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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044012
Receipt No. 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 2021/07/28

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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
Email 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
Email takaoka@kusw.ac.jp

Sponsor
Institute Kansai University of Social Welfare
Institute
Department

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

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
Email 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 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 Open public recruiting
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
2023 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
2021 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050255

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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