UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062240 |
|---|---|
| Receipt number | R000071213 |
| Scientific Title | Educational Effects of the Japanese Version of Improving Palliative Care Teamwork in the ICU - Interprofessional Education (IMPACT-IPE) among Healthcare Professionals and Exploratory Evaluation of Patient Outcomes: A Single-Group Pre-Post Study |
| Date of disclosure of the study information | 2026/09/01 |
| Last modified on | 2026/07/25 03:41:38 |
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Basic information
Public title
A Study of the Effects of Interprofessional Education on Healthcare Professionals in the ICU and an Evaluation of Patient Outcomes
Acronym
A Study of the Effects of Interprofessional Education in the ICU and Patient Outcomes
Scientific Title
Educational Effects of the Japanese Version of Improving Palliative Care Teamwork in the ICU - Interprofessional Education (IMPACT-IPE) among Healthcare Professionals and Exploratory Evaluation of Patient Outcomes: A Single-Group Pre-Post Study
Scientific Title:Acronym
IMPACT-IPE in Japan: Educational Effects and Patient Outcomes Study
Region
| Japan |
Condition
Condition
Patients admitted to the ICU (no specific condition),
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate changes in participants' self-rated confidence and skills in activities related to communication with patients and families and interprofessional collaboration, as well as changes in moral distress measured using the Japanese version of the Measure of Moral Distress for Healthcare Professionals (MMD-HP), before and after participation in IMPACT-IPE in Japan, an interprofessional education program consisting of pre-workshop e-learning and a workshop. In addition, changes in care processes and clinical outcomes among patients admitted to the ICU before and after implementation of the program will be explored.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the score on the IMPACT-IPE self-assessment scale, which assesses activities related to communication with patients and families and interprofessional collaboration, from baseline before starting the IMPACT-IPE in Japan program to 3 months after completion of the workshop.
Key secondary outcomes
1. Change in the total score of the Japanese version of the Measure of Moral Distress for Healthcare Professionals (MMD-HP) from baseline before implementation of the program (before starting the e-learning) to 3 months after completion of the workshop.
2. Changes from baseline in the IMPACT-IPE self-assessment scale score and the total score of the Japanese version of the MMD-HP within 1 week and at 1 and 6 months after completion of the workshop.
3. Monthly number of interprofessional conferences per 1,000 ICU patient-days before and after implementation of the program.
4. Proportion of ICU admission episodes with an ICU length of stay of 5 days or longer in which at least one interprofessional conference was conducted during the ICU stay.
5. ICU length of stay, status at ICU discharge, hospital length of stay, and status at hospital discharge before and after implementation of the program.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will receive IMPACT-IPE in Japan, an interprofessional education program consisting of pre-workshop e-learning and a synchronous online workshop. The e-learning materials will take approximately 20 minutes in total and will be completed before the workshop. The 90-minute workshop will be conducted via Zoom and will include interprofessional discussion, role-play, and reflection using case scenarios and simulation videos. Each participant will attend the workshop once in principle. Each session will include approximately 5 to 10 participants and, in principle, participants from multiple professions.
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. Healthcare professionals
Healthcare professionals who work in the ICU or are routinely involved in the care of patients in the ICU.
Individuals who have received an explanation of the study and provided informed consent to participate.
2. Patients
All patients admitted to the ICU during either the pre-implementation period from August 1, 2025, to July 31, 2026, or the post-implementation period from October 1, 2026, to Spetember 30, 2027.
Eligibility will be determined according to the date of ICU admission. Multiple ICU admissions during the same hospitalization will be included as separate ICU admission episodes.
Key exclusion criteria
1. Healthcare professionals
Individuals who did not complete the pre-workshop e-learning or the 90-minute online workshop
2. Patients
Patients for whom the patient or an authorized representative requested exclusion from the study before the start of data analysis
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Shiota |
Organization
Institute of Science Tokyo Hospital
Division name
Department of Intensive Care Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-5959
shiota.n.27d2@m.isct.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Mishima |
Organization
Institute of Science Tokyo
Division name
Department of Intensive Care Medicine
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-5959
Homepage URL
ykmishima.icu@tmd.ac.jp
Sponsor or person
Institute
Institute of Science Tokyo
Institute
Department
Personal name
Funding Source
Organization
Institute of Science Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Research Ethics Committee, Institute of Science Tokyo
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel
03-5803-4547
rinri.adm@tmd.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
| 2026 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 08 | 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
| 2026 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071213
