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NCT Number: NCT06935253

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford

Palo Alto, California, 94303, United States

Location status: Recruiting

Location contact

Euan A Ashley, MD, PhD

CONTACT

[email protected]

650-736-7878

Euan A Ashley, MD, PhD

PRINCIPAL_INVESTIGATOR

Jack W O'Sullivan, MD, PhD

CONTACT

[email protected]

6503009129

Jack W O'Sullivan, MD, PhD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Board certified or board eligible Cardiologist.

Exclusion criteria

  • Not currently practicing clinically

Treatment and study plan

Large Language Model

Other

The intervention is a Large Language Model.

Other names: AMIE (Articulate Medical Intelligence Explorer)

Primary outcomes

  1. Subspecialist Preference

    Time frame: Subspecialist evaluation will occur within 1 month of participant completing their assessment

    The 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 outcomes

  1. Participants perspective on use of Large Language model

    Time frame: Within one-hour

    Percentage of Cardiologists that felt the use of the Large Language Model helped their assessment.

Study contacts

Contact information is provided by the study sponsor or research team.

Euan A Ashley, BSc, MB ChB, DPhil

CONTACT

[email protected]

+16507367878

Jack W O'Sullivan, MBBS, DPhil

CONTACT

[email protected]

+16507367878

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Google LLC.

Registry information

Official study title

Towards Bridging Generalists to Subspecialists With Large Language Models

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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