Preventability of Infections in Residents of French Nursing Homes
ENLIL
Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)
1 other identifier
interventional
3,500
0 countries
N/A
Brief Summary
STUDY HYPOTHESIS : An infection prevention program adapted for the nursing home context can reduce by 5% the number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes. STUDY DESIGN : The proposal is for an interventional cluster (nursing home) study comprising 2 randomized groups: group 1 (interventional), comprising 25 nursing homes implementing a specific infection prevention program; and group 2 (control), 25 nursing homes continuing to implement their routine prevention measures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 16, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFebruary 17, 2010
September 1, 2009
5 months
February 16, 2010
February 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes
every month
Secondary Outcomes (3)
Number of death
every month
Number of hospitalizations
every month
Number of of prescriptions for antimicrobials
every month
Study Arms (2)
Intervention Nursing Homes
EXPERIMENTALComprising 24 nursing homes implementing a specific infection prevention program
Usual care Nursing Homes
NO INTERVENTIONInterventions
The intervention mainly involves implementing urinary, respiratory and gastrointestinal infection prevention measures. Study nursing home medical coordinators will be in charge of training their own teams. For this, they will be provided with: * a slide-show of recommendations (commented by an expert), * recommendations guides (on paper and on computer) to be shown to their teams. Means will be provided to the intervention nursing homes : Hydro-alcoholic solutions, disinfectant detergent-impregnated tissues, mouth care kits, tec.
Eligibility Criteria
You may qualify if:
- Nursing homes which contain a medical coordinator and at least one nurse and/or nursing auxiliary.
- Nursing Homes located in France (North-West)
- All the residents present or entering the facility during the study period
You may not qualify if:
- Nursing homes where a prevention program has already been implemented
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Observatoire du Risque Infectieux en Gériatrielead
- Ministry of Health, Francecollaborator
- Pierre Fabre Laboratoriescollaborator
- Gaba Laboratoriescollaborator
Related Publications (1)
Chami K, Gavazzi G, Bar-Hen A, Carrat F, de Wazieres B, Lejeune B, Armand N, Rainfray M, Hajjar J, Piette F, Rothan Tondeur M. A short-term, multicomponent infection control program in nursing homes: a cluster randomized controlled trial. J Am Med Dir Assoc. 2012 Jul;13(6):569.e9-17. doi: 10.1016/j.jamda.2012.04.008. Epub 2012 Jun 7.
PMID: 22682697DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monique Rothan Tondeur, PhD
ORIG, EHESP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 16, 2010
First Posted
February 17, 2010
Study Start
November 1, 2009
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 17, 2010
Record last verified: 2009-09