Abstract
BACKGROUND: Preventing falls in hospital is a perennial patient safety issue. The University Hospital Coventry and Warwickshire initiated a programme to train ward staff in accordance with guidelines. The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care West Midlands was asked to expedite an independent evaluation of the initiative. We set out to describe the intervention to implement the guidelines and to evaluate it by means of a step-wedge cluster study using routinely collected data. METHODS: The evaluation was set up as a partially randomised, step-wedge cluster study, but roll-out across wards was more rapid than planned. The study was therefore analysed as a time-series. Primary outcome was rate of falls per 1000 Occupied Bed Days (OBDs) collected monthly using routine data. Data was analysed using a mixed-effects Poisson regression model, with a fixed effect for intervention, time and post-intervention time. We allowed for random variations across clusters in initial fall rate, pre-intervention slope and post-intervention slope. RESULTS: There was an average of 6.62 falls per 1000 OBDs in the control phase, decreasing to an average of 5.89 falls per 1000 OBDs in the period after implementation to the study end. Regression models showed no significant step change in fall rates (IRR: 1.02, 95% CI: 0.92-1.14). However, there was a gradual decrease, of approximately 3%, after the intervention was introduced (IRR: 0.97 per month, 95% CI: 0.95-0.99). CONCLUSION: The intervention was associated with a small but statistically significantly improvement in falls rates. Expedited roll-out of an intervention may vitiate a step-wedge cluster design, but the intervention can still be studied using a time-series analysis. Assuming that there is some value in time series analyses, this is better than no evaluation at all. However, care is needed in making causal inferences given the non-experimental nature of the design.