AI-Enhanced Consent for Cataract Surgery

NCT06528509 | Not Yet Recruiting DMC

• 1 other identifier: KANS1002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cataract surgery; Complaints; Litigation; Informed consent

Outcome Measures

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.

  One week after intervention

Secondary Outcomes (7)

• Patient Anxiety Level

  Baseline; pre-intervention

• Patient Anxiety Level

  On day of surgery

• Time and Motion Study

  On day of surgery

• Participant-reported engagement time with the information material

  One week after intervention

• Cancellation rates

  Within 7 days of surgery

Study Arms (2)

AI-Generated Informative Videos

EXPERIMENTAL

Participants in this arm will receive an AI-generated informative video. The video will provide comprehensive information about cataract surgery, including the procedure, risks, benefits, and postoperative care. The content will be generated using the Synthesia platform, which uses artificial intelligence to create realistic, photo-realistic digital avatars to deliver the information. The aim is to improve patient understanding, satisfaction, and reduce preoperative anxiety compared to traditional information delivery methods. The video will be produced in English for Cohort A, and translated into Bengali for Cohort B.

Behavioral: AI-Generated Informative Videos

Standard Written Information Brochures

ACTIVE COMPARATOR

Participants in this arm will receive the standard information provided to patients undergoing cataract surgery, which consists of written information brochures. These brochures include comprehensive details about the cataract surgery procedure, potential risks, benefits, and postoperative care. The brochures are designed to provide all necessary information to help patients make an informed decision regarding their surgery. The leaflet will be supplied in English for Cohort A, and Bengali for Cohort B.

Behavioral: Standard Written Information Brochures

Interventions

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.

AI-Generated Informative Videos

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.

Standard Written Information Brochures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have capacity to consent
• Listed for first time cataract surgery
• English speakers for Cohort A
• Bengali speakers for Cohort B

You may not qualify if:

• 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

Sponsors & Collaborators

• Moorfields Eye Hospital NHS Foundation Trust: lead
• Medical Protection Society Foundation: collaborator

Study Sites (2)

Moorfields Eye Hospital Stratford

London, E15 4BQ, United Kingdom

Location

Moorfields Eye Hospital

London, EC1V 2PD, United Kingdom

Location

Related Publications (10)

• Ali N, Little BC. Causes of cataract surgery malpractice claims in England 1995-2008. Br J Ophthalmol. 2011 Apr;95(4):490-2. doi: 10.1136/bjo.2010.182774. Epub 2010 Aug 30.

  PMID: 20805130 BACKGROUND

• Zhang Y, Ruan X, Tang H, Yang W, Xian Z, Lu M. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial. J Ophthalmol. 2017;2017:9593631. doi: 10.1155/2017/9593631. Epub 2017 Jan 16.

  PMID: 28191349 BACKGROUND

• Shukla AN, Daly MK, Legutko P. Informed consent for cataract surgery: patient understanding of verbal, written, and videotaped information. J Cataract Refract Surg. 2012 Jan;38(1):80-4. doi: 10.1016/j.jcrs.2011.07.030. Epub 2011 Nov 6.

  PMID: 22062774 BACKGROUND

• Zhang MH, Haq ZU, Braithwaite EM, Simon NC, Riaz KM. A randomized, controlled trial of video supplementation on the cataract surgery informed consent process. Graefes Arch Clin Exp Ophthalmol. 2019 Aug;257(8):1719-1728. doi: 10.1007/s00417-019-04372-5. Epub 2019 May 30.

  PMID: 31144057 BACKGROUND

• Wagner SK, Raja L, Cortina-Borja M, Huemer J, Struyven R, Keane PA, Balaskas K, Sim DA, Thomas PBM, Rahi JS, Solebo AL, Kang S. Determinants of non-attendance at face-to-face and telemedicine ophthalmic consultations. Br J Ophthalmol. 2024 Mar 20;108(4):625-632. doi: 10.1136/bjo-2022-322389.

  PMID: 37217292 BACKGROUND

• Bhan A, Dave D, Vernon SA, Bhan K, Bhargava J, Goodwin H; Medical Defence Union; Medical Protection Society; Medical and Dental Defence Union of Scotland. Risk management strategies following analysis of cataract negligence claims. Eye (Lond). 2005 Mar;19(3):264-8. doi: 10.1038/sj.eye.6701493.

  PMID: 15286671 BACKGROUND

• Mathew RG, Ferguson V, Hingorani M. Clinical negligence in ophthalmology: fifteen years of national health service litigation authority data. Ophthalmology. 2013 Apr;120(4):859-64. doi: 10.1016/j.ophtha.2012.01.009. Epub 2012 Mar 2.

  PMID: 22386949 BACKGROUND

• Ali N. A decade of clinical negligence in ophthalmology. BMC Ophthalmol. 2007 Dec 20;7:20. doi: 10.1186/1471-2415-7-20.

  PMID: 18096077 BACKGROUND

• Gill ZS, Caldwell AS, Patnaik JL, Marin AI, Mudie LI, Grove N, Ifantides C, Ertel MK, Puente MA, Seibold LK. Comparison of cataract surgery outcomes in English proficient and limited English proficiency patients. J Cataract Refract Surg. 2023 Jun 1;49(6):595-601. doi: 10.1097/j.jcrs.0000000000001164.

  PMID: 36779806 BACKGROUND

• Patel DN, Wakeam E, Genoff M, Mujawar I, Ashley SW, Diamond LC. Preoperative consent for patients with limited English proficiency. J Surg Res. 2016 Feb;200(2):514-22. doi: 10.1016/j.jss.2015.09.033. Epub 2015 Oct 3.

  PMID: 26541685 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Swan Kang, MBBS, MBioch (Oxon), FRCOphth

  Moorfields Eye Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Swan Kang, MBBS, MBioch (Oxon), FRCOphth

CONTACT

07958585904; swan.kang1@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care Providers: The clinicians responsible for confirming consent on the day of surgery will be blinded to the group assignments of the patients. They will not know whether a patient received the AI-generated video or the standard written information brochure. Outcomes Assessors: The individuals assessing the outcomes, including patient understanding and satisfaction, as well as preoperative anxiety levels, will also be blinded to the group assignments. This includes the personnel administering and analyzing the multiple-choice questionnaires and anxiety scales. Participants: Participants will not be blinded as they will be aware of the type of information they received (AI-generated video or written brochure).
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is designed as a parallel, randomized controlled trial. Participants scheduled for cataract surgery are randomly allocated into two groups: the intervention group and the control group. The intervention group receives AI-generated informative videos, while the control group receives standard written information brochures. The study will run in two cohorts, with Cohort A including English speaking patients and Cohort B Bengali speakers.

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 30, 2024
• Study Start: September 11, 2024
• Primary Completion: September 11, 2025
• Study Completion (Estimated): September 11, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)