NCT01806103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

February 4, 2013

Last Update Submit

March 5, 2013

Conditions

Acute SinusitisStreptococcal PharyngitisPneumoniaViral Infection

Keywords

antimicrobial stewardship programinappropriate prescribing of antibioticsphysician prescribingantibiotic prescribing for respiratory tract infectionsrespiratory tract infections

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • The rate of antibiotic prescribing for targeted conditions for which antibiotic therapy is not indicated

    from 20 months prior through 13 months post intervention

Study Arms (2)

Antimicrobial Stewardship Bundle

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Antimicrobial Stewardship BundleBEHAVIORAL

Guidelines, Education, Audit and Feedback

Antimicrobial Stewardship Bundle

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Primary care pediatric practices within the CHOP Care Network

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (2)

  • 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.

    PMID: 25317759DERIVED

  • 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.

    PMID: 23757082DERIVED

MeSH Terms

Conditions

PneumoniaVirus DiseasesRespiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Jeffrey S Gerber, MD, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2013

First Posted

March 7, 2013

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

December 1, 2012

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(1)