Reducing Empiric VAncomycin Use in Pediatric Suspected Sepsis

NCT05975671 | Recruiting

• 3 other identifiers: 21-019410U54CK000610-02-00U54CK000610
• Study Type: interventional
• Target: 52,500
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this quasi-experimental interventional study is to determine the effectiveness of a multifaceted stewardship intervention in reducing overall vancomycin use in five tertiary care Pediatric Intensive Care Units (PICU). There are two groups of subjects in this study: PICU clinicians/sepsis stakeholders and patients admitted to one of the participating PICUs during the study period. The intervention will at a minimum include:

• Implementation of a clinical guideline indicating when vancomycin should and should not be used
• Unit-level feedback on overall vancomycin use within and across centers
• Clinician education.

Conditions

Sepsis; Sepsis Mrsa; Sepsis Bacteremia; Antimicrobial - Induced Nephropathy; Sepsis, Severe; Septic Shock; Septic Syndrome

Keywords

Sepsis; Vancomycin use; methicillin-resistant Staphylococcus aureus (MRSA); Antibiotic Stewardship; Implementation science

Outcome Measures

Primary Outcomes (1)

• Change in vancomycin use

  Vancomycin use will be measured as DOT per 1000 PICU patient days, measured monthly. Every day in which one or more doses of parenteral vancomycin is administered is classified as one vancomycin DOT. Every day or portion of a day a patient is admitted to the PICU is classified as one PICU patient day.

  Baseline to 5 years

Secondary Outcomes (9)

• Change in rate of suspected and confirmed sepsis episodes per 1000 PICU patient days.

  Baseline to 5 years

• PICU all-cause mortality

  Up to 3 years

• PICU length of stay

  Up to 3 years

• Hospital length of stay

  Up to 3 years

• 30-day PICU readmission

  Within 30 days of discharge from a PICU admission

Other Outcomes (4)

• Adoption of intervention

  Onset of intervention to 2 years

• Appropriateness of intervention

  Onset of intervention to 2 years

• Acceptability of intervention

  Onset of intervention to 2 years

Study Arms (2)

PICU Clinicians and Sepsis stakeholders

OTHER

Clinicians and sepsis stakeholders in the participating sites will be primarily recruited via email. During the course of this multifaceted intervention: * All the PICU (Pediatric Intensive Care Unit) prescribing clinicians and sepsis stakeholders in the participating sites will receive clinical guidelines, unit-level feedback reports, and education on Vancomycin use during the intervention. * Investigators will perform semi-structured interviews with 90 PICU clinicians and sepsis stakeholders. * Surveys will be sent to all eligible clinicians, estimated to be up to 2500 individuals across the 4 sites. These structured surveys will be done at baseline and at 9 months post-implementation.

Behavioral: Multifaceted de-implementation strategy to reduce vancomycin overuse

PICU Patients with suspected sepsis

NO INTERVENTION

Research procedures involving patients will be limited to medical record review. This medical record review will help inform the intervention directed at PICU clinicians/stakeholders and the assessment of study outcomes. Approximately 50,000 patients will participate in the study. Data elements will be collected at each site and stored as password-protected Comma-separated values (CSV) files. These files will not contain any direct Protected Health Information (PHI) but will contain elements of date (e.g., date of admission, date of suspected sepsis episode). The study Identification (ID) number will be used to identify each unique patient. Each site will collect and store data in compliance with the Children's Hospital of Philadelphia (CHOP) and local Institutional Review Board (IRB) policies.

Interventions

Multifaceted de-implementation strategy to reduce vancomycin overuse BEHAVIORAL

* Clinical guidelines and group-level feedback on vancomycin use will be provided to clinicians/sepsis stakeholders at each site. * The semi-structured interviews will be performed by a trained member of the research team, under the supervision of a medical sociologist who is one of the co-investigators. A semi-structured interview guide will be used during the interviews. Interviews will be recorded and transcribed, then uploaded to a qualitative analysis software for management and coding. Names will not be recorded, and pseudonyms will be used in notes, communications about the study, and any presentations. Verbal consent will be obtained before conducting and recording the interviews. * The surveys will be performed using REDCap survey software, and participation will be voluntary. No identifiers will be collected.

Also known as: Mixed methods intervention

PICU Clinicians and Sepsis stakeholders

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to one of the participating PICUs during the study period

You may not qualify if:

• None
• PICU prescribing clinician (including attending physicians, fellows, residents, nurse practitioners, and physician assistants) OR sepsis stakeholder (leader of sepsis quality improvement work, medical director) at one of the participating sites at the time the survey is deployed
• Age ≥ 18 years old
• Employed by one of the participating sites
• Volunteers or other non-employee hospital staff
• Limited English proficiency

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Children's Healthcare of Atlanta: collaborator
• St. Louis Children's Hospital: collaborator
• Johns Hopkins University: collaborator
• University of Pennsylvania: collaborator
• Centers for Disease Control and Prevention: collaborator

Study Sites (4)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

Johns Hopkins Children's Center

Baltimore, Maryland, 21287, United States

RECRUITING

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

RECRUITING

Related Publications (57)

• Kissoon N, Reinhart K, Daniels R, Machado MFR, Schachter RD, Finfer S. Sepsis in Children: Global Implications of the World Health Assembly Resolution on Sepsis. Pediatr Crit Care Med. 2017 Dec;18(12):e625-e627. doi: 10.1097/PCC.0000000000001340.

  PMID: 28914721 BACKGROUND

• Weiss SL, Peters MJ, Alhazzani W, Agus MSD, Flori HR, Inwald DP, Nadel S, Schlapbach LJ, Tasker RC, Argent AC, Brierley J, Carcillo J, Carrol ED, Carroll CL, Cheifetz IM, Choong K, Cies JJ, Cruz AT, De Luca D, Deep A, Faust SN, De Oliveira CF, Hall MW, Ishimine P, Javouhey E, Joosten KFM, Joshi P, Karam O, Kneyber MCJ, Lemson J, MacLaren G, Mehta NM, Moller MH, Newth CJL, Nguyen TC, Nishisaki A, Nunnally ME, Parker MM, Paul RM, Randolph AG, Ranjit S, Romer LH, Scott HF, Tume LN, Verger JT, Williams EA, Wolf J, Wong HR, Zimmerman JJ, Kissoon N, Tissieres P. Surviving Sepsis Campaign International Guidelines for the Management of Septic Shock and Sepsis-Associated Organ Dysfunction in Children. Pediatr Crit Care Med. 2020 Feb;21(2):e52-e106. doi: 10.1097/PCC.0000000000002198.

  PMID: 32032273 BACKGROUND

• Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.

  PMID: 28098591 BACKGROUND

• Tamma PD, Avdic E, Li DX, Dzintars K, Cosgrove SE. Association of Adverse Events With Antibiotic Use in Hospitalized Patients. JAMA Intern Med. 2017 Sep 1;177(9):1308-1315. doi: 10.1001/jamainternmed.2017.1938.

  PMID: 28604925 BACKGROUND

• Same RG, Hsu AJ, Cosgrove SE, Klein EY, Amoah J, Hersh AL, Kronman MP, Tamma PD. Antibiotic-Associated Adverse Events in Hospitalized Children. J Pediatric Infect Dis Soc. 2021 May 28;10(5):622-628. doi: 10.1093/jpids/piaa173.

  PMID: 33452808 BACKGROUND

• Hensgens MP, Goorhuis A, Dekkers OM, Kuijper EJ. Time interval of increased risk for Clostridium difficile infection after exposure to antibiotics. J Antimicrob Chemother. 2012 Mar;67(3):742-8. doi: 10.1093/jac/dkr508. Epub 2011 Dec 6.

  PMID: 22146873 BACKGROUND

• Bell BG, Schellevis F, Stobberingh E, Goossens H, Pringle M. A systematic review and meta-analysis of the effects of antibiotic consumption on antibiotic resistance. BMC Infect Dis. 2014 Jan 9;14:13. doi: 10.1186/1471-2334-14-13.

  PMID: 24405683 BACKGROUND

• Lovegrove MC, Geller AI, Fleming-Dutra KE, Shehab N, Sapiano MRP, Budnitz DS. US Emergency Department Visits for Adverse Drug Events From Antibiotics in Children, 2011-2015. J Pediatric Infect Dis Soc. 2019 Nov 6;8(5):384-391. doi: 10.1093/jpids/piy066.

  PMID: 30137509 BACKGROUND

• Downes KJ, Cowden C, Laskin BL, Huang YS, Gong W, Bryan M, Fisher BT, Goldstein SL, Zaoutis TE. Association of Acute Kidney Injury With Concomitant Vancomycin and Piperacillin/Tazobactam Treatment Among Hospitalized Children. JAMA Pediatr. 2017 Dec 4;171(12):e173219. doi: 10.1001/jamapediatrics.2017.3219. Epub 2017 Dec 4.

  PMID: 28973124 BACKGROUND

• Navalkele B, Pogue JM, Karino S, Nishan B, Salim M, Solanki S, Pervaiz A, Tashtoush N, Shaikh H, Koppula S, Koons J, Hussain T, Perry W, Evans R, Martin ET, Mynatt RP, Murray KP, Rybak MJ, Kaye KS. Risk of Acute Kidney Injury in Patients on Concomitant Vancomycin and Piperacillin-Tazobactam Compared to Those on Vancomycin and Cefepime. Clin Infect Dis. 2017 Jan 15;64(2):116-123. doi: 10.1093/cid/ciw709. Epub 2016 Oct 20.

  PMID: 27986669 BACKGROUND

• Rutter WC, Cox JN, Martin CA, Burgess DR, Burgess DS. Nephrotoxicity during Vancomycin Therapy in Combination with Piperacillin-Tazobactam or Cefepime. Antimicrob Agents Chemother. 2017 Jan 24;61(2):e02089-16. doi: 10.1128/AAC.02089-16. Print 2017 Feb.

  PMID: 27895019 BACKGROUND

• Dethlefsen L, Huse S, Sogin ML, Relman DA. The pervasive effects of an antibiotic on the human gut microbiota, as revealed by deep 16S rRNA sequencing. PLoS Biol. 2008 Nov 18;6(11):e280. doi: 10.1371/journal.pbio.0060280.

  PMID: 19018661 BACKGROUND

• McKamy S, Hernandez E, Jahng M, Moriwaki T, Deveikis A, Le J. Incidence and risk factors influencing the development of vancomycin nephrotoxicity in children. J Pediatr. 2011 Mar;158(3):422-6. doi: 10.1016/j.jpeds.2010.08.019.

  PMID: 20888013 BACKGROUND

• Sinclair EA, Yenokyan G, McMunn A, Fadrowski JJ, Milstone AM, Lee CK. Factors associated with acute kidney injury in children receiving vancomycin. Ann Pharmacother. 2014 Dec;48(12):1555-62. doi: 10.1177/1060028014549185. Epub 2014 Sep 3.

  PMID: 25186624 BACKGROUND

• Ragab AR, Al-Mazroua MK, Al-Harony MA. Incidence and predisposing factors of vancomycin-induced nephrotoxicity in children. Infect Dis Ther. 2013 Jun;2(1):37-46. doi: 10.1007/s40121-013-0004-8. Epub 2013 Mar 26.

  PMID: 25135822 BACKGROUND

• Fiorito TM, Luther MK, Dennehy PH, LaPlante KL, Matson KL. Nephrotoxicity With Vancomycin in the Pediatric Population: A Systematic Review and Meta-Analysis. Pediatr Infect Dis J. 2018 Jul;37(7):654-661. doi: 10.1097/INF.0000000000001882.

  PMID: 29280786 BACKGROUND

• Feiten HDS, Okumura LM, Martinbiancho JK, Andreolio C, da Rocha TS, Antonacci Carvalho PR, Pedro Piva J. Vancomycin-associated Nephrotoxicity and Risk Factors in Critically Ill Children Without Preexisting Renal Injury. Pediatr Infect Dis J. 2019 Sep;38(9):934-938. doi: 10.1097/INF.0000000000002391.

  PMID: 31232892 BACKGROUND

• Bradley JS, Byington CL, Shah SS, Alverson B, Carter ER, Harrison C, Kaplan SL, Mace SE, McCracken GH Jr, Moore MR, St Peter SD, Stockwell JA, Swanson JT; Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. The management of community-acquired pneumonia in infants and children older than 3 months of age: clinical practice guidelines by the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America. Clin Infect Dis. 2011 Oct;53(7):e25-76. doi: 10.1093/cid/cir531. Epub 2011 Aug 31.

  PMID: 21880587 BACKGROUND

• Mermel LA, Allon M, Bouza E, Craven DE, Flynn P, O'Grady NP, Raad II, Rijnders BJ, Sherertz RJ, Warren DK. Clinical practice guidelines for the diagnosis and management of intravascular catheter-related infection: 2009 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Jul 1;49(1):1-45. doi: 10.1086/599376.

  PMID: 19489710 BACKGROUND

• Tribble AC, Lee BR, Flett KB, Handy LK, Gerber JS, Hersh AL, Kronman MP, Terrill CM, Sharland M, Newland JG; Sharing Antimicrobial Reports for Pediatric Stewardship (SHARPS) Collaborative. Appropriateness of Antibiotic Prescribing in United States Children's Hospitals: A National Point Prevalence Survey. Clin Infect Dis. 2020 Nov 5;71(8):e226-e234. doi: 10.1093/cid/ciaa036.

  PMID: 31942952 BACKGROUND

• Brogan TV, Thurm C, Hersh AL, Gerber JS, Smith MJ, Shah SS, Courter JD, Patel SJ, Parker SK, Kronman MP, Lee BR, Newland JG. Variability in Antibiotic Use Across PICUs. Pediatr Crit Care Med. 2018 Jun;19(6):519-527. doi: 10.1097/PCC.0000000000001535.

  PMID: 29533352 BACKGROUND

• Blinova E, Lau E, Bitnun A, Cox P, Schwartz S, Atenafu E, Yau Y, Streitenberger L, Parshuram CS, Marshall J, Seto W. Point prevalence survey of antimicrobial utilization in the cardiac and pediatric critical care unit. Pediatr Crit Care Med. 2013 Jul;14(6):e280-8. doi: 10.1097/PCC.0b013e31828a846d.

  PMID: 23823209 BACKGROUND

• Williams MC, Obermeier H, Hurst AL, Saporta-Keating SR, Pearce K, MacBrayne CE, Child J, Parker SK. Hospital-wide Description of Clinical Indications for Pediatric Anti-infective Use. Clin Ther. 2019 Aug;41(8):1605-1611.e0. doi: 10.1016/j.clinthera.2019.05.008. Epub 2019 Jun 11.

  PMID: 31196642 BACKGROUND

• Mermel LA. Respiratory protection for healthcare workers caring for COVID-19 patients. Infect Control Hosp Epidemiol. 2020 Sep;41(9):1064-1065. doi: 10.1017/ice.2020.175. Epub 2020 Apr 23. No abstract available.

  PMID: 32321614 BACKGROUND

• Metlay JP, Waterer GW, Long AC, Anzueto A, Brozek J, Crothers K, Cooley LA, Dean NC, Fine MJ, Flanders SA, Griffin MR, Metersky ML, Musher DM, Restrepo MI, Whitney CG. Diagnosis and Treatment of Adults with Community-acquired Pneumonia. An Official Clinical Practice Guideline of the American Thoracic Society and Infectious Diseases Society of America. Am J Respir Crit Care Med. 2019 Oct 1;200(7):e45-e67. doi: 10.1164/rccm.201908-1581ST.

  PMID: 31573350 BACKGROUND

• Levine DP. Vancomycin: a history. Clin Infect Dis. 2006 Jan 1;42 Suppl 1:S5-12. doi: 10.1086/491709.

  PMID: 16323120 BACKGROUND

• Weiner-Lastinger LM, Abner S, Benin AL, Edwards JR, Kallen AJ, Karlsson M, Magill SS, Pollock D, See I, Soe MM, Walters MS, Dudeck MA. Antimicrobial-resistant pathogens associated with pediatric healthcare-associated infections: Summary of data reported to the National Healthcare Safety Network, 2015-2017. Infect Control Hosp Epidemiol. 2020 Jan;41(1):19-30. doi: 10.1017/ice.2019.297. Epub 2019 Nov 25.

  PMID: 31762428 BACKGROUND

• Waters CD, Caraccio J. Rate of positive cultures necessitating definitive treatment in patients receiving empiric vancomycin therapy. Infect Control Hosp Epidemiol. 2018 Aug;39(8):989-990. doi: 10.1017/ice.2018.123. Epub 2018 Jun 12.

  PMID: 29893660 BACKGROUND

• Jones M, Jernigan JA, Evans ME, Roselle GA, Hatfield KM, Samore MH. Vital Signs: Trends in Staphylococcus aureus Infections in Veterans Affairs Medical Centers - United States, 2005-2017. MMWR Morb Mortal Wkly Rep. 2019 Mar 8;68(9):220-224. doi: 10.15585/mmwr.mm6809e2.

  PMID: 30845116 BACKGROUND

• Jones BE, Jones MM, Huttner B, Stoddard G, Brown KA, Stevens VW, Greene T, Sauer B, Madaras-Kelly K, Rubin M, Goetz MB, Samore M. Trends in Antibiotic Use and Nosocomial Pathogens in Hospitalized Veterans With Pneumonia at 128 Medical Centers, 2006-2010. Clin Infect Dis. 2015 Nov 1;61(9):1403-10. doi: 10.1093/cid/civ629. Epub 2015 Jul 29.

  PMID: 26223995 BACKGROUND

• Jones BE, Brown KA, Jones MM, Huttner BD, Greene T, Sauer BC, Madaras-Kelly K, Rubin MA, Bidwell Goetz M, Samore MH. Variation in Empiric Coverage Versus Detection of Methicillin-Resistant Staphylococcus aureus and Pseudomonas aeruginosa in Hospitalizations for Community-Onset Pneumonia Across 128 US Veterans Affairs Medical Centers. Infect Control Hosp Epidemiol. 2017 Aug;38(8):937-944. doi: 10.1017/ice.2017.98. Epub 2017 Jun 21.

  PMID: 28633678 BACKGROUND

• Sutter DE, Milburn E, Chukwuma U, Dzialowy N, Maranich AM, Hospenthal DR. Changing Susceptibility of Staphylococcus aureus in a US Pediatric Population. Pediatrics. 2016 Apr;137(4):e20153099. doi: 10.1542/peds.2015-3099. Epub 2016 Mar 1.

  PMID: 26933211 BACKGROUND

• Kim NH, Koo HL, Choe PG, Cheon S, Kim M, Lee MJ, Jung Y, Park WB, Song KH, Kim ES, Bang JH, Kim HB, Park SW, Kim NJ, Oh MD, Kim EC. Inappropriate continued empirical vancomycin use in a hospital with a high prevalence of methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 2015 Feb;59(2):811-7. doi: 10.1128/AAC.04523-14. Epub 2014 Nov 17.

  PMID: 25403664 BACKGROUND

• Davies P, Evans C, Kanthimathinathan HK, Lillie J, Brierley J, Waters G, Johnson M, Griffiths B, du Pre P, Mohammad Z, Deep A, Playfor S, Singh D, Inwald D, Jardine M, Ross O, Shetty N, Worrall M, Sinha R, Koul A, Whittaker E, Vyas H, Scholefield BR, Ramnarayan P. Intensive care admissions of children with paediatric inflammatory multisystem syndrome temporally associated with SARS-CoV-2 (PIMS-TS) in the UK: a multicentre observational study. Lancet Child Adolesc Health. 2020 Sep;4(9):669-677. doi: 10.1016/S2352-4642(20)30215-7. Epub 2020 Jul 9.

  PMID: 32653054 BACKGROUND

• Choe PG, Koo HL, Yoon D, Bae JY, Lee E, Hwang JH, Song KH, Park WB, Bang JH, Kim ES, Kim HB, Park SW, Oh MD, Kim NJ. Effect of an intervention targeting inappropriate continued empirical parenteral vancomycin use: a quasi-experimental study in a region of high MRSA prevalence. BMC Infect Dis. 2018 Apr 16;18(1):178. doi: 10.1186/s12879-018-3081-1.

  PMID: 29661158 BACKGROUND

• Junior MS, Correa L, Marra AR, Camargo LF, Pereira CA. Analysis of vancomycin use and associated risk factors in a university teaching hospital: a prospective cohort study. BMC Infect Dis. 2007 Aug 1;7:88. doi: 10.1186/1471-2334-7-88.

  PMID: 17678541 BACKGROUND

• Rhee C, Kadri SS, Dekker JP, Danner RL, Chen HC, Fram D, Zhang F, Wang R, Klompas M; CDC Prevention Epicenters Program. Prevalence of Antibiotic-Resistant Pathogens in Culture-Proven Sepsis and Outcomes Associated With Inadequate and Broad-Spectrum Empiric Antibiotic Use. JAMA Netw Open. 2020 Apr 1;3(4):e202899. doi: 10.1001/jamanetworkopen.2020.2899.

  PMID: 32297949 BACKGROUND

• Jones BE, Ying J, Stevens V, Haroldsen C, He T, Nevers M, Christensen MA, Nelson RE, Stoddard GJ, Sauer BC, Yarbrough PM, Jones MM, Goetz MB, Greene T, Samore MH. Empirical Anti-MRSA vs Standard Antibiotic Therapy and Risk of 30-Day Mortality in Patients Hospitalized for Pneumonia. JAMA Intern Med. 2020 Apr 1;180(4):552-560. doi: 10.1001/jamainternmed.2019.7495.

  PMID: 32065604 BACKGROUND

• Hranjec T, Rosenberger LH, Swenson B, Metzger R, Flohr TR, Politano AD, Riccio LM, Popovsky KA, Sawyer RG. Aggressive versus conservative initiation of antimicrobial treatment in critically ill surgical patients with suspected intensive-care-unit-acquired infection: a quasi-experimental, before and after observational cohort study. Lancet Infect Dis. 2012 Oct;12(10):774-80. doi: 10.1016/S1473-3099(12)70151-2. Epub 2012 Aug 28.

  PMID: 22951600 BACKGROUND

• Hoelen DW, Tjan DH, van Vugt R, van der Meer YG, van Zanten AR. Severe local vancomycin induced skin necrosis. Br J Clin Pharmacol. 2007 Oct;64(4):553-4. doi: 10.1111/j.1365-2125.2007.02897.x. Epub 2007 Apr 10. No abstract available.

  PMID: 17425624 BACKGROUND

• Fridkin SK, Edwards JR, Courval JM, Hill H, Tenover FC, Lawton R, Gaynes RP, McGowan JE Jr; Intensive Care Antimicrobial Resistance Epidemiology (ICARE) Project and the National Nosocomial Infections Surveillance (NNIS) System Hospitals. The effect of vancomycin and third-generation cephalosporins on prevalence of vancomycin-resistant enterococci in 126 U.S. adult intensive care units. Ann Intern Med. 2001 Aug 7;135(3):175-83. doi: 10.7326/0003-4819-135-3-200108070-00009.

  PMID: 11487484 BACKGROUND

• Brownlee S, Chalkidou K, Doust J, Elshaug AG, Glasziou P, Heath I, Nagpal S, Saini V, Srivastava D, Chalmers K, Korenstein D. Evidence for overuse of medical services around the world. Lancet. 2017 Jul 8;390(10090):156-168. doi: 10.1016/S0140-6736(16)32585-5. Epub 2017 Jan 9.

  PMID: 28077234 BACKGROUND

• Norton WE, Chambers DA, Kramer BS. Conceptualizing De-Implementation in Cancer Care Delivery. J Clin Oncol. 2019 Jan 10;37(2):93-96. doi: 10.1200/JCO.18.00589. Epub 2018 Nov 8. No abstract available.

  PMID: 30407894 BACKGROUND

• Niven DJ, Mrklas KJ, Holodinsky JK, Straus SE, Hemmelgarn BR, Jeffs LP, Stelfox HT. Towards understanding the de-adoption of low-value clinical practices: a scoping review. BMC Med. 2015 Oct 6;13:255. doi: 10.1186/s12916-015-0488-z.

  PMID: 26444862 BACKGROUND

• Barlam TF, Childs E, Zieminski SA, Meshesha TM, Jones KE, Butler JM, Damschroder LJ, Goetz MB, Madaras-Kelly K, Reardon CM, Samore MH, Shen J, Stenehjem E, Zhang Y, Drainoni ML. Perspectives of Physician and Pharmacist Stewards on Successful Antibiotic Stewardship Program Implementation: A Qualitative Study. Open Forum Infect Dis. 2020 Jun 15;7(7):ofaa229. doi: 10.1093/ofid/ofaa229. eCollection 2020 Jul.

  PMID: 32704510 BACKGROUND

• Newland JG, Stach LM, De Lurgio SA, Hedican E, Yu D, Herigon JC, Prasad PA, Jackson MA, Myers AL, Zaoutis TE. Impact of a Prospective-Audit-With-Feedback Antimicrobial Stewardship Program at a Children's Hospital. J Pediatric Infect Dis Soc. 2012 Sep;1(3):179-86. doi: 10.1093/jpids/pis054. Epub 2012 Jul 12.

  PMID: 26619405 BACKGROUND

• Aizawa Y, Suwa J, Higuchi H, Fukuoka K, Furuichi M, Kaneko T, Morikawa Y, Okazaki K, Shimizu N, Horikoshi Y. Antimicrobial Stewardship Program in a Pediatric Intensive Care Unit. J Pediatric Infect Dis Soc. 2018 Aug 17;7(3):e156-e159. doi: 10.1093/jpids/piy031.

  PMID: 29688433 BACKGROUND

• Cantey JB, Wozniak PS, Pruszynski JE, Sanchez PJ. Reducing unnecessary antibiotic use in the neonatal intensive care unit (SCOUT): a prospective interrupted time-series study. Lancet Infect Dis. 2016 Oct;16(10):1178-1184. doi: 10.1016/S1473-3099(16)30205-5. Epub 2016 Jul 22.

  PMID: 27452782 BACKGROUND

• Woods-Hill CZ, Fackler J, Nelson McMillan K, Ascenzi J, Martinez DA, Toerper MF, Voskertchian A, Colantuoni E, Klaus SA, Levin S, Milstone AM. Association of a Clinical Practice Guideline With Blood Culture Use in Critically Ill Children. JAMA Pediatr. 2017 Feb 1;171(2):157-164. doi: 10.1001/jamapediatrics.2016.3153.

  PMID: 27942705 BACKGROUND

• Prusaczyk B, Swindle T, Curran G. Defining and conceptualizing outcomes for de-implementation: key distinctions from implementation outcomes. Implement Sci Commun. 2020 Apr 30;1:43. doi: 10.1186/s43058-020-00035-3. eCollection 2020.

  PMID: 32885200 BACKGROUND

• Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4.

  PMID: 28178770 BACKGROUND

• Lorencatto F, Charani E, Sevdalis N, Tarrant C, Davey P. Driving sustainable change in antimicrobial prescribing practice: how can social and behavioural sciences help? J Antimicrob Chemother. 2018 Oct 1;73(10):2613-2624. doi: 10.1093/jac/dky222.

  PMID: 30020464 BACKGROUND

• Pandolfo AM, Horne R, Jani Y, Reader TW, Bidad N, Brealey D, Enne VI, Livermore DM, Gant V, Brett SJ; INHALE WP2 Study Group. Understanding decisions about antibiotic prescribing in ICU: an application of the Necessity Concerns Framework. BMJ Qual Saf. 2022 Mar;31(3):199-210. doi: 10.1136/bmjqs-2020-012479. Epub 2021 Jun 7.

  PMID: 34099497 BACKGROUND

• Wunderink RG, Srinivasan A, Barie PS, Chastre J, Dela Cruz CS, Douglas IS, Ecklund M, Evans SE, Evans SR, Gerlach AT, Hicks LA, Howell M, Hutchinson ML, Hyzy RC, Kane-Gill SL, Lease ED, Metersky ML, Munro N, Niederman MS, Restrepo MI, Sessler CN, Simpson SQ, Swoboda SM, Guillamet CV, Waterer GW, Weiss CH. Antibiotic Stewardship in the Intensive Care Unit. An Official American Thoracic Society Workshop Report in Collaboration with the AACN, CHEST, CDC, and SCCM. Ann Am Thorac Soc. 2020 May;17(5):531-540. doi: 10.1513/AnnalsATS.202003-188ST.

  PMID: 32356696 BACKGROUND

• Cressman AM, MacFadden DR, Verma AA, Razak F, Daneman N. Empiric Antibiotic Treatment Thresholds for Serious Bacterial Infections: A Scenario-based Survey Study. Clin Infect Dis. 2019 Aug 30;69(6):930-937. doi: 10.1093/cid/ciy1031.

  PMID: 30535310 BACKGROUND

• Szymczak JE, Muller BM, Shakamuri NS, Hamilton KW, Gerber JS, Laguio-Vila M, Dumyati GK, Fridkin SK, Guh AY, Reddy SC, Lautenbach E; CDC Prevention Epicenters Program. Prescriber perceptions of fluoroquinolones, extended-spectrum cephalosporins, and Clostridioides difficile infection. Infect Control Hosp Epidemiol. 2020 Aug;41(8):914-920. doi: 10.1017/ice.2020.183. Epub 2020 May 29.

  PMID: 32468967 BACKGROUND

• Proctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7.

  PMID: 20957426 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Toxemia

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Kathleen Chiotos, MD, MSCE

  children's hospital of philadelphia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Chiotos, MD, MSCE

CONTACT

215-590-5505; chiotosk@chop.edu

Kai Inoki, MPH

CONTACT

215-590-5505; meyahnwid@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, mixed methods, implementation science study with a quasi-experimental design.

Study Record Dates

• First Submitted: July 27, 2023
• First Posted: August 4, 2023
• Study Start: August 21, 2023
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)