Digital Informed Consent for Older Adults in Emergency Department Research.

BACKGROUND

The objective of the informed consent (IC) process is to inform potential participants about the purpose, procedures, risks, and benefits associated with clinical research and medical procedures. Traditional paper consent processes are generally long and confusing, especially in busy settings for research such as the emergency department (ED). We describe how we used a tablet-based digital IC process to recruit (N = 1,002) older adults for an elder mistreatment study in the ED.

METHODS

The Virtual Multimedia Interactive Informed Consent (VIC) consent tool was previously developed and tested in an AHRQ-funded R21 study and was found to be usable, acceptable, and it enhanced participants' comprehension and satisfaction when compared to a traditional paper-based IC process (Abujarad et al., 2021a). VIC was developed using a user-centered design (UCD) approach, incorporating digital coaching, multimedia features such as animated videos to explain research procedures, automated text-to-speech audio, and automated teach-back to emphasize key concepts. The VIC digital consent tool was used to recruit patients for an NIA-funded R01 study evaluating the feasibility of the VOICES Elder Mistreatment Intervention, a self-administered digital health intervention to increase identification of elder mistreatment in ED settings. Due to the complexities of elder mistreatment identification, we recognized the need for an IC process that ensures participant privacy, autonomy, and comprehension, with particular focus on the risks and benefits of recognizing and disclosing mistreatment. A total of 1,002 participants ages 60 and older were consented and enrolled during their visit in the ED.

RESULTS

A total of 1,204 of eligible participants agreed to participate in the study and started the consent, of whom 1,012 (84%) participants completed the consent process and enrolled in the VOICES study. Of the 192 (16%) participants who were not enrolled in the study: 158 (13%) did not complete the IC process for varying reasons, the most common reason being due to pain, and 34 (3%) completed the IC fully and chose not to participate in VOICES study. Of the consented participants, 99% fully completed the VOICES study and filled all surveys. Consented participants included older adults from 60 to 102 years old with a mean age of 73.5. Most participants were female, white, and high school educated or higher.

DISCUSSION

We believe that the use of a digital IC process benefitted the participants who were able to complete the IC process on their own and with minimal help from the study coordinators. We received a high study completion rate among consented participants, and we believe that emphasizing key concepts and using multimedia to explain the more complicated research topics helped better educate potential participants to make a true informed decision about their participation in the VOICES study. It is likely that research participants who have a better understanding of the nature of the study are more likely to finish study procedures, increasing study retention. For the patients who did not complete the IC, they associated that to their chief complaint and medical reasons related to the nature of their visit to the ED. More research is needed to compare traditional and digital consent processes to better evaluate the effectiveness of digital consent.