ICU sedation, delirium & recovery

The FICUS cluster randomized controlled trial of a family support intervention in adult intensive care units: mental health and family functioning outcomes

Intensive Care MedPublished Cluster randomised controlled trial

Authors' conclusion

No evidence of a significant improvement in family functioning or mental health was found within the first year after ICU treatment.

Study context

Population
Family members of adult ICU patients with expected ICU stay ≥ 48 h and high risk of death, serious impairment, or prolonged mechanical ventilation609–613 analysed
Participants
885 members
Comparison
Nurse-led, interprofessional family support intervention vs usual care
Methodological detailscluster-randomized, multicentre (16 Swiss intensive care units (ICUs)), 43% of invited family members participated (May 2022 to January 2024), Follow-ups completed on time by 736 (83.2%), 665 (75.1%), 643 (71.6%), and 593 (67.0%)
  • Cluster-randomized
  • Multicentre (16 Swiss ICUs)
  • 43% of invited family members participated (May 2022 to January 2024)
  • Follow-ups completed on time by 736 (83.2%), 665 (75.1%), 643 (71.6%), and 593 (67.0%)

Primary result

As reported in the abstract

Family functioning, resilience, life satisfaction, quality of life, distress, anxiety, depression, posttraumatic stress · ICU admission, discharge, 3, 6 and 12 months post-ICU
  • No significant difference between study arms for any outcome
  • Linear mixed effects models

Further findings

Patient characteristics at baseline

Patient mechanical ventilation, intervention vs control
60.3 vs. 49.5%
ICU death, intervention vs control
19.9 vs. 13.2%

Mental health over time

Mental health systematically improved post-ICU

Original publication

The FICUS cluster randomized controlled trial of a family support intervention in adult intensive care units: mental health and family functioning outcomes. Intensive Care Med. Published 18 May 2026. doi:10.1007/s00134-026-08425-2

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