Digital Informed Consent for Older Adults in Emergency Department Research.

Area of Science:

• Gerontology
• Clinical Research Methodology
• Public Health

Background:

• Traditional paper-based informed consent (IC) is often lengthy and confusing, particularly in busy clinical settings like emergency departments (EDs).
• Effective IC is crucial for clinical research and medical procedures, ensuring participants understand study purpose, procedures, risks, and benefits.
• Older adults in EDs require a clear and accessible IC process, especially for sensitive research topics like elder mistreatment.

Purpose of the Study:

• To describe the implementation of a tablet-based digital IC process for recruiting older adults into an elder mistreatment study in the ED.
• To evaluate the feasibility and effectiveness of the Virtual Multimedia Interactive Informed Consent (VIC) tool in a real-world research setting.
• To enhance participant comprehension, satisfaction, and retention in a study involving sensitive health information.

Main Methods:

• Utilized the Virtual Multimedia Interactive Informed Consent (VIC) tool, featuring digital coaching, animated videos, text-to-speech audio, and automated teach-back.
• Recruited 1,002 participants aged 60 and older for the VOICES Elder Mistreatment Intervention study conducted in an ED.
• Employed a user-centered design approach to ensure the digital IC process prioritized participant privacy, autonomy, and comprehension.

Main Results:

• 1,012 (84%) of 1,204 eligible participants completed the digital IC process and enrolled in the VOICES study.
• 99% of consented participants fully completed the study, indicating high retention rates.
• Reasons for non-completion of IC were primarily medical or pain-related, with 16% not enrolling.

Conclusions:

• A tablet-based digital IC process, like the VIC tool, can effectively recruit and retain older adults in sensitive research conducted in ED settings.
• Multimedia features and interactive elements in digital IC enhance participant understanding and decision-making, potentially improving study completion.
• Further research is needed to directly compare digital and traditional IC methods for optimizing recruitment and retention in diverse clinical populations.