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
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
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
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
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