The FICUS cluster randomized controlled trial of a family support intervention in adult intensive care units: mental health and family functioning outcomes.
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Riguzzi Marco, Jeitziner Marie-Madlen, Rufer Michael, von Felten Stefanie, Verweij Lotte, Oesch Saskia, Sutter Simone, Safford Judith, Wenzler Monique Seraina, Welter JoEllen, Wiegand Jan, Wiechmann Dirk, von Dach Christoph, Steiger Peter, Siegrist Esther, Ruch Naira, Pietsch Urs, Moser Michaela, Massarotto Paola, Lussmann Fabienne, Keller Yvonne, Hoffmann Johanna Elisabeth, Hertler Benjamin, Heise Antje, Dullenkopf Alexander, Burkhalter Hanna, Bühler Philipp Karl, Brunner Christoph, Brülhart Damian, Betschart Ursula, Bergmann-Kipfer Bettina, Filipovic Miodrag, Naef Rahel, FICUS study group
Аннотация
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.