UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052596 |
|---|---|
| Receipt number | R000057194 |
| Scientific Title | Verification of reliability and validity of triage system using the Emergency Severity Index in emergency department. |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2025/02/02 09:36:13 |
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Basic information
Public title
Effects of introducing new triage tools in emergency clinical practice in Japan: A controlled before after study
Acronym
Effects of introducing new triage tools in emergency clinical practice in Japan: A controlled before after study
Scientific Title
Verification of reliability and validity of triage system using the Emergency Severity Index in emergency department.
Scientific Title:Acronym
Clinical introduction study of ESI
Region
| Japan |
Condition
Condition
Emergency physician and 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 emergency the changes in emergency determination accuracy, docters examination waiting time , and stay time in the emergency department due to the introduction of ESI in emergency clinical practice.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Inter-rater agreement for triage assessments performed by triage nurses and emergency physicians
Key secondary outcomes
Under/Over triage
docters examination waiting time
stay time in the emergency department
Convenience of triage tool
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Conduct an educational intervention program for 6 hours using the Emergency Severity Index.
For data collection, we will investigate the triage status for 3 months before and after the introduction of the triage tool for patients who visited the emergency outpatient department at night and on holidays at each facility.
Interventions/Control_2
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
3 years or more and less than 20 years of professional experience.
Responsible for triage of emergency outpatient clinics (nurse).
Responsible for initial examinations at emergency outpatient clinics (physician).
Written consent has been obtained from the research subject to participate in the research.
Key exclusion criteria
Experienced in conducting triage decision using triage tools.
Other research subjects who are judged by the principal investigator or investigator to be inappropriate for the safe conduct of this research.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | Chiharu |
| Middle name | |
| Last name | Akazawa |
Organization
Osaka Medical and Pharmaceutical University
Division name
Adult Nursing (Acute)
Zip code
5698686
Address
2-7 daigakutyou, takatuki, Osaka
TEL
0726831221
ompu73121002@s.ompu.ac.jp
Public contact
Name of contact person
| 1st name | Koichi |
| Middle name | |
| Last name | Takaoka |
Organization
Osaka Medical and Pharmaceutical University
Division name
Graduate School of Nursing Science
Zip code
5698686
Address
2-7 daigakutyou, takatuki, Osaka
TEL
07085773677
Homepage URL
ompu73121002@s.ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Osaka Medical and Pharmaceutical University Ethical Review Board
Address
2-7 daigakutyou, takatuki, Osaka
Tel
0726831221
rinri@ompu.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
| 2023 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
152
Results
Two nurses and one emergency physician participated. The total number of triaged cases analyzed was 75 before and 77 after the intervention. Overall inter-rater agreement between the emergency physician and nurse was kappa (95 % confidence interval) = 0.35 (0.23-0.46 Fair) pre-intervention and 0.66 (0.48-0.83 Substantial) post-intervention. All severity levels showed higher inter-rater agreement after the intervention. There was a significant reduction and large effect size for UT post-intervention.
Results date posted
| 2025 | Year | 02 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 10 | Month | 05 | Day |
Date analysis concluded
| 2024 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057194
