De-Implementation of Unnecessary Surgical Antibiotic Prophylaxis in Children
NCT ID: NCT04366440
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
39363 participants
INTERVENTIONAL
2020-11-01
2024-11-30
Brief Summary
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Detailed Description
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In this study, our team will develop and test two theoretically informed strategies to eliminate ("de-implement") unnecessary postoperative antibiotic prophylaxis through the collaboration of surgeons and antimicrobial stewardship programs (ASPs). One promising strategy is the implementation of standard surgical order sets, which offer relative ease of implementation and a systematic approach across surgical subspecialties. While evidence suggests that order set standardization is a good approach, barriers to implementation are commonly noted, especially the lack of engagement with clinicians affected by change when initiating a new strategy. As such, complementary strategies are needed to extend the impact of order set standardization.
This study will be guided by the i-PARIHS framework (Integrated Framework for Promoting Action on Research Implementation in Health Services), an implementation science framework designed to guide implementation of evidence-based practices. This framework posits that successful implementation of evidence into practice is a function of the quality and type of evidence to be implemented, the characteristics of the context where the evidence will be implemented, and the means by which it is integrated or facilitated into practice. Four primary constructs comprise the i-PARIHS framework: the innovation, recipients, context, and facilitation. Innovation describes the evidence and knowledge regarding a particular issue, as well as the qualities of the evidence that may influence how it is perceived by the potential user, recognizing that evidence may or may not be valuable to the end user based on local circumstances and priorities. Recipients are actors involved in implementation who may be affected by and influence the implementation of evidence. Context characterizes the circumstances in which knowledge and innovation uptake occurs, consisting of multiple factors at the micro, meso, and macro levels. Finally, integral to this framework is facilitation as the active mechanism by which uptake and implementation of evidence occurs, making it an ideal and appropriate fit for this study.
All research activities for this study will be conducted in 9 children's hospitals that participate in both the SHARPS Collaborative and NSQIP-P. Our participating hospitals are geographically dispersed and (like most children's hospitals) are located in urban settings. SHARPS Collaborative hospitals feature active ASPs operated by dedicated pharmacists and physician leaders. Clinicians (MD/DO or PharmD) overseeing ASPs and surgical champions in participating hospitals will implement the proposed strategies and collect implementation outcomes that quantify the extent to which the test strategies are successfully deployed in the hospital. The daily work of these individuals to improve antibiotic use includes frequent interaction with surgical specialties that perform clean and clean-contaminated surgeries. Implementing our proposed strategies via established ASP clinicians and a surgical leader (rather than, for example, directly by a member of the research team) will leverage existing relationships between these clinicians and their associated surgical teams, creating a more realistic circumstance under which new ASP strategies are implemented. This approach will provide better insight into the feasibility of implementing these strategies in a sustainable way in the future. In addition to being SHARPS Collaborative hospitals, our participating hospitals will also be NSQIP-P hospitals, each with a full-time, trained dedicated data abstractor collecting data on surgeries and surgical outcomes.
The investigators will compare the efficacy of the two strategies designed to reduce unnecessary postoperative antibiotic prophylaxis, using a cross-sectional stepped-wedge design. The investigators have identified 9 Children's Hospitals from across the US to participate in the study. Each of the 9 hospitals will be randomized into one of 3 clusters (cluster size = 3). All hospitals will begin with the control intervention-implementation of order set review and modification-at time 0. Each Step will last 6 months. Prior to the beginning of Step 1, Cluster 1 hospitals will receive the experimental intervention -order set review and modification plus facilitation. Just prior to steps 1, 2 and 3, the ASP teams will receive a 2-day in-person workshop led by the implementation scientist (Co-I Dr. McKay) and PI Dr. Newland, covering the specific facilitation strategies to be utilized. Every 6 months, an additional cluster will initiate the experimental condition (Steps 2 and 3). The amount of time each cluster will receive the experimental condition will be 30 months (Cluster 1), 24 months (Cluster 2), and 18 months (Cluster 3). Monthly study webinars will occur with all sites in step 0. During steps 1 and 2, sites in the experimental arm will have a monthly webinar separate from the group still in the control arm. By step 3 all sites will be a part of the same monthly webinar.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Order set review and modification
The antimicrobial stewardship program will review and change order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
Order set review and modification
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 plus facilitation
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 with facilitation
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.
Interventions
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Order set review and modification with facilitation
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
The antimicrobial stewardship program will work to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
Eligibility Criteria
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Inclusion Criteria
2. 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
Exclusion Criteria
0 Days
75 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Jason G Newland, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Johns Hopkins University School of Medicine / Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Harvard Medical School / Boston Children's Hospital
Boston, Massachusetts, United States
University of Michigan / CS Mott Children's Hospital
Ann Arbor, Michigan, United States
University of Missouri - Kansas City / The Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University in St. Louis / St. Louis Children's Hospital
St Louis, Missouri, United States
The Ohio State University College of Medicine / Nationwide Children's Hospital
Columbus, Ohio, United States
Vanderbilt University / Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, United States
University of Utah / Primary Children's Hospital
Salt Lake City, Utah, United States
University of Washington / Seattle Children's Hospital
Seattle, Washington, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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SHARPS Collaborative Website
American Academy of Pediatrics Choosing Wisely- Infectious Diseases
Other Identifiers
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201912100
Identifier Type: -
Identifier Source: org_study_id