Family Support Intervention in Intensive Care Units
Key facts
- Who runs it
- Rahel Naef
- Where
- Switzerland12 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 885 people enrolled
- Started
- 12 May 2022
- Ended
- 2 Jan 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Family Support Intervention (FSI)
- Record updated
- 30 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Expected length of stay in ICU ≥48 hours, as predicted by the intaking ICU clinician (physician or nurse) at admission
- Life-threatening condition with a high risk of death or long-lasting functional impairment
- High risk of prolonged mechanical ventilation (>24 hours)
- Primary support person of the patient
- Able to complete family-reported outcome measures (questionnaires) in German language
- Age ≥18 years
- Signed informed consent form
Who cannot take part
- Prior inclusion in FICUS trial on another study ICU
- Preexisting declined general consent
- ICU stay <24 hours
- Cognitive inability to understand the study or complete the questionnaire as appraised by clinicians and / or study recruitment staff
- Inability to complete baseline data collection within the required timeframe after admission / study enrollment (Calvert et al., 2018)
Other criteria
- Potential participants are family members of critically ill persons admitted to a study ICU. A family member is defined as a close other from the patient's perspective, as noted in the clinical record or in advanced directives, or as indicated by the legally defined surrogate decision-maker
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
Background: Family members of critically ill patients face considerable uncertainty and distress during their close other's intensive care unit (ICU) stay, with about 20-60% of family members experiencing post-traumatic distress post-ICU. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation.
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Methods: To test the clinical effectiveness and explore the implementation of a multicomponent, nurse-led family support intervention in ICUs, the investigators will undertake a parallel, cluster-randomized, controlled, multicenter superiority hybrid-type 1 trial. The trial will include eight clusters (ICUs) per study arm, with a projected total sample size of 896 family members of adult, critically ill patients treated in the German-speaking part of Switzerland. The trial targets family members of critically ill patients with an expected ICU stay of 48 hours or longer. Families in the control arm will receive usual care. Families in the intervention arm, in addition to usual care, will receive a family support intervention consisting of specialist nurse support along the patient pathway at defined time-points, including follow-up care, and nurse-coordinated liaison and structured, interprofessional communication by the ICU team. The primary study endpoint is quality of family care, operationalized as family members' satisfaction with ICU care at discharge. Secondary endpoints include quality of communication and nurse support, family management of critical illness (functioning, resilience), and family members' mental health (well-being, psychological distress) measured at admission, discharge, and after three, six, and twelve months. Data of all participants, regardless of protocol adherence, will be analyzed using linear mixed-effects models, with the individual participant as the unit of inference.
Discussion: The FICUS trial will establish the effectiveness of the family support intervention and generate knowledge of its implementability. Both types of evidence are necessary to determine whether the intervention works as intended in clinical practice and whether an effective intervention could be scaled-up to other ICUs. The study findings will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being.
The 2 groups in the trial
- Family Support InterventionOther group
Families in the intervention group receive the Family Support Intervention in addition to usual care
Treatment: Family Support Intervention (FSI)
- Usual CareNo study treatment, for comparison
Families in the control group will receive usual care.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multi-center, Cluster Randomized Superiority Trial of a Guideline-based Family Support Intervention in Intensive Care Units
- Record updated
- 30 June 2026