Acute SinusitisPARTINCT01806103
Antimicrobial Stewardship for Primary Care Pediatricians
A study testing Antimicrobial Stewardship Bundle in people with Acute Sinusitis and Streptococcal Pharyngitis, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Sinusitis, Streptococcal Pharyngitis, Pneumonia
- What is being tested?
- Antimicrobial Stewardship Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2012
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary care pediatric practices within the CHOP Care Network
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Sinusitis, Streptococcal Pharyngitis, Pneumonia, Viral Infection
- Being tested
- Antimicrobial Stewardship Bundle
- Keywords
- antimicrobial stewardship program, inappropriate prescribing of antibiotics, physician prescribing, antibiotic prescribing for respiratory tract infections, respiratory tract infections
- Medical subject headings
- Pneumonia, Virus Diseases, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial Stewardship BundleBehavioural
Guidelines, Education, Audit and Feedback
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Antimicrobial Stewardship Bundle |
| Control | No intervention | Control sites will be within strata to maintain balance of treatment arm within strata |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: from 20 months prior through 13 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute SinusitisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey S Gerber, MD, PhD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806103
- Sponsor's protocol ID
- 09-007305
- Other IDs
- HHSA2900200710013
- Acronym
- PARTI
- Status last verified
- Mar 2013
- First submitted
- 4 Feb 2013
- Last updated
- 7 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25317759Gerber 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.
PubMed 23757082