Postintensive Care SyndromeFICUSNCT05280691
Family Support Intervention in Intensive Care Units
A study testing Family Support Intervention (FSI) in people with Postintensive Care Syndrome and Family Members, run by Rahel Naef at 12 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postintensive Care Syndrome, Family Members, Quality of Life
- What is being tested?
- Family Support Intervention (FSI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 885 participants
- Where
- 12 sitesSwitzerland
- Study dates
- 12 May 2022to 2 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Inclusion criteria regarding family members (all must apply):
- Primary support person of the patient.
- Able to complete family-reported outcome measures (questionnaires) in German language.
Show all 15Show fewer
- Age ≥18 years.
- Signed informed consent form.
- Exclusion criteria regarding patients (one leads to exclusion):
- Preexisting declined general consent.
- ICU stay <24 hours.
- Exclusion criteria regarding family members (one leads to exclusion):
- Prior inclusion in FICUS trial on another study ICU.
- 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).
Who cannot join
None listed.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Switzerland12 sites
Cantonal Hospital Baden
Baden
Lindenhof-Hospital
Bern
University Hospital Bern - Inselspital
Bern
Cantonal Hospital Graubünden
Chur
Spital Thurgau AG, Cantonal Hospital Frauenfeld
Frauenfeld
Lucerne Cantonal Hospital
Lucerne
Solothurn Hospitals AG, Cantonal Hospital Olten
Olten
Cantonal Hospital St. Gallen
Sankt Gallen
Hospital Thun
Thun
Cantonal Hospital Winterthur
Winterthur, Canton of Zurich, 8400
University Hospital Zurich
Zurich, 8091
Hirslanden Clinic Zurich
Zurich
About this study
Official title: A Multi-center, Cluster Randomized Superiority Trial of a Guideline-based Family Support Intervention in Intensive Care Units
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.
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.
Read the detailed description
Background: Family members are important to the well-being and recovery of critically ill persons, yet are themselves profoundly affected by the critical illness. During a close other's treatment in an intensive care unit (ICU), families experience high levels of stress and uncertainty, particularly in the event of surrogate decision-making and loss. Poor communication, insufficient shared decision-making, and inadequate emotional and practical support by intensive care staff have been found to add to families' burden. Poor-quality care has been associated with adverse mental health outcomes, which is reported by 20-60% of family members. A lack of engagement and support, coupled with acute stress, not only increases family suffering, but affects family members' functioning in everyday life, and limits their ability to engage in caregiving activities needed by the survivor of critical illness or cope with their loss.
Rationale: To increase the quality of family care and prevent adverse mental health outcomes, ICU guidelines recommend family engagement, communication, and support as well as the use of specific roles, but the evidence base for these recommendations is weak to date. Only a few studies have investigated family support interventions that consist of structured communication and / or specific family nursing roles. Promising effects have been found on family members' communication and support experience. However, findings on psychological distress remain inconclusive whereas insights on family management ability are virtually absent. Moreover, best practice around family engagement in ICU is often not implemented consistently in routine care. Hence, real-world evidence generated by randomized controlled designs is necessary to establish the effect of such multi-component interventions on quality of family care and their potential in supporting family management of critical illness and in reducing adverse mental health outcomes.
Aims: The study aims to determine the effect of a guideline-based, nurse-led, interprofessional family support intervention on quality of family care, family management, and individual mental health compared to usual care provided to family members. The study also aims to identify implementation barriers/enablers in the real-world context in which the study intervention is implemented to discern determinants and strategies of implementation success.
Methodology: The trial is designed as a multi-center, parallel cluster randomized superiority hybrid-type 1 trial with 8 clusters per study arm and a projected sample size of 896 family members of adult, critically ill patients treated in acute care hospitals in the German-speaking part of Switzerland. It will target family members with great needs, such as those of patients with more complex and longer-lasting critical illness, those of patients admitted with a life-threatening condition, and those who are required to make surrogate decisions. Family members of patients requiring short-lasting peri-operative or peri-interventional ICU treatment will be excluded. In addition to usual care, families in the intervention group will receive (1) specialist nurse support along the patient pathway at defined time-points, from admission to discharge with subsequent follow-up care, and (2) nurse-coordinated liaison and structured, interprofessional communication by the ICU team. Family members in the control group will receive usual care. 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 index family members' mental health (well-being, psychological distress) obtained upon admission, discharge, and after 3, 6, and 12 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. A mixed-method study will be used to examine implementation barriers / facilitators and successful strategies at intervention units.
Expected outcomes and impact: The FICUS trial will establish the effectiveness of the family support intervention and generate knowledge on effective implementation processes. Both types of evidence are necessary to determine whether the intervention works as intended, but also to explore how it works in clinical practice, so that 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. They will also promote evidence-based family care in ICU.
- Conditions
- Postintensive Care Syndrome, Family Members, Quality of Life, Depression, Anxiety, Posttraumatic Stress Disorder, Family Dynamics
- Being tested
- Family Support Intervention (FSI)
- Keywords
- Family illness management, Family support intervention
- Medical subject headings
- postintensive care syndrome, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Support Intervention (FSI)Other
In addition to usual care, families in the intervention group will receive (1) specialist nurse support along the patient pathway at defined time-points, from admission to discharge including follow-up care, and (2) nurse-coordinated liaison and structured, interprofessional communication by the ICU team. The intervention is grounded in a family systems approach and guideline-based strategies for family engagement in the ICU and has been pilot-tested in one ICU.
| Study group | Role | What they receive |
|---|---|---|
| Family Support Intervention | Other | Families in the intervention group receive the Family Support Intervention in addition to usual care Receives: Other: Family Support Intervention (FSI) |
| Usual Care | No intervention | Families in the control group will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction With Care (Quality of Family Care) - Total Score
Quality of family care in ICU is operationalized as family satisfaction with ICU care, and measured with the Family Satisfaction in ICU questionnaire (FS-ICU-24R, German version). The FS-ICU-24R is a well-established instrument that assesses satisfaction with care (16 items) and satisfaction with involvement in decision-making (ten items). Its scores range from 0-100 with 100 indicating maximal satisfaction.
Measured: Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
Secondary outcomes (11)
Quality of Communication (Quality of Family Care) - Total Score
The Questionnaire on the Quality of Physician-Patient Interaction (QQPPI, original German version) is used to assess quality of communication between the ICU staff and family members during consultation. The 14 items assess aspects such as relationship-building, information exchange, and shared decision-making. The mean score ranges from 1-5 with a higher score indicating higher quality.
Measured: Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
Nurse Cognitive and Emotional Support to Family (Quality of Family Care) - Total Score
The Iceland Family Perceived Support Questionnaire (ICE-FPSQ, German version) is used to measure families' perception of support provided by nurses. The original English version has two subscales - emotional support (nine items) and cognitive support (five items). The ICE-FPSQ has been translated into German and is currently being validated prior to its use in the trial. A sum score is calculated for the total scale (range 14-70) and each subscale - emotional support (range 9-45) and cognitive support (range 5-25) - with higher scores indicating perception of better family support by nurses.
Measured: Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
Family Functioning (Family Management) - Mean Score
The Family Assessment Device - General Functioning Scale (FAD-GF-12, German version) - is used to assess overall functioning of the family system by six positive and six negative items. The mean score ranges from 1-4 with a lower score reflecting better functioning.
Measured: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Family Resilience (Family Management) - Mean Score
The Brief Resilience Scale (BRS, German version) measures the essence of resilience as the ability to bounce back from stress and is made up of three positive and three negative items. The items will be reformulated from "I" to "we" statements to assess the families' ability to bounce back from stress. The mean score ranges from 1-5 with a higher score indicating greater resilience.
Measured: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Satisfaction With Life (Subjective Well-Being) - Total Score
The Satisfaction with Life Scale (SWLS-5, German version) measures the global dimension of subjective well-being. The sum score ranges from 5-35 with a higher score indicating a higher degree of satisfaction. It can be treated as an ordinal variable with seven levels using established thresholds.
Measured: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Well-Being (Subjective Well-Being) - Total Score
The World Health Organization-5 Well-being Index (WHO-5, German version) measures subjective psychological well-being and is made up of five items tapping three major dimensions of positive affect as well as energy within the past two weeks. Its score ranges from 0-100, with a higher score indicating greater well-being, and has a threshold of 50 indicating depression.
Measured: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Quality of Life (Subjective Well-Being) - Total Score
An adapted version of the general Quality of Life a Visual Analog Scale (QoL-VAS) as used in the EuroQol EQ-5D questionnaire will be employed to measure general rather than health-related quality of life. The score ranges from 0-100 with a higher score representing higher quality of life.
Measured: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Psychological Distress (Mental Health) - Score
The Distress Thermometer (DT, German version) is a validated single-item screening instrument for distress in the past week originally (and still primarily) used among cancer patients with an established threshold for potential distress It ranges from 0-100 with a higher score indicating a higher level of distress.
Measured: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Anxiety (Mental Health) - Total Score
The Hospital Anxiety and Depression Scale (HADS, German version) is made up of 7 items related to anxiety (HADS-A subscale, seven items) - and has thresholds for mild anxiety and caseness for anxiety. The scores range from 0-21 with a higher score indicating worse symptoms.
Measured: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Depression (Mental Health) - Total Score
The Hospital Anxiety and Depression Scale (HADS, German version) is made up of 7 items related to depression (HADS-D subscale, seven items) - and has thresholds for mild depression and caseness for depression. The scores range from 0-21 with a higher score indicating worse symptoms.
Measured: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Posttraumatic Stress (Mental Health) - Mean Score
The Impact of Events Scale-R (IES-R) measures the presence and severity of symptoms associated with a traumatic event during the past week, and has three subscales - intrusion, avoidance, and hyperarousal. The six-item brief version (IES-6) used in this study includes two items from each of the three subscales, and its simple sum score (range 0-4 with a higher score indicating higher impact) has been shown to be highly correlated to the IES-R in various populations.
Measured: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start12 May 2022
- Primary completion31 Mar 2024
- Study completion2 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postintensive Care SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial is designed as a multi-center, parallel-cluster randomized, superiority trial with 16 clusters of ICUs in the German-speaking part of Switzerland. The study aims to determine the effect of a nurse-led, interprofessional family support intervention on quality of family care, family management, and individual mental health compared to usual care provided to family members. The study also aims to identify implementation barriers/enablers in the real-world context in which the study intervention is implemented to discern determinants and strategies of implementation success.
- Masking
- None (open label)
- Enrolment
- 885 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rahel Naef
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation
- Responsible party
- Sponsor-investigator, Rahel Naef, University of Zurich
- Investigators
- Rahel Naef, PhD, RN, Principal investigator, University of ZurichMiodrag Filipovic, MD, Principal investigator, Cantonal Hospital of St. GallenMarie-Madlen Jeitziner, PhD, RN, Principal investigator, University Hospital Bern, Inselspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280691
- Sponsor's protocol ID
- 0001
- Acronym
- FICUS
- Status last verified
- May 2026
- First submitted
- 20 Feb 2022
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
von Felten S, Filipovic M, Jeitziner MM, Verweij L, Riguzzi M, Naef R. Multicomponent family support intervention in intensive care units: statistical analysis plan for the cluster-randomized controlled FICUS trial. Trials. 2024 Aug 28;25(1):568. doi: 10.1186/s13063-024-08351-y.
PubMed 39198900Naef R, Filipovic M, Jeitziner MM, von Felten S, Safford J, Riguzzi M, Rufer M. A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial). Trials. 2022 Jun 27;23(1):533. doi: 10.1186/s13063-022-06454-y.
PubMed 35761343Oesch S, Verweij L, Clack L, Finch T, Riguzzi M, Naef R. Implementation of a multicomponent family support intervention in adult intensive care units: study protocol for an embedded mixed-methods multiple case study (FICUS implementation study). BMJ Open. 2023 Aug 8;13(8):e074142. doi: 10.1136/bmjopen-2023-074142.
PubMed 37553195Oesch S, Verweij L, Riguzzi M, Finch T, Naef R. Exploring Implementation Processes of a Multicomponent Family Support Intervention in Intensive Care Units (FICUS) Study: A Mixed-Methods Process Evaluation. J Adv Nurs. 2025 Nov;81(11):7245-7265. doi: 10.1111/jan.16544. Epub 2024 Oct 18.
PubMed 39422155Walkling R, Verweij L, Oesch S, Naef R. Families' experiences with a novel nurse-led family support intervention in adult intensive care units: A qualitative thematic analysis. Intensive Crit Care Nurs. 2026 Feb;92:104248. doi: 10.1016/j.iccn.2025.104248. Epub 2025 Oct 10.
PubMed 41072380Naef R, Jeitziner MM, Riguzzi M, von Felten S, Verweij L, Rufer M, Safford J, Sutter S, Bergmann-Kipfer B, Betschart U, Boltshauser S, Brulisauer N, Brunner C, Buhler PK, Burkhalter H, Dullenkopf A, Heise A, Hertler B, Hoffmann JE, Karde C, Keller Y, Kohler S, Lussmann F, Massarotto P, Moser M, Pietsch U, Segalada DL, Siegrist E, Steiger P, Ruch N, von Dach C, Wenzler MS, Wiegand J, Zante B, Filipovic M; FICUS Study Group. Nurse-Led Family Support Intervention for Families of Critically Ill Patients: The FICUS Cluster Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1138-1149. doi: 10.1001/jamainternmed.2025.3406.
PubMed 40720110Verweij L, Oesch S, Naef R. Tailored implementation of the FICUS multicomponent family support intervention in adult intensive care units: findings from a mixed methods contextual analysis. BMC Health Serv Res. 2023 Dec 1;23(1):1339. doi: 10.1186/s12913-023-10285-1.
PubMed 38041092Oesch S, Verweij L, Riguzzi M, Finch T, Clack L, Naef R. Integrating a family support intervention in intensive care units: A mixed-methods summative evaluation with health professionals. Int J Nurs Stud. 2026 Feb;174:105308. doi: 10.1016/j.ijnurstu.2025.105308. Epub 2025 Nov 29.
PubMed 41385997Riguzzi M, Jeitziner MM, Rufer M, von Felten S, Verweij L, Oesch S, Sutter S, Safford J, Wenzler MS, Welter J, Wiegand J, Wiechmann D, von Dach C, Steiger P, Siegrist E, Ruch N, Pietsch U, Moser M, Massarotto P, Lussmann F, Keller Y, Hoffmann JE, Hertler B, Heise A, Dullenkopf A, Burkhalter H, Buhler PK, Brunner C, Brulhart D, Betschart U, Bergmann-Kipfer B, Filipovic M, Naef R; FICUS study group. The FICUS cluster randomized controlled trial of a family support intervention in adult intensive care units: mental health and family functioning outcomes. Intensive Care Med. 2026 Apr;52(4):637-650. doi: 10.1007/s00134-026-08425-2. Epub 2026 May 18.
PubMed 42149244
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Cluster Randomized Superiority Trial of a Guideline-based Family Support Intervention in Intensive Care Units
- ClinicalTrials.gov ID
- NCT05280691
- Acronym / sponsor ID
- FICUS / 0001
- Conditions
- Postintensive Care Syndrome, Family Members, Quality of Life, Depression, Anxiety, Posttraumatic Stress Disorder, Family Dynamics
- Keywords
- Family illness management, Family support intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 885 participants (actual)
- Lead sponsor
- Rahel NaefUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation
- Study start
- 12 May 2022 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 2 Jan 2025 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Detailed description
Background: Family members are important to the well-being and recovery of critically ill persons, yet are themselves profoundly affected by the critical illness. During a close other's treatment in an intensive care unit (ICU), families experience high levels of stress and uncertainty, particularly in the event of surrogate decision-making and loss. Poor communication, insufficient shared decision-making, and inadequate emotional and practical support by intensive care staff have been found to add to families' burden. Poor-quality care has been associated with adverse mental health outcomes, which is reported by 20-60% of family members. A lack of engagement and support, coupled with acute stress, not only increases family suffering, but affects family members' functioning in everyday life, and limits their ability to engage in caregiving activities needed by the survivor of critical illness or cope with their loss.
Rationale: To increase the quality of family care and prevent adverse mental health outcomes, ICU guidelines recommend family engagement, communication, and support as well as the use of specific roles, but the evidence base for these recommendations is weak to date. Only a few studies have investigated family support interventions that consist of structured communication and / or specific family nursing roles. Promising effects have been found on family members' communication and support experience. However, findings on psychological distress remain inconclusive whereas insights on family management ability are virtually absent. Moreover, best practice around family engagement in ICU is often not implemented consistently in routine care. Hence, real-world evidence generated by randomized controlled designs is necessary to establish the effect of such multi-component interventions on quality of family care and their potential in supporting family management of critical illness and in reducing adverse mental health outcomes.
Aims: The study aims to determine the effect of a guideline-based, nurse-led, interprofessional family support intervention on quality of family care, family management, and individual mental health compared to usual care provided to family members. The study also aims to identify implementation barriers/enablers in the real-world context in which the study intervention is implemented to discern determinants and strategies of implementation success.
Methodology: The trial is designed as a multi-center, parallel cluster randomized superiority hybrid-type 1 trial with 8 clusters per study arm and a projected sample size of 896 family members of adult, critically ill patients treated in acute care hospitals in the German-speaking part of Switzerland. It will target family members with great needs, such as those of patients with more complex and longer-lasting critical illness, those of patients admitted with a life-threatening condition, and those who are required to make surrogate decisions. Family members of patients requiring short-lasting peri-operative or peri-interventional ICU treatment will be excluded. In addition to usual care, families in the intervention group will receive (1) specialist nurse support along the patient pathway at defined time-points, from admission to discharge with subsequent follow-up care, and (2) nurse-coordinated liaison and structured, interprofessional communication by the ICU team. Family members in the control group will receive usual care. 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 index family members' mental health (well-being, psychological distress) obtained upon admission, discharge, and after 3, 6, and 12 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. A mixed-method study will be used to examine implementation barriers / facilitators and successful strategies at intervention units.
Expected outcomes and impact: The FICUS trial will establish the effectiveness of the family support intervention and generate knowledge on effective implementation processes. Both types of evidence are necessary to determine whether the intervention works as intended, but also to explore how it works in clinical practice, so that 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. They will also promote evidence-based family care in ICU.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial is designed as a multi-center, parallel-cluster randomized, superiority trial with 16 clusters of ICUs in the German-speaking part of Switzerland. The study aims to determine the effect of a nurse-led, interprofessional family support intervention on quality of family care, family management, and individual mental health compared to usual care provided to family members. The study also aims to identify implementation barriers/enablers in the real-world context in which the study intervention is implemented to discern determinants and strategies of implementation success.
| Arm | Type | Receives |
|---|---|---|
| Family Support Intervention | Other | Other: Family Support Intervention (FSI)Families in the intervention group receive the Family Support Intervention in addition to usual care |
| Usual Care | No intervention | –Families in the control group will receive usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family Support Intervention (FSI)In addition to usual care, families in the intervention group will receive (1) specialist nurse support along the patient pathway at defined time-points, from admission to discharge including follow-up care, and (2) nurse-coordinated liaison and structured, interprofessional communication by the ICU team. The intervention is grounded in a family systems approach and guideline-based strategies for family engagement in the ICU and has been pilot-tested in one ICU. | Other | Family Support Intervention |
Primary outcome
Satisfaction With Care (Quality of Family Care) - Total Score
Time frame: Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
Quality of family care in ICU is operationalized as family satisfaction with ICU care, and measured with the Family Satisfaction in ICU questionnaire (FS-ICU-24R, German version). The FS-ICU-24R is a well-established instrument that assesses satisfaction with care (16 items) and satisfaction with involvement in decision-making (ten items). Its scores range from 0-100 with 100 indicating maximal satisfaction.
11 secondary outcomes
Quality of Communication (Quality of Family Care) - Total Score
Time frame: Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
Nurse Cognitive and Emotional Support to Family (Quality of Family Care) - Total Score
Time frame: Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
Family Functioning (Family Management) - Mean Score
Time frame: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Family Resilience (Family Management) - Mean Score
Time frame: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Satisfaction With Life (Subjective Well-Being) - Total Score
Time frame: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Well-Being (Subjective Well-Being) - Total Score
Time frame: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Quality of Life (Subjective Well-Being) - Total Score
Time frame: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Psychological Distress (Mental Health) - Score
Time frame: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Anxiety (Mental Health) - Total Score
Time frame: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Depression (Mental Health) - Total Score
Time frame: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Posttraumatic Stress (Mental Health) - Mean Score
Time frame: Assessed within 96 hours after the admission of the patient to ICU, at the discharge from ICU (between 24 hours prior and 14 days after), 3 months (76-104 days), 6 months (166-194 days), and 12 months (351-379 days) after the discharge from ICU.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39198900von Felten S, Filipovic M, Jeitziner MM, Verweij L, Riguzzi M, Naef R. Multicomponent family support intervention in intensive care units: statistical analysis plan for the cluster-randomized controlled FICUS trial. Trials. 2024 Aug 28;25(1):568. doi: 10.1186/s13063-024-08351-y.
- Background: PubMed 35761343Naef R, Filipovic M, Jeitziner MM, von Felten S, Safford J, Riguzzi M, Rufer M. A multicomponent family support intervention in intensive care units: study protocol for a multicenter cluster-randomized trial (FICUS Trial). Trials. 2022 Jun 27;23(1):533. doi: 10.1186/s13063-022-06454-y.
- Background: PubMed 37553195Oesch S, Verweij L, Clack L, Finch T, Riguzzi M, Naef R. Implementation of a multicomponent family support intervention in adult intensive care units: study protocol for an embedded mixed-methods multiple case study (FICUS implementation study). BMJ Open. 2023 Aug 8;13(8):e074142. doi: 10.1136/bmjopen-2023-074142.
- Results publication: PubMed 39422155Oesch S, Verweij L, Riguzzi M, Finch T, Naef R. Exploring Implementation Processes of a Multicomponent Family Support Intervention in Intensive Care Units (FICUS) Study: A Mixed-Methods Process Evaluation. J Adv Nurs. 2025 Nov;81(11):7245-7265. doi: 10.1111/jan.16544. Epub 2024 Oct 18.
- Results publication: PubMed 41072380Walkling R, Verweij L, Oesch S, Naef R. Families' experiences with a novel nurse-led family support intervention in adult intensive care units: A qualitative thematic analysis. Intensive Crit Care Nurs. 2026 Feb;92:104248. doi: 10.1016/j.iccn.2025.104248. Epub 2025 Oct 10.
- Results publication: PubMed 40720110Naef R, Jeitziner MM, Riguzzi M, von Felten S, Verweij L, Rufer M, Safford J, Sutter S, Bergmann-Kipfer B, Betschart U, Boltshauser S, Brulisauer N, Brunner C, Buhler PK, Burkhalter H, Dullenkopf A, Heise A, Hertler B, Hoffmann JE, Karde C, Keller Y, Kohler S, Lussmann F, Massarotto P, Moser M, Pietsch U, Segalada DL, Siegrist E, Steiger P, Ruch N, von Dach C, Wenzler MS, Wiegand J, Zante B, Filipovic M; FICUS Study Group. Nurse-Led Family Support Intervention for Families of Critically Ill Patients: The FICUS Cluster Randomized Clinical Trial. JAMA Intern Med. 2025 Sep 1;185(9):1138-1149. doi: 10.1001/jamainternmed.2025.3406.
- Results publication: PubMed 38041092Verweij L, Oesch S, Naef R. Tailored implementation of the FICUS multicomponent family support intervention in adult intensive care units: findings from a mixed methods contextual analysis. BMC Health Serv Res. 2023 Dec 1;23(1):1339. doi: 10.1186/s12913-023-10285-1.
- Results publication: PubMed 41385997Oesch S, Verweij L, Riguzzi M, Finch T, Clack L, Naef R. Integrating a family support intervention in intensive care units: A mixed-methods summative evaluation with health professionals. Int J Nurs Stud. 2026 Feb;174:105308. doi: 10.1016/j.ijnurstu.2025.105308. Epub 2025 Nov 29.
- Derived from this study: PubMed 42149244Riguzzi M, Jeitziner MM, Rufer M, von Felten S, Verweij L, Oesch S, Sutter S, Safford J, Wenzler MS, Welter J, Wiegand J, Wiechmann D, von Dach C, Steiger P, Siegrist E, Ruch N, Pietsch U, Moser M, Massarotto P, Lussmann F, Keller Y, Hoffmann JE, Hertler B, Heise A, Dullenkopf A, Burkhalter H, Buhler PK, Brunner C, Brulhart D, Betschart U, Bergmann-Kipfer B, Filipovic M, Naef R; FICUS study group. The FICUS cluster randomized controlled trial of a family support intervention in adult intensive care units: mental health and family functioning outcomes. Intensive Care Med. 2026 Apr;52(4):637-650. doi: 10.1007/s00134-026-08425-2. Epub 2026 May 18.
- Project database of the Swiss National Science Fund (SNSF)Link provided by the sponsor.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rahel Naef, PhD, RN principal investigator
University of Zurich
Miodrag Filipovic, MD principal investigator
Cantonal Hospital of St. Gallen
Marie-Madlen Jeitziner, PhD, RN principal investigator
University Hospital Bern, Inselspital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Support Intervention (FSI) in people with Postintensive Care Syndrome and Family Members, run by Rahel Naef at 12 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction With Care (Quality of Family Care) - Total Score (time frame: Assessed at a single time point no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05280691, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.