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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Information understanding and retention
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
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).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have capacity to consent
- •Listed for first time cataract surgery
- •English speakers for Cohort A
- •Bengali speakers for Cohort B
排除标准
- •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
研究组 & 干预措施
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.
干预措施: AI-Generated Informative Videos (Behavioral)
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.
干预措施: Standard Written Information Brochures (Behavioral)
结局指标
主要结局
Information understanding and retention
时间窗: One week after intervention
Assessed via a 12-question multiple-choice quiz sent via text message one week after the initial appointment.
次要结局
- Cancellation rates(Within 7 days of surgery)
- 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)
- Incidence of incidents and complaints(Up to 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)
- Patient Anxiety Level(Baseline; pre-intervention)