Adrian Hernandez, MD, MHS, Co-Principal Investigator for the ADAPTABLE study and Director of Outcomes Research at Duke Clinical Research Institute spoke recently to Clinical Leader magazine about this pragmatic clinical trial. ADAPTABLE is designed to compare the effectiveness of two daily doses of aspirin widely used to prevent heart attacks and strokes in individuals living with heart disease. The study hopes to improve care and outcomes for patients with heart disease.
In addition to answering a question of clinical importance, ADAPTABLE is unique in that its study design incorporated input from patients, physicians, and other stakeholders.
“Patients were vital to the protocol design process,” says Hernandez. “They helped design the interface for the patient portal, and they were instrumental in helping to create the patient consent form, which ensured it was patient-friendly. They are also helping us to spread the word about why it is so important to participate in this study. That is a level of patient interaction that you don’t generally see in a clinical trial.”
Hernandez is hopeful the ADAPTABLE study will change the way the industry looks at patient recruitment. Patients with heart disease will be identified electronically via inclusion/exclusion criteria based on a phenotype. Patients identified as suitable for the trial are then contacted and can learn about the trial via a web portal. After answering a few comprehension questions, they can enroll and be randomized to receive one of two doses of aspirin. Follow-up is also performed electronically via a patient portal as well as through data from the participating healthcare systems.
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.