The informed consent process protects patients and ensures ethical conduct of research. For patients to fully understand the content of the informed consent process, it should clearly explain the purpose, process, risks, benefits and alternatives to medical procedures or clinical research as well as a patient's rights and responsibilities. Patient safety and quality of care are at risk if the informed consent process is not delivered in way that assures patient comprehension. To minimize cost and risks, many providers opt for electronic informed consent that doesn't go beyond the paper based informed consent process. While it is an effort at improvement, this method still does not enhance patient comprehension or the quality of care. Adoption of methods that allow researchers to conduct brief and virtual interviews with participants to complete the informed consent process using tablet computers (e.g. iPads) with a comprehensive multimedia library (e.g. video clips, animations, presentations, etc.) to explains the risks, benefits, and alternatives of the clinical care will enhance patient comprehension. The goal of this project is to help make the conduct of patient centered outcomes research (PCOR) more efficient and more widely implemented by engaging key stakeholders, including patients, through the development and evaluation of a new mobile health (mHealth) informed consent tool to disseminate PCOR findings in informed consent research. Therefore we propose to enhance the traditional informed consent process by developing the Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC). VIC will be developed as a patient-centered web-based mobile application and will be able to run on mobile devices. The overarching motivation for the development of VIC is to create a reusable infrastructure for integrating the informed consent process into clinical care and the clinical workflow in a way that enhances patient comprehension while improving the efficiency of obtaining patient consent. VIC will be tested in an existing clinical research study to demonstrate that it can facilitate the study of complex interventions in real-world clinical settins.
Our aims are: 1) To develop, test and refine the Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC) to enhance patient comprehension while improving the efficiency of obtaining patient consent; 2) To evaluate the effectiveness of VIC compared to a standard PI/coordinator-delivered consent in a real-world clinical research study.
Patient safety and quality of care are at risk if the process of obtaining informed consent is not delivered in a way that assures patient comprehension. In this study we will develop and evaluate the Patient Centered Virtual Multimedia Interactive Informed Consent (VIC) mobile informed consent tool that will enable the informed consent process to be performed on handheld devices (e.g. iPads) utilizing interactive multimedia libraries (e.g. graphics, video clips, animations, presentations, etc.) designed to enhance patient comprehension and quality of care, while improving the efficiency of obtaining patient consent.
| Abujarad, Fuad; Alfano, Sandra; Bright, Tiffani J et al. (2017) Building an Informed Consent Tool Starting with the Patient: The Patient-Centered Virtual Multimedia Interactive Informed Consent (VIC). AMIA Annu Symp Proc 2017:374-383 |
