Family support intervention in adult Intensive Care UnitS: The FICUS hybrid type 1 effectiveness-implementation study

Family members of critically ill persons face considerable uncertainty and distress during their close others’ intensive care unit (ICU) stay. About 20-60% of family members experience adverse mental health outcomes post-ICU, such as symptoms of anxiety, depression, and posttraumatic stress. Guidelines recommend structured family inclusion, communication, and support, but the existing evidence base around protocolized family support interventions is modest and requires substantiation.

To close the know-do gap around evidence-based, family-focused ICU care and to improve quality of care and family health and well-being, we launched the FICUS hybrid type 1 effectiveness-implementation study, which investigates a multicomponent, nurse-led, interprofessional delivered Family Support Intervention (FSI) in 16 Swiss adult ICUs. This new FSI denotes a complex intervention, and combines three interacting core components, namely early engaging and liaising, supporting, and communicating with families. Embedding complex health care interventions such as the FSI is highly challenging, particularly as part of a multisite clinical trial. The FSI is therefore introduced into the intervention ICUs using a tailored implementation strategy. Attention to the implementation process alongside clinical intervention outcomes is needed to better understand the intervention’s effectiveness.

Thus, the FICUS study aims to 1) test the FSI’s clinical effectiveness and 2) assess implementation processes and outcomes including fidelity of the FSI.

To address the study aims, we employ a cluster-randomized controlled trial and a case-based process and summative mixed-methods evaluation approach. Implementation theories, such as the Normalization Process Theory and the Consolidated Framework for Implementation Research, guide the implementation study, which focuses on the integration of FSI in the eight ICUs assigned to the intervention group of the FICUS study. The FICUS study also incorporates a Patient and Public Involvement and Engagement (PPIE) strategy.

Evidence on effectiveness and implementation are necessary to determine whether the intervention works as intended in clinical ICU practice and could be scaled up to other ICUs. First, the FICUS study results will make a significant contribution to the current body of knowledge on effective ICU care that promotes family participation and well-being. Second, findings will provide insights into implementation and its contribution to intervention outcomes, enabling understanding of the usefulness of applied implementation strategies and highlighting main barriers that need to be addressed for scaling the FSI to other healthcare contexts. Finally, the study findings will inform future implementation of complex health interventions in ICUs.