Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnity Health Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital-Supported Informed Consent Pathway
BehavioralThe 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.
Standard Physician-Led Informed Consent
BehavioralThe 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.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Digital-Supported Informed ConsentExperimental treatment 1 intervention
Group B: Standard Physician-Led Informed ConsentActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient Comprehension of Informed Consent Information
Patient comprehension will be assessed using a structured procedure-specific comprehension instrument after the assigned consent pathway. The instrument will assess understanding of the nature of the procedure, purpose or indication, risks, benefits, alternatives, right to ask questions or refuse, and expectations before and after the procedure.
Time frame
Immediately after the assigned consent pathway and before sedation/procedureSecondary outcomes
1
Pre-Procedural Anxiety
Participant-reported anxiety after completion of the assigned consent pathway, assessed using a study questionnaire or validated anxiety measure, as finalized in the study assessment plan.
Time frame
Immediately after the assigned consent pathway and before sedation/procedure2
Satisfaction With Consent Process
Participant-reported satisfaction with the assigned consent process, including perceived clarity and helpfulness of the information provided.
Time frame
Immediately after the assigned consent pathway and before sedation/procedure3
Decisional Confidence or Self-Efficacy
Participant-reported confidence in the decision to proceed with the procedure and perceived ability to make an informed decision after the consent process.
Time frame
Immediately after the assigned consent pathway and before sedation/procedure4
Usability and Acceptability of Consent Process
Participant-reported usability and acceptability of the assigned consent process. For participants in the digital-supported arm, this will include perceived usability and acceptability of the video and AI-based question-answering tool.
Time frame
Immediately after the assigned consent pathway and before sedation/procedureOther outcomes
1
Retention of Key Knowledge
Participant retention of key consent-related knowledge at short follow-up after the procedure.
Time frame
immediately after the intervention2
Subgroup Differences in Comprehension and Consent Outcomes
Exploratory subgroup analyses by age, education, prior endoscopy experience, digital literacy, procedure type, and site.
Time frame
immediately after the intervention3
Comparative Performance Across Study Settings
Exploratory comparison of intervention performance across North American and European participating sites.
Time frame
immediately after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Unity Health Toronto
Lead sponsor
University of Toronto
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: