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

NCT07724327 | Enrolling By Invitation DMC

• 1 other identifier: IIT-2026-511
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peritoneal Dialysis (PD); Large Language Models

Outcome Measures

Primary Outcomes (1)

• Management Reasoning

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

  Within the 120-minute test period of the first test.

Secondary Outcomes (5)

• Domain-Specific Scores

  Within the 120-minute test period of the first test.

• Severity of Potential Harm

  Within the 120-minute test period of the first test.

• Time per Scenario Case

  Within the 120-minute test period of the first test.

• Self-Reported Confidence per Case

  Within the 120-minute test period of the first test.

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

  After 1-2 months of washout of first test

Study Arms (2)

Phys Group

NO INTERVENTION

Participants could search for relevant knowledge, but access to large language model (LLM)-related websites was prohibited. Participants will be invited to test again with the assistance of PD-LLM after 1-2 months of washout.

Phys+PD-LLM Group

EXPERIMENTAL

Participants had access to the web and a specialized PD-LLM provided by the First Affiliated Hospital of Sun Yat-sen University.

Other: Peritoneal dialysis-specialized large language model.

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).

Phys+PD-LLM Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead
• Vantive Health LLC: collaborator

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 24, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)