Background:
Implementation research is concerned with bridging the gap between evidence and practicethrough the study of methods to promote the uptake of research into routine practice. Goodquality evidence has been summarised into guideline recommendations to show that peri-operativefasting times could be considerably shorter than patients currently experience. Theobjective of this trial was to evaluate the effectiveness of three strategies for theimplementation of recommendations about peri-operative fasting.
Methods:
A pragmatic cluster randomised trial underpinned by the PARIHS framework was conductedduring 2006 to 2009 with a national sample of UK hospitals using time series with mixedmethods process evaluation and cost analysis. Hospitals were randomised to one of threeinterventions: standard dissemination (SD) of a guideline package, SD plus a web-basedresource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). Theprimary outcome was duration of fluid fast prior to induction of anaesthesia. Secondaryoutcomes included duration of food fast, patients’ experiences, and stakeholders’ experiencesof implementation, including influences. ANOVA was used to test differences over time andinterventions.
Results:
Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fastingobservations were recorded. No significant effect of the interventions was observed for eitherfluid or food fasting times. The effect size was 0.33 for the web-based intervention comparedto SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone.The process evaluation showed different types of impact, including changes to practices,policies, and attitudes. A rich picture of the implementation challenges emerged, includinginter-professional tensions and a lack of clarity for decision-making authority andresponsibility.
Conclusions:
This was a large, complex study and one of the first national randomised controlled trialsconducted within acute care in implementation research. The evidence base for fastingpractice was accepted by those participating in this study and the messages from it simple;however, implementation and practical challenges influenced the interventions’ impact. A setof conditions for implementation emerges from the findings of this study, which arepresented as theoretically transferable propositions that have international relevance.Trial registrationISRCTN18046709 – Peri-operative Implementation Study Evaluation (POISE)