Condition category
Infections and Infestations
Date applied
08/07/2015
Date assigned
20/07/2015
Last edited
24/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Laura Temime

ORCID ID

Contact details

Laboratoire MESuRS
Conservatoire national des Arts et Métiers
292 rue Saint-Martin
Paris
75003
France

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

http://www.cnam.fr

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

Publication citations

Additional files

Editorial Notes