Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2024-09-11
2026-09-11
Brief Summary
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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.
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Detailed Description
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Cataract surgery is one of the most frequently performed procedures in the NHS, yet the process of obtaining informed consent remains a significant challenge. Traditional methods of informed consent, primarily involving verbal discussions and written materials, often fail to ensure that patients fully understand the surgery, its risks, and benefits. This is especially problematic for patients with limited health literacy, language barriers, or other socioeconomic factors that affect their ability to comprehend complex medical information.
Objectives
The primary objective of this study is to enhance the informed consent process for cataract surgery by using artificial intelligence (AI) to create personalized informative videos. These videos will be tailored to meet the specific needs of patients, taking into account their educational levels, language preferences, and cultural backgrounds. The AI-generated videos will be compared against traditional information delivery methods, such as verbal briefings and written brochures, to assess their effectiveness in improving patient understanding, satisfaction, and reducing anxiety.
Study Design
This study will be conducted with two cohorts, each targeting different patient demographics to assess the feasibility and effectiveness of the AI intervention.
Cohort A:
Focus on English-proficient patients. Participants will be randomized into two groups: one receiving the AI-generated video and the other receiving standard written brochures.
Cohort B:
Expand to a Bengali speaking population with limited English proficiency. Same randomized design as Cohort A.
Methods
Participants will be recruited from Moorfields Eye Hospital and will include 100 patients in each cohort. The study will use a mixed-methods approach, incorporating both quantitative and qualitative data collection.
Quantitative Measures:
A multiple-choice questionnaire will assess patient understanding of the surgery.
State Trait Anxiety Inventory (STAI) will measure patient anxiety levels. Time and motion studies will track the duration of information delivery and consent confirmation processes.
Cancellation rates and incidence of complaints or litigations will be recorded.
Qualitative Measures:
Semi-structured interviews will explore patient experiences with the information delivery methods, their engagement with digital tools, and their overall satisfaction with the consent process.
Anticipated Benefits:
* Improved patient understanding of cataract surgery, leading to higher satisfaction and reduced anxiety.
* Potential reduction in surgery cancellations and complaints, improving overall theatre utilization.
* Enhanced clinician satisfaction by streamlining the consent process and reducing the likelihood of malpractice claims.
Ethical Considerations:
The study will ensure that all AI-generated content is rigorously reviewed for accuracy and cultural sensitivity. Participants will be informed about the AI nature of the videos, and all data will be handled in compliance with GDPR regulations to ensure confidentiality and security. All materials in Cohort B will be checked by a native Bengali speaker with a medical background. The investigators will be using a validated Bengali translation of the State Trait Anxiety Inventory (STAI).
Dissemination Strategy
Findings from the study will be disseminated through various channels, including academic publications, presentations at national and international conferences, and reports to relevant healthcare authorities. The results will also be shared with participants and the broader public through social media and community engagement initiatives.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
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).
Study Groups
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AI-Generated Informative Videos
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.
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.
Standard Written Information Brochures
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Listed for first time cataract surgery
* English speakers for Cohort A
* Bengali speakers for Cohort B
Exclusion Criteria
* Partner who has undergone cataract surgery
* Below the age of 18
* Unable to utilise a device for watching information videos and completing quiz
18 Years
ALL
No
Sponsors
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Medical Protection Society Foundation
UNKNOWN
Moorfields Eye Hospital NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Swan Kang, MBBS, MBioch (Oxon), FRCOphth
Role: PRINCIPAL_INVESTIGATOR
Moorfields Eye Hospital NHS Foundation Trust
Locations
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Moorfields Eye Hospital Stratford
London, , United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Swan Kang, MBBS, MBioch (Oxon), FRCOphth
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Ali N. A decade of clinical negligence in ophthalmology. BMC Ophthalmol. 2007 Dec 20;7:20. doi: 10.1186/1471-2415-7-20.
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.
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.
Other Identifiers
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KANS1002
Identifier Type: -
Identifier Source: org_study_id
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