Communication Research Clinical Trial
Official title:
An Interactive Patient-Centered Consent for Research Using Medical Records
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. 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. This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of the interactive, trust-enhanced consent application to an interactive consent and standard consent (no interactivity, no trust- enhancement) using a randomized trial of the three consents with 750 adults in a network of family medicine practices. Primary outcomes will be satisfaction with the consent decision and understanding of the consent content. 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. This first phase of this project (IRB#:201500678) was innovative because it created a virtual, patient-centered discussion about research using EHR data. Moreover, this project produced a consent application that clinicians and researchers will use in this phase (Phase two) of the trial as an ethically sound and practical tool for consenting patients, in a clinical setting, for research involving EHRs. Overall, 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.
This study (Specific Aim 2 of the linked study protocol) will compare the effectiveness of
the interactive, trust-enhanced consent application to an interactive consent and standard
consent (no interactivity, no trust- enhancement) using a randomized trial of the three
consents with 750 adults in a network of family medicine practices. Primary outcomes will be
satisfaction with the consent decision and understanding of the consent content.
Conceptually, the hypothesized effectiveness of this study's new consent application relies
on two constructs, interactivity and trust. Many studies have identified the importance of
trust in researchers when it comes to people's willingness to participate in research.
Moreover, trust in the source of information is critical to participants' evaluations of risk
information. And, risk information is an important element of the research consent process.
Thus, highlighted relevant messages to participants at the outset of a research consent
process. It is expected that these messages will not coerce participants nor will they
dramatically alter participants' general trust in researchers. More importantly, empirically
assessments of both of these expectations to ensure the application delivers an ethically
appropriate consenting experience. However, it is expected that presenting key facts about
research data protections, researcher training, and research regulations will increase the
likelihood that participants will be willing to learn about research using medical records.
In turn, this will increase participants' understanding and help them make a more informed
decision. In the absence of these trust-related messages, it is expected that many
participants will simply disengage from the details of the consent information and thus make
a less informed decision about participating. Next, the investigators' use of interactivity
is supported by research on the effectiveness of communications that interactively deliver
detail, empower audiences, and allow a self - discovery process. Indeed, an interactive,
person-to-person consent process is the standard approach in clinical trials. Therefore, in
the new consent application, the interface will allow participants to interactively explore
the details that are most important for their personal understanding of research using EHRs
and most relevant to their personal information needs and satisfaction with the consent
decision. Without this interactive information exploration, which is essentially dynamically
tailored to their personal information needs, participants are more likely to be overwhelmed
by the volume of information presented and unable to obtain the information they want most.
Under these circumstances, participants' overall understanding of the consent information is
likely to decrease, and they are likely to make less satisfactory decisions. There are two
specific hypotheses: (1) compared to the 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.
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