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NCT01806103 Clinical Trial

Antimicrobial Stewardship for Primary Care Pediatricians

Pneumonia Clinical Trial

— PARTI  

Official title:
Reducing Inappropriate Prescribing of Antibiotics by Primary Care Clinicians

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01806103
Other study ID # 09-007305
Secondary ID HHSA290020071001
Status Completed
Phase N/A
First received February 4, 2013
Last updated March 5, 2013
Start date June 2010
Est. completion date December 2012

Study information
Verified date March 2013
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 170
Est. completion date December 2012
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Antimicrobial Stewardship Bundle
Guidelines, Education, Audit and Feedback

Locations
Country Name City State
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in the rate of broad-spectrum antibiotic prescribing for targeted conditions for which narrow-spectrum antibiotic therapy is indicated 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. from 20 months prior through 13 months post intervention No
Secondary The rate of antibiotic prescribing for targeted conditions for which antibiotic therapy is not indicated 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 from 20 months prior through 13 months post intervention No
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