Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
- Conditions
- Acute Otitis MediaCommunity-acquired PneumoniaPharyngitis
- Interventions
- Behavioral: Mixed methods intervention
- Registration Number
- NCT06027593
- Lead Sponsor
- Children's Hospital of Philadelphia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 511000
- Diagnosis of one of four conditions based on ICD-10 diagnostic codes.
Patient
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Prescribing Clinicians Mixed methods intervention 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.
- Primary Outcome Measures
Name Time Method Guideline-concordant antibiotic Use for CAP Up to 4 years Percentage of CAP encounters with guideline-concordant antibiotic use for both the duration and choice metrics.
Guideline-concordant antibiotic Use for adult pharyngitis Up to 4 years 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).
Guideline-concordant antibiotic Use for pediatric acute otitis media Up to 4 years 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).
- Secondary Outcome Measures
Name Time Method Guideline-concordant decision to not prescribe antibiotics for pediatric acute otitis media Up to 4 years Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for acute otitis media
Guideline-concordant decision to prescribe antibiotics for adult pharyngitis Up to 4 years Percentage of patients for which the decision to prescribe an antibiotic was correct.
Guideline-concordant decision to not prescribe antibiotics for adult pharyngitis Up to 4 years Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for adult pharyngitis
Guideline-concordant decision to prescribe antibiotics for pediatric acute otitis media Up to 4 years Percentage of patients for which the decision to prescribe an antibiotic was correct.
Guideline-concordant antibiotic choice Up to 4 years Percentage of patients who received guideline-concordant antibiotic choice for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media.
Guideline-concordant antibiotic duration Up to 4 years Percentage of patients who received guideline-concordant antibiotic duration for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media
Readmissions within 14 days of the index visit for CAP Up to 2 years Percentage of inpatients with CAP who are readmitted within 14 days of the index visit for the same or related condition.
Return to the emergency department Up to 2 years Percentage of patients who return to the emergency department within 14 days of discharge following hospitalization for CAP.
Return to the clinic Up to 2 years Percentage of patients who return for an outpatient visit within 7 days of being diagnosed with adult pharyngitis or pediatric acute otitis media.
New antibiotic prescription within 7 days of the index visit Up to 2 years Percentage of patients who receive a new antibiotic prescription within 7 days of the index visit.
Trial Locations
- Locations (2)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
University of Pennsylvania Health System
🇺🇸Philadelphia, Pennsylvania, United States