UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045861 |
|---|---|
| Receipt number | R000052350 |
| Scientific Title | Does hybrid-PBL advance teaching in clinical reasoning for general medicine clerkship? - A mixed method study |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2023/04/27 09:33:19 |
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Basic information
Public title
Does hybrid-PBL advance teaching in clinical reasoning for general medicine clerkship? - A mixed method study
Acronym
Does hybrid-PBL advance teaching in clinical reasoning for general medicine clerkship?
Scientific Title
Does hybrid-PBL advance teaching in clinical reasoning for general medicine clerkship? - A mixed method study
Scientific Title:Acronym
Does hybrid-PBL advance teaching in clinical reasoning for general medicine clerkship?
Region
| Japan |
Condition
Condition
clinical reasoning
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Problem-based learning (PBL) is a method of integrated learning that links basic and clinical medicine by identifying problems in patient cases and using those problems as cues for further learning. PBL has been adopted by many medical schools for pre-graduation clinical education as an effective method for acquiring practical knowledge that links lectures and clinical practice. However, many studies have pointed out that PBL tutorials have some problems that need to be improved, such as the fact that instructors often witness students stuck in a problem, and the need to adapt PBL tutorials to students' knowledge and supplement them with guided sessions (e.g., lectures). In other words, hybrid PBL, which combines PBL tuitorial and lectures, has the potential to advance education in the biomedical field. However, there are no studies to date that have compared hybrid PBL and PBL alone (pure PBL) in clinical reasoning education in general medicine.
Basic objectives2
Others
Basic objectives -Others
Problem-based learning (PBL) is a method of integrated learning that links basic and clinical medicine by identifying problems in patient cases and using those problems as cues for further learning. PBL has been adopted by many medical schools for pre-graduation clinical education as an effective method for acquiring practical knowledge that links lectures and clinical practice. However, many studies have pointed out that PBL tutorials have some problems that need to be improved, such as the fact that instructors often witness students stuck in a problem, and the need to adapt PBL tutorials to students' knowledge and supplement them with guided sessions (e.g., lectures). In other words, hybrid PBL, which combines PBL tuitorial and lectures, has the potential to advance education in the biomedical field. However, there are no studies to date that have compared hybrid PBL and PBL alone (pure PBL) in clinical reasoning education in general medicine.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We planned to conduct a study of PBL in clinical reasoning education in general medicine by dividing students into two groups: the Hybrid PBL group and the Pure PBL group. In order to evaluate the learning outcomes of Hybrid PBL, we assessed the achievement of the two groups in PBL tutorials, their satisfaction with the entire session, their confidence in the educational strategy for acquiring clinical reasoning skills, and the performance of each student on a test at the end of the study.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
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
Hybrid PBL
Interventions/Control_2
Pure PBL
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
| 33 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study was conducted at a single facility of Chiba University Hospital (hereinafter referred to as "our department") in Japan.
The subjects were 109 fifth-year medical students of Chiba University School of Medicine who participated in clinical practice at our department from January 2020 to October 2021. All the subjects received lectures and simulation training in basic medicine and clinical medicine by the fourth year, and took computer-based testing (CBT) and objective structured clinical examination (OSCE) before clinical practice to evaluate their skills. They have passed the computer-based testing (CBT) and objective structured clinical examination (OSCE) before clinical practice.
Key exclusion criteria
The students who could not participate in any of the PBL tutorials due to sickness or school events were excluded from this study.
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Ishizuka |
Organization
Chiba University Hospital
Division name
Department of General Medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba pref. Japan
TEL
0432227171
e103007c@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Ishizuka |
Organization
Chiba University Hospital
Division name
Department of General Medicine
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba pref. Japan
TEL
0432227171
Homepage URL
e103007c@yokohama-cu.ac.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Chiba University Hospital
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
Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba-city, Chiba pref. Japan
Tel
0432227171
e103007c@yokohama-cu.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
| 2021 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0279554
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0279554
Number of participants that the trial has enrolled
109
Results
In two-way repeated measure analysis of variance, self-evaluation of competency in clinical reasoning was significantly improved in the intervention group in recalling appropriate differential diagnosis from patients chief complaint and practicing the appropriate clinical reasoning process.
Results date posted
| 2023 | Year | 04 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study was conducted at a single facility in the Department of General Medicine, Chiba University Hospital in Japan. The study included 109 fifth year medical students at the Chiba University School of Medicine who participated in a clinical clerkship at our department from January 2020 to October 2021. This study was embedded into a clinical clerkship rotation in the department, thus, the participants were not sampled randomly. In the clinical clerkship, 5 to 6 medical students per group would rotate through the department every two weeks. A total of 20 groups were rotated during the study period. Each group was exposed to PBL in one case. All subjects had already received lectures and simulation training in basic and clinical medicine by the fourth year and had passed computer based testing and objective structured clinical examinations before their clinical clerkship. Additionally, all students have experienced Pure PBL since it is integrated into Chiba University curriculum from the first to the fourth year of medical school. Students who were unable to participate in one of the conferences for any reason were excluded from the study.
Participant flow
Hybrid PBL was conducted in the intervention group, and Pure PBL was conducted in the control group. The quantitative data in this study examined students' perceived competence in PBL, satisfaction with sessions after educational intervention, and self-evaluation of competency in clinical reasoning before and after the educational intervention in the intervention and control groups. In the clinical clerkship, participants were rotated in groups assigned by the university before this study. The participants were equally allocated to the intervention or control groups. To improve the reporting quality, we conducted a cluster randomized controlled trial based on the CONSORT 2010 statement. To integrate quantitative and qualitative assessments, we designed a mixed-method sequential explanatory study . In the intervention group, we evaluated the advantages of learning clinical reasoning via Hybrid PBL qualitatively using focus group interview after PBL completion to examine the cognitive aspects of the medical students.
Adverse events
None
Outcome measures
Students perceived competence in PBL and satisfaction with sessions The students perceived competence in PBL and satisfaction with sessions after educational intervention were compared between the intervention and control groups.
After the PBL, in addition to the five students perceived competence in PBL at the university, item 6. satisfaction with sessions was also surveyed. The five students perceived competence in PBL was determined by the faculty members of the Medical Education Laboratory of Chiba University based on the report of Barrows et al.
Self-evaluation of competency in clinical reasoning Before and after the educational intervention, we investigated the self-evaluation of competency in clinical reasoning using the following eight items, 7. recalling appropriate history, physical examination, and tests on clinical hypothesis generation, 8. recalling appropriate differential diagnosis from the patients chief complaint, 9. verbalizing points that fit/do not fit the recalled differential diagnosis appropriately, 10. verbalizing and reflecting appropriately on own mistakes, 11. selecting keywords from the whole aspect of the patient, 12. examining the patient while visualizing his or her daily life, 13. considering biological, psychological, and social perspectives, and 14. practicing the appropriate clinical reasoning process . The self evaluation of competency in clinical reasoning investigated in this study was based on the report of Cooper et al. and was determined through discussions among the faculty members of our department.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 29 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052350
