Health TrialsbyHealthPanel

AI-Enhanced Consent for Cataract Surgery

ConditionCataract
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMoorfields Eye Hospital NHS Foundation Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have capacity to consent

Listed for first time cataract surgery

English speakers for Cohort A

Bengali speakers for Cohort B

Disqualifiers

Previously undergone cataract surgery

Partner who has undergone cataract surgery

Below the age of 18

Unable to utilise a device for watching information videos and completing quiz

Trial design

Design model

Parallel

Treatments tested in this trial

  • AI-Generated Informative Videos

    Behavioral

    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.

  • Standard Written Information Brochures

    Behavioral

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: AI-Generated Informative VideosExperimental treatment 1 intervention
Group B: Standard Written Information BrochuresActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Information understanding and retention

Assessed via a 12-question multiple-choice quiz sent via text message one week after the initial appointment.

Time frame
One week after intervention

Secondary outcomes

1

Patient Anxiety Level

Measured using the State Trait Anxiety Inventory (STAIT) at the initial consultation and on the day of surgery.

Time frame
Baseline; pre-intervention
2

Patient Anxiety Level

Measured using the State Trait Anxiety Inventory (STAIT) at the initial consultation and on the day of surgery.

Time frame
On day of surgery
3

Time and Motion Study

Time taken for information delivery and consent confirmation on the day of surgery will be recorded.

Time frame
On day of surgery
4

Participant-reported engagement time with the information material

This will be added as a question following the information understanding and retention quiz.

Time frame
One week after intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Moorfields Eye Hospital NHS Foundation Trust

Lead sponsor

Medical Protection Society Foundation

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: