UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assesment of urinary catheter appropriateness and a multimodal approarch to reduce urinary catheter use.
Title of the study (Brief title)	Assesment of urinary catheter appropriateness and a multimodal approarch to reduce urinary catheter use.
Region	Japan

Condition
Condition	Patients in intensive care units (ICUs)
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Determine baseline urinary catheter point prevalence in multipie hospital in Japan
Basic objectives2	Others
Basic objectives -Others	Implement a multimodal intervention to reduce the unnecessary use of indwelling urinary catheters and assess the efficacy of the intervention
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Prevalence of the appropriate use of urinary catheters
Key secondary outcomes	Prevalence of the use of urinary catheters

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	A multimodal approach to reduce the unnecessary use of urinary catheters including education to nurses for 2 months and then the prevalence of urinary catheter will be measured (Pre-intervention phase)
Interventions/Control_2	Usual care (Post-intervention phase)
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	All adults patients who are admitted to ICUs
Key exclusion criteria	Nothing spectacular
Target sample size	438

Research contact person
Name of lead principal investigator	Akira Kuriyama
Organization	Kurashiki Central Hospital
Division name	Department of General Medicine
Address	1-1-1 Miwa Kurashiki Okayama 710-8602 JAPAN
TEL	086-422-0210
Email	akira-kuriyama-jpn@yahoo.co.jp

Public contact
Name of contact person	Akira Kuriyama
Organization	Kurashiki Central Hospital
Division name	Department of General Medicine
Address	1-1-1 Miwa Kurashiki Okayama 710-8602 JAPAN
TEL	086-422-0210
Homepage URL
Email	akira-kuriyama-jpn@yahoo.co.jp

Sponsor
Institute	Kurashiki Central Hospital
Institute
Department

Funding Source
Organization	Kurashiki Central Hospital
Organization
Division
Category of Funding Organization	Self funding
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	水戸協同病院（茨城県） 神戸中央市民病院（兵庫県） 浦添総合病院（沖縄県） JA広島総合病院（広島県） 倉敷中央病院（岡山県） University of Michigan（米国）

Other administrative information
Date of disclosure of the study information	2015 Year 08 Month 23 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 01 Month 22 Day
Anticipated trial start date	2015 Year 08 Month 24 Day
Last follow-up date	2017 Year 06 Month 20 Day
Date of closure to data entry	2017 Year 06 Month 30 Day
Date trial data considered complete	2017 Year 07 Month 01 Day
Date analysis concluded	2017 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 08 Month 23 Day
Last modified on	2018 Year 10 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021721