Israeli Judicious Antibiotic Prescription Study (IJAP)

This study has been completed.
Sponsor:
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01187758
First received: August 23, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted

August 23, 2010
August 23, 2010
February 2002
October 2005   (final data collection date for primary outcome measure)
antibiotic prescription rate of physicians [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Antibiotic prescrption rate at baseline will be compared to changes following the intervention between the 2 groups (control and intervention).
Same as current
No Changes Posted
Carriage of antibiotic resistant bacteria by treated patients [ Time Frame: 4 years ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Israeli Judicious Antibiotic Prescription Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Antibiotic Use
  • Carriage of Antibiotic Resistant Pathogens
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
  • Experimental: Educational intervention
    Multifacet educational intervention that includes workshops, seminars and focus group meetings
    Intervention: Behavioral: Workshops and focus group meetings
  • No Intervention: Control - no intervention
    This group did not have any intervention, but their population was screened for carriage of antibiotic resistant bacteria
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5700
December 2007
October 2005   (final data collection date for primary outcome measure)

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.

Both
up to 5 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01187758
SHEBA-01-2357-GRY-CTIL
No
Gili Regev-Yochay, Sheba medical Center
Sheba Medical Center
Maccabi Healthcare Services, Israel
Not Provided
Sheba Medical Center
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP