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Effectiveness of an Interactive Consulting System to Enhance Patients' Decision-making: A Randomized Controlled Trial

NCT ID: NCT04262596

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

492 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2023-08-31

Brief Summary

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To compare the effectiveness of an interactive mobile chatbot and traditional decision aid booklets to enhance informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate ChatGPT-level responses.

Detailed Description

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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, patients are uaually not aware whether they should receive the surgery or not. In clinical practice, traditional Patient Decision Aids (PDA) booklets are used to provide health education to patients. However, PDAs lack real-time interaction with patients, and are unable to answer the new questions raised. Patients still have doubts about whether they should receive cataract surgery or not. In this study, the investigators aim to assess the effectiveness of an interactive Q\&A mobile application based on natural language processing technology to enhance informed decisions made by cataract patients.

Conditions

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Age-related Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Interactive Consulting System

The AI system adheres to the AHRQ SHARE approach (https://www.ahrq.gov/health-literacy/professional-training/shared-decision/tools/factsheet.html) for shared decision-making, which involves evaluating healthcare options, weighing pros and cons, and assessing potential risks while allowing patients to express their preferences.

Group Type EXPERIMENTAL

Interactive Consulting System

Intervention Type OTHER

Potential participants use the Interactive Consulting System on a mobile application with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.

Traditional decision aid brochure

A traditional patient decision aid brochure that includes provide standard general information, quantitative risk information on the possible outcomes of cataract surgery and value clarification exercise.

Group Type ACTIVE_COMPARATOR

A traditional patient decision aid brochure

Intervention Type OTHER

Potential participants receive a traditional patient decision aid brochure with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.

Interventions

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Interactive Consulting System

Potential participants use the Interactive Consulting System on a mobile application with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.

Intervention Type OTHER

A traditional patient decision aid brochure

Potential participants receive a traditional patient decision aid brochure with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Individuals aged 50-80, living in the designated research area for more than 6 months;
2. Primary diagnosis of cataract and have not undergone cataract surgery;
3. Ownership of a smartphone/tablet capable of using the study app and the ability to smoothly type in chat content
4. Willing to participate in the research and provide informed content.

Exclusion Criteria

1. Blindness in both eyes (manifesting as a distant vision less than 3/60);
2. Eye, hearing, or mental disorders that hinder reading or telephone interviews;
3. Permanent vision loss due to eye diseases other than cataracts, which cannot be corrected by cataract surgery;
4. Contraindications for cataract surgery.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Yingfeng Zheng

Clinical investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yingfeng Zheng

Role: PRINCIPAL_INVESTIGATOR

Zhognshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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2020KYPJ002

Identifier Type: -

Identifier Source: org_study_id