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Antimicrobial Stewardship for Primary Care Pediatricians (PARTI)

Primary Purpose

Acute Sinusitis, Streptococcal Pharyngitis, Pneumonia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antimicrobial Stewardship Bundle
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Sinusitis focused on measuring antimicrobial stewardship program, inappropriate prescribing of antibiotics, physician prescribing, antibiotic prescribing for respiratory tract infections, respiratory tract infections

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Antimicrobial Stewardship Bundle

Control

Arm Description

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.

Control sites will be within strata to maintain balance of treatment arm within strata

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2013
Last Updated
March 5, 2013
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT01806103
Brief Title
Antimicrobial Stewardship for Primary Care Pediatricians
Acronym
PARTI
Official Title
Reducing Inappropriate Prescribing of Antibiotics by Primary Care Clinicians
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Sinusitis, Streptococcal Pharyngitis, Pneumonia, Viral Infection
Keywords
antimicrobial stewardship program, inappropriate prescribing of antibiotics, physician prescribing, antibiotic prescribing for respiratory tract infections, respiratory tract infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antimicrobial Stewardship Bundle
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control sites will be within strata to maintain balance of treatment arm within strata
Intervention Type
Behavioral
Intervention Name(s)
Antimicrobial Stewardship Bundle
Intervention Description
Guidelines, Education, Audit and Feedback
Primary Outcome Measure Information:
Title
Reduction in the rate of broad-spectrum antibiotic prescribing for targeted conditions for which narrow-spectrum antibiotic therapy is indicated
Description
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.
Time Frame
from 20 months prior through 13 months post intervention
Secondary Outcome Measure Information:
Title
The rate of antibiotic prescribing for targeted conditions for which antibiotic therapy is not indicated
Description
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
Time Frame
from 20 months prior through 13 months post intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S Gerber, MD, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25317759
Citation
Gerber JS, Prasad PA, Fiks AG, Localio AR, Bell LM, Keren R, Zaoutis TE. Durability of benefits of an outpatient antimicrobial stewardship intervention after discontinuation of audit and feedback. JAMA. 2014 Dec 17;312(23):2569-70. doi: 10.1001/jama.2014.14042. No abstract available.
Results Reference
derived
PubMed Identifier
23757082
Citation
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.
Results Reference
derived

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Antimicrobial Stewardship for Primary Care Pediatricians

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