Community-acquired PneumoniaEMPOWERNCT06027593
Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
A study testing Quasi experimental intervention in people with Community-acquired Pneumonia and Acute Otitis Media, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial 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; 2) pediatric inpatients with community-acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Community-acquired Pneumonia, Acute Otitis Media, Pharyngitis
- What is being tested?
- Quasi experimental intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26,139 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official 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:
- 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.
Read the 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:
- 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.
- Implement a scalable and sustainable antimicrobial stewardship feedback report-based intervention for these four conditions informed by a rapid user-centered design process.
- Track the impact of the 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 electronic health record-based approaches hold the promise to greatly enhance the effectiveness and efficiency of antimicrobial stewardship initiatives.
- Being tested
- Quasi experimental intervention
- Keywords
- Antibiotic stewardship, Implementation Science, Antibiotic Use, Outpatient antibiotic prescribing, Inpatient antibiotic prescribing
- Medical subject headings
- Community-Acquired Pneumonia, Otitis Media, Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quasi experimental interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Intervention: Patients diagnosed with conditions of interest during study period | No intervention | 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 |
| Post-Intervention: Patients diagnosed with conditions of interest during study period | Other | 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 Receives: Other: Quasi experimental intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guideline-concordant Antibiotic Use for Adults With Pharyngitis
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Use for Children With Acute Otitis Media
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Use for Adults With Community-acquired Pneumonia
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Use for Children With Community-acquired Pneumonia
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Secondary outcomes (20)
Guideline-concordant Antibiotic Choice for Adults Hospitalized With Community Acquired Pneumonia
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Duration for Adults Hospitalized With Community Acquired Pneumonia
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.
Measured: 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
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.
Measured: 30 days
30-day Readmissions for Community Acquired Pneumonia in Adults
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.
Measured: 30 days
Guideline-concordant Antibiotic Choice for Pediatric Community Acquired Pneumonia
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Duration for Pediatric Community Acquired Pneumonia
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.
Measured: 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
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.
Measured: 28 days
28-day Readmissions for Pediatric Community Acquired Pneumonia
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.
Measured: 28 days
Guideline-concordant Decision to Prescribe Antibiotics for Adult Pharyngitis
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Choice Adult Pharyngitis
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Duration for Adult Pharyngitis
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.
Measured: Pre-intervention and post-intervention, up to 2 years
30-day Pharyngitis Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Adults
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.
Measured: 30 days
30-day Deep Neck Space Infection Admission
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.
Measured: 30 days
Guideline-concordant Decision to Prescribe Antibiotics for Pediatric Acute Otitis Media
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Choice for Pediatric Acute Otitis Media
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Antibiotic Duration for Pediatric Acute Otitis Media
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.
Measured: Pre-intervention and post-intervention, up to 2 years
28-day Acute Otitis Media-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care)
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.
Measured: 28 days
28-day Mastoiditis or Intracranial Infection Admissions
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.
Measured: 28 days
Guideline-concordant Decision to Not Prescribe Antibiotics for Pediatric Acute Otitis Media
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Guideline-concordant Decision to Not Prescribe Antibiotics for Adult Pharyngitis
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.
Measured: Pre-intervention and post-intervention, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2023
- Study start18 Oct 2022
- Primary completion30 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental study measuring the impact of an antibiotic stewardship intervention consisting of clinician education and audit and feedback reports on antibiotic use for adult inpatients with community acquired pneumonia, pediatric inpatients with community acquired pneumonia, adult outpatients with acute pharyngitis, and pediatric outpatients with acute otitis media.
- Masking
- None (open label)
- Enrolment
- 26,139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Ebbing Lautenbach, MD, MSCE, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06027593
- Sponsor's protocol ID
- 22-019749
- Other IDs
- 75D30121F00002, 850722, 851400
- Acronym
- EMPOWER
- Status last verified
- Oct 2025
- First submitted
- 14 Aug 2023
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study was initiated prior to the NIH Data Management and Sharing Policy update that was released on January 25, 2023.
Publications
Gerber JS, Newland JG, Coffin SE, Hall M, Thurm C, Prasad PA, Feudtner C, Zaoutis TE. Variability in antibiotic use at children's hospitals. Pediatrics. 2010 Dec;126(6):1067-73. doi: 10.1542/peds.2010-1275. Epub 2010 Nov 15.
PubMed 21078728Polk RE, Hohmann SF, Medvedev S, Ibrahim O. Benchmarking risk-adjusted adult antibacterial drug use in 70 US academic medical center hospitals. Clin Infect Dis. 2011 Dec;53(11):1100-10. doi: 10.1093/cid/cir672. Epub 2011 Oct 13.
PubMed 21998281Roberts RM, Hicks LA, Bartoces M. Variation in US outpatient antibiotic prescribing quality measures according to health plan and geography. Am J Manag Care. 2016 Aug;22(8):519-23.
PubMed 27541698Hicks LA, Bartoces MG, Roberts RM, Suda KJ, Hunkler RJ, Taylor TH Jr, Schrag SJ. US outpatient antibiotic prescribing variation according to geography, patient population, and provider specialty in 2011. Clin Infect Dis. 2015 May 1;60(9):1308-16. doi: 10.1093/cid/civ076. Epub 2015 Mar 5.
PubMed 25747410Barnett ML, Linder JA. Antibiotic prescribing for adults with acute bronchitis in the United States, 1996-2010. JAMA. 2014 May 21;311(19):2020-2. doi: 10.1001/jama.2013.286141. No abstract available.
PubMed 24846041Barnett ML, Linder JA. Antibiotic prescribing to adults with sore throat in the United States, 1997-2010. JAMA Intern Med. 2014 Jan;174(1):138-40. doi: 10.1001/jamainternmed.2013.11673. No abstract available.
PubMed 24091806Fairlie T, Shapiro DJ, Hersh AL, Hicks LA. National trends in visit rates and antibiotic prescribing for adults with acute sinusitis. Arch Intern Med. 2012 Oct 22;172(19):1513-4. doi: 10.1001/archinternmed.2012.4089. No abstract available.
PubMed 23007315Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, Lynfield R, Margolis DJ, May LS, Merenstein D, Metlay JP, Newland JG, Piccirillo JF, Roberts RM, Sanchez GV, Suda KJ, Thomas A, Woo TM, Zetts RM, Hicks LA. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73. doi: 10.1001/jama.2016.4151.
PubMed 27139059Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, Huskins WC, Paterson DL, Fishman NO, Carpenter CF, Brennan PJ, Billeter M, Hooton TM; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.
PubMed 17173212Gerber JS, Grundmeier R, Hamilton KW, Hicks L, Neuhauser M, Frager N, Menon M, Kratz E, Jaskowiak A, Cressman L, James T, Omorogbe J, Lautenbach E. Development of an Electronic Algorithm to Identify Inappropriate Antibiotic Prescribing for Pediatric Pharyngitis. Infection Control and Hospital Epidemiology. 2020;41 (S1):S188-189
Gerber JS, Grundmeier R, Hamilton KW, Hicks L, Neuhauser M, Frager N, Menon M, Kratz E, Jaskowiak A, Cressman L, James T, Omorogbe J, Lautenbach E. An Electronic Algorithm to Better Target Antimicrobial Stewardship Program (ASP) Efforts for Children Hospitalized with Community-Acquired Pneumonia (CAP). Open Forum Infectious Diseases. 2020;7 (S1):S85-86
Lautenbach E, Hamilton KW, Grundmeier R, Neuhauser MM, Hicks LA, Jaskowiak-Barr A, Cressman L, James T, Omorogbe J, Frager N, Menon M, Kratz E, Dutcher L, Chiotos K, Gerber JS. Development of an Electronic Algorithm to Target Outpatient Antimicrobial Stewardship Efforts for Acute Bronchitis and Pharyngitis. Open Forum Infect Dis. 2022 Jun 6;9(7):ofac273. doi: 10.1093/ofid/ofac273. eCollection 2022 Jul.
PubMed 35854991Lautenbach E, Hamilton KH, Grundmeier R, Neuhauser M, Hicks L, Jaskowiak A, Cressman L, James T, Omorogbe J, Frager N, Menon M, Kratz E, Gerber JS. Construction of an Electronic Algorithm to Efficiently Target Antimicrobial Stewardship Efforts for Adults Hospitalized with Community-acquired Pneumonia. Open Forum Infectious Diseases. 2020;7 (S1):S175-176
Meeker D, Linder JA, Fox CR, Friedberg MW, Persell SD, Goldstein NJ, Knight TK, Hay JW, Doctor JN. Effect of Behavioral Interventions on Inappropriate Antibiotic Prescribing Among Primary Care Practices: A Randomized Clinical Trial. JAMA. 2016 Feb 9;315(6):562-70. doi: 10.1001/jama.2016.0275.
PubMed 26864410Charani E, Ahmad R, Rawson TM, Castro-Sanchez E, Tarrant C, Holmes AH. The Differences in Antibiotic Decision-making Between Acute Surgical and Acute Medical Teams: An Ethnographic Study of Culture and Team Dynamics. Clin Infect Dis. 2019 Jun 18;69(1):12-20. doi: 10.1093/cid/ciy844.
PubMed 30445453
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Electronically Derived AutoMated RePOrts of Appropriate Antibiotic Use to Inform SteWardship IntERventions
- ClinicalTrials.gov ID
- NCT06027593
- Acronym / sponsor ID
- EMPOWER / 22-019749
- Keywords
- Antibiotic stewardship, Implementation Science, Antibiotic Use, Outpatient antibiotic prescribing, Inpatient antibiotic prescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26,139 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Centers for Disease Control and Prevention
- Study start
- 18 Oct 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 7 Sep 2023 (actual)
- Results
- Posted 14 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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; 2) pediatric inpatients with community-acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media.
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:
- 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.
- Implement a scalable and sustainable antimicrobial stewardship feedback report-based intervention for these four conditions informed by a rapid user-centered design process.
- Track the impact of the 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 electronic health record-based approaches hold the promise to greatly enhance the effectiveness and efficiency of antimicrobial stewardship initiatives.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasi-experimental study measuring the impact of an antibiotic stewardship intervention consisting of clinician education and audit and feedback reports on antibiotic use for adult inpatients with community acquired pneumonia, pediatric inpatients with community acquired pneumonia, adult outpatients with acute pharyngitis, and pediatric outpatients with acute otitis media.
| Arm | Type | Receives |
|---|---|---|
| Pre-Intervention: Patients diagnosed with conditions of interest during study period | No intervention | –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 |
| Post-Intervention: Patients diagnosed with conditions of interest during study period | Other | Other: Quasi experimental interventionFour 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quasi experimental interventionThe 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. | Other | Post-Intervention: Patients diagnosed with conditions of interest during study period |
Primary outcome
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.
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.
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.
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.
20 secondary outcomes
Guideline-concordant Antibiotic Choice for Adults Hospitalized With Community Acquired Pneumonia
Time frame: 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
30-day Community Acquired Pneumonia-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Adults
Time frame: 30 days
30-day Readmissions for Community Acquired Pneumonia in Adults
Time frame: 30 days
Guideline-concordant Antibiotic Choice for Pediatric Community Acquired Pneumonia
Time frame: 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
28-day Community Acquired Pneumonia-related Outpatient Revisits (Emergency Department, Urgent Care, or Primary Care) in Children
Time frame: 28 days
28-day Readmissions for Pediatric Community Acquired Pneumonia
Time frame: 28 days
Guideline-concordant Decision to Prescribe Antibiotics for Adult Pharyngitis
Time frame: 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
Guideline-concordant Antibiotic Duration for Adult Pharyngitis
Time frame: 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
30-day Deep Neck Space Infection Admission
Time frame: 30 days
Guideline-concordant Decision to Prescribe Antibiotics for Pediatric Acute Otitis Media
Time frame: 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
Guideline-concordant Antibiotic Duration for Pediatric Acute Otitis Media
Time frame: 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
28-day Mastoiditis or Intracranial Infection Admissions
Time frame: 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
Guideline-concordant Decision to Not Prescribe Antibiotics for Adult Pharyngitis
Time frame: Pre-intervention and post-intervention, up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21078728Gerber JS, Newland JG, Coffin SE, Hall M, Thurm C, Prasad PA, Feudtner C, Zaoutis TE. Variability in antibiotic use at children's hospitals. Pediatrics. 2010 Dec;126(6):1067-73. doi: 10.1542/peds.2010-1275. Epub 2010 Nov 15.
- Background: PubMed 21998281Polk RE, Hohmann SF, Medvedev S, Ibrahim O. Benchmarking risk-adjusted adult antibacterial drug use in 70 US academic medical center hospitals. Clin Infect Dis. 2011 Dec;53(11):1100-10. doi: 10.1093/cid/cir672. Epub 2011 Oct 13.
- Background: PubMed 27541698Roberts RM, Hicks LA, Bartoces M. Variation in US outpatient antibiotic prescribing quality measures according to health plan and geography. Am J Manag Care. 2016 Aug;22(8):519-23.
- Background: PubMed 25747410Hicks LA, Bartoces MG, Roberts RM, Suda KJ, Hunkler RJ, Taylor TH Jr, Schrag SJ. US outpatient antibiotic prescribing variation according to geography, patient population, and provider specialty in 2011. Clin Infect Dis. 2015 May 1;60(9):1308-16. doi: 10.1093/cid/civ076. Epub 2015 Mar 5.
- Background: PubMed 24846041Barnett ML, Linder JA. Antibiotic prescribing for adults with acute bronchitis in the United States, 1996-2010. JAMA. 2014 May 21;311(19):2020-2. doi: 10.1001/jama.2013.286141. No abstract available.
- Background: PubMed 24091806Barnett ML, Linder JA. Antibiotic prescribing to adults with sore throat in the United States, 1997-2010. JAMA Intern Med. 2014 Jan;174(1):138-40. doi: 10.1001/jamainternmed.2013.11673. No abstract available.
- Background: PubMed 23007315Fairlie T, Shapiro DJ, Hersh AL, Hicks LA. National trends in visit rates and antibiotic prescribing for adults with acute sinusitis. Arch Intern Med. 2012 Oct 22;172(19):1513-4. doi: 10.1001/archinternmed.2012.4089. No abstract available.
- Background: PubMed 27139059Fleming-Dutra KE, Hersh AL, Shapiro DJ, Bartoces M, Enns EA, File TM Jr, Finkelstein JA, Gerber JS, Hyun DY, Linder JA, Lynfield R, Margolis DJ, May LS, Merenstein D, Metlay JP, Newland JG, Piccirillo JF, Roberts RM, Sanchez GV, Suda KJ, Thomas A, Woo TM, Zetts RM, Hicks LA. Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011. JAMA. 2016 May 3;315(17):1864-73. doi: 10.1001/jama.2016.4151.
- Background: PubMed 17173212Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, Huskins WC, Paterson DL, Fishman NO, Carpenter CF, Brennan PJ, Billeter M, Hooton TM; Infectious Diseases Society of America; Society for Healthcare Epidemiology of America. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for developing an institutional program to enhance antimicrobial stewardship. Clin Infect Dis. 2007 Jan 15;44(2):159-77. doi: 10.1086/510393. Epub 2006 Dec 13. No abstract available.
- BackgroundGerber JS, Grundmeier R, Hamilton KW, Hicks L, Neuhauser M, Frager N, Menon M, Kratz E, Jaskowiak A, Cressman L, James T, Omorogbe J, Lautenbach E. Development of an Electronic Algorithm to Identify Inappropriate Antibiotic Prescribing for Pediatric Pharyngitis. Infection Control and Hospital Epidemiology. 2020;41 (S1):S188-189
- BackgroundGerber JS, Grundmeier R, Hamilton KW, Hicks L, Neuhauser M, Frager N, Menon M, Kratz E, Jaskowiak A, Cressman L, James T, Omorogbe J, Lautenbach E. An Electronic Algorithm to Better Target Antimicrobial Stewardship Program (ASP) Efforts for Children Hospitalized with Community-Acquired Pneumonia (CAP). Open Forum Infectious Diseases. 2020;7 (S1):S85-86
- Background: PubMed 35854991Lautenbach E, Hamilton KW, Grundmeier R, Neuhauser MM, Hicks LA, Jaskowiak-Barr A, Cressman L, James T, Omorogbe J, Frager N, Menon M, Kratz E, Dutcher L, Chiotos K, Gerber JS. Development of an Electronic Algorithm to Target Outpatient Antimicrobial Stewardship Efforts for Acute Bronchitis and Pharyngitis. Open Forum Infect Dis. 2022 Jun 6;9(7):ofac273. doi: 10.1093/ofid/ofac273. eCollection 2022 Jul.
- Individual participant dataSharing planned: No. This study was initiated prior to the NIH Data Management and Sharing Policy update that was released on January 25, 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ebbing Lautenbach, MD, MSCE principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quasi experimental intervention in people with Community-acquired Pneumonia and Acute Otitis Media, run by Children's Hospital of Philadelphia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Guideline-concordant Antibiotic Use for Adults With Pharyngitis (time frame: Pre-intervention and post-intervention, up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06027593, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.