Peritoneal Dialysis (PD) Specialized LLM for PD Management

N/AEnrolling By InvitationNCT07539428

First Affiliated Hospital, Sun Yat-Sen University150 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Peritoneal Dialysis (PD)Large Language Models

Interventions

Peritoneal dialysis-specialized large language model.OTHER

The peritoneal dialysis-specialized large language model (PD-LLM) used in this study was jointly developed by the Department of Nephrology at the First Affiliated Hospital of Sun Yat-sen University and Digital Health China (DHC).

Generalized LLM tools such as deepseekOTHER

Participants were permitted to ask the LLM any questions related to the clinical scenarios. However, they were explicitly instructed to critically evaluate the model's suggestions and to take full responsibility for the final clinical plans.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Internal medicine or nephrology standardized training residents, licensed residents, or attending physicians. 2. Independent experience in PD management ≤ 3 years. 3. Provided signed informed consent and agreed to comply with the trial procedures. Exclusion Criteria: 1. 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. 2. Participation in the pilot testing of all clinical scenarios used in this trial. 3. Inability or unwillingness to access the study platform or use online resources during the study period. 4. Experienced PD experts.

Locations (1)

Sixiu Chen

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Management Reasoning

Percent correct (range: 0 to 100) for each case.

Time frame: Within 90-min study

Secondary Outcomes

Domain-Specific Scores

Percent correct (range: 0 to 100) for each case.

Time frame: within 90-min study.

Severity of Potential Harm

The severity of potential harm will be classified as none, mild-to-moderate, or severe.

Time frame: Within 90-min study.

Time Spent on Management

The time participants spend per case.

Time frame: Within 90-min study.

Self-Reported Confidence per Case

Scale 1-10. 10 represents being very confident.

Time frame: Within 90-min study.

Data from ClinicalTrials.gov

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