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

Community-acquired Pneumonia Clinical Trial

— EMPOWER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027593
• Other study ID #: 22-019749
• Secondary ID: 75D30121F0000285
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2022
• Est. completion date: November 2025

Study information

• Verified date: September 2023
• Source: Children's Hospital of Philadelphia
• Contact: Kathleen Chiotos, MD, MSCE
• Phone: 215-590-5505
• Email: chiotosk[@]chop.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (CAP); 2) pediatric inpatients with CAP; 3) adult outpatients with acute pharyngitis; and 4) pediatric outpatients with acute otitis media.

There are two cohorts in this study: Patients with one of the aforementioned conditions who meet inclusion criteria, and the clinicians providing clinical care to these patients.

Description:

Antibiotic stewardship (AS) has been shown to improve patient outcomes, decrease adverse events, and decrease antibiotic resistance. This group of investigators previously partnered with collaborators at the Centers for Disease Control and Prevention (CDC) and conducted relevant pilot work in developing and validating electronic indicators of inappropriate antibiotic prescribing for 8 conditions, amongst which are the four conditions of interest in this study: adult inpatients with CAP; pediatric inpatients with CAP; adult outpatients with acute pharyngitis; and pediatric outpatients with acute pharyngitis). Methods were developed to generate automatic, routine reports to identify elements of inappropriate antibiotic use including; 1) the decision to initiate antibiotic therapy; 2) the choice of antibiotic agent; and 3) the duration of antibiotic use.

The purpose of this project is to assess the impact of these developed electronic indicators on supporting AS efforts to improve the appropriateness of antibiotic use, as well as the acceptability and feasibility of delivering these reports to prescribers. The investigators aim to:

1. Refine and validate indicators of appropriate antibiotic use by utilizing Electronic Health Record (EHR) data, including International Classification of Diseases (ICD-10) codes, medications, laboratory data, comorbid medical conditions, site of care, clinical documentation, prior hospitalizations, and medication exposure. The researchers will validate the definitions of the various conditions and appropriateness captured electronically with a manual chart review of clinical documentation.

2. Implement a scalable and sustainable AS feedback report-based intervention for these four conditions informed by a rapid user-centered design process.

3. Track the impact of stewardship interventions and report to key stakeholders, including prescribers.

4. Create a publicly available toolkit based on the findings of this project that includes:

(i) analytic tools and resources for using the automated reports of key indicators to target stewardship interventions and (ii) an implementation guide to inform the application of automated reports to stewardship in the inpatient and outpatient settings.

If proven effective, these EHR-based approaches hold the promise to greatly enhance the effectiveness and efficiency of AS initiatives.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 511000
• Est. completion date: November 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Otitis Media
• Community-acquired Pneumonia
• Otitis Media
• Pharyngitis

Intervention

Behavioral:
• Mixed methods intervention
Investigators will implement the intervention at the completion of the rapid user-centered design process and consultation with CDC collaborators. During the rapid user-centered design process, the team will engage key stakeholders to create and optimize feedback reports that will fit the prescribing context, and determine appropriate implementation supports that will be needed to accompany the introduction of the feedback reports to each setting. Following the initial awareness-building activities, investigators will circulate the antibiotic prescribing feedback reports. After the first 3 months (approximately) of report dissemination, the team will assess the feasibility and acceptability of the reports and implementation activities by administering a brief survey to prescribers and also conducting interviews with them. No direct identifiers will be collected.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Centers for Disease Control and Prevention, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (22)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. 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

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Measure of feasibility of intervention	Feasibility, the extent to which the intervention can be carried out in the clinical setting, will be determined in collaboration with our local stakeholders but may include the proportion of clinicians who attend educational sessions and/or unit-based meetings during which antibiotic use data is reviewed.	Up to 2 years
Other	Acceptability of intervention	Acceptability, how well the intervention was received by the prescribing clinicians will be measured during surveys and structured interviews using the Likert Scale; where 1 = completely disagree and 5 = completely agree.	Up to 2 years
Primary	Guideline-concordant antibiotic Use for adult pharyngitis	This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).	Up to 4 years
Primary	Guideline-concordant antibiotic Use for pediatric acute otitis media	This is the percentage of visits with guideline-concordant antibiotic use for all three metrics (decision to prescribe an antibiotic, antibiotic duration, and antibiotic choice).	Up to 4 years
Primary	Guideline-concordant antibiotic Use for CAP	Percentage of CAP encounters with guideline-concordant antibiotic use for both the duration and choice metrics.	Up to 4 years
Secondary	Guideline-concordant decision to prescribe antibiotics for adult pharyngitis	Percentage of patients for which the decision to prescribe an antibiotic was correct.	Up to 4 years
Secondary	Guideline-concordant decision to not prescribe antibiotics for adult pharyngitis	Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for adult pharyngitis	Up to 4 years
Secondary	Guideline-concordant decision to prescribe antibiotics for pediatric acute otitis media	Percentage of patients for which the decision to prescribe an antibiotic was correct.	Up to 4 years
Secondary	Guideline-concordant decision to not prescribe antibiotics for pediatric acute otitis media	Percentage of patients for which the decision to not prescribe an antibiotic was correct during a patient visit for acute otitis media	Up to 4 years
Secondary	Guideline-concordant antibiotic choice	Percentage of patients who received guideline-concordant antibiotic choice for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media.	Up to 4 years
Secondary	Guideline-concordant antibiotic duration	Percentage of patients who received guideline-concordant antibiotic duration for adult and pediatric CAP, adult pharyngitis, and pediatric otitis media	Up to 4 years
Secondary	Return to the emergency department	Percentage of patients who return to the emergency department within 14 days of discharge following hospitalization for CAP.	Up to 2 years
Secondary	Return to the clinic	Percentage of patients who return for an outpatient visit within 7 days of being diagnosed with adult pharyngitis or pediatric acute otitis media.	Up to 2 years
Secondary	Readmissions within 14 days of the index visit for CAP	Percentage of inpatients with CAP who are readmitted within 14 days of the index visit for the same or related condition.	Up to 2 years
Secondary	New antibiotic prescription within 7 days of the index visit	Percentage of patients who receive a new antibiotic prescription within 7 days of the index visit.	Up to 2 years