Abstract
IntroductionAchieving a sustained improvement in hand-hygiene compliance is the WHO’s first global patient safety challenge. There is no RCT evidence showing how to do this. Systematic reviews suggest feedback is most effective and call for long term well designed RCTs, applying behavioural theory to intervention design to optimise effectiveness.MethodsThree year stepped wedge cluster RCT of a feedback intervention testing hypothesis that the intervention was more effective than routine practice in 16 English/Welsh Hospitals (16 Intensive Therapy Units [ITU]; 44 Acute Care of the Elderly [ACE] wards) routinely implementing a national cleanyourhands campaign). Intervention-based on Goal & Control theories. Repeating 4 week cycle (20 mins/week) of observation, feedback and personalised action planning, recorded on forms. Computer-generated stepwise entry of all hospitals to intervention. Hospitals aware only of own allocation. Primary outcome: direct blinded hand hygiene compliance (%).ResultsAll 16 trusts (60 wards) randomised, 33 wards implemented intervention (11 ITU, 22 ACE). Mixed effects regression analysis (all wards) accounting for confounders, temporal trends, ward type and fidelity to intervention (forms/month used).Intention to Treat AnalysisEstimated odds ratio (OR) for hand hygiene compliance rose post randomisation (1.44; 95% CI 1.18, 1.76;p<0.001) in ITUs but not ACE wards, equivalent to 7–9% absolute increase in compliance.Per-Protocol Analysis for Implementing WardsOR for compliance rose for both ACE (1.67 [1.28–2.22]; p<0.001) & ITUs (2.09 [1.55–2.81];p<0.001) equating to absolute increases of 10–13% and 13–18% respectively. Fidelity to intervention closely related to compliance on ITUs (OR 1.12 [1.04, 1.20];p = 0.003 per completed form) but not ACE wards.ConclusionDespite difficulties in implementation, intention-to-treat, per-protocol and fidelity to intervention, analyses showed an intervention coupling feedback to personalised action planning produced moderate but significant sustained improvements in hand-hygiene compliance, in wards implementing a national hand-hygiene campaign. Further implementation studies are needed to maximise the intervention’s effect in different settings.Trial RegistrationControlled-Trials.com ISRCTN65246961
Highlights
Achieving a sustained improvement in hand-hygiene compliance is the WHO’s first global patient safety challenge
Eight wards began implementation very late, and for these the end of the trial was extended to December 31st 2009 to ensure that they had a year of data collection post-implementation
Numbers Analysed For the primary outcome, intention-to-treat analysis was conducted for the 60 wards randomised into the intervention, and per-protocol analysis was performed for the 33 implementing wards
Summary
Achieving a sustained improvement in hand-hygiene compliance is the WHO’s first global patient safety challenge. There is substantial evidence from systematic reviews of randomised controlled trials, that feedback significantly improves healthcare workers’ compliance with other evidence-based guidelines [14,15] the improvement is modest, possibly due to the absence of behavioural theory to optimise intervention design [15,16]. Taken together, these reviews call for well-designed, long-term trials of a feedback intervention to improve hand-hygiene compliance, designed using behavioural theory
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