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Peritoneal Dialysis (PD) Specialized LLM for PD Management

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07539428
Acronym
PIONEER-PD
Enrollment
150
Registered
2026-04-20
Start date
2026-04-05
Completion date
2026-05-30
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Large Language Models, Peritoneal Dialysis (PD)

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).

Interventions

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).

OTHERGeneralized LLM tools such as deepseek

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.

Sponsors

First Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER
Vantive Health LLC
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Management ReasoningWithin 90-min studyPercent correct (range: 0 to 100) for each case.

Secondary

MeasureTime frameDescription
Domain-Specific Scoreswithin 90-min study.Percent correct (range: 0 to 100) for each case.
Severity of Potential HarmWithin 90-min study.The severity of potential harm will be classified as none, mild-to-moderate, or severe.
Time Spent on ManagementWithin 90-min study.The time participants spend per case.
Self-Reported Confidence per CaseWithin 90-min study.Scale 1-10. 10 represents being very confident.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 21, 2026