Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study.

BACKGROUND: The use of electronic informed consent (eIC) in decentralized trials offers a pragmatic approach to enrolling participants across multiple geographic areas. METHODS: Using a randomized, cross-over study design, we conducted a qualitative descriptive evaluation of two eIC approaches-text-only eIC and enhanced eIC-in a mock hypertension Phase III clinical trial. We assessed participant comprehension and acceptability (usability, satisfaction, and eIC preference). RESULTS: A total of 24 individuals with hypertension participated in the study: 12 reviewed the text-only eIC first, followed by the enhanced eIC, and 12 reviewed the enhanced eIC first, followed by the text-only eIC. The study population was diverse in gender, age, race, and geographic location. We found no descriptive differences in participant comprehension and satisfaction between the two eIC approaches. However, more participants preferred the enhanced eIC, and participants indicated that the digital elements were personable and made them feel more informed, engaged, comfortable, and prepared to participate in clinical research. CONCLUSIONS: Our findings suggest that enhancing the eIC process with digital elements may have beneficial outcomes among potential participants beyond comprehension and satisfaction.

Duke Scholars

Author Amy Lynn Corneli Population Health Sciences