UMIN-CTR Clinical Trial

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
Email	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
Email	ahna5650@chiba-u.jp

Sponsor
Institute	Chiba University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048503