Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy

Summary

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.

Conditions

• Informed Consent
• Patient Education
• Patient Comprehension
• Therapeutic Endoscopy
• Digital Health

Interventions

BEHAVIORAL

Digital-Supported Informed Consent Pathway

The digital-supported informed consent pathway consists of a standardized procedure-specific educational video, an offline AI-based question-answering interface, and final physician confirmation. The video explains the nature of the procedure, indication, expected benefits, major and common risks, alternatives, what to expect before and after the procedure, and the patient's right to ask questions or decline. The AI tool provides plain-language responses based only on investigator-approved educational materials and redirects individualized or high-risk questions to the treating clinical team.

BEHAVIORAL

Standard Physician-Led Informed Consent

The standard physician-led informed consent process consists of usual pre-procedure counseling by the treating physician according to local clinical practice. The physician discusses the procedure, indication, expected benefits, risks, alternatives, and patient questions, and completes standard institutional procedural consent documentation before the advanced therapeutic endoscopy procedure.

Sponsors & Collaborators

• University of Toronto

  collaborator OTHER

• Unity Health Toronto

  lead OTHER

Principal Investigators

• Natalia Causada Calo · Division of Gastroenterology, St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-12-01

Completion

2028-03-01

Countries

• Canada

Study Locations