UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029043 |
|---|---|
| Receipt number | R000033220 |
| Scientific Title | Impact of clinical decision support system on the appropriate use of antibiotics |
| Date of disclosure of the study information | 2017/12/01 |
| Last modified on | 2017/09/07 16:51:39 |
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Basic information
Public title
Impact of clinical decision support system on the appropriate use of antibiotics
Acronym
Impact of clinical decision support system on the appropriate use of antibiotics
Scientific Title
Impact of clinical decision support system on the appropriate use of antibiotics
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Haku Ishida |
Organization
Yamaguchi University
Division name
Department of medical informatics and decision sciences
Zip code
Address
Minami-kogushi 1-1-1 Ube Yamaguchi JAPAN
TEL
0836-22-2716
hishida@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Ikai |
Organization
Yamaguchi University
Division name
Department of medical informatics and decision sciences
Zip code
Address
Minami-kogushi 1-1-1 Ube Yamaguchi JAPAN
TEL
0836-22-2717
Homepage URL
ikaih@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
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)
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 | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 12 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033220
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
