UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040466 |
|---|---|
| Receipt number | 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 17:02:50 |
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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
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
kshikino@gmail.com
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046188
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