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Antimicrobial Stewardship for Primary Care Pediatricians (PARTI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01806103
First received: February 4, 2013
Last updated: March 5, 2013
Last verified: March 2013

February 4, 2013
March 5, 2013
June 2010
June 2011   (final data collection date for primary outcome measure)
Reduction in the rate of broad-spectrum antibiotic prescribing for targeted conditions for which narrow-spectrum antibiotic therapy is indicated [ Time Frame: from 20 months prior through 13 months post intervention ] [ Designated as safety issue: No ]
The primary outcome measure seeks to determine if the incorporation of treatment guidelines coupled with audit and feedback of physician prescribing can reduce the the rate of antibiotic prescribing for targeted conditions for which antibiotic therapy is not indicated.
Same as current
Complete list of historical versions of study NCT01806103 on ClinicalTrials.gov Archive Site
The rate of antibiotic prescribing for targeted conditions for which antibiotic therapy is not indicated [ Time Frame: from 20 months prior through 13 months post intervention ] [ Designated as safety issue: No ]
The secondary outcome measure seeks to determine the rate of broad-spectrum antibiotic prescribing for targeted conditions for which narrow-spectrum antibiotic therapy is indicated. Thus, two classes of diagnoses will be collected: 1) respiratory tract infections for which no antibiotics are indicated, represented by a group codes indicating common infections with presumed viral etiology and 2) bacterial respiratory tract infections for which narrow spectrum antibiotics are indicated
Same as current
Not Provided
Not Provided
 
Antimicrobial Stewardship for Primary Care Pediatricians
Reducing Inappropriate Prescribing of Antibiotics by Primary Care Clinicians

The purpose of the study is to determine if physician education coupled with audit and feedback of antibiotic prescribing can improve antibiotic prescribing by primary care clinicians.

Using a large, diverse pediatric primary care network sharing a comprehensive electronic health record (EHR), a cluster-randomized trial will be performed to determine the effectiveness of an outpatient antimicrobial stewardship bundle, including treatment guidelines coupled with audit and feedback of physician prescribing, to curb inappropriate antibiotic prescribing for respiratory tract infections.

Aim 1: To determine the impact of an outpatient antimicrobial stewardship bundle within a pediatric primary care network on antibiotic prescribing for conditions for which antibiotics are not indicated.

Hypothesis: Antimicrobial stewardship will decrease rates of antibiotic prescribing for conditions for which antibiotics are not indicated.

Aim 2: To determine the impact of an outpatient antimicrobial stewardship bundle within a pediatric primary care network on broad-spectrum antibiotic prescribing for conditions for which narrow-spectrum antibiotics are indicated.

Hypothesis: Antimicrobial stewardship will decrease the rate of broad-spectrum antibiotic prescribing for conditions for which narrow-spectrum antibiotics are indicated.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Sinusitis
  • Streptococcal Pharyngitis
  • Pneumonia
  • Viral Infection
Behavioral: Antimicrobial Stewardship Bundle
Guidelines, Education, Audit and Feedback
  • Experimental: Antimicrobial Stewardship Bundle
    An intervention "bundle" to reduce outpatient antibiotic use in children will include education, creation of and access to guidelines, and audit of and feedback on individual prescribing within the context of achievable benchmarks.
    Intervention: Behavioral: Antimicrobial Stewardship Bundle
  • No Intervention: Control
    Control sites will be within strata to maintain balance of treatment arm within strata
Gerber JS, Prasad PA, Fiks AG, Localio AR, Grundmeier RW, Bell LM, Wasserman RC, Keren R, Zaoutis TE. Effect of an outpatient antimicrobial stewardship intervention on broad-spectrum antibiotic prescribing by primary care pediatricians: a randomized trial. JAMA. 2013 Jun 12;309(22):2345-52. doi: 10.1001/jama.2013.6287.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
December 2012
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary care pediatric practices within the CHOP Care Network

Exclusion Criteria:

  • Academic primary care pediatric practices within the CHOP Care Network
  • Providers entering a practice after the start of the intervention
  • Providers with less than 25 antibiotic prescriptions in the 6 months prior to the start of the intervention
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01806103
09-007305, HHSA2900200710013
No
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Jeffrey S Gerber, MD, PhD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
March 2013

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