UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048403 |
|---|---|
| Receipt number | R000054832 |
| Scientific Title | Multi-center Exploratory Controlled before-after Study for Efficacy and Safety of the Reducing Clinician Burden with Standardized Clinical Pathways |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2024/01/22 15:48:25 |
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Basic information
Public title
Multi-center Exploratory Controlled before-after Study for Efficacy and Safety of the Reducing Clinician Burden with Standardized Clinical Pathways
Acronym
Multi-center Exploratory Controlled before-after Study for Efficacy and Safety of the Reducing Clinician Burden with Standardized Clinical Pathways
Scientific Title
Multi-center Exploratory Controlled before-after Study for Efficacy and Safety of the Reducing Clinician Burden with Standardized Clinical Pathways
Scientific Title:Acronym
Multi-center Exploratory Controlled before-after Study for Efficacy and Safety of the Reducing Clinician Burden with Standardized Clinical Pathways
Region
| Japan |
Condition
Condition
Arrhythmia, angina pectoris, acute myocardial infarction, lung cancer
Classification by specialty
| Cardiology | Chest surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For physicians, nurses and clinical laboratory technicians working in the cardiovascular and respiratory surgery wards.
We will Exploratory study the efficacy and safety of the Reducing Clinician Burden with the clinical pathways (the cardiovascular area (Radiofrequency catheter ablation pathway, percutaneous coronary intervention pathway, acute myocardial infarction pathway), respiratory surgery area (vats lobectomy for lung cancer pathway)).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change in average total time of physicians from baseline after the pathway revision.
Key secondary outcomes
The amount of change in average total time of nurses and clinical laboratory technicians from baseline after the pathway revision.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
There are a total of 4,500 cases. There are 3,000 cases of three cardiovascular area pathways (1,000 cases at each facility) and 1,500 cases of VATS pathway for respiratory surgery (500 cases at each facility: Kyushu University Hospital, Saiseikai Kumamoto Hospital, NTT East Kanto Hospital).
Twenty-four physicians use a behavior identification application at three facilities in two years.
(Sixteen physicians: Kyushu University Hospital, four physicians: Saiseikai Kumamoto Hospital, four physicians: NTT East Kanto Hospital).
There are eight nurses working in the ward (four nurses: Kyushu University Hospital, two nurses: Saiseikai Kumamoto Hospital, two nurses: NTT East Kanto Hospital).
A clinical laboratory technologist working in the ward (Saiseikai Kumamoto Hospital).
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those for which written consent has been obtained by the free will of the person himself / herself.
Those who are 18 years of age or older at the time of patient registration.
Occupation of a physician, nurse, or clinical laboratory technologist.
Those who have been in business for more than 5 years at the time of registration.
Those who are enrolled in the laboratory facility throughout the study period.
(1) Adult cases in which the radiofrequency catheter ablation pathway or percutaneous coronary intervention pathway or acute myocardial infarction pathway is applied in the cardiovascular ward at Kyushu University Hospital, Saiseikai Kumamoto Disease, and NTT East Kanto Hospital.
(2) Adult patients applying vats lobectomy for lung cancer pathway at Kyushu University Hospital, Saiseikai Kumamoto Hospital, and Shikoku Cancer Center in respiratory surgery wards.
Key exclusion criteria
Those who are judged by the investigator to be inappropriate for intervention in this study.
Target sample size
4500
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Nakashima |
Organization
Kyushu University
Division name
Medical Informatics Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
0926425881
nakashima.naoki.351@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Yamashita |
Organization
Kyushu University Hospital
Division name
Medical Information Center
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka city
TEL
0926425881
Homepage URL
yamashita.takanori.804@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
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
Kyushu University Hospital Clinical Trial Ethics Review Board
Address
3-1-1Maidashi, Higashi-ku, Fukuoka city
Tel
0926425082
byskenkyu@jimu.kyushu-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
| 2022 | Year | 07 | Month | 20 | 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
| 2022 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 19 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054832
| 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 |
