Israeli Judicious Antibiotic Prescription Study

Not Applicable

Completed

• Conditions: Carriage of Antibiotic Resistant Pathogens; Antibiotic Use
• Interventions: Behavioral: Workshops and focus group meetings

• Registration Number: NCT01187758
• Lead Sponsor: Sheba Medical Center

Brief Summary

This study aims to implement judicious antibiotic prescription habits to primary care pediatricians using a multifacet educational intervention and assess two main outcomes: 1) Direct outcome - prescription rates of the physicians. 2)Indirect outcome - carriage of antibiotic resistant bacteria by the treated population, specifically nasopharyngeal S. pneumoniae, nasal S. aureus and rectal E.coli.

Detailed Description

Background: Bacterial antibiotic resistance is an increasing problem.

Aims: This study aims to implement judicious antibiotic prescription habits among 30 physicians and their treated population as compared to a control group of 30 physicians and their treated population. The outcomes to be measured are:

1. Change in antibiotic prescriptions to the treated patients of the intervention vs. control physicians during the study period (4years).

2. Change in carriage of antibiotic resistant pathogens, specifically nasopharyngeal penicillin resistant S. pneumoniae,nasal MRSA, and rectal quinolone resistant E. coli.

Study design: All primary care pediatricians of Hashfela district of Macabbi Healthcare services who will agree to participate will be randomly assigned to an intervention or control group. The intervention group will be led by local leaders (primary care physicians from that district) and will take part in educational activities involving annual workshops and quarterly focus group meetings. The intervention is a multifacet intervention that will include guideline preparation, knowledge building, dealing with uncertainties, etc.

The patients of both intervention and control physicians will be screened twice a year for carriage of the bacteria mentioned above. Cross-sectional screening of the treated population will be carried in Summer and winter for 5 consecutive years. Screening will include signing an informed consent, filling a questionnaire and screening with nasal, nasopharyngeal and rectal swabs.

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2005-10
• Study Completion: 2007-12
• Status Verified: 2010-08
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-08-23
• Last Update Submitted: 2010-08-23
• Study First Posted: 2010-08-24
• Last Update Posted: 2010-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5700

Inclusion Criteria

• All treated patients of the participating physicians under the age of 5y, who came for any reason for a visit during the study period, who's parents agreed to participate.

Exclusion Criteria

The only reason to exclude a child from being recruited was age>5y or refusal of the parent/child to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational intervention	Workshops and focus group meetings	Multifacet educational intervention that includes workshops, seminars and focus group meetings

Primary Outcome Measures

Name	Time	Method
antibiotic prescription rate of physicians	5 years	Antibiotic prescrption rate at baseline will be compared to changes following the intervention between the 2 groups (control and intervention).

Secondary Outcome Measures

Name	Time	Method
Carriage of antibiotic resistant bacteria by treated patients	4 years	Every summer and winter a crosssectional survey of the treated patients of the control and intervention physicians will be carried out to determine the rate of carriage of penicillin-resistant S. pneumonaie, MRSA and Quinolone-resistant E.coli.