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

October 29, 2025 updated by: Children's Hospital of Philadelphia

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; 2) pediatric inpatients with community-acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media.

Study Overview

Detailed Description

Antibiotic stewardship 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 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 community-acquired pneumonia; pediatric inpatients with community-acquired pneumonia; adult outpatients with acute pharyngitis; and pediatric outpatients with acute otitis media. Methods were developed to generate automatic, routine reports to identify elements of inappropriate antibiotic use including; 1) the decision to initiate antibiotic therapy (pharyngitis and acute otitis media only); 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 antibiotic stewardship 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 data, including International Classification of Diseases version 10 codes, medications, laboratory data, co-morbid 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 antimicrobial stewardship feedback report-based intervention for these four conditions informed by a rapid user-centered design process.
  3. Track the impact of the 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 electronic health record-based approaches hold the promise to greatly enhance the effectiveness and efficiency of antimicrobial stewardship initiatives.

Study Type

Interventional

Enrollment (Actual)

26139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-Intervention: Patients diagnosed with conditions of interest during study period
Four population groups were included in the pre-intervention data: 1) adult inpatients with community acquired pneumonia; 2) pediatric inpatients with community acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media
Other: Post-Intervention: Patients diagnosed with conditions of interest during study period
Four population groups were included in the post-intervention data: 1) adult inpatients with community acquired pneumonia; 2) pediatric inpatients with community acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media
The intervention included clinician education and sharing of audit and feedback reports summarizing antibiotic use metrics for each of the four target conditions with treating clinicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guideline-concordant Antibiotic Use for Adults With Pharyngitis
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with pharyngitis with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with pharyngitis with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with pharyngitis to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Use for Children With Acute Otitis Media
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with acute otitis media with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with acute otitis media with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with pediatric acute otitis media who were prescribed antibiotics to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Use for Adults With Community-acquired Pneumonia
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Use for Children With Community-acquired Pneumonia
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic choice, and antibiotic duration). The count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for all three metrics was divided by the total number of participants with pediatric community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for all three metrics. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Guideline-concordant Antibiotic Choice for Adults Hospitalized With Community Acquired Pneumonia
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for antibiotic choice. The count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for this metric was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic choice. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Duration for Adults Hospitalized With Community Acquired Pneumonia
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for antibiotic duration. The count of participants with community-acquired pneumonia with guideline-concordant antibiotic use for this metric was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic duration. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
30-day Community Acquired Pneumonia-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Adults
Time Frame: 30 days
Count of participants with community-acquired pneumonia with a return visit in the outpatient setting (emergency department, urgent care, or primary care) for community acquired pneumonia within 30 days of discharge following index hospitalization for adult community acquired pneumonia. The count of participants with community-acquired pneumonia with a return visit in the outpatient setting was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants with a return visit in the outpatient setting.
30 days
30-day Readmissions for Community Acquired Pneumonia in Adults
Time Frame: 30 days
Count of participants with a readmission for community-acquired pneumonia within 30 days of discharge following an index hospitalization for community-acquired pneumonia. The count of participants with a readmission for community-acquired pneumonia was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants with readmissions within 30 days of discharge following an index hospitalization for community-acquired pneumonia.
30 days
Guideline-concordant Antibiotic Choice for Pediatric Community Acquired Pneumonia
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for antibiotic choice. The count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pediatric community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic choice. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Duration for Pediatric Community Acquired Pneumonia
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for antibiotic duration. The count of participants with pediatric community-acquired pneumonia with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pediatric community-acquired pneumonia to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic duration. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
28-day Community Acquired Pneumonia-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Children
Time Frame: 28 days
Count of participants with pediatric community-acquired pneumonia with a return visit in the outpatient setting (emergency department, urgent care, or primary care) for pediatric community acquired pneumonia within 28 days of discharge following index hospitalization for pediatric community acquired pneumonia. The count of participants with pediatric community-acquired pneumonia with a return visit in the outpatient setting was divided by the total number of participants with pediatric community-acquired pneumonia to generate the percentage of participants with a return visit in the outpatient setting.
28 days
28-day Readmissions for Pediatric Community Acquired Pneumonia
Time Frame: 28 days
Count of participants with a readmission for community-acquired pneumonia within 28 days of discharge following an index hospitalization for community-acquired pneumonia. The count of participants with a readmission for community-acquired pneumonia was divided by the total number of participants with community-acquired pneumonia to generate the percentage of participants with readmissions within 28 days of discharge following an index hospitalization for community-acquired pneumonia.
28 days
Guideline-concordant Decision to Prescribe Antibiotics for Adult Pharyngitis
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with pharyngitis for which the decision to prescribe an antibiotic was correct. The count of participants with pharyngitis for which the decision to prescribe an antibiotic was correct was divided by the total number of participants with pharyngitis to generate the percentage of participants for which the decision to prescribe an antibiotic was correct. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Choice Adult Pharyngitis
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with adult pharyngitis with guideline-concordant antibiotic use for antibiotic choice. The count of participants with pharyngitis with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pharyngitis to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic choice. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Duration for Adult Pharyngitis
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with adult pharyngitis with guideline-concordant antibiotic use for antibiotic duration. The count of participants with pharyngitis with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pharyngitis to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic duration. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
30-day Pharyngitis Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Adults
Time Frame: 30 days
Count of participants with adult pharyngitis with a return visit in the outpatient setting (emergency department, urgent care, or primary care) for pharyngitis within 30 days of discharge following index hospitalization for adult pharyngitis. The count of participants with pharyngitis with a return visit in the outpatient setting was divided by the total number of participants with pharyngitis to generate the percentage of participants with a return visit in the outpatient setting.
30 days
30-day Deep Neck Space Infection Admission
Time Frame: 30 days
Count of participants with a readmission for deep neck space infection within 30 days of index encounter for pharyngitis. The count of participants with a readmission for deep neck space infection was divided by the total number of participants with adult pharyngitis to generate the percentage of participants with readmissions for deep neck space infection within 30 days of index encounter for pharyngitis.
30 days
Guideline-concordant Decision to Prescribe Antibiotics for Pediatric Acute Otitis Media
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with pediatric acute otitis media for which the decision to prescribe an antibiotic was correct. The count of participants with pediatric acute otitis media for which the decision to prescribe an antibiotic was correct was divided by the total number of participants with pediatric acute otitis media to generate the percentage of participants for which the decision to prescribe an antibiotic was correct. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Choice for Pediatric Acute Otitis Media
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with pediatric acute otitis media with guideline-concordant antibiotic use for antibiotic choice. The count of participants with pediatric acute otitis media visits with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pediatric acute otitis media who were prescribed antibiotics to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic choice. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Duration for Pediatric Acute Otitis Media
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with pediatric acute otitis media with guideline-concordant antibiotic use for antibiotic duration. The count of participants with pediatric acute otitis media with guideline-concordant antibiotic use for this metric was divided by the total number of participants with pediatric acute otitis media who were prescribed antibiotics to generate the percentage of participants receiving guideline-concordant antibiotic use for antibiotic duration. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
28-day Acute Otitis Media-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care)
Time Frame: 28 days
Count of participants with pediatric acute otitis media with a return visit in the outpatient setting (emergency department, urgent care, or primary care) for pediatric acute otitis media within 28 days of the index acute otitis media encounter. The count of participants with pediatric acute otitis media with a return visit in the outpatient setting was divided by the total number of participants with pediatric acute otitis media to generate the percentage of participants with a return visit in the outpatient setting.
28 days
28-day Mastoiditis or Intracranial Infection Admissions
Time Frame: 28 days
Count of participants with a readmission for mastoiditis or intracranial infection within 28 days of the index encounter for pediatric acute otitis media. The count of participants with a readmission for mastoiditis or intracranial infection was divided by the total number of participants with pediatric acute otitis media to generate the percentage of participants with readmissions within 28 days of discharge following an index hospitalization for acute otitis media.
28 days
Guideline-concordant Decision to Not Prescribe Antibiotics for Pediatric Acute Otitis Media
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with pediatric acute otitis media with guideline-concordant antibiotic use for appropriate decision not to prescribe antibiotics. The count of participants with pediatric acute otitis media with an appropriate decision not to prescribe antibiotics was divided by the total number of participants with no antibiotics prescribed to generate the percentage of participants appropriately not prescribed antibiotics for acute otitis media. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Decision to Not Prescribe Antibiotics for Adult Pharyngitis
Time Frame: Pre-intervention and post-intervention, up to 2 years
Count of participants with adult pharyngitis with guideline-concordant antibiotic use for appropriate decision not to prescribe antibiotics. The count of participants with adult pharyngitis with an appropriate decision not to prescribe antibiotics was divided by the total number of participants with no antibiotics prescribed to generate the percentage of participants appropriately not prescribed antibiotics for pharyngitis. These proportions were compared for the group of participants in the pre intervention period (1 year) and the post intervention period (1 year). There were not individual participant level measures for this outcome.
Pre-intervention and post-intervention, up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention - Outpatient
Time Frame: One time measure in the post intervention time period
Feasibility is defined as the extent to which the intervention can be carried out in the clinical setting. The feasibility of intervention measure is the full name of this scale. The feasibility of intervention scale consists of four questions, each with 5 possible responses (completely disagree, disagree, neither agree or disagree, agree, or completely agree) on a numeric 1-5 scale. These four subscores are summed to generate a total score, with possible scores ranging from 4-20. A higher score indicates that the intervention is more feasible. There are no validated cutoffs for feasibility. The mean total score and standard deviation of the mean total score for all respondents are reported. The feasibility of intervention measure was assessed by a one time survey in the post-intervention time period.
One time measure in the post intervention time period
Acceptability of Intervention - Outpatient
Time Frame: One time measure in the post intervention time period
Acceptability is defined as how well the intervention was received by the prescribing clinicians. The acceptability of intervention measure is the full name of this scale. The acceptability of intervention scale consists of four questions, each with 5 possible responses (completely disagree, disagree, neither agree or disagree, agree, or completely agree) on a numeric 1-5 scale. These four subscores are summed to generate a total score, with possible scores ranging from 4-20. A higher score indicates that the intervention is more acceptable. There are no validated cutoffs for acceptability. The mean total score and standard deviation of the mean total score for all respondents are reported. The acceptability of intervention measure was assessed by a one time survey in the post-intervention time period.
One time measure in the post intervention time period
Feasibility of Intervention Measure - Inpatient
Time Frame: One time measure in the post intervention time period
Feasibility is defined as the extent to which the intervention can be carried out in the clinical setting. The feasibility of intervention measure is the full name of this scale. The feasibility of intervention scale consists of four questions, each with 5 possible responses (completely disagree, disagree, neither agree or disagree, agree, or completely agree) on a numeric 1-5 scale. These four subscores are summed to generate a total score, with possible scores ranging from 4-20. A higher score indicates that the intervention is more feasible. There are no validated cutoffs for feasibility. The mean total score and standard deviation of the mean total score for all respondents are reported. The feasibility of intervention measure was assessed by a one time survey in the post-intervention time period.
One time measure in the post intervention time period
Acceptability of Intervention Measure - Inpatient
Time Frame: One time measure in the post intervention time period.
Acceptability is defined as how well the intervention was received by the prescribing clinicians. The acceptability of intervention measure is the full name of this scale. The acceptability of intervention scale consists of four questions, each with 5 possible responses (completely disagree, disagree, neither agree or disagree, agree, or completely agree) on a numeric 1-5 scale. These four subscores are summed to generate a total score, with possible scores ranging from 4-20. A higher score indicates that the intervention is more acceptable. There are no validated cutoffs for acceptability. The mean total score and standard deviation of the mean total score for all respondents are reported. The acceptability of intervention measure was assessed by a one time survey in the post-intervention time period.
One time measure in the post intervention time period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ebbing Lautenbach, MD, MSCE, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

August 14, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

October 29, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 22-019749
  • 75D30121F00002 (Other Grant/Funding Number: Centers for Disease Control and Prevention)
  • 850722 (Other Identifier: University of Pennsylvania Institutional Review Board)
  • 851400 (Other Identifier: University of Pennsylvania Institutional Review Board)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study was initiated prior to the NIH Data Management and Sharing Policy update that was released on January 25, 2023.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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