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Enrolling by Invitation

NCT Number: NCT07724327

A Simulated Case Study of a Peritoneal Dialysis-Specialized Large Language Model Assisting Doctors in Improving Decision-Making in Peritoneal Dialysis Management

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.

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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

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: Yes

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).

Primary outcomes

  1. Management Reasoning

    Time frame: Within the 120-minute test period of the first test.

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

Secondary outcomes

  1. Domain-Specific Scores

    Time frame: Within the 120-minute test period of the first test.

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

  2. Severity of Potential Harm

    Time frame: Within the 120-minute test period of the first test.

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

  3. Time per Scenario Case

    Time frame: Within the 120-minute test period of the first test.

    The time (in seconds) participants spend per case.

  4. Self-Reported Confidence per Case

    Time frame: Within the 120-minute test period of the first test.

    Scale 1-10. 10 represents being very confident.

  5. Difference between the Phys group's scores when tested with PD-LLM assistance and when assisted only by traditional search methods

    Time frame: After 1-2 months of washout of first test

    range from -100 to 100

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • Vantive Health LLC

Registry information

Official study title

Generative AI-Assisted Understanding and Decision Enhancement in Peritoneal Dialysis: A Randomized Controlled Trial (The GUIDE-PD Trial)

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2026
Registry last updated
Jul 24, 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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