Exploring Implementation Processes of a Multicomponent Family Support Intervention in Intensive Care Units (FICUS) Study: A Mixed-Methods Process Evaluation.

AIM To investigate the experience with and progress of the implementation of a Family Support Intervention (FSI) into adult intensive care units (ICUs) as part of the cluster-randomised FICUS trial. DESIGN A mixed-methods process evaluation using a multiple case study approach guided by the normalisation process theory. METHODS This study took place between June 2022 and July 2023 in eight Swiss ICUs randomised to the intervention arm. A tailored implementation strategy was used to introduce the multicomponent FSI, consisting of a new family nursing role and a family care pathway, into interprofessional ICU teams. Participants were 40 ICU key clinical partners. Qualitative data were collected twice, early (3-6 months) and mid-implementation (9-12 months), using small group interviews. A questionnaire with psychometric measures (Acceptability of Intervention Measure, Feasibility of Intervention Measure, Intervention Appropriateness Measure, Normalisation Measure Development Questionnaire) was administered at mid-implementation. RITA pragmatic rapid thematic analysis and descriptive statistics were used to analyse the data. Qualitative and quantitative results were then compared across ICUs (cases). FINDINGS Findings indicated the desired progress of the FSI integration overall and across cases, with high acceptability and appropriateness ratings but only moderate to high feasibility scores. Study-related barriers were noted in all ICUs (i.e., FSI delivery as part of a clinical trial). Implementation barriers included family nurses' limited capacity and clinician's attitudes towards the FSI. Leadership support and interprofessional collaboration were identified as facilitators. Case-based, integrated findings yielded two implementation pathways, namely early and protracted adopters. CONCLUSION Implementation barriers were related to the feasibility of FSI delivery within the study context that required a high degree of standardisation and protocol adherence. Implementation progress was shaped by an interprofessional culture of family care, sufficient staff and time resources, and leadership support. The study's findings will inform future implementation of complex health interventions in ICUs. REPORTING METHOD Good reporting of a Mixed-Methods Study (GRAMMS). PATIENT OR PUBLIC CONTRIBUTION Within the FICUS trial, a patient and family advisory board with a patient expert, three family members and a patient with own lived experience of critical care collaborate with the research team.