An Interactive Informed Consent Program for Cardiac Procedures

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DESCRIPTION (provided by applicant): Informed consent has become an essential component of the doctor-patient interaction. The informed consent process requires that patients not only be given information about proposed medical treatment, but that it be presented in an understandable way so the patient can make meaningful choices about medical alternatives. At the heart of the informed consent doctrine, is the notion that the patient understands the procedure/therapy as well as its benefits and risks. Unfortunately, this is frequently not the case. Indeed, several studies suggest that many patients do not understand, recall, or even read the consent form. To ensure understanding of informed consent, didactic alternatives to the current informed process need to be applied. ArchieMD Inc. has developed a comprehensive interactive medical simulation environment which has the potential to visually convey complex information to patients to improve understanding of surgical procedures. In Phase I, ArchieMD will use this environment as a basis for developing a prototype interactive informed consent program for cardiac catheterization. This prototype will be evaluated by the University of Michigan in prospective, randomized controlled study comparing standard verbal informed consent to interactive multimedia informed consent for a cardiac catheterization procedure. This project will contribute to public health by improving the quality of understanding achieved during informed consent. This may improved patients medical decision- making, decrease medical litigation, and improve enrollment for clinical trials.