Evaluation of a UC-wide Quality Improvement Effort to Improve Blood Pressure Control Using Remote (Home) Monitoring

Study Overview
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Brief Summary
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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
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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. 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. 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. 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.

Official Title
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Evaluation of a UC-wide Quality Improvement Effort to Improve Blood Pressure Control Using Remote (Home) Monitoring

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: manual monitoring and general education on use
* Behavioral: integrated monitoring and local wrap-around hypertension program


Participation Criteria
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Eligibility Criteria
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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 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 electronic health record with the older reading within the last 6 months of the more recent reading. 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 (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 < 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrated<br>Participants will have their home blood pressure readings sent directly to their participating health systems. Participants will also receive a wrap-around intervention. | Behavioral: integrated monitoring and local wrap-around hypertension program<br>* Patients will receive a standard blood pressure monitor and a local wrap-around hypertension program. Data will be sent directly to their participating health system.<br>|
| Active Comparator: Manual<br>Participants will record their own blood pressures and report them to their health care system as per usual care. | Behavioral: manual monitoring and general education on use<br>* Patients will receive a standard blood pressure monitor and education on how to use it. Data will be reported as part of usual care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuous change in blood pressure | the difference in blood pressure after six months (adjusted for baseline variables) | Baseline, six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary 5mm change in blood pressure | whether participants achieved greater than or equal to 5 mmHg change in systolic blood pressure. | Baseline, six months | 
| Binary measure of controlled vs uncontrolled hypertension | where uncontrolled is defined as SBP > 130 mmHg or DBP > 80 mmHg. | Baseline, six months | 
| Exploratory pre-post analysis of overall change in BP | for all participants, subanalysis for select demographics including elderly. | Baseline, six months | 
| HTN outcomes from integrated monitor readings | This will be done with those in the integrated group only due to data availability | Baseline, six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remote Blood Pressure Monitoring