Plain English Summary
Background and study aims
In nursing homes, the infectious risk for residents is high, making infection control using approaches such as hand hygiene (HH) a major issue. However, the effectiveness of HH to reduce the infectious risk in nursing home settings is not well documented and compliance with HH recommendations often remains low. The objective of this study is to investigate how HH may lower the risk of infections among nursing home residents.
Who can participate?
All residents and staff in the nursing homes participating in the study.
What does the study involve?
The participating nursing homes are randomly allocated to two groups. In the first group, standard infection control practices are used. In the other group, a bundle of interventions related to HH are implemented, including staff education, HH promotion and increased availability of hand-rub solution. Antibiotic prescriptions, as well as glove and hand-rub solution use, are monitored in all participating nursing homes over the study period.
What are the possible benefits and risks of participating?
Nursing homes from the intervention group will benefit from free access to hand-rub solution, as well as material for HH promotion and staff education. There are no risks to participating.
Where is the study run from?
Nursing homes in France run by the Korian group.
When is the study starting and how long is it expected to run for?
January 2014 to March 2015
Who is funding the study?
Funding was provided by Institute of Ageing Well Korian and Korian Medica (France)
Who is the main contact?
Laura Temime
laura.temime@cnam.fr
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Impact of a multifaceted intervention for hand-hygiene in nursing homes: a cluster randomized controlled trial.
Acronym
Study hypothesis
It is hypothesised that increasing compliance to hand hygiene recommendations among the staff and residents in nursing homes may lead to a reduction in the infectious risk for residents.
Ethics approval
No ethics approval required, as the study did not change patient care, include new drugs or medical devices or add any procedure for patients. In addition, no sensitive data was collected.
Study design
Clustered randomized controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Epidemics of acute respiratory infections and acute gastro-enteritis; hospitalizations; deaths
Intervention
Nursing homes are randomly assigned to the intervention or control arm.
1. Control arm: nursing home use standard infection control practices
2. Intervention arm: a multifaceted hand-hygiene intervention is implemented. The key elements of the multifaceted intervention are the following:
2.1. Increased availability of alcohol-based hand-rub for the staff as well as for residents and visitors
2.2. An educational program for the staff based on e-learning
2.3. The creation of a work group within each nursing home which will propose a list of local recommendations
2.4. A hand hygiene promotion campaign aimed at the staff, as well as at residents and visitors
Intervention type
Behavioural
Phase
Drug names
Primary outcome measures
1. Total number of cases of acute respiratory infections and acute gastro-enteritis that are reported to regional health agencies (ARS) in the context of clustered cases episodes
2. Episodes of clustered cases are defined as at least 5 cases over 4 days
Secondary outcome measures
1. Number of antibiotic prescriptions for 1000 resident-days (measured at 0, 6 and 12 months)
2. Mortality rate (measured at 0, 6 and 12 months)
3. Hospitalization rate (measured at 0, 6 and 12 months)
4. Hand hygiene compliance assessed by direct observation at 0, 6 and 12 months
Overall trial start date
01/01/2014
Overall trial end date
31/03/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. For the primary outcome: all residents in the participating nursing homes
2. For the secondary outcomes and the intervention: all residents and staff in the participating nursing homes
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
26 nursing homes (13 per arm), with an average of 80 residents per nursing home.
Participant exclusion criteria
Anyone not a resident or staff member in any of the participating nursing homes.
Recruitment start date
01/01/2014
Recruitment end date
01/03/2014
Locations
Countries of recruitment
France
Trial participating centre
Korian Les Jardins d'Alesia
187 bis Avenue du Maine
Paris
75014
France
Trial participating centre
Korian Hameau du Roy
16 Boulevard Saint-Antoine
Le Chesnay
78150
France
Trial participating centre
Korian L'Age Bleu
7 Grande Rue
Roubaix
59100
France
Trial participating centre
Korian La Goélette
34 Rue Surcouf
Équeurdreville-Hainneville
50120
France
Trial participating centre
Korian Reine Mathilde
4 Rue des Hauts Vents
Grainville-sur-Odon
14120
France
Trial participating centre
Korian Le Castelli
Rue des Lauriers
L'Huisserie
53970
France
Trial participating centre
Korian Les Meunières
Place Denfert Rochereau
Lunel
34402
France
Trial participating centre
Korian Les Blés d'or
Lieu dit La Mouline
Castelnau-de-Lévis
81150
France
Trial participating centre
Korian Mas de Lauze
17 Chemin du Puits de Louiset
Nîmes
30900
France
Trial participating centre
Korian Frontenac
Rue Diderot
Bram
11150
France
Trial participating centre
Korian Les Annabelles
1 Rue du Diapason
Lyon
69003
France
Trial participating centre
Korian L'Astrée
26-28 Rue de Molina
Saint-Etienne
42000
France
Trial participating centre
Korian Vill'alizé
2 Rue des Chenevières
Thise
25220
France
Trial participating centre
Korian Villa Victoria
Le Clos -Vincent
20 Rue du Dr Jean Vaquier
Noisy-le-Grand
93160
France
Trial participating centre
Korian Les Arcades
116 Avenue Daumesnil
Paris
75012
France
Trial participating centre
Korian Hauts de Jardy
1 Allée des Lauriers
Vaucresson
92420
France
Trial participating centre
Korian Au Fil du Temps
2 Rue de Condé
Meaux
77100
France
Trial participating centre
Korian Nymphéas Bleus
15 Avenue Pierre Mendès
Vernon
27200
France
Trial participating centre
Korian Le Jardin
121 Avenue des Martyrs de la Résistance
Rouen
76100
France
Trial participating centre
Korian Catalogne
18 Cours Lazare Escarguel
Perpignan
66000
France
Trial participating centre
Korian Lo Solelh
46 Avenue Enseigne Albertini
Béziers
34500
France
Trial participating centre
Korian Les Alpilles
Centre Urbain, Rue Hilaire Touche
Vitrolles
13127
France
Trial participating centre
Korian Les Parents
22 Rue Vandel
Marseille
13008
France
Trial participating centre
Korian Sorgentino
52 Rue Auguste Gal
Nice
06300
France
Trial participating centre
Korian Villa Janin
9 Rue du Treyve
Saint-Etienne
42000
France
Trial participating centre
Korian L'isle Verte
50 Rue de Mortillet
Grenoble
38000
France
Trial participating centre
Korian Villa d'Albon
13 Avenue Gambetta
Roanne
42300
France
Sponsor information
Organisation
National Conservatory of Arts and Crafts (Conservatoire National des Arts et Métiers)
Sponsor details
292 rue Saint-Martin
Paris
75003
France
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Institute of Ageing Well Korian (Institut du bien vieillir Korian)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Korian Medica
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to submit for publication at least one paper describing our study and its main results regarding the impact of the hand hygiene intervention that was implemented on hospitalization and mortality rates.
Intention to publish date
Participant level data
Not expected to be available
Results - basic reporting
Publication summary