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

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.

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Journal
Intensive Care Medicine
Published
2026-05-18
DOI
https://doi.org/10.1007/s00134-026-08425-2
Primary Topic
Family and Patient Care in Intensive Care Units
Type
article
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article

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

Deborah Wolf, Ursula Betschart, Cindy Groen, Paola Massarotto et al.
Intensive Care Medicine
Family and Patient Care in Intensive Care Units
article

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

Deborah Wolf, Ursula Betschart, Cindy Groen, Paola Massarotto, F Hellmann, Lotte Verweij, Erika Sigrist, Michael Rufer, Simone Sutter, Urs Pietsch, Stephanie Bossi, Franziska Rutz, Miodrag Filipovic, Diana Segalada, Dimitri Barreto, Benjamin Hertler, Roger Lussmann, Thomas Zurbrügg, Hanna Burkhalter, Judith Safford, Michael Studhalter, Christoph von Dach, Dirk Wiechmann, Antje Heise, Sabine Berger, JoEllen Welter, Kim-Jana Fehlbier, Ernst Näf, Matthias Moos, Susann Endermann, Yvonne Keller, Jan Wiegand, Johanna Hoffmann, Marion Jourdan, Stefanie von Felten, Jacqueline Rütsche, Björn Zante, Christian Schandl, Alexander Dullenkopf, Andreas Bosshard, Michaela Moser, Saskia Oesch, Fabienne Lussmann, Andrea Zimmermann, Sarah Schmidt, Philipp Bühler, Martina Keller, Noëlle Tenner, Doreen Trautwein, Merel van de Westelaken, Tobias Weitbrecht, Sabina Boltshauser, Jeannina Wiedmer, Esther Siegrist, Monique Seraina Wenzler, Tessa Allgaier, Nicole Balsiger, Tanja Brülhart, Regine Büdel, Cristina de Basio Marinello, Esther Doron, Sabine Fazlic, Gaby Gürber, Stefanie Henkensmeier, Mandy Jentsch, Monica Julmy, Patrick Leute, Gabriela Manetsch, Priska Odelli, Eva Pietzke, Bettina Bergmann-Kipfer, Yvonne Seiffert, Ursina Spörri, Birgit Steiger, Marco Riguzzi, Naira Ruch, Damian Brulhart, Stefan Christ, Micaela Vaerini, Carsten Klein, Christoph Brunner, Rahel Naef, Senta Hug, Marlene Wegmann Oswald, Cornelia Lips, Jasmin Rüesch, Peter Steiger, Marion Springer, Eun Joo Beers, for the FICUS study group, Andrea Müller Paul, Nadine Kipfer, Sonia Santini, Christa Stalder, Evelin Bläs, Marie-Madlen Jeitziner, Béatrice Jenny Moser, Nadine Brühlisauer, Ramona Kehl
article en

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.

Intensive Care Medicine
University of Lucerne (CH), ZHAW Zurich University of Applied Sciences (CH), University of Zurich (CH), Kantonsspital St. Gallen (CH), University Hospital of Bern (CH), Spital STS (CH), Klinik Hirslanden (CH), Kantonsspital Winterthur (CH), University Hospital of Zurich (CH), Kantonsspital Baden (CH), Schweizerische Ärztegesellschaft für Psycholytische Therapie (CH), Solothurner Spitäler (CH), Kantonsschule Olten (CH), Lindenhofspital (CH), University of Teacher Education Zug (CH), Kantonsspital Graubünden (CH), Spital Thurgau (Switzerland) (CH), Kantonsspital Frauenfeld (CH)
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
Openalex Percentile: Top 6%
Family and Patient Care in Intensive Care Units
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