The use of multimedia in the informed consent process

Area of Science:

• Clinical Research
• Health Informatics
• Patient Education

Background:

• The informed consent process in clinical trials is complex.
• Patients, particularly those with cognitive impairments, may struggle to understand trial information.
• Current paper-based methods can be stressful and disempowering.

Purpose of the Study:

• To develop recommendations and design specifications for a multimedia tool to enhance clinical trial informed consent.
• To focus on the needs of patients with potential cognitive impairment.
• To assess the feasibility and effectiveness of a prototype multimedia informed consent tool.

Main Methods:

• Needs assessment via focus groups and interviews with patients, researchers, and IRB members.
• Development of a prototype multimedia tool with general and trial-specific modules.
• Usability testing of the prototype in follow-up focus groups and interviews.

Main Results:

• The multimedia tool was adaptable to specific trials and improved content understandability.
• Patients found the tool useful, less stressful, and preferred it over paper documents.
• Researchers and IRB members saw value but raised concerns about bias review and legal issues.

Conclusions:

• A multimedia approach is feasible for improving clinical trial informed consent, particularly for vulnerable populations.
• The tool enhances patient understanding, control, and reduces stress.
• Further work is needed to address concerns regarding bias and legal implications.