UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045418 |
|---|---|
| Receipt number | R000051856 |
| Scientific Title | The effect of an implementation of team STEPPS in training for emergency response of IVR |
| Date of disclosure of the study information | 2021/09/10 |
| Last modified on | 2022/08/04 17:01:29 |
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Basic information
Public title
The effect of an implementation of team STEPPS in training for emergency response of IVR
Acronym
The effect of an implementation of team STEPPS in training for emergency response of IVR
Scientific Title
The effect of an implementation of team STEPPS in training for emergency response of IVR
Scientific Title:Acronym
The effect of an implementation of team STEPPS in training for emergency response of IVR
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We conduct simulation training in emergency response of catheterization to staff engaged in interventional radiology after they acquire standard knowledge team STEPPS, which is an interprofessional training program to promote teamwork and quality of medical care.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A five-point rating of individual teamwork and awareness surveys on teamwork within the team
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
A non-randomized controlled trial in which the research subjects are provided with training on team STEPPS and simulation training, and a questionnaire survey on teamwork is conducted to them before and after the intervention.
The training on team STEPPS has two parts: one is basic part such as the cause of medical accidents and the necessity of team training, and the other is a practical part to understand the ideal way of team medical care incorporating team STEPPS. Incorporate video viewing and remote training as measures against COVID-19.
Simulation training is conducted on the on patients who have experienced rapid deterioration during IVR treatment. All of these are scheduled for about 1 hour.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Those who are 20 years of age or older at the time of obtaining consent
2) Qualified person of doctor, nurse or radiological technologist
3) Gender: Any
4) Staff engaged in IVR work
5) Those who have received sufficient an explanation before participating in this research, and who have obtained the voluntary consent of the research subject after sufficient understanding.
Key exclusion criteria
1) Those who have decided to retire or transfer by the end of the observation
2) Persons who have difficulty engaging in IVR work
3) Others who are judged by the principal investigator to be inappropriate as research subjects
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Naomi |
| Middle name | |
| Last name | Tanemura |
Organization
Kansai medical university hospital
Division name
Faculty of nursing
Zip code
5731191
Address
3-1 Shinmachi 2 Chome, Hirakata City, Osaka, Japan
TEL
0728040101
tanemuna@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Naomi |
| Middle name | |
| Last name | Tanemura |
Organization
Kansai medical university hospital
Division name
Faculty of nursing
Zip code
5731191
Address
3-1 Shinmachi 2 Chome, Hirakata City, Osaka, Japan
TEL
0728040101
Homepage URL
tanemuna@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai medical university
Institute
Department
Personal name
Funding Source
Organization
Kansai medical university
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
Kansai medical university
Address
3-1 Shinmachi 2 Chome, Hirakata City, Osaka, Japan
Tel
0728040101
tanemuna@hirakata.kmu.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
| 2021 | Year | 09 | Month | 10 | 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
43
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
| 2021 | Year | 09 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051856
