Highlight
- The FICUS trial evaluated a novel nurse-led, interprofessional family support intervention in 16 Swiss ICUs.
- The intervention modestly improved overall family satisfaction with ICU care (mean difference 2.39 points).
- Greater improvements were observed in family involvement in decision-making and in quality of communication.
- Significant enhancement in cognitive and emotional support was reported by families receiving the intervention.
Study Background and Disease Burden
Families of critically ill patients experience significant distress, exacerbated by the intensive care environment, emotional burden, and often insufficient communication with clinical teams. Poor communication and inadequate support can contribute to adverse psychological health outcomes such as anxiety, depression, or post-traumatic stress disorder among family members. Family-centered care is a cornerstone recommendation in critical care guidelines, emphasizing engagement, information sharing, and emotional support. However, despite these recommendations, high-quality experimental data assessing the impact of structured family support interventions led by nursing staff within the ICU environment remain sparse. There is a pressing unmet need to rigorously test interventions that improve family satisfaction, communication quality, and support cognitive and emotional needs during the ICU trajectory.
Study Design
The FICUS (Family Support in Intensive Care Units) trial was a pragmatic, multicenter, cluster-randomized clinical study conducted across 16 adult ICUs in 12 hospitals in Switzerland. Units were randomized in a 1:1 ratio using minimization to ensure balance. Eligible participants were family members of patients admitted to ICU for at least 48 hours, enrolled consecutively between May 2022 and January 2024. The study compared a nurse-led, interprofessional, multicomponent family support intervention against usual ICU care.
The intervention introduced a dedicated family nurse role responsible for engaging and liaising with families. This role involved delivering relationship-focused and psychoeducational support, establishing consistent communication pathways, and facilitating interprofessional communication during the patient’s ICU trajectory. Family members’ outcomes were assessed after patient discharge from ICU.
Primary outcome was family satisfaction with ICU care measured by the Family Satisfaction with ICU survey (range: 0–100). Secondary outcomes encompassed quality of family-clinician communication measured by the Questionnaire on Quality of Physician-Patient Interaction (range: 1–5) and cognitive and emotional support via the Family Perceived Support Questionnaire (range: 14–70). The analysis employed linear mixed-effects models with the individual family member as the unit of inference.
Key Findings
From 2057 eligible family members invited, 885 consented and were enrolled: 412 in the intervention and 473 in the control arm. Participants had a median age of 54 years (IQR 42–65), with approximately 48% partners and 64% women.
The intervention showed a statistically significant although small increase in the primary outcome of overall family satisfaction, with a mean difference between groups of 2.39 points (95% CI, 0.31 to 4.47; P = .02). Satisfaction regarding involvement in medical decision-making improved more notably than satisfaction with direct care, highlighting the intervention’s effectiveness in family engagement.
Communication quality significantly improved, evidenced by an increased mean score difference of 0.37 (95% CI, 0.16 to 0.58; P = .002). Families in the intervention group reported higher cognitive and emotional support, with a substantial mean difference of 8.71 points (95% CI, 4.71 to 12.71; P < .001).
Sensitivity analyses accounting for cluster and individual-level covariates, along with multiple imputation for missing data, reinforced the robustness of these results.
The intervention was implemented without reported safety concerns, and family nurses were successfully integrated into the ICU teams, demonstrating feasibility.
Expert Commentary
This large, rigorous cluster-randomized trial adds valuable evidence supporting nurse-led, interprofessional family support interventions in critical care settings. The modest effect size on overall family satisfaction may reflect inherent challenges in modulating patient family perceptions, which are influenced by complex factors including patient outcomes and ICU culture.
Improvements in shared decision-making and communication resonate with current critical care practice imperatives focusing on family engagement and respect for autonomy. Cognitive and emotional support enhancements underscore the importance of these dedicated nursing roles in bridging gaps often overlooked by time-pressured clinicians.
However, the clinical significance of the modest increase in family satisfaction scores requires careful interpretation, and longer-term outcomes such as family psychological distress or post-ICU syndrome in relatives warrant investigation.
Study generalizability is strengthened by the multicenter Swiss context, though cultural differences in ICU family roles may influence applicability globally. Future research might evaluate cost-effectiveness, sustainability of the intervention, and integration with digital communication platforms.
Conclusion
The FICUS trial demonstrates that a nurse-led, multicomponent family support intervention in adult ICUs leads to a small but statistically significant improvement in family satisfaction with care and meaningfully enhances communication quality and emotional/cognitive support. This intervention model offers a viable approach to address family distress and improve family-centered critical care. Nonetheless, clinical impact magnitude is modest, highlighting the need for continued innovation and evaluation of supportive care strategies for families facing critical illness.
References
1. Naef R, Jeitziner MM, Riguzzi M, et al; FICUS Study Group. Nurse-Led Family Support Intervention for Families of Critically Ill Patients: The FICUS Cluster Randomized Clinical Trial. JAMA Intern Med. 2025;185(9):1138-1149. doi:10.1001/jamainternmed.2025.3406.
2. Davidson JE, Aslakson RA, Long AC, et al. Guidelines for family-centered care in the neonatal, pediatric, and adult ICU. Crit Care Med. 2017;45(1):103-128.
3. Kentish-Barnes N, Chaize M, Seegers V, et al. Effect of a nurse-led family support intervention on family well-being and ICU resource use: A randomized clinical trial. Intensive Care Med. 2020;46(7):1362-1373.
4. Azoulay E, Kentish-Barnes N, et al. Family participation in the ICU experience: Current evidence and future challenges. Crit Care. 2022;26(1):81.
5. Davidson JE. Providing support for families in ICU: Are we there yet? Am J Crit Care. 2019;28(4):249-252.