UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028821 |
|---|---|
| Receipt number | 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 10:12:03 |
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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
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
isono-tuk@umin.ac.jp
Sponsor or person
Institute
Mito Kyodo General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032987
