Emergency MedicineNCT07766863
AI-support in Emergency Medicine
An observational study of Emergency Medicine and AI (Artificial Intelligence), run by Region Stockholm at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate whether the use of generative artificial intelligence (AI) as a support tool can improve physicians' ability to establish accurate differential diagnoses in emergency care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergency Medicine, AI (Artificial Intelligence), Differential Diagnosis
- How many people
- 500 participants
- Where
- 1 siteSweden
- Study dates
- 8 Jun 2026to Jun 2029
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the hospital via the emergency department at Karolinska University Hospital in Huddinge and Solna, Sweden.
Who may be able to join
- Adult patients >18 years admitted through the emergency departments at Karolinska University Hospital in Huddinge and Solna.
Who cannot join
- Children <18 years
- Patients without a recorded final diagnosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Huddinge, 14186
Maria Ygland Rödström, PhD, Specialist in EM, +46 702653628, maria.ygland-rodstrom@regionstockholm.se
maria@ygland.se
About this study
Official title: Evaluation of AI Support for Differential Diagnosis in Emergency Medicine.
The purpose of this study is to investigate whether the use of generative artificial intelligence (AI) as a support tool can improve physicians' ability to establish accurate differential diagnoses in emergency care.
The main questions it aims to answer are:
- Is AI-assisted differential diagnosis more accurate than the differential diagnosis performed by physicians?
- Does physicians' differential diagnosis change - in terms of the number of correct diagnoses - when they have access to AI-assisted differential diagnosis?
Read the detailed description
The study is based on a prospective cohort of patients admitted through the emergency departments at Karolinska University Hospital in Huddinge and Solna. After completion of the hospital length of stay, excerpts from the medical record are collected according to a predefined variable list and used to create case descriptions corresponding to the information available at the initial assessment. Within this cohort, physicians will be randomized to evaluate patient cases either with or without AI support. The AI tool generates a structured list of likely differential diagnoses. Differential diagnoses proposed by physicians, AI alone, and physicians using AI support will be compared with the clinically established final diagnosis in the discharge summary. In a pilot material, the AI support has shown good agreement with final diagnoses and expert clinical assessment.
The results will be analyzed to assess AI's impact on physicians' diagnostic accuracy and decision-making in various scenarios and case presentations.
Given known challenges in diagnosing complex patients, the study is designed to account for variations in information quality and clinical complexity. Patient cases are presented in a standardized format, and it will be documented how much and what type of information is available in each case, such as symptoms, clinical findings, laboratory results, and disease progression. The analysis focuses on how this may affect the diagnostic suggestions. Difficult-to-diagnose cases are also included to clarify in which clinical situations the decision-support tool is useful, when it is not, and what informational requirements need to be met ahead of a future implementation study evaluating the impact of real-time AI support during the management of acutely ill patients.
There is a lack of large clinical studies that systematically evaluate how generative AI affects physicians' differential diagnostic performance in emergency medicine when used as a complement to clinical judgment. This project addresses this knowledge gap by examining the extent to which AI-generated differential diagnoses align with physicians' assessments and whether access to AI support can improve diagnostic precision.
The results will provide evidence on how AI-based decision support should be evaluated and potentially implemented within emergency care.
Methods:
Study Population Patients admitted to the hospital via the emergency department at Karolinska University Hospital in Huddinge and Solna. The plan is to collect data from 500 patients. The sample size was calculated using G*Power version 3.1.97, with a significance level (alpha) of 0.05, statistical power (1 - beta) of 0.8, and an expected effect size of 0.25, resulting in 210 patient cases per group. To compensate for potential loss to follow up and missing data, the planned included patients is set to 500.
Inclusion criteria: adult patients admitted to the hospital and discharged with a primary diagnosis in the discharge summary. Exclusion criteria: pediatric patients and cases lacking a discharge diagnosis. Emergency "red alert" patients will also be included. Patients will receive written and verbal information about the study and provide informed consent prior to participation. The patients may withdraw at any time. Patient inclusion will begin in the spring 2026. For validation, 30 patient cases from the study "ChatGPT and Generating a Differential Diagnosis Early in an Emergency Department Presentation" will be used.
Data Collection Patient data will be retrieved from the medical record, including the emergency department admission note, any ambulance report, diagnostic workup, and the discharge summary with final diagnosis. Collected data include medical history, vital signs, physical examination findings, laboratory results, imaging results, preliminary diagnosis, and-when applicable-differential diagnoses. After collection, all data will be pseudonymized.
AI Model and IT Security API calls are used to submit structured input, including the user's data (history, physical findings, test results, and point of care investigations). The input structure is based on iterative testing and simulations to ensure that the AI model performs as intended. In addition to patient data, specific prompts instruct the AI model to generate a structured list of differential diagnoses, ranked with the most likely diagnosis first. The code and prompts have been developed to optimize the model's ability to propose accurate differential diagnoses based on patient information. A customized version of a generative language model is used via Microsoft Azure OpenAI Service under the agreements of Karolinska Institutet and Karolinska University Hospital. All data processing occurs in Sweden in accordance with applicable laws and regulations.
Assessment Approximately 30 clinically active resident and specialist physicians in emergency medicine and internal medicine will review the patient cases. Physicians are randomized to assess cases either with or without access to the AI model's suggestions. Patient cases are presented to both physicians and the AI model in a standardized format developed through simulation and iterative refinement.
Data Processing and Analysis
The final diagnosis is defined as the primary diagnosis documented in the discharge summary. Descriptive statistics will be used for background characteristics of physicians and patients, as well as outcome distributions. Differences in diagnostic accuracy between groups will be analyzed using one way ANOVA. Logistic regression will be used to adjust for covariates and calculate odds ratios. Agreement between physicians and the AI model will be assessed using Cohen's kappa. Data on 30 day mortality will also be requested from the national Cause of Death Register.
- Keywords
- emergency medicine, AI (artificial intelligence), Differential diagnosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of cases in which the final diagnosis is ranked highest by the physician and by the AI support, respectively
Considering the final diagnosis after discharge from the hospital.
Measured: At discharge from the hospital
The proportion of physicians' differential diagnosis that change, in terms of the number of correct diagnoses, when they have access to AI-assisted differential diagnosis
This is meassured after the patient has been discharged from the hospital
Measured: After discharge from the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start8 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency MedicineStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Karolinska University Hospital
- Responsible party
- Principal investigator, Maria Ygland Rodstrom, Region Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766863
- Sponsor's protocol ID
- K 2024-7038
- Status last verified
- Aug 2026
- First submitted
- 6 May 2026
- Last updated
- 17 Aug 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 shared due to privacy considerations, the risk of re-identification, and regulatory requirements governing sensitive health information. Only aggregated and fully anonymized results will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of AI Support for Differential Diagnosis in Emergency Medicine.
- ClinicalTrials.gov ID
- NCT07766863
- Acronym / sponsor ID
- K 2024-7038
- Keywords
- emergency medicine, AI (artificial intelligence), Differential diagnosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Karolinska Institutet, Karolinska University Hospital
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 17 Aug 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.
The purpose of this study is to investigate whether the use of generative artificial intelligence (AI) as a support tool can improve physicians' ability to establish accurate differential diagnoses in emergency care.
The main questions it aims to answer are:
- Is AI-assisted differential diagnosis more accurate than the differential diagnosis performed by physicians?
- Does physicians' differential diagnosis change - in terms of the number of correct diagnoses - when they have access to AI-assisted differential diagnosis?
Detailed description
The study is based on a prospective cohort of patients admitted through the emergency departments at Karolinska University Hospital in Huddinge and Solna. After completion of the hospital length of stay, excerpts from the medical record are collected according to a predefined variable list and used to create case descriptions corresponding to the information available at the initial assessment. Within this cohort, physicians will be randomized to evaluate patient cases either with or without AI support. The AI tool generates a structured list of likely differential diagnoses. Differential diagnoses proposed by physicians, AI alone, and physicians using AI support will be compared with the clinically established final diagnosis in the discharge summary. In a pilot material, the AI support has shown good agreement with final diagnoses and expert clinical assessment.
The results will be analyzed to assess AI's impact on physicians' diagnostic accuracy and decision-making in various scenarios and case presentations.
Given known challenges in diagnosing complex patients, the study is designed to account for variations in information quality and clinical complexity. Patient cases are presented in a standardized format, and it will be documented how much and what type of information is available in each case, such as symptoms, clinical findings, laboratory results, and disease progression. The analysis focuses on how this may affect the diagnostic suggestions. Difficult-to-diagnose cases are also included to clarify in which clinical situations the decision-support tool is useful, when it is not, and what informational requirements need to be met ahead of a future implementation study evaluating the impact of real-time AI support during the management of acutely ill patients.
There is a lack of large clinical studies that systematically evaluate how generative AI affects physicians' differential diagnostic performance in emergency medicine when used as a complement to clinical judgment. This project addresses this knowledge gap by examining the extent to which AI-generated differential diagnoses align with physicians' assessments and whether access to AI support can improve diagnostic precision.
The results will provide evidence on how AI-based decision support should be evaluated and potentially implemented within emergency care.
Methods:
Study Population Patients admitted to the hospital via the emergency department at Karolinska University Hospital in Huddinge and Solna. The plan is to collect data from 500 patients. The sample size was calculated using G*Power version 3.1.97, with a significance level (alpha) of 0.05, statistical power (1 - beta) of 0.8, and an expected effect size of 0.25, resulting in 210 patient cases per group. To compensate for potential loss to follow up and missing data, the planned included patients is set to 500.
Inclusion criteria: adult patients admitted to the hospital and discharged with a primary diagnosis in the discharge summary. Exclusion criteria: pediatric patients and cases lacking a discharge diagnosis. Emergency "red alert" patients will also be included. Patients will receive written and verbal information about the study and provide informed consent prior to participation. The patients may withdraw at any time. Patient inclusion will begin in the spring 2026. For validation, 30 patient cases from the study "ChatGPT and Generating a Differential Diagnosis Early in an Emergency Department Presentation" will be used.
Data Collection Patient data will be retrieved from the medical record, including the emergency department admission note, any ambulance report, diagnostic workup, and the discharge summary with final diagnosis. Collected data include medical history, vital signs, physical examination findings, laboratory results, imaging results, preliminary diagnosis, and-when applicable-differential diagnoses. After collection, all data will be pseudonymized.
AI Model and IT Security API calls are used to submit structured input, including the user's data (history, physical findings, test results, and point of care investigations). The input structure is based on iterative testing and simulations to ensure that the AI model performs as intended. In addition to patient data, specific prompts instruct the AI model to generate a structured list of differential diagnoses, ranked with the most likely diagnosis first. The code and prompts have been developed to optimize the model's ability to propose accurate differential diagnoses based on patient information. A customized version of a generative language model is used via Microsoft Azure OpenAI Service under the agreements of Karolinska Institutet and Karolinska University Hospital. All data processing occurs in Sweden in accordance with applicable laws and regulations.
Assessment Approximately 30 clinically active resident and specialist physicians in emergency medicine and internal medicine will review the patient cases. Physicians are randomized to assess cases either with or without access to the AI model's suggestions. Patient cases are presented to both physicians and the AI model in a standardized format developed through simulation and iterative refinement.
Data Processing and Analysis
The final diagnosis is defined as the primary diagnosis documented in the discharge summary. Descriptive statistics will be used for background characteristics of physicians and patients, as well as outcome distributions. Differences in diagnostic accuracy between groups will be analyzed using one way ANOVA. Logistic regression will be used to adjust for covariates and calculate odds ratios. Agreement between physicians and the AI model will be assessed using Cohen's kappa. Data on 30 day mortality will also be requested from the national Cause of Death Register.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital via the emergency department at Karolinska University Hospital in Huddinge and Solna, Sweden.
Key inclusion criteria (1 listed)
- Adult patients >18 years admitted through the emergency departments at Karolinska University Hospital in Huddinge and Solna.
Key exclusion criteria (2 listed)
- Children <18 years
- Patients without a recorded final diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of cases in which the final diagnosis is ranked highest by the physician and by the AI support, respectively
Time frame: At discharge from the hospital
Considering the final diagnosis after discharge from the hospital.
The proportion of physicians' differential diagnosis that change, in terms of the number of correct diagnoses, when they have access to AI-assisted differential diagnosis
Time frame: After discharge from the hospital
This is meassured after the patient has been discharged from the hospital
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 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy considerations, the risk of re-identification, and regulatory requirements governing sensitive health information. Only aggregated and fully anonymized results will be made available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Medicine and AI (Artificial Intelligence), run by Region Stockholm at 1 site in Sweden.
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 1 inclusion and 2 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 Aug 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 Sweden. 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 Maria Ygland Rödström, PI (+46 702653628, maria.ygland.rodstrom@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of cases in which the final diagnosis is ranked highest by the physician and by the AI support, respectively (time frame: At discharge from the hospital). 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 Aug 2026.