Patient CommunicationCLEAR2NCT07222644
Clinical Language Evaluation With AI for Residents
A study testing educational LLM-based feedback tool in people with Patient Communication, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to refine and test existing enterprise-grade large language model (LLM) based on generative artificial intelligence (AI), to assess the feasibility and acceptability of LLM-based feedback, to assess the ability of LLM-based feedback to improve residents' communications,to explore the… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Patient Communication
- What is being tested?
- educational LLM-based feedback tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2025to 28 May 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- McGovern Medical School (MMS) general surgery residents
- postgraduate year (PGY) 1-5
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Krislynn M Mueck, MD, MS, MPH, (713) 500-7409, Krislynn.M.Mueck@uth.tmc.edu
William D Rieger, (713) 500-7300, William.D.Rieger@uth.tmc.edu
About this study
Official title: Clinical Language Evaluation With AI for Residents (CLEAR2) - A Pilot Randomized Controlled Trial
The purpose of this study is to refine and test existing enterprise-grade large language model (LLM) based on generative artificial intelligence (AI), to assess the feasibility and acceptability of LLM-based feedback, to assess the ability of LLM-based feedback to improve residents' communications,to explore the ability of standardized patients to assess residents' communication and to explore the ability of residents to self-assess their communication complexity
- Conditions
- Patient Communication
- Being tested
- educational LLM-based feedback tool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational LLM-based feedback toolBehavioural
Participants will have their verbal communications with standardized patients (SP) regarding 3 different scenarios recorded, transcribed, and analyzed in real-time by the large language model (LLM) and will receive feedback as suggestions and alternative scripts. These will be reviewed by residents between SP scenarios
| Study group | Role | What they receive |
|---|---|---|
| Educational LLM-based feedback tool | Experimental | Not described Receives: Behavioral: educational LLM-based feedback tool |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readability discernment as assessed by a survey
This will be scored by the by Cohen's Kappa values from 1-5. Higher Cohen's kappa scores mean better outcome
Measured: end of intervention ( 1 hour after baseline)
Quality discernment as assessed by a survey
This will be scored by the by Cohen's Kappa values from 1-5. Higher Cohen's kappa scores mean better outcome
Measured: end of intervention ( 1 hour after baseline)
Correctness of recommendations as assessed by a survey
This will be reported on a 5 point Likert scale form 1 very incorrect to 5 very correct
Measured: end of intervention ( 1 hour after baseline)
Applicability of recommendations as assessed by a survey
This will be reported on a 5 point Likert scale form 1 very inapplicable to 5 very applicable
Measured: end of intervention ( 1 hour after baseline)
Perceived readability of resident-standardized patient (SP) interactions as assessed by a survey: schooling level
This will be categorically reported in the following categories:
Elementary middle high college graduate
Measured: end of intervention ( 1 hour after baseline)
confidence in communication ability
This is scored from 1( very unconfident) to 5 (very confident)
Measured: end of intervention ( 1 hour after baseline)
usefulness of the LLM
This is scored from 1( very useless) to 5 (very useful)
Measured: end of intervention ( 1 hour after baseline)
acceptability of future use
This is scored from 1( very unlikely) to 5 (very likely)
Measured: end of intervention ( 1 hour after baseline)
Secondary outcomes (5)
Survey feedback on the LLM interface
This is scored from 1( very unrealistic) to 5 (very realistic)
Measured: end of intervention ( 1 hour after baseline)
readability grade level of resident-SP transcripts as assessed by the Flesch-Kincaid Grade Level (FKGL) readability tool
Readability of resident-SP encounter transcripts will be assessed using the Flesch-Kincaid Grade Level formula, which estimates the U.S. school grade level required to understand the text. Higher scores indicate a higher reading grade level (i.e., lower readability).
Formula used:
Grade level= 0.39(total words/total sentences) + 11.8 (total syllables/total words)-15.59
Measured: end of intervention ( 1 hour after baseline)
Quality based on Ensuring Quality Information for Patients (EQIP) score of resident-SP transcripts
Percentage score based on a validated questionnaire This has 20 questions and each is scored from 1(yes), 0.5(partly), 0 (no) and question is removed if it does not apply.Scores are reported as a percentage and higher percentage score indicates better quality
Measured: end of intervention ( 1 hour after baseline)
Perceived readability of SP-resident interactions as assessed by a standardized survey
This will be categorically reported in the following categories:
Elementary middle high college graduate
Measured: end of intervention ( 1 hour after baseline)
confidence in communication ability
This is scored from 1( very unconfident) to 5 (very confident)
Measured: end of intervention ( 1 hour after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start23 Oct 2025 (estimated)
- Primary completion26 Mar 2026 (estimated)
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient CommunicationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Health Science Education Small Grants Program
- Responsible party
- Principal investigator, Krislynn Michelle Mueck, The University of Texas Health Science Center, Houston
- Investigators
- Krislynn M Mueck, MD, MS, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222644
- Sponsor's protocol ID
- HSC-MS-25-0920
- Acronym
- CLEAR2
- Status last verified
- Oct 2025
- First submitted
- 28 Oct 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Language Evaluation With AI for Residents (CLEAR2) - A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07222644
- Acronym / sponsor ID
- CLEAR2 / HSC-MS-25-0920
- Conditions
- Patient Communication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Health Science Education Small Grants Program
- Study start
- 23 Oct 2025 (estimated)
- Primary completion
- 26 Mar 2026 (estimated)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 30 Oct 2025 (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.
The purpose of this study is to refine and test existing enterprise-grade large language model (LLM) based on generative artificial intelligence (AI), to assess the feasibility and acceptability of LLM-based feedback, to assess the ability of LLM-based feedback to improve residents' communications,to explore the ability of standardized patients to assess residents' communication and to explore the ability of residents to self-assess their communication complexity
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational LLM-based feedback tool | Experimental | Behavioral: educational LLM-based feedback tool |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- McGovern Medical School (MMS) general surgery residents
- postgraduate year (PGY) 1-5
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| educational LLM-based feedback toolParticipants will have their verbal communications with standardized patients (SP) regarding 3 different scenarios recorded, transcribed, and analyzed in real-time by the large language model (LLM) and will receive feedback as suggestions and alternative scripts. These will be reviewed by residents between SP scenarios | Behavioural | Educational LLM-based feedback tool |
Primary outcome
Readability discernment as assessed by a survey
Time frame: end of intervention ( 1 hour after baseline)
This will be scored by the by Cohen's Kappa values from 1-5. Higher Cohen's kappa scores mean better outcome
Quality discernment as assessed by a survey
Time frame: end of intervention ( 1 hour after baseline)
This will be scored by the by Cohen's Kappa values from 1-5. Higher Cohen's kappa scores mean better outcome
Correctness of recommendations as assessed by a survey
Time frame: end of intervention ( 1 hour after baseline)
This will be reported on a 5 point Likert scale form 1 very incorrect to 5 very correct
Applicability of recommendations as assessed by a survey
Time frame: end of intervention ( 1 hour after baseline)
This will be reported on a 5 point Likert scale form 1 very inapplicable to 5 very applicable
Perceived readability of resident-standardized patient (SP) interactions as assessed by a survey: schooling level
Time frame: end of intervention ( 1 hour after baseline)
This will be categorically reported in the following categories: Elementary middle high college graduate
confidence in communication ability
Time frame: end of intervention ( 1 hour after baseline)
This is scored from 1( very unconfident) to 5 (very confident)
usefulness of the LLM
Time frame: end of intervention ( 1 hour after baseline)
This is scored from 1( very useless) to 5 (very useful)
acceptability of future use
Time frame: end of intervention ( 1 hour after baseline)
This is scored from 1( very unlikely) to 5 (very likely)
5 secondary outcomes
Survey feedback on the LLM interface
Time frame: end of intervention ( 1 hour after baseline)
readability grade level of resident-SP transcripts as assessed by the Flesch-Kincaid Grade Level (FKGL) readability tool
Time frame: end of intervention ( 1 hour after baseline)
Quality based on Ensuring Quality Information for Patients (EQIP) score of resident-SP transcripts
Time frame: end of intervention ( 1 hour after baseline)
Perceived readability of SP-resident interactions as assessed by a standardized survey
Time frame: end of intervention ( 1 hour after baseline)
confidence in communication ability
Time frame: end of intervention ( 1 hour after baseline)
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 30 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Krislynn M Mueck, MD, MS, MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational LLM-based feedback tool in people with Patient Communication, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 inclusion and 0 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 30 Oct 2025. 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 United States. 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 Krislynn M Mueck, MD, MS, MPH ((713) 500-7409, Krislynn.M.Mueck@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readability discernment as assessed by a survey (time frame: end of intervention ( 1 hour after baseline)). The study lists 8 primary outcomes in all. 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 30 Oct 2025.