UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044012 |
|---|---|
| Receipt number | R000050255 |
| Scientific Title | Verification of reliability and validity of triage system using the Emergency Severity Index in emergency department. |
| Date of disclosure of the study information | 2021/05/01 |
| Last modified on | 2024/04/23 16:45:23 |
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Basic information
Public title
Verification of the availability of triage using Emergency Severity Index in critical care centers
Acronym
Verification of the availability of ESI
Scientific Title
Verification of reliability and validity of triage system using the Emergency Severity Index in emergency department.
Scientific Title:Acronym
Clinical introduction study of ESI
Region
| Japan |
Condition
Condition
Triage nurse in the emergency department.
Classification by specialty
| Emergency medicine | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to introduce ESI to emergency nurses who have no experience of using triage tools, and to compare the decision accuracy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
The inter-rater agreement regarding the accuracy of the ESI for triage decisions in simulated clinical scenarios based.
The Under triage ratios and Over triage ratios.
Key secondary outcomes
Usability of ESI : Visual Analog Scale
Decision time of simulated clinical scenarios.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment | Behavior,custom | Maneuver |
Interventions/Control_1
Conduct an educational intervention program for 5 hours using the Emergency Severity Index.
Intervention asked to answer the simulated patient tests 30 questions before and after, to compare verify the decision accuracy.
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
In this study, we target triage nurses who are engaged in triage work in the emergency department.
Specific selection criteria are for nurses who have more than 3 years of experience as a nurse, perform urgency judgments without using triage tools on a daily basis, and have no experience of using triage tools in emergency outpatient departments. limit.
Key exclusion criteria
Nurses who have no work experience in the emergency department or who use triage tools on a daily basis.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Koichi |
| Middle name | |
| Last name | Takaoka |
Organization
Kansai University of Social Welfare
Division name
Department of Nursing, Faculty of Nursing
Zip code
678-0255
Address
380-3 Shinden, Ako, Hyogo
TEL
+81-791-46-2525
takaoka@kusw.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Takaoka |
Organization
Kansai University of Social Welfare
Division name
Department of Nursing, Faculty of Nursing
Zip code
678-0255
Address
380-3 Shinden, Ako, Hyogo
TEL
+81-791-46-2525
Homepage URL
takaoka@kusw.ac.jp
Sponsor or person
Institute
Kansai University of Social Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science, Grants-in-Aid for Scientific Research.
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical review board of Kansai University of Social Welfare.
Address
380-3 Shinden, Ako, Hyogo
Tel
+81-791-46-2525
kusw-kango@kusw.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 | 05 | Month | 01 | 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
11
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
| 2020 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | 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 | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050255
