UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061441 |
|---|---|
| Receipt number | R000070299 |
| Scientific Title | Feasibility and Implementation of Multidisciplinary Rounds Using a Wellness Checklist in the Intensive Care Unit: A Prospective Quality Improvement Study |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/05/27 16:51:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Feasibility and Implementation of Multidisciplinary Rounds Using a Wellness Checklist in the Intensive Care Unit: A Prospective Quality Improvement Study
Acronym
Feasibility and Implementation of Multidisciplinary Rounds Using a Wellness Checklist in the Intensive Care Unit: A Prospective Quality Improvement Study
Scientific Title
Feasibility and Implementation of Multidisciplinary Rounds Using a Wellness Checklist in the Intensive Care Unit: A Prospective Quality Improvement Study
Scientific Title:Acronym
Feasibility and Implementation of Multidisciplinary Rounds Using a Wellness Checklist in the Intensive Care Unit: A Prospective Quality Improvement Study
Region
| Japan |
Condition
Condition
Critically ill patients in the Intensive Care Unit (ICU)
Classification by specialty
| Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To implement multidisciplinary care rounds using a novel 4-domain wellness checklist for communicative critically ill patients admitted to the ICU, and to evaluate its feasibility and explore its preliminary effectiveness.
Basic objectives2
Others
Basic objectives -Others
Feasibility and Quality Improvement (QI)
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Feasibility of the multidisciplinary care rounds, evaluated comprehensively by the following three a priori-defined success criteria:
1. Completion rate: Care rounds are completed for 70% or more of eligible patients.
2. Consent rate: Verbal consent is obtained from 60% or more of approached eligible patients.
3. Documentation completeness rate: 80% or more of applicable items on the wellness checklist are documented without missing data.
Key secondary outcomes
1. Implementation rate of specialist-recommended interventions (proportion of recommendations by pharmacists and dietitians approved and executed by intensivists).
2. Number of preventive interventions performed.
3. Intervention success rate: proportion of identified discomforts for which interventions resulted in improvement or resolution as assessed by the next-day nurse.
4. Pre- and post-intervention changes in sleep quality (NRS-Sleep, 0-10), pain intensity (NRS, 0-10), and delirium prevalence (CAM-ICU positive rate).
5. Safety outcome: incidence of unexpected clinical deterioration or excessive fatigue-related worsening within 24 hours of the care rounds.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Multidisciplinary care rounds are conducted twice weekly (every Monday and Friday) for communicative critically ill patients in the ICU. A multidisciplinary team consisting of a physician, nurse, pharmacist, dietitian, and physical therapist conducts bedside assessments using a novel 30-item wellness checklist covering 4 domains: physical comfort, environmental comfort, psychological and emotional support, and dignity and communication. Identified discomforts are addressed with immediate on-site interventions by the respective specialists. Outcomes are evaluated by the next-day nurse approximately 24 hours after each round. The intervention period is from June 1, 2026 to December 31, 2026.
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
1. Adult patients aged 18 years or older admitted to the ICU of St. Luke's International Hospital.
2. Patients deemed capable of communication (verbal or non-verbal).
3. Patients expected to remain in the ICU for 2 or more days.
Key exclusion criteria
1. Patients under deep sedation (incapable of communication).
2. Patients undergoing emergency procedures or in critical deterioration at the time of rounds.
3. Patients who refuse participation.
4. Patients deemed inappropriate for inclusion by the principal investigator or sub-investigators.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Shodai |
| Middle name | |
| Last name | Shimano |
Organization
St. Lukes International Hospital
Division name
Department of Nursing
Zip code
104-8560
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
TEL
03-3541-5151
shoshima@luke.ac.jp
Public contact
Name of contact person
| 1st name | Shodai |
| Middle name | |
| Last name | Shimano |
Organization
St. Lukes International Hospital
Division name
Department of Nursing
Zip code
104-8560
Address
9-1 Akashi-cho, Chuo-ku, Tokyo, Japan.
TEL
03-3541-5151
Homepage URL
https://hospital.luke.ac.jp
shoshima@luke.ac.jp
Sponsor or person
Institute
St. Luke's International University
Institute
Department
Personal name
Shodai Shimano
Funding Source
Organization
St. Luke's International University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japanese
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of St. Luke's International University
Address
10-1 Akashi-cho, Chuo-ku, Tokyo 104-0044
Tel
03-5550-2423
kenkyukikaku@luke.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
St. Luke's International Hospital (Tokyo)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 15 | 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
No
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 02 | Day |
Last modified on
| 2026 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070299
