However, there was marked variation in rates of recruitment between sites, and the longest component of the diagnostic pathway remained time from hospital admission to test initiation, resulting in an overall time from hospital admission to genomic result of 17.5 days (95% CI 14.6–21.1) 19. A high degree of consistency was achieved between the clinical and laboratory sites, with little variability in the duration of each step of the diagnostic pathway (time from hospital admission to test initiation, consent, sample transport, or reporting). This highly coordinated clinical and laboratory program in a public healthcare system delivered laboratory reports with a mean time of 3.3 calendar days (95% CI: 3.2–3.5), with a diagnostic yield of 51%. We used the CFIR to design a collaborative multi-site network, the Australian Genomics Acute Care program, to deliver ultra-rapid genomic testing across 12 tertiary hospitals and two laboratories in Australia 19. However, there is limited application of implementation science findings into “real life” adoption of clinical genomics in practice. The CFIR has been used in the genomics context 15 to describe contextual factors influencing uptake, for example, identifying key drivers needed for sustainable clinical genomic programs 16, system-level barriers 17 and challenges and strategies for implementation 18. 1), the CFIR covers: (i) Intervention characteristics, e.g., evidence strength and quality (ii) Outer setting, e.g., economic, political and social context (iii) Inner setting, e.g., culture and context of the organization (iv) Characteristics of individuals, e.g., personal traits and belief about capabilities (v) Process, e.g., planning and reflection 14. Formed from five domains with 39 underlying constructs (Fig. Such hybrid study designs may be used alongside frameworks such as the Consolidated Framework for Implementation Research (CFIR) 14, which facilitates systematized understanding of the influences on the implementation process and can be used to inform implementation strategies. Employing a hybrid design from the outset allows a structured approach to early identification of implementation strategies to match the specific clinical context 12, 13, while the evidence base for clinical efficacy continues to grow. To overcome this impasse, effectiveness-implementation hybrid study designs 11 can be used to evaluate processes and outcomes simultaneously, thereby reducing time to translation of findings into clinical practice. Although it is recognized that implementation science principles can be used to cultivate a learning healthcare system 7, expediate spread and scaling up of innovation and provide a framework for iterative learning, aiding replication, and planning 8, 9, there are concerns that the limited application of such frameworks is hampering efforts to integrate genomics into healthcare 10. Despite growing evidence of efficacy, implementation to date has been mostly limited to single academic centers, and most of the reported outcomes have been restricted to diagnostic yield and clinical utility 2, 3, 4, 5, 6. Rapid genomic diagnosis can influence the management of critically ill infants and children with genetic conditions 1. Our findings demonstrate where common approaches can be used and, significantly, where there is a need to tailor support by professional role and implementation phase, to maximize the potential of ultra-rapid genomic testing to improve patient care. The relative advantage of ultra-rapid genomics and trust in consistent and transparent delivery were significant in creating engagement at initial implementation, with appropriate resourcing highlighted as important for longer term sustainability of implementation. Although clinical geneticists focused on intervention characteristics and the fit with patient-centered care, intensivists emphasized the importance of access to knowledge, in particular from clinical geneticists. Interviews with key professionals revealed the importance of networks and relationship building, leadership, culture, and the relative advantage afforded by ultra-rapid genomics in the care of critically ill children. In scaling up an ultra-rapid genomics program, we used implementation science principles to design and investigate influences on implementation and identify strategies required for sustainable “real-world” services.
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