This study will evaluate whether a digital-supported informed consent process improves patient understanding before advanced therapeutic endoscopy procedures.
Patients undergoing advanced therapeutic endoscopy are often asked to make decisions about procedures that may be complex and involve important risks, benefits, and alternatives. Standard informed consent is usually provided through discussion with the treating physician. However, this process can vary between clinicians and may be affected by time pressures in busy endoscopy units.
In this study, eligible adult patients scheduled for elective advanced therapeutic endoscopy will be randomly assigned to one of two consent pathways. One group will receive standard physician-led informed consent. The other group will receive a digital-supported consent pathway that includes a standardized procedure-specific educational video, an offline artificial intelligence-based question-answering tool, and final confirmation with the treating physician before the procedure.
The digital tool is designed to provide plain-language information about the procedure, including why it is being done, expected benefits, common and serious risks, alternatives, what to expect before and after the procedure, and the patient's right to ask questions or decline the procedure. The AI question-answering tool will use only investigator-approved educational content and will not provide individualized medical advice. Questions requiring patient-specific medical judgment will be directed back to the treating clinical team.
The main outcome of the study is patient comprehension of the consent information, measured after the assigned consent process and before the procedure. The study will also evaluate patient anxiety, satisfaction, confidence in decision-making, usability of the consent process, workflow outcomes, and consent-related safety or ethical concerns.
Inclusion Criteria:
Exclusion Criteria:
kareem.khalaf@unityhealth.to+1-416-360-4000 ext. 77537
Participants and treating clinicians cannot be blinded because the intervention involves exposure to a digital consent pathway. Where feasible, outcome assessors scoring open-ended comprehension responses or reviewing de-identified outcome forms will remain blinded to treatment allocation.
Participants assigned to this arm will receive a digital-supported informed consent pathway before elective advanced therapeutic endoscopy. The pathway includes a standardized procedure-specific educational video, an offline AI-based question-answering tool using investigator-approved content, and final physician confirmation before the procedure. The treating physician remains responsible for individualized risk discussion and final procedural consent.
Participants assigned to this arm will receive the usual physician-led informed consent process before elective advanced therapeutic endoscopy according to local clinical practice. The treating physician will review the procedure, risks, benefits, alternatives, and patient questions, and will complete standard institutional procedural consent documentation.
kareem.khalaf@unityhealth.to
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