Antimicrobial Stewardship for Primary Care Pediatricians (PARTI)

March 5, 2013 updated by: Children's Hospital of Philadelphia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • The Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Antimicrobial Stewardship Bundle
Guidelines, Education, Audit and Feedback
No Intervention: Control
Control sites will be within strata to maintain balance of treatment arm within strata

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (Estimate)

March 7, 2013

Study Record Updates

Last Update Posted (Estimate)

March 7, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09-007305
  • HHSA2900200710013 (Other Grant/Funding Number: AHRQ HHSA2900200710013)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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