Peritoneal Dialysis (PD) Specialized LLM for PD Management

NCT07539428 | Enrolling By Invitation

• 1 other identifier: IIT-2025-965
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Peritoneal Dialysis (PD); Large Language Models

Outcome Measures

Primary Outcomes (1)

• Management Reasoning

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

  Within 90-min study

Secondary Outcomes (4)

• Domain-Specific Scores

  within 90-min study.

• Severity of Potential Harm

  Within 90-min study.

• Time Spent on Management

  Within 90-min study.

• Self-Reported Confidence per Case

  Within 90-min study.

Other Outcomes (2)

• Total vignette performance score of LLM generated answers

  Within 90-min study.

• Severity of Potential Harm of LLM-generated answers

  Within 90-min study.

Study Arms (3)

Phys Group

NO INTERVENTION

Participants could search for relevant knowledge, but access to large language model (LLM)-related websites was prohibited.

Phys+DS Group

PLACEBO COMPARATOR

Participants had access to both the web and the DeepSeek interface.

Other: Generalized LLM tools such as deepseek

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

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.

Phys+DS Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• 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)

Sixiu Chen

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: April 5, 2026
• First Posted: April 20, 2026
• Study Start: April 5, 2026
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)