Use of Electronic Health Records, Patient Reported Outcomes, and the Common Data Model to Transform Clinical Trials

Adrian Hernandez, MD, MHS, Co-Principal Investigator for the PCORnet Coordinating Center and Director of Health Services  and Outcomes Research at Duke Clinical Research Institute spoke recently to Clinical Leader magazine on leveraging electronic health records (EHRs), patient reported outcomes, and the PCORnet Common Data Model in the ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness) Study.

PCORI is investing over $300 million into a clinical research network that will unite patients, clinicians, health systems, and EHRs,” says Dr. Adrian Hernandez, associate director of the Duke Clinical Research Institute. “The network itself has medical information and data on over 100 million subjects, and the patient EHRs are mapped to the PCORnet Common Data Model (CDM), which essentially organizes data into a standard structure. That network will make ADAPTABLE the first pragmatic clinical trial to use the network. The trial will select patients via their EHRs, reach out to them electronically, consent them electronically, and then follow up with them electronically.”

ADAPTABLE  is comparing the effectiveness of two daily doses of aspirin  widely used to prevent heart attacks and strokes in individuals living with heart disease.  Every year, over 720,000 Americans suffer heart-attacks and 380,000 die of coronary artery disease (CAD). While new therapies for CAD are needed, an increased use of aspirin is believed to have a positive impact on the rates of death and disability. Unfortunately, the dose of aspirin that would result in the lowest risk of bleeding events has not been determined. The main objective of the ADAPTABLE study is to identify that optimal dose of aspirin.

Click here to access the complete interview in the Clinical Leader.

The ADAPTABLE study is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (Contract Number: ASP-1502-27079). ADAPTABLE is the first demonstration project to be conducted through PCORnet, the National Patient-Centered Clinical Research Network. PCORnet is a PCORI-funded initiative designed to improve the nation’s capacity to conduct comparative clinical effectiveness research. More information about PCORnet can be found here.