UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042831 |
|---|---|
| Receipt number | R000048503 |
| Scientific Title | Assessment of the Japanese diagnostic support tool to avoid diagnostic errors in inexperienced medical students. |
| Date of disclosure of the study information | 2020/12/24 |
| Last modified on | 2022/11/13 12:54:55 |
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Basic information
Public title
Assessment of the Japanese diagnostic support tool to avoid diagnostic errors in inexperienced medical students.
Acronym
Assessment of the Japanese diagnostic support tool to avoid diagnostic errors in inexperienced medical students.
Scientific Title
Assessment of the Japanese diagnostic support tool to avoid diagnostic errors in inexperienced medical students.
Scientific Title:Acronym
Assessment of the Japanese diagnostic support tool to avoid diagnostic errors in inexperienced medical students.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research was designed to reveal the effectiveness of the Japanese diagnostic support tool to avoid diagnostic errors due to an inability to recall differential diagnoses in inexperienced medical students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Assessment of the percentage of correct answers and response time to the 20 case questions.
The case questions consist of 10 common and 10 emergency disease questions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Students answer the case questions without any tools.
Interventions/Control_2
Students answer the case questions with a Japanese diagnostic support tool.
Interventions/Control_3
Students answer the case questions by searching Google.
Interventions/Control_4
Residents answer the case questions without any tools.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 21 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study population consisted of 64 medical students participating in a general medicine clerkship rotation from March to September 2020 and 12 residents participating in rotation from March to December 2020.
Key exclusion criteria
NA
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Masatomi |
| Middle name | |
| Last name | Ikusaka |
Organization
Chiba University Hospital
Division name
General Medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chu-ou-ku
TEL
043-222-7171
ikusaka@ga2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Yanagita |
Organization
Chiba University Hospital
Division name
General Medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chu-ou-ku
TEL
043-222-7171
Homepage URL
ahna5650@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
NA
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University
Address
1-8-1, Inohana, Chu-ou-ku
Tel
043-222-7171
igaku-rinri@office.chiba-u.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
| 2020 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
64
Results
The means of scores of the three medical student groups showed a significant difference. Post-hoc comparisons showed that the mean scores of the CDSS and Google groups were significantly higher than those of the control group. The difference between the CDSS group and Google group was not statistically significant.
Results date posted
| 2022 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We received consent from all 64 medical students and 13 of 14 residents.
The medical students passed a CBT test before their clerkship started.
Participant flow
Explained individually
Adverse events
NA
Outcome measures
Percentage of correct answers and response time for case questions.
Plan to share IPD
NA
IPD sharing Plan description
NA
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 12 | Month | 24 | Day |
Last modified on
| 2022 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048503
