Clinical Decision Support SystemsNCT07829731
Physician-Supervised GPT Assistance for Communicating Cardiopulmonary Exercise Test Results
A study testing Physician-Supervised GPT-Assisted Drafting and Physician-Only Drafting in people with Clinical Decision Support Systems and Cardiopulmonary Exercise Testing, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
Cardiopulmonary exercise testing requires clinicians to integrate multiple physiological measurements and explain their meaning, limitations, safety implications, and appropriate next steps. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Decision Support Systems, Cardiopulmonary Exercise Testing
- What is being tested?
- Physician-Supervised GPT-Assisted Drafting and Physician-Only Drafting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2026to 16 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Provision of written informed consent.
Who cannot join
- 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.
- Withdrawal of consent before completion of the assigned study procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Randomized Crossover Study of Physician-Supervised GPT-Assisted Drafting for Communication of Cardiopulmonary Exercise Test Results
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.
Read the detailed description
Before the human-participant crossover study, four large language models were evaluated in a separate model-comparison phase using a non-overlapping 60-case benchmark. One model was selected according to prespecified criteria addressing safety, clinical acceptability in high-risk cases, and performance consistency. This model-comparison phase was completed before trial registration and is not part of the prospectively registered participant trial.
Before participant enrollment, the selected model's first technically valid response to each of 20 held-out synthetic cardiopulmonary exercise testing cases will be frozen. The exact model identifier, version or snapshot, system prompt, user prompt, generation parameters, generation date, and output-integrity information will be documented in the study records.
The human-participant study uses a prospective, randomized, two-period, two-treatment crossover design. Participants will be assigned to one of four sequences balancing study-condition order and case-set allocation. Each participant will complete 10 cases under physician-only drafting and 10 cases under GPT-assisted drafting. The two periods will be separated by 7 plus or minus 2 days.
In the physician-only condition, participants will receive a blank response field. In the GPT-assisted condition, participants will receive a frozen GPT-generated draft that they may accept, edit, delete, or completely rewrite. The physician remains responsible for the submitted final response. Each case has a maximum completion time of 8 minutes. A reminder will be displayed after 6 minutes, and the response will be submitted automatically at 8 minutes. Participants will receive a fixed 3-minute rest after every five cases. Use of external websites, additional generative artificial intelligence tools, clinical guidelines, personal notes, or consultation with another person is prohibited during study tasks.
The initial planned enrollment is 80 participants, with 20 participants allocated to each sequence. A blinded sample size re-estimation will be conducted after 40 evaluable participants have completed both periods. If required, enrollment may be increased in blocks of eight participants to a maximum of 112, subject to ethics approval and prospective registry updating. All study cases are synthetic. No real patient records will be used. Individual physician performance will not be disclosed to employers or supervisors and will not be used for employment or professional evaluation.
- Being tested
- Physician-Supervised GPT-Assisted Drafting, Physician-Only Drafting
- Keywords
- Large Language Models, Artificial Intelligence, Cardiopulmonary Exercise Testing, Human-AI Collaboration, Physician-Computer Interaction, Clinical Communication, GPT-Assisted Drafting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-Supervised GPT-Assisted DraftingOther
A 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 DraftingOther
The 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.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: A Physician-Only Then B GPT-Assisted | Experimental | Participants will complete Case Set A using physician-only drafting during Period 1 and Case Set B using GPT-assisted drafting during Period 2. Receives: Other: Physician-Supervised GPT-Assisted Drafting; Other: Physician-Only Drafting |
| Sequence 2: A GPT-Assisted Then B Physician-Only | Experimental | Participants will complete Case Set A using GPT-assisted drafting during Period 1 and Case Set B using physician-only drafting during Period 2. Receives: Other: Physician-Supervised GPT-Assisted Drafting; Other: Physician-Only Drafting |
| Sequence 3: B Physician-Only Then A GPT-Assisted | Experimental | Participants will complete Case Set B using physician-only drafting during Period 1 and Case Set A using GPT-assisted drafting during Period 2. Receives: Other: Physician-Supervised GPT-Assisted Drafting; Other: Physician-Only Drafting |
| Sequence 4: B GPT-Assisted Then A Physician-Only | Experimental | Participants will complete Case Set B using GPT-assisted drafting during Period 1 and Case Set A using physician-only drafting during Period 2. Receives: Other: Physician-Supervised GPT-Assisted Drafting; Other: Physician-Only Drafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During each study period, with the second period occurring 5 to 9 days after the first period
Secondary outcomes (10)
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.
Measured: During each study period, with the second period occurring 5 to 9 days after the first period
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.
Measured: During each study period, with the second period occurring 5 to 9 days after the first period
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.
Measured: During each study period, with the second period occurring 5 to 9 days after the first period
Clinical Accuracy Score
Accuracy of the final response assessed by masked outcome assessors on a 5-point scale. Higher scores indicate greater clinical accuracy.
Measured: During each study period, with the second period occurring 5 to 9 days after the first period
Communication Quality Score
Communication quality of the final response assessed by masked outcome assessors on a 5-point scale. Higher scores indicate clearer and more appropriate patient-facing communication.
Measured: During each study period, with the second period occurring 5 to 9 days after the first period
Raw NASA Task Load Index Score
Workload will be assessed using the six Raw NASA Task Load Index dimensions, each scored from 0 to 100. The unweighted mean of the six dimensions will be calculated. Higher scores indicate greater perceived workload.
Measured: Immediately after each 10-case study period, with study periods occurring 5 to 9 days apart
Perceived Helpfulness of the GPT-Assisted Workflow
Participant-reported helpfulness rating on a 5-point Likert scale. Higher scores indicate greater perceived helpfulness.
Measured: Immediately after completion of the GPT-assisted study period
Trust in the GPT-Assisted Workflow
Participant-reported trust rating on a 5-point Likert scale. Higher scores indicate greater trust.
Measured: Immediately after completion of the GPT-assisted study period
Perceived Risk of the GPT-Assisted Workflow
Participant-reported risk rating on a 5-point Likert scale. Higher scores indicate greater perceived risk.
Measured: Immediately after completion of the GPT-assisted study period
Willingness to Use the GPT-Assisted Workflow Under Physician Supervision
Participant-reported willingness rating on a 5-point Likert scale. Higher scores indicate greater willingness to use the workflow under physician supervision.
Measured: Immediately after completion of the GPT-assisted study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start23 Sep 2026 (estimated)
- Primary completion16 Nov 2026 (estimated)
- Study completion16 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Decision Support SystemsStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized in equal proportions to four sequences that balance study-condition order and synthetic case-set allocation. Each participant will receive both physician-only drafting and GPT-assisted drafting during two study periods separated by 7 plus or minus 2 days.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cong Wang, MD, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829731
- Sponsor's protocol ID
- CPET-LLM-PRO-01
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to researchers outside the study team.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Study of Physician-Supervised GPT-Assisted Drafting for Communication of Cardiopulmonary Exercise Test Results
- ClinicalTrials.gov ID
- NCT07829731
- Acronym / sponsor ID
- CPET-LLM-PRO-01
- Keywords
- Large Language Models, Artificial Intelligence, Cardiopulmonary Exercise Testing, Human-AI Collaboration, Physician-Computer Interaction, Clinical Communication, GPT-Assisted Drafting
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 23 Sep 2026 (estimated)
- Primary completion
- 16 Nov 2026 (estimated)
- Study completion
- 16 Nov 2026 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Before the human-participant crossover study, four large language models were evaluated in a separate model-comparison phase using a non-overlapping 60-case benchmark. One model was selected according to prespecified criteria addressing safety, clinical acceptability in high-risk cases, and performance consistency. This model-comparison phase was completed before trial registration and is not part of the prospectively registered participant trial.
Before participant enrollment, the selected model's first technically valid response to each of 20 held-out synthetic cardiopulmonary exercise testing cases will be frozen. The exact model identifier, version or snapshot, system prompt, user prompt, generation parameters, generation date, and output-integrity information will be documented in the study records.
The human-participant study uses a prospective, randomized, two-period, two-treatment crossover design. Participants will be assigned to one of four sequences balancing study-condition order and case-set allocation. Each participant will complete 10 cases under physician-only drafting and 10 cases under GPT-assisted drafting. The two periods will be separated by 7 plus or minus 2 days.
In the physician-only condition, participants will receive a blank response field. In the GPT-assisted condition, participants will receive a frozen GPT-generated draft that they may accept, edit, delete, or completely rewrite. The physician remains responsible for the submitted final response. Each case has a maximum completion time of 8 minutes. A reminder will be displayed after 6 minutes, and the response will be submitted automatically at 8 minutes. Participants will receive a fixed 3-minute rest after every five cases. Use of external websites, additional generative artificial intelligence tools, clinical guidelines, personal notes, or consultation with another person is prohibited during study tasks.
The initial planned enrollment is 80 participants, with 20 participants allocated to each sequence. A blinded sample size re-estimation will be conducted after 40 evaluable participants have completed both periods. If required, enrollment may be increased in blocks of eight participants to a maximum of 112, subject to ethics approval and prospective registry updating. All study cases are synthetic. No real patient records will be used. Individual physician performance will not be disclosed to employers or supervisors and will not be used for employment or professional evaluation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Participants will be randomized in equal proportions to four sequences that balance study-condition order and synthetic case-set allocation. Each participant will receive both physician-only drafting and GPT-assisted drafting during two study periods separated by 7 plus or minus 2 days.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: A Physician-Only Then B GPT-Assisted | Experimental | Other: Physician-Supervised GPT-Assisted Drafting, Other: Physician-Only DraftingParticipants will complete Case Set A using physician-only drafting during Period 1 and Case Set B using GPT-assisted drafting during Period 2. |
| Sequence 2: A GPT-Assisted Then B Physician-Only | Experimental | Other: Physician-Supervised GPT-Assisted Drafting, Other: Physician-Only DraftingParticipants will complete Case Set A using GPT-assisted drafting during Period 1 and Case Set B using physician-only drafting during Period 2. |
| Sequence 3: B Physician-Only Then A GPT-Assisted | Experimental | Other: Physician-Supervised GPT-Assisted Drafting, Other: Physician-Only DraftingParticipants will complete Case Set B using physician-only drafting during Period 1 and Case Set A using GPT-assisted drafting during Period 2. |
| Sequence 4: B GPT-Assisted Then A Physician-Only | Experimental | Other: Physician-Supervised GPT-Assisted Drafting, Other: Physician-Only DraftingParticipants will complete Case Set B using GPT-assisted drafting during Period 1 and Case Set A using physician-only drafting during Period 2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- Provision of written informed consent.
Key exclusion criteria (5 listed)
- 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.
- Withdrawal of consent before completion of the assigned study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physician-Supervised GPT-Assisted DraftingA 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. | Other | Sequence 1: A Physician-Only Then B GPT-Assisted, Sequence 2: A GPT-Assisted Then B Physician-Only, Sequence 3: B Physician-Only Then A GPT-Assisted, Sequence 4: B GPT-Assisted Then A Physician-Only |
| Physician-Only DraftingThe 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. | Other | Sequence 1: A Physician-Only Then B GPT-Assisted, Sequence 2: A GPT-Assisted Then B Physician-Only, Sequence 3: B Physician-Only Then A GPT-Assisted, Sequence 4: B GPT-Assisted Then A Physician-Only |
Primary outcome
Proportion of Final Responses Meeting the Composite Clinical Acceptability Criterion
Time frame: During each study period, with the second period occurring 5 to 9 days after the first period
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.
10 secondary outcomes
Task Completion Time
Time frame: During each study period, with the second period occurring 5 to 9 days after the first period
Proportion of Responses Containing an S2 Safety Error
Time frame: During each study period, with the second period occurring 5 to 9 days after the first period
Proportion of Responses Containing an S3 Safety Error
Time frame: During each study period, with the second period occurring 5 to 9 days after the first period
Clinical Accuracy Score
Time frame: During each study period, with the second period occurring 5 to 9 days after the first period
Communication Quality Score
Time frame: During each study period, with the second period occurring 5 to 9 days after the first period
Raw NASA Task Load Index Score
Time frame: Immediately after each 10-case study period, with study periods occurring 5 to 9 days apart
Perceived Helpfulness of the GPT-Assisted Workflow
Time frame: Immediately after completion of the GPT-assisted study period
Trust in the GPT-Assisted Workflow
Time frame: Immediately after completion of the GPT-assisted study period
Perceived Risk of the GPT-Assisted Workflow
Time frame: Immediately after completion of the GPT-assisted study period
Willingness to Use the GPT-Assisted Workflow Under Physician Supervision
Time frame: Immediately after completion of the GPT-assisted study period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to researchers outside the study team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cong Wang, MD, PhD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-Supervised GPT-Assisted Drafting and Physician-Only Drafting in people with Clinical Decision Support Systems and Cardiopulmonary Exercise Testing, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cong Wang, MD, PhD (+86-21-64041990, wang.cong1@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Final Responses Meeting the Composite Clinical Acceptability Criterion (time frame: During each study period, with the second period occurring 5 to 9 days after the first period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.