UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Impact of clinical decision support system on the appropriate use of antibiotics
Title of the study (Brief title)	Impact of clinical decision support system on the appropriate use of antibiotics
Region	Japan

Condition
Condition	Infectious diseases
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the appropriateness of antibiotics use before and after the implementation of clinical decision support systems.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Proportion of patients treated with vancomycin who are tested for serum vancomycin concentration within initial 3 days of treatment
Key secondary outcomes	Proportion of patients treated with broad-spectrum antibiotics who kept receiving the same antibiotics for over 14 days

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Clinical decision support system equipped within electronic medical record
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	Any patients who have received either parenteral vancomycin or broad spectrum antibiotics
Key exclusion criteria	none
Target sample size	1500

Research contact person
Name of lead principal investigator	Haku Ishida
Organization	Yamaguchi University
Division name	Department of medical informatics and decision sciences
Address	Minami-kogushi 1-1-1 Ube Yamaguchi JAPAN
TEL	0836-22-2716
Email	hishida@yamaguchi-u.ac.jp

Public contact
Name of contact person	Hiroshi Ikai
Organization	Yamaguchi University
Division name	Department of medical informatics and decision sciences
Address	Minami-kogushi 1-1-1 Ube Yamaguchi JAPAN
TEL	0836-22-2717
Homepage URL
Email	ikaih@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University
Institute
Department

Funding Source
Organization	self-funded
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

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 12 Month 01 Day
Anticipated trial start date	2017 Year 12 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 09 Month 07 Day
Last modified on	2017 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033220