UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054984 |
|---|---|
| Receipt number | R000062824 |
| Scientific Title | Objective structured clinical examination as a method to assess patient safety competencies of Japanese medical students: development and validation argument |
| Date of disclosure of the study information | 2024/07/17 |
| Last modified on | 2024/07/16 23:36:30 |
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Basic information
Public title
Objective structured clinical examination as a method to assess patient safety competencies of Japanese medical students: development and validation argument
Acronym
Development and validation of patient safety OSCE
Scientific Title
Objective structured clinical examination as a method to assess patient safety competencies of Japanese medical students: development and validation argument
Scientific Title:Acronym
PS-OSCE development and validation
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and validate the questions for the objective structured clinical examination (OSCE), which is used to assess students' abilities at the time of graduation from medical school.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Five criteria in the Messick's validity framework (content, response process, relation s to other variables, internal structure and consequences)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patient safety managers at university hospitals, educational experts, and medical educators who regularly teach medical students at workplaces
Key exclusion criteria
Those who do not expect the enrollment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Shimizu |
Organization
Shinshu University
Division name
Center for Medical Education and Clinical Training
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto Japan
TEL
0263-37-3114
qingshuiyufu@gmail.com
Public contact
Name of contact person
| 1st name | Ikuo |
| Middle name | |
| Last name | Shimizu |
Organization
Shinshu University
Division name
Center for Medical Education and Clinical Training
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto Japan
TEL
0263-37-3114
Homepage URL
qingshuiyufu@gmail.com
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Japanese Medical Education Foundation
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
Research Ethics Committee for Life Sciences and Medical Sciences, Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2024 | Year | 07 | Month | 17 | 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
22
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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As of July 1, 2024, this is a work in progress.
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062824
