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
  Purpose

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.


Condition Intervention
Acute Sinusitis
Streptococcal Pharyngitis
Pneumonia
Viral Infection
Behavioral: Antimicrobial Stewardship Bundle

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reducing Inappropriate Prescribing of Antibiotics by Primary Care Clinicians

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 170
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806103

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Jeffrey S Gerber, MD, PhD Children's Hospital of Philadelphia
  More Information

No publications provided by Children's Hospital of Philadelphia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01806103     History of Changes
Other Study ID Numbers: 09-007305, HHSA2900200710013
Study First Received: February 4, 2013
Last Updated: March 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
antimicrobial stewardship program
inappropriate prescribing of antibiotics
physician prescribing
antibiotic prescribing for respiratory tract infections
respiratory tract infections

Additional relevant MeSH terms:
Pharyngitis
Pneumonia
Sinusitis
Virus Diseases
Acute Disease
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Lung Diseases
Paranasal Sinus Diseases
Nose Diseases
Disease Attributes
Pathologic Processes
Anti-Infective Agents
Anti-Bacterial Agents
Antibiotics, Antitubercular
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 24, 2014