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Published on: September 20, 2019
A cluster randomized stepped-wedge trial to de-implement unnecessary post-operative antibiotics in children: the
Sara Malone1,2, Virginia R McKay1, Christina Krucylak2
1Brown School, Washington University in St. Louis, St. Louis, MO, USA.
Insights
This study evaluates strategies to reduce unnecessary antibiotic use in children after low-risk surgery. Findings will inform antibiotic stewardship programs and combat resistance.
Area of Science:
- Implementation Science
- Pediatric Infectious Diseases
- Antimicrobial Stewardship
Background:
- Antibiotic-resistant infections pose a significant public health threat, largely due to antibiotic misuse.
- Antibiotic stewardship programs (ASP) are crucial in the US for combating antibiotic resistance.
- Overuse of post-operative antibiotics in low-risk pediatric surgeries is a key area for intervention.
Purpose of the Study:
- To assess the effectiveness of order set changes and facilitation training in de-implementing unnecessary post-operative antibiotics in children.
- To evaluate the impact of these strategies on clinical outcomes, including surgical site infections and C. difficile infections.
- To understand the implementation process and outcomes, such as acceptability, appropriateness, and feasibility.
Main Methods:
- A 3-year stepped wedge cluster randomized trial across nine US Children's Hospitals.
- Intervention involves order set modification and a 2-day facilitation training workshop for antibiotic stewardship teams.
- Primary outcome: percentage of surgical cases receiving unnecessary post-operative antibiotics; secondary outcomes: surgical site infection and C. difficile infection rates.
Main Results:
- The study is ongoing; results are pending.
- Data collection includes monthly interviews to assess implementation progress.
- Key implementation metrics focus on order set penetration and team-reported strategy assessments.
Conclusions:
- This trial will yield critical data on de-implementation strategies for unnecessary antibiotic use in pediatric surgery.
- Rigorous evaluation of de-implementation methods, including facilitation, is essential for improving healthcare practices.
- Further research is needed to advance the field of de-implementation in medicine.
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 .
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