PCORnet® Study Comparing Blood Pressure Control Strategies Seeks Answers
During the COVID-19 pandemic, researchers are using PCORnet®, the National Patient-Centered Clinical Research Network, to support several efforts to rapidly inform the nation’s response to the disease caused by the novel coronavirus. The PCORnet Study, “Using PCORnet to Compare Blood Pressure Control Strategies,” is leveraging a broad cohort of hypertensive patients to better understand what, if any, connection exists between the use of ACE inhibitors or angiotensin receptor blockers and incidence and severity of a COVID-19 infection.
This effort is an enhancement to a study that was already underway with funding from the Patient-Centered Outcomes Research Institute (PCORI). The research team recognized the opportunity to capitalize on the work and resources they had built during their study to answer an important question about the coronavirus’s effects on people with heart disease. They received supplemental funding from PCORI to pursue this additional aim.
“Millions of people around the world use ACE inhibitors and angiotensin receptor blockers for blood pressure control, and early concerns exist that the novel coronavirus may enter human cells through receptors that increase with the use of these medications, making those patients more susceptible,” said Rhonda Cooper-DeHoff, co-principal investigator of the study from the University of Florida College of Pharmacy. “Because of the research-ready infrastructure created through PCORnet, our study team was able to expand our aims to rapidly explore this concern.”
PCORnet is a network of networks with fast access to secure, curated data from millions of patients across the largest health systems in the United States, making it a powerful resource for the rapid insights needed in a pandemic environment. Cooper-DeHoff’s study team is drawing on electronic health record data from 1.5 million patients to explore whether there is a statistically significant relationship between the use of blood pressure medications and incidence or severity of coronavirus infection. The PCORnet Common Data Model, which standardizes data across each PCORnet Network Partner, is structured to enable the team to quickly classify detailed medication use, as well as other important patient insights like underlying conditions and comorbidities.
“The robust infrastructure of PCORnet, and particularly the Common Data Model that unites millions of disparate data points so they are usable and meaningful for research, is giving us a significant head start in our search for answers,” said Mark Pletcher, from UCSF, co-Principal Investigator. “In a traditional clinical study, these types of efforts can take years. That’s time we don’t have in a pandemic environment, where we need answers fast.”
Results from this study are expected in late 2020.
A comparison of blood pressure control strategies
Prior to receiving the supplemental funding, “Using PCORnet to Compare Blood Pressure Control Strategies” was focused on three other aims anticipated to give meaningful answers to questions that are important to patients. Pletcher and Cooper-DeHoff also hopes the framework for the study, the PCORnet Blood Pressure Control Laboratory, will serve as a platform used in future research to improve surveillance of patients with hypertension and enhance comparative effectiveness research on the topic.
The first study aim, BP Track, is to conduct national surveillance of blood pressure control with a goal to understand disparities. BP MAP, the second aim, is a cluster-randomized trial comparing two versions of a blood control quality improvement intervention from the American Medical Association. Finally, BP Home is a patient-level randomized trial comparing standard home blood pressure monitoring with a smartphone-linked blood pressure monitoring system. Details of each of these efforts, as well as interim results, have been published at Circulation: Cardiovascular Quality and Outcomes.
“The broad scope of PCORnet means that, unlike many studies of blood pressure control, we are working with a sample that represents the full spectrum of the country,” said Pletcher. “What’s more exciting is that it won’t end with these aims; the PCORnet Blood Pressure Control Laboratory is designed to be a reusable platform to help us pinpoint the health care processes related to blood pressure control that need improvement, learn from high-performing health systems, and better understand how to improve blood pressure control and adherence in our patient communities.”
Patients at the heart of every effort
Every PCORnet Study demonstrates patient engagement in all study aspects and commits to disseminating study progress, metrics, best practices, and results across the Network and in relevant patient communities. “Using PCORnet to Compare Blood Pressure Control Strategies” is no exception, with the University of California San Francisco’s Health Research Alliance of patients engaged in the process. These patients serve on the study’s advisory board for all aims, offering input on materials and methods, dissemination, and more.
“Blood pressure control is part of the daily health regimen for millions of Americans, which makes patient input in this study absolutely crucial,” said Pletcher. “With their guidance, we can ensure that we not only explore the right questions, but also deliver answers to the community in a way that is well received and impactful to our national health.”
Full results from BP Track, BP MAP, and BP Home are all expected late summer 2021.