UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049565 |
|---|---|
| Receipt number | R000056446 |
| Scientific Title | A study of the experiences and support resources of second victims of medical errors and adverse events: validity and reliability of the Japanese version of SVEST-R |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2024/11/18 14:11:24 |
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Basic information
Public title
A study of the experiences and support resources of second victims of medical errors and adverse events: validity and reliability of the Japanese version of SVEST-R
Acronym
Study on a second victim evalutation tool
Scientific Title
A study of the experiences and support resources of second victims of medical errors and adverse events: validity and reliability of the Japanese version of SVEST-R
Scientific Title:Acronym
Study on a second victim evalutation tool
Region
| Japan |
Condition
Condition
second victim syndrome
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the validity and reliability of the Japanese version of SVEST-R
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
clarity, content validity, structural validity, retest reliability, internal consistency
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Experienced in medical errors and adverse events.
Key exclusion criteria
unable to read Japanese
Target sample size
615
Research contact person
Name of lead principal investigator
| 1st name | Nobutake |
| Middle name | |
| Last name | Shimojo |
Organization
University of Tsukuba
Division name
Department of Emergency and Critical Care Medicine, Faculty of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba
TEL
029-853-3210
nkshimojo@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Gen |
| Middle name | |
| Last name | Aikawa |
Organization
University of Tsukuba Hospital
Division name
Department of Nursing
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3900
Homepage URL
gen-aikawa@umin.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Kyushu International College of Nursing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Red Cross Kyushu International College of Nursing
Ibaraki Christian University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Research and Development Organization
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1097/PTS.0000000000001292
Number of participants that the trial has enrolled
335
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
"Research Procedures"
1. Evaluation of clarity in pilot tests
Clarity of each item in the Japanese version of SVEST-R, which was created using the back-translation method, will be evaluated. A convenience sampling of 10-40 healthcare professionals will be surveyed using the SurveyMonkey platform to evaluate the clarity of the SVEST-R.
2. Evaluation of clarity and content validity in the expert panel
Clarity of the Japanese version of SVEST-R as modified in the pilot test will be evaluated. The evaluators for this process will consist of 6 to 10 experts knowledgeable in the field of patient safety. Clarity will be assessed by the experts using the same procedure as in the pilot test.
In addition, this panel of experts will assess content equivalence.
3. Evaluation of structural validity
To evaluate the structural validity of the Japanese version of the SVEST-R, a web-based questionnaire will be administered to healthcare professionals affiliated with our hospital who have experience with medical errors and adverse events, and confirmatory factor analysis will be conducted.
4. Evaluation of retest reliability and internal consistency
To assess retest reliability, a convenience sampling of health care professionals will be used to examine intraclass correlation coefficients using the retest method. In addition, Cronbach's alpha will be used to assess internal consistency.
If all of these criteria are met, validation of the Japanese version of SVEST-R is complete.
"Recruitment"
For 1, 2, and 4, we will recruit healthcare professionals and researchers through network sampling among researchers. For 3, we will distribute posters to healthcare professionals in the hospital with the URL and QR code and an outline of the study. The posters will also be posted in the hospital and on the hospital's website to publicize the study.
Management information
Registered date
| 2022 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056446
