- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334795
Intermountain Stewardship in Community Outpatient Settings-Resources & Engagement-Pediatrics (SCORE-Peds)
The goal of this implementation project is to detail the process of implementing the best practice of antibiotic stewardship in the pediatric population across the Intermountain Health medical system. The main questions it aims to answer are:
- How can a large healthcare system drive high adherence to antibiotic stewardship across a large and diverse number of sites?
- How do determinants of implementation and needed strategies vary by context?
- What is the utility of a higher-resource implementation effort (named "Boost) focusing on outlier sites?
Data will be collected on number of children reached, adherence changes over time, types of implementation strategies employed, and characteristics of sites, prescribers, and patients.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Utah
-
Murray, Utah, United States, 84107
- Intermountain Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 6 months through 17 years
- ARTI diagnosis (acute otitis media (AOM), Group A Streptococcal (GAS) pharyngitis, acute sinusitis, and community-acquired pneumonia (CAP))
Exclusion Criteria:
- Age <6months or >18 years
- No ARTI diagnosis
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Children with ARTIs, Wave 1
Children under 18 treated in Wave 1 of antibiotic stewardship for the following conditions: acute otitis media (AOM), Group A Streptococcal (GAS) pharyngitis, acute sinusitis, and community-acquired pneumonia (CAP)
|
o facilitate improved adherence to guideline-based prescribing, we plan a variety of implementation strategies to be employed in tandem including training & education, EMR tools (e.g., Smart sets, express lanes, preference lists), audit and feedback reports and dashboards, and facilitation.
|
|
Children with ARTIs, Wave 2
Children under 18 treated in Wave 2 of antibiotic stewardship for the following conditions: acute otitis media (AOM), Group A Streptococcal (GAS) pharyngitis, acute sinusitis, and community-acquired pneumonia (CAP)
|
o facilitate improved adherence to guideline-based prescribing, we plan a variety of implementation strategies to be employed in tandem including training & education, EMR tools (e.g., Smart sets, express lanes, preference lists), audit and feedback reports and dashboards, and facilitation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Guideline-adherent Broad vs. Narrow Spectrum Antibiotic Prescribing
Time Frame: Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation.
|
Rates of narrow-spectrum antibiotic (AB) prescriptions as a proportion of all antibiotics prescribed in aggregate and within each of these diagnoses: Acute otitis media, Group A streptococcal pharyngitis, Acute sinusitis, and Pneumonia.
|
Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation.
|
|
Guideline-adherent Duration of Antimicrobial Therapy
Time Frame: Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation.
|
Rate of AB prescriptions with guideline-adherent number of days prescribed as proportion of all AB prescriptions in aggregate and for each of the target ARTI diagnoses.
|
Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of Treatment Failure
Time Frame: Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation
|
Clinical encounter for the same diagnosis between 2 and 14 days following the index encounter and receipt of an alternative antibiotic for the same respiratory diagnosis during the return visit.
|
Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation
|
|
Adoption (Staff): Adherence to Protocols
Time Frame: Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation
|
Number and proportion of prescribers who are "adherent" to guideline-based prescribing protocols for Broad vs. Narrow Spectrum AB Prescribing, and Duration.
|
Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation
|
|
Adoption (Organization): Adherence to Protocols
Time Frame: Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation.
|
Number and proportion of sites where 60% of prescribers are adherent.
|
Baseline month adherence and post implementation (12 months). Maintenance period is 6 months post implementation.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSII_IHC_IMP-PS2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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