Digital-Supported Versus Standard Informed Consent for Advanced Therapeutic Endoscopy: A Pragmatic Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Patient Comprehension of Informed Consent Information
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Patient Comprehension of Informed Consent Information
时间窗: Immediately after the assigned consent pathway and before sedation/procedure
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.
次要结局
- 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)
- Preference for Future Consent Format(Immediately after the assigned consent pathway and before sedation/procedure)
- Physician Time Spent on Consent(From start to completion of the consent process on the procedure day)
- Consent-Related Staff Time(From start to completion of the consent process on the procedure day)
- Consent-Related Delay(Procedure day, before procedure start)
- Same-Day Cancellation or Deferral Due to Consent Concerns(Procedure day)
- Additional Pre-Procedural Contact Related to Consent(From enrollment to procedure start)
- Video Completion Rate(Before procedure start)
- AI Tool Utilization Rate(Before procedure start)
- Number and Categories of Patient Questions Asked(Before procedure start)
- Frequency of Questions Escalated to Clinician Review(Before procedure start)
- Digital Intervention Completion Before Arrival(Before arrival for procedure)
- Withdrawal of Procedural Consent After Assigned Intervention(After assigned consent pathway through procedure start)
- Questionnaire Assessing Patient Understanding(immediately after the intervention)
- Complaints Related to Consent Process(immediately after the intervention)
- Protocol Deviations Involving Consent(From enrollment through study follow-up)
- Adverse Events Related to Misunderstanding of Instructions or Procedural Expectations(immediately after the intervention)
研究者
Natalia Calo
Assistant Professor
Unity Health Toronto