UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000040466
Receipt No. R000046188
Scientific Title Does the Problem Based Learning style teleconference improve medical students psychological safety and self-explanation in clinical reasoning conference? A randomized controlled trial
Date of disclosure of the study information 2020/05/20
Last modified on 2020/11/21 (Ver. 4)

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments

Basic information
Public title Does the Problem Based Learning style teleconference improve medical students psychological safety and self-explanation in clinical reasoning conference? A randomized controlled trial
Acronym PBL style teleconference in the perspective of students psychological safety
Scientific Title Does the Problem Based Learning style teleconference improve medical students psychological safety and self-explanation in clinical reasoning conference? A randomized controlled trial
Scientific Title:Acronym PBL style teleconference in the perspective of students psychological safety
Region
Japan

Condition
Condition Medical students
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Improvement of medical education.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Psychological safety
Self-explanation
Key secondary outcomes Autonomy
Satisfaction
Preference of the conference

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Use of teleconference style
Interventions/Control_2 Traditional face-to-face conference
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 The study participants consisted of medical students participating in a general medicine clinical clerkship rotation from September 2019 to February 2020, and those who were able to participate to both traditional style and intervention style conferences.
Key exclusion criteria Students who were not able to participate to either control style or intervention style conference.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Masatomi
Middle name Shikino
Last name Ikusaka
Organization Chiba University Hospital
Division name General Medicine
Zip code 2608677
Address 1-8-1, Inohana, Chu-ou-ku, Chiba-city
TEL 043-222-7171
Email ikusaka@ga2.so-net.ne.jp

Public contact
Name of contact person
1st name Kiyoshi
Middle name
Last name Shikino
Organization Chiba University Hospital
Division name General Medicine
Zip code 2608677
Address Chiba
TEL 0432227171
Homepage URL
Email kshikino@gmail.com

Sponsor
Institute Chiba University Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee of Chiba University School of Medicine
Address 1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba pref. Japan
Tel 043-226-2501
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 千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2020 Year 05 Month 20 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 34
Results 
Psychological safety score and autonomy, Number of students who did self-explanation were higher in PBL style teleconference. Moreover, PBL style teleconference was preferred by 18 (44%), traditional live style conference by 8 (24%) and neutral by 11 (32%) participants. There was no significant difference in satisfaction between conferences with a high score in both types.
Results date posted
2020 Year 05 Month 20 Day
Results Delayed
Delay expected
Results Delay Reason Outbreak of COVID-19
Date of the first journal publication of results
2020 Year 12 Month 30 Day
Baseline Characteristics 
Psychological safety score and autonomy, Number of students who did self-explanation were higher in PBL style teleconference. Moreover, PBL style teleconference was preferred by 18 (44%), traditional live style conference by 8 (24%) and neutral by 11 (32%) participants. There was no significant difference in satisfaction between conferences with a high score in both types.
Participant flow 
Teleconferences were held in a separate room with a screen showing the live conference with one doctor to help students understand the discussion when it exceeded their level of medical expertise. Students were allowed to share their ideas during the discussion. For the control style, students who participated in the live conference were also allowed to share their opinions about the case. After each type of conference, questionnaires assessed the participants psychological safety using Edmondsons psychological safety scale along with autonomy, satisfaction, and preference of the conference. We also counted the number of students SE during each conference.
Adverse events 
N/A
Outcome measures 
Psychological safety,Self-explanation, Autonomy, Satisfaction, Preference of the conference
Plan to share IPD No
IPD sharing Plan description No

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 06 Month 30 Day
Date of IRB
2019 Year 08 Month 30 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2020 Year 02 Month 28 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date
2020 Year 05 Month 20 Day
Last modified on
2020 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000046188