UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033519 |
|---|---|
| Receipt number | 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 | 2021/07/28 18:59:26 |
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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
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
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 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038219
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
