UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056327
Receipt number R000064358
Scientific Title A study comparing the educational effectiveness of video and paper-based teaching materials in the education of medical students on diagnostic errors
Date of disclosure of the study information 2024/12/02
Last modified on 2025/06/04 16:11:42

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Basic information

Public title

A study comparing the educational effectiveness of video and paper-based teaching materials in the education of medical students on diagnostic errors

Acronym

Research on the effectiveness of teaching medical students about diagnostic errors using videos

Scientific Title

A study comparing the educational effectiveness of video and paper-based teaching materials in the education of medical students on diagnostic errors

Scientific Title:Acronym

Research on the effectiveness of teaching medical students about diagnostic errors using videos

Region

Japan


Condition

Condition

none

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In Japan, it has been reported that when medical students were given a one-hour lesson on diagnostic errors, they became more aware of the importance of learning about diagnostic errors, and on the other hand, they no longer felt the need to blame those who made diagnostic errors or felt ashamed of having made diagnostic errors, but there have been no reports in Japan to date evaluating the effectiveness of this approach in reducing diagnostic errors. In the United States, it has been reported that reflecting on diagnostic errors did not have any effect on reducing subsequent diagnostic errors among medical students. The reason for this is thought to be that medical students are not performing professional medical practice in the first place. Therefore, in a report that examined the effectiveness of diagnostic error education for medical students in the United States, it was suggested that simulation education using simulated patients may be effective. However, this report was a pilot study, and there was no evaluation of the actual video content created. After that, we were unable to find any other studies that used video content to educate medical students about diagnostic errors, as far as the research representative could find.
Therefore, this study is the world's first research to evaluate the effectiveness of educational content using simulated diagnostic error experiences from the perspective of doctors for medical students.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The period of time the research subjects are scheduled to participate in the research
The research subjects will participate in the observation period within one month of agreeing to take part in the survey

Observation and examination items
The subjects' age, grade, university affiliation (national, municipal, or private), and whether or not they had previously taken a lecture on diagnostic errors were evaluated. In addition, the subjects were asked to evaluate the effectiveness of educational videos and diagnostic error lectures they had previously taken using a 7-point Likert scale. The qualitative aspects were analyzed using content analysis, and questions were asked based on themes set in accordance with the revised Bloom's taxonomy.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

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

Watch the 5 diagnostic error videos and answer the questionnaire.

Interventions/Control_2

Paper data of diagnostic error

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

21 years-old <=

Age-upper limit

60 years-old >=

Gender

Male and Female

Key inclusion criteria

5th or 6th year medical student
Medical student who has completed CBT and OSCE
Those who have consented to participate in the study

Key exclusion criteria

Persons deemed unsuitable as research subjects by the principal investigator

Target sample size

134


Research contact person

Name of lead principal investigator

1st name Taiju
Middle name
Last name Miyagami

Organization

Juntendo University Hospital

Division name

Department of general medicine

Zip code

1138431

Address

Tokyoto Bunkyo-ku Hongo

TEL

0338133111

Email

tmiyaga@juntendo.ac.jp


Public contact

Name of contact person

1st name Taiju
Middle name Yamashita,
Last name Miyagami

Organization

Juntendo University Hospital

Division name

General medicine

Zip code

1138431

Address

Tokyo Bunkyo-ku Hongo

TEL

08050657077

Homepage URL


Email

tmiyaga@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University Hospital

Institute

Department

Personal name



Funding Source

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University Hospital

Address

Tokyo Bunkyo-ku Hongo

Tel

0338133111

Email

tmiyaga@juntendo.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

E24-0064

Org. issuing International ID_1

Juntendo University Hospital

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 12 Month 02 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

134

Results

The video-based group showed a greater improvement from baseline knowledge compared to the paper-based group (mean change: 1.6 vs. 1.9, p = 0.019). 17 themes and subcategories corresponding to the six cognitive process dimensions of Fink's important learning classification were identified.The most frequent themes were related to immersive learning styles, the application of diagnostic error processes, and the consideration of diverse perspectives on diagnostic errors.

Results date posted

2025 Year 06 Month 04 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Japanese medical student.

Participant flow


Adverse events


Outcome measures

None.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2024 Year 06 Month 14 Day

Date of IRB

2024 Year 06 Month 14 Day

Anticipated trial start date

2024 Year 07 Month 31 Day

Last follow-up date

2024 Year 10 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

2024 Year 12 Month 02 Day

Last modified on

2025 Year 06 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064358