Physician Implementation of an NLP-Empowered Electronic Resource for Peritoneal Dialysis Management: A Randomized Controlled Trial (The PIONEER-PD Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Management Reasoning
研究概览
简要总结
This study conducted a randomized controlled trial using clinical vignettes to evaluate differences in the quality of PD management among two large language model-assisted workflows and a physician-only decision-making process, and to identify potential risks (e.g., generating clearly erroneous or even harmful suggestions).
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
- 否
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.
研究组 & 干预措施
Phys Group
Participants could search for relevant knowledge, but access to large language model (LLM)-related websites was prohibited.
Phys+DS Group
Participants had access to both the web and the DeepSeek interface.
干预措施: Generalized LLM tools such as deepseek (Other)
Phys+PD-LLM Group
Participants had access to the web and a specialized PD-LLM provided by the First Affiliated Hospital of Sun Yat-sen University.
干预措施: Peritoneal dialysis-specialized large language model. (Other)
结局指标
主要结局
Management Reasoning
时间窗: Within 90-min study
Percent correct (range: 0 to 100) for each case.
次要结局
- Domain-Specific Scores(within 90-min study.)
- Severity of Potential Harm(Within 90-min study.)
- Time Spent on Management(Within 90-min study.)
- Self-Reported Confidence per Case(Within 90-min study.)
研究者
Wei Chen
Vice President
First Affiliated Hospital, Sun Yat-Sen University