UMIN-CTR Clinical Trial

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	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/pii/S0099176721000763?via%3Dihub
Number of participants that the trial has enrolled	23
Results	Inter-rater agreement between expert triage nurses was kappa = 0.82 (almost perfect) in the ESI group and kappa = 0.74 (substantial) in the JTAS group. In addition, the UT and OT ratios were 20.3% and 14.8%, respectively, in the ESI group, and 30.3% and 16.7%, respectively, in the JTAS group. The results revealed that the ESI scale was associated with higher agreement than the JTAS.
Results date posted	2021 Year 04 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 07 Month 16 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
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 08 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	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=R000038219