Israeli Judicious Antibiotic Prescription Study (IJAP)

Can Change in Physicians' Prescribing Habits Decrease Carriage of Resistant Bacteria in the Community?

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.

Study Overview

• Status: Completed
• Conditions: Antibiotic Use; Carriage of Antibiotic Resistant Pathogens
• Intervention / Treatment: Behavioral: Workshops and focus group meetings

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 Type: Interventional
• Enrollment (Actual): 5700
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Educational intervention; Multifacet educational intervention that includes workshops, seminars and focus group meetings	Behavioral: Workshops and focus group meetings; Multifacet intervention that includes: Guideline preparation and implementation, preparing clinic campaign, improving knowledge about Ab resistance and diagnosis of respiratory infections
No Intervention: Control - no intervention; This group did not have any intervention, but their population was screened for carriage of antibiotic resistant bacteria

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carriage of antibiotic resistant bacteria by treated patients	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.	4 years

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Collaborators: Maccabi Healthcare Services, Israel

Publications and helpful links

General Publications

• Regev-Yochay G, Raz M, Dagan R, Roizin H, Morag B, Hetman S, Ringel S, Ben-Israel N, Varon M, Somekh E, Rubinstein E. Reduction in antibiotic use following a cluster randomized controlled multifaceted intervention: the Israeli judicious antibiotic prescription study. Clin Infect Dis. 2011 Jul 1;53(1):33-41. doi: 10.1093/cid/cir272.

Study record dates

Study Major Dates

• Study Start: February 1, 2002
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: August 23, 2010
• First Submitted That Met QC Criteria: August 23, 2010
• First Posted (Estimate): August 24, 2010

Study Record Updates

• Last Update Posted (Estimate): August 24, 2010
• Last Update Submitted That Met QC Criteria: August 23, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: MRSA; antibiotic prescription; antibiotic use; antibiotic resistant S. pneumoniae
• Other Study ID Numbers: SHEBA-01-2357-GRY-CTIL