LLMs Improve Patient Understanding of Ultrasound Reports

NCT07647536 | Active Not Recruiting

• 1 other identifier: 2026-AI-US-report
• Study Type: interventional
• Target: 660
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter, patient-blinded, controlled evaluation assessed whether expert-reviewed artificial intelligence (AI)-simplified ultrasound reports improved patient- or guardian-reported understanding and reading experience compared with standard ultrasound reports. Routine ultrasound reports were completed through existing clinical processes. After completion of the routine report, participants were assigned to view either the standard report or an expert-reviewed plain-language version generated with a large language model workflow. The simplified report was intended only as a patient-facing communication aid. It did not replace the standard clinical report and did not alter ultrasound acquisition, diagnostic interpretation, treatment decisions, follow-up, or subsequent clinical management. Patient- or guardian-reported outcomes included cognitive workload, comprehension, report perception, and reading time. Expert review assessed whether AI-generated simplified reports preserved source meaning and identified factual errors, omissions, or unsupported additions before patient presentation.

Conditions

Patient Understanding of Ultrasound Reports

Keywords

Artificial intelligence; Ultrasound reports; Plain language; Patient communication; Health literacy; Report comprehension; Large language model

Outcome Measures

Primary Outcomes (1)

• Text comprehension composite score

  Participant- or guardian-reported text comprehension after reading the assigned ultrasound report format. The composite score was calculated as the arithmetic mean of three seven-point questionnaire items assessing clarity, readability, and comprehensibility. Higher scores indicate better comprehension.

  Immediately after reading the assigned report

Secondary Outcomes (3)

• Cognitive workload composite score

  Immediately after reading the assigned report

• Report perception composite score

  Immediately after reading the assigned report

• Reading time

  Immediately after reading the assigned report

Study Arms (2)

Standard ultrasound report

ACTIVE COMPARATOR

Participants or legal guardians viewed the standard ultrasound report generated through routine clinical reporting processes

Other: Standard ultrasound report presentation

Expert-reviewed AI-simplified ultrasound report

EXPERIMENTAL

Participants or legal guardians viewed a plain-language ultrasound report generated by an AI workflow after completion of the routine report and reviewed by ultrasound physicians before presentation

Other: Expert-reviewed AI-simplified ultrasound report presentation

Interventions

Standard ultrasound report presentation OTHER

Presentation of the completed routine ultrasound report to the participant or legal guardian

Standard ultrasound report

Expert-reviewed AI-simplified ultrasound report presentation OTHER

Presentation of a patient-facing plain-language ultrasound report generated by an AI workflow and reviewed by ultrasound physicians before participant or guardian exposure. The intervention did not alter ultrasound acquisition, diagnostic interpretation, treatment decisions, follow-up, or clinical management

Expert-reviewed AI-simplified ultrasound report

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving an ultrasound report at a participating center. Adult participants able to provide written informed consent. For participants younger than 18 years, a legal guardian able to provide written informed consent, read the assigned report, and complete the questionnaire.
• Participants or legal guardians able to read one assigned report presentation format and complete the study questionnaire immediately after reading.

You may not qualify if:

• Refusal or inability to provide written informed consent by the adult participant or legal guardian.
• Inability of the participant or legal guardian to read the assigned report presentation format or complete the questionnaire.
• Incomplete evaluation, including missing responses to any of the nine rating items or the reading-time item.
• Missing key study information required for analysis, including participating center or assigned report presentation format.

Sponsors & Collaborators

• Lu Wang: lead

Study Sites (1)

Sichuan cancer hospital

Chengdu, Sichuan, 610041, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants or legal guardians were not informed whether they viewed the standard ultrasound report or the expert-reviewed AI-simplified report. Staff responsible for preparing and reviewing the simplified reports were aware of the assigned presentation format. Blinding success was not formally assessed.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator，Ultrasound department

Model Details: Participants or legal guardians were assigned to one of two parallel report presentation formats: a standard ultrasound report or an expert-reviewed AI-simplified patient-facing ultrasound report. The workflow began only after the routine ultrasound report had been completed and did not alter ultrasound acquisition, diagnostic interpretation, treatment decisions, follow-up, or subsequent clinical management.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 15, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 15, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)