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

Sun Yat-sen University

Status: Completed

Conditions: Age-related Cataract

Treatments: Other: A traditional patient decision aid brochure; Other: Interactive Consulting System

Study type: Interventional

Funder types: Other

Identifiers

NCT04262596

2020KYPJ002

Details and patient eligibility

About

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.

Full 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, 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.

Enrollment: 492 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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492 participants in 2 patient groups

Interactive Consulting System

Experimental group

Description:

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.

Treatment:

Other: Interactive Consulting System

Traditional decision aid brochure

Active Comparator group

Description:

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.

Treatment:

Other: A traditional patient decision aid brochure