Effectiveness of Using Interactive Consulting System to Enhance Informed Choice

Effectiveness of Using Interactive Consulting System Based on Large Language Model to Enhance Informed Choice of Cataract Patients: a Non-inferiority Randomized Controlled Trial

To compare the performance of an interactive chatbot versus senior ophthalmologists for enhancing informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate medical expert-level responses.

Study Overview

• Status: Recruiting
• Conditions: Age-related Cataract
• Intervention / Treatment: Other: An interactive chatbot for patient decision aid; Other: Senior ophthalmologists

Detailed Description

Cataract surgery is the only way to treat age-related cataract. For patients at early or moderate stages, cataract surgery is an elective surgery without objective indications. Therefore the patients are uaually not aware whether they should receive the surgery. The number of trained and qualified ophthalmologists are limited in China and lots of patients cannot have detailed consultation with ophthalmologists. As a result, many patients still have doubts about whether they should receive cataract surgery or not. In this study, we aim to assess the effectiveness of an interactive chatbot based on large language models versus senior ophthalmologists to enhance informed decisions made by cataract patients.

• Study Type: Interventional
• Enrollment (Estimated): 660
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yingfeng Zheng, MD, PhD; Phone Number: +8613922286455; Email: zhyfeng@mail.sysu.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhognshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Yingfeng Zheng, M.D, Ph.D; Phone Number: +8613922286455; Email: zhyfeng@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals aged 45-80 years who have been resident in the selected study district for more than six months;
2. A definite diagnosis of age-related cataract;
3. Having not received cataract surgery;
4. Willing to participate the study and provide informed consent.

Exclusion Criteria:

1. Bilateral blindness (presenting distance visual acuity worse than 3/60);
2. Having ocular, hearing or mental disorders precluding reading or telephone interview;
3. Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
4. Having cataract surgery contraindication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interactive chatbot; A chatbot embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.	Other: An interactive chatbot for patient decision aid; A chatbot embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.
Active Comparator: Senior ophthalmologists; Senior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.	Other: Senior ophthalmologists; Senior ophthalmologists would communicate with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Informed choice about cataract surgery (the proportion of participants who make an informed choice，which is defined as a good knowledge score and an intention that is consistent with their attitude score)	Informed choice is an aggregated measure of multiple measurements, including knowledge (a 12-item questionnaire that assesses conceptual (items 1-10) and numerical (items 11-12) knowledge), attitudes (6 items, with 5 responses for each), and intentions (single item with 5 responses)	2 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of speech recognition by the Interactive Consulting System	The researchers will manually check the content of patients' speech and that generated after speech recognition by the mobile application	Immediately after speech data sent to the server and processed
Utilization and acceptability of the Interactive Consulting System (1)	The proportion of participants who could read the information all the way through	two weeks post intervention
Utilization and acceptability of the Interactive Consulting System (2)	The proportion of participants who agree that the information is new	two weeks post intervention
Utilization and acceptability of the Interactive Consulting System (3)	The proportion of participants who agree that the length is just about right	two weeks post intervention
Utilization and acceptability of the Interactive Consulting System (4)	The proportion of participants who think the information is balanced	two weeks post intervention
Utilization and acceptability of the Interactive Consulting System (5)	The proportion of participants who agree that the Interactive Consulting System is clear and easy to understand	two weeks post intervention
Utilization and acceptability of the Interactive Consulting System (6)	The proportion of participants who find the information helpful	two weeks post intervention
Utilization and acceptability of the Interactive Consulting System (7)	The proportion of participants who feel it worth recommending to others	two weeks post intervention

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Yingfeng Zheng, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 1, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 27, 2020
• First Posted (Actual): January 29, 2020

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 2020KYPJ003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified will be shared after the study being published.
• IPD Sharing Time Frame: The data will be available upon request after the study being accepted by peer-reviewed journal and published online.
• IPD Sharing Access Criteria: The data will be available upon request. Requestors will be asked to sign data sharing agreements.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No