UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027615
Receipt number 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 21:32:02

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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 or person

Institute

Department of nursing, Faculty of Nursing, Kansai University of Social Welfare.

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031476


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name