UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048682 |
|---|---|
| Receipt number | R000055473 |
| Scientific Title | Development of a program to support the creation of a clinical learning environment |
| Date of disclosure of the study information | 2022/08/17 |
| Last modified on | 2025/02/19 11:52:06 |
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Basic information
Public title
Development of a program to support the creation of a clinical learning environment
Acronym
Development of a program to support the creation of a clinical learning environment
Scientific Title
Development of a program to support the creation of a clinical learning environment
Scientific Title:Acronym
Development of a program to support the creation of a clinical learning environment
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement and evaluate a program to support the creation of a clinical learning environment and to verify its educational effectiveness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical Learning Environment
Diagnostic Inventory
Key secondary outcomes
Competencies, perceptions, and needs related to supporting nursing learners
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
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
Intervention group: Clinical judgment competency seminar (lecture)
Workshop on creating a clinical learning environment, and line open chat (optional)
Interventions/Control_2
Control group: Clinical judgment competency seminar (lecture)
Materials from the workshop on creating a clinical learning environment were sent to those who requested them.
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
Educational instructors affiliated with medical institutions
Nurses who provide educational instruction to nursing students and new nurses
Experienced in educational instruction to nursing students and new nurses
Key exclusion criteria
Not a manager of the head nurse or higher.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuko |
| Middle name | |
| Last name | Hosoda |
Organization
Osaka Metropolitan (Prefecture) University
Division name
Graduate School of Nursing
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-City, Osaka
TEL
072-950-2921
hosoday@omu.ac.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Hosoda |
Organization
Osaka Metropolitan (Prefecture) University
Division name
Graduate School of Nursing
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-City, Osaka
TEL
072-950-2921
Homepage URL
hosoday@omu.ac.jp
Sponsor or person
Institute
Graduate School of Nursing, Osaka Metropolitan (Prefecture) University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka Medical and Pharmaceutical University, Doshisha Women's College of Liberal Arts, University of Shizuoka, Takarazuka University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan (Prefecture) University
Address
3-7-30 Habikino, Habikino-City, Osaka
Tel
072-950-2111
gr-hab-rinri@omu.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
| 2022 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
https://www.omu.ac.jp/nurs/hosoday/19h03926/
Publication of results
Partially published
Result
URL related to results and publications
https://www.omu.ac.jp/nurs/hosoday/19h03926/
Number of participants that the trial has enrolled
67
Results
In terms of support regarding clinical judgment skills, the intervention group was significantly higher at T1(the end of the program) for [effective interpreting] and [effective responding] by new nurses. In support of promoting metacognition, the intervention group was significantly higher than the control group in [metacognitive knowledge] and [metacognitive activities] of students and new nurses, all at T1.
Results date posted
| 2024 | Year | 09 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gender was 29 women and 3 men in the intervention group, 26 women and 6 men in the control group; age was 5 in their 20s, 9 in their 30s, 14 in their 40s, and 4 in their 50s in the intervention group, and 4 in their 20s, 10 in their 30s, 16 in their 40s, and 2 in their 50s in the control group. Positions held were: in the intervention group, 7 deputy nursing (nurse) managers, 14 chiefs, 1 deputy chief, and 10 staff; in the control group, 9 deputy nursing (nurse) managers, 8 chiefs, 1 deputy chief, 13 staff, and 1 other; in the intervention group, 6 in internal medicine wards, 10 in surgery wards, 5 in mixed wards, 5 in psychiatric wards, 1 in pediatric wards, and 5 in other In the control group, 5 were in the internal medicine ward, 7 in the surgical ward, 7 in the mixed ward, 3 in the psychiatric ward, 2 in the pediatric ward, 1 in the obstetrics or obstetrics/gynecology ward, and 7 in the others.
Participant flow
Consent to participate in the study was obtained from 73 educational leaders from 28 medical facilities, who were assigned to 36 intervention and 37 control groups to ensure homogeneity of background. Dropouts were 4 in the intervention group and 5 in the control group, and 32 in the intervention group and 32 in the control group who were able to respond to the survey at all three time points were included in the analysis.
Adverse events
None
Outcome measures
The items evaluated were the need for support regarding clinical judgment skills, the Clinical Learning Environment Diagnostic Inventory, the Belief in Cooperation Scale, the Help-Seeking Preferences Scale, the Basic Communication Skills Scale, the Workplace Competency Improvement Scale, support for promoting metacognition, and program operation.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 08 | Month | 17 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055473
