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HSRProj (Health Services Research Projects in Progress)

Information about ongoing health services research and public health projects


Using PCORnet to compare blood pressure control strategies
Investigator (PI): Pletcher, Mark
Performing Organization (PO): (Current): University of California, San Francisco, School of Medicine, Department of Epidemiology and Biostatistics / (415) 476-2300
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2018
Final Year: 2022
Record Source/Award ID: PCORI/PaCR-2017C2-8153
Funding: Total Award Amount: $6,476,991
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: This research project is in progress. PCORI will post the research findings on the PCORI website 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), and 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 health care 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, and 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. Design: Study 1 is a descriptive study. Study 2 is a randomized controlled trial. Study 3 is a randomized controlled trial. Population: Study 1: The study population is patients ages 18-85 who have had least one outpatient visit with a hypertension diagnosis. Study 2: The study population is patients at 20 clinics who are ages 18-85 and who have had least one outpatient visit with a hypertension diagnosis. Study 3: The study population is 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 are 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; and study 3: standard HBPM device versus smartphone-linked HBPM device and associated app. Outcomes: Outcomes are study 1: prescriptions for uncontrolled blood pressure, repeat high blood pressure readings in clinic, and repeat visit in 4 weeks after uncontrolled high blood pressure; study 2: (a) 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; and (b) 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; and use of a calcium channel blocker or thiazide-type diuretic among African American patients on one medication; and study 3: systolic blood pressure and likelihood of recommending the HBPM device to a friend. The timeframes are study 2: 6- to 12-month follow-up for primary outcome and study 3: 6- to 18-month follow-up for study outcomes.
Abstract Archived: Uncontrolled blood pressure causes nearly 400,000 deaths/year in the US. Medications are available to control blood pressure, but often multiple medications are required, and it is not always clear if and when medication changes are needed. Patients and clinicians worry about blood pressure, wonder how to measure it accurately and conveniently, and want better ways to control it with fewer medications that are more convenient to take and cause fewer side effects. New programs and new technology are being developed that could help control blood pressure, but it is not clear which will be most effective. We are working with our partners--the American Heart Association (AHA) and American Medical Association (AMA)--to find effective ways to control blood pressure. We will use data already being collected by doctors' offices across the country to find new ways of improving blood pressure. Blood pressure measurements collected in doctors' offices can demonstrate which offices do a great job already at controlling blood pressure for their patients, and which need help. We will then compare two different ways of helping doctors' offices control blood pressure--by giving them access to lots of AMA/AHA materials that can help doctors improve what they do, with or without a "practice facilitator" who can guide their use of those materials. Finally, we will test two different types of home blood pressure monitors--one that connects with your smartphone, and one that does not--to see which is more effective at helping patients achieve their own personal goals for blood pressure control. The Health eHeart Alliance, which leads this project, is a Patient-Powered Research Network led by patients. The Alliance will support and pay a patient advisory board with a lead patient, 3 patient representatives on the steering committee, and a voice in all major project decisions. The patient advisory board will be especially involved in overseeing things that patients will need to read and respond to and will help us spread the word about our results. We hope our study will help patients and their doctors across the country meet their goals for blood pressure control and improved heart health.

MeSH Terms:
  • American Heart Association
  • American Medical Association
  • * Blood Pressure
  • Blood Pressure Monitoring, Ambulatory /*instrumentation
  • /methods
  • * Blood Pressure Monitors
  • Decision Making
  • Health Services Accessibility
  • Humans
  • Hypertension /*therapy
  • * Outcome Assessment, Health Care
  • Patient Participation
  • * Patient-Centered Care
  • * Self Care
  • Smartphone
  • United States
Country: United States
State: California
Zip Code: 94158
UI: 20191556
Project Status: Ongoing
Record History: ('2020: Archived abstract to Abstract Archived 1 field and added new abstract. Alternate Title: Comparing ways for patients and clinics to improve blood pressure control',)