The FICUS cluster randomized controlled trial of a family support intervention in adult intensive care units: mental health and family functioning outcomes.
Publisher DOI
PubMed ID
42149244
Abstract
Purpose
To examine the effect of a multicomponent, nurse-led, interprofessional family support intervention on family functioning and mental health in adult intensive care units (ICUs).Methods
A cluster-randomized controlled trial in 16 Swiss ICUs compared an intervention-a family care pathway with specially trained ICU family nurses engaging and liaising with families, giving psychoeducational and relationship-focused care, and providing structured, interprofessional communication-to usual care. Family members of patients with an expected ICU stay of ≥ 48 h and a high risk of death, serious impairment, or prolonged mechanical ventilation participated. Outcomes included family functioning, resilience, life satisfaction, quality of life, distress, anxiety, depression, and posttraumatic stress, assessed at patient ICU admission, discharge, 3-, 6-, and 12 months post-ICU, and analyzed by linear mixed effects models.Results
Almost half (43%) of the invited family members participated (885; May 2022 to January 2024). Follow-ups were completed on time by 736 (83.2%), 665 (75.1%), 643 (71.6%), and 593 (67.0%), respectively. Between 609 and 613 were included in the analysis. Family member characteristics were comparable at baseline, yet patient mechanical ventilation (60.3 vs. 49.5%) and ICU death (19.9 vs. 13.2%) were higher in the intervention than the control arm. There was no significant difference between the study arms for any of the outcomes. Type of relationship, prior ICU experience, and patient mechanical ventilation were associated with some of the outcomes. Mental health systematically improved post-ICU.Conclusion
No evidence of a significant improvement in family functioning or mental health was found within the first year after ICU treatment. Due to limitations, the results of our study have to be interpreted cautiously and in a hypothesis-generating manner.Trial Registration
Clinicaltrials.gov NCT05280691.
To examine the effect of a multicomponent, nurse-led, interprofessional family support intervention on family functioning and mental health in adult intensive care units (ICUs).Methods
A cluster-randomized controlled trial in 16 Swiss ICUs compared an intervention-a family care pathway with specially trained ICU family nurses engaging and liaising with families, giving psychoeducational and relationship-focused care, and providing structured, interprofessional communication-to usual care. Family members of patients with an expected ICU stay of ≥ 48 h and a high risk of death, serious impairment, or prolonged mechanical ventilation participated. Outcomes included family functioning, resilience, life satisfaction, quality of life, distress, anxiety, depression, and posttraumatic stress, assessed at patient ICU admission, discharge, 3-, 6-, and 12 months post-ICU, and analyzed by linear mixed effects models.Results
Almost half (43%) of the invited family members participated (885; May 2022 to January 2024). Follow-ups were completed on time by 736 (83.2%), 665 (75.1%), 643 (71.6%), and 593 (67.0%), respectively. Between 609 and 613 were included in the analysis. Family member characteristics were comparable at baseline, yet patient mechanical ventilation (60.3 vs. 49.5%) and ICU death (19.9 vs. 13.2%) were higher in the intervention than the control arm. There was no significant difference between the study arms for any of the outcomes. Type of relationship, prior ICU experience, and patient mechanical ventilation were associated with some of the outcomes. Mental health systematically improved post-ICU.Conclusion
No evidence of a significant improvement in family functioning or mental health was found within the first year after ICU treatment. Due to limitations, the results of our study have to be interpreted cautiously and in a hypothesis-generating manner.Trial Registration
Clinicaltrials.gov NCT05280691.
Date Issued
2026-04
Publication Type
Article
Subjects
Communication
•
Critical care
•
Family functioning
•
Family members
•
Nursing
•
Post-intensive care syndrome-family
Language(s)
en
Author(s)
Rufer, Michael | |
von Felten, Stefanie | |
Verweij, Lotte | |
Oesch, Saskia | |
Sutter, Simone | |
Wenzler, Monique Seraina | |
Welter, JoEllen | |
von Dach, Christoph | |
Steiger, Peter | |
Siegrist, Esther | |
Moser, Michaela | |
Massarotto, Paola | |
Lussmann, Fabienne | |
Keller, Yvonne | |
Hoffmann, Johanna Elisabeth | |
Hertler, Benjamin | |
Heise, Antje | |
Burkhalter, Hanna | |
Bühler, Philipp Karl | |
Brülhart, Damian | |
Betschart, Ursula | |
Bergmann-Kipfer, Bettina | |
Filipovic, Miodrag | |
Naef, Rahel |
Additional Credits
Journal
Intensive care medicine
ISSN
1432-1238
Access(Rights)
open.access