UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056209 |
|---|---|
| Receipt number | R000064217 |
| Scientific Title | A Study on the Utility of Text Mining Techniques for Analyzing Near-Miss Incidents |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2024/11/20 10:53:15 |
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Basic information
Public title
A Study on the Utility of Text Mining Techniques for Analyzing Near-Miss Incidents
Acronym
A Study on the Utility of Text Mining Techniques for Analyzing Near-Miss Incidents
Scientific Title
A Study on the Utility of Text Mining Techniques for Analyzing Near-Miss Incidents
Scientific Title:Acronym
A Study on the Utility of Text Mining Techniques for Analyzing Near-Miss Incidents
Region
| Japan |
Condition
Condition
Since near-miss reports are the focus of this study, specific disease names are not applicable.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The advancement of mechanical technologies, represented by AI, has been remarkable, with active research being conducted across various fields. The medical field is no exception, with diagnostic imaging being a well-known example.
However, in the domain of patient safety, the utilization of mechanical technologies remains in its early stages, and the number of researchers involved in this area is still limited.
Therefore, this study aims to demonstrate that incorporating mechanical technologies into near-miss analysis can facilitate the acquisition of highly accurate patient safety information with ease. Furthermore, it seeks to promote the adoption of text mining techniques in the field.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of correct responses to near-miss report analysis
Key secondary outcomes
Time required to analyze near-miss reports
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
A pilot study will be conducted with two participants to determine an appropriate sample size for the main study. Using the difference between the two groups and the standard deviation obtained from the pilot study, the appropriate sample size will be calculated based on a t-test with a significance level of 5% and a statistical power of 80%.
For the study, two sets of 50 pre-collected "near-miss" incident reports will be prepared. Both sets will be analyzed using text mining techniques and manual methods. The primary outcome measure will be the accuracy of the analysis, while the secondary outcome measure will be the time required for analysis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinically experienced nurses without a specialization in patient safety.
Key exclusion criteria
Nurses specializing in patient safety.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ueno |
| Middle name | |
| Last name | Takayoshi |
Organization
Osaka University Graduate School of Medicine, Division of Health Sciences
Division name
Research Laboratory of Peripatetic Management
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-5111
uenotm@sahs.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Furukawa |
| Middle name | |
| Last name | Taishi |
Organization
Osaka University Graduate School of Medicine, Division of Health Sciences
Division name
Research Laboratory of Peripatetic Management
Zip code
565-0871
Address
1-7 Yamadaoka, Suita, Osaka
TEL
06-6879-5111
Homepage URL
u094295d@ecs.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
Osaka university
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Osaka University Hospital
Address
4th Floor, Advanced Medical Innovation Center, 2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2024 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2025 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064217
