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

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Recruiting

CT.gov ID

NCT06027593

Collaborator

University of Pennsylvania (Other), Centers for Disease Control and Prevention (U.S. Fed)

511,000

Enrollment

Locations

Arms

36.5

Anticipated Duration (Months)

255500

Patients Per Site

7006.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main goal of this study is to use automated electronic reports to assess and improve guideline-concordant antibiotic use for:

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.

Condition or Disease	Intervention/Treatment	Phase
Community-acquired Pneumonia Acute Otitis Media Pharyngitis	Behavioral: Mixed methods intervention	N/A

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:

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

511000 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 18, 2022

Anticipated Primary Completion Date :

Nov 1, 2024

Anticipated Study Completion Date :

Nov 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Prescribing Clinicians 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 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. Other Names: Quasi experimental intervention
No Intervention: Patients diagnosed with conditions of interest during study period 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.

Arm

Intervention/Treatment

Other: Prescribing Clinicians

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

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.

Other Names:

Quasi experimental intervention

No Intervention: Patients diagnosed with conditions of interest during study period

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.

Outcome Measures

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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 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 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
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.
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.
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.

Other Outcome Measures

Measure of feasibility of intervention [Up to 2 years]
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.
Acceptability of intervention [Up to 2 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania	United States	19104
2	University of Pennsylvania Health System	Philadelphia	Pennsylvania	United States	19104