AI-Enhanced Consent for Cataract Surgery
NCT Number: NCT06528509
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Cataract
Interventions: BEHAVIORAL: AI-Generated Informative Videos|BEHAVIORAL: Standard Written Information Brochures
Sponsor: Moorfields Eye Hospital NHS Foundation Trust
Collaborators: Medical Protection Society Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09-11
Completion Date: 2026-09-11
Locations: Moorfields Eye Hospital Stratford, London, E15 4BQ, United Kingdom|Moorfields Eye Hospital, London, EC1V 2PD, United Kingdom

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.

Primary Outcome Measures: Information understanding and retention, Assessed via a 12-question multiple-choice quiz sent via text message one week after the initial appointment., One week after intervention
Secondary Outcome Measures: Patient Anxiety Level, Measured using the State Trait Anxiety Inventory (STAIT) at the initial consultation and on the day of surgery., Baseline; pre-intervention|Patient Anxiety Level, Measured using the State Trait Anxiety Inventory (STAIT) at the initial consultation and on the day of surgery., On day of surgery|Time and Motion Study, Time taken for information delivery and consent confirmation on the day of surgery will be recorded., On day of surgery|Participant-reported engagement time with the information material, This will be added as a question following the information understanding and retention quiz., One week after intervention|Cancellation rates, Day-of surgery and short notice cancellation rates and reasons will be documented., Within 7 days of surgery|Incidence of incidents and complaints, Any complaints or formal claims related to the surgery will be followed up for 12 months post-operatively, Up to 12 months post-operatively|Patient and clinician satisfaction: Assessed on the surgery day using a 5-point Likert scale Patient and clinician satisfaction, Assessed on the surgery day using a 5-point Likert scale, On day of surgery