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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
manual monitoring and general education on use
integrated monitoring and local wrap-around hypertension program
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Remote Blood Pressure Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

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 (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

Sites / Locations

  • University of California, Davis
  • University of California, Los AngelesRecruiting
  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Integrated

Manual

Arm Description

Participants will have their home blood pressure readings sent directly to their participating health systems. Participants will also receive a wrap-around intervention.

Participants will record their own blood pressures and report them to their health care system as per usual care.

Outcomes

Primary Outcome Measures

Continuous change in blood pressure
the difference in blood pressure after six months (adjusted for baseline variables)

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2022
Last Updated
May 16, 2023
Sponsor
University of California, Los Angeles
Collaborators
University of California Office of the President- Quality and Population Health Management, University of California, Davis, University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05390502
Brief Title
Evaluation of a UC-wide Quality Improvement Effort to Improve Blood Pressure Control Using Remote (Home) Monitoring
Official Title
Evaluation of a UC-wide Quality Improvement Effort to Improve Blood Pressure Control Using Remote (Home) Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
University of California Office of the President- Quality and Population Health Management, University of California, Davis, University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Remote Blood Pressure Monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
660 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Integrated
Arm Type
Experimental
Arm Description
Participants will have their home blood pressure readings sent directly to their participating health systems. Participants will also receive a wrap-around intervention.
Arm Title
Manual
Arm Type
Active Comparator
Arm Description
Participants will record their own blood pressures and report them to their health care system as per usual care.
Intervention Type
Behavioral
Intervention Name(s)
manual monitoring and general education on use
Intervention Description
Patients will receive a standard blood pressure monitor and education on how to use it. Data will be reported as part of usual care.
Intervention Type
Behavioral
Intervention Name(s)
integrated monitoring and local wrap-around hypertension program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Continuous change in blood pressure
Description
the difference in blood pressure after six months (adjusted for baseline variables)
Time Frame
Baseline, six months
Secondary Outcome Measure Information:
Title
Binary 5mm change in blood pressure
Description
whether participants achieved greater than or equal to 5 mmHg change in systolic blood pressure.
Time Frame
Baseline, six months
Title
Binary measure of controlled vs uncontrolled hypertension
Description
where uncontrolled is defined as SBP > 130 mmHg or DBP > 80 mmHg.
Time Frame
Baseline, six months
Title
Exploratory pre-post analysis of overall change in BP
Description
for all participants, subanalysis for select demographics including elderly.
Time Frame
Baseline, six months
Title
HTN outcomes from integrated monitor readings
Description
This will be done with those in the integrated group only due to data availability
Time Frame
Baseline, six months
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
acute coronary syndrome, myocardial infarction, NSTEMI, STEMI, stroke (ischemic, hemorrhagic), decompensated heart failure, all-cause mortality, hospitalization, syncope, hyponatremia, hypokalemia, hyperkalemia
Time Frame
Baseline, six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linh H Chuong, MPH
Phone
7608408492
Email
linhchuong@g.ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine Sarkisian, MD, MSHS
Email
CSarkisian@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Sarkisian, MD, MSHS
Organizational Affiliation
Director, Value-Based Care Research Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reshma Gupta, MSHPM, MD
Phone
510-847-6226
First Name & Middle Initial & Last Name & Degree
Reshma Gupta, MD
First Name & Middle Initial & Last Name & Degree
Kaumaka M Shimatsu, MD
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Han, MD, MS
Phone
513-255-5891
Email
MHan@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Hannah Kwak, MD
Phone
310-869-8323
Email
hkwak@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Maria Han, MD
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Therese Chan Tack, DO, MPH
Phone
415-353-7900
Email
Therese.ChanTack@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Therese Chan Tack, DO, MPH

12. IPD Sharing Statement

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

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