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.
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Patient Comprehension of Informed Consent Information
Timeframe: Immediately after the assigned consent pathway and before sedation/procedure