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Clinical Trial Summary

The main goal of this study is to use automated electronic reports to assess and improve guideline-concordant antibiotic use for: 1) adult inpatients with community-acquired pneumonia (CAP); 2) pediatric inpatients with CAP; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media. There are two cohorts in this study: Patients with one of the aforementioned conditions who meet inclusion criteria, and the clinicians providing clinical care to these patients.


Clinical Trial Description

Antibiotic stewardship (AS) has been shown to improve patient outcomes, decrease adverse events, and decrease antibiotic resistance. This group of investigators previously partnered with collaborators at the Centers for Disease Control and Prevention (CDC) and conducted relevant pilot work in developing and validating electronic indicators of inappropriate antibiotic prescribing for 8 conditions, amongst which are the four conditions of interest in this study: adult inpatients with CAP; pediatric inpatients with CAP; adult outpatients with acute pharyngitis; and pediatric outpatients with acute pharyngitis). Methods were developed to generate automatic, routine reports to identify elements of inappropriate antibiotic use including; 1) the decision to initiate antibiotic therapy; 2) the choice of antibiotic agent; and 3) the duration of antibiotic use. The purpose of this project is to assess the impact of these developed electronic indicators on supporting AS efforts to improve the appropriateness of antibiotic use, as well as the acceptability and feasibility of delivering these reports to prescribers. The investigators aim to: 1. Refine and validate indicators of appropriate antibiotic use by utilizing Electronic Health Record (EHR) data, including International Classification of Diseases (ICD-10) codes, medications, laboratory data, comorbid medical conditions, site of care, clinical documentation, prior hospitalizations, and medication exposure. The researchers will validate the definitions of the various conditions and appropriateness captured electronically with a manual chart review of clinical documentation. 2. Implement a scalable and sustainable AS feedback report-based intervention for these four conditions informed by a rapid user-centered design process. 3. Track the impact of stewardship interventions and report to key stakeholders, including prescribers. 4. Create a publicly available toolkit based on the findings of this project that includes: (i) analytic tools and resources for using the automated reports of key indicators to target stewardship interventions and (ii) an implementation guide to inform the application of automated reports to stewardship in the inpatient and outpatient settings. If proven effective, these EHR-based approaches hold the promise to greatly enhance the effectiveness and efficiency of AS initiatives. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06027593
Study type Interventional
Source Children's Hospital of Philadelphia
Contact Kathleen Chiotos, MD, MSCE
Phone 215-590-5505
Email chiotosk@chop.edu
Status Recruiting
Phase N/A
Start date October 18, 2022
Completion date November 2025

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