Plain English Summary
Background and study aims
Healthcare-associated infections (HCAI) are infections that are acquired as a result of health care. Studies have shown that in a wide variety of hospital and community settings, hand hygiene significantly reduces the number of HCAI. Despite this evidence, hand hygiene compliance amongst healthcare workers (HCWs) is poor, difficult to change, and any changes are difficult to sustain. Previous studies suggest that giving feedback to HCWs may be the most effective way to improve hand hygiene. In this study we tested whether a hand hygiene intervention would improve rates of hand hygiene compared to standard practice (i.e., the routine use of hand hygiene information).
Who can participate?
16 intensive therapy units (ITUs) & 44 acute care of the elderly (ACE) wards in 16 English/Welsh hospitals were recruited to the study.
What does the study involve?
Trusts were randomly allocated to carry out the hand hygiene intervention in blocks of two to four at five time points. By the end of the study all of the trusts had been allocated to the intervention. The intervention was carried out by an allocated ward coordinator who was generally a junior ward sister or infection control link nurse, and involved a repeating four-week cycle. In week 1 the hand hygiene of an individual Nurse/Health Care Assistant was observed for a 20-minute period. Immediate feedback was given after the period of observation, and where relevant, the person observed was helped to create an action plan to improve their behaviour. Week 2 was the same as week 1 except that a ‘non-nurse’ (doctor or other health care professional) was observed. In week 3 a ward area was observed for 20 minutes, recording the hand hygiene behaviour of all HCWs entering that area. Poor practice was documented but feedback was not given at the time. In week 4 the week 3 observations were fed back and action plans created at a ward meeting.
What are the possible benefits and risks of participating?
There was no risk involved for the patients on the wards as they all received routine hand hygiene practice before their ward entered the intervention and all wards were intended to enter the intervention although at different time points.
Where is the study run from?
University College London (UK).
When is the study starting and how long is it expected to run for?
October 2006 to August 2009.
Who is funding the study?
The Patient Safety Research Programme, the Royal Free Hospital Trustees and GOJO industries.
Who is the main contact?
Dr Sheldon Stone
s.stone@ucl.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
National Research Register N0256159318
Study information
Scientific title
The Feedback Intervention Trial (FIT) - improving hand hygiene compliance in UK healthcare workers: a stepped wedge cluster randomised controlled trial
Acronym
FIT
Study hypothesis
Null hypothesis:
Providing feedback to healthcare workers (HCWs) on their hand hygiene using a feedback intervention based on behavioural theory has no effect on hand hygiene compliance compared to standard practice.
Ethics approval
Multi-Centre Research Ethics Committee, Scotland B, January 2005, ref: 05/MRE10/2
Study design
Stepped wedge cluster randomised controlled multi centre trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please contact Mr Christopher Fuller, christopher.fuller@ucl.ac.uk to request a patient information sheet
Condition
Healthcare Associated Infection
Intervention
Computer generated stepped wedge randomisation. Hospitals aware only of own allocation. Hand hygiene observer blinded to allocation.
A theory-based, sustainable intervention was designed by two of the study researchers (Health Psychologists) following the MRC framework for complex interventions. The development phase involved identifying an appropriate theoretical framework and associated techniques to inform intervention design. Goal-setting, control and operant learning theories were identified, and the individual and group level behaviour change techniques of feedback, goals, action planning and contingent reward were selected.
The intervention was carried out by an allocated 'ward coordinator' who was generally a junior ward sister or infection control link nurse, and involved a repeating four-week cycle.
Week1: Hand hygiene observation of an individual Nurse/Health Care Assistant for a 20-minute period. Immediate feedback was given after the period of observation, and, for instances of non-compliance with hand hygiene, the person observed was helped to formulate an action plan to improve behaviour.
Week 2: As for week one except that a 'non-nurse' (doctor or other health care professional) was observed.
Week 3: Hand hygiene observation of a ward area for 20 minutes, recording the hand hygiene behaviour of all HCWs entering that area (group compliance). Poor practice was documented but feedback was not given at the time.
Week 4: The week 3 observations (group compliance) were fed back and action plans formulated at a ward meeting.
The effect of this intervention on hand hygiene compliance was compared with that of standard practice.
Standard practice involved implementation of the pragmatically designed national cleanyourhands campaign consisting of:
1. Bedside placement of alcohol hand rub
2. Posters and patient empowerment materials encouraging healthcare workers to clean their hands
3. Audit of hand hygiene compliance
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Hand hygiene compliance measured by covert direct observation by an observer blinded as to ward allocation or randomisation to the intervention.
Observation periods of one hour, every 6 weeks, using a previously tested Hand Hygiene Observation Tool (the HHOT).
Secondary outcome measures
Monthly soap and AHR procurement data (litres per bed day) were collected as a proxy measure of hand hygiene compliance for each of the study wards.
Data were collected either from hospital supplies departments or directly from NHS Supply Chain.
Data routinely collected by trusts for national mandatory reporting on healthcare associated infections (cases per 10,000 bed days) (Methicillin resistant-, and sensitive Staphylococcus aureus bacteraemias and Clostridium difficile infection. Data collected monthly for individual wards from hospital infection control teams).
Overall trial start date
01/10/2006
Overall trial end date
31/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Acute care of the elderly (ACE) or general medical wards and intensive therapy units (ITUs) in acute NHS trust hospitals across England and Wales. In each hospital, one ITU and a maximum of three acute care of the elderly wards were recruited. Sites recruited by requests posted on the "cleanyourhands campaign" website and by contacting infection control teams directly. Sites were eligible if they still wished to be involved after three or four site visits to gain the support of senior infection control team and management, ward managers, senior nurses and consultants, could offer the ITU and two or three acute care of the elderly wards as the clinical settings for the trial and were implementing the cleanyourhands campaign.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 wards (16 intensive therapy units (ITUs) & 44 acute care of the elderly (ACE) wards in 16 English/Welsh hospitals.
Participant exclusion criteria
Wards that do not meet the above inclusion criteria
Recruitment start date
01/10/2006
Recruitment end date
31/08/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
London
NW3 2PF
United Kingdom
Sponsor information
Organisation
University College London (UK)
Sponsor details
c/o Mr David Wilson
Research & Development
Maple House
Rosenheim Wing
25 Grafton Way
London
WC1E 6DB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NHS - National Patient Safety Agency - Patient Safety Research Programme (UK) ref: PS-029
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Royal Free Hospital Trustees (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
GOJO industries (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23110040
Publication citations
-
Results
Fuller C, Michie S, Savage J, McAteer J, Besser S, Charlett A, Hayward A, Cookson BD, Cooper BS, Duckworth G, Jeanes A, Roberts J, Teare L, Stone S, The Feedback Intervention Trial (FIT)--improving hand-hygiene compliance in UK healthcare workers: a stepped wedge cluster randomised controlled trial., PLoS ONE, 2012, 7, 10, e41617, doi: 10.1371/journal.pone.0041617.