AI-Assisted DiagnosisNCT07728513
Improving AI-Assisted Medical Diagnosis and Triage by the General Public
A study testing new GPT-4o Interface in people with AI-Assisted Diagnosis and Large Language Models, run by Lahore University of Management Sciences at 1 site in Pakistan.
Trial summary
This study is a randomized controlled trial (RCT) investigating whether access to a new LLM interface can improve medical triage and diagnostic accuracy for laypeople compared to access to a standard LLM interface. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- AI-Assisted Diagnosis, Large Language Models
- What is being tested?
- new GPT-4o Interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2026to 1 Jul 2027
- 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
- Enrolled student or employed administrative staff at LUMS.
- 18 years of age or older.
- Able to read and understand English.
Who cannot join
- Individuals with any formal education or professional training in medicine, nursing, or any other healthcare profession.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Lahore University of Management Sciences
Lahore, Punjab Province, 54000
Ihsan Ayyub Qazi, PhD, +923233333766, ihsan.qazi@lums.edu.pk
Ayesha Ali, PhD, 04235608368, ayeshaali@lums.edu.pk
About this study
This study is a randomized controlled trial (RCT) investigating whether access to a new LLM interface can improve medical triage and diagnostic accuracy for laypeople compared to access to a standard LLM interface. It addresses previous findings where laypeople using standard LLMs performed worse than those using conventional methods (e.g., web search) due to incomplete symptom sharing and poor interpretation of AI advice. To address this, the research tests a structured LLM system that proactively asks clinical history questions before providing a standardized, easy-to-read diagnostic output.
Read the detailed description
As large language models (LLMs) become widely accessible, a growing share of the public already turns to AI-powered chatbots for health-related information: surveys suggest that one in six American adults consults AI chatbots for health queries at least once a month. At the same time, diagnostic errors and misplaced triage decisions represent a persistent source of preventable patient harm globally [4]. This has prompted considerable interest in whether LLMs can serve as a reliable "front door" to the healthcare system for patients who lack immediate access to a clinician.
However, incidents involving misguided medical suggestions from LLMs to the general public such as fatal overdose and erroneous diagnosis leading to life-threatening treatment delay have been reported. A recent controlled study shows LLMs perform significantly worse for medical assistance in real-world settings compared to their performance on controlled benchmarks. Bean et al. [1] conducted a large preregistered study with 1,298 UK participants in which laypeople were assigned to receive assistance from one of three popular LLMs (GPT-4o, Llama 3, or Command R+) or to use a source of their choice when assessing ten standardized medical scenarios. Although the LLMs alone correctly identified relevant conditions in up to 94.9% of cases, participants using those same LLMs did so in fewer than 34.5% of cases, significantly worse than the group using their typical home resources (∼60%). Similarly, triage accuracy showed no signifcant difference between LLM users and controls, with an overall correct response rate of 43.0% across all groups. This poor performance can be linked to two main failure modes: users providing incomplete symptom information to the AI, and users failing to correctly interpret or act upon the LLM's output.
To address these failure modes, the study tests a new GPT-4o interface wrapped with a fixed system prompt. Rather than passively responding to whatever the user volunteers, the AI is instructed to ask clarifying questions to gather a proper clinical history before offering any medical suggestions. Once the model judges that enough information is gathered, it provides a structured, easy-to-read response detailing possible conditions, their likelihoods, and a clear triage recommendation.
The trial is structured as a two-arm, single-blind RCT. Both arms retain access to whatever assistance methods participants would normally use at home (e.g., web search), and both arms additionally get a GPT-4o-based LLM interface. The difference lies in which interface: the treatment arm receives the new interface described above, while the control arm receives a standard, unmodified GPT-4o interface with no special prompting. Participants are restricted to using the provided LLM interface (GPT-4o) only, and not other LLMs. AI-overview in web searches will be disabled through an extension. The trial utilizes ten previously validated clinical vignettes covering various medical urgencies, ranging from self-care routines up to ambulance-level emergencies, with each participant randomly assigned two of the ten. To achieve sufficient statistical power (accounting for within-participant clustering across those two responses), the target sample size is calculated at 220 total participants, split evenly with 110 individuals per arm.
The participant pool is drawn from the enrolled students and administrative staff at the Lahore University of Management Sciences (LUMS) in Pakistan. To ensure the sample consists strictly of laypeople, anyone currently enrolled in or who has completed a medical, nursing, or allied health professional degree is explicitly excluded from participating.
The study is driven by two co-primary hypotheses: participants with access to the new LLM interface will identify relevant medical conditions at a higher rate than participants using the standard LLM interface, and they will correctly assess the urgency of the medical scenarios at a higher rate. Accuracy is measured by comparing participant responses to a physician-generated gold-standard list using fuzzy matching, then analyzed via mixed-effects logistic regression with participant-level covariates and a Bonferroni-corrected significance threshold. The study also tracks secondary outcomes - self-reported confidence and time spent per scenario - and several exploratory analyses, including an LLM-alone benchmark, moderation by LLM experience, internet usage patterns, digital literacy, and scenario-level variation in accuracy.
- Conditions
- AI-Assisted Diagnosis, Large Language Models
- Being tested
- new GPT-4o Interface, Control
- Keywords
- LLMs, Diagnosis, Triage
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
new GPT-4o InterfaceDevice
Participants can access any assistance methods they would typically employ (e.g., web search or health portals) in addition to a new LLM (GPT-4o) interface to complete medical scenarios. The new LLM interface uses a fixed system prompt that (a) instructs the model to ask targeted clarifying questions before providing any diagnostic or triage suggestions, and (b) requires all final responses to follow a structured template listing: possible conditions, approximate likelihood of each, and a recommended triage with brief reasoning.
ControlOther
Participants use any assistance methods they would typically employ at home (e.g., Google or health portals) in addition to a standard LLM (GPT-4o) to complete medical scenarios. AI-overview in web searches will be disabled via an extension. They would not be allowed to access any LLMs other than the standard LLM interface.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm (new GPT-4o Interface) | Experimental | Participants can access any assistance methods they would typically employ (e.g., web search or health portals) in addition to a new LLM interface (based on GPT-4o) to complete medical scenarios. The new LLM interface uses a fixed system prompt that (a) instructs the model to ask targeted clarifying questions before providing any diagnostic or triage suggestions, and (b) requires all final responses to follow a structured template listing: possible conditions, approximate likelihood of each, and a recommended triage with brief reasoning. Receives: Device: new GPT-4o Interface |
| Control | Placebo comparator | Participants can use any assistance methods they would typically employ (e.g., web search or health portals) in addition to a standard LLM (GPT-4o) to complete medical scenarios. AI-overview in web searches will be disabled via an extension. They would not be allowed to access any LLMs other than the standard LLM interface. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urgency Assessment Accuracy
The primary outcome will be the percentage of correct urgency assessments, ranging from 0 to 100%, where higher scores indicate better urgency assessment (or triage) performance. The rating which participants give for the urgency of each case, will be measured on a five-point scale: Self-care, Routine GP, Urgent Primary Care, Accident \& Emergency, and Ambulance. Responses will be compared against the gold-standard answers to produce an accuracy measure. The primary outcome will be compared at the case-level between the randomized groups.
Measured: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
Condition Identification Accuracy
The co-primary outcome is the Condition Identification Accuracy, which is the percentage of cases in which the condition was correctly identified, ranging from 0 to 100%., where higher scores indicate better medical condition identification performance. Participants name all medical conditions they considered relevant to their decision. A response is scored as correct for that scenario if at least one named condition matches the physician-generated gold-standard list of relevant conditions. The co-primary outcome will be compared at the case-level between the randomized groups.
Measured: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
Secondary outcomes (2)
Self-Reported Confidence
Participants' self-reported confidence in their urgency assessments, measured using a scale ranging from 0 to 100.
Measured: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
Time Spent
The amount of time participants spend completing each medical scenario in milliseconds.
Measured: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Jul 2026
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AI-Assisted DiagnosisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore University of Management Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ihsan Ayyub Qazi, PhD, Lahore University of Management Sciences
- Investigators
- Ihsan Ayyub Qazi, PhD, Study chair, Lahore University of Management Sciences (LUMS)Ayesha Ali, PhD, Principal investigator, Lahore University of Management Sciences (LUMS)Zafar Ayyub Qazi, PhD, Principal investigator, Lahore University of Management Sciences (LUMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728513
- Sponsor's protocol ID
- AI-Assisted-Diag-Public789
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2026
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving AI-Assisted Medical Diagnosis and Triage by the General Public
- ClinicalTrials.gov ID
- NCT07728513
- Acronym / sponsor ID
- AI-Assisted-Diag-Public789
- Conditions
- AI-Assisted Diagnosis, Large Language Models
- Keywords
- LLMs, Diagnosis, Triage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Lahore University of Management SciencesUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 27 Jul 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.
This study is a randomized controlled trial (RCT) investigating whether access to a new LLM interface can improve medical triage and diagnostic accuracy for laypeople compared to access to a standard LLM interface. It addresses previous findings where laypeople using standard LLMs performed worse than those using conventional methods (e.g., web search) due to incomplete symptom sharing and poor interpretation of AI advice. To address this, the research tests a structured LLM system that proactively asks clinical history questions before providing a standardized, easy-to-read diagnostic output.
Detailed description
As large language models (LLMs) become widely accessible, a growing share of the public already turns to AI-powered chatbots for health-related information: surveys suggest that one in six American adults consults AI chatbots for health queries at least once a month. At the same time, diagnostic errors and misplaced triage decisions represent a persistent source of preventable patient harm globally [4]. This has prompted considerable interest in whether LLMs can serve as a reliable "front door" to the healthcare system for patients who lack immediate access to a clinician.
However, incidents involving misguided medical suggestions from LLMs to the general public such as fatal overdose and erroneous diagnosis leading to life-threatening treatment delay have been reported. A recent controlled study shows LLMs perform significantly worse for medical assistance in real-world settings compared to their performance on controlled benchmarks. Bean et al. [1] conducted a large preregistered study with 1,298 UK participants in which laypeople were assigned to receive assistance from one of three popular LLMs (GPT-4o, Llama 3, or Command R+) or to use a source of their choice when assessing ten standardized medical scenarios. Although the LLMs alone correctly identified relevant conditions in up to 94.9% of cases, participants using those same LLMs did so in fewer than 34.5% of cases, significantly worse than the group using their typical home resources (∼60%). Similarly, triage accuracy showed no signifcant difference between LLM users and controls, with an overall correct response rate of 43.0% across all groups. This poor performance can be linked to two main failure modes: users providing incomplete symptom information to the AI, and users failing to correctly interpret or act upon the LLM's output.
To address these failure modes, the study tests a new GPT-4o interface wrapped with a fixed system prompt. Rather than passively responding to whatever the user volunteers, the AI is instructed to ask clarifying questions to gather a proper clinical history before offering any medical suggestions. Once the model judges that enough information is gathered, it provides a structured, easy-to-read response detailing possible conditions, their likelihoods, and a clear triage recommendation.
The trial is structured as a two-arm, single-blind RCT. Both arms retain access to whatever assistance methods participants would normally use at home (e.g., web search), and both arms additionally get a GPT-4o-based LLM interface. The difference lies in which interface: the treatment arm receives the new interface described above, while the control arm receives a standard, unmodified GPT-4o interface with no special prompting. Participants are restricted to using the provided LLM interface (GPT-4o) only, and not other LLMs. AI-overview in web searches will be disabled through an extension. The trial utilizes ten previously validated clinical vignettes covering various medical urgencies, ranging from self-care routines up to ambulance-level emergencies, with each participant randomly assigned two of the ten. To achieve sufficient statistical power (accounting for within-participant clustering across those two responses), the target sample size is calculated at 220 total participants, split evenly with 110 individuals per arm.
The participant pool is drawn from the enrolled students and administrative staff at the Lahore University of Management Sciences (LUMS) in Pakistan. To ensure the sample consists strictly of laypeople, anyone currently enrolled in or who has completed a medical, nursing, or allied health professional degree is explicitly excluded from participating.
The study is driven by two co-primary hypotheses: participants with access to the new LLM interface will identify relevant medical conditions at a higher rate than participants using the standard LLM interface, and they will correctly assess the urgency of the medical scenarios at a higher rate. Accuracy is measured by comparing participant responses to a physician-generated gold-standard list using fuzzy matching, then analyzed via mixed-effects logistic regression with participant-level covariates and a Bonferroni-corrected significance threshold. The study also tracks secondary outcomes - self-reported confidence and time spent per scenario - and several exploratory analyses, including an LLM-alone benchmark, moderation by LLM experience, internet usage patterns, digital literacy, and scenario-level variation in accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm (new GPT-4o Interface) | Experimental | Device: new GPT-4o InterfaceParticipants can access any assistance methods they would typically employ (e.g., web search or health portals) in addition to a new LLM interface (based on GPT-4o) to complete medical scenarios. The new LLM interface uses a fixed system prompt that (a) instructs the model to ask targeted clarifying questions before providing any diagnostic or triage suggestions, and (b) requires all final responses to follow a structured template listing: possible conditions, approximate likelihood of each, and a recommended triage with brief reasoning. |
| Control | Placebo comparator | Other: ControlParticipants can use any assistance methods they would typically employ (e.g., web search or health portals) in addition to a standard LLM (GPT-4o) to complete medical scenarios. AI-overview in web searches will be disabled via an extension. They would not be allowed to access any LLMs other than the standard LLM interface. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Enrolled student or employed administrative staff at LUMS.
- 18 years of age or older.
- Able to read and understand English.
Key exclusion criteria (1 listed)
- Individuals with any formal education or professional training in medicine, nursing, or any other healthcare profession.
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 |
|---|---|---|
| new GPT-4o InterfaceParticipants can access any assistance methods they would typically employ (e.g., web search or health portals) in addition to a new LLM (GPT-4o) interface to complete medical scenarios. The new LLM interface uses a fixed system prompt that (a) instructs the model to ask targeted clarifying questions before providing any diagnostic or triage suggestions, and (b) requires all final responses to follow a structured template listing: possible conditions, approximate likelihood of each, and a recommended triage with brief reasoning. | Device | Treatment Arm (new GPT-4o Interface) |
| ControlParticipants use any assistance methods they would typically employ at home (e.g., Google or health portals) in addition to a standard LLM (GPT-4o) to complete medical scenarios. AI-overview in web searches will be disabled via an extension. They would not be allowed to access any LLMs other than the standard LLM interface. | Other | Control |
Primary outcome
Urgency Assessment Accuracy
Time frame: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
The primary outcome will be the percentage of correct urgency assessments, ranging from 0 to 100%, where higher scores indicate better urgency assessment (or triage) performance. The rating which participants give for the urgency of each case, will be measured on a five-point scale: Self-care, Routine GP, Urgent Primary Care, Accident \& Emergency, and Ambulance. Responses will be compared against the gold-standard answers to produce an accuracy measure. The primary outcome will be compared at the case-level between the randomized groups.
Condition Identification Accuracy
Time frame: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
The co-primary outcome is the Condition Identification Accuracy, which is the percentage of cases in which the condition was correctly identified, ranging from 0 to 100%., where higher scores indicate better medical condition identification performance. Participants name all medical conditions they considered relevant to their decision. A response is scored as correct for that scenario if at least one named condition matches the physician-generated gold-standard list of relevant conditions. The co-primary outcome will be compared at the case-level between the randomized groups.
2 secondary outcomes
Self-Reported Confidence
Time frame: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
Time Spent
Time frame: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.
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 17 Sep 2026.
- 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.
Ihsan Ayyub Qazi, PhD study chair
Lahore University of Management Sciences (LUMS)
Ayesha Ali, PhD principal investigator
Lahore University of Management Sciences (LUMS)
Zafar Ayyub Qazi, PhD principal investigator
Lahore University of Management Sciences (LUMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing new GPT-4o Interface in people with AI-Assisted Diagnosis and Large Language Models, run by Lahore University of Management Sciences at 1 site in Pakistan.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 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 Pakistan. 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. Some participants in this study may receive a placebo. 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 Ihsan Ayyub Qazi, PhD (+923233333766, ihsan.qazi@lums.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urgency Assessment Accuracy (time frame: Assessed at a single time point for each case, during the scheduled diagnostic evaluation session, which takes place between 0-5 days after participant enrollment.). The study lists 2 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 17 Sep 2026.