Digital-Supported Versus Standard Consent for Advanced Therapeutic Endoscopy (DIGI-CONSENT)

Digital-Supported Versus Standard Informed Consent for Advanced Therapeutic Endoscopy: A Pragmatic Multicenter Randomized 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Informed Consent; Patient Education; Digital Health; Therapeutic Endoscopy; Patient Comprehension
• Intervention / Treatment: Behavioral: Digital-Supported Informed Consent Pathway; Behavioral: Standard Physician-Led Informed Consent

Detailed Description

This is a pragmatic multicenter randomized controlled trial evaluating digital-supported informed consent compared with standard physician-led informed consent for adults undergoing elective advanced therapeutic endoscopy.

The study will be conducted in three sequential phases. In the first phase, the digital consent tool will be developed through an iterative co-design process involving the study team, a specialist engineer, and at least one patient partner. The tool will include a standardized procedure-specific educational video and an offline artificial intelligence-based question-answering interface. The AI component will be developed using only investigator-approved educational materials, standardized consent language, and curated frequently asked questions. It will not browse the internet, retrieve external information in real time, or provide individualized medical advice.

In the second phase, a pilot study will assess feasibility, usability, acceptability, and operational performance of the digital consent pathway. The pilot will assess whether participants can access and complete the video and AI interface, whether the digital tool functions as intended, whether the survey-based outcome assessment workflow is practical, and whether refinements are needed before the full randomized trial. The pilot phase is not intended to provide definitive comparative effectiveness results.

In the third phase, the finalized intervention will be evaluated in a multicenter, parallel-group randomized controlled trial. Eligible participants will be randomized in a 1:1 ratio to either standard physician-led informed consent or the digital-supported consent pathway. Randomization will be centralized and concealed using a secure web-based system, with stratification by site and potentially by major procedure category.

Participants assigned to the standard consent arm will receive the usual physician-led informed consent process according to local clinical practice. Participants assigned to the digital-supported arm will receive access to a procedure-specific digital consent package, ideally before the procedure. The digital package will include a standardized educational video explaining the nature of the procedure, the reason it is being performed, expected benefits, major and common risks, reasonable alternatives, what to expect before and after the procedure, and the right to ask questions or decline the procedure. After viewing the video, participants may ask questions through a secure offline AI-based interface. The tool will provide plain-language responses grounded only in pre-approved study materials and will redirect individualized or high-risk questions to the treating clinical team.

In both study arms, final procedural consent remains the responsibility of the treating physician. In the digital-supported arm, the physician will conduct a final confirmation discussion before the procedure to review unresolved questions, address individualized risks, benefits, and alternatives, confirm patient understanding, and complete standard institutional consent documentation.

The primary outcome is patient comprehension of informed consent information, assessed immediately after completion of the assigned consent pathway and before the procedure. The comprehension assessment will address key domains of informed consent, including the nature of the procedure, indication, risks, benefits, alternatives, right to ask questions or refuse, and basic expectations before and after the procedure.

Secondary outcomes include pre-procedural anxiety, satisfaction with the consent process, decisional confidence or self-efficacy, perceived usability and acceptability, perceived opportunity to ask questions, preference for future consent format, physician time spent on consent, staff time where measurable, consent-related delays, same-day cancellation or deferral due to unresolved consent concerns, and need for additional pre-procedural contact related to consent. Digital process outcomes will include video completion rate, AI tool utilization rate, number and categories of patient questions, frequency of questions escalated to clinician review, and completion of the intervention before arrival. Safety and ethical quality outcomes will include withdrawal of procedural consent after the assigned intervention, patient-reported misunderstanding, complaints related to the consent process, protocol deviations involving consent, and any adverse event judged related to misunderstanding of instructions or procedural expectations.

The study is designed to minimize collection of identifiable information. Study outcomes will be collected primarily through secure survey links, and the research dataset will not include direct identifiers such as names, dates of birth, medical record numbers, addresses, email addresses, telephone numbers, or IP addresses. Any retained AI interaction data will be anonymized and will not be linked to participant identifiers.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kareem Khalaf, MD; Phone Number: 77537 +1-416-360-4000; Email: kareem.khalaf@unityhealth.to
• Study Contact Backup: Name: Kareem Khalaf, MD; Email: kareem.khalaf@unityhealth.to

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital - Unity Health Toronto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital-Supported Informed Consent; 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; 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.; Other Names: Digital consent pathway; Video and AI-supported consent
Active Comparator: Standard Physician-Led Informed Consent; 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; 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.; Other Names: Usual consent; Standard consent process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Immediately after the assigned consent pathway and before sedation/procedure
Satisfaction With Consent Process	Participant-reported satisfaction with the assigned consent process, including perceived clarity and helpfulness of the information provided.	Immediately after the assigned consent pathway and before sedation/procedure
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.	Immediately after the assigned consent pathway and before sedation/procedure
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.	Immediately after the assigned consent pathway and before sedation/procedure
Perceived Opportunity to Ask Questions	Participant-reported perception of whether they had adequate opportunity to ask questions and have concerns addressed during the consent process.	Immediately after the assigned consent pathway and before sedation/procedure
Preference for Future Consent Format	Participant preference for future consent format, including whether they would prefer standard physician-led consent, digital-supported consent, or a combined approach in future procedures.	Immediately after the assigned consent pathway and before sedation/procedure
Physician Time Spent on Consent	Total physician time spent on the consent process, measured where feasible using workflow tracking or routine operational data.	From start to completion of the consent process on the procedure day
Consent-Related Staff Time	Total staff time related to the consent process, where measurable using workflow tracking or routine operational data.	From start to completion of the consent process on the procedure day
Consent-Related Delay	Delay attributable to the consent process, measured where feasible using routine operational or workflow data.	Procedure day, before procedure start
Same-Day Cancellation or Deferral Due to Consent Concerns	Proportion of participants whose procedure is canceled or deferred on the same day because of unresolved consent-related concerns.	Procedure day
Additional Pre-Procedural Contact Related to Consent	Need for additional pre-procedural contact with the clinical or research team related to consent questions or concerns.	From enrollment to procedure start
Video Completion Rate	Proportion of participants assigned to the digital-supported arm who complete the standardized procedure-specific educational video.	Before procedure start
AI Tool Utilization Rate	Proportion of participants assigned to the digital-supported arm who use the offline AI-based question-answering tool.	Before procedure start
Number and Categories of Patient Questions Asked	Number and categories of questions submitted by participants through the digital question-answering interface.	Before procedure start
Frequency of Questions Escalated to Clinician Review	Number and proportion of participant questions that are flagged as individualized, complex, high-risk, or requiring clinician review.	Before procedure start
Digital Intervention Completion Before Arrival	Proportion of participants assigned to the digital-supported arm who complete the digital consent pathway before arrival for the procedure.	Before arrival for procedure
Withdrawal of Procedural Consent After Assigned Intervention	Proportion of participants who withdraw procedural consent after completing the assigned consent pathway.	After assigned consent pathway through procedure start
Questionnaire Assessing Patient Understanding	Participant-reported misunderstanding related to the consent information, procedure instructions, or procedural expectations identified after the procedure.	immediately after the intervention
Complaints Related to Consent Process	Number of participant complaints related to the consent process.	immediately after the intervention
Protocol Deviations Involving Consent	Number of protocol deviations related to delivery or documentation of the study consent or procedural consent process.	From enrollment through study follow-up
Adverse Events Related to Misunderstanding of Instructions or Procedural Expectations	Any adverse event judged to be related to misunderstanding of procedural instructions or expectations following the assigned consent pathway.	immediately after the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention of Key Knowledge	Participant retention of key consent-related knowledge at short follow-up after the procedure.	immediately after the intervention
Subgroup Differences in Comprehension and Consent Outcomes	Exploratory subgroup analyses by age, education, prior endoscopy experience, digital literacy, procedure type, and site.	immediately after the intervention
Comparative Performance Across Study Settings	Exploratory comparison of intervention performance across North American and European participating sites.	immediately after the intervention

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: University of Toronto
• Investigators: Principal Investigator: Natalia Causada Calo, Division of Gastroenterology, St. Michael's Hospital, Unity Health Toronto, University of Toronto, Toronto, Ontario, Canada

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: July 11, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Patient satisfaction; Patient education; Artificial intelligence; Therapeutic endoscopy; Informed consent; Advanced endoscopy; Pragmatic randomized trial; Patient comprehension; Pre-procedural anxiety; Digital consent; AI question-answering tool; Video-based consent; Endoscopy workflow
• Additional Relevant MeSH Terms: Behavior; Treatment Adherence and Compliance; Health Behavior; Patient Satisfaction; Technology, Industry, and Agriculture; Technology; Tape Recording; Audiovisual Aids; Educational Technology; Television; Videotape Recording
• Other Study ID Numbers: DIGI-CONSENT-ATE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study is designed to collect anonymous, non-identifiable survey-based data without direct participant identifiers or a participant linking log. The protocol does not include a formal plan for external sharing of participant-level data. Aggregate study results may be reported in publications and presentations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No