Impact of a bundle of hand hygiene-related interventions in nursing homes on the infectious risk.
| ISRCTN | ISRCTN16474757 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16474757 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/07/2015
- Registration date
- 20/07/2015
- Last edited
- 24/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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
Contact information
Scientific
Laboratoire MESuRS
Conservatoire national des Arts et Métiers
292 rue Saint-Martin
Paris
75003
France
Study information
| Study design | Clustered randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Impact of a multifaceted intervention for hand-hygiene in nursing homes: a cluster randomized controlled trial. |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2014 |
| Completion date | 31/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 26 nursing homes (13 per arm), with an average of 80 residents per nursing home. |
| Key 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 |
| Key exclusion criteria | Anyone not a resident or staff member in any of the participating nursing homes. |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 01/03/2014 |
Locations
Countries of recruitment
- France
Study participating centres
Paris
75014
France
Le Chesnay
78150
France
Roubaix
59100
France
Équeurdreville-Hainneville
50120
France
Grainville-sur-Odon
14120
France
L'Huisserie
53970
France
Lunel
34402
France
Castelnau-de-Lévis
81150
France
Nîmes
30900
France
Bram
11150
France
Lyon
69003
France
Saint-Etienne
42000
France
Thise
25220
France
20 Rue du Dr Jean Vaquier
Noisy-le-Grand
93160
France
Paris
75012
France
Vaucresson
92420
France
Meaux
77100
France
Vernon
27200
France
Rouen
76100
France
Perpignan
66000
France
Béziers
34500
France
Vitrolles
13127
France
Marseille
13008
France
Nice
06300
France
Saint-Etienne
42000
France
Grenoble
38000
France
Roanne
42300
France
Sponsor information
University/education
292 rue Saint-Martin
Paris
75003
France
| Website | http://www.cnam.fr |
|---|---|
"ROR" |
https://ror.org/0175hh227 |
Funders
Funder type
Industry
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2018 | 24/07/2020 | Yes | No |
Editorial Notes
24/07/2020: Publication reference added.
