Impact of a Printed Decision Aid on Cataract Surgery Choice: A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 696
- 试验地点
- 11
- 主要终点
- Informed choice about cataract surgery
研究概览
简要总结
The purpose of the study is to explore whether a decision aid booklet is more effective than the usual booklet for patients to make an informed choice on cataract surgery.
详细描述
Shared decision making is increasingly recommended to facilitate quality care, but there is a lack of cataract surgery decision aid in clinical practice. The aim of this study is to evaluate the effectiveness of a cataract surgery decision aid for cataract patients with different levels of health literacy.
We will conduct a randomized controlled trial for cataract patients aged 50-80 years. We will randomly assign participants to either the intervention using a decision aid booklet or the one using a usual cataract booklet. The primary outcome is informed choice (defined as adequate knowledge and consistency between attitudes and intentions) 2 weeks after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite diagnosis of age-related cataract;
- •The best corrected visual acuity (BCVA) is above 20/60;
- •Cataract opacity meets any of the following criterion based on lens opacity classification system (LOCS) III: nuclear color and nuclear opalescence is greater than or equal to grade 2 (NO2/NC2); cortical opacity is greater than or equal to grade 2 (C2); posterior subcapsular opacity is greater than or equal to grade 2 (P2);
- •Willing to know about cataract and cataract surgery;
- •Being able to afford cataract surgery;
- •Willing to participate in the study and provide the informed content.
排除标准
- •Having received cataract surgery;
- •Having hearing disorders;
- •Having mental disorders;
- •Having ocular disorders other than cataract;
- •Having surgery contraindication;
- •Unwilling to participate in this study.
研究组 & 干预措施
A decision aid booklet
A decision aid booklet about cataract surgery choice
干预措施: A decision aid booklet about cataract surgery choice (Other)
An usual booklet
An usual booklet about cataract and cataract surgery
干预措施: An usual booklet about cataract and cataract surgery (Other)
结局指标
主要结局
Informed choice about cataract surgery
时间窗: 2 weeks
Informed choice is measured as the proportion of participants who make an informed choice about whether to receive cataract surgery as soon as possible or not. For the individual, making an informed choice is defined as (i) having adequate knowledge and (ii) expressing intentions that are consistent with （iii）one's attitudes. Knowledge will be measured by assessing participants' understanding of the numerical and conceptual information in the booklets, using items modified from previous screening decision aid trials (Hersch 2015). Attitudes towards cataract surgery will be assessed using a theory-based generic screening attitudes scale (Dormandy 2006). A single item will measure intentions about having cataract surgery as soon as possible (or not), using a set of 5 response options (Gwyn 2003; Watson 2006).
次要结局
- Anticipated regret(2 weeks)
- Cataract worry and anxiety(2 weeks)
- Time perspective(2 weeks)
- Decision regret(1 year)
- Perceived importance of cataract surgery benefit/harms(2 weeks)
- Decisional confidence(2 weeks)
- Booklet utilization and acceptability(2 weeks)
- Undergoing cataract surgery(1 year)
- Decisional conflict(2 weeks)
- Perceived personal chances of surgical benefit/harms(2 weeks)
研究者
Yingfeng Zheng
Clinical investigator
Sun Yat-sen University