UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050484 |
|---|---|
| Receipt number | R000053336 |
| Scientific Title | The efficacy of displaying the working diagnosis at the last of the case presentation to reduce diagnostic error: an open-label randomized controlled study |
| Date of disclosure of the study information | 2023/03/03 |
| Last modified on | 2024/06/30 19:06:19 |
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Basic information
Public title
The efficacy of displaying the working diagnosis at the last of the case presentation to reduce diagnostic error: an open-label randomized controlled study
Acronym
The efficacy of displaying the working diagnosis at the last of the case presentation to reduce diagnostic error: an open-label randomized controlled study
Scientific Title
The efficacy of displaying the working diagnosis at the last of the case presentation to reduce diagnostic error: an open-label randomized controlled study
Scientific Title:Acronym
The efficacy of displaying the working diagnosis at the last of the case presentation to reduce diagnostic error: an open-label randomized controlled study
Region
| Japan |
Condition
Condition
Diseases in general internal medicine
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clarify the effects of the order of displaying the working diagnosis in the meeting for patient handoff on the diagnostic accuracy of physicians.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence of making misdiagnosis.
Key secondary outcomes
The association between the diagnostic error and age, sex, post graduated year, the degree of trust in diagnostic sense, and the length of training of emergency medicine.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants are required to declare whether agree or disagree on the oral case presentation of 8 fictional clinical scenarios. If they do not agree, they are asked to name their own diagnosis. The working diagnosis are displayed at the beginning of the presentation. They are containing an equal number of correct and incorrect diagnosis.
Interventions/Control_2
Participants are required to declare whether agree or disagree on the oral case presentation of 8 fictional clinical scenarios. If they do not agree, they are asked to name their own diagnosis. The working diagnosis are displayed at the end of the presentation. They are containing an equal number of correct and incorrect diagnosis.
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
| 24 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Junior residents (postgraduate year 1 or 2) working in Japan.
Key exclusion criteria
no consent for participating in this study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | MASAYUKI |
| Middle name | |
| Last name | AMANO |
Organization
Dokkyo Medical University
Division name
Department of Diagnostic and Generalist Medicine
Zip code
321-0293
Address
Kitakobayashi 880,Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
work.photo.1111@gmail.com
Public contact
Name of contact person
| 1st name | MASAYUKI |
| Middle name | |
| Last name | AMANO |
Organization
Dokkyo Medical University
Division name
Department of Diagnostic and Generalist Medicine
Zip code
321-0293
Address
Kitakobayashi 880,Mibu, Shimotsuga, Tochigi
TEL
0282-86-1111
Homepage URL
work.photo.1111@gmail.com
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
Ethics committee of Dokkyo Medical University
Address
Kitakobayashi 880,Mibu, Shimotsuga, Tochigi
Tel
Kitakobayashi 880,Mibu, Shimotsuga, Tochigi
kenkyu@dokkyomed.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
| 2023 | Year | 03 | Month | 03 | 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
40
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
| 2022 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2023 | Year | 03 | Month | 03 | Day |
Last modified on
| 2024 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053336
