NCT06774612

Brief Summary

This study aims to evaluate whether large language model-trained medical doctors demonstrate enhanced diagnostic reasoning performance when utilizing ChatGPT-4o alongside conventional resources compared to using conventional resources alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

January 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2025

Completed
Last Updated

July 17, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

January 4, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

clinical reasoninglarge language modelscomputer-assisted diagnosis

Outcome Measures

Primary Outcomes (1)

  • Diagnostic reasoning

    The primary outcome will be the percent correct for each case (range: 0 to 100). For each case, participants will be asked for three top diagnoses, findings from the case that support that diagnosis, and findings from the case that oppose that diagnosis. For each plausible diagnosis, participants will receive 1 point. Findings supporting the diagnosis and findings opposing the diagnosis will also be graded based on correctness, with 1 point for partially correct and 2 points for completely correct responses. Participants will then be asked to name their top diagnosis, earning one point for a reasonable response and two points for the most correct response. Finally participants will be asked to name up to 3 next steps to further evaluate the patient with one point awarded for a partially correct response and two points for a completely correct response. The primary outcome will be compared on the case-level by the randomized groups.

    Assessed at a single time point for each case, during the scheduled diagnostic reasoning evaluation session, which takes place between 0-4 days after participant enrollment.

Secondary Outcomes (1)

  • Time Spent on Diagnosis

    Assessed at a single time point for each case, during the scheduled diagnostic reasoning evaluation session, which takes place between 0-4 days after participant enrollment.

Study Arms (2)

ChatGPT-4o

ACTIVE COMPARATOR

Group will be given access to ChatGPT-4o.

Other: ChatGPT-4o

Conventional resources

NO INTERVENTION

Group will not be given access to ChatGPT-4o but will be encouraged to use any resources they wish besides large language models (PubMed, Google without AI Overviews, etc).

Interventions

OpenAI's ChatGPT-4o large language model with chat interface.

ChatGPT-4o

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Full or Provisionally Registered Medical Practitioners with the Pakistan Medical and Dental Council (PMDC).
  • Completed Bachelor of Medicine, Bachelor of Surgery (MBBS) Exam. The equivalent degree of MBBS in US and Canada is called Doctor of Medicine (MD).
  • Participants must have completed a structured training program on the use of ChatGPT (or a comparable large language model), totaling at least 10 hours of instruction. The program must include hands-on practice related to LLM's aspects, specifically prompt engineering and content evaluation.

You may not qualify if:

  • Any other Registered Medical Practitioners (Full or Provisional) with PMDC (e.g., Professionals with Bachelor of Dental Surgery or BDS).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore University of Management Sciences

Lahore, Punjab Province, 54792, Pakistan

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ihsan Ayyub Qazi, PhD

    Lahore University of Management Sciences

    PRINCIPAL INVESTIGATOR
  • Muhammad Asadullah Khawaja, MBBS

    King Edward Medical University

    PRINCIPAL INVESTIGATOR
  • Ayesha Ali, PhD

    Lahore University of Management Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Single (Outcomes Assessor)
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: The trial will be designed as a randomized, two-arm, single-blind parallel group study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, PhD

Study Record Dates

First Submitted

January 4, 2025

First Posted

January 14, 2025

Study Start

January 10, 2025

Primary Completion

May 17, 2025

Study Completion

May 17, 2025

Last Updated

July 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations