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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034467
Receipt No. R000039300
Scientific Title Effectiveness of rapid response education program founded on outcome-based education in nurses working at cardiovascular surgery and cardiology department
Date of disclosure of the study information 2018/10/12
Last modified on 2018/10/12

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Basic information
Public title Effectiveness of rapid response education program founded on outcome-based education in nurses working at cardiovascular surgery and cardiology department
Acronym Effectiveness of rapid response education program characterized by outcome-based education
Scientific Title Effectiveness of rapid response education program founded on outcome-based education in nurses working at cardiovascular surgery and cardiology department
Scientific Title:Acronym Effectiveness of rapid response education program characterized by outcome-based education
Region
Japan

Condition
Condition Nurses working at cardiovascular surgery and cardiology ward
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarity the effectiveness of the rapid response educational program characterized by outcome-based education in nurses working at cardiovascular surgery and cardiology unit.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes A difference of total rating scales between pre-intervention period and post-intervention period.
Key secondary outcomes Changes of rating scale btween pre-intervention perion and post-intervention period.Changes of Values obtained by the New Brief Job Stress Quetionnaire between the pre- and post- period.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 1:While the rapid response simulation is implemented for all participants, their perfprmance is evaluated using rating scales,
which is defined as a pre-intervention period. To maintaine validity and reliability. An evaluator is not a member of this study. In addition, thier job stress is assessed by using the New Brief Job Stress Questionnaire.
2:An educational program specialized in rapid response situation begins for the participants.
3:The above-mentioned evaluations are performed, which is defined as a post-intervention period.
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 Nurses who wark at cardiovascular surgery and cardiology unit.
Nurses who join this education program after getting informed consent.
Key exclusion criteria A head nurse
Rapid response educators
A nurse who is not able to join this education due to working.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Abe Michiyo
Organization Tohoku university hospital
Nursing division
Division name East 9 ward
Zip code
Address 1-1 Seiryou-machi Aoba-ku Sendai Miyagi
TEL 022-717-7000
Email akiko-kusakari.b2@tohokku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kusakari Akiko
Organization Tohoku university hospital Nursing division
Division name East 9 ward
Zip code
Address 1-1 Seiryou-machi Aoba-ku Sendai Miyagi
TEL 022-717-7000
Homepage URL
Email akiko-kusakari.b2@tohokku.ac.jp

Sponsor
Institute Tohoku university hospital
Institute
Department

Funding Source
Organization Tohoku university hospital
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
Address
Tel
Email

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 10 Month 12 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
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 Preinitiation
Date of protocol fixation
2018 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 12 Day
Last modified on
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039300

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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