A pragmatic cluster randomised trial evaluating three implementation interventions
1 Centre for Health Related Research, School of Healthcare Sciences, Bangor University, Ffriddoedd Road, Bangor, UK
2 RCN Research Institute, School of Health and Social Studies, Warwick University, Coventry, UK
3 Faculty of Health and Social Care, London South Bank University, London, UK
4 Cochrane Collaboration, Summertown Pavilion, Oxford, UK
5 National Clinical Guideline Centre (NCGC), Royal College of Physicians, St Andrews Place, London, UK
6 former President of the Royal College of Anaesthetists, London, UK
Implementation Science 2012, 7:80 doi:10.1186/1748-5908-7-80Published: 30 August 2012
Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting.
A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD) of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA). The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions.
Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to 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, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility.
This was a large, complex study and one of the first national randomised controlled trials conducted within acute care in implementation research. The evidence base for fasting practice was accepted by those participating in this study and the messages from it simple; however, implementation and practical challenges influenced the interventions’ impact. A set of conditions for implementation emerges from the findings of this study, which are presented as theoretically transferable propositions that have international relevance.
ISRCTN18046709 - Peri-operative Implementation Study Evaluation (POISE).