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The University of Nebraska Medical Center is participating in a study comparing the effects of two dosages of aspirin in patients who have a history of vascular disease. Called the ADAPTABLE trial, it is a nationwide study that marks the first time UNMC will be able to draw extensively from electronic health records for data.
James Campbell, M.D., and James McClay, M.D., are the principal investigators for UNMC. Dr. McClay is the principal investigator on UNMC's participation in the National Patient Centered Research Network (PCORnet).
Working with the Greater Plains Collaborative Research Network, UNMC has been building and enhancing its clinical research data warehouse to make that electronic health record information reusable for clinical research and education. The University of Iowa is the lead on the project for the GPC Network.
The study will compare the effects of two different dosages of aspirin – 325 milligrams, the normal adult aspirin dosage, and 81 milligrams, the amount in a standard baby aspirin – in patients who have known vascular diseases.
“There is good evidence in clinical medicine that aspirin can be beneficial to help to prevent heart attacks and strokes,” said Dr. Campbell, who is professor of general internal medicine. “But it irritates some people's stomachs and causes them to bleed."
Historically, there have been studies that have studied everything from 81 to 650 milligrams, and have shown benefits of one type or another, but always with some downside. This study will examine head-to-head effects of the probably minimal effective dose of 81 milligrams and 325 milligrams, the common tablet strength.
“This study is simply trying to verify whether there is a difference in outcomes, complications and also the incidence of heart attack and stroke that differs between those two doses, to try to establish an optimal treatment,” Dr. Campbell said.
“The ADAPTABLE trial is a major demonstration of PCORnet, the national patient-centered research network we've built over the past three years,” said Dr. McClay, who is associate professor, emergency medicine. “PCORnet pulls together electronic health record data from over 80 million patients for research.”
“The vision for the use and sharing of electronic health records is to improve health care,” Dr. McClay said. “We can transform clinical research through this system.”
“We're in the process of networking all of our electronic health records so that physicians can get information in a timely basis, but also so that we can re-use that data – when the patient agrees – for research and public health purposes,” said Dr. Campbell, who is professor of general internal medicine. “So, as a part of the recruitment for this study, we've actually pulled up our electronic health record data, and we've searched through historical information in order to identify patients that are likely to fit the study criteria.”
In addition to using electronic health records for recruitment of patients through their physicians, investigators – the GPC Research Network, a 13-university collaboration across the Midwest – will be periodically running queries on that data warehouse to look for outcomes in the study.
"If the patient comes in and is hospitalized, and has a heart attack or stroke, we can expect to get that report out of the electronic health record abstract," Dr. Campbell said. "That will be part of the way of reporting study results. So, it is sort of an observational study where the electronic health record is a participant, and we're networking our electronic health records across the United States. The ADAPTABLE study represents a new way to run comparative effectiveness research."
"PCORNet and the ADAPTABLE trial, with their use of the electronic health record to answer critically important medical questions, serve as excellent examples of benefits directly related to the integration of UNMC and Nebraska Medicine," said Chris Kratochvil, M.D., associate vice chancellor for clinical research, UNMC, and vice president for research, Nebraska Medicine.
About the ADAPTABLE trial
The ADAPTABLE study is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award. ADAPTABLE is the first demonstration project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network.
About PCORnet
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation's capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available here.
About PCORI
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available here.
About the Greater Plains Collaborative Research Network (GPC Network)
The Greater Plains Collaborative (GPC) is a research network of 12 leading medical centers in eight states committed to a shared vision of improving health care delivery through ongoing learning, adoption of evidence-based practices and active research dissemination. More information is available here.
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