Virtual Multimedia Interactive Informed Consent (VIC)

Virtual Multimedia Interactive Informed Consent (VIC)

The Informed Consent is a process designed to protect patients and ensure ethical conduct of clinical care and research. However, patients may not understand the risks, the benefits and alternatives of their treatments, even after signing a consent form. To minimize cost and risks, the Dr. Fuad Abujarad developed a new mHealth tool known as Patient Center Virtual Multimedia Interactive Informed Consent (VIC) that uses virtual coaching to conduct a brief interview with patients and to complete the informed consent process. He uses iPads equipped with a comprehensive multimedia library to explains the risks, benefits, and alternatives of the clinical care to enhance patient comprehension. VIC includes many functions and features such as ‘teach-back’ process, automated readability evaluation, retrievable electronic IC, electronic signature, and integration with electronic health record.

The VIC team is composed of the project PI Fuad Abujarad (PhD), and Co-investigators Geoffrey Chupp (MD), Sandra Alfano (PharmD), and Peter Peduzzi (PhD). They developed, tested, and refined the VIC mHealth tool via User-Centered Design (UCD) methodology and User Experience (UX) evaluations. VIC research project was funded by an R21 grant from AHRQ.

For more information, please visit our project website at vic.yale.edu.

Geoffrey Lowell Chupp, MD

Professor of Medicine (Pulmonary); Director, Yale Center for Asthma and Airways Disease (YCAAD); Director, Pulmonary Function Laboratory, Yale-New Haven Hospital

After graduating from Tufts University and the George Washington School of Medicine, Dr. Geoffrey Chupp completed a residency in Internal Medicine at the Tufts University School of Medicine and a Pulmonary and Critical Care Medicine Fellowship at Boston University School of Medicine. In 1997 Dr. Chupp came to Yale in 1997 and developed the Yale Center for Asthma and Airways Disease. This multifaceted program is a multidisciplinary clinical program that focuses on the care of patients with severe as and other complicated airways diseases, a center for translational research in airways disease, and a center where patients can participate in cutting edge industry sponsored research trials. The success of YCAAD has recently been realized with the publications on novel observations on chitinases in patients with asthma recruited from this multidisciplinary center.

geoffrey.chupp@yale.edu

Sandra Alfano, PharmD

Research Scientist in Medicine (General Medicine) and Assistant Clinical Professor of Nursing; Senior Research Analyst, Conflict of Interest Committee

As a former Chair of two of the Yale biomedical IRBs (referred to as the Human Investigation Committee, HIC) I worked closely with key leaders at the Yale Center for Clinical Investigation (YCCI), actively collaborating on YCCI grants focused on IRB metrics improvement, and subject recruitment and satisfaction methodologies. Through this active collaboration, YCCI’s role and expertise in clinical research is incorporated into the University’s overall Human Research Protection Program. I also have an active interest in informed consent for research participants and improving the informed consent process. These experiences well-positioned me to add meaningful insight to this proposal to create a model informed consent and a reusable infrastructure for integrating the informed consent process into clinical care and workflow in a way that enhances participant understanding. The overall goal will be to ultimately improve the protection of human subjects while minimizing research burden and interference with clinical care.

sandra.alfano@yale.edu

Peter Natale Peduzzi, PhD

Professor of Biostatistics; Director, Yale Center for Analytical Sciences (YCAS); Director Yale Data Coordinating Center

Peter is professor of biostatistics at YSPH and director of the Yale Center for Analytical Sciences (YCAS) and the Yale Data Coordinating Center. Dr. Peduzzi has nearly 40 years’ experience in the design, conduct and analysis of clinical trials with a particular focus on pragmatic trials. He is the PI of several data coordinating centers funded by NIH and PCORI. Before coming to Yale he was the Director of the Department of Veterans Affairs (VA) Cooperative Studies Program Coordinating Center in West Haven, Connecticut, which conducts multi-center, multi-national clinical trials and epidemiologic studies. He still maintains an affiliation with this center. His primary research interests have focused on the efficient design and analysis of clinical trials, with a recent focus on clustered randomized trials.

peter.peduzzi@yale.edu