Effectiveness of an Interactive Consulting System to Enhance Patients' Decision-making: A Randomized Controlled Trial
- Conditions
- Age-related Cataract
- Interventions
- Other: A traditional patient decision aid brochureOther: Interactive Consulting System
- Registration Number
- NCT04262596
- Lead Sponsor
- Sun Yat-sen University
- 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.
- 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, 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 492
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Traditional decision aid brochure A traditional patient 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. Interactive Consulting System 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.
- Primary Outcome Measures
Name Time Method 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) 2 weeks post intervention 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.
- Secondary Outcome Measures
Name Time Method Anticipated regret 2 weeks post intervention Two items from a validated scale will measure anticipated regret about having cataract surgery (action regret, 4 points) and about not having cataract (inaction regret, 0 point). Higher scores indicate higher probability of anticipated regret after the surgery.
Decisional conflict 2 weeks post intervention Decisional conflict will be assessed using a 16-item Decisional Conflict Scale. Each item has 5 responses. Each response will earn 0-4 points respectively. Lower scores indicate a stronger ability to decide wheter or not receiving a cataract surgery.
Decisional confidence 2 weeks post intervention Decisional confidence will be assessed using a 11-item Decision Self Efficacy Scale. Each item has 5 responses. Each response will earn 0-4 points respectively. Higher scores indicate the paricipant is more confident about his/her decision.
Cataract worry 2 weeks post intervention A validated single item will measure participants' level of worry about progression of cataract, using four verbal response categories ranging from not worried at all to very worried. There are five response categories ranging from strongly agree (3 points) to strongly disagree (0 point). Higher scores indicate more worried about the disease status.
Perceived importance of surgical benefit/harms Time Frame: 2 weeks post intervention Purpose-developed items will be used to ask participants about their personal perceptions of the importance of specific outcomes in their decision-making about cataract surgery. The questionnaire contains 2 items, each with 5 responses14. Each response will earn 0-4 points respectively). Higher scores indicate a better knowledge on the understanding of importance of surgical benefit/harms.
Time perspective 2 weeks post intervention This will be assessed using a 4-item short form of the Consideration of Future Consequences Scale, with five response categories ranging from strongly agree (4 points) to strongly disagree (0 point). Higher scores indicate more consideration of future consequences by the participants.
Cataract anxiety 2 weeks post intervention Anxiety will be measured with a six-item short form.A validated single item will measure participants' level of worry about progression of cataract, using four verbal response categories ranging from not worried at all to very worried. Each question has five response categories ranging from strongly agree (3 points) to strongly disagree (0 point). Higher scores indicate more anxious about the disease status.
Trial Locations
- Locations (1)
Zhognshan Ophthalmic Center, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China