Abstract Body: Obtaining consent for participation in acute stroke trials is particularly challenging due to the time pressure of delivering immediate treatment. As a result, patients are often not able to provide informed consent to participate in clinical trials. Modifications to standard consent practices such as deferral of consent, surrogate consent, or 2-physician consent can produce problems including violating patient autonomy, disadvantaging patients through their participation and biasing results. Alternatively, advance consent, in which patients at risk of stroke consent to participate in RCTs before they experience a stroke, could address these challenges. In this study, we assessed the acceptability of advance consent to people at risk of stroke.

Methods: We approached patients deemed at risk of stroke in the Stroke Prevention Clinic of the Ottawa Hospital, a tertiary care facility in Ontario, Canada. Eligible patients were invited to complete a questionnaire regarding advance consent. Patients who responded positively to questions about advance consent were offered the opportunity to consent in advance to the EASI-TOC and/or FASTEST clinical trials.

Results: We screened 1547 patients over a 1-year period (July 2023 – July 2024), of whom 431 (28%) were eligible to participate. Of the 431 eligible participants, 157 (36%) completed the initial questionnaire. Of these, 96% (151/157) either agreed or strongly agreed that inviting stroke patients to provide advance consent to participate in clinical research trials is appropriate. Further, 95% (149/157) of participants either agreed or strongly agreed that they would provide advance consent to specific acute stroke clinical research trials, and 69% (108/157) either agreed or strongly agreed that they would provide advance consent to all acute stroke research trials, whether or not they were given the details of the trial. Ultimately, 123 respondents were eligible to be offered advance consent, of whom 45 (37%) provided advance consent to participate in at least one ongoing trial. One participant (0.8%) specified in advance that they would not want to participate in these trials.

Discussion: Preliminary results of this feasibility study show that patients were open to the idea of providing advance consent to participate in acute stroke research and a sizable portion of patients were willing to provide advance consent for ongoing trials.