NCT06027593

Brief Summary

The main goal of this study is to use automated electronic reports to assess and improve guideline-concordant antibiotic use for: 1\) adult inpatients with community-acquired pneumonia; 2) pediatric inpatients with community-acquired pneumonia; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,139

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 14, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 14, 2025

Completed
Last Updated

November 14, 2025

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

August 14, 2023

Results QC Date

June 26, 2025

Last Update Submit

October 29, 2025

Conditions

Keywords

Antibiotic stewardshipImplementation ScienceAntibiotic UseOutpatient antibiotic prescribingInpatient antibiotic prescribing

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Pre-intervention and post-intervention, up to 2 years

Secondary Outcomes (20)

  • Guideline-concordant Antibiotic Choice for Adults Hospitalized With Community Acquired Pneumonia

    Pre-intervention and post-intervention, up to 2 years

  • Guideline-concordant Antibiotic Duration for Adults Hospitalized With Community Acquired Pneumonia

    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

    30 days

  • 30-day Readmissions for Community Acquired Pneumonia in Adults

    30 days

  • Guideline-concordant Antibiotic Choice for Pediatric Community Acquired Pneumonia

    Pre-intervention and post-intervention, up to 2 years

  • +15 more secondary outcomes

Other Outcomes (4)

  • Feasibility of Intervention - Outpatient

    One time measure in the post intervention time period

  • Acceptability of Intervention - Outpatient

    One time measure in the post intervention time period

  • Feasibility of Intervention Measure - Inpatient

    One time measure in the post intervention time period

  • +1 more other outcomes

Study Arms (2)

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

Other: Quasi experimental intervention

Interventions

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.

Post-Intervention: Patients diagnosed with conditions of interest during study period

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of one of four conditions based on ICD-10 diagnostic codes.

You may not qualify if:

  • Presence of specific complex chronic conditions
  • Use of immunocompromising medications
  • Transfer from another health facility.
  • 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
  • Volunteers or other non-employee hospital staff
  • Limited English proficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (22)

  • 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.

    PMID: 21078728BACKGROUND
  • Polk 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.

    PMID: 21998281BACKGROUND
  • Roberts 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.

    PMID: 27541698BACKGROUND
  • Hicks 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.

    PMID: 25747410BACKGROUND
  • Barnett 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.

    PMID: 24846041BACKGROUND
  • Barnett 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.

    PMID: 24091806BACKGROUND
  • Fairlie 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.

    PMID: 23007315BACKGROUND
  • Fleming-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.

    PMID: 27139059BACKGROUND
  • Dellit 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.

    PMID: 17173212BACKGROUND
  • 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. Development of an Electronic Algorithm to Identify Inappropriate Antibiotic Prescribing for Pediatric Pharyngitis. Infection Control and Hospital Epidemiology. 2020;41 (S1):S188-189

    BACKGROUND
  • 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

    BACKGROUND
  • Lautenbach 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. Development of an Electronic Algorithm to Target Outpatient Antimicrobial Stewardship Efforts for Acute Bronchitis. Infection Control and Hospital Epidemiology. 2020;41 (S1):S188-189

    BACKGROUND
  • 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.

    PMID: 35854991BACKGROUND
  • 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.

    PMID: 26864410BACKGROUND
  • Charani 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.

    PMID: 30445453BACKGROUND
  • Szymczak JE. Are Surgeons Different? The Case for Bespoke Antimicrobial Stewardship. Clin Infect Dis. 2019 Jun 18;69(1):21-23. doi: 10.1093/cid/ciy847. No abstract available.

    PMID: 30445615BACKGROUND
  • Landis-Lewis Z, Kononowech J, Scott WJ, Hogikyan RV, Carpenter JG, Periyakoil VS, Miller SC, Levy C, Ersek M, Sales A. Designing clinical practice feedback reports: three steps illustrated in Veterans Health Affairs long-term care facilities and programs. Implement Sci. 2020 Jan 21;15(1):7. doi: 10.1186/s13012-019-0950-y.

    PMID: 31964414BACKGROUND
  • Redding LE, Muller BM, Szymczak JE. Small and Large Animal Veterinarian Perceptions of Antimicrobial Use Metrics for Hospital-Based Stewardship in the United States. Front Vet Sci. 2020 Sep 8;7:582. doi: 10.3389/fvets.2020.00582. eCollection 2020.

    PMID: 33102546BACKGROUND
  • Szymczak JE, Feemster KA, Zaoutis TE, Gerber JS. Pediatrician perceptions of an outpatient antimicrobial stewardship intervention. Infect Control Hosp Epidemiol. 2014 Oct;35 Suppl 3:S69-78. doi: 10.1086/677826.

    PMID: 25222901BACKGROUND
  • Szymczak JE, Kitt E, Hayes M, Chiotos K, Coffin SE, Schriver ER, Patton AM, Metjian TA, Gerber JS. Threatened efficiency not autonomy: Prescriber perceptions of an established pediatric antimicrobial stewardship program. Infect Control Hosp Epidemiol. 2019 May;40(5):522-527. doi: 10.1017/ice.2019.47. Epub 2019 Mar 28.

    PMID: 30919799BACKGROUND
  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3.

    PMID: 28851459BACKGROUND
  • Chiotos K, Dutcher L, Grundmeier RW, Meyahnwi D, Lautenbach E, Neuhauser MM, Hicks LA, Hamilton KW, Li Y, Szymczak JE, Muller BM, Congdon M, Kane E, Hart J, Utidjian L, Cressman L, Jaskowiak-Barr A, Gerber JS. Impact of Clinician Feedback Reports on Antibiotic Use in Children Hospitalized With Community-acquired Pneumonia. Clin Infect Dis. 2025 Feb 24;80(2):263-270. doi: 10.1093/cid/ciae593.

MeSH Terms

Conditions

Community-Acquired PneumoniaOtitis MediaPharyngitis

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract DiseasesOtitisEar DiseasesOtorhinolaryngologic DiseasesPharyngeal DiseasesStomatognathic Diseases

Results Point of Contact

Title
Kathleen Chiotos
Organization
Children's Hospital of Philadelphia

Study Officials

  • Ebbing Lautenbach, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2023

First Posted

September 7, 2023

Study Start

October 18, 2022

Primary Completion

June 30, 2024

Study Completion

July 31, 2024

Last Updated

November 14, 2025

Results First Posted

November 14, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

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

Locations