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Enrolling by invitation NCT07539428

Peritoneal Dialysis (PD) Specialized LLM for PD Management

No phase Interventional Peritoneal Dialysis (PD) Large Language Models

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peritoneal dialysis-specialized large language model., Generalized LLM tools such as deepseek.
Who it may be relevant to
Registry conditions: Peritoneal Dialysis (PD), Large Language Models. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Physician Implementation of an NLP-Empowered Electronic Resource for Peritoneal Dialysis Management: A Randomized Controlled Trial (The PIONEER-PD Trial)

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).

Interventions

  • Other Peritoneal dialysis-specialized large language model.
    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).
  • Other Generalized LLM tools such as deepseek
    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.

Primary outcome measures

  • Management Reasoning [Time frame: Within 90-min study]
Secondary outcome measures (4)
  • Domain-Specific Scores [Time frame: within 90-min study.]
  • Severity of Potential Harm [Time frame: Within 90-min study.]
  • Time Spent on Management [Time frame: Within 90-min study.]
  • Self-Reported Confidence per Case [Time frame: Within 90-min study.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Sixiu Chen — Guangzhou

Identifiers

NCT: NCT07539428 · IIT-2025-965

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗