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A Study on the Impact of Pamphlet-Based Information for Families of ICU Patients on Their Psychological Burden

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 - PICS-F Pamphlet Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000058033
Enrollment
180
Registered
2025-05-31
Start date
2025-06-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-intensive Care Syndrome-Family (PICS-F)

Interventions

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
s ICU discharge. Duration: Within the scope of usual care.

Sponsors

Social Medical Corporation Foundation Chiyukai Shin Yukuhashi Hospital Department of Nursing Fumiya Kanaya
Lead 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
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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).

Countries

Japan

Contacts

Public ContactFumiya Kanaya

Social Medical Corporation Foundation Chiyukai Shin Yukuhashi Hospital Department of Nursing

shinyukuhashi.kanaya@gmail.com+81-930-24-8899

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026