UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056300 |
|---|---|
| Receipt number | R000063588 |
| Scientific Title | Investigation of the impact of automatic creation of explanatory document and IC template using application created with Python on the work time of anesthesiology preoperative consultation services. |
| Date of disclosure of the study information | 2024/11/29 |
| Last modified on | 2025/03/31 21:54:48 |
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Basic information
Public title
Investigation of the impact of automatic creation of explanatory document using application created with Python on the work time of anesthesiology preoperative consultation services.
Acronym
Investigation of the impact of automatic document creation assistance application on the work time of anesthesiology preoperative consultation services.
Scientific Title
Investigation of the impact of automatic creation of explanatory document and IC template using application created with Python on the work time of anesthesiology preoperative consultation services.
Scientific Title:Acronym
Investigation of the impact of automatic document creation assistance application on the work time of anesthesiology preoperative consultation services.
Region
| Japan |
Condition
Condition
Anesthesiologist's work time
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We develop automatic document creation application using python, an open-source programming language in-house at our hospital and implement automatic input and electronic medical record operation functions. Targeting anesthesiology preoperative consultation services that involve a lot of routine documentation work, we will measure the time required to complete preoperative consultation forms with or without the use of the application and investigate whether documentation time will be reduced.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to create anesthesia documentation
Key secondary outcomes
Satisfaction questionnaire for the subject (anesthesiologist)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
After the application operation explanation and trial operation, measure the document creation time under the use of the application.
Interventions/Control_2
Measure the document creation time without the use of the application.
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
Anesthesiologist at Shinshu University Hospital
Key exclusion criteria
1. Consent cannot be obtained from the individual
2. The principal investigator determines that the subject is inappropriate for the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Takeklshi |
Organization
Shinshu University Hospital
Division name
the department of anesthesiology and resuscitology
Zip code
390-0802
Address
3-1-1 Asahi, Matsumoto city, Nagano prefecture, Japan
TEL
0263-37-2670
masakit@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Takekoshi |
Organization
Shinshu University Hospital
Division name
the department of anesthesiology and resuscitology
Zip code
380-0802
Address
3-1-1 Asahi, Matsumoto City, Nagano Prefecture, Japan
TEL
0263372670
Homepage URL
masakit@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Masaki Takekoshi
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Life Sciences and Medical Research Ethics Committee
Address
3-1-1 Asahi, Matsumoto city, Nagano prefecture, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2024 | Year | 11 | Month | 29 | 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
20
Results
The total time to complete the anesthesiology preoperative forms for 5 subjects overall was 9.7 (1.7) minutes with the application and 16.0 (2.6) minutes without the application (mean (SD)), with significantly shorter completion times with the application compared to without (mean difference, -6.2 minutes; 95% confidence interval, -7.2 ~ - 5.2 minutes; p < 0.001).
Results date posted
| 2025 | Year | 03 | Month | 31 | Day |
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
Completed
Date of protocol fixation
| 2024 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063588
