DCRI Executive Director Adrian Hernandez, MD, MHS, called for a platform that will enable clinical research to be embedded into patient care, allowing research to be conducted at patients’ homes.
DCRI Executive Director Adrian Hernandez, MD, MHS, emphasized the importance of pragmatic research by providing an overview of the ADAPTABLE trial during a symposium held as part of the virtual presentation of the European Society of Cardiology Congress 2020.
ADAPTABLE is a fully pragmatic clinical trial led by Hernandez and other co-investigators at the DCRI. The trial is supported by the Patient-Centered Outcomes Research Institute (PCORI) and leverages PCORnet, the Patient-Centered Outcomes Clinical Research Network, which represents over 100 million patients who have had a medical encounter in the past five years. ADAPTABLE is meant to function as a demonstration project to identify benefits and challenges of pragmatic research, paving the way for future pragmatic projects.
The trial is investigating which dose of aspirin is the optimal dose to prevent heart attacks and strokes in patients living with heart disease. True to the criteria of pragmatic trials, ADAPTABLE seeks to answer a question that is relevant and important to patients, as information about this over-the-counter medication could prevent thousands of heart attacks, bleeds, and deaths per year in the U.S.
“The ADAPTABLE trial was designed to fit into the participants’ lifestyles from beginning to end,” Hernandez said. “By embedding clinical trials into clinical practice, we can imagine a world where research is done at home and does not require any additional site visits.”
From the design phase, when investigators used electronic health records (EHRs) to inform estimates of eligible patients and event rates, to recruitment, when patients were identified by EHRs and enrolled via e-consent, the trial implemented technology and pragmatic elements at every step to reduce the burden of research. The ADAPTABLE team successfully identified and enrolled over 15,000 patients using this approach.
In addition, ADAPTABLE includes novel forms of patient engagement, such as a monthly guest blog featuring one of the patient advocates who helped design the study (a group called the Adaptors) and Facebook Live events and Q&As.
The ADAPTABLE team also completes most of its data collection and follow up electronically, but these pragmatic approaches are mixed with personal approaches. For example, if a patient does not have internet access or misses follow-up periods online, a representative from the DCRI call center, which is part of its Outcomes research group, will make attempts to follow up.
“While ADAPTABLE shows great promise for conducting clinical trials more efficiently, it also underscores the importance of a platform that enables us to embed clinical trials within clinical practice,” Hernandez said. “This will require a reusable research system that unites patients, clinicians, and data.”
Outcomes and results from the ADAPTABLE trial are expected in fall 2021.