Background:
Systematic reviews of RCTs show feedback improves healthcare workers' (HCWs) implementation of evidence based guidelines. Effects are modest, as most trials don't use psychological theory to design interventions. Systematic review of hand hygiene interventions suggests feedback is successful but needs regular repetition; studies were small, shortlived & poorly designed. We performed a national 3 year RCT of a theoretically grounded feedback intervention to improve hand hygiene compliance
Objective: Null hypothesis was that feedback would be ineffective
Methods:
Trial Design: Stepped Wedge cluster RCT
Participants 60 wards (16 ITUs & 44 acute care of the elderly [ACE] wards in 16 English/Welsh hospitals (Oct 2006-Dec 2009)
Intervention Based on Goal & Control theories. Repeating 4 week cycle (20-30 mins/week) of observation, feedback & action planning, with HCWs & groups, recorded on forms.
Outcomes Primary- 6 weekly directly observed hand hygiene compliance (%); Secondary- monthly soap & alcohol hand rub (AHR) procurement (mls/bed day). Fidelity to intervention (forms used/month) & Confounders (staffing levels, skills mix, agency rates) measured
Randomisation Computer generated (www.randomizer.org) step wise entry of hospitals every 2 months
Blinding of hand hygiene observers to allocation
Results:
Nos.randomised; All 60 wards randomised. 33 wards implemented intervention (11 ITU, 22 ACE)
Nos. analysed: 60 including 8 wards closing during study
Recruitment Closed to follow up
Outcome: Mixed effects regression analysis, accounting for confounders & temporal trends
Intention to treat (ITT) analysis: estimated odds ratio (OR) for hand hygiene compliance rose post-randomisation (1.44; 95% CI 1.18, 1.76; p<0.001) in ITUs (Figure) but not ACE
Per protocol analysis for implementing wards: OR for compliance rose for both ACE wards (1.67 [1.28-2.22]; p<0.001) & ITUs (2.09 [1.55-2.81] p<0.001). OR fell for non-implementing wards fell (ACE) or was unchanged (ITU). Fidelity to intervention was closely related to compliance on ITUs (OR for compliance 1.12 [1.04, 1.20] p=0.003 per completed form)
ITT analysis for 20 outcome: a significant 31% (11-55%;p=0.003) relative increase in soap (but not AHR) procurement for ITUs only, with an effect of fidelity to intervention of a 12% (4-20%;p=0.003) rise per form
Conclusions:
Despite difficulties in implementation, both ITT & per protocol analyses showed a feedback intervention based on psychological theories improved hand hygiene compliance, with the effect increasing with fidelity to intervention, so that for any one month, the greater the adherence to the intervention, the higher the compliance. The effect was greater on ITU than ACE wards. A study of the predictors of fidelity is needed to improve implementation and thus maximise the effect of this feedback intervention in different settings