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Background The Family in Intensive Care UnitS (FICUS) trial investigates the clinical effectiveness of a multicomponent, nurse-led interprofessional family support intervention (FSI) and explores its implementation in intensive care units (ICUs). The local context of each ICU strongly influences intervention performance in practice. To promote FSI uptake and to reduce variation in intervention delivery, we aimed to develop tailored implementation strategies. Methods A mixed method contextual analysis guided by the Consolidated Framework for Implementation Research (CFIR) was performed from March to June 2022 on eight ICUs assigned to the intervention group. ICU key clinical partners were asked to complete a questionnaire on CFIR inner setting measures (i.e., organizational culture, resources, learning climate and leadership engagement) and the Organizational Readiness for Implementing Change (ORIC) scale prior to group interviews, which were held to discuss barriers and facilitators to FSI implementation. Descriptive analysis and pragmatic rapid thematic analysis were used. Then, tailored implementation strategies were developed for each ICU. Results In total, 33 key clinical partners returned the questionnaire and 40 attended eight group interviews. Results showed a supportive environment, with CFIR inner setting and ORIC measures each rated above 3 (scale: 1 low—5 high value), with leadership engagement scoring highest (median 4.00, IQR 0.38). Interview data showed that the ICU teams were highly motivated and committed to implementing the FSI. They reported limited resources, new interprofessional information exchange, and role adoption of nurses as challenging. Conclusion We found that important pre-conditions for FSI implementation, such as leadership support, a supportive team culture, and a good learning climate were present. Some aspects, such as available resources, interprofessional collaboration and family nurses’ role adoption were of concern and needed attention. An initial set of implementation strategies were relevant to all ICUs, but some additions and adaptation to local needs were required. Multi-component interventions are challenging to implement within complex systems, such as ICUs. This pragmatic, theory-guided, mixed methods contextual analysis demonstrated high readiness and commitment to FSI implementation in the context of a clinical trial and enabled the specification of a tailored, multifaceted implementation strategy.

Background In healthcare research and practice, intervention and implementation fidelity represent the steadfast adherence to core components of research-supported interventions and the strategies employed for their implementation. Evaluating fidelity involves determining whether these core components were delivered as intended. Without fidelity data, the results of complex interventions cannot be meaningfully interpreted. Increasingly, the necessity for firmness and strict adherence by implementers and their organizations has been questioned, with calls for flexibility to accommodate contextual conditions. This shift makes contemporary fidelity a balancing act, requiring researchers to navigate various tensions. This debate paper explores these tensions, drawing on experiences from developing fidelity assessments in two ongoing effectiveness-implementation hybrid trials. Main body First , given often scarce knowledge about the core components of complex interventions and implementation strategies, decisions about fidelity requirements involve a degree of subjective reasoning. Researchers should make these decisions transparent using theory or logic models. Second , because fidelity is context-dependent and applies to both interventions and implementation strategies, researchers must rethink fidelity concepts with every study while balancing firmness and flexibility. This is particularly crucial for hybrid studies, with their differing emphasis on intervention and implementation fidelity. Third , fidelity concepts typically focus on individual behaviors. However, since organizational and system factors also influence fidelity, there is a growing need to define fidelity criteria at these levels. Finally , as contemporary fidelity concepts prioritize flexible over firm adherence, building, evaluating, and maintaining fidelity in healthcare research has become more complex. This complexity calls for intensified efforts to expand the knowledge base for pragmatic and adaptive fidelity measurement in trial and routine healthcare settings. Conclusion Contemporary conceptualizations of fidelity place greater demands on how fidelity is examined, necessitating the expansion of fidelity frameworks to include organizational and system levels, the service- and study-specific conceptualizations of intervention and implementation fidelity, and the development of pragmatic approaches for assessing fidelity in research and practice. Continuing to build knowledge on how to balance requirements for firmness and flexibility remains a crucial task within the field of implementation science.

BackgroundThe implementation of complex interventions is considered challenging, particularly in multi-site clinical trials and dynamic clinical settings. This study protocol is part of the family intensive care units (FICUS) hybrid effectiveness-implementation study. It aims to understand the integration of a multicomponent family support intervention in the real-world context of adult intensive care units (ICUs). Specifically, the study will assess implementation processes and outcomes of the study intervention, including fidelity, and will enable explanation of the clinical effectiveness outcomes of the trial.Methods and analysisThis mixed-methods multiple case study is guided by two implementation theories, the Normalisation Process Theory and the Consolidated Framework for Implementation Research. Participants are key clinical partners and healthcare professionals of eight ICUs allocated to the intervention group of the FICUS trial in the German-speaking part of Switzerland. Data will be collected at four timepoints over the 18-month active implementation and delivery phase using qualitative (small group interviews, observation, focus group interviews) and quantitative data collection methods (surveys, logs). Descriptive statistics and parametric and non-parametric tests will be used according to data distribution to analyse within and between cluster differences, similarities and factors associated with fidelity and the level of integration over time. Qualitative data will be analysed using a pragmatic rapid analysis approach and content analysis.Ethics and disseminationEthics approval was obtained from the Cantonal Ethics Committee of Zurich BASEC ID 2021-02300 (8 February 2022). Study 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 intervention to other healthcare contexts. Findings will be disseminated in peer-reviewed journals and conferences.Protocol registration numberOpen science framework (OSF) https://osf.io/8t2ud Registered on 21 December 2022.