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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Learn more: PMC Disclaimer | PMC Copyright Notice Intensive Care Med . 2026 May 18;52(4):637–650. doi: 10.1007/s00134-026-08425-2 The FICUS cluster randomized controlled trial of a family support intervention in adult intensive care units: mental health and family functioning outcomes Marco Riguzzi 1, 2, # , Marie-Madlen Jeitziner 3, # , Michael Rufer 4, 5 , Stefanie von Felten 6 , Lotte Verweij 1, 2 , Saskia Oesch 1, 2 , Simone Sutter 1, 2 , Judith Safford 7 , Monique Seraina Wenzler 8 , JoEllen Welter 9 , Jan Wiegand 10 , Dirk Wiechmann 11 , Christoph von Dach 12 , Peter Steiger 13 , Esther Siegrist 14 , Naira Ruch 3 , Urs Pietsch 15 , Michaela Moser 16 , Paola Massarotto 14 , Fabienne Lussmann 17 , Yvonne Keller 18 , Johanna Elisabeth Hoffmann 19 , Benjamin Hertler 13 , Antje Heise 20 , Alexander Dullenkopf 9 , Hanna Burkhalter 21 , Philipp Karl Bühler 11 , Christoph Brunner 15 , Damian Brülhart 6 , Ursula Betschart 22 , Bettina Bergmann-Kipfer 20 , Miodrag Filipovic 15 , Rahel Naef 1, 2, ✉ , for the FICUS study group Author information Article notes Copyright and License information 1 Faculty of Medicine, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland 2 Centre for Clinical Nursing Science, University Hospital Zurich, Zurich, Switzerland 3 Department of Intensive Care Medicine, Inselspital, Bern University Hospital, Bern, Switzerland 4 Center for Psychiatry and Psychotherapy, Clinic Zugersee, Oberwil‑Zug, Switzerland 5 Department of Psychiatry, Psychotherapy, and Psychosomatics, Psychiatric University Hospital Zurich, University of Zurich, Zurich, Switzerland 6 Department of Biostatistics at Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland 7 Patient Research Partner, Bern, Switzerland 8 Institute for Anesthesia and Intensive Care Medicine, Hirslanden Clinic Zurich, Zurich, Switzerland 9 Institute for Anesthesia, Spital Thurgau Frauenfeld, Frauenfeld, Switzerland 10 Intensive Care Unit, Lindenhofgruppe, Lindenhofspital, Bern, Switzerland 11 Center of Intensive Care Medicine, Cantonal Hospital Winterthur, Winterthur, Switzerland 12 Department of Nursing, Solothurn Hospitals AG, Solothurn, Switzerland 13 Institute of Intensive Care Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland 14 Institute of Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland 15 Division of Perioperative Intensive Care Medicine, Kantonsspital St.Gallen, St. Gallen, Switzerland 16 Interdisciplinary Intensive Care Unit, Department of Perioperative Medicine, Solothurn Hospitals AG, Cantonal Hospital Olten, Olten, Switzerland 17 Center of Intensive Care Medicine, Lucerne Cantonal Hospital, Lucerne, Switzerland 18 Nurse Development Department, Cantonal Hospital Baden, Baden, Switzerland 19 Nursing Development and Quality Unit, Lucerne Cantonal Hospital, Lucerne, Switzerland 20 Intensive Care Unit, Hospital of Thun, Thun, Switzerland 21 Department of Nursing and Specialist Support, Nursing Development, Cantonal Hospital Graubünden, Chur, Switzerland 22 Department of Intensive Care Medicine, Kantonsspital St.Gallen, St. Gallen, Switzerland ✉ Corresponding author. # Contributed equally. Received 2025 Nov 10; Accepted 2026 Apr 2; Issue date 2026. © The Author(s) 2026 Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ . PMC Copyright notice PMCID: PMC13221400  PMID: 42149244 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 . Visual abstract Supplementary Information The online version contains supplementary material available at 10.1007/s00134-026-08425-2. Keywords: Family members, Critical care, Nursing, Communication, Post-intensive care syndrome-family, Family functioning Take-home message A multicomponent, nurse-led, interprofessional family support intervention, which increased quality of family care outcomes (satisfaction, quality of family-clinician communication, cognitive/emotional support), showed no evidence of improving family functioning or mental health in family members of critically ill adults. Patient mechanical ventilation, being a spouse/partner, and previous ICU experience were associated with many of the investigated outcomes, but not with intervention effectiveness. Open in a new tab Introduction Family members of adults admitted to intensive care units (ICUs) for critical illness or trauma experience unexpected challenges and high burden, some with devastating consequences for family life [ 1 , 2 ]. They are at risk of adverse mental health outcomes, termed Postintensive Care Syndrome-Family (PICS-F), which is a constellation of symptoms such as anxiety, depression, posttraumatic stress, or prolonged grief [ 3 , 4 ], affecting 20–40% of family members of critically ill adults [ 3 , 5 ]. Besides personal risk factors, such as preexisting mental illness and female gender, care-related risk factors are dissatisfaction with care and poor communication [ 3 , 5 , 6 ]. Interventions to increase the quality of care and communication to the family and to mitigate psychological distress and adverse mental health outcomes have therefore been called for, with ICU nurses playing a central role [ 7 ]. Prior nurse-facilitated family-focused interventions, using decision-making support and structured communication strategies, have primarily targeted surrogate decision-makers of persons at high risk of dying in the ICU [ 8 – 14 ], without clear benefit regarding PICS-F. At six months post-ICU, one trial identified a decrease in prolonged grief disorder [ 10 ], one decreased depressive symptoms [ 9 ], and another one reduced posttraumatic stress [ 14 ]. Only two trials have co-investigated communication quality, with contradictory results [ 8 , 12 ]. Cost benefits of family-focused interventions have been identified [ 15 , 16 ]. We tested the nurse-led family support intervention (FSI) targeting families of critically ill adults during and after patients’ ICU stay with a cluster-randomized design to avoid contamination (FICUS trial) [ 17 ]. The intervention uses a family systems care approach and combines engaging and liaising practices, family assessment, psychoeducation, relationship-focused support, and an interprofessional communication structure [ 17 ]. The FICUS trial identified a small improvement in family satisfaction (primary outcome) and a strong increase in quality of communication and emotional/cognitive support to families [ 18 ]. A further objective of the FICUS trial was to test whether the intervention improves family functioning and individual family member well-being while reducing mental health symptoms over the first year post-ICU. Methods Study design The cluster-randomized controlled FICUS trial included 16 Swiss adult ICUs (clusters) with a patient and public engagement strategy [ 17 ]. The trial was registered with clinicaltrials.gov (04.03.2022) and approved by all appropriate Swiss cantonal ethics committees (No. 2021–02300). Family members were enrolled from May 2022 to January 2024. Informed consent was obtained before study start by a nurse or intensivist. Reporting follows the appropriate CONSORT statements. Participants Family members of critically ill patients with an expected length of ICU stay (LoS-ICU) ≥ 48 h and either a high risk of death or long-lasting functional impairment or prolonged mechanical ventilation were eligible if they were a significant other, 18 years or older, cognitively able to participate, and able to complete German-language measures. Refusal of general patient consent for the use of routine clinical data for research led to exclusion. ICUs had to operate ≥ 8 beds and admit ≥ 300 patients per year (LoS-ICU ≥ 48 h). Only one member per family was included in the trial. Randomization ICUs were randomized 1:1 to intervention or control using minimization stratified by certification of the ICU (academic/major versus other teaching hospital) and site (a total of 12 hospitals, one with two and one with four study ICUs) [ 19 ]. Clinicians, data assessors, and family members were not masked. Intervention and control The FSI, described in detail elsewhere [ 17 , 18 ], is based on a family systems care approach and best practice recommendations for family-centered ICU care, targeting all members of the family [ 20 ]. It aims to improve the quality of interaction and communication between families and the ICU team. Specifically, it seeks to reduce family burden, strengthen family illness management and well-being, and mitigate the impact of the critical illness on family members’ mental health. Three intervention elements are combined and delivered along a structured family care pathway, starting with patient ICU admission and continuing into the post-ICU phase, with at least one contact around four weeks post-ICU. Designated ICU nurses delivered the pathway in close collaboration with the interprofessional ICU team. A minimum of five intervention sessions reflecting all three elements was pre-specified. Dose and frequency could be increased according to family needs. Details are given in Table 1 . Table 1. FICUS intervention activities Elements Activities Deliverers Timepoints Fidelity to intervention element a n (%) family members Engaging and liaising (nurse-family encounters) Building, maintaining, and concluding relationships with families Family nurse At admission b 374 (90.8) at admission b Liaising and facilitating interactions between family and ICU team and ensuring continuity ICU team As required Coordinating care, referrals, and transitions Supporting (nurse-family therapeutic conversations) Assessing family structure, functioning, needs, and preferences Family nurse At admission b 363 (88.1) at admission b Providing psychoeducation At discharge c 290 (70.4) at discharge c Offering relationship-focused, emotional, cognitive, and behavioural support Post-ICU d As required 181 (43.9) post-ICU d Communicating (interprofessional, family meetings) Listening to family concerns and questions Intensivist At admission b 301 (73.1) at admission b Providing information on the patient’s situation Family nurse Every five (±2) days Discussing treatment options Others Making decisions together Open in a new tab a Fidelity consistency defined as minimum dose of five intervention sessions, reflecting all three intervention elements, offered within the prespecified time points along the family care pathway b ≤ 96 h after patient ICU admission c ± 48 h ICU from patient discharge or death at the ICU d + 4 weeks post-ICU Two to three interested ICU-certified nurses per ICU assumed the family nurse role and received a five-day training in family systems care and the protocolized intervention activities, followed by monthly case conferences and two refresher days [ 17 , 21 ]. Further implementation activities were tailored to each ICU based on an assessment of barriers and facilitators [ 21 ]. This included, for example, nurse and physician leadership support, ICU team information, champions, an implementation support person, and external facilitation by the research team through regular meetings and observations. The intervention was introduced in addition to and compared to non-standardized usual care as established before trial start (defined as family care practices offered by nurses, intensivists, and others, including visitation, information provision, and communication) [ 17 ]. Outcomes Family functioning, well-being, and mental health symptoms were assessed at patient ICU admission (+4 days), patient ICU discharge or death (−1 day/+4 weeks), and 3 (−14 days/+4 weeks), 6 (−14 days/+6 weeks), and 12 months (−14 days/+6 weeks) after discharge [ 19 ] using German versions of psychometrically validated instruments that were completed by one member of the family. The Family Assessment Device - General Functioning Scale (FAD-GF, range 1–4, with 4 representing low functioning) and Brief Resilience Scale (BRS, score range 1–5, 5 representing high resilience) were used to assess family functioning and resilience. Individual family members’ well-being was obtained through the Satisfaction with Life Scale (SWLS-5, score range 5–35, 35 representing high satisfaction), WHO-5 Well-being Index (WHO-5, score range 0–100, 100 representing high psychological well-being), and a visual analog scale (QoL-VAS, score range 0–100, 100 representing high general QoL). Mental health symptoms, namely distress, depression, anxiety, and posttraumatic stress, were measured using the Distress Thermometer (DT, score range 0–100, 100 representing high distress), Hospital Depression and Anxiety Scale (HADS, score range 0–21, 21 representing worse symptoms), and Impact of Event Scale-6 (IES-6, score range 0–4, 4 representing worse symptoms). These were secondary outcomes of the FICUS trial [ 17 ] (eTable 1). Data collection Family members were screened for eligibility, informed about the intervention versus usual care and data collection processes, and enrolled by ICU clinicians or research nurses, using a video, flyer, and detailed study information package. Data was collected using REDCap©. After completion of informed consent, participants completed the (1) outcome measures, (2) demographic form, and (3) questions on ICU survivor functional status, support need, or death (post-ICU only) either online through a personalized survey link or by paper–pencil questionnaire, which was entered into REDCap© by research staff. At least one reminder occurred per phone, complemented by email or letter. Patient demographic and health data at ICU admission and discharge were extracted from clinical records. Intervention characteristics and fidelity were recorded in structured logs. Statistical analysis All analyses were done using R [ 22 ] by linear mixed-effects models (LMM) with a random intercept per cluster and a random intercept per family member (nested within clusters) to account for the dependence of participants from the same center and for repeated measurements from the same study participant. The serial autocorrelation of residuals was modelled using a first-order autoregressive correlation structure. The models included the treatment (intervention vs. control), the baseline outcome measurement (if returned within 4 days of ICU admission), the visit (factor with visit T3 as the reference group), and the visit × treatment interaction to assess whether the treatment effect changed over time. In addition, we included the covariates patient age, type of admission (unplanned or planned), mechanical ventilation (yes/no), SAPS-2 and SOFA scores at admission, the type of family relationship (spouse/partner, child, or other), and the family members’ previous ICU experience, which we report as the main model (see [ 19 ] for the originally planned statistical analysis). The six-month follow-up was chosen as the reference category for follow-up visits in the models with interaction. One outcome, FAD-GF, was log-transformed to better meet normality assumptions. In addition, the LMMs were fitted (1) using multiple imputation of missing data (and pooling of results according to Rubin’s rules) and (2) without the visit × treatment interaction to estimate an average intervention effect. Results Participants From 12th May 2022 to 1st February 2024, 3181 family members were screened, and 885 participated (42.7% of those invited), with 473 in the control and 412 in the intervention arm (eTable 2). Loss to follow-up was comparable between study arms and ranged between 6.3 to 9.7% per timepoint (Fig. 1 ). Between 609 and 613 participants were included in the main LMMs with covariate adjustment (a total of 2071 to 2085 outcome measurements). Fig. 1. Open in a new tab Participant flow diagram Baseline family member characteristics were similar between study arms, but patient characteristics differed slightly (Table 2 ) [ 18 ]. In the intervention arm, there were fewer unplanned patient admissions (77.1 vs. 89.9% in control), more frequent mechanical ventilation (60.3 vs 49.5%), slightly longer LoS-ICU (10 vs. 8 days), and more patient ICU deaths (19.9 vs. 13.2%). Table 2. ICU, patient and family member characteristics Variable Control Intervention Missing (%) ICU baseline characteristics n = 8 ICUs n = 8 ICUs Operated ICU beds (annual average), median (IQR) 15.4 (9.5–36.1) 11.6 (8.0–20.0) 0 Patients admitted per year, median (IQR) 1146 (533–3718) 919 (701–2203) 0 Treatment days per year, median (IQR) 4076 (2543–13177) 3828 (2233–5531) 0 High-risk admissions (SAPS-2 score > 45%), median (IQR) 24.1 (14.0–46.0) 21.0 (14.5–28.0) 0 Unplanned admissions in %, median (IQR) 77.0 (59.0–94.2) 77.0 (43.9–91.0) 0 Mechanically ventilated patients in %, median (IQR) 44.0 (20.0–65.1) 35.5 (25.0–83.3) 0 Length of ICU stay (days), median (IQR) 3.4 (2.3–6.5) 3.7 (1.2–4.9) 0 FTE a nurses per operated beds, median (IQR) 4.5 (3.8–5.4) 4.5 (2.8–7.1) 0 Patient baseline characteristics n = 473 n = 412 Unplanned admission to ICU, n (%) 417 (89.9) 309 (77.1) 2.3 Patient age (years), median (q1, q3) 66 (55, 75) 67.5 (56, 75) 2.3 Patient sex, n (%) 2.1 Female 154 (33.1) 159 (39.7) Male 311 (66.9) 241 (60.1) Other 0 (0.0) 1 (0.2) SAPS-2 b score, median (q1, q3) 51.0 (18.6) 50.5 (17.3) 2.8 Mechanical ventilation, n (%) 230 (49.5) 242 (60.3) 2.1 Patient discharge characteristics Patient deceased in ICU, n (%) 61 (13.2) 79 (19.9) 3.2 Length of stay, median (q1, q3) 8 (5, 13) 10 (6, 16) 3.2 Family member baseline characteristics c n = 473 n = 412 Family member age (years), median (q1, q3) 55.0 (42.0, 63.8) 54.0 (43.0, 66.0) 4.1 Family member sex, n (%) 4.0 Female 314 (69.6) 254 (63.7) Male 136 (30.2) 145 (36.3) Other 1 (0.2) 0 (0.0) Type of family member, n (%) 4.0 Partner/spouse 215 (47.7) 214 (53.6) Parent 65 (14.4) 59 (14.8) Child 113 (25.1) 98 (24.6) Other 58 (12.9) 28 (7.0) Prior ICU experience of family member, n (%) , 4.3 As patient 36 (8.0) 19 (4.8) As family member of patient 168 (37.4) 141 (35.4) Both 23 (5.1) 21 (5.3) None 222 (49.4) 217 (54.5) Prior/current psychological treatment of family member, n (%) 175 (39.0) 148 (37.2) 4.3 Family functioning (FAD-GF-12) d , median (IQR) 1.5 (0.6) 1.5 (0.6) 26.2 Threshold for healthy (low problematic) functioning met (< 2), % e 81.5 78.5 Family resilience (BRS-6), median (IQR) 3.5 (1.0) 3.5 (1.0) 26.1 Threshold for normal or higher resilience met (≥ 3), % e 81.0 77.9 Satisfaction with life (SWLS-5), median (IQR) 28 (7.0) 28 (7.0) 26.1 Threshold for neutrality or higher (satisfaction) met (> 20), % e 85.0 85.6 Quality of life (WHO-5), median (IQR) 56 (40.0) 60 (40.0) 25.9 Threshold for adequate or higher quality of life met (≥ 50), % e 58.3 59.7 Quality of life (QoL-VAS), median (IQR) 80 (23.0) 80 (29.0) 26.3 Score ≥ 50, % e 90.0 91.0 Distress (DT), median (IQR) 80 (30.0) 80 (25.0) 26.1 Threshold for moderate or higher distress met (≥ 40), % e 92.1 93.0 Anxiety (HADS-14 A), median (IQR) 8 (6.0) 9.5 (7.0) 26.0 Threshold for at least minor/mild anxiety met (≥ 8), % e 59.2 65.1 Depression (HADS-14 D), median (IQR) 6 (6.0) 6 (7.0) 26.2 Threshold for at least minor/mild depressive symptoms met (≥ 8), % e 36.2 39.0 Impact of events (IES), median (IQR) 1.8 (1.0) 1.8 (1.0) 26.2 Threshold for post-traumatic stress met (≥ 1.75), % e 55.3 60.1 Open in a new tab ICU intensive care unit, IQR inter-quartile range, SAPS-2 Simplified Acute Physiology Score-2, FTE full-time equivalent, FAD-GF-12 Family Assessment Device - General Functioning Scale, BRS-6 Brief Resilience Scale (BRS-6), SWLS-5 Satisfaction with Life Scale, WHO-5 Well-Being Index, QoL-VAS adapted visual analog scale on quality of life, DT Distress Thermometer (DT), HADS-14 A Hospital Anxiety and Depression Scale (Anxiety), HADS-14 D Hospital Anxiety and Depression Scale (Depression), IES-6 Impact of Events Scale-6 a Full time equivalents (1 = 100% degree of employment) b Simplified Acute Physiology Score-2 c T0 outcome measurements outside of the specified time windows are considered as missing d Reverse-coded scale with higher score indicating lower family functioning e As percentage of non-missing T0 outcome measurements Intervention characteristics and fidelity The intervention was delivered by 22 ICU-certified family nurses with a median work experience of 19 years (IQR, 2.5–29.0). Most interventionists (n = 18) were ICU team members and involved in patient care. A few, known to the ICU team, worked in another hospital unit. Interventions were delivered by family nurses to a single (53.5%) or several family members, and 22.2% of interventions were team-delivered. Fidelity consistency to the pathway was achieved by 23.1% (n = 95) of cases, representing a minimum of five intervention sessions covering all three intervention components within the pre-defined timeframe (Table 1 ). The total intervention duration per family (fidelity dose) amounted to 250 min at the median, which equals 25.0 min (IQR = 18.7) per patient LoS-ICU. Fidelity frequency had a median of 11 contacts overall, or 1.1 (IQR = 0.7) per patient LoS-ICU [ 18 ]. Details are reported in eTables 3–4. Intervention effectiveness at 6 months No significant difference between the control and intervention arms was observed for the family functioning, resilience, life satisfaction, quality of life, anxiety, depression, and posttraumatic stress outcomes (Table 3 , significant results with p < 0.05 are shown in bold). Models fitted after multiple imputation of missing values (eTables 5–13) showed similar results across all outcomes, except for a negative intervention effect on life satisfaction (−1.02, 95% CI −1.93 to −0.12, p = 0.027). eTables 14–17 show baseline characteristics by the timing of the baseline survey, and eTables 18–21 compare them by completeness of all outcome measurements, revealing no major imbalance. eTable 22 shows the proportion of incomplete outcome measurements per visit per ICU, with similar dropout rates across ICUs. Table 3. Family functioning, well-being and mental health symptoms Outcome/measure Functioning/FAD-GF-12 a Family resilience/BRS-6 Life satisfaction/SWLS-5 Quality of life/WHO-5 Quality of life/QoL-VAS n (n family members) b 2084 (610) 2081 (611) 2078 (611) 2083 (613) 2071 (609) Control: outcome at ICU discharge + 6 mos., mean (SD) 1.70 (0.53) 3.59 (0.77) 25.92 (6.17) 61.43 (24.29) 80.91 (18.01) Intervention: outcome at ICU discharge + 6 mos., mean (SD) 1.69 (0.53) 3.53 (0.75) 24.62 (7.05) 57.85 (24.25) 78.01 (19.58) Coefficient estimates (95% CI) Outcome at baseline (ICU admission) 1.966 (1.86 to 2.08)*** 0.626 (0.58 to 0.68)*** 0.676 (0.62 to 0.74)*** 0.322 (0.27 to 0.38)*** 0.434 (0.38 to 0.49)*** Intervention (vs. control), at ICU discharge + 6 mos. 1.004 (0.95 to 1.06) −0.041 (−0.16 to 0.07) −0.911 (−2.21 to 0.39) −3.695 (−7.93 to 0.54) −1.524 (−4.58 to 1.53) ICU discharge (vs. ICU discharge + 6 mos.) 0.944 (0.92 to 0.97)*** −0.031 (−0.11 to 0.04) −0.137 (−0.73 to 0.46) −19.448 (−22.29 to −16.60)*** −4.974 (−7.01 to −2.94)*** ICU discharge + 3 mos. (vs. ICU discharge + 6 mos.) 0.994 (0.97 to 1.02) −0.075 (−0.15 to −0.00)* −0.274 (−0.81 to 0.26) −3.856 (−6.51 to −1.20)** −1.114 (−2.83 to 0.60) ICU discharge + 12 mos. (vs. ICU discharge + 6 mos.) 1.002 (0.98 to 1.03) −0.033 (−0.11 to 0.04) 0.272 (−0.27 to 0.82) 2.542 (−0.17 to 5.25) 1.555 (−0.20 to 3.31) Intervention (vs. control) × ICU discharge 0.966 (0.93 to 1.01) 0.031 (−0.08 to 0.14) 0.896 (0.04 to 1.75)* 2.409 (−1.68 to 6.50) 2.592 (−0.33 to 5.51) Intervention (vs. control) × ICU discharge + 3 mos. 0.985 (0.95 to 1.02) 0.079 (−0.02 to 0.18) 0.553 (−0.21 to 1.32) 2.177 (−1.63 to 5.99) 2.194 (−0.26 to 4.65) Intervention (vs. control) × ICU discharge + 12 mos. 0.984 (0.95 to 1.02) 0.057 (−0.05 to 0.16) 0.640 (−0.15 to 1.43) 1.107 (−2.81 to 5.03) 2.162 (−0.38 to 4.70) Patient age (years) 1.000 (1.00 to 1.00) −0.001 (−0.00 to 0.00) 0.022 (−0.00 to 0.05) 0.110 (0.01 to 0.21)* −0.018 (−0.09 to 0.06) Planned ICU admission (vs. unplanned) 1.006 (0.96 to 1.05) −0.101 (−0.21 to 0.01) 0.202 (−0.81 to 1.22) −2.180 (−6.37 to 2.01) 1.345 (−1.78 to 4.47) Mechanical ventilation at baseline (vs. none) 1.012 (0.98 to 1.05) −0.054 (−0.13 to 0.03) −0.570 (−1.31 to 0.17) −4.452 (−7.55 to −1.35)** −0.835 (−3.17 to 1.50) SAPS-2 score 0.999 (1.00 to 1.00) 0.001 (−0.00 to 0.00) −0.013 (−0.04 to 0.01) −0.008 (−0.10 to 0.09) −0.030 (−0.10 to 0.04) SOFA score 1.000 (1.00 to 1.01) 0.001 (−0.01 to 0.01) −0.005 (−0.11 to 0.10) −0.305 (−0.74 to 0.13) 0.083 (−0.24 to 0.41) FM parent (vs. spouse/partner) 1.038 (0.99 to 1.09) 0.027 (−0.08 to 0.14) 1.320 (0.31 to 2.33)* 4.391 (0.05 to 8.73)* 4.190 (0.88 to 7.50)* FM child (vs. spouse/partner) 1.024 (0.99 to 1.06) 0.006 (−0.09 to 0.10) 1.096 (0.27 to 1.92)** 0.462 (−3.11 to 4.03) 2.187 (−0.51 to 4.89) FM other relationship (vs. spouse/partner) 1.028 (0.98 to 1.08) −0.076 (−0.20 to 0.05) 1.639 (0.46 to 2.82)** 4.963 (−0.11 to 10.03) 2.615 (−1.20 to 6.43) Prior ICU experience as patient (vs. none) 0.979 (0.92 to 1.04) 0.167 (0.01 to 0.32)* −0.247 (−1.65 to 1.16) −0.723 (−6.80 to 5.36) −0.184 (−4.75 to 4.38) Prior ICU experience as FM (vs. none) 1.006 (0.98 to 1.04) −0.004 (−0.08 to 0.07) −0.113 (−0.82 to 0.59) −1.904 (−4.93 to 1.12) −0.233 (−2.52 to 2.05) Prior ICU experience as both (vs. none) 1.002 (0.94 to 1.07) −0.047 (−0.22 to 0.12) 0.176 (−1.35 to 1.70) −5.712 (−12.29 to 0.87) −0.516 (−5.47 to 4.43) Outcome/measure Distress/DT Anxiety/HADS-14-A Depression/HADS-14 D Posttraumatic stress/IES-6 n (n family members) 2079 (611) 2085 (612) 2080 (610) 2072 (610) Control: outcome at ICU discharge + 6 mos., mean (SD) 42.32 (30.92) 5.88 (4.11) 4.10 (3.69) 1.18 (0.81) Intervention: outcome at ICU discharge + 6 mos., mean (SD) 44.23 (29.40) 6.57 (4.25) 4.66 (4.09) 1.31 (0.90) Coefficient estimates (95% CI) Outcome at baseline (ICU admission) 0.398 (0.32 to 0.48)*** 0.539 (0.48 to 0.59)*** 0.438 (0.39 to 0.49)*** 0.594 (0.53 to 0.66)*** Intervention (vs. control), at ICU discharge + 6 mos. 1.630 (−3.72 to 6.98) 0.334 (−0.34 to 1.01) 0.150 (−0.59 to 0.89) 0.073 (−0.06 to 0.21) ICU discharge (vs. ICU discharge + 6 mos.) 28.620 (24.74 to 32.50)*** 1.909 (1.49 to 2.33)*** 1.561 (1.16 to 1.97)*** 0.661 (0.57 to 0.75)*** ICU discharge + 3 mos. (vs. ICU discharge + 6 mos.) 4.348 (0.80 to 7.90)* 0.429 (0.04 to 0.82)* 0.218 (−0.14 to 0.58) 0.159 (0.07 to 0.24)*** ICU discharge + 12 mos. (vs. ICU discharge + 6 mos.) −2.329 (−5.95 to 1.30) −0.255 (−0.65 to 0.14) −0.355 (−0.72 to 0.01) −0.012 (−0.10 to 0.08) Intervention (vs. control) × ICU discharge −1.635 (−7.21 to 3.94) −0.036 (−0.63 to 0.56) −0.034 (−0.62 to 0.55) −0.005 (−0.14 to 0.12) Intervention (vs. control) × ICU discharge + 3 mos. −0.877 (−5.97 to 4.21) −0.235 (−0.79 to 0.32) 0.061 (−0.46 to 0.58) −0.039 (−0.16 to 0.08) Intervention (vs. control) × ICU discharge + 12 mos. −1.165 (−6.41 to 4.08) −0.354 (−0.93 to 0.22) 0.000 (−0.54 to 0.53) −0.036 (−0.16 to 0.09) Patient age (years) −0.105 (−0.22 to 0.01) −0.002 (−0.02 to 0.01) 0.005 (−0.01 to 0.02) −0.001 (−0.00 to 0.00) Planned ICU admission (vs. unplanned) 1.568 (−3.08 to 6.22) 0.228 (−0.46 to 0.91) −0.065 (−0.75 to 0.62) 0.034 (−0.10 to 0.17) Mechanical ventilation at baseline (vs. none) 3.389 (−0.07 to 6.85) 0.558 (0.05 to 1.07)* 0.440 (−0.06 to 0.94) 0.012 (−0.09 to 0.11) SAPS-2 score −0.003 (−0.11 to 0.10) −0.002 (−0.02 to 0.01) 0.001 (−0.01 to 0.02) 0.001 (−0.00 to 0.00) SOFA score 0.107 (−0.38 to 0.60) −0.009 (−0.08 to 0.06) −0.011 (−0.08 to 0.06) 0.006 (−0.01 to 0.02) FM parent (vs. spouse/partner) −0.832 (−5.63 to 3.97) 0.134 (−0.58 to 0.85) −0.859 (−1.55 to −0.17)* −0.053 (−0.19 to 0.09) FM child (vs. spouse/partner) −0.301 (−4.27 to 3.66) −0.701 (−1.28 to −0.12)* −1.126 (−1.69 to −0.56)*** −0.061 (−0.18 to 0.05) FM other relationship (vs. spouse/partner) −3.599 (−9.22 to 2.02) −0.511 (−1.33 to 0.31) −0.995 (−1.79 to −0.20)* −0.152 (−0.31 to 0.01) Prior ICU experience as patient (vs. none) −2.253 (−8.94 to 4.44) 0.675 (−0.31 to 1.66) 1.085 (0.13 to 2.04)* 0.112 (−0.08 to 0.31) Prior ICU experience as FM (vs. none) 0.767 (−2.58 to 4.11) 0.095 (−0.40 to 0.59) 0.374 (−0.11 to 0.85) 0.000 (−0.10 to 0.10) Prior ICU experience as both (vs. none) 1.194 (−6.04 to 8.42) 0.081 (−1.00 to 1.16) 0.655 (−0.39 to 1.70) 0.045 (−0.17 to 0.26) Open in a new tab ICU intensive care unit, SD standard deviation, CI confidence interval, mos. months, FAD-GF-12 Family Assessment Device - General Functioning Scale, BRS-6 Brief Resilience Scale, SWLS-5 Satisfaction with Life Scale, WHO-5 Well-Being Index, QoL-VAS adapted visual analog scale on quality of life, DT Distress Thermometer, HADS-14 A Hospital Anxiety and Depression Scale (Anxiety), HADS-14 D Hospital Anxiety and Depression Scale (Depression), IES-6 Impact of Events Scale ***p-value < 0.001; ** p -value < 0.01; * p -value < 0.05; significant results with p < 0.05 are shown in bold a Reverse-coded scale with a higher score indicating lower family functioning. Outcome log-transformed for the regression model where exp(estimate) is displayed (interpretation as a multiplicative factor) b Number of observations referring to the regression model Associations between covariates and family functioning and mental health outcomes Resilience was higher in family members with prior ICU experience as a patient (+0.17, 95% CI 0.01 to 0.32, p = 0.035) (Table 3 ). Life satisfaction was lower for spouses/partners of patients compared to all other relationships (point estimate −1.64 to −1.10, p ≤ 0.011). Quality of life (WHO-5) scores were lower in the case of mechanical ventilation at ICU admission (−4.45, 95% CI −7.55 to −1.35, p = 0.005) and for spouses/partners (vs. parents of adult patients; −4.39, 95% CI −8.73 to −0.05, p = 0.047), and they increased with patient age (+0.11 per year, 95% CI 0.01 to 0.21, p = 0.031). QoL-VAS scores were lower for spouses/partners (vs. parents of adult patients; −4.19, 95% CI −7.50 to −0.88, p = 0.013). Anxiety was higher in the case of mechanical ventilation at ICU admission (+0.56, 95% CI 0.05 to 1.07, p = 0.031) and for spouses/partners (vs. the family member being an adult child of the patient; +0.70, 95% CI 0.12 to 1.28, p = 0.018). Depression was higher in spouses/partners compared to all other relationships (point estimate +0.86 to +1.13, p ≤ 0.015) and after prior ICU experience as a patient (+1.09, 95% CI 0.13 to 2.04, p = 0.026). Family functioning and mental health outcomes over the entire follow-up Figure 2 provides a descriptive overview of the outcomes over one year post-ICU. Descriptive statistics for all outcomes at all visits are detailed in eTable 23 and eFigures 1 –10. eTables 24–32 report the models without interaction. The estimated average intervention effect over the whole follow-up was non-significant for all outcomes. Family functioning slightly deteriorated between ICU discharge and six months post-ICU (factor of 0.93 for ICU discharge vs. 6 months post-ICU for reverse-coded score, p < 0.0001). Life satisfaction did not change significantly up to 6 months post-ICU but increased thereafter by 0.6 points (p = 0.004). Quality of life improved from ICU discharge until 6 months post-ICU, WHO-5 scores by 18.3 points (p < 0.0001) and QoL-VAS scores by 3.7 points (p < 0.0001), respectively, and from 6 to 12 months post-ICU, WHO-5 by 3.1 (p = 0.002) and QoL-VAS by 2.6 points (p < 0.0001). Mental health symptoms systematically decreased post-ICU: Distress by 27.8 over 6 months (p < 0.0001) and by another 2.9 points thereafter (p = 0.031), anxiety by 1.9 points over 6 months (p < 0.0001) and by another 0.4 points thereafter (p = 0.004), depression by 1.5 points over 6 months (p < 0.0001) and by another 0.4 points thereafter (p = 0.009), and posttraumatic stress by 0.7 points over 6 months (p < 0.0001) with no significant change thereafter. Fig. 2. Open in a new tab Secondary outcomes over one-year post-ICU Discussion In this cluster-randomized trial with 885 family members of critically ill adults, we examined a nurse-led family care pathway with engagement and liaison, support, and interprofessional communication as core elements [ 18 ]. The intervention did not show improvements in family functioning or mental health—the secondary outcomes of the FICUS trial [ 17 , 18 ]—within the first year post-ICU. Our results align with previous trials on nurse-led or facilitated, family-focused interventions, which mostly failed to demonstrate effects on mental health outcomes up to six months post-ICU [ 8 , 11 , 12 ], with two exceptions [ 9 , 13 ], in comparison to non-standardized, usual care. Life satisfaction was lower in the intervention arm in the multiple imputation model. A similar observation has been made in the Four Supports trial, which found higher posttraumatic stress in the intervention arm [ 8 ]. In our study, differences in patient mechanical ventilation and death between study arms may explain slightly less favorable outcomes in the intervention arm, as evidenced in the sensitivity analyses, but these differences were not associated with the intervention’s effectiveness. As previously shown, psychological sequelae declined during the first six months [ 3 , 13 ], indicating a stabilization and adaptation process independent of the intervention. Some patient and family-related characteristics were associated with several outcomes, but not with intervention effectiveness. First, mechanical ventilation increased family member anxiety and decreased quality of life, which has been previously noted [ 23 , 24 ], and is not surprising given that it is indicative of severe illness, life-sustaining treatment, and communication challenges. Second, family members with prior experience as an ICU patient had both higher resilience and higher depression, suggesting that prior ICU exposure may support their role as family members [ 25 ], but also adds to their mental burden. Third, spouses/partners had higher anxiety and depression and lower satisfaction and quality of life than other family members. Prior research has similarly demonstrated that the effectiveness of coping responses varies with the relationship to the patient [ 26 ]. These differences imply that family-focused interventions should be adaptive to the individual patient, family, and relationship contexts. FICUS, together with the recently published, mono-center Caregiver Pathway Intervention study [ 13 , 14 ], is the first trial of a nurse-led, family-focused intervention in ICUs to collect one-year follow-up data and to assess quality of life, life satisfaction, family functioning, and resilience [ 18 ]. The intervention is rooted in a family systems approach, which has only been used in a post-ICU nurse-led intervention [ 27 , 28 ], with favorable effects on family functioning at one year [ 27 ]. In a qualitative evaluation with families, we observed a high need for post-ICU care [ 29 ], and it may therefore be important to increase intensity and duration of follow-up to families, which has also been suggested elsewhere [ 8 ]. Post-ICU care delivered by the same family nurse who is part of the ICU team to ensure continuity of care may be particularly important because family members of critically ill patients are especially vulnerable due to either bereavement or persistent illness with caregiving responsibilities, both resulting in an ongoing need for support [ 4 , 30 , 31 ]. One review highlights the importance of bereavement follow-up [ 32 ], including information on grief together with the identification and referral of those at risk for prolonged grief to specialist support [ 33 , 34 ], which was part of the intervention, albeit limited to the first four to 12 weeks post-ICU. Families appreciated having a trusted and familiar person to turn to, even after patient ICU discharge, as evidenced in a qualitative sub-study [ 29 ], together with proactive, skilled communication and emotional, behavioral, and practical support [ 18 ], which are important implications for nursing practice. Further research is needed to clarify the optimal timing, content, and delivery of such interventions along the patient trajectories, including along the post-ICU continuum [ 2 , 4 , 35 ]. As previously suggested, specialist mental health support may need to complement preventive, nurse-led, collaborative care by the ICU team to families affected by critical illness and its consequences [ 2 , 8 , 11 ]. Also, in end-of-life situations, a physician-driven communication strategy has been found to reduce prolonged grief disorder and grief intensity [ 10 ] and may therefore be of value. Despite a failure of nurse-led or -facilitated interventions to consistently produce a measurable impact on PICS-F, the FICUS trial [ 18 ], together with the PARTNER [ 12 ] and the Caregiver Pathway Intervention trials [ 13 , 14 ], provides convincing evidence that nurse-led family care pathways with emotional, behavioral, cognitive, and practical support by designated nurses who are part of the ICU team, combined with structured, interprofessional communication, are of benefit for families. Limitations This study has several limitations [ 18 ]. First, our study included a small number of clusters, and there were differences between the control and intervention arms in ICU characteristics, patient-related baseline characteristics, and patient outcome (higher mortality in the intervention arm despite comparable SAPS-2 scores). To minimize the danger of confounding, we therefore controlled for several patient and family member characteristics, including illness severity (mechanical ventilation, SOFA and SAPS-2). However, there may be unmeasured confounders at the ICU or patient level which we were not able to adjust for, such as patient case mix, quality of patient care, treatment guidelines, or organizational structures and processes. Causal interpretations of the trial results may therefore be limited. Second, the large proportion of missing outcome data, particularly at baseline, was handled by multiple imputation. The underlying assumption of missingness at random, which also underlies the mixed-effects models, cannot be verified. Exploration of missingness per cluster revealed different levels and patterns over time between ICUs, but not between study arms. Nevertheless, non-random missingness may distort the results. Third, while fidelity to each prespecified intervention element was moderate to high, combined fidelity to all prespecified time points in the family care pathway was low. Deviations from the predefined timeline and minimal dose may mean that many families did not get a sufficient intervention dose. Fourth, while attrition rates were comparable between study arms and acceptable overall, the analysis included about only 70% of the sample because of the late return of the baseline questionnaire that served as a covariate. Fifth, post-ICU patient illness trajectories may have influenced family functioning and mental health, which we were unable to assess with this trial. Sixth, socially disadvantaged and non-German-speaking families and families with a high burden may be underrepresented in our sample. Conclusion In conclusion, no evidence was found that the multicomponent, nurse-led, interprofessional FSI improves short- or long-term family functioning or well-being or mitigates PICS-F in families of critically ill adults in the Swiss healthcare context. Our findings are consistent with those reported in other randomized, clinical trials of nurse-led or -facilitated family care pathways. Due to the limitations, the results of our study have to be interpreted cautiously and in a hypothesis-generating manner. Overall, this evolving body of research suggests that these nurse-led interventions, while effective in improving the quality of family care and communication and economically feasible, may not translate into reduced mental health burden post-ICU. Supplementary Information Below is the link to the electronic supplementary material. Supplementary file1 (PDF 1583 KB) (1.5MB, pdf) Acknowledgements We would like to thank all family participants for their willingness to contribute to this trial. We would also like to express our gratitude to the hospital and ICU staff for their support of this study. The Swiss Society for Intensive Care Medicine supported the study by hosting the FICUS study group at its annual meetings. We also warmly thank Tanja Brühlhart, Cristina de Biasio Marinello, Marion Jourdan and Thomas Zurbrügg, who serve as members of the patient and family advisory group, for the ongoing collaboration. Andrea Thesenvitz supported us as trial manager. FICUS study group: Nicole Balsiger: Cantonal Hospital Baden, Senta Hug: Cantonal Hospital Baden, Ramona Kehl: Cantonal Hospital Baden, Yvonne Keller: Cantonal Hospital Baden, Patrick Leute: Cantonal Hospital Baden, Priska Odelli: Cantonal Hospital Baden, Eva Pietzke: Cantonal Hospital Baden, Franziska Rutz: Cantonal Hospital Baden, Sarah Schmidt: Cantonal Hospital Baden, Doreen Trautwein: Cantonal Hospital Baden, Deborah Wolf: Cantonal Hospital Baden, Eun Joo Beers: Cantonal Hospital Graubünden, Stephanie Bossi: Cantonal Hospital Graubünden, Nadine Brühlisauer: Cantonal Hospital Graubünden, Hanna Burkhalter: Cantonal Hospital Graubünden, Franziska Hellmann: Cantonal Hospital Graubünden, Gabriela Manetsch: Cantonal Hospital Graubünden, Jasmin Rüesch: Cantonal Hospital Graubünden, Noëlle Tenner: Cantonal Hospital Graubünden, Micaela Vaerini: Cantonal Hospital Graubünden, Tobias Weitbrecht: Cantonal Hospital Graubünden, Michaela Moser: Cantonal Hospital Olten, Michael Studhalter: Cantonal Hospital Olten, Philipp Karl Bühler: Cantonal Hospital Winterthur, Stefan Christ: Cantonal Hospital Winterthur, Martina Keller: Cantonal Hospital Winterthur, Cornelia Lips: Cantonal Hospital Winterthur, Christian Schandl: Cantonal Hospital Winterthur, Diana Segalada: Cantonal Hospital Winterthur, Ursina Spörri: Cantonal Hospital Winterthur, Merel van de Westelaken: Cantonal Hospital Winterthur, Marlene Wegmann Oswald: Cantonal Hospital Winterthur, Dirk Wiechmann: Cantonal Hospital Winterthur, Michael Rufer: Clinic Zugersee, Triaplus AG, Sabine Fazlic: Hirslanden Clinic Zurich, Stefanie Henkensmeier: Hirslanden Clinic Zurich, Roger Lussmann: Hirslanden Clinic Zurich, Birgit Steiger: Hirslanden Clinic Zurich, Monique Seraina Wenzler: Hirslanden Clinic Zurich, Bettina Bergmann-Kipfer: Hospital of Thun, Antje Heise: Hospital of Thun, Nadine Kipfer: Hospital of Thun, Sonia Santini: Hospital of Thun, Christa Stalder: Hospital of Thun, Jeannina Wiedmer: Hospital of Thun, Marie-Madlen Jeitziner: Inselspital Bern, Béatrice Jenny Moser: Inselspital Bern, Dunja Nery Barreto: Inselspital Bern, Naira Ruch: Inselspital Bern, Björn Zante: Inselspital Bern, Ursula Betschart: Kantonsspital St.Gallen, Christoph Brunner: Kantonsspital St.Gallen, Regine Büdel: Kantonsspital St.Gallen, Esther Doron: Kantonsspital St.Gallen, Susann Endermann: Kantonsspital St.Gallen, Miodrag Filipovic: Kantonsspital St.Gallen, Mandy Jentsch: Kantonsspital St.Gallen, Carsten Klein: Kantonsspital St.Gallen, Urs Pietsch: Kantonsspital St.Gallen, Jacqueline Rütsche: Kantonsspital St.Gallen, Andrea Zimmermann: Kantonsspital St.Gallen, Sabine Berger: Lindenhofspital, Andreas Bosshard: Lindenhofspital, Cindy Groen: Lindenhofspital, Andrea Müller Paul: Lindenhofspital, Yvonne Seiffert: Lindenhofspital, Erika Sigrist: Lindenhofspital, Jan Wiegand: Lindenhofspital, Gaby Gürber: Lucerne Cantonal Hospital, Johanna Elisabeth Hoffmann: Lucerne Cantonal Hospital, Fabienne Lussmann: Lucerne Cantonal Hospital, Tanja Brülhart: Patient research partner, Cristina de Basio Marinello: Patient research partner, Marion Jourdan: Patient research partner, Judith Safford: Patient research partner, Thomas Zurbrügg: Patient research partner, Ernst Näf: Solothurn Hospitals AG, Christoph von Dach: Solothurn Hospitals AG, Sabina Boltshauser: Spital Thurgau Frauenfeld, Alexander Dullenkopf: Spital Thurgau Frauenfeld, Monica Julmy: Spital Thurgau Frauenfeld, Matthias Moos: Spital Thurgau Frauenfeld, Marion Springer: Spital Thurgau Frauenfeld, JoEllen Welter: Spital Thurgau Frauenfeld, Rahel Naef: University & University Hospital of Zurich, Marco Riguzzi: University & University Hospital of Zurich, Simone Sutter: University & University Hospital of Zurich, Lotte Verweij: University & University Hospital of Zurich, Tessa Allgaier: University Hospital Zurich, Evelin Bläs: University Hospital Zurich, Kim-Jana Fehlbier: University Hospital Zurich, Debora Figi: University Hospital Zurich, Sophie Valentine Gruber: University Hospital Zurich, Monika Hahn: University Hospital Zurich, Benjamin Hertler: University Hospital Zurich, Sandy Hesselberth: University Hospital Zurich, Maria Katharina Iberl: University Hospital Zurich, Carmen Karde: University Hospital Zurich, Lea Kinteh-Vischherr: University Hospital Zurich, Eva-Maria Kleinert: University Hospital Zurich, Susanne Kohler: University Hospital Zurich, Lisa Elena Loparco: University Hospital Zurich, Paola Massarotto: University Hospital Zurich, Friederike Nellessen: University Hospital Zurich, Claudio Rebelo: University Hospital Zurich, Irina Schwenk: University Hospital Zurich, Nadine Schwindt: University Hospital Zurich, Esther Siegrist: University Hospital Zurich, Peter Steiger: University Hospital Zurich, Sabine Vögele: University Hospital Zurich, Iris Weber: University Hospital Zurich, Saskia Oesch: University of Zurich, Andrea Thesenvitz: University of Zurich, Stefanie von Felten: University of Zurich, Dirk Würzberg: Univesity Hospital Zurich. Author contributions Drs Naef, von Felten, Brülhart and Riguzzi had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Concept and design: Naef, Jeitziner, Rufer, Filipovic, von Felten, Riguzzi, Safford. Acquisition, analysis, or interpretation of data: Bergmann-Kipfer, Betschart, Brunner, Bühler, Burkhalter, Dullenkopf, Filipovic, Heise, Hertler, Hoffmann, Jeitziner, Keller, Lussmann, Massarotto, Moser, Naef, Oesch, Pietsch, Riguzzi, Ruch, Rufer, Safford, Siegrist, Steiger, Sutter, Verweij, von Dach, von Felten, Welter, Wenzler, Wiechmann, Wiegand. Drafting of the manuscript: Riguzzi, Jeitziner, Naef, von Felten, Rufer, Safford, Sutter, Verweij. Critical review of the manuscript for important intellectual content: Bergmann-Kipfer, Betschart, Brülhart, Brunner, Bühler, Burkhalter, Dullenkopf, Heise, Hertler, Hoffmann, Keller, Lussmann, Massarotto, Moser, Oesch, Pietsch, Siegrist, Steiger, Ruch, von Dach, Welter, Wenzler, Wiechmann, Wiegand, Filipovic. Data curation: Sutter, Riguzzi, Verweij. Statistical analysis: von Felten, Brülhart, Riguzzi. Obtained funding: Naef, Jeitziner, Filipovic. Administrative, technical, or material support: Sutter, Verweij, Safford, von Felten, Riguzzi, Jeitziner, Filipovic, Naef. Supervision: Naef, Jeitziner, Rufer, Filipovic. All authors read and approved the final manuscript. All authors certify that the manuscript represents valid work. Neither this manuscript nor one with substantially similar content under our authorship has been published or is being considered for publication elsewhere. Funding This study was supported by grant 198778 from the Swiss National Science Fund. The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. Data availability Data of individual participants on which the results reported in this article are based will be available, after de-identification and if consent for reuse of data has been given, starting one year after trial completion, without an end date, in a data repository. It will be shared with investigators or researchers who provide a methodologically sound proposal and whose proposed use of the data has been approved by an independent review identified for this purpose. The study protocol and statistical analysis plan were published. Declarations Conflicts of interest None reported. Informed consent All participants signed a written informed consent before study entry. A patient’s general consent for use of clinical data for research purposes or surrogate informed consent by their legal representative was required. Ethics approval The study was submitted to all applicable Swiss cantonal ethics committees: Zurich (lead), Bern, Nordwest- und Zentralschweiz EKNZ, and Ostschweiz EKOS, which approved the study (No. 2021-02300). All participants signed a written informed consent before study entry. Footnotes The members of “FICUS study group” are listed in Acknowledgements section. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Marco Riguzzi and Marie-Madlen Jeitziner should be considered as joint first authors. References 1. Sui W, Gong X, Qiao X et al (2023) Family members’ perceptions of surrogate decision-making in the intensive care unit: a systematic review. Int J Nurs Stud 137:104391. 10.1016/j.ijnurstu.2022.104391 [ DOI ] [ PubMed ] [ Google Scholar ] 2. 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