UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062550 |
|---|---|
| Receipt number | R000071584 |
| Scientific Title | The Effect of AI Diagnostic Support on Paramedics' Clinical Assessment and Transport Destination Selection: A Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/08/11 01:52:04 |
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Basic information
Public title
The Effect of AI Diagnostic Support on Paramedics' Clinical Assessment and Transport Destination Selection: A Randomized Crossover Trial
Acronym
The Effect of AI Diagnostic Support on Paramedics' Clinical Assessment and Transport Destination Selection: A Randomized Crossover Trial
Scientific Title
The Effect of AI Diagnostic Support on Paramedics' Clinical Assessment and Transport Destination Selection: A Randomized Crossover Trial
Scientific Title:Acronym
The Effect of AI Diagnostic Support on Paramedics' Clinical Assessment and Transport Destination Selection: A Randomized Crossover Trial
Region
| Japan |
Condition
Condition
Prehospital emergency care
Classification by specialty
| Emergency medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantitatively evaluate how the auxiliary use of AI diagnostic tools affects the quality (accuracy, validity, and appropriateness) of paramedics' clinical judgments, including condition assessment, differential diagnosis, and hospital destination selection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of clinical condition assessment (agreement with standard answers for the suspected disease and urgency level). Validity of the differential diagnosis list (absence of missed critical diseases and appropriate prioritization). Appropriateness of the selected transport destination hospital.
Key secondary outcomes
Time required to complete the assessment. Subjective evaluation of the AI tool (e.g., usability and perceived usefulness, assessed via questionnaire).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants evaluate simulated cases by inputting data into an AI system and using the generated differential diagnosis list to make their final clinical judgment.
Interventions/Control_2
Participants evaluate simulated cases relying solely on their own knowledge and experience.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Active paramedics or emergency medical technicians. Individuals who provided voluntary written informed consent after receiving a thorough explanation of the study.
Key exclusion criteria
Individuals directly involved in developing the simulated cases or AI tools for this study. Individuals deemed unsuitable for participation by the principal investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7489
tetsuya.sato.b6@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Sato |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7489
Homepage URL
tetsuya.sato.b6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Foundation for Ambulance Service Development
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-728-4105
ec-med@grp.tohoku.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 11 | Day |
Last modified on
| 2026 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071584
