Clinical trial NCT06528509: AI-Enhanced Consent for Cataract Surgery
Official title: An Artificial-intelligence-powered Intervention to Aid the Informed Consent Process for Cataract Surgery for English Speaking and Bengali Speaking Patient Population Groups: A Mixed-methods Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cataract
Keywords: Cataract surgery
Complaints
Litigation
Informed consent
Lead sponsor: Moorfields Eye Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Medical Protection Society Foundation
First posted: 2024-07-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Information understanding and retention
timeFrame: One week after intervention
Secondary outcomes:
measure: Patient Anxiety Level
timeFrame: Baseline; pre-intervention
measure: Patient Anxiety Level
timeFrame: On day of surgery
measure: Time and Motion Study
timeFrame: On day of surgery
measure: Participant-reported engagement time with the information material
timeFrame: One week after intervention
measure: Cancellation rates
timeFrame: Within 7 days of surgery
measure: Incidence of incidents and complaints
timeFrame: Up to 12 months post-operatively
measure: Patient and clinician satisfaction: Assessed on the surgery day using a 5-point Likert scale Patient and clinician satisfaction
timeFrame: On day of surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Moorfields Eye Hospital Stratford
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Swan Kang, MBBS, MBioch (Oxon), FRCOphth
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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