Clinical trial NCT06027593: Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
Official title: Using Electronically Derived AutoMated RePOrts of Appropriate Antibiotic Use to Inform SteWardship IntERventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Community-acquired Pneumonia
Acute Otitis Media
Pharyngitis
Keywords: Antibiotic stewardship
Implementation Science
Antibiotic Use
Outpatient antibiotic prescribing
Inpatient antibiotic prescribing
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Centers for Disease Control and Prevention
First posted: 2023-09-07
Enrollment: 26139
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Eligibility criteria: Patient Inclusion Criteria:

* Diagnosis of one of four conditions based on ICD-10 diagnostic codes.

Patient Exclusion Criteria:

* Presence of specific complex chronic conditions
* Use of immunocompromising medications
* Transfer from another health facility.

Clinician Inclusion Criteria:

* Prescribing clinicians (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) at one of the participating outpatient practices or inpatient units.
* Age ≥ 18 years old
* Employed by one of the participating sites

Clinician Exclusion Criteria:

* Volunteers or other non-employee hospital staff
* Limited English proficiency

Primary outcomes:
measure: Guideline-concordant antibiotic Use for adult pharyngitis
timeFrame: Up to 4 years
measure: Guideline-concordant antibiotic Use for pediatric acute otitis media
timeFrame: Up to 4 years
measure: Guideline-concordant antibiotic Use for CAP
timeFrame: Up to 4 years
Secondary outcomes:
measure: Guideline-concordant decision to prescribe antibiotics for adult pharyngitis
timeFrame: Up to 4 years
measure: Guideline-concordant decision to not prescribe antibiotics for adult pharyngitis
timeFrame: Up to 4 years
measure: Guideline-concordant decision to prescribe antibiotics for pediatric acute otitis media
timeFrame: Up to 4 years
measure: Guideline-concordant decision to not prescribe antibiotics for pediatric acute otitis media
timeFrame: Up to 4 years
measure: Guideline-concordant antibiotic choice
timeFrame: Up to 4 years
measure: Guideline-concordant antibiotic duration
timeFrame: Up to 4 years
measure: Return to the emergency department
timeFrame: Up to 2 years
measure: Return to the clinic
timeFrame: Up to 2 years
measure: Readmissions within 14 days of the index visit for CAP
timeFrame: Up to 2 years
measure: New antibiotic prescription within 7 days of the index visit
timeFrame: Up to 2 years
Other outcomes:
measure: Measure of feasibility of intervention
timeFrame: Up to 2 years
measure: Acceptability of intervention
timeFrame: Up to 2 years
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Ebbing Lautenbach, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
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