Project Summary

COVID-19-Related Project Enhancement

It is unknown how medicines for high blood pressure affect COVID-19 infection. With this enhancement, the research team will look at two types of medicines to treat high blood pressure. One type is angiotensin converting enzyme inhibitors, or ACEIs. The other type is angiotensin receptor blockers, or ARBs. The team will look at patient health records to learn how taking an ACEI, ARB, or other blood pressure medicines affects

  • Patients’ risks for infection with COVID-19
  • How severe the infection is

Enhancement Award Amount: $357,993

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Uncontrolled high blood pressure causes nearly 400,000 deaths each year in the United States. Medicine can help patients control their blood pressure. But patients and doctors need better ways of managing blood pressure to make sure that treatments work well for patients in practice. New clinic programs and technologies for patients may help.

The research team is creating a system to monitor how well clinics and patients are controlling blood pressure. The team is using this system in three studies. The studies are

  • Describing blood pressure control in the United States overall and in different patients and places (Study 1)
  • Comparing blood pressure control between clinics that receive extra support for doctors in using educational materials about blood pressure control versus those that don’t have this extra support (Study 2)
  • Comparing blood pressure control between patients who receive a home blood pressure monitor with and without a smartphone app (Study 3)

Who can this research help?

Results may help clinics considering ways to help doctors and patients control blood pressure.

What is the research team doing?

Study 1. The research team is using electronic health records, or EHRs, from healthcare organizations across the United States to study blood pressure control at their clinics. The team is looking at indicators including

  • Prescriptions for uncontrolled blood pressure
  • Repeat high blood pressure readings in clinics
  • How often patients return to the doctor’s office within four weeks after a high blood pressure reading

The research team is using this information to learn which clinics control their patients’ blood pressure well and which clinics need help. In addition, the team is building a registry where doctors and nurses can see how well their clinics are doing compared with other clinics. They can also compare patient outcomes at their clinics before and after treatment and by factors such as age, sex, and race.

Study 2. Twenty clinics receive access to a website with educational materials on blood pressure control. Site champions, who are existing clinic staff members like doctors and nurses, use these materials to help their peers at the clinic improve how they control blood pressure.

The research team is assigning clinics by chance to either receive extra help for their site champions or not. Site champions who receive extra help work with a site facilitator to improve their clinic processes and monitor how well clinics are controlling blood pressure. Expert staff from the American Medical Association train and support the facilitators. Site champions from clinics assigned not to receive help use the educational materials without help from a facilitator.

The research team is measuring clinic patients’ blood pressure at the start of the study and again six months later. The team is also measuring how often doctors prescribe new medicines for patients with uncontrolled blood pressure. The team is comparing these outcomes between clinics with and without site facilitator support for the site champions, and between study clinics and non-study clinics that provide usual care.

Study 3. The research team is assigning 2,000 patients with high blood pressure to one of two groups by chance. Patients in the first group receive a home blood pressure monitoring, or HBPM, device with instructions. Patients track their blood pressure over time using the device and can share this information with their doctor.

Patients in the second group receive a HBPM device linked to a smartphone app. They receive instructions on how to download the app and use the HBPM device to measure blood pressure. Patients can get reminders to check their blood pressure, track their blood pressure over time, and share this information with their doctor using the app.

The research team is collecting information on patients’ blood pressure, measured in their doctor’s offices, from EHRs for at least six months and up to 18 months. The team is also surveying patients on an online portal about whether they would recommend the HBPM device to a friend. From patients in the second group, the team is collecting data from the app.

Patients are helping to design all three studies and study materials for patient use.

Research methods at a glance

Design Elements Description
Design Study 1: descriptive study
Study 2: randomized controlled trial
Study 3: randomized controlled trial
Population Study 1: patients ages 18–85 who have had least one outpatient visit with a hypertension diagnosis

Study 2: patients at 20 clinics who are ages 18–85 and who have had least one outpatient visit with a hypertension diagnosis

Study 3: 2,000 patients ages 18 and older with at least one ambulatory visit at a participating study site during the past year, systolic blood pressure >145 mmHg at their most recent clinic visit, and a self-reported commitment to “work on lowering blood pressure by 10 points or more to reduce risk of heart attack and stroke”
Interventions/
Comparators
Study 1: N/A

Study 2: clinics receive educational materials on blood pressure control versus clinics receive educational materials on blood pressure control plus training for a practice change facilitator

Study 3: standard HBPM device versus smartphone-linked HBPM device and associated app
Outcomes Study 1: prescriptions for uncontrolled blood pressure, repeat high blood pressure readings in clinic, repeat visit in 4 weeks after uncontrolled high blood pressure

Study 2: 
Primary: clinic-level change in proportion of patients with controlled blood pressure, defined as the percent of patients with systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg

Secondary: clinic-level change in proportion of patients with controlled blood pressure, defined as systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg; improvement in blood pressure, defined as either a reduction of 10 mmHg in systolic blood pressure or systolic blood pressure that is <140 mmHg over a period of 3 months; medicine intensification, defined as percentage of patients with uncontrolled blood pressure who receive a prescription for a new medicine class; average systolic blood pressure reduction after medicine intensification; confirmatory repeated blood pressure measurement taken in the same visit when first measurement is high; repeat visit in 4 weeks after uncontrolled high blood pressure; inappropriate rounding of blood pressure measurements; use of fixed-dose combination medicines among patients taking two or more classes of medicine; use of a calcium channel blocker or thiazide-type diuretic among African-American patients on one medication

Study 3: systolic blood pressure, likelihood of recommending the HBPM device to a friend
Timeframe Study 2: 6- to 12-month follow-up for primary outcome

Study 3: 6- to 18-month follow-up for study outcomes

Journal Articles

Project Information

Mark Pletcher, MD, MPH
The Regents of the University of California, San Francisco
$6,834,984

Key Dates

36 months
April 2018
February 2023
2018

Study Registration Information

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PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders.

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Intervention Strategies

PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care.

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Last updated: November 15, 2021