Antibiotic Use in French Nursing Home

January 4, 2019 updated by: Monique ROTHAN-TONDEUR, University of Paris 13

Effect of a Nurse-centered Multimodal Intervention on Prescribing Antibiotics in Nursing Home: A Randomized Cluster Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • n/a

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotics prescription for UTI
Time Frame: Twelve months
The percentage of reduction in prescriptions of antibiotics for urinary tract infection
Twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total prescriptions of antibiotics
Time Frame: Twelve months
whatever the infection
Twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Paris 13

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 1, 2019

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

March 30, 2020

Study Registration Dates

First Submitted

June 1, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (ACTUAL)

June 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 4, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Prot_ATOUM4_V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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