Physician-Supervised GPT Assistance for Communicating Cardiopulmonary Exercise Test Results
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShanghai Zhongshan Hospital
About this trial
Cardiopulmonary exercise testing requires clinicians to integrate multiple physiological measurements and explain their meaning, limitations, safety implications, and appropriate next steps. This randomized two-period crossover study will evaluate whether physician-supervised GPT-assisted drafting preserves the clinical acceptability of final patient-facing responses while reducing task completion time compared with physician-only drafting. Licensed physicians or institutionally recognized clinical trainees will respond in Chinese to 20 synthetic cardiopulmonary exercise testing scenarios. Each participant will complete 10 scenarios in each condition using two non-overlapping case sets. In the GPT-assisted condition, a frozen model-generated draft will be displayed and may be edited, deleted, or completely rewritten by the physician. The primary hypothesis is that GPT-assisted drafting is noninferior to physician-only drafting for clinical acceptability, using a noninferiority margin of 5 percentage points. Completion time will be evaluated for superiority only if noninferiority is established.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Licensed physicians or institutionally recognized clinical trainees.
Able to read and write Chinese.
Experience in, or relevant training involving, cardiopulmonary exercise testing, cardiology, respiratory medicine, rehabilitation medicine, or related clinical interpretation within the previous 24 months.
Able to complete the computer-based study procedures.
Disqualifiers
Participation in the development of the study case bank, reference answers, scoring manual, or frozen GPT-generated drafts.
Previous exposure to any Phase 2 study case.
Inability to complete the study tasks independently using the study computer interface.
A direct financial conflict of interest related to the evaluated artificial intelligence system.
Trial design
Design model
Crossover
Treatments tested in this trial
Physician-Supervised GPT-Assisted Drafting
Other interventionA frozen GPT-generated draft will be displayed for each synthetic case. The participant may accept, edit, delete, or completely rewrite the draft before submitting the final response. The participant remains responsible for the final response. Each task has a maximum duration of 8 minutes, and external information sources or additional artificial intelligence tools are prohibited.
Physician-Only Drafting
Other interventionThe participant will receive a blank response field and will independently prepare the final response. Each task has a maximum duration of 8 minutes, and external information sources or artificial intelligence tools are prohibited.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Sequence 1: A Physician-Only Then B GPT-AssistedExperimental treatment 2 interventions
Group B: Sequence 2: A GPT-Assisted Then B Physician-OnlyExperimental treatment 2 interventions
Group C: Sequence 3: B Physician-Only Then A GPT-AssistedExperimental treatment 2 interventions
Group D: Sequence 4: B GPT-Assisted Then A Physician-OnlyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of Final Responses Meeting the Composite Clinical Acceptability Criterion
A task-level binary outcome. A final response is classified as clinically acceptable only when all of the following criteria are met: no S2 or S3 safety error; inclusion of all case-specific critical facts; inclusion of at least 75% of general required facts; an accuracy score of at least 4 on a 5-point scale; and a communication score of at least 3 on a 5-point scale. A higher proportion indicates better performance. The primary comparison is the marginal absolute probability difference between GPT-assisted and physician-only drafting, with a noninferiority margin of minus 5 percentage points.
Time frame
During each study period, with the second period occurring 5 to 9 days after the first periodSecondary outcomes
1
Task Completion Time
Time in seconds from display of the case and response interface to submission of the final response. Responses automatically submitted at the 8-minute limit will be recorded as 480 seconds. A shorter completion time indicates greater efficiency.
Time frame
During each study period, with the second period occurring 5 to 9 days after the first period2
Proportion of Responses Containing an S2 Safety Error
An S2 event is a clinically important error or omission with a plausible potential to alter clinical management. Each response will be classified by masked outcome assessors using the prespecified safety rubric.
Time frame
During each study period, with the second period occurring 5 to 9 days after the first period3
Proportion of Responses Containing an S3 Safety Error
An S3 event is an error or omission with a plausible potential for immediate serious harm. Each response will be classified by masked outcome assessors using the prespecified safety rubric.
Time frame
During each study period, with the second period occurring 5 to 9 days after the first period4
Clinical Accuracy Score
Accuracy of the final response assessed by masked outcome assessors on a 5-point scale. Higher scores indicate greater clinical accuracy.
Time frame
During each study period, with the second period occurring 5 to 9 days after the first periodSponsors and contacts
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Source ClinicalTrials.gov
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