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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Peritoneal Dialysis (PD); Large Language Models
• Intervention / Treatment: Other: Peritoneal dialysis-specialized large language model.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Internal medicine or nephrology standardized training residents, licensed residents, or attending physicians.
2. Independent experience in PD management ≤ 3 years.
3. Provided signed informed consent and agreed to comply with the trial procedures.

Exclusion Criteria:

1. 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.
2. Participation in the pilot testing of all clinical scenarios used in this trial.
3. Inability or unwillingness to access the study platform or use online resources during the study period.
4. Experienced PD experts.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phys+PD-LLM Group; 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.; 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).
No Intervention: Phys Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Management Reasoning	Percent correct (range: 0 to 100) for each case.	Within the 120-minute test period of the first test.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Domain-Specific Scores	Percent correct (range: 0 to 100) for each case in each domain.	Within the 120-minute test period of the first test.
Severity of Potential Harm	The severity of potential harm will be classified as none, mild-to-moderate, or severe.	Within the 120-minute test period of the first test.
Time per Scenario Case	The time (in seconds) participants spend per case.	Within the 120-minute test period of the first test.
Self-Reported Confidence per Case	Scale 1-10. 10 represents being very confident.	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	range from -100 to 100	After 1-2 months of washout of first test

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Collaborators: Vantive Health LLC

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: June 28, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 20, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IIT-2026-511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No