NCT01107223

Brief Summary

Respiratory tract infections are the most common indication for antibiotic prescribing in primary care. Several studies have shown a strong relationship between antibiotic use and bacterial resistance. The aim of this trial was to assess the long-term effect of a continuous education program on general practitioners antibiotic prescribing behaviour. 170 physicians were included in this study. Physicians randomized in the education group attended a two days seminar focused on evidence-based guidelines on antibiotic use in respiratory tract infections. The intervention was limited at physicians level and did not target the patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2004

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2010

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 20, 2010

Completed
Last Updated

April 20, 2010

Status Verified

February 1, 2010

Enrollment Period

4.6 years

First QC Date

March 4, 2010

Last Update Submit

April 19, 2010

Conditions

Keywords

AntibioticPrescribing behaviourGuidelinesRespiratory tract infectionsNon-antibiotic prescription

Outcome Measures

Primary Outcomes (2)

  • Change in the percentage of prescriptions containing an antibiotic between control and intervention groups (seminar on the treatment of respiratory tract infections).

    All prescriptions written by all general practitioners enrolled in the study were extracted each year from the French National Health System database. All data were compared to 2004 (baseline). Education group GPs attended a two-day seminar presenting evidence-based guidelines on antibiotic prescription in respiratory tract infections. The change (compared to baseline) in the percentage of prescriptions containing an antibiotic (antibiotic prescription rates) was compared between control and intervention groups.

    Effect of the intervention 4 to 6 months after the educational training.

  • Change in the cost of antibiotic prescription between control and intervention groups (seminar on the treatment of respiratory tract infections).

    All prescriptions written by all general practitioners enrolled in the study were extracted each year from the French National Health System database. All data were compared to 2004 (baseline). Education group GPs attended a two-day seminar presenting evidence-based guidelines on antibiotic prescription in respiratory tract infections. The change (compared to baseline) in the cost of antibiotic prescription was compared between control and intervention groups.

    Effect of the intervention 4 to 6 months after the educational training.

Secondary Outcomes (6)

  • Long term antibiotic prescription rates

    Effect of the intervention 28 to 30 months after the educational training.

  • Long term antibiotic cost.

    Effect of the intervention 28 to 30 months after the educational training.

  • Symptomatic drug prescription rates

    Effect of the intervention 28 to 30 months after the educational training.

  • Symptomatic drug cost.

    Effect of the intervention 28 to 30 months after the educational training.

  • Effect of patient age.

    Effect of the intervention 28 to 30 months after the educational training.

  • +1 more secondary outcomes

Study Arms (2)

Training to antibiotic prescription

EXPERIMENTAL

Physicians randomized in the education group attended a two days seminar focussed on evidence-based guidelines on antibiotic use in respiratory tract infections.

Other: Experimental: Training to antibiotic prescription

control

PLACEBO COMPARATOR
Other: No education on antibiotic prescription rules.

Interventions

GPs assigned to the intervention group attended a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection.

Training to antibiotic prescription

GPs assigned to control group received no specific recommendations on antibiotic prescription.

control

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • General practitioners practicing in three departments of the Parisian area in France
  • General practitioners attending a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henri Mondor Hospital, department of general practice

Créteil, 94000, France

Location

Related Publications (1)

  • Ferrat E, Le Breton J, Guery E, Adeline F, Audureau E, Montagne O, Roudot-Thoraval F, Attali C, Le Corvoisier P, Renard V. Effects 4.5 years after an interactive GP educational seminar on antibiotic therapy for respiratory tract infections: a randomized controlled trial. Fam Pract. 2016 Apr;33(2):192-9. doi: 10.1093/fampra/cmv107. Epub 2016 Jan 21.

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Clause Attali, MD

    Henri Mondor University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 4, 2010

First Posted

April 20, 2010

Study Start

September 1, 2004

Primary Completion

April 1, 2009

Study Completion

April 1, 2010

Last Updated

April 20, 2010

Record last verified: 2010-02

Locations