Implementation of the Department of Veterans Affairs' first point-of-care clinical trial

The Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC) and the Stanford Center for Innovative Study Design have developed a new method for the implementation of experimental clinical research. The point-of-care clinical trial (POCCT) is designed to be embedded directly into the clinical care setting thereby addressing the issues of cost and translation, and creating an integrated environment of research-based care. The POCCT capitalizes on the Veterans Affairs (VA) electronic medical record (EMR) system to perform study activities traditionally conducted by a study team such as enrolment, randomization, and longitudinal data collection. In addition, as evidence accumulates in favor of a specific intervention, it can be transitioned to decision support in the same EMR. As a result, POCCT integrate clinical research and clinical care providing a valuable tool for achieving the vision of a ‘learning healthcare system’. In this article, the implementation of the VA's first POCCT is described, citing experience to date with an ongoing comparative effectiveness study comparing two common regimens of administering insulin. The informatics-related challenges and strategies used to overcome them are the primary focus of this article, with additional consideration of the potential of POCCT to diffuse within and beyond the VA healthcare system.