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Antibiotic Use in French Nursing Home

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ClinicalTrials.gov Identifier: NCT03180983
Recruitment Status : Not yet recruiting
First Posted : June 8, 2017
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Monique ROTHAN-TONDEUR, University of Paris 13

Brief Summary:

CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. However, it can most often be bacteriuria requiring no antibiotic therapy. In nursing home, nurses who alert prescribers when an infection is suspected by describing clinical signs.However, his propensity to perform too rapidly and systematically an examination with dipsticks leads the physician to prescribe antibiotic. This is how a program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The present ATOUM 4 study builds on this program.

OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a randomized double-arm interventional study in 40 nursing home. The intervention group of 20 nursing home will receive a blended-learning intervention.


Condition or disease Intervention/treatment Phase
Antibiotic Resistant Infection Behavioral: multimodal intervention Not Applicable

Detailed Description:

CONTEXT: France is still one of the biggest consumers of antibiotics in Europe. An explanation for this increase in consumption would be aging. Thus, part of this aging population lives in nursing home, where the urinary tract infection is the second most suspected pathology. However, it can most often be bacteriuria requiring no antibiotic therapy. In nursing home, nurses alert prescribers when an infection is suspected by describing clinical signs. However, their propensity to perform too rapidly and systematically an examination with dipsticks leads physicians to prescribe antibiotic. This is how a program called ATOUM is set up to reduce the prescription of antibiotics in nursing home. The present ATOUM 4 study builds on this program.

OBJECTIVE: To measure the effect of a nurse-centered multimodal intervention involving training and sensitization on urinary tract infection, asymptomatic bacteriuria, antibiotic resistance and interprofessional communication on antibiotic therapy. METHODS: This will be a randomized double-arm interventional study in 40 nursing home. The intervention group of 20 nursing home will receive a blended-learning intervention.The primary outcome will be the percentage of reduction in antibiotic prescription at the end of the twelve months following the first visit to nursing home. This data, aggregated by nursing home, will be obtained from the structures concerned via their prescription registration system.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: CLUSTER RANDOMIZED STUDY
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of a Nurse-centered Multimodal Intervention on Prescribing Antibiotics in Nursing Home: A Randomized Cluster Study
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
INTERVENTIONAL GROUP
The intervention group will receive a blended-learning intervention.
Behavioral: multimodal intervention
Investigators will propose an online training. In addition, investigators will make phone calls to nursing home interlocutor between two nursing home visits. The tools of this intervention will consist on posters , quiz about bacteriuria and urinary tract infection (UTI) and algorithm to help nurse's reasoning when UTI is suspected.

No Intervention: CONTROL GROUP
No intervention



Primary Outcome Measures :
  1. Antibiotics prescription for UTI [ Time Frame: Twelve months ]
    The percentage of reduction in prescriptions of antibiotics for urinary tract infection


Secondary Outcome Measures :
  1. Total prescriptions of antibiotics [ Time Frame: Twelve months ]
    whatever the infection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • nursing home with registred nursing
  • Presence of prescription registration system
  • Situated in Paris and surb of Paris

Exclusion Criteria:

  • n/a

Additional Information:
Publications:

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Responsible Party: Monique ROTHAN-TONDEUR, Head of nursing research chair, University of Paris 13
ClinicalTrials.gov Identifier: NCT03180983     History of Changes
Other Study ID Numbers: Prot_ATOUM4_V1
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anti-Bacterial Agents
Anti-Infective Agents