UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061004 |
|---|---|
| Receipt number | R000069809 |
| Scientific Title | Prospective observational study on the construction of a next-generation medical operations support system and hospital operations efficiency and reduction of medical staff burden through AI and digital technology |
| Date of disclosure of the study information | 2026/03/21 |
| Last modified on | 2026/03/21 17:39:02 |
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Basic information
Public title
Prospective observational study on the construction of a next-generation medical operations support system and hospital operations efficiency and reduction of medical staff burden through AI and digital technology
Acronym
Project R (AI & DX): Next-generation hospital management and workload reduction using AI
Scientific Title
Prospective observational study on the construction of a next-generation medical operations support system and hospital operations efficiency and reduction of medical staff burden through AI and digital technology
Scientific Title:Acronym
Project R (AI & DX): Next-generation hospital management and workload reduction using AI
Region
| Japan |
Condition
Condition
Hospital Administration and Management, AI and Digital Technology, Reduction of Medical Staff Burden, Acute Care
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate how various functions of an AI-driven system contribute to accelerating management decision-making, reducing physician overtime, and improving hospital financial performance.
Basic objectives2
Others
Basic objectives -Others
To investigate the organizational challenges associated with AI implementation and the process of behavioral and psychological shifts among staff (including psychological and structural barriers, and changes in AI acceptance).
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Integrated index of hospital operation efficiency and burden reduction: trends in time required for major decision-making (e.g., bed adjustment, emergency acceptance) and changes in physician overtime hours.
Key secondary outcomes
Labor environment indicators (overtime hours)
Management indicators (operating income, labor distribution rate)
Work efficiency indicators (time reduced by AI automation)
Operational indicators (patient volume, wait times, surgery room usage)
Psychological indicators (burnout scale, AI acceptance)
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. Management projects deliberated or decided upon in the strategy meetings of the Business Planning and Strategy Office.
2. Budget and financial closing data of all departments and management statistical records.
3. Minutes of strategy meetings and records of associated decision-making processes.
Key exclusion criteria
Routine maintenance and management tasks not directly related to the implementation of this system.
Other records deemed inappropriate for this study by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | TAKEHIRO |
| Middle name | |
| Last name | IZUMO |
Organization
Japanese Red Cross Medical Center
Division name
Business Planning and Strategy Office and Department of Respiratory Medicine
Zip code
1508935
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
03-3400-1311
drtake1118@gmail.com
Public contact
Name of contact person
| 1st name | TAKEHIRO |
| Middle name | |
| Last name | IZUMO |
Organization
Japanese Red Cross Medical Center
Division name
Business Planning and Strategy Office and Department of Respiratory Medicine
Zip code
1660004
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
09074122408
Homepage URL
izumo_takehiro@med.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center
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
Institutional Review Board of Japanese Red Cross Medical Center
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
Tel
03-3400-1311
izumo_takehiro@med.jrc.or.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
| 2026 | Year | 03 | Month | 21 | 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
| 2026 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study. We will evaluate the construction process of a next-generation medical operations support system, developed in collaboration with external partner companies, and its effectiveness in improving hospital management and the labor environment. A historical control design will be employed to compare the data with management records from the same period in previous years.
Management information
Registered date
| 2026 | Year | 03 | Month | 21 | Day |
Last modified on
| 2026 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069809
