Evidence mapPaperPMID 42149244Full record

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.

Marco Riguzzi, Marie-Madlen Jeitziner, Michael Rufer, Stefanie von Felten, Lotte Verweij, Saskia Oesch, Simone Sutter, Judith Safford, Monique Seraina Wenzler, JoEllen Welter and 24 more

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

NCT05280691 nacompletednot on this map

A Multi-center, Cluster Randomized Superiority Trial of a Guideline-based Family Support Intervention in Intensive Care Units

TypeinterventionalSponsorRahel NaefRan2022 to 2025Enrolled885ConditionsPostintensive Care Syndrome, Family Members, Quality of Life, Depression, AnxietyArmsFamily Support Intervention (FSI)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors.

Marco Riguzzi *Faculty of Medicine, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0003-3056-351X
Marie-Madlen Jeitziner *Department of Intensive Care Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.ORCID http://orcid.org/0000-0002-0275-4602
Michael RuferCenter for Psychiatry and Psychotherapy, Clinic Zugersee, Oberwil‑Zug, Switzerland.ORCID http://orcid.org/0000-0003-4964-4213
Stefanie von FeltenDepartment of Biostatistics at Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-5264-6394
Lotte VerweijFaculty of Medicine, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-4727-0126
Saskia OeschFaculty of Medicine, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0001-6639-5875
Simone SutterFaculty of Medicine, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0009-0004-7293-7262
Judith SaffordPatient Research Partner, Bern, Switzerland.ORCID http://orcid.org/0000-0002-4933-7304
Monique Seraina WenzlerInstitute for Anesthesia and Intensive Care Medicine, Hirslanden Clinic Zurich, Zurich, Switzerland.
JoEllen WelterInstitute for Anesthesia, Spital Thurgau Frauenfeld, Frauenfeld, Switzerland.ORCID http://orcid.org/0000-0003-1458-6121
Jan WiegandIntensive Care Unit, Lindenhofgruppe, Lindenhofspital, Bern, Switzerland.
Dirk WiechmannCenter of Intensive Care Medicine, Cantonal Hospital Winterthur, Winterthur, Switzerland.
Christoph von DachDepartment of Nursing, Solothurn Hospitals AG, Solothurn, Switzerland.ORCID http://orcid.org/0000-0002-5812-5426
Peter SteigerInstitute of Intensive Care Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0000-0002-3617-5174
Esther SiegristInstitute of Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland.
Naira RuchDepartment of Intensive Care Medicine, Inselspital, Bern University Hospital, Bern, Switzerland.ORCID http://orcid.org/0009-0006-7594-3566
Urs PietschDivision of Perioperative Intensive Care Medicine, Kantonsspital St.Gallen, St. Gallen, Switzerland.ORCID http://orcid.org/0000-0001-6957-2638
Michaela MoserInterdisciplinary Intensive Care Unit, Department of Perioperative Medicine, Solothurn Hospitals AG, Cantonal Hospital Olten, Olten, Switzerland.
Paola MassarottoInstitute of Intensive Care Medicine, University Hospital Zurich, Zurich, Switzerland.
Fabienne LussmannCenter of Intensive Care Medicine, Lucerne Cantonal Hospital, Lucerne, Switzerland.
Yvonne KellerNurse Development Department, Cantonal Hospital Baden, Baden, Switzerland.
Johanna Elisabeth HoffmannNursing Development and Quality Unit, Lucerne Cantonal Hospital, Lucerne, Switzerland.
Benjamin HertlerInstitute of Intensive Care Medicine, University Hospital Zurich, University of Zurich, Zurich, Switzerland.
Antje HeiseIntensive Care Unit, Hospital of Thun, Thun, Switzerland.
Alexander DullenkopfInstitute for Anesthesia, Spital Thurgau Frauenfeld, Frauenfeld, Switzerland.ORCID http://orcid.org/0000-0002-1456-6457
Hanna BurkhalterDepartment of Nursing and Specialist Support, Nursing Development, Cantonal Hospital Graubünden, Chur, Switzerland.ORCID http://orcid.org/0000-0001-7011-0481
Philipp Karl BühlerCenter of Intensive Care Medicine, Cantonal Hospital Winterthur, Winterthur, Switzerland.
Christoph BrunnerDivision of Perioperative Intensive Care Medicine, Kantonsspital St.Gallen, St. Gallen, Switzerland.
Damian BrülhartDepartment of Biostatistics at Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.ORCID http://orcid.org/0009-0008-3337-403X
Ursula BetschartDepartment of Intensive Care Medicine, Kantonsspital St.Gallen, St. Gallen, Switzerland.
Bettina Bergmann-KipferIntensive Care Unit, Hospital of Thun, Thun, Switzerland.
Miodrag FilipovicDivision of Perioperative Intensive Care Medicine, Kantonsspital St.Gallen, St. Gallen, Switzerland.ORCID http://orcid.org/0000-0003-1764-7145
Rahel NaefFaculty of Medicine, Institute for Implementation Science in Health Care, University of Zurich, Zurich, Switzerland. rahel.naef@usz.ch.ORCID http://orcid.org/0000-0002-5872-076X
FICUS study group

Funding

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung 198778
6 · The paper itself

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.

Indexed as

FamilyMental HealthAdultAgedFamily SupportFemaleHumansIntensive Care UnitsMaleMiddle AgedQuality of LifeSwitzerlandCommunicationCritical careFamily functioningFamily membersNursingPost-intensive care syndrome-family

Identifiers

PMID42149244
PMCPMC13221400

What Socratic holds

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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.