Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-25 @ 11:22 PM
Study NCT ID:
NCT06027593
Status:
COMPLETED
Last Update Posted:
2025-11-14
First Post:
2023-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
Sponsor:
Children's Hospital of Philadelphia
Organization:
Study Overview
Official Title:
Using Electronically Derived AutoMated RePOrts of Appropriate Antibiotic Use to Inform SteWardship IntERventions
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EMPOWER
Brief 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; 2) pediatric inpatients with community-acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media.
1\) adult inpatients with community-acquired pneumonia; 2) pediatric inpatients with community-acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media.
Detailed Description:
Antibiotic stewardship 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 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 community-acquired pneumonia; pediatric inpatients with community-acquired pneumonia; adult outpatients with acute pharyngitis; and pediatric outpatients with acute otitis media. Methods were developed to generate automatic, routine reports to identify elements of inappropriate antibiotic use including; 1) the decision to initiate antibiotic therapy (pharyngitis and acute otitis media only); 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 antibiotic stewardship 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 data, including International Classification of Diseases version 10 codes, medications, laboratory data, co-morbid 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 antimicrobial stewardship feedback report-based intervention for these four conditions informed by a rapid user-centered design process.
3. Track the impact of the 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 electronic health record-based approaches hold the promise to greatly enhance the effectiveness and efficiency of antimicrobial stewardship initiatives.
The purpose of this project is to assess the impact of these developed electronic indicators on supporting antibiotic stewardship 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 data, including International Classification of Diseases version 10 codes, medications, laboratory data, co-morbid 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 antimicrobial stewardship feedback report-based intervention for these four conditions informed by a rapid user-centered design process.
3. Track the impact of the 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 electronic health record-based approaches hold the promise to greatly enhance the effectiveness and efficiency of antimicrobial stewardship initiatives.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: