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Large Language Models To Improve the Quality of Care of Cardiology Patients

Towards Bridging Generalists to Subspecialists With Large Language Models

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06935253
Enrollment
12
Registered
2025-04-20
Start date
2025-01-10
Completion date
2025-12-31
Last updated
2025-05-15

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

Conditions

Cardiology, Cardiomyopathy, Genetic Disease, Hypertrophic Cardiomyopathy (HCM)

Keywords

Large language models, Cardiology

Brief summary

This study evaluates the impact of large language models (LLMs) versus traditional decision support tools on clinical decision-making in cardiology. General cardiologists will be randomized to manage real patient cases from a cardiovascular genetic cardiomyopathy clinic, with or without AI assistance. Each case will be assessed by two cardiologists, and their responses will be graded by blinded subspecialty experts using a standardized evaluation rubric.

Detailed description

Large language models have been shown to improve physician performance in simulated settings. Large language models have demonstrated promise in various healthcare contexts, including medical note-writing, addressing patient inquiries, and facilitating medical consultation. However, it remains uncertain whether large language models improve clinical reasoning of clinicians using real world cases. Clinicians dedicate years of training to develop expertise, with clinical knowledge a key component. Clinicians have different areas of expertise, from generalists spanning diseases of all organ systems and patients of all ages, to subspecialists dedicated to often a handful of diseases effecting a specific organ. Both skill sets are vital to a well-functioning medical system, as generalists generally care for patients and refer to specialists when dedicated, specialty knowledge is required. There is a paucity of specialists, and thus the quality of triaging and referral to specialists is of upmost importance. We hypothesis that large language models may be able help generalists management complex patients, and improve their triage to specialists and subspecialists. The scarcity of subspecialist medical expertise, particularly in rare, complex and life-threatening diseases, poses a significant challenge for healthcare delivery. This issue is particularly acute in cardiology where timely, accurate management determines outcomes. In this study, we will recruit General Cardiologists as participants who will be randomized to answer clinical management cases with or without access to a large language model. Each case is a real patient case of a patient referred to a subspeciality cardiovascular genetic cardiomyopathy clinic. Each case will be performed by two general cardiologists (one with access to a large language model and one without access). Each case has multiple components, and the participants will be asked to answer questions related to the management. Answers will be graded by independent, blinded subspeciality Cardiologists with expertise and training in genetic cardiomyopathies. An evaluation rubric was developed by 10 expert discussants.

Interventions

OTHERLarge Language Model

The intervention is a Large Language Model.

Sponsors

Google LLC.
CollaboratorINDUSTRY
Stanford University
Lead SponsorOTHER

Study design

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

Masking description

The evaluation of responses will be performed by assessors blinded to participant identity and treatment assignment.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Board certified or board eligible Cardiologist.

Exclusion criteria

* Not currently practicing clinically

Design outcomes

Primary

MeasureTime frameDescription
Subspecialist PreferenceSubspecialist evaluation will occur within 1 month of participant completing their assessmentThe primary outcome is the preference of the subspecialist between answers provided by a) Cardiologist with access to Large Language Model vs. b) Cardiologist without access to Large Language Model.

Secondary

MeasureTime frameDescription
Participants perspective on use of Large Language modelWithin one-hourPercentage of Cardiologists that felt the use of the Large Language Model helped their assessment.

Countries

United States

Contacts

Primary ContactJack W O'Sullivan, MBBS, DPhil
jackos@stanford.edu+16507367878
Backup ContactEuan A Ashley, BSc, MB ChB, DPhil
deptmedchair@stanford.edu+16507367878

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026