Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy (NCT07723105)
Digital-Supported Versus Standard Informed Consent for Advanced Therapeutic Endoscopy: A Pragmatic Multicenter Randomized Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: St. Michael's Hospital - Unity Health Toronto — Toronto, Ontario
Age range: 18 Years
🧪 Interventions in This Study
- Digital-Supported Informed Consent Pathway (BEHAVIORAL)
- Standard Physician-Led Informed Consent (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- St. Michael's Hospital - Unity Health Toronto — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 360-4000
Email: kareem.khalaf@unityhealth.to
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Informed Consent
- Chatbot Implementation In The Clinical Informed Consent Process — Houston, Texas
- AI-Driven Consent Simplification Study — Los Angeles, California
Explore by condition: All Informed Consent clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.