Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy

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: * Adults aged 18 years or older * Scheduled to undergo elective advanced therapeutic endoscopy * Able to provide informed consent for study participation * Able to engage with study materials in a language supported by the site * Willing and able to complete study questionnaires and follow-up assessments Exclusion Criteria: * Emergent or urgent procedures where the consent process cannot reasonably incorporate the study intervention * Inability or unwillingness to provide informed consent for study participation * Requirement for substitute decision-maker consent for the procedural decision itself, if this precludes meaningful use of the study intervention * Severe cognitive, visual, hearing, or communication limitations not adequately accommodated by site resources * Inability to complete the planned pre-procedural assessments * Prior enrollment in this study for the same procedural episode * Any clinical situation in which the treating endoscopist determines that study participation would be unsafe or inappropriate