- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05280691
Family Support Intervention in Intensive Care Units (FICUS)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Simone Sutter, BA
- Phone Number: +41 44 634 37 59
- Email: ficus@ifis.uzh.ch
Study Locations
-
-
-
Baden, Switzerland
- Recruiting
- Cantonal Hospital Baden
-
Contact:
- Yvonne Liebert, MScN
-
Principal Investigator:
- Yvonne Liebert, MScN
-
Bern, Switzerland
- Recruiting
- Lindenhof-Hospital
-
Contact:
- Jan Wiegand, MD
-
Contact:
- Erika Sigrist, RN
-
Principal Investigator:
- Jan Wiegand, MD
-
Bern, Switzerland
- Not yet recruiting
- University Hospital Bern - Inselspital
-
Contact:
- Marie-Madlen Jeitziner, PhD, RN
-
Contact:
- Bjoern Zante, MD
-
Principal Investigator:
- Bjoern Zante, MD
-
Chur, Switzerland
- Recruiting
- Cantonal Hospital Graubünden
-
Contact:
- Hanna Burkhalter, PhD, RN
-
Contact:
- Tobias Weitbrecht, MScN
-
Principal Investigator:
- Hanna Burkhalter, PhD, RN
-
Frauenfeld, Switzerland
- Recruiting
- Spital Thurgau AG, Cantonal Hospital Frauenfeld
-
Contact:
- Alexander Dullenkopf, MD
-
Contact:
- Marion Springer, RN
-
Principal Investigator:
- Alexander Dullenkopf, MD
-
Lucerne, Switzerland
- Recruiting
- Lucerne Cantonal Hospital
-
Contact:
- Fabienne Lussmann, BScN
-
Contact:
- Gaby Guerber-Buob
-
Principal Investigator:
- Fabienne Lussmann, BScN
-
Olten, Switzerland
- Recruiting
- Solothurn Hospitals AG, Cantonal Hospital Olten
-
Contact:
- Christoph von Dach, DNP
-
Contact:
- Oliver Röpke
-
Principal Investigator:
- Christoph von Dach, DNP
-
St. Gallen, Switzerland
- Recruiting
- Cantonal Hospital St. Gallen
-
Contact:
- Urs Pietsch, MD
-
Contact:
- Ursula Betschart
-
Principal Investigator:
- Urs Pietsch, MD
-
Principal Investigator:
- Ursula Betschart, RN
-
Thun, Switzerland
- Recruiting
- Hospital Thun
-
Contact:
- Antje Heise, MD
-
Contact:
- Bettina Bergmann-Kipfer, RN
-
Principal Investigator:
- Antje Heise, MD
-
Zürich, Switzerland, 8091
- Recruiting
- University Hospital Zurich
-
Contact:
- Paola Massarotto, MScN
-
Contact:
- Esther Siegrist, MScN
-
Principal Investigator:
- Paola Massarotto, MScN
-
Principal Investigator:
- Esther Siegrist, MScN
-
Principal Investigator:
- Peter Steiger, MD
-
Principal Investigator:
- Benjamin Hertler, MD
-
Zürich, Switzerland
- Recruiting
- Hirslanden Clinic Zurich
-
Contact:
- Monique Wenzler, RN
-
Contact:
- Roger Lussmann, MD
-
Principal Investigator:
- Monique Wenzler, RN
-
-
ZH
-
Winterthur, ZH, Switzerland, 8400
- Not yet recruiting
- Cantonal Hospital Winterthur
-
Contact:
- Marlene Wegmann Oswald, PhD
-
Principal Investigator:
- Karl Philipp Bühler, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Inclusion criteria regarding patients (one or several):
- 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.
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Family Support Intervention
Families in the intervention group receive the Family Support Intervention in addition to usual care
|
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.
|
No Intervention: Usual Care
Families in the control group will receive usual care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with Care (Quality of Family Care)
Time Frame: Assessed 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.
|
Assessed no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Communication (Quality of Family Care)
Time Frame: Assessed no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
|
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.
|
Assessed no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
|
Nurse Support (Quality of Family Care)
Time Frame: Assessed no earlier than 24 hours prior to and no later than 14 days following the discharge of the patient from ICU.
|
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.
|
Assessed 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)
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.
|
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.
|
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)
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.
|
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.
|
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)
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.
|
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.
|
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)
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.
|
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.
|
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)
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.
|
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.
|
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)
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.
|
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.
|
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)
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.
|
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 0-24 with a higher score indicating higher impact) has been shown to be highly correlated to the IES-R in various populations.
|
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, Anxiety (Mental Health)
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.
|
The Hospital Anxiety and Depression Scale (HADS, German version) is made up of 14 items with different response categories scored in two subscales - anxiety (HADS-A, seven items) and depression (HADS-D, seven items) - and has thresholds for mild depression or anxiety and caseness for depression or anxiety, respectively.
The scores range from 0-21 with a higher score indicating worse symptoms.
|
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.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rahel Naef, PhD, RN, University of Zurich
- Principal Investigator: Miodrag Filipovic, MD, Cantonal Hospital St. Gallen
- Principal Investigator: Marie-Madlen Jeitziner, PhD, RN, University Hospital Bern, Inselspital
Publications and helpful links
General Publications
- Naef R, von Felten S, Petry H, Ernst J, Massarotto P. Impact of a nurse-led family support intervention on family members' satisfaction with intensive care and psychological wellbeing: A mixed-methods evaluation. Aust Crit Care. 2021 Nov;34(6):594-603. doi: 10.1016/j.aucc.2020.10.014. Epub 2021 Feb 24.
- Naef R, Massarotto P, Petry H. Family and health professional experience with a nurse-led family support intervention in ICU: A qualitative evaluation study. Intensive Crit Care Nurs. 2020 Dec;61:102916. doi: 10.1016/j.iccn.2020.102916. Epub 2020 Aug 15.
- Naef 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0001 (Cancer Research Institute)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Quality of Life
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Linkoeping UniversityRecruiting
-
South Valley UniversityActive, not recruitingDeterminants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRSHealth Related Quality of LifeEgypt
-
Region VästmanlandUnknownHealth Related Quality of Life
-
Ain Shams UniversityCompletedHealth Related Quality of LifeEgypt
-
Institute of Oncology LjubljanaUnknownHealth-related Quality of LifeSlovenia
Clinical Trials on Family Support Intervention (FSI)
-
Boston CollegeUnited States Agency for International Development (USAID); World Bank; Network... and other collaboratorsCompletedChild DevelopmentRwanda
-
Harvard School of Public Health (HSPH)Boston Children's Hospital; Harvard University; Partners in HealthCompletedAnxiety | Depressive Symptoms | ParentingRwanda
-
Boston CollegeWorld BankCompleted
-
Boston CollegeCompleted
-
University of PittsburghNational Institute on Aging (NIA)CompletedPhysician-Family Communication in Intensive Care Units | Surrogate Decision-making for Critically Ill PatientsUnited States
-
Children's Hospital of PhiladelphiaAgency for Healthcare Research and Quality (AHRQ)Completed
-
University of PittsburghDuke University; National Institute on Aging (NIA); Oregon Health and Science... and other collaboratorsRecruiting
-
National Institute of Diabetes and Digestive and...Completed
-
Johns Hopkins UniversityMU-JHU CARECompletedBreast Feeding | HIV-infection/Aids
-
University of TorontoUniversity Health Network, Toronto; University of Ottawa; Dalhousie University; Toronto Rehabilitation Institute and other collaboratorsCompletedStroke | Caregiver Social Support | Caregiver Mental Health | Caregiver Sense of Control Over Life | Caregiver ParticipationCanada