Effectiveness of Large Language Model for Anaesthesia and Procedural Consent

NCT06949462 | Recruiting

• 1 other identifier: 2025-04-22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Patient understanding of anaesthesia risks remains inconsistent due to time constraints, language barriers, and variable clinician communication styles. Traditional verbal consent may not consistently ensure comprehension or reduce preoperative anxiety. PEAR (Patient Education of Anesthesia Risks) is a multilingual, AI-driven chatbot developed to enhance patient education and improve the quality of anaesthesia risk counselling. Study Objective: To compare PEAR's performance in delivering anaesthesia risk consent against the standard face-to-face verbal method.

Conditions

Consent Forms; Anesthesia; Artificial Intelligence (AI)

Keywords

Anaesthesia; Informed Consent; Large Language Model; Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Patient self-reported understanding of anaesthesia risks

  The primary outcome was assessed using a Patient-Reported Experience Measure (PREM) focused on subjective comprehension of anesthesia. This was measured via three validated 5-point Likert scale items (1 = strongly disagree, 5 = strongly agree) evaluating: (1) clarity of risks and procedures, (2) confidence in the anesthesia plan, and (3) self-reported ability to recall and explain key risks. While both groups completed these items following the clinician consultation, the intervention group underwent additional longitudinal assessments-at baseline and post-chatbot interaction-to facilitate a within-group analysis of the chatbot's independent educational impact.

  Immediately post-interaction with the PEAR Chatbot

Secondary Outcomes (5)

• Perceived Usefulness

  Immediately pre-consent and post-consent (within the same clinic visit)

• Cost effectiveness

  Immediately post-chatbot use (same clinic visit)

• Perceived Ease of Use (PEOU)

  Immediately pre-consent and immediately post-consent (within the same clinic visit).

• Attitude Toward Using (ATT)

  Immediately pre-consent and immediately post-consent (within the same clinic visit).

• Behavioral Intention to Use (BI)

  Immediately pre-consent and immediately post-consent (within the same clinic visit).

Study Arms (2)

Control

NO INTERVENTION

Participants in the control arm will receive the standard anaesthesia risk counselling conducted face-to-face by a licensed anaesthetist. This process follows institutional protocols and includes a verbal explanation of anaesthesia procedures, associated risks, benefits, and potential complications, tailored to the patient's specific surgical context. Patients are encouraged to ask questions and engage in discussion during the session. No digital tools or chatbot assistance will be used in this arm.

PEAR

EXPERIMENTAL

Participants in this arm will receive anaesthesia risk counselling through the PEAR (Patient Education of Anaesthesia Risks) chatbot, a multilingual, AI-powered conversational tool. The chatbot provides personalized education on anaesthesia risks, procedures, and post-operative expectations. Patients interact with the chatbot prior to meeting the anaesthetist, enhancing their understanding and preparing them for the face-to-face consultation.

Other: PEAR

Interventions

PEAR OTHER

Participants in the intervention arm will receive anaesthesia risk counselling through the PEAR (Patient Education of Anaesthesia Risks) chatbot prior to their face-to-face consultation with an anaesthetist. PEAR is a multilingual, AI-powered conversational tool designed to provide personalized, interactive education on anaesthesia-related procedures, risks, and safety information. The chatbot delivers content aligned with institutional guidelines and allows patients to explore topics at their own pace, ask questions in natural language, and revisit information as needed. After completing the chatbot interaction, patients proceed with their standard preoperative consultation, where any further questions are addressed by the anaesthetist. This approach is designed to enhance patient understanding, reduce anxiety, and optimize the in-person consultation by preparing patients in advance.

PEAR

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Adults (≥21 years old) undergoing elective surgery requiring anaesthesia
• Classified as ASA Physical Status I to III
• Able to provide informed consent
• Able to communicate effectively in English, Chinese (Mandarin), Malay, or Tamil
• Willing and able to complete questionnaires and interact with the PEAR chatbot (intervention arm)

You may not qualify if:

• ASA Physical Status IV or above
• Cognitive impairment or psychiatric conditions that may limit comprehension or communication
• Non-literate patients or those unable to understand English, Chinese, Malay, or Tamil
• Emergency surgery cases
• Prior participation in the study (to prevent bias)

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (2)

Singapore General Hospital

Singapore, Singapore, 249094, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore, 751126, Singapore

NOT YET RECRUITING

Related Publications (1)

• Ke YH, Jin L, Elangovan K, Abdullah HR, Liu N, Sia ATH, Soh CR, Tung JYM, Ong JCL, Kuo CF, Wu SC, Kovacheva VP, Ting DSW. Retrieval augmented generation for 10 large language models and its generalizability in assessing medical fitness. NPJ Digit Med. 2025 Apr 5;8(1):187. doi: 10.1038/s41746-025-01519-z.

  PMID: 40185842 BACKGROUND

Central Study Contacts

Yuhe Ke, MMED (ANES)

CONTACT

+6581022852; yuhe.ke36@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: There will be no blinding of the participants and investigators due to the impracticality. The outcome assessor will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Model Details: This study uses a parallel-group, randomized controlled trial (RCT) design to evaluate the effectiveness of PEAR, a conversational AI chatbot for anaesthesia risk counselling. Participants are randomly assigned in a 1:1 allocation ratio to one of two arms: Intervention Group: Receives anaesthesia risk information through the PEAR chatbot prior to their consultation with an anaesthetist. Control Group: Receives anaesthesia counselling through the standard, face-to-face verbal consent process by a clinician. Randomisation is stratified by surgical specialty to ensure balanced representation across different clinical settings.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: January 7, 2026
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• Time Frame: 1st July 2025 - 1st july 2028
• Access Criteria: Access to de-identified individual participant data (IPD) will be granted to qualified academic researchers, healthcare professionals, or institutions conducting methodologically sound research that aligns with ethical standards and scientific purpose.

Locations

SG (2)