Trial reportIntensive care medicine2026
The FICUS cluster randomized controlled trial of a family support intervention in adult intensive care units: mental health and family functioning outcomes.
Trial report in Intensive care medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05280691 (A Multi-center, Cluster Randomized Superiority Trial of a Guideline-based Family Support Intervention in Intensive Care Units), which is not on this map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-center, Cluster Randomized Superiority Trial of a Guideline-based Family Support Intervention in Intensive Care Units
Who cites it
1 citing paper in PubMed.
- Family support in intensive care: beyond no effect trials and the hidden challenges of cluster randomization.Intensive care medicine · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
34 authors.
Funding
Abstract
purposeTo examine the effect of a multicomponent, nurse-led, interprofessional family support intervention on family functioning and mental health in adult intensive care units (ICUs).
methodsA 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.
resultsAlmost 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.
conclusionNo 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 registrationClinicaltrials.gov NCT05280691.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.