The Feedback Intervention Trial (FIT) — Improving Hand-Hygiene Compliance in UK Healthcare Workers: A Stepped Wedge Cluster Randomised Controlled Trial

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

Impact of observing hand hygiene in practice and research: a methodological reconsideration

“…In these environments and perhaps more generally, direct observation should be questioned as the gold standard approach to hand hygiene audit. One of the most powerful arguments in favour of audit by direct observation, ability to intervene and correct poor practice in real time, appears to be rarely capitalised upon and there are only a few published examples 65 . Feedback is more often delayed while audit results are analysed while intervention at the point of care has the capacity to disrupt clinical practice and may be resented by staff as well as being impractical as it is likely to take place in front of patients.…”

“…There is also need to explore the most helpful and meaningful audit strategies and ensure they are in place. The way that audit is undertaken tends to drift over time 65 . In some organisations it is undertaken by managers, in others by infection prevention teams or local staff.…”

Applying psychological frameworks of behaviour change to improve healthcare worker hand hygiene: a systematic review

“…7 Following a baseline period, hospitals were randomized into the intervention every two months. The first component of the intervention was based on goal-setting and control theories.…”

“…Among studies examining theory-informed interventions, the most significant limitation was a lack of clear descriptions indicating how interventions were designed to address theoretical behavioural constructs. 7,11,13,15 Lack of adequate controls, unrepresentative HCW samples, and attrition also negatively influenced risk of bias and study quality. 7,11,13 The quality of included predictive studies was influenced by a lack of clear inclusion/exclusion criteria and unrepresentative samples.…”

Psychosocial determinants of self-reported hand hygiene behaviour: a survey comparing physicians and nurses in intensive care units

“…12 No intervention studies with explicit reference to psychological theories had been published until April 2011, 13 and recent trials have been limited to nurses 14,15 or are still underway. 16,17 Exploratory studies have tended to consider hand hygiene behaviour (HHB) as reasoned actions directly influenced by behavioural intentions.…”