De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children

NCT04366440 | Completed

• 2 other identifiers: 2019121001R01HS026742-01A1
• Study Type: interventional
• Target: 39,363
• Locations: 1 country
• Sites: 10

Brief Summary

The overall objective of this study is to identify the best strategy to eliminate unnecessary antibiotic use after surgery in pediatric surgical procedures considered low-risk for an SSI. Based on literature and our preliminary data suggesting surgeons will not fully accept standardized order sets based on current guidelines, the investigators hypothesize that order set modification combined with ASP facilitation will outperform standard order set modification alone in de-implementing unnecessary postoperative antibiotic use.

Conditions

Surgical Site Infection

Keywords

children; antimicrobial stewardship; post-operative antibiotic prophylaxis; Deimplementation

Outcome Measures

Primary Outcomes (1)

• Percentage of clean and clean-contaminated cases in children receiving post-operative antibiotic prophylaxis.

  Clean and clean-contaminated surgical cases in children will be assessed for whether they are receiving post operative prophylaxis utilizing the Pediatric National Surgical Quality Improvement Project (NSQIP) database. A percentage will be determined with the numerator being total number of clean and clean-contaminated cases receiving post operative surgical prophylaxis and the denominator will be total number of clean and clean-contaminated cases.

  3 years

Secondary Outcomes (2)

• Rate of Surgical Site Infections (SSI) in clean and clean-contaminated cases

  3 years

• Rate of Clostridioides difficile infections (CDI) in clean and clean-contaminated cases

  3 years

Other Outcomes (3)

• Implementation Outcome: Acceptability of the Interventions

  3 years

• Implementation Outcome: Feasibility of the Interventions

  3 years

• Implementation Outcome: Appropriateness of the Interventions

  3 years

Study Arms (2)

Order set review and modification

OTHER

The antimicrobial stewardship program will review and change order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.

Other: Order set review and modification

Order Set review and Modification plus facilitation

OTHER

The antimicrobial stewardship program will receive facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.

Behavioral: Order set review and modification with facilitation

Interventions

Order set review and modification with facilitation BEHAVIORAL

The antimicrobial stewardship program will receive facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.

Order Set review and Modification plus facilitation

Order set review and modification OTHER

The antimicrobial stewardship program will work to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.

Order set review and modification

Eligibility Criteria

• Age: 0 Days - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgeries performed at the Children's Hospitals included in the study and are collected by NSQIP-P.
• Clean and clean-contaminated surgical procedures within the following specialties that are included in NSQIP-P:
• General Surgery, Neurosurgery, Orthopedics, Otolaryngology, Plastic Surgery, Otolaryngology, and Urology

You may not qualify if:

• \. Children undergoing clean or clean-contaminated procedures that are not collected by NSQIP-P data abstractors.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (10)

Johns Hopkins University School of Medicine / Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Harvard Medical School / Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan / CS Mott Children's Hospital

Ann Arbor, Michigan, 48109, United States

Location

University of Missouri - Kansas City / The Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Washington University in St. Louis / St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

The Ohio State University College of Medicine / Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Vanderbilt University / Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

Location

Baylor College of Medicine / Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Utah / Primary Children's Hospital

Salt Lake City, Utah, 84108, United States

Location

University of Washington / Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Related Publications (17)

• Logan LK, Renschler JP, Gandra S, Weinstein RA, Laxminarayan R; Centers for Disease Control; Prevention Epicenters Program. Carbapenem-Resistant Enterobacteriaceae in Children, United States, 1999-2012. Emerg Infect Dis. 2015 Nov;21(11):2014-21. doi: 10.3201/eid2111.150548.

  PMID: 26486124 BACKGROUND

• Logan LK, Braykov NP, Weinstein RA, Laxminarayan R; CDC Epicenters Prevention Program. Extended-Spectrum beta-Lactamase-Producing and Third-Generation Cephalosporin-Resistant Enterobacteriaceae in Children: Trends in the United States, 1999-2011. J Pediatric Infect Dis Soc. 2014 Dec;3(4):320-8. doi: 10.1093/jpids/piu010. Epub 2014 Mar 19.

  PMID: 26625452 BACKGROUND

• Logan LK, Gandra S, Mandal S, Klein EY, Levinson J, Weinstein RA, Laxminarayan R; Prevention Epicenters Program, US Centers for Disease Control and Prevention. Multidrug- and Carbapenem-Resistant Pseudomonas aeruginosa in Children, United States, 1999-2012. J Pediatric Infect Dis Soc. 2017 Nov 24;6(4):352-359. doi: 10.1093/jpids/piw064.

  PMID: 27856730 BACKGROUND

• Herigon JC, Hersh AL, Gerber JS, Zaoutis TE, Newland JG. Antibiotic management of Staphylococcus aureus infections in US children's hospitals, 1999-2008. Pediatrics. 2010 Jun;125(6):e1294-300. doi: 10.1542/peds.2009-2867. Epub 2010 May 17.

  PMID: 20478934 BACKGROUND

• Berrios-Torres SI, Umscheid CA, Bratzler DW, Leas B, Stone EC, Kelz RR, Reinke CE, Morgan S, Solomkin JS, Mazuski JE, Dellinger EP, Itani KMF, Berbari EF, Segreti J, Parvizi J, Blanchard J, Allen G, Kluytmans JAJW, Donlan R, Schecter WP; Healthcare Infection Control Practices Advisory Committee. Centers for Disease Control and Prevention Guideline for the Prevention of Surgical Site Infection, 2017. JAMA Surg. 2017 Aug 1;152(8):784-791. doi: 10.1001/jamasurg.2017.0904.

  PMID: 28467526 BACKGROUND

• Sandora TJ, Fung M, Melvin P, Graham DA, Rangel SJ. National Variability and Appropriateness of Surgical Antibiotic Prophylaxis in US Children's Hospitals. JAMA Pediatr. 2016 Jun 1;170(6):570-6. doi: 10.1001/jamapediatrics.2016.0019.

  PMID: 27088649 BACKGROUND

• Harvey G, Kitson A. PARIHS revisited: from heuristic to integrated framework for the successful implementation of knowledge into practice. Implement Sci. 2016 Mar 10;11:33. doi: 10.1186/s13012-016-0398-2.

  PMID: 27013464 BACKGROUND

• Kitson AL, Rycroft-Malone J, Harvey G, McCormack B, Seers K, Titchen A. Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges. Implement Sci. 2008 Jan 7;3:1. doi: 10.1186/1748-5908-3-1.

  PMID: 18179688 BACKGROUND

• Burnham JP, Olsen MA, Kollef MH. Re-estimating annual deaths due to multidrug-resistant organism infections. Infect Control Hosp Epidemiol. 2019 Jan;40(1):112-113. doi: 10.1017/ice.2018.304. Epub 2018 Nov 22. No abstract available.

  PMID: 30463634 BACKGROUND

• Rycroft-Malone J, Seers K, Chandler J, Hawkes CA, Crichton N, Allen C, Bullock I, Strunin L. The role of evidence, context, and facilitation in an implementation trial: implications for the development of the PARIHS framework. Implement Sci. 2013 Mar 9;8:28. doi: 10.1186/1748-5908-8-28.

  PMID: 23497438 BACKGROUND

• Helfrich CD, Damschroder LJ, Hagedorn HJ, Daggett GS, Sahay A, Ritchie M, Damush T, Guihan M, Ullrich PM, Stetler CB. A critical synthesis of literature on the promoting action on research implementation in health services (PARIHS) framework. Implement Sci. 2010 Oct 25;5:82. doi: 10.1186/1748-5908-5-82.

  PMID: 20973988 BACKGROUND

• Liu J, Colditz GA. Optimal design of longitudinal data analysis using generalized estimating equation models. Biom J. 2017 Mar;59(2):315-330. doi: 10.1002/bimj.201600107. Epub 2016 Nov 23.

  PMID: 27878852 BACKGROUND

• Liu J, Colditz GA. Relative efficiency of unequal versus equal cluster sizes in cluster randomized trials using generalized estimating equation models. Biom J. 2018 May;60(3):616-638. doi: 10.1002/bimj.201600262. Epub 2018 Mar 25.

  PMID: 29577363 BACKGROUND

• McKay V, Malone S, Tetteh E, Saito J, Rangel S, Bono K, Tao J, Liu J, Obeng H, Atkinson A, Newland JG. Facilitation as an effective strategy to reduce excessive antibiotic prophylaxis in Children's hospitals: A stepped-wedge cluster randomized controlled trial. Implement Sci. 2025 Oct 21;20(1):45. doi: 10.1186/s13012-025-01455-2.

  PMID: 41121325 DERIVED

• McKay V, Malone S, Tetteh E, Saito J, Rangel S, Bono K, Tao J, Liu J, Obeng H, Atkinson A, Newland J. Facilitation as an effective strategy to reduce excessive antibiotic prophylaxis in Children's hospitals: A stepped-wedge cluster randomized controlled trial. Res Sq [Preprint]. 2025 May 30:rs.3.rs-6579066. doi: 10.21203/rs.3.rs-6579066/v1.

  PMID: 40502788 DERIVED

• Malone S, Bono K, Saito JM, Rangel S, Liu J, Newland JG, McKay V. Evaluating a virtual facilitation workshop with antimicrobial stewardship teams within a cluster randomized stepped-wedge trial. BMC Health Serv Res. 2024 Oct 21;24(1):1263. doi: 10.1186/s12913-024-11714-5.

  PMID: 39434072 DERIVED

• Malone S, McKay VR, Krucylak C, Powell BJ, Liu J, Terrill C, Saito JM, Rangel SJ, Newland JG. A cluster randomized stepped-wedge trial to de-implement unnecessary post-operative antibiotics in children: the optimizing perioperative antibiotic in children (OPerAtiC) trial. Implement Sci. 2021 Mar 19;16(1):29. doi: 10.1186/s13012-021-01096-1.

  PMID: 33741048 DERIVED

Related Links

• SHARPS Collaborative Website
• NSQIP-P Website
• American Academy of Pediatrics Choosing Wisely- Infectious Diseases

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason G Newland, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A stepped-wedge study design will be utilized. All sites will begin in the control intervention, order set review and modification. Sequentially, clusters of 3 hospitals will begin in the experimental intervention, order set review and modification plus facilitation.

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 28, 2020
• Study Start: November 1, 2020
• Primary Completion: February 1, 2024
• Study Completion: November 30, 2024
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)