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The Big Unknown: A Journey Into Generative AI's Transformative Effect on Medical Professions

M

Maastricht University

Status

Completed

Conditions

Diagnosis
Vignette of Fictional Patients

Treatments

Other: GPT-4o

Study type

Interventional

Funder types

Other

Identifiers

NCT07374926
ERCIC_572_25_04_2024

Details and patient eligibility

About

A parallel group randomized controlled trial using a superiority framework. Clinical vignettes will be used to assess the impact of a large language model on the clinical reasoning of physicians. Quantitative analyses will be performed on graded vignette responses.

Full description

This study is a multi-country, parallel-group randomized controlled trial designed to evaluate whether access to a large language model (LLM) improves physician clinical decision-making. The trial uses a superiority framework and compares physicians randomized to either complete standardized clinical vignettes with access to GPT-4o or without any AI assistance.

Clinical vignettes simulate common primary care conditions such as cardiovascular, respiratory, musculoskeletal, fatigue-related, and infectious diseases. Each vignette includes multiple steps in the clinical reasoning process, from initial history-taking to diagnosis, treatment, and follow-up. Physician responses are graded using rubrics developed from evidence-based, context-specific best-practice guidelines.

The study is conducted across three countries-Indonesia, Kenya, and the Netherlands-representing different income levels and health system contexts. The primary outcome is performance on clinical vignettes, defined as adherence to best-practice guidelines. Secondary objectives include examining cross-country variation in physician performance, variation in performance distributions, and the role of engagement with the LLM in shaping outcomes.

Enrollment

249 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Registered medical physicians
  • Training in internal or family medicine

Exclusion criteria

  • Not currently practicing clinically

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

249 participants in 2 patient groups

Own Knowlege
No Intervention group
Description:
Group will not be given access to GPT-4 or other online resources
GPT-4o
Active Comparator group
Description:
Group given GPT-4o access
Treatment:
Other: GPT-4o

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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