UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060726 |
|---|---|
| Receipt number | R000069475 |
| Scientific Title | Prospective observational study on clinician-led management reform in an acute care hospital: Construction and evaluation of a cross-functional governance model led by the Business Planning and Strategy Office |
| Date of disclosure of the study information | 2026/02/21 |
| Last modified on | 2026/02/21 17:29:55 |
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Basic information
Public title
Prospective observational study on clinician-led management reform in an acute care hospital: Construction and evaluation of a cross-functional governance model led by the Business Planning and Strategy Office
Acronym
Project R: Clinician-led cross-functional hospital management reform
Scientific Title
Prospective observational study on clinician-led management reform in an acute care hospital: Construction and evaluation of a cross-functional governance model led by the Business Planning and Strategy Office
Scientific Title:Acronym
Project R: Clinician-led cross-functional hospital management reform
Region
| Japan |
Condition
Condition
Hospital management, Organizational governance, Acute care delivery system
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to describe the implementation process of the Business Planning and Strategy Office led by a clinician (Chief Strategy Officer), and to evaluate its impact on accelerating management decision-making, improving frontline acceptance, and enhancing financial indicators.
Basic objectives2
Others
Basic objectives -Others
Evaluation of organizational stability and impact on the healthcare delivery system during hospital management reform.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Acceleration of the decision-making process (Changes in the duration from the start of deliberation to consensus building and commencement of implementation)
Key secondary outcomes
1. Implementation rate of key projects deliberated by the Business Planning and Strategy Office
2. Results of interventions in "sacred cow" areas (e.g., physician allocation, high-cost medical materials) and their economic impact
3. Qualitative evaluation of frontline consensus and acceptance (analysis of hearing records and interviews)
4. Trends in key performance indicators (e.g., bed occupancy rate, referral rate, and operating income)
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
Management projects deliberated or decided upon in the strategy meetings of the Business Planning and Strategy Office
Budget and financial closing data of all departments and management statistical records
Minutes of strategy meetings and records of associated decision-making processes
Key exclusion criteria
Daily routine administrative tasks not directly related to management reform
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
Department of Respiratory Medicine and Business Planning and Strategy Office
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
Department of Respiratory Medicine and Business Planning and Strategy Office
Zip code
1508935
Address
4-1-22, Hiroo, Shibuya-ku, Tokyo
TEL
03-3400-1311
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 | 02 | 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 | 01 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 19 | Day |
Last follow-up date
| 2028 | 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 chronologically collect and analyze the progress of management reform projects led by the Business Planning and Strategy Office, the duration required for decision-making, and relevant financial and operational indicators (e.g., labor distribution rate, bed occupancy rate). 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 | 02 | Month | 21 | Day |
Last modified on
| 2026 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069475
