A Randomized Controlled Trial of Video-Assisted Electronic Consent vs. Standard Consent for Percutaneous Kidney Biopsy (eConsent Bx)

A Randomized Controlled Trial of Video-Assisted Electronic Consent vs. Standard Consent for Percutaneous Kidney Biopsy (eConsent Bx)
Pedro Henrique Franca Gois, Vera Y. Miao, Rebecca Saunderson, Marina Wainstein, Kylie-Ann Mallitt, Shaun Patrick Chandler, Belinda Elford, Rebecca Hudson, Julia Jefferis, Helen Healy, Ann Bonner,
Journal of the American Society of Nephrology, October 2024
Abstract
Background
Video-assisted electronic consent (eConsent) enhances understanding, reduces anxiety, and boosts satisfaction in medical procedures. Yet, its impact on percutaneous kidney biopsies (PKB) remains unexplored. We aimed to assess patient-reported benefits of eConsent versus conventional consent for PKB.
Methods
In a single-center, open-label, RCT, consecutive patients undergoing PKB were randomized (1:1) to either video-assisted eConsent (intervention) or conventional consent (control). The intervention group accessed an online platform featuring an 8-minute explanatory animation before providing eConsent, while the control group was consented by clinicians and signed a paper form. The primary outcome was questionnaire-based patient comprehension, with secondary outcomes including patient-reported experience (KidneyPREM), anxiety, and satisfaction with consent.
Results
Median participant age was 52 years (IQR [34-65]), 30.7% had ≤ year 12 education and 69.3% post-secondary qualifications. Baseline characteristics were similar between groups. PKB comprehension was significantly higher in the intervention group compared to control (3 more questions correct/9; p<0.001), regardless of education level. Moreover, the intervention group demonstrated better understanding of critical information related to pre- and post-PKB care and when to seek medical attention for complications. There were no statistically significant differences in KidneyPREM, anxiety, or satisfaction between groups.
Conclusion
Video-assisted eConsent enhances PKB comprehension without affecting KidneyPREM, anxiety or satisfaction. These benefits extend to patients with lower education levels. Its implementation could standardize and streamline consent processes in PKB, with potential application in other nephrology domains.