Active, not recruiting NA INTERVENTIONAL NCT07647536

Medical-AI trial: using a large language model to simplify ultrasound reports and improve patient understanding — vs. standard reports (NCT07647536)

Lu Wang Updated 2026-06-15

A multicenter, patient-blinded controlled evaluation of whether expert-reviewed, AI (large language model)-simplified ultrasound reports improve patient- or guardian-reported understanding and reading experience versus standard reports. The simplified report is a patient-facing aid only; it does not replace the standard clinical report. The primary outcome is a text-comprehension composite score. 660 participants.

Trial overview (primary data)

  • StatusActive, not recruiting
  • ConditionsPatient Understanding of Ultrasound Reports
  • InterventionsOTHER: Standard ultrasound report presentation, OTHER: Expert-reviewed AI-simplified ultrasound report presentation
  • SponsorLu Wang
  • Target enrollment660 participants
  • Period2026-06-01 〜 2026-06-30

Key points

  • A multicenter, patient-blinded evaluation of whether expert-reviewed LLM-simplified ultrasound reports improve patient/guardian-reported understanding and reading experience vs. standard reports.
  • After the routine report, participants viewed either the standard report or an expert-reviewed plain-language version.
  • The simplified version is a patient-facing aid only; it does not replace the standard clinical report or change its content.
  • The primary outcome is a text-comprehension composite score. 660 participants.
  • AI used for patient communication (health literacy), not diagnosis; an understanding/readability evaluation, not an establishment of clinical-outcome improvement.

Test reports are written in technical language so clinicians can communicate precisely with one another. But as patients increasingly read their own results online, a string of jargon easily breeds anxiety and misunderstanding. Ultrasound reports are no exception, and their meaning can be hard for patients to grasp.

This study examines whether a large language model (LLM) can rephrase reports into plain language and help patients understand.

Per the registry summary, this is a multicenter, patient-blinded controlled evaluation of whether expert-reviewed LLM-simplified ultrasound reports improve patient- or guardian-reported understanding and reading experience versus standard reports.

Routine reports were completed through existing clinical processes, and afterward participants were assigned to view either the standard report or an expert-reviewed plain-language version generated with an LLM workflow. Crucially, the simplified version is only a patient-facing communication aid; it does not replace the standard clinical report or change its content. The primary outcome is a text-comprehension composite score, and the size is 660.

What stands out is that this uses AI not for diagnosis but for health communication with patients. Patients understanding their information supports informed decisions and engagement in care. Inserting expert review and simplifying only the patient-facing aid while leaving the clinical report unchanged is a cautious, practical way to help understanding while guarding against generative-AI errors.

That said, this study evaluates understanding and reading experience; it does not imply improvement in clinical outcomes or replacement of the standard report.

Why it matters

Using AI for patient communication (health literacy) rather than diagnosis, this design inserts expert review and simplifies only the patient-facing aid while leaving the clinical report unchanged, a cautious, practical way to aid understanding while guarding against generative-AI errors (this study evaluates understanding and readability, not clinical-outcome improvement).

FAQ

Does the simplified report change diagnosis or treatment?
No. The simplified version is used only as a patient-facing communication aid; it does not replace the standard clinical report or change its content.
What about the risk of generative-AI errors?
The study inserts expert review of the simplified version and leaves the clinical report itself unchanged, testing a way to aid understanding while guarding against errors.

Sources (primary)

Source: ClinicalTrials.gov (U.S. NIH/NLM, public domain). This site does not provide medical advice. Verify the latest and exact details with the official source. This site is not endorsed or certified by the NIH/NLM.

#Medical AI#Clinical trial#Large language model#Patient communication#Ultrasound#Health literacy
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