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

NCT04262596 | Completed DMC

• 1 other identifier: 2020KYPJ002
• Study Type: interventional
• Target: 492
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-related Cataract

Outcome Measures

Primary Outcomes (1)

• Change in 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: 1. Knowledge (a 12-item questionnaire that assesses conceptual knowledge of cataract and cataract surgery). Questions with right answers will earn 1 point otherwise 0 point. Each participant may get 12 points maximally and 0 point minimally. 2. Attitudes (6 items, with 5 responses for each. Each response will earn 0-4 points respectively); 3. Intentions (single item with 5 responses. Each response will earn 0-4 points respectively). Higher scores indicate a better knowledge on informed choice of cataract surgery.

  2 weeks post intervention

Secondary Outcomes (8)

• Decisional conflict

  2 weeks post intervention

• Decisional confidence

  2 weeks post intervention

• Time perspective

  2 weeks post intervention

• Anticipated regret

  2 weeks post intervention

• Cataract worry

  2 weeks post intervention

Study Arms (2)

Interactive Consulting System

EXPERIMENTAL

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.

Other: Interactive Consulting System

Traditional decision aid brochure

ACTIVE COMPARATOR

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.

Other: A traditional patient decision aid brochure

Interventions

Interactive Consulting System 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.

Interactive Consulting System

A traditional patient decision aid brochure 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.

Traditional decision aid brochure

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Study Officials

• Yingfeng Zheng

  Zhognshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical investigator

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: February 10, 2020
• Study Start: May 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)