UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039402 |
|---|---|
| Receipt number | R000044923 |
| Scientific Title | The investigation of incidents and accidents in the implementation of the clinical information system in the department of intensive care |
| Date of disclosure of the study information | 2020/02/06 |
| Last modified on | 2023/08/22 09:21:10 |
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Basic information
Public title
The investigation of incidents and accidents in the implementation of the clinical information system in the intensive care unit
Acronym
The investigation of incidents and accidents in the implementation of the clinical information system for intensive care
Scientific Title
The investigation of incidents and accidents in the implementation of the clinical information system in the department of intensive care
Scientific Title:Acronym
The investigation of incidents and accidents in the implementation of the clinical information system for intensive care
Region
| Japan |
Condition
Condition
Incidents and accidents in the intensive care unit
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The number and incidence of incidents and accidents by the implementation of the clinical information system (CIS) in the intensive care unit (ICU) have been unknown. In this research, we investigate what kind of incidents and accidents related to CIS occur in the early phase of the implementation of the system in ICU.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The number and incidence of the incidents and accidents related to the clinical information system for intensive care
Key secondary outcomes
The kind of incidents and accidents related to the clinical information system in the ICU, the number and incidence of the incidents and accidents in the intensive care unit and high care unit
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients admitting to the intensive care unit and high care unit in Tokyo Women's Medical University Hospital
2. Patients with incidents or accidents related the clinical information system for intensive care
3. The incidents or accidents are recorded to the incident reporting system
The patients who fulfill all the conditions are enrolled.
Key exclusion criteria
No exclusion criteria
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Nomura |
Organization
Tokyo Women's Medical University
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
tnomura@twmu.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Seino |
Organization
Tokyo Women's Medical University
Division name
Department of Intensive Care Medicine
Zip code
162-8666
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
yu-seino@twmu.ac.jp
Sponsor or person
Institute
Department of Intensive Care Medicine, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Tokyo Women's Medical University Institutional Review Board
Address
8-1, Kawada-cho, Shinjuku-ku, Tokyo, Japan
Tel
03-3353-8111
ohta.megumi@twmu.ac.jp
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
| 2020 | Year | 02 | Month | 06 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/twmuj/advpub/0/advpub_2020015/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/twmuj/advpub/0/advpub_2020015/_article/-char/ja
Number of participants that the trial has enrolled
32
Results
Overall, 122 and 140 errors in the ICU and IMU, respectively, during the study period. Incidence rates of the errors in the ICU and IMU were 31.7 (95% confidence interval [CI] 26.3-37.8) and 51.3 (43.2-60.6) events per 1000 patient-days, respectively. There were 17 (14%) and 15 (11%) CIS-related errors in the ICU and IMU, respectively. The incidence rates of errors in the ICU and IMU were 5.3 (3.1-8.5) and 6.5 (3.6-10.7) events per 1000 CIS operation patient-days, respectively.
Results date posted
| 2021 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 04 | Month | 13 | Day |
Baseline Characteristics
ICU patients with errors
Participant flow
not applicable
Adverse events
none
Outcome measures
Incidence rate and background factors of clinical information system related errors
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 06 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 07 | Month | 31 | Day |
Other
Other related information
The patients who admit to the intensive care unit and high care unit in Tokyo Women's Medical University Hospital with incidents or accidents related to the clinical information system are enrolled.
Demographic data including patients' age, sex, departments, diagnosis, complications, past history, treatment, and length of stay, are obtained from medical records.
The data of the incidents and accidents including the number, class, context, and background factors of the incidents and accidents are obtained from the incident reporting system.
The number, incidence, and configuration of the incidents and accidents are investigated. In addition, the incidents and accidents related to the clinical information system are analyzed.
Management information
Registered date
| 2020 | Year | 02 | Month | 06 | Day |
Last modified on
| 2023 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044923
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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