Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06528509
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-05
Brief Title:
AI-Enhanced Consent for Cataract Surgery
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 its a fundamental patient right Ensuring patients truly understand their treatment options leads to better satisfaction both from the patient and clinicians 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
Why is this important Informed consent is not just a legal requirement but its a fundamental patient right Ensuring patients truly understand their treatment options leads to better satisfaction both from the patient and clinicians 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None