UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028821
Receipt No. R000032987
Scientific Title New Work Improvement Method: Training for Effective and Efficient Action in Medical Service Better Process (TEAMS-BP) to Reduce Door to Balloon Time in Japan
Date of disclosure of the study information 2017/08/26
Last modified on 2017/08/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title New Work Improvement Method: Training for Effective and Efficient Action in Medical Service Better Process (TEAMS-BP) to Reduce Door to Balloon Time in Japan
Acronym Reduce DTB time for STEMI
Scientific Title New Work Improvement Method: Training for Effective and Efficient Action in Medical Service Better Process (TEAMS-BP) to Reduce Door to Balloon Time in Japan
Scientific Title:Acronym Reduce DTB time for STEMI
Region
Japan

Condition
Condition ST elevation myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We developed a new process using TEAMS-BP and assessed whether it was effective for reducing DTB time for STEMI patients receiving primary PCI.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Door to balloon time
Key secondary outcomes the proportion of cases in which the DTB time met the clinical guidelines
proportion of cases in which the DTB time was > 120 min, signifying delay
components of DTB time, such as door to ECG time, door to laboratory time, laboratory to balloon time, and FMC to balloon time;
FMC to door time,
DTB time stratified by arrival time and transportation mode

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 We recruited consecutive STEMI patients aged => 20 years who visited the ER between April 1, 2013 and October 31, 2016, and received primary PCI.
Key exclusion criteria Patients who were refused PCI, went into cardiopulmonary arrest on arrival, in whom PCI was not successful, were diagnosed with STEMI in the second or a later 12-lead ECG, and who were transferred to another hospital without PCI were excluded. Patients who presented to the outpatient clinic first were also excluded.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroki Isono
Organization University of Tsukuba
Division name Graduate School of Comprehensive Human Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL 029-853-3189
Email isono-tuk@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Isono
Organization University of Tsukuba
Division name Graduate School of Comprehensive Human Sciences
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan
TEL 029-853-3189
Homepage URL
Email isono-tuk@umin.ac.jp

Sponsor
Institute Mito Kyodo General Hospital
Institute
Department

Funding Source
Organization None
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
2017 Year 08 Month 26 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
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 Completed
Date of protocol fixation
2015 Year 04 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Isono, H; Maeno, T; Watanabe, S . NEW WORK IMPROVEMENT METHOD: TRAINING FOR EFFECTIVE & EFFICIENT ACTION IN MEDICAL SERVICE (TEAMS) TO REDUCE DOOR-TO-BALLOON TIME IN JAPAN [abstract]. Journal of Hospital Medicine. 2017; 12 (suppl 2).

Management information
Registered date
2017 Year 08 Month 25 Day
Last modified on
2017 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032987

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.