AI-Enhanced Consent for Cataract Surgery
NCT06528509 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-07-30
Summary
This research focuses on enhancing the informed process for patients before undergoing cataract surgery. Currently, this process involves verbal discussions and written materials that may not fully address patients' understanding of the surgery, its risks, and benefits. This study aims to introduce an innovative approach using artificial intelligence (AI) to generate informative videos tailored to patients' needs, accounting for education level, ethnicity, and language barriers.
Why is this important? Informed consent is not just a legal requirement; but it's a fundamental patient right. Ensuring patients truly understand their treatment options leads to better satisfaction, both from the patient and clinician's perspective.
This study compares the effectiveness of AI-generated videos against traditional information delivery methods (information brochures). Patients scheduled for cataract surgery will experience either the new AI video approach or the standard process. The goal is to see if the videos lead to better understanding of the procedure and overall satisfaction. The investigators will be running the study in two parallel cohorts - with Cohort A involving an English speaking population, and Cohort B a Bengali speaking population with all patient facing materials translated into Bengali.
This research is crucial for patients seeking clarity about cataract surgery, for doctors aiming to improve patient care, and for researchers exploring patient education innovations. Funded by the Medical Protection Society (MPS), the investigators hope this intervention has broader effects such as reducing the number of complaints and litigations, improving the efficiency of consenting for surgery and delivering information, and improving theatre utilisation by reducing last minute cancellations.
Conditions
- Cataract
Interventions
- BEHAVIORAL
-
AI-Generated Informative Videos
Participants in the experimental arm will receive an AI-generated video designed to provide comprehensive information about cataract surgery. The video will cover key aspects of the procedure, including the nature of the surgery, potential risks, benefits, and postoperative care. The video will be produced in English for Cohort A, and translated into Bengali for Cohort B. The video will be delivered to participants via a secure link sent to their mobile devices or email. Patients can watch the video at their convenience, and they are encouraged to view it as many times as necessary to fully understand the information provided. The video link will be provided once after the initial clinic appointment, but patients can access and watch the video multiple times. The videos will be created using the Synthesia platform, which uses artificial intelligence to generate realistic, photo-realistic digital avatars that deliver the information in a personalized and engaging manner.
- BEHAVIORAL
-
Standard Written Information Brochures
Participants in the control arm will receive traditional written information brochures about cataract surgery. These brochures are designed to deliver detailed and essential information in a clear and understandable format. The brochures will be handed to participants during their face-to-face clinic appointment. Patients can read the material at their convenience and keep it for future reference. These brochures follow standardized guidelines and recommendations to ensure that all relevant information is included and presented in an accessible manner. The leaflet will be supplied in English for Cohort A, and Bengali for Cohort B.
Sponsors & Collaborators
-
Medical Protection Society Foundation
collaborator UNKNOWN -
Moorfields Eye Hospital NHS Foundation Trust
lead OTHER
Principal Investigators
-
Swan Kang, MBBS, MBioch (Oxon), FRCOphth · Moorfields Eye Hospital NHS Foundation Trust
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-11
- Primary Completion
- 2025-09-11
- Completion
- 2026-09-11
Countries
- United Kingdom
Study Locations
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