Electronic Informed Consent in the Multi-Arm Optimization of Stroke Thrombolysis Trial

Abstract

Background: Obtaining timely informed consent is a key barrier in acute ischemic stroke clinical trial recruitment. Electronic consent (eConsent) allows electronic delivery and documentation of the informed consent process, which may optimize recruitment. eConsent in acute ischemic stroke clinical trials, however, is limited and understudied. We conducted a post hoc analysis of eConsent adoption in MOST (Multi-Arm Optimization of Stroke Thrombolysis Trial), a phase III acute ischemic stroke clinical trial, and studied the impact on recruitment.

Methods: From October 10, 2019, to July 5, 2023, MOST enrolled 514 participants at 57 sites in the United States. Study databases were reviewed to determine informed consent modality for each participant: paper-in person, paper-remote, eConsent-in person, and eConsent-remote. Study sites could use paper consent or eConsent for each enrollment. eConsent adoption trends and participant demographic diversity were reported using descriptive statistics. We utilized χ² and Kruskal-Wallis tests to compare individual site enrollment, remote consent utilization, baseline neuroimaging-to-randomization times, data clarification requests, and reportable consent-related unanticipated events.

Results: eConsent was utilized for 173 (33.7%) of 514 participants. Of 57 sites, 32 (56.1%) utilized eConsent at least once: those sites had higher median enrollment over the course of the entire trial than non-eConsent sites (7.5 [interquartile range, 5-17] versus 3 [interquartile range, 2-4]; P<0.001). eConsent was completed remotely more frequently than paper consent (46.2% versus 1.2%; P<0.001). Participant demographic diversity and baseline neuroimaging-to-randomization times were similar between eConsent-in person and paper-in person (median, 58.5 [interquartile range, 46.5-72.5] versus 55 [interquartile range, 39-70] minutes). Consent documentation adherence was superior with eConsent-in person compared with paper-in person including decreased data clarification requests (44 versus 81 per 100 participants) and reportable unanticipated events (6 versus 25 per 100 participants).

Conclusions: eConsent in MOST was associated with higher individual site enrollment, higher remote consent rates, and improved consent documentation adherence over paper consent. Our study outlines the potential advantages of eConsent adoption in future acute ischemic stroke clinical trials and stroke research networks.

Keywords: informed consent; ischemic stroke; random allocation; research; stroke.