Abstract TP289: Legal Authorized Representative Feedback on the use of Smartphone Platform for Electronic Informed Consent in an Acute Stroke Trial

Introduction: We have recently reported the pilot use of a smartphone platform for electronic informed consenting (e-Consent) in acute stroke trials. We here report the feedback provided by legal authorized representatives (LAR) after consenting for a large vessel occlusion acute ischemic stroke (LVOS) randomized clinical trial. Methods: This is a single-center prospective study investigating the criticism of LAR after the use of e-Consent for a clinical trial of neuroprotectant in LVOS within 12 hours of last normal. REDCap (Research Electronic Data Capture) is a secure, Health Insurance Portability and Accountability Act compliant, web-based platform designed for research data capture that was used to create a survey project located on a static URL that can be remotely accessed (via smartphone browser). Regardless of the geographical position of the LAR, a standard link to the URL was sent via text message to the LAR and signed. A structured survey was applied to each LAR at least 12 hours after enrollment. Results: From February-August 2018, 33 patients were enrolled in the trial. Four LARs were unavailable, 3 expired before the questionnaire could be applied, and 1 refused to participate, leaving 25 patients for the primary analysis. Mean LAR age was 49±13 years, 68% were female, 44% black/48% white, 44% had high-school education or less. All LARs reported e-Consent to be “clear”. Eighty percent felt “ very confortable” in signing an e-Consent, 16% “somewhat” and 4% “not comfortable at all”. Four (16%) LARs would prefer paper consent. The overall experience was “excellent” in 64%, “good” in 28%, and “poor” in 8%. Seventy-two percent of surveys were done via phone and 28% in person. The patient’s median baseline and discharge NIHSS was 17[IQR 12-22] and 2[1-7], and 60% had discharge modified Rankin Scale 0-2. Male gender (75% vs 6%;p=0.04) and education level less than college (100% vs 0%);p=0.03 were associated with preference of paper over e-consent, while baseline and discharge NIHSS were not. Conclusion: e-Consent was overall very well perceived by LAR in a randomized clinical trial of LVOS. A small percentage of LAR, who were more commonly male and formally less educated, preferred paper consent.