UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000027615
Receipt No. R000031476
Scientific Title Study of the inter-rater reliability of two triage tools by Japan Triage and Acuity Scale(JTAS) and Emergency Severity Index (ESI) : A randomized trial.
Date of disclosure of the study information 2017/06/22
Last modified on 2020/06/02 (Ver. 15)

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Basic information
Public title Study of the inter-rater reliability of two triage tools by Japan Triage and Acuity Scale(JTAS) and Emergency Severity Index (ESI) : A randomized trial.
Acronym Study of the inter-rater reliability of two triage tools by Japan Triage and Acuity Scale(JTAS) and Emergency Severity Index (ESI) : A randomized trial.
Scientific Title Study of the inter-rater reliability of two triage tools by Japan Triage and Acuity Scale(JTAS) and Emergency Severity Index (ESI) : A randomized trial.
Scientific Title:Acronym Study of the inter-rater reliability of two triage tools by Japan Triage and Acuity Scale(JTAS) and Emergency Severity Index (ESI) : A randomized trial.
Region
Japan

Condition
Condition Subjects will be recruited the triage nurses using the JTAS in emergency department. This study will divide subjects into two groups.
Classification by specialty
Gastroenterology Emergency medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to compare the accuracy of acuity decision between the ESI and the JTAS, and to clarify whether the ESI can be applied to the emergency department 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. In addition, the secondary endpoint will establish the inter-rater reliability of the results on practice cases in each urgency criteria.
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 100 practice cases.
Interventions/Control_2 After completion of review with the JTAS for 3 hours, subjects in each group solved 100 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 2 years or more and less than 5 years, have experienced in nurse for 5 years or more and less than 20 years. Moreover, subjects had participated in the triage seminar. Also subjects have used triage tool with the JTAS on a daily basis.
Key exclusion criteria The exception criteria were as follows; except certified nurse specialist of critical care nursing and Japanese nurse practitioner.Subjects do not have chance of acuity decision on a daily basis.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Takaoka
Organization Kansai University of Social Welfare
Division name Faculty of Nursing
Zip code 678-0255
Address 380-3 Sinden, Ako, Hyogo
TEL 0791-46-2686
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 Faculty of Nursing
Zip code 678-0255
Address 380-3 Sinden, Ako, Hyogo
TEL 0791-46-2686
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 of Private Colleges and Universities of Nursing
Organization
Division
Category of Funding Organization Other
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
2017 Year 06 Month 22 Day

Related information
URL releasing protocol https://www.jstage.jst.go.jp/article/jsem/22/6/22_753/_pdf/-char/ja
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/jsem/22/6/22_753/_pdf/-char/ja
Number of participants that the trial has enrolled 18
Results 
A quadratically weighted kappa was used tomeasure inter-observer reliability; the ESI was superior to the JTAS in concordance rate(0.82 and 0.74, respectively). For all rating categories, except level 5, the Fleiss' Kappa was higher in the ESI group. The ESI was more sensitive for category level 2, as an indication of high-risk situations, than the JTAS.
Results date posted
2020 Year 01 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 01 Month 08 Day
Baseline Characteristics 
Eighteen JTAS-trained triage nurses, from 3 Japanese EDs, were randomly assigned to the ESI group or JTAS group. Nurses independently assigned triage scores to 100 emergency cases.
Participant flow 
Four indexes were used: accuracy, each urgency accuracy of rating individual category-stage, answer time, and a subjective usability.
There were no significant differences in age, clinical experience, or JTAS experience between groups.
Adverse events 
N/ A
Outcome measures 
As a scale to evaluate the agreement between evaluators in the decision of emergency, we verified with the Kappa coefficient, which is an index of inter-evaluator reliability.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 03 Month 08 Day
Date of IRB
2017 Year 03 Month 08 Day
Anticipated trial start date
2017 Year 06 Month 03 Day
Last follow-up date
2018 Year 06 Month 30 Day
Date of closure to data entry
2018 Year 09 Month 18 Day
Date trial data considered complete
2018 Year 09 Month 21 Day
Date analysis concluded
2018 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 06 Month 03 Day
Last modified on
2020 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031476