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OpenTrials
Completed

NCT Number: NCT07374926

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia, Jakarta, Indonesia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Registered medical physicians
  • Training in internal or family medicine

Exclusion criteria

  • Not currently practicing clinically

Treatment and study plan

GPT-4o

Other

GPT-4o provided via an iFrame in the online Qualtrics environment

Primary outcomes

  1. Percentage Correct Score

    Time frame: During Evaluation

    Following Peabody et al (2000), the primary outcome is a percentage correct score across all steps in a vignette. This is generated by dividing the weighted total sum of rubric items assessed as present by the total number of rubric items possible in a vignette. Rubric items will be weighted with regards to their relevance by our expert panel.

Secondary outcomes

  1. Quality Per Answer

    Time frame: During Evaluation

    This outcome is generated as the average weight of rubric items assessed as present across vignettes. As each item is provided a weight (0.33,0.5,1), the average weight is the sum of weights divided by the number of answers marked as present.

  2. Number of Answers

    Time frame: During evaluation

    This outcome is generated as the count of the total number of answers assessed as present by reviewers per vignette

  3. Less obvious answers

    Time frame: During evaluation

    This outcome is generated as the number of answers given that are less obvious, i.e. mentioned less frequently by the control group. If the answer is mentioned by 25% or less of the control group, it is considered less obvious.

Sponsors and collaborators

Lead sponsor

Maastricht University

Other

Collaborators

  • Aga Khan University
  • University of Indonesia, Jakarta, Indonesia

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2026
Registry last updated
Jan 29, 2026

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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