 2022-05-25
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study sets out to evaluate a University of California-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.

Detailed description: 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 University of California-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 (SBP).

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.

Eligibility criteria: Inclusion Criteria:

* 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 outpatient visit within the last 12 months, and have a prior visit within 6 months of inclusion outpatient visit with diagnosis of hypertension, defined as having two readings of SBP \> 140 or DBP \> 90 mmHg
* Has visit with a primary care physician within one year.
* Takes zero or three anti-hypertensive prescriptions (can include pills with 2 different drugs so could be on 2 medications).

Exclusion Criteria:

* BP \> 180/110 mmHg (office) or \> 175/105 mmHg (self-measured BP 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 \< 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
* Orthostatic hypotension (drop in SBP \>20 mmHg)
* Other secondary causes of hypertension
* Receiving hypertension management from other services (home health, hospice, already enrolled in hypertension management program)
* White coat hypertension

Primary outcomes:
measure: Continuous change in blood pressure (BP)
timeFrame: Baseline, six months
Secondary outcomes:
measure: Binary 5mm change in blood pressure
timeFrame: Baseline, six months
measure: Binary measure of controlled vs uncontrolled hypertension
timeFrame: Baseline, six months
measure: Exploratory pre-post analysis of overall change in BP
timeFrame: Baseline, six months
measure: Changes in blood pressure (BP) outcomes from integrated monitor readings
timeFrame: Baseline, six months
Other outcomes:
measure: Adverse events
timeFrame: Baseline, six months
Locations:
city: Davis
country: United States
facility: University of California, Davis
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: Director, Value-Based Care Research Consortium
name: Catherine Sarkisian, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Carey RM, Whelton PK. The 2017 American College of Cardiology/American Heart Association Hypertension Guideline: A Resource for Practicing Clinicians. Ann Intern Med. 2018 Mar 6;168(5):359-360. doi: 10.7326/M18-0025. Epub 2018 Jan 23. No abstract available.
citation: 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.