Evaluation of a University of California-wide Quality Improvement Effort to Improve Blood Pressure Control Using Remote (Home) Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 660
- 试验地点
- 6
- 主要终点
- Continuous change in blood pressure (BP)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Continuous change in blood pressure (BP)
时间窗: Baseline, six months
the difference in systolic blood pressure after six months (adjusted for baseline variables)
次要结局
- Binary measure of controlled vs uncontrolled hypertension(Baseline, six months)
- Binary 5mm change in blood pressure(Baseline, six months)
- Exploratory pre-post analysis of overall change in BP(Baseline, six months)
- Changes in blood pressure (BP) outcomes from integrated monitor readings(Baseline, six months)
研究者
Catherine A. Sarkisian
Director, Value-Based Care Research Consortium
University of California, Los Angeles