Condition category
Infections and Infestations
Date applied
27/03/2012
Date assigned
30/04/2012
Last edited
08/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Didier Pittet

ORCID ID

Contact details

Service Prévention et Contrôle de l'Infection
Hôpitaux Universitaires de Genève
Rue Gabrielle-Perret-Gentil 4
Genève
1211
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

3200B0–122324/1

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 measures

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

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

http://www.unige.ch/medecine/index.html

Funders

Funder type

Government

Funder name

Swiss National Science Foundation (Switzerland) (3200B0–122324/1)

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

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

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27599874

Publication citations

Additional files

Editorial Notes

08/09/2016: Publication reference added.