Advance Consent for participation in Acute Stroke Trials (ACTION): protocol for a feasibility study

Area of Science:

• Neurology
• Clinical Research Ethics
• Biomedical Research

Background:

• Informed consent for medical research in emergencies, especially acute stroke, is challenging due to rapid treatment needs and patient incapacitation.
• Current methods like surrogate consent or deferred consent have notable limitations.
• Advance consent offers a potential solution to streamline emergency trial enrollment.

Purpose of the Study:

• To assess the feasibility of implementing an advance consent approach for patients at risk of stroke.
• To evaluate the potential of advance consent to improve the speed, fairness, and transparency of acute stroke trial enrollment.
• To determine if advance consent can lead to more generalizable research findings in stroke care.

Main Methods:

• A five-part study conducted at a quaternary care stroke center.
• Patient and staff questionnaires to gauge perspectives and experiences with advance consent.
• Tracking of patient enrollment in acute stroke trials over one year to measure outcomes like eligibility, recruitment, and withdrawal rates.

Main Results:

• The study will provide data on the feasibility of advance consent in acute stroke research.
• Key outcomes will include eligibility, recruitment, and withdrawal rates for patients enrolled via advance consent.
• Staff experiences with the advance consent process will also be evaluated.

Conclusions:

• This study will determine the practicality of using advance consent for enrolling patients at risk of stroke in clinical trials.
• The findings will inform future strategies for ethical and efficient research participation in time-sensitive medical situations.
• Advance consent has the potential to enhance the quality and applicability of acute stroke research.