The goal of this project is to develop and evaluate a novel, electronic informed consent application for research involving electronic health record (EHR) data. In response to NIH RFA-OD-15-002, this study addresses research using clinical records and data, including the issues of the appropriate content and duration of informed consent and patient preferences about research use of clinical information. First, this study will design an electronic consent application intended to improve patients' satisfaction with and understanding of consent for research using their EHR data. The electronic application will provide interactive functionality that creates a virtual, patient-centered discussion with patients about research that uses EHR data. Also, to correct potential misconceptions and increase informedness, the application will present trust-enhancing messages that highlight facts about research regulations, researcher training, and data protections. Second, in a randomized trial, this study will compare the effectiveness of this new interactive, trust-enhanced consent to an interactive consent with no trust enhancement (interactive) and a consent with no interactivity and no trust enhancement (standard).
Specific Aim 1. Design and qualitatively evaluate an interactive, trust-enhanced consent application that provides interactive information exploration capabilities and factual trust-relevant messages. First, we will develop a prototype based on a multidisciplinary design workshop that involves researchers, ethicists, software developers, and patients. Next, we will conduct think-aloud interviews with 30 adult patients to further improve the application's usability based on patients' perspectives.
Specific Aim 2. Compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust-enhancement). We will conduct a randomized trial of the three consents with 600 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content. We hypothesize that (1) compared to standard consent, the interactive consent will lead to increased decisional satisfaction and understanding of the consent; and (2) compared to the interactive consent, the interactive, trust-enhanced consent will lead to increased decisional satisfaction and understanding of the consent. This project is innovative because it will create a virtual, patient-centered discussion about research using EHR data. Moreover, this project will produce a consent application that clinicians and researchers can use as an ethically sound and practical tool for consenting patients, in a clinical setting, for research involving EHRs.
This study will improve understanding of how to best give patients information about research that uses their health records and data. With this understanding, this study will develop a new computer application that patients can use in their doctors' offices. This application will allow patients to learn more about clinical research and make informed choices about whether or not they want their health records and data to be used for research.
