Plain English Summary
Background and study aims
Healthcare-associated infections (HAIs) represent the leading preventable adverse event amongst hospitalised patients. Hand hygiene is considered the single most important measure to prevent HAIs.
Previous studies have shown that campaigns to promote hand hygiene must contain multiple elements (multimodal), but the relative importance of each component remains unclear. In addition, to achieve further improvement, new strategies might be required given that sustained improvement has rarely been achieved. Another important issue is the extent to which hand hygiene can prevent HAIs. In this study, we aim to assess the effectiveness of two different strategies (enhanced performance feedback and patient participation) to produce a sustained improvement in healthcare worker hand hygiene. In addition, we aim to test the impact of increased hand hygiene compliance on HAIs and refine the understanding of factors associated with hand hygiene behaviour.
Who can participate?
This study will take place at the University of Geneva Hospitals. All healthcare workers working in and patients admitted to wards in which the study is active will participate in the study.
What does the study involve?
After an initial baseline period, the intervention phase will continue for two years. Wards will be randomly allocated to one of three groups: 1) standard multimodal hand hygiene promotion, 2) standard hand hygiene promotion with additional enhanced performance feedback, or 3) standard hand hygiene promotion with additional enhanced performance feedback and patient participation.
What are the possible benefits and risks of participating?
The major benefit is the possibility of improved hand hygiene and therefore a lower risk of hospital-associated infection.
Where is the study run from?
The study will be conducted at the University of Geneva Hospitals, Geneva, Switzerland.
When is the study starting and how long is it expected to run for?
The active intervention phase of the study will run for two years from July 2010.
Who is funding the study?
This study in funded by a grant from the Swiss National Science Foundation.
Who is the main contact?
Dr Hugo Sax, hugo.sax@hcuge.ch
Professor Didier Pittet, didier.pittet@hcuge.ch
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
3200B0122324/1
Study information
Scientific title
Effectiveness of enhanced performance feedback and patient participation to improve hand hygiene amongst healthcare workers and reduce healthcare-associated infections: a cluster randomised controlled trial
Acronym
Study hypothesis
A statistically significant increase in hand hygiene compliance will occur in each of the interventional study arms, and that the increase will be greater in the arm receiving both interventions. We also hypothesise that the increase in hand hygiene compliance will lead to a decreased incidence of healthcare-associated infections (HAIs) and in a reduced transmission of multiresistant bacteria.
Ethics approval
Internal Medicine Ethics Committee (Comité départemental d'éthique de médecime interne et médecine départementale), 27/01/2010, ref: 09-299
Study design
Single-centre cluster-randomized controlled 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 use the contact details below to request a patient information sheet
Condition
Healthcare-associated infections
Intervention
The intervention phase will continue for 24 months. The intervention phase is preceded by a 15-month baseline phase. The level of randomization is the hospital ward.
Wards will be randomly allocated to one of three groups:
1. Standard multimodal hand hygiene promotion
2. Standard hand hygiene promotion with additional enhanced performance feedback
3. Standard hand hygiene promotion with additional enhanced performance feedback and patient participation
Enhanced performance feedback: comprised of immediate and systematic components. Following each observation session, hand hygiene observers provide immediate verbal and written feedback to the healthcare workers observed during that session. Systematic feedback is provided by emails and posters distributed at the end of each quarter of the intervention phase.
Patient participation: On admission, patients are informed about the indications for their own and for healthcare worker (HCW) hand hygiene, with particular emphasis on hand hygiene 'before patient contact'. They are provided with a 'welcome kit' consisting of a brochure and bottle of alcohol-based hand rub (ABHR). Finally, they are invited to ask HCWs that do not perform hand hygiene in front of them to do so, just as HCWs would remind them, the patient, to perform hand hygiene when indicated.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Overall hand hygiene compliance amongst healthcare workers measured by direct observation according to the WHO 'My 5 moments for hand hygiene' methodology.
Secondary outcome measures
1. Hand hygiene compliance before patient contact measured by direct observation according to the WHO My 5 Moments methodology
2. ABHR consumption
3. New methicillin-resistant Staphylococcus aureus (MRSA) colonization rate
4. New MRSA colonization incidence rate
5. MRSA clinical isolates
6. New colonization with extended-spectrum beta-lactamse (ESBL) producing bacteria
7. ESBL-producing clinical isolates
8. Clostridium difficile associated diarhoea (CDAD)
9. Primary bloodstream infection (BSI) incidence rate
10. Secondary blood stream infections (BSI) incidence rate
11. Prevalence of HAI
Overall trial start date
01/04/2009
Overall trial end date
30/06/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. For primary outcome and first secondary outcome: all healthcare workers in study wards
2. For other secondary outcomes: all patients admitted to study wards
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
8000 hospital admissions during the intervention phase
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/04/2009
Recruitment end date
30/06/2012
Locations
Countries of recruitment
Switzerland
Trial participating centre
Hôpitaux Universitaires de Genève
Genève
1211
Switzerland
Sponsor information
Organisation
University of Geneva Hospitals and Faculty of Medicine (Switzerland)
Sponsor details
24 rue du Général-Dufour
Geneva
1211
Switzerland
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Swiss National Science Foundation (Switzerland) (3200B0122324/1)
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
Switzerland
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
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27599874