204 Electronic confirmed versus conventional consenting process (ECCCO): a randomized controlled trial

Abstract

To evaluate an internet-based multimedia education and consent process for repeat cesarean. Patients scheduled for repeat cesarean were randomly assigned to in-person consenting (in-person group), internet-based multimedia consenting only (electronic group), or both (combined group). Patients in the in-person group underwent consenting on the day of surgery as usual at the site. Within 14 days of surgery, patients in the electronic and combined groups accessed a cloud-based interactive platform that delivered standardized surgical information in a video format followed by a knowledge assessment which participants needed to pass for e-signature to occur. A validated scale (COMRADE) of 20 statements to assess risk communication and treatment decision-making satisfaction was obtained after completion of assigned intervention. We calculated that 38 in each group would be needed to detect a 20% improvement in COMRADE scores. From June 2018 to August 2020, 114 patients were randomized (in-person: 38, electronic: 37, combined: 39). 11 were lost to follow up (4, 3, 4 respectively). Baseline characteristics were similar between groups. Median [range] COMRADE scores did not differ among groups (in-person: 97 [49-100]; electronic: 98 [55-100]; combined: 97 [70-100]; p=0.75). Compared with the in-person group, patients who received internet-based multimedia educational content were significantly more likely to know about the disadvantages of the proposed surgery (risks), know about other treatment choices (alternatives), and feel that an informed choice has been made (satisfaction). Some of the COMRADE components were better in the internet only, some in the combined, and some in both, but none were better in the in-person only group (Table). Internet-based consenting with multimedia educational content is an alternative to traditional in-person consenting and provides better patient understanding of the procedure’s risks and alternatives, increased patient confidence in their choice of procedure, as well as electronic documentation and confirmation of the consenting process.