Generative AI-Assisted Understanding and Decision Enhancement in Peritoneal Dialysis: A Randomized Controlled Trial (The GUIDE-PD Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Management Reasoning
研究概览
简要总结
This study is a randomized controlled trial based on simulated clinical cases, aiming to establish a standardized evaluation system for PD physicians, to assess the differences in PD management quality between a workflow assisted by a PD-specialized large language model and physician-only decision-making, and to identify potential risks (such as generating obviously erroneous or even harmful recommendations). This simulated clinical case framework not only supports standardized and blinded evaluation, but also provides preliminary evidence for the model's effectiveness and safety before its deployment in real clinical settings, while avoiding direct impact on real patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Internal medicine or nephrology standardized training residents, licensed residents, or attending physicians.
- •Independent experience in PD management ≤ 3 years.
- •Provided signed informed consent and agreed to comply with the trial procedures.
排除标准
- •Direct involvement in the development or training of the specialized PD large language model, or in the construction of the clinical scenarios/ scoring criteria used in this trial.
- •Participation in the pilot testing of all clinical scenarios used in this trial.
- •Inability or unwillingness to access the study platform or use online resources during the study period.
- •Experienced PD experts.
结局指标
主要结局
Management Reasoning
时间窗: Within the 120-minute test period of the first test.
Percent correct (range: 0 to 100) for each case.
次要结局
- Self-Reported Confidence per Case(Within the 120-minute test period of the first test.)
- Domain-Specific Scores(Within the 120-minute test period of the first test.)
- Severity of Potential Harm(Within the 120-minute test period of the first test.)
- Time per Scenario Case(Within the 120-minute test period of the first test.)
- Difference between the Phys group's scores when tested with PD-LLM assistance and when assisted only by traditional search methods(After 1-2 months of washout of first test)
研究者
Wei Chen
Vice President
First Affiliated Hospital, Sun Yat-Sen University