OBJECTIVE: Patients are commonly presented with complex documents that they have difficulty understanding. The objective of this study was to design and evaluate an animated computer agent to explain research consent forms to potential research participants. METHODS: Subjects were invited to participate in a simulated consent process for a study involving a genetic repository. Explanation of the research consent form by the computer agent was compared to explanation by a human and a self-study condition in a randomized trial. Responses were compared according to level of health literacy. RESULTS: Participants were most satisfied with the consent process and most likely to sign the consent form when it was explained by the computer agent, regardless of health literacy level. Participants with adequate health literacy demonstrated the highest level of comprehension with the computer agent-based explanation compared to the other two conditions. However, participants with limited health literacy showed poor comprehension levels in all three conditions. Participants with limited health literacy reported several reasons, such as lack of time constraints, ability to re-ask questions, and lack of bias, for preferring the computer agent-based explanation over a human-based one. CONCLUSION: Animated computer agents can perform as well as or better than humans in the administration of informed consent. PRACTICE IMPLICATIONS: Animated computer agents represent a viable method for explaining health documents to patients.
RCT Entities:
OBJECTIVE:Patients are commonly presented with complex documents that they have difficulty understanding. The objective of this study was to design and evaluate an animated computer agent to explain research consent forms to potential research participants. METHODS: Subjects were invited to participate in a simulated consent process for a study involving a genetic repository. Explanation of the research consent form by the computer agent was compared to explanation by a human and a self-study condition in a randomized trial. Responses were compared according to level of health literacy. RESULTS:Participants were most satisfied with the consent process and most likely to sign the consent form when it was explained by the computer agent, regardless of health literacy level. Participants with adequate health literacy demonstrated the highest level of comprehension with the computer agent-based explanation compared to the other two conditions. However, participants with limited health literacy showed poor comprehension levels in all three conditions. Participants with limited health literacy reported several reasons, such as lack of time constraints, ability to re-ask questions, and lack of bias, for preferring the computer agent-based explanation over a human-based one. CONCLUSION: Animated computer agents can perform as well as or better than humans in the administration of informed consent. PRACTICE IMPLICATIONS: Animated computer agents represent a viable method for explaining health documents to patients.
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