358 The Feedback Intervention Trial- a randomised controlled trial (RCT) to improve hand hygiene compliance in ITUs and acute elderly wards in 16 hospitals

Sunday, April 3, 2011: 8:45 AM
Chantilly Ballroom (Hilton Anatole)
Chris Fuller, RGN, MSc , University College London, London, England
Sheldon Stone, BSc, MD, FRCP , UCL Royal Free Campus, London, England
Joanne Savage, BSSc, MRes , University College London, London, England
Andre Charlett, PhD , Health Protection Agency, London, United Kingdom
Barry D. Cookson, FRCPath, FRCP , Health Protection Agency, London, England
Ben S. Cooper, BSc, MSc, PhD , Mahidol University Tropical Medicine Research Unit, Bangkok, Thailand
Andrew Hayward, FFPHM , University College London, London, England
Louise Teare, FRCPath , Mid-Essex NHS Trust, Chelmsford, United Kingdom
Susan Michie, PhD , University College London, London, England
John McAteer, MSc , University College London, London, England
Sarah Besser, MSc , Kings College London, London, England
Miranda Murray, PhD , Health Protection Agency, London, United Kingdom


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


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


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


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