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

Email

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


Email

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

Email

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


Research Plan
Registered date File name
2022/08/04 20210928_研究計画書_第1版 [2021166].pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name