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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033519
Receipt No. R000038219
Scientific Title The new role of triage nurse ordering in emergency department depend on Emergency Severity Index : A randomized control trial
Date of disclosure of the study information 2018/07/26
Last modified on 2019/06/04

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Basic information
Public title The new role of triage nurse ordering in emergency department depend on Emergency Severity Index : A randomized control trial
Acronym The new role of triage nurse ordering in emergency department depend on Emergency Severity Index : A randomized control trial
Scientific Title The new role of triage nurse ordering in emergency department depend on Emergency Severity Index : A randomized control trial
Scientific Title:Acronym The new role of triage nurse ordering in emergency department depend on Emergency Severity Index : A randomized control trial
Region
Japan

Condition
Condition Expert 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 compare the accuracy of acuity decision and the prediction of resources between the ESI and the JTAS in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II,III

Assessment
Primary outcomes The primary endpoint will establish the inter-rater reliability of the results on practice cases in each group.
The secondary endpoint will establish the inter-rater reliability of the results on practice cases in each urgency criteria.
In addition, tertiary endpoint will be to verify the prediction accuracy of the resources.
Key secondary outcomes At first, the Visual Analog Scale which can be indicator of subjective evaluation will be employed to measure usability of each triage tool.
Secondary, the total time taken to solve practice cases is related between the ESI and the JTAS.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 After completion of training with the ESI for 3 hours, subjects in each group will solve 80 practice cases.
Interventions/Control_2 After completion of review with the JTAS for 3 hours, subjects in each group solved 80 practice cases.
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 Subjects have experienced in triage for 3 years or more and less than 10 years, have experienced in nurse for 10 years or more and less than 20 years. Moreover, subjects had except certified nurse specialist of critical care nursing and Japanese nurse practitioner.
Key exclusion criteria The exception criteria were as follows; do not have except certified nurse specialist of critical care nursing and Japanese nurse practitioner.Subjects do not have knowledge of basic acuity decision on a daily basis.
Target sample size 80

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 Sinden, Ako, Hyogo
TEL 0791-20-2704
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 Sinden, Ako, Hyogo
TEL 0791-20-2704
Homepage URL
Email takaoka@kusw.ac.jp

Sponsor
Institute Department of Nursing, Faculty of Nursing, 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 Research ethics committee of Kansai University of Social Welfare
Address 380-3 Sinden, Ako, Hyogo
Tel 0791-46-2525
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
2018 Year 07 Month 26 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
2017 Year 07 Month 02 Day
Date of IRB
2018 Year 07 Month 02 Day
Anticipated trial start date
2018 Year 07 Month 26 Day
Last follow-up date
2020 Year 03 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
2018 Year 07 Month 26 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038219

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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