Medical Informatics ApplicationsNCT05065931
Real-world Effectiveness Evaluation of Clinical Decision Support System Based on Artificial Intelligence (AI-CDSS)
An observational study of Medical Informatics Applications, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study intends to explore the accuracy of clinical diagnosis of AI based CDSS system and promotion of clinical work by comparing CDSS before and after the online. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Informatics Applications
- What is being tested?
- Auxiliary diagnostic system by AI-CDSS
- How many people
- 34,113 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population was the hospitalized patient from December 2016 to February 2019 in 6 clinical departments. The six clinical departments were Otolaryngology, Orthopaedic, Respiratory Medicine, General Surgery, Cardiology and Hematology.
Who may be able to join
- all hospitalized patients in 6 clinical departments, Otolaryngology, Orthopaedic, Respiratory Medicine, General Surgery, Cardiology and Hematology from December 2016 to February 2019.
Who cannot join
- Missing data for key variables
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Effectiveness Evaluation of Clinical Decision Support System Based on Artificial Intelligence (AI-CDSS) on Diagnosis
This study intends to explore the accuracy of clinical diagnosis of AI based CDSS system and promotion of clinical work by comparing CDSS before and after the online.
Read the detailed description
This study intends to explore the accuracy of clinical diagnosis of AI based CDSS system and promotion of clinical work by comparing CDSS before and after the online. The difference of diagnostic accuracy before and after AI-CDSS application will be compared by the before and after design, and the role of AI-CDSS will be explored.
- Conditions
- Medical Informatics Applications
- Being tested
- Auxiliary diagnostic system by AI-CDSS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auxiliary diagnostic system by AI-CDSSOther
Helping clinicians to make diagnoses by using CDSS based-on AI
| Study group | Role | What they receive |
|---|---|---|
| Before | before CDSS on-line | |
| After | after CDSS on-line Receives: Other: Auxiliary diagnostic system by AI-CDSS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Rate of Recommended Diagnosis by CDSS, up to 12 weeks
Based on the patient's discharge diagnosis as a standard, it is explored whether the diagnosis given by the CDSS is consistent with the discharge diagnosis in the patient's medical record.
Measured: When the subject was discharged from the hospital
Patients' hospitalization time (days), up to 24 weeks
The length of a patient's stay is the number of days he or she experiences from the time of admission to the time of discharge.
Measured: When the subject was discharged from the hospital
consistency between admission diagnosis and discharge diagnosis up to 12 weeks
When the patient comes to the hospital, the clinician will write an inpatient record and give a preliminary diagnosis, which we call admission diagnosis.After the patient is hospitalized, all kinds of examinations will be improved. After all the examination results come out, the patient's diagnosis on admission may be modified. Because there are no auxiliary examination results on admission, the diagnosis on admission may not be completely correct.This modified diagnosis is called discharge diagnosis.This study compared the consistent rate of admission diagnosis and discharge diagnosis before and after CDSS on-line.
Measured: When the subject was discharged from the hospital
Secondary outcomes (1)
length of confirmed time, up to 6 weeks
he length of confirmed time (days) was the duration between the preliminary admission diagnosis and the definite diagnosis.
Measured: When the subject was discharged 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 posted4 Oct 2021
- Study start1 Mar 2019
- Primary completion1 May 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Informatics ApplicationsStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 34,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Qi, Ph.D, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065931
- Sponsor's protocol ID
- 324-01
- Status last verified
- Jul 2019
- First submitted
- 12 Jul 2019
- Last updated
- 4 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After the results of the study are published for one year, the data can be published to other researchers. But the data needs to be de-identified to protect the patient's privacy.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Effectiveness Evaluation of Clinical Decision Support System Based on Artificial Intelligence (AI-CDSS) on Diagnosis
- ClinicalTrials.gov ID
- NCT05065931
- Acronym / sponsor ID
- 324-01
- Conditions
- Medical Informatics Applications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34,113 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 4 Oct 2021 (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 intends to explore the accuracy of clinical diagnosis of AI based CDSS system and promotion of clinical work by comparing CDSS before and after the online.
Detailed description
This study intends to explore the accuracy of clinical diagnosis of AI based CDSS system and promotion of clinical work by comparing CDSS before and after the online. The difference of diagnostic accuracy before and after AI-CDSS application will be compared by the before and after design, and the role of AI-CDSS will be explored.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before | – | –before CDSS on-line |
| After | – | Other: Auxiliary diagnostic system by AI-CDSSafter CDSS on-line |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population was the hospitalized patient from December 2016 to February 2019 in 6 clinical departments. The six clinical departments were Otolaryngology, Orthopaedic, Respiratory Medicine, General Surgery, Cardiology and Hematology.
Key inclusion criteria (1 listed)
- all hospitalized patients in 6 clinical departments, Otolaryngology, Orthopaedic, Respiratory Medicine, General Surgery, Cardiology and Hematology from December 2016 to February 2019.
Key exclusion criteria (1 listed)
- Missing data for key variables
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 |
|---|---|---|
| Auxiliary diagnostic system by AI-CDSSHelping clinicians to make diagnoses by using CDSS based-on AI | Other | After |
Primary outcome
Accuracy Rate of Recommended Diagnosis by CDSS, up to 12 weeks
Time frame: When the subject was discharged from the hospital
Based on the patient's discharge diagnosis as a standard, it is explored whether the diagnosis given by the CDSS is consistent with the discharge diagnosis in the patient's medical record.
Patients' hospitalization time (days), up to 24 weeks
Time frame: When the subject was discharged from the hospital
The length of a patient's stay is the number of days he or she experiences from the time of admission to the time of discharge.
consistency between admission diagnosis and discharge diagnosis up to 12 weeks
Time frame: When the subject was discharged from the hospital
When the patient comes to the hospital, the clinician will write an inpatient record and give a preliminary diagnosis, which we call admission diagnosis.After the patient is hospitalized, all kinds of examinations will be improved. After all the examination results come out, the patient's diagnosis on admission may be modified. Because there are no auxiliary examination results on admission, the diagnosis on admission may not be completely correct.This modified diagnosis is called discharge diagnosis.This study compared the consistent rate of admission diagnosis and discharge diagnosis before and after CDSS on-line.
1 secondary outcome
length of confirmed time, up to 6 weeks
Time frame: When the subject was discharged from the hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Individual participant dataSharing planned: Undecided. After the results of the study are published for one year, the data can be published to other researchers. But the data needs to be de-identified to protect the patient's privacy.
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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. This study is not recruiting at the moment.
Hong Qi, Ph.D principal investigator
Peking University Third Hospital
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 Medical Informatics Applications, run by Peking University Third 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 1 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: finished, as of the sponsor's last update on 4 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy Rate of Recommended Diagnosis by CDSS, up to 12 weeks (time frame: When the subject was discharged from the hospital). The study lists 3 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 4 Oct 2021.