Family Support Intervention in Intensive Care Units

NCT05280691 | Completed

• 1 other identifier: 0001
• Study Type: interventional
• Target: 885
• Locations: 1 country
• Sites: 12

Brief 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. 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.

Conditions

Postintensive Care Syndrome; Family Members; Quality of Life; Depression, Anxiety; Posttraumatic Stress Disorder; Family Dynamics

Keywords

Family illness management; Family support intervention

Outcome Measures

Primary Outcomes (1)

• Satisfaction with Care (Quality of Family Care)

  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 Outcomes (10)

• Quality of Communication (Quality of Family Care)

  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)

  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)

  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)

  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)

  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.

Study Arms (2)

Family Support Intervention

OTHER

Families in the intervention group receive the Family Support Intervention in addition to usual care

Other: Family Support Intervention (FSI)

Usual Care

NO INTERVENTION

Families in the control group will receive usual care.

Interventions

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.

Family Support Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Rahel Naef: lead
• Swiss National Science Foundation: collaborator

Study Sites (12)

Cantonal Hospital Winterthur

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Cantonal Hospital Baden

Baden, Switzerland

Location

Lindenhof-Hospital

Bern, Switzerland

Location

University Hospital Bern - Inselspital

Bern, Switzerland

Location

Cantonal Hospital Graubünden

Chur, Switzerland

Location

Spital Thurgau AG, Cantonal Hospital Frauenfeld

Frauenfeld, Switzerland

Location

Lucerne Cantonal Hospital

Lucerne, Switzerland

Location

Solothurn Hospitals AG, Cantonal Hospital Olten

Olten, Switzerland

Location

Cantonal Hospital St. Gallen

Sankt Gallen, Switzerland

Location

Hospital Thun

Thun, Switzerland

Location

University Hospital Zurich

Zurich, 8091, Switzerland

Location

Hirslanden Clinic Zurich

Zurich, Switzerland

Location

Related Publications (7)

• Oesch 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.

  PMID: 39422155 BACKGROUND

• Verweij 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.

  PMID: 38041092 BACKGROUND

• Walker SP, Gaskin P, Powell CA, Bennett FI, Forrester TE, Grantham-McGregor S. The effects of birth weight and postnatal linear growth retardation on blood pressure at age 11-12 years. J Epidemiol Community Health. 2001 Jun;55(6):394-8. doi: 10.1136/jech.55.6.394.

  PMID: 11350995 BACKGROUND

• 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.

  PMID: 35761343 BACKGROUND

• Oesch 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.

  PMID: 37553195 BACKGROUND

• Naef 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.

  PMID: 40720110 DERIVED

• 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.

  PMID: 39198900 DERIVED

Related Links

• Project database of the Swiss National Science Fund (SNSF)

MeSH Terms

Conditions

postintensive care syndrome; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Rahel Naef, PhD, RN

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Miodrag Filipovic, MD

  Cantonal Hospital of St. Gallen

  PRINCIPAL INVESTIGATOR

• Marie-Madlen Jeitziner, PhD, RN

  University Hospital Bern, Inselspital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Implementation Science in Nursing

Model Details: 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.

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 15, 2022
• Study Start: May 12, 2022
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (12)