UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000053796
Receipt number R000061399
Scientific Title Development of operation system in emergency room and a seamless recording method for disasters
Date of disclosure of the study information 2024/04/01
Last modified on 2024/03/07 13:30:19

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Basic information

Public title

Development of operation system in emergency room and a seamless recording method for disasters

Acronym

Development of operation system for emergency room and disasters

Scientific Title

Development of operation system in emergency room and a seamless recording method for disasters

Scientific Title:Acronym

Development of operation system for emergency room and disasters

Region

Japan


Condition

Condition

Simulated patients and medical staff receiving treatment in the emergency room and disaster treatment area

Classification by specialty

Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In this study, we have developed a research plan in collaboration with Taiyo Yuden to develop software, an input tool using smartphones and tablets, as a new emergency room operation system.
The software may improve the problems of conventional medical treatment using paper charts and triage tags, such as the limitation of the amount of information that can be written on paper, errors due to misrecognition of written characters, and loss of paper charts. We will first verify whether the above issues can be improved through appropriate operation of the software. Furthermore, we will conduct an intervention study to clarify whether it contributes to the improvement of the quality of medical care.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time spent in the area by injured or ill persons

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Use of new medical record systems

Interventions/Control_2

Use of conventional paper medical records

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

Participants in disaster drills who are assigned to the red and yellow areas to treat mock injured and sick patients.

Key exclusion criteria

Those deemed inappropriate as subjects by the researcher's judgment

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Yuta
Middle name
Last name Isshiki

Organization

Gunma University Hospital

Division name

Emergency Medical Center

Zip code

3718511

Address

3-39-15, Showa machi, Maebashi city, Gunma

TEL

0272208541

Email

yuta.1shiki@gunma-u.ac.jp


Public contact

Name of contact person

1st name Yuta
Middle name
Last name Isshiki

Organization

Gunma University Hospital

Division name

Emergency Medical Center

Zip code

3718511

Address

3-39-15, Showa machi, Maebashi city, Gunma

TEL

0272208541

Homepage URL


Email

yuta.1shiki@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Emergency Medicine, Gunma University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Taiyo Yuden Co., Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Gunma University Hospital Clinical Research Review Board

Address

3-39-15 Showa-machi, Maebashi city, GUNMA

Tel

027-220-7111

Email

irb-jimukk-ciru@ml.gunma-u.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

2024 Year 04 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

12

Results


Results date posted


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

No longer recruiting

Date of protocol fixation

2023 Year 11 Month 08 Day

Date of IRB

2023 Year 11 Month 24 Day

Anticipated trial start date

2023 Year 12 Month 03 Day

Last follow-up date

2023 Year 12 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2024 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2024 Year 03 Month 07 Day

Last modified on

2024 Year 03 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061399