Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-28 @ 4:56 PM
Study NCT ID:
NCT07166692
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Retrieval Augmented Large Language Model as a Diagnostic Copilot in Rheumatology
Sponsor:
Philipps University Marburg
Organization:
Study Overview
Official Title:
Evaluation of a Retrieval Augmented Large Language Model as a Diagnostic Copilot in Rheumatology
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALLIANCE
Brief Summary:
This trial evaluates whether providing physicians with access to Prof. Valmed, a clinical decision support medical product, improves identification of rheumatic diseases and formulation of differential diagnoses compared with conventional decision support.
Detailed Description:
Advanced AI, particularly large language models, shows promise for enhancing clinical reasoning, yet most systems such as ChatGPT are not certified as medical products. Prof. Valmed is a clinical decision support medical product designed to assist physicians in diagnostic decision making. Given frequent referral problems and diagnostic delays in rheumatology, evaluating such support is highly relevant for clinical workflows.
This randomized controlled trial will test whether access to Prof. Valmed improves physicians' diagnostic performance in cases of suspected rheumatic disease compared with conventional decision support. Participants will be randomized to either use Prof. Valmed or rely on conventional tools while working through standardized clinical cases. For each case, participants will submit up to three differential diagnoses and a confidence rating. Independent reviewers, blinded to group allocation, will adjudicate accuracy. Findings will clarify the benefits and limitations of integrating Prof. Valmed into routine practice.
This randomized controlled trial will test whether access to Prof. Valmed improves physicians' diagnostic performance in cases of suspected rheumatic disease compared with conventional decision support. Participants will be randomized to either use Prof. Valmed or rely on conventional tools while working through standardized clinical cases. For each case, participants will submit up to three differential diagnoses and a confidence rating. Independent reviewers, blinded to group allocation, will adjudicate accuracy. Findings will clarify the benefits and limitations of integrating Prof. Valmed into routine practice.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: