UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058033 |
|---|---|
| Receipt number | R000066054 |
| Scientific Title | The Effect of a Pamphlet Intervention for Surrogate Decision-Makers in Critical Care on Post-Intensive Care Syndrome-Family (PICS-F): A Non-Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/05/31 |
| Last modified on | 2025/05/31 15:21:25 |
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Basic information
Public title
A Study on the Impact of Pamphlet-Based Information for Families of ICU Patients on Their Psychological Burden
Acronym
ICU Family Pamphlet Study
Scientific Title
The Effect of a Pamphlet Intervention for Surrogate Decision-Makers in Critical Care on Post-Intensive Care Syndrome-Family (PICS-F): A Non-Randomized Controlled Trial
Scientific Title:Acronym
PICS-F Pamphlet Study
Region
| Japan |
Condition
Condition
Post-intensive Care Syndrome-Family (PICS-F)
Classification by specialty
| Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to implement a pamphlet-based nursing intervention, designed to provide appropriate information and psychological support from before ICU discharge, for surrogate decision-makers (family members, etc.) of patients admitted to the ICU in the critical care setting, and to clarify the impact of this intervention on the prevention and reduction of Post-intensive Care Syndrome-Family (PICS-F).
Basic objectives2
Others
Basic objectives -Others
To investigate whether the pamphlet intervention used in this study is effective in preventing and reducing Post-intensive Care Syndrome-Family (PICS-F) in surrogate decision-makers in the critical care setting.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Presence of psychological distress in surrogate decision-makers at 3 months after ICU discharge (defined as IES-R score >=25, HADS-Anxiety subscale score >=8, or HADS-Depression subscale score >=8).
Key secondary outcomes
Anxiety symptoms (HADS-Anxiety) in surrogate decision-makers at 1 week after ICU discharge.
Depressive symptoms (HADS-Depression) in surrogate decision-makers at 1 week after ICU discharge.
Anxiety symptoms (HADS-Anxiety) in surrogate decision-makers at 3 months after ICU discharge.
Depressive symptoms (HADS-Depression) in surrogate decision-makers at 3 months after ICU discharge.
PTSD symptoms (IES-R) in surrogate decision-makers at 3 months after ICU discharge.
Frequency of pamphlet use, time spent using pamphlet, sections used, understanding of each section, usefulness in specific situations, and specific situations of use (pamphlet group only, at 3 months after ICU discharge).
Patient data (diagnosis, emergency admission, APACHE II score on ICU admission, length of ICU stay, surgery, mechanical ventilation, patient outcome, content of surrogate decision).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants: Surrogate decision-makers (family members, etc.) of patients admitted to the ICU in a critical care setting.
Intervention: In addition to standard nursing support for surrogate decision-making (verbal explanation), nurses will provide an explanation using an informational pamphlet on PICS-F prevention and coping (Contents: 1. About the ICU, 2. About decision-making, 3. Role of surrogate decision-makers, 4. About end-of-life care, 5. About family care support).
Timing/Frequency: Once when the family makes a surrogate decision.
Duration: Approximately 10-15 minutes.
Interventions/Control_2
Participants: Surrogate decision-makers (family members, etc.) of patients admitted to the ICU in a critical care setting.
Intervention: Standard nursing support for surrogate decision-making (verbal explanation) as routinely practiced at each participating facility. No pamphlet will be used.
Timing/Frequency: Provided as appropriate as part of usual care before the patient's ICU discharge.
Duration: Within the scope of usual care.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Provided written informed consent to participate in the study.
Family members who have made surrogate decisions regarding treatment (including choices about life-sustaining treatment) for patients admitted to an E-ICU or general ICU with an expected ICU stay of 48 hours or more.
Able to communicate in Japanese.
Aged 18 to 85 years.
Key exclusion criteria
Known history of psychiatric illness in the surrogate decision-maker.
Expected ICU stay for the patient is less than 24 hours.
Surrogate decision-maker has had ICU experience (as a surrogate) within the past 6 months.
Already enrolled as an intervention subject in this study (to prevent duplication).
Attending physician judges the surrogate decision-maker not to be in a suitable physical or mental state to participate in the study.
Otherwise deemed unsuitable for participation by the principal investigator (or co-investigator).
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Fumiya |
| Middle name | |
| Last name | Kanaya |
Organization
Social Medical Corporation Foundation Chiyukai Shin Yukuhashi Hospital
Division name
Department of Nursing
Zip code
824-0026
Address
1411 Dojoji, Yukuhashi-shi, Fukuoka, Japan
TEL
+81-930-24-8899
shinyukuhashi.kanaya@gmail.com
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Kanaya |
Organization
Social Medical Corporation Foundation Chiyukai Shin Yukuhashi Hospital
Division name
Department of Nursing
Zip code
824-0026
Address
1411 Dojoji, Yukuhashi-shi, Fukuoka, Japan
TEL
+81-930-24-8899
Homepage URL
shinyukuhashi.kanaya@gmail.com
Sponsor or person
Institute
Social Medical Corporation Foundation Chiyukai Shin Yukuhashi Hospital
Department of Nursing
Fumiya Kanaya
Institute
Department
Personal name
Funding Source
Organization
KIMURA FOUNDATION FOR NURSING EDUCATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Red Cross Wakayama Medical Center
Matsuyama Municipal Hospital, Eiraikai General Incorporated Association
Maizuru Kyosai Hospital, Federation of National Public Service Personnel Mutual Aid Associations
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Social Medical Corporation Foundation Chiyukai Shin Yukuhashi Hospital
Address
1411 Dojoji, Yukuhashi-shi, Fukuoka, Japan
Tel
0930-58-5566
pt-ikeda@waltz.ocn.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
日本赤十字社 和歌山医療センター
一般社団法人永頼会 松山市民病院
国家公務員共済組合連合会 舞鶴共済病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 31 | 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
| 2025 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 05 | Month | 31 | Day |
Last modified on
| 2025 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066054
