UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hiroki Isono
Organization	University of Tsukuba
Division name	Graduate School of Comprehensive Human Sciences
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	Hiroki Isono
Organization	University of Tsukuba
Division name	Graduate School of Comprehensive Human Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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