Community-acquired Pneumonia Clinical Trial
— EMPOWEROfficial title:
Using Electronically Derived AutoMated RePOrts of Appropriate Antibiotic Use to Inform SteWardship IntERventions
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.
Status | Recruiting |
Enrollment | 511000 |
Est. completion date | November 2025 |
Est. primary completion date | November 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | University of Pennsylvania Health System | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Children's Hospital of Philadelphia | Centers for Disease Control and Prevention, University of Pennsylvania |
United States,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Measure of feasibility of intervention | Feasibility, the extent to which the intervention can be carried out in the clinical setting, will be determined in collaboration with our local stakeholders but may include the proportion of clinicians who attend educational sessions and/or unit-based meetings during which antibiotic use data is reviewed. | Up to 2 years | |
Other | Acceptability of intervention | Acceptability, how well the intervention was received by the prescribing clinicians will be measured during surveys and structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree. | Up to 2 years | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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