Israeli Judicious Antibiotic Prescription Study

NCT ID: NCT01187758

Last Updated: 2010-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2007-12-31

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.

Conditions

Antibiotic Use; Carriage of Antibiotic Resistant Pathogens

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Educational intervention

Multifacet educational intervention that includes workshops, seminars and focus group meetings

Group Type: EXPERIMENTAL

Workshops and focus group meetings

Intervention Type: BEHAVIORAL

Multifacet intervention that includes: Guideline preparation and implementation, preparing clinic campaign, improving knowledge about Ab resistance and diagnosis of respiratory infections

Control - no intervention

This group did not have any intervention, but their population was screened for carriage of antibiotic resistant bacteria

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maccabi Healthcare Services, Israel

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sheba medical Center

References

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.

Reference Type: DERIVED

PMID: 21653300 (View on PubMed)

Other Identifiers

SHEBA-01-2357-GRY-CTIL

Identifier Type: -

Identifier Source: org_study_id