Preventability of Infections in Residents of French Nursing Homes

Infection Control Clinical Trial

— ENLIL  

Official title:

Impact of a Multifaceted Intervention on the Preventability of Infections in Residents of French Nursing Homes: Cluster-randomised Controlled Trial (ENLIL Study)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01069497
• Other study ID #: V15
• Status: Active, not recruiting
• Phase: N/A
• First received: February 16, 2010
• Last updated: February 16, 2010
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: September 2009
• Source: Observatoire du Risque Infectieux en Gériatrie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: French Ministry of Education, Research and TechnologyFrance: Institutional Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3500
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Nursing homes where a prevention program has already been implemented

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Infection Control

Intervention

Other:
• Prevention of infections program
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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Observatoire du Risque Infectieux en Gériatrie	Gaba Laboratoires, Ministry of Health, France, Pierre Fabre Laboratories

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of infections (urinary, upper and lower respiratory and gastrointestinal) in elderly residents in nursing homes		every month	No
Secondary	Number of death		every month	No
Secondary	Number of hospitalizations		every month	No
Secondary	Number of of prescriptions for antimicrobials		every month	No