Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions

Study Overview
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Brief Summary
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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
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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: 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. Implement a scalable and sustainable AS feedback report-based intervention for these four conditions informed by a rapid user-centered design process. Track the impact of stewardship interventions and report to key stakeholders, including prescribers. 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.

Official Title
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Using Electronically Derived AutoMated RePOrts of Appropriate Antibiotic Use to Inform SteWardship IntERventions

Conditions
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Community-acquired Pneumonia, Acute Otitis Media, Pharyngitis

Intervention / Treatment
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* Behavioral: Mixed methods intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prescribing Clinicians<br>During the pre-intervention period which will last up to approximately 24 months, investigators will retrospectively collect data on appropriate antibiotic prescribing for the conditions. In the post-intervention period of approximately 24 months, investigators will implement a provider-focused intervention, consisting of feedback reports to providers using the validated metrics of antibiotic prescribing. These measures are based on national guidelines for appropriate antibiotic prescribing. Following implementation of the intervention, the investigative team will collect the same measures. | Behavioral: Mixed methods intervention<br>* Investigators will implement the intervention at the completion of the rapid user-centered design process and consultation with CDC collaborators. During the rapid user-centered design process, the team will engage key stakeholders to create and optimize feedback reports that will fit the prescribing context, and determine appropriate implementation supports that will be needed to accompany the introduction of the feedback reports to each setting. Following the initial awareness-building activities, investigators will circulate the antibiotic prescribing feedback reports. After the first 3 months (approximately) of report dissemination, the team will assess the feasibility and acceptability of the reports and implementation activities by administering a brief survey to prescribers and also conducting interviews with them. No direct identifiers will be collected.<br>* Other names: Quasi experimental intervention;|
| No Intervention: Patients diagnosed with conditions of interest during study period<br>Interactions between investigators and patients will be limited to review of existing EHR data. Investigators will have no direct contact with patients. The data from the University of Pennsylvania Health System (UPHS) and Children's Hospital of Philadelphia (CHOP) will be extracted from data warehouses that store data from the electronic health record. These data will be used in feedback report generation as well as in outcome assessment. An estimated total of 10,000 inpatients with CAP (adult and pediatric) will be recruited. Similarly, about 500,000 patients (adult pharyngitis and pediatric acute otitis media combined) will be recruited in the outpatient setting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Guideline-concordant antibiotic Use for adult pharyngitis | This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice). | Up to 4 years | 
| Guideline-concordant antibiotic Use for pediatric acute otitis media | This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice). | Up to 4 years | 
| Guideline-concordant antibiotic Use for CAP | Percentage of CAP encounters with guideline-concordant antibiotic use for both the duration and choice metrics. | Up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Guideline-concordant decision to prescribe antibiotics for adult pharyngitis | Percentage of patients for which the decision to prescribe an antibiotic was correct. | Up to 4 years | 
| Guideline-concordant decision to not prescribe antibiotics for adult pharyngitis | Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for adult pharyngitis | Up to 4 years | 
| Guideline-concordant decision to prescribe antibiotics for pediatric acute otitis media | Percentage of patients for which the decision to prescribe an antibiotic was correct. | Up to 4 years | 
| Guideline-concordant decision to not prescribe antibiotics for pediatric acute otitis media | Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for acute otitis media | Up to 4 years | 
| Guideline-concordant antibiotic choice | Percentage of patients who received guideline-concordant antibiotic choice for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media. | Up to 4 years | 
| Guideline-concordant antibiotic duration | Percentage of patients who received guideline-concordant antibiotic duration for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media | Up to 4 years | 
| Return to the emergency department | Percentage of patients who return to the emergency department within 14 days of discharge following hospitalization for CAP. | Up to 2 years | 
| Return to the clinic | Percentage of patients who return for an outpatient visit within 7 days of being diagnosed with adult pharyngitis or pediatric acute otitis media. | Up to 2 years | 
| Readmissions within 14 days of the index visit for CAP | Percentage of inpatients with CAP who are readmitted within 14 days of the index visit for the same or related condition. | Up to 2 years | 
| New antibiotic prescription within 7 days of the index visit | Percentage of patients who receive a new antibiotic prescription within 7 days of the index visit. | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibiotic stewardship, Implementation Science, Antibiotic Use, Outpatient antibiotic prescribing, Inpatient antibiotic prescribing