Clinical trial NCT01806103: Antimicrobial Stewardship for Primary Care Pediatricians
Official title: Reducing Inappropriate Prescribing of Antibiotics by Primary Care Clinicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2013-03-07
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Reduction in the rate of broad-spectrum antibiotic prescribing for targeted conditions for which narrow-spectrum antibiotic therapy is indicated
timeFrame: from 20 months prior through 13 months post intervention
Secondary outcomes:
measure: The rate of antibiotic prescribing for targeted conditions for which antibiotic therapy is not indicated
timeFrame: from 20 months prior through 13 months post intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Jeffrey S Gerber, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.