Status:
COMPLETED
Family Support Intervention in Intensive Care Units
Lead Sponsor:
Rahel Naef
Collaborating Sponsors:
Swiss National Science Foundation
Conditions:
Postintensive Care Syndrome
Family Members
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Family members of critically ill patients face considerable uncertainty and distress during their close other's intensive care unit (ICU) stay, with about 20-60% of family members experien...
Detailed Description
Background: Family members are important to the well-being and recovery of critically ill persons, yet are themselves profoundly affected by the critical illness. During a close other's treatment in a...
Eligibility Criteria
Inclusion
- Potential participants are family members of critically ill persons admitted to a study ICU. A family member is defined as a close other from the patient's perspective, as noted in the clinical record or in advanced directives, or as indicated by the legally defined surrogate decision-maker.
- Inclusion criteria regarding patients (one or several):
- Expected length of stay in ICU ≥48 hours, as predicted by the intaking ICU clinician (physician or nurse) at admission.
- Life-threatening condition with a high risk of death or long-lasting functional impairment.
- High risk of prolonged mechanical ventilation (\>24 hours).
- Inclusion criteria regarding family members (all must apply):
- Primary support person of the patient.
- Able to complete family-reported outcome measures (questionnaires) in German language.
- Age ≥18 years.
- Signed informed consent form.
- Exclusion criteria regarding patients (one leads to exclusion):
- Preexisting declined general consent.
- ICU stay \<24 hours.
- Exclusion criteria regarding family members (one leads to exclusion):
- Prior inclusion in FICUS trial on another study ICU.
- Cognitive inability to understand the study or complete the questionnaire as appraised by clinicians and / or study recruitment staff.
- Inability to complete baseline data collection within the required timeframe after admission / study enrollment (Calvert et al., 2018).
Exclusion
Key Trial Info
Start Date :
May 12 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
885 Patients enrolled
Trial Details
Trial ID
NCT05280691
Start Date
May 12 2022
End Date
December 31 2024
Last Update
July 2 2025
Active Locations (12)
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1
Cantonal Hospital Winterthur
Winterthur, Canton of Zurich, Switzerland, 8400
2
Cantonal Hospital Baden
Baden, Switzerland
3
Lindenhof-Hospital
Bern, Switzerland
4
University Hospital Bern - Inselspital
Bern, Switzerland