Patient-centered and Economic Effectiveness of a Decision Aid for Patients With Age-related Cataract: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Age-related Cataract
- Sponsor
- Sun Yat-sen University
- Enrollment
- 773
- Locations
- 1
- Primary Endpoint
- 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)
- Last Updated
- 6 years ago
Overview
Brief Summary
To determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.
Detailed Description
The need for cataract surgery is on the rise globally due to the aging population and high demands for greater visual functioning. Patients with age-related cataract face their initial decision about when to undergo cataract surgery. Although the majority of patients want to participate in a shared decision-making process, no decision aid has been available to improve the quality of decision. The purpose of this study is to determine whether a decision aid increases informed decision about cataract surgery for patients with age-related cataract.
Investigators
Yingfeng Zheng
Principal Investigator
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Individuals aged 50-80 years who have been resident in the selected study district for more than six months;
- •A definite diagnosis of age-related cataract;
- •Having not received cataract surgery;
- •Willing to participate in the study and provide informed content.
- •Exclusion criteria
- •Bilateral blindness (presenting distance visual acuity worse than 3/60);
- •Having ocular, hearing or mental disorder precluding reading or telephone interview;
- •Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
- •Having cataract surgery contraindication.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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)
Time Frame: 2 weeks post intervention
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) Analysis: Informed Choice= Good Knowledge (score ≥50% in basic knowledge, ≥40% in knowledge associated with each treatment option, and at least 1 point in each numerical knowledge question) AND Positive Attitude (score ≥24) AND Positive Intention ("definitely will" or "likely to"), OR Good Knowledge AND Negative Attitude (score \<23) AND Negative Intention ("unsure", "not likely to", or "definitely will not")
Secondary Outcomes
- Decisional confidence(2 weeks post intervention)
- Anticipated regret(2 weeks post intervention)
- Perceived importance of surgical benefit/harms(2 weeks post intervention)
- Perceived personal chances of surgical benefit/harms(2 weeks post intervention)
- Decisional conflict(2 weeks post intervention)
- Time perspective(2 weeks post intervention)
- Heath-related quality of life: Chinese version of the EQ-5D-5L telephone interview script(Baseline, 1 year post intervention)
- Costs(Baseline, 1 year post intervention)
- Cataract worry and anxiety(2 weeks post intervention)
- Booklet utilization and acceptability(2 weeks post intervention)
- Undergoing cataract surgery(1 year post intervention)
- Decision regret(1 year post intervention)
- Visual functioning(Baseline, 1 year post intervention)
- Fall questionnaire(1 year post intervention)