Ignite Creation Date:
2024-05-06 @ 7:28 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06027593
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2023-08-14
Brief Title:
Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
Sponsor:
Childrens Hospital of Philadelphia
Organization:
Childrens Hospital of Philadelphia
Study Overview
Official Title:
Using Electronically Derived AutoMated RePOrts of Appropriate Antibiotic Use to Inform SteWardship IntERventions
Status:
COMPLETED
Status Verified Date:
2024-09
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 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
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
Detailed 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
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 Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 851400 | OTHER | University of Pennsylvania Institutional Review Board | None |
| 75D30121F00002 | OTHER_GRANT | None | None |
| 850722 | OTHER | None | None |