Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy

NCT07723105 | Not Yet Recruiting DMC

• 1 other identifier: DIGI-CONSENT-ATE
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Digital consent; Informed consent; Advanced endoscopy; Therapeutic endoscopy; Patient comprehension; Patient education; Artificial intelligence; AI question-answering tool; Video-based consent; Patient satisfaction; Pre-procedural anxiety; Pragmatic randomized trial; Endoscopy workflow

Outcome Measures

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.

  Immediately after the assigned consent pathway and before sedation/procedure

Secondary Outcomes (21)

• Pre-Procedural Anxiety

  Immediately after the assigned consent pathway and before sedation/procedure

• Satisfaction With Consent Process

  Immediately after the assigned consent pathway and before sedation/procedure

• Decisional Confidence or Self-Efficacy

  Immediately after the assigned consent pathway and before sedation/procedure

• Usability and Acceptability of Consent Process

  Immediately after the assigned consent pathway and before sedation/procedure

• Perceived Opportunity to Ask Questions

  Immediately after the assigned consent pathway and before sedation/procedure

Other Outcomes (3)

• Retention of Key Knowledge

  immediately after the intervention

• Subgroup Differences in Comprehension and Consent Outcomes

  immediately after the intervention

• Comparative Performance Across Study Settings

  immediately after the intervention

Study Arms (2)

Digital-Supported Informed Consent

EXPERIMENTAL

Participants assigned to this arm will receive a digital-supported informed consent pathway before elective advanced therapeutic endoscopy. The pathway includes a standardized procedure-specific educational video, an offline AI-based question-answering tool using investigator-approved content, and final physician confirmation before the procedure. The treating physician remains responsible for individualized risk discussion and final procedural consent.

Behavioral: Digital-Supported Informed Consent Pathway

Standard Physician-Led Informed Consent

ACTIVE COMPARATOR

Participants assigned to this arm will receive the usual physician-led informed consent process before elective advanced therapeutic endoscopy according to local clinical practice. The treating physician will review the procedure, risks, benefits, alternatives, and patient questions, and will complete standard institutional procedural consent documentation.

Behavioral: Standard Physician-Led Informed Consent

Interventions

Standard Physician-Led Informed Consent BEHAVIORAL

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.

Also known as: Usual consent, Standard consent process

Standard Physician-Led Informed Consent

Digital-Supported Informed Consent Pathway BEHAVIORAL

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.

Also known as: Digital consent pathway, Video and AI-supported consent

Digital-Supported Informed Consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator

Study Sites (1)

St. Michael's Hospital - Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (5)

• Padival R, Harris KB, Garber A, El-Khider F, Kichler A, Vargo J, Baggott BB. Video Consent for Colonoscopy Improves Knowledge Retention and Patient Satisfaction: A Randomized Controlled Study. J Clin Gastroenterol. 2022 May-Jun 01;56(5):433-437. doi: 10.1097/MCG.0000000000001589.

  PMID: 34319948 BACKGROUND

• Hall DE, Prochazka AV, Fink AS. Informed consent for clinical treatment. CMAJ. 2012 Mar 20;184(5):533-40. doi: 10.1503/cmaj.112120. Epub 2012 Mar 5. No abstract available.

  PMID: 22392947 BACKGROUND

• Agre P, Kurtz RC, Krauss BJ. A randomized trial using videotape to present consent information for colonoscopy. Gastrointest Endosc. 1994 May-Jun;40(3):271-6. doi: 10.1016/s0016-5107(94)70054-0.

  PMID: 8056226 BACKGROUND

• Xia T, Zhu YB, Zeng YB, Chen C, Wang SL, Zhao SB, Su XJ, Wang D, Yao J, Li ZS, Bai Y. Video education can improve awareness of risks for patients undergoing endoscopic retrograde cholangiopancreatography: A randomized trial. J Dig Dis. 2019 Dec;20(12):656-662. doi: 10.1111/1751-2980.12824. Epub 2019 Nov 21.

  PMID: 31618520 BACKGROUND

• Tan CM, Bernstein M, Raboud J, Mannino B, Tinmouth J. Efficiency in the Endoscopy Unit: Can We 'Turn Around' Room Turnover? An Observational Quality Improvement Study. J Can Assoc Gastroenterol. 2022 Mar 10;5(4):e57-e64. doi: 10.1093/jcag/gwac005. eCollection 2022 Aug.

  PMID: 35919763 BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Natalia Causada Calo

  Division of Gastroenterology, St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kareem Khalaf, MD

CONTACT

+1-416-360-4000; kareem.khalaf@unityhealth.to

Kareem Khalaf, MD

CONTACT

kareem.khalaf@unityhealth.to

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and treating clinicians cannot be blinded because the intervention involves exposure to a digital consent pathway. Where feasible, outcome assessors scoring open-ended comprehension responses or reviewing de-identified outcome forms will remain blinded to treatment allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a pragmatic, multicenter, parallel-group randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to either standard physician-led informed consent or a digital-supported informed consent pathway consisting of a standardized procedure-specific educational video, an offline AI-based question-answering tool, and final physician confirmation. Randomization will be centralized and concealed using a secure web-based system, with stratification by site and potentially by major procedure category.

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 23, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)