AI-Enhanced Consent for Cataract Surgery
- Conditions
- Cataract
- Interventions
- Behavioral: AI-Generated Informative VideosBehavioral: Standard Written Information Brochures
- Registration Number
- NCT06528509
- Lead Sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- 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.
- Detailed Description
Background and Rationale
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Have capacity to consent
- Listed for first time cataract surgery
- English speakers for Cohort A
- Bengali speakers for Cohort B
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AI-Generated Informative Videos 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. Standard Written Information Brochures 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.
- Primary Outcome Measures
Name Time Method Information understanding and retention One week after intervention Assessed via a 12-question multiple-choice quiz sent via text message one week after the initial appointment.
- Secondary Outcome Measures
Name Time Method Cancellation rates Within 7 days of surgery Day-of surgery and short notice cancellation rates and reasons will be documented.
Patient Anxiety Level On day of surgery Measured using the State Trait Anxiety Inventory (STAIT) at the initial consultation and on the day of surgery.
Time and Motion Study On day of surgery Time taken for information delivery and consent confirmation on the day of surgery will be recorded.
Participant-reported engagement time with the information material One week after intervention This will be added as a question following the information understanding and retention quiz.
Incidence of incidents and complaints Up to 12 months post-operatively Any complaints or formal claims related to the surgery will be followed up for 12 months post-operatively
Patient and clinician satisfaction: Assessed on the surgery day using a 5-point Likert scale Patient and clinician satisfaction On day of surgery Assessed on the surgery day using a 5-point Likert scale
Related Research Topics
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Trial Locations
- Locations (2)
Moorfields Eye Hospital
🇬🇧London, United Kingdom
Moorfields Eye Hospital Stratford
🇬🇧London, United Kingdom