TY - JOUR
T1 - A cluster randomized stepped-wedge trial to de-implement unnecessary post-operative antibiotics in children
T2 - the optimizing perioperative antibiotic in children (OPerAtiC) trial
AU - Malone, Sara
AU - McKay, Virginia R.
AU - Krucylak, Christina
AU - Powell, Byron J.
AU - Liu, Jingxia
AU - Terrill, Cindy
AU - Saito, Jacqueline M.
AU - Rangel, Shawn J.
AU - Newland, Jason G.
N1 - Funding Information:
Research reported in this publication was made possible by the Washington University Institute of Clinical and Translational Sciences grant UL1TR002345 from the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH). Specifically, the Dissemination and Implementation Research Core provided key assistance to the success of this proposal. The content is solely the responsibility of the authors and does not necessarily represent the official view of the NIH.
Funding Information:
This work was funded by the Agency for Healthcare Research and Quality R01 HS26742-01A1. BP was supported by the National Institute of Mental Health through K01 MH113806. The content is solely the responsibility of the authors and does not necessarily represent the views of the agency.
Funding Information:
JGN has funding from Pfizer and Merck to perform industry funded clinical trials. Additionally, Merck has funded projects to assess antibiotic use in children’s hospitals and adult post-operative antibiotic use. All other authors declare that they have no competing interests.
Publisher Copyright:
© 2021, The Author(s).
PY - 2021/12
Y1 - 2021/12
N2 - Background: Antibiotic-resistant infections have become a public health crisis that is driven by the inappropriate use of antibiotics. In the USA, antibiotic stewardship programs (ASP) have been established and are required by regulatory agencies to help combat the problem of antibiotic resistance. Post-operative antibiotic use in surgical cases deemed low-risk for infection is an area with significant overuse of antibiotics in children. Consensus among leading public health organizations has led to guidelines eliminating post-operative antibiotics in low-risk surgeries. However, the best strategies to de-implement these inappropriate antibiotics in this setting are unknown. Methods/design: A 3-year stepped wedge cluster randomized trial will be conducted at nine US Children’s Hospitals to assess the impact of two de-implementation strategies, order set change and facilitation training, on inappropriate post-operative antibiotic prescribing in low risk (i.e., clean and clean-contaminated) surgical cases. The facilitation training will amplify order set changes and will involve a 2-day workshop with antibiotic stewardship teams. This training will be led by an implementation scientist expert (VRM) and a pediatric infectious diseases physician with antibiotic stewardship expertise (JGN). The primary clinical outcome will be the percentage of surgical cases receiving unnecessary post-operative antibiotics. Secondary clinical outcomes will include the rate of surgical site infections and the rate of Clostridioides difficile infections, a common negative consequence of antibiotic use. Monthly semi-structured interviews at each hospital will assess the implementation process of the two strategies. The primary implementation outcome is penetration, which will be defined as the number of order sets changed or developed by each hospital during the study. Additional implementation outcomes will include the ASP team members’ assessment of the acceptability, appropriateness, and feasibility of each strategy while they are being implemented. Discussion: This study will provide important information on the impact of two potential strategies to de-implement unnecessary post-operative antibiotic use in children while assessing important clinical outcomes. As more unnecessary medical practices are identified, de-implementation strategies, including facilitation, need to be rigorously evaluated. Along with this study, other rigorously designed studies evaluating additional strategies are needed to further advance the burgeoning field of de-implementation. Trial registration: NCT04366440. Registered April 28, 2020, https://clinicaltrials.gov/ct2/show/NCT04366440.
AB - Background: Antibiotic-resistant infections have become a public health crisis that is driven by the inappropriate use of antibiotics. In the USA, antibiotic stewardship programs (ASP) have been established and are required by regulatory agencies to help combat the problem of antibiotic resistance. Post-operative antibiotic use in surgical cases deemed low-risk for infection is an area with significant overuse of antibiotics in children. Consensus among leading public health organizations has led to guidelines eliminating post-operative antibiotics in low-risk surgeries. However, the best strategies to de-implement these inappropriate antibiotics in this setting are unknown. Methods/design: A 3-year stepped wedge cluster randomized trial will be conducted at nine US Children’s Hospitals to assess the impact of two de-implementation strategies, order set change and facilitation training, on inappropriate post-operative antibiotic prescribing in low risk (i.e., clean and clean-contaminated) surgical cases. The facilitation training will amplify order set changes and will involve a 2-day workshop with antibiotic stewardship teams. This training will be led by an implementation scientist expert (VRM) and a pediatric infectious diseases physician with antibiotic stewardship expertise (JGN). The primary clinical outcome will be the percentage of surgical cases receiving unnecessary post-operative antibiotics. Secondary clinical outcomes will include the rate of surgical site infections and the rate of Clostridioides difficile infections, a common negative consequence of antibiotic use. Monthly semi-structured interviews at each hospital will assess the implementation process of the two strategies. The primary implementation outcome is penetration, which will be defined as the number of order sets changed or developed by each hospital during the study. Additional implementation outcomes will include the ASP team members’ assessment of the acceptability, appropriateness, and feasibility of each strategy while they are being implemented. Discussion: This study will provide important information on the impact of two potential strategies to de-implement unnecessary post-operative antibiotic use in children while assessing important clinical outcomes. As more unnecessary medical practices are identified, de-implementation strategies, including facilitation, need to be rigorously evaluated. Along with this study, other rigorously designed studies evaluating additional strategies are needed to further advance the burgeoning field of de-implementation. Trial registration: NCT04366440. Registered April 28, 2020, https://clinicaltrials.gov/ct2/show/NCT04366440.
KW - Antibiotic stewardship
KW - Cluster randomized stepped-wedge trial
KW - De-implementation
KW - Facilitation
UR - http://www.scopus.com/inward/record.url?scp=85102800189&partnerID=8YFLogxK
U2 - 10.1186/s13012-021-01096-1
DO - 10.1186/s13012-021-01096-1
M3 - Article
C2 - 33741048
AN - SCOPUS:85102800189
VL - 16
JO - Implementation Science
JF - Implementation Science
SN - 1748-5908
IS - 1
M1 - 29
ER -