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Enrolling by Invitation

NCT Number: NCT07539428

Peritoneal Dialysis (PD) Specialized LLM for PD Management

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).

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Key information

Conditions

Peritoneal Dialysis (PD) Large Language Models

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sixiu Chen

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 deepseek

Other

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 outcomes

  1. Management Reasoning

    Time frame: Within 90-min study

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

Secondary outcomes

  1. Domain-Specific Scores

    Time frame: within 90-min study.

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

  2. Severity of Potential Harm

    Time frame: Within 90-min study.

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

  3. Time Spent on Management

    Time frame: Within 90-min study.

    The time participants spend per case.

  4. Self-Reported Confidence per Case

    Time frame: Within 90-min study.

    Scale 1-10. 10 represents being very confident.

Other outcomes

  1. Total vignette performance score of LLM generated answers

    Time frame: Within 90-min study.

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

  2. Severity of Potential Harm of LLM-generated answers

    Time frame: Within 90-min study.

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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • Vantive Health LLC

Registry information

Official study title

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

Acronym: PIONEER-PD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 20, 2026
Registry last updated
Apr 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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