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Purpose <p>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).</p> Methods <p>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&#xa0;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&#xa0;months post-ICU, and analyzed by linear mixed effects models.</p> Results <p>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&#xa0;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.</p> Conclusion <p>No evidence of a significant improvement in family functioning or mental health was found&#xa0;within the first year after&#xa0;ICU treatment. Due to limitations, the results of our study have to be interpreted cautiously and in a hypothesis-generating manner.</p> Trial registration <p>Clinicaltrials.gov NCT05280691.</p> Visual abstract <p></p>

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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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  • 发表日期：

    2026年4月1日

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  • Marco Riguzzi,
  • Marie-Madlen Jeitziner,
  • Michael Rufer,
  • Stefanie von Felten,
  • Lotte Verweij,
  • Saskia Oesch,
  • Simone Sutter,
  • Judith Safford,
  • Monique Seraina Wenzler,
  • JoEllen Welter,
  • Jan Wiegand,
  • Dirk Wiechmann,
  • Christoph von Dach,
  • Peter Steiger,
  • Esther Siegrist,
  • Naira Ruch,
  • Urs Pietsch,
  • Michaela Moser,
  • Paola Massarotto,
  • Fabienne Lussmann,
  • Yvonne Keller,
  • Johanna Elisabeth Hoffmann,
  • Benjamin Hertler,
  • Antje Heise,
  • Alexander Dullenkopf,
  • Hanna Burkhalter,
  • Philipp Karl Bühler,
  • Christoph Brunner,
  • Damian Brülhart,
  • Ursula Betschart,
  • Bettina Bergmann-Kipfer,
  • Miodrag Filipovic,
  • Rahel Naef,
  • Nicole Balsiger,
  • Senta Hug,
  • Ramona Kehl,
  • Patrick Leute,
  • Priska Odelli,
  • Eva Pietzke,
  • Franziska Rutz,
  • Sarah Schmidt,
  • Doreen Trautwein,
  • Deborah Wolf,
  • Eun Joo Beers,
  • Stephanie Bossi,
  • Nadine Brühlisauer,
  • Franziska Hellmann,
  • Gabriela Manetsch,
  • Jasmin Rüesch,
  • Noëlle Tenner,
  • Micaela Vaerini,
  • Tobias Weitbrecht,
  • Michael Studhalter,
  • Stefan Christ,
  • Martina Keller,
  • Cornelia Lips,
  • Christian Schandl,
  • Diana Segalada,
  • Ursina Spörri,
  • Merel van de Westelaken,
  • Marlene Wegmann Oswald,
  • Sabine Fazlic,
  • Stefanie Henkensmeier,
  • Roger Lussmann,
  • Birgit Steiger,
  • Nadine Kipfer,
  • Sonia Santini,
  • Christa Stalder,
  • Jeannina Wiedmer,
  • Béatrice Jenny Moser,
  • Dunja Nery Barreto,
  • Björn Zante,
  • Regine Büdel,
  • Esther Doron,
  • Susann Endermann,
  • Mandy Jentsch,
  • Carsten Klein,
  • Jacqueline Rütsche,
  • Andrea Zimmermann,
  • Sabine Berger,
  • Andreas Bosshard,
  • Cindy Groen,
  • Andrea Müller Paul,
  • Yvonne Seiffert,
  • Erika Sigrist,
  • Gaby Gürber,
  • Tanja Brülhart,
  • Cristina de Basio Marinello,
  • Marion Jourdan,
  • Thomas Zurbrügg,
  • Ernst Näf,
  • Christoph von Dach,
  • Sabina Boltshauser,
  • Monica Julmy,
  • Matthias Moos,
  • Marion Springer,
  • Tessa Allgaier,
  • Evelin Bläs,
  • Kim-Jana Fehlbier,
  • Debora Figi,
  • Sophie Valentine Gruber,
  • Monika Hahn,
  • Sandy Hesselberth,
  • Maria Katharina Iberl,
  • Carmen Karde,
  • Lea Kinteh-Vischherr,
  • Eva-Maria Kleinert,
  • Susanne Kohler,
  • Lisa Elena Loparco,
  • Friederike Nellessen,
  • Claudio Rebelo,
  • Irina Schwenk,
  • Nadine Schwindt,
  • Sabine Vögele,
  • Iris Weber,
  • Andrea Thesenvitz,
  • Stefanie von Felten,
  • Dirk Würzberg

摘要

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.

Visual abstract