Neonates undergoing surgical procedures are commonly exposed to antibiotics to prevent morbidity and mortality from infection. “Clean” and “clean-contaminated” operative wounds have a low risk of infection: 1–5 percent and 5–15 percent, respectively.1 There is substantial variation among hospitals in Canada and the U.S. regarding appropriate postoperative antibiotic prophylaxis for the neonatal population.2-6 Limited data and guidelines for pediatric patients can be found in the literature, but these resources are extrapolated from adult data and are inapplicable to infants.7-9 No consensus guidelines are available at present for postoperative antibiotic use in neonates; notably, no evidence exists to support the prolonged use of antibiotics in the immediate postoperative period.
FIGURE 1. FISHBONE DIAGRAM DEMONSTRATING POTENTIAL CAUSES OF PROLONGED USE OF POSTOPERATIVE ANTIBIOTICS
Inappropriate antibiotic use in this vulnerable population has adverse effects, including altered microbiome, antimicrobial resistance, increased rates of necrotizing enterocolitis, and longer duration of intravenous access.10-12 Therefore, judicious use of antibiotics only for neonates at significant risk of infection, such as newborns who have contaminated operations, is warranted.
A preliminary review of antibiotic use in the neonatal intensive care unit (NICU) at The Hospital for Sick Children, Toronto, ON, demonstrated that the preferred duration of prophylactic antibiotics during the immediate postoperative period varies greatly among surgeons, ranging from 24 hours to seven days. This wide variation in practice provided an opportunity to improve quality of care and outcomes. Baseline data for the period July 1 to December 31, 2018, for neonates admitted to the NICU with clean or clean-contaminated general surgical conditions identified that 14 of 25 (56 percent) patients who fulfilled the inclusion criteria received postoperative antibiotic prophylaxis for more than 24 hours. The median (interquartile range [IQR]) duration of antibiotics during this baseline period was 41 (24, 48) hours.
Putting the QI initiative into place
The NICU at The Hospital for Sick Children serves as the quaternary NICU for a catchment area of 75,000 annual births in Ontario, Canada. The unit has 38 beds, with 800 admissions annually, among which approximately 350 have a primary admission diagnosis of a surgical condition, and 10–20 surgical procedures are performed monthly. This quality improvement (QI) project aligned with our corporate QI plan to improve antibiotic prophylaxis after surgery. Discontinuation of routine use of antibiotics for prophylaxis against surgical site infection (SSI) after leaving the operating room (OR) was among the hospital’s own 2017 Choosing Wisely Canada list of five questions physicians and patients should consider.13,14
FIGURE 2. PROCESS MAP DEMONSTRATING THE STEPS LEADING TO A DECISION TO DISCONTINUE POSTOPERATIVE ANTIBIOTICS
We recruited a multidisciplinary team of neonatal and surgical physicians, infectious disease specialists, and an antimicrobial stewardship pharmacist. Problem characterization through analysis of a fishbone diagram (see Figure 1) and process mapping (see Figure 2) revealed that creating a clear, evidence-based guideline with consistent definitions would likely be most effective. We anticipated that the acceptance and implementation of a new practice guideline among a large group of practitioners in both the neonatal and surgical teams would be challenging. Hence, we identified and engaged key stakeholders, including nurses, physicians, pharmacists, and policy administrators, through education sessions and regular team rounds led by our neonatology and surgical QI team leads.
All stakeholders had an opportunity to review and provide feedback throughout the project. Our strategy included a series of plan-do-study-act (PDSA) cycles. Evaluation of the data generated by each test of change was both quantitative and qualitative to help determine the best next step based on the adopt, adapt, or abandon model.
Our core QI team met monthly to monitor progress through the cycles, seek feedback, and ensure successful implementation. We reviewed the literature as well as guidelines from other institutions and surveyed our clinicians to create a practice recommendation.15-19 A draft of the guideline was presented to the main stakeholders, feedback was incorporated, and consensus was achieved. We planned to focus on neonates with congenital general surgery conditions who underwent clean or clean-contaminated procedures, and the guideline recommended the discontinuation of prophylactic antibiotics at or before 24 hours postoperatively (see Appendix A in Figure 3). The definitions of wound classifications, including “clean” and “clean-contaminated,” were derived from the Centers for Disease Control and Prevention.
FIGURE 3. APPENDIX A: NICU POST-OPERATIVE ANTIBIOTIC PROPHYLAXIS GUIDELINE
After reaching consensus on the guideline, our project leads presented education sessions to key stakeholders, which included individuals across varying levels of training and focus. Residents, fellows, attending physicians, bedside nurses, and nurse practitioners were involved. The guideline was implemented February 20, 2019, and we evaluated the impact on antibiotic use monthly. We observed that the initial improvement during the first month was not sustained; therefore, we added interventions to increase awareness of the guidelines. These activities included education sessions during NICU team and research rounds, during which we highlighted the presence of, and rationale for, the guideline, as well as discussions during twice-weekly NICU antimicrobial stewardship program (ASP) rounds. We further promoted the guideline through e-mails to all NICU staff and the addition of a screensaver highlighting the rationale for the guidelines on all computers in the NICU.
Next, we tackled the challenge of connecting the multiple subspecialty teams. We increased discussion between NICU and surgery house staff regarding antibiotic duration during weekly subspecialty NICU and surgery rounds. We also added a prompt to discuss the duration of postoperative antibiotics on our existing postoperative huddle checklist. The postoperative huddle checklist was implemented in October 2017 as part of a Children’s Hospitals Neonatal Consortium QI collaborative, which has demonstrated success in improving postoperative hypothermia.20
Our final intervention was to audit and provide feedback to the NICU and surgery teams. We presented and discussed the results of our project during combined NICU and surgery rounds in November 2019, with emphasis on the indications observed for noncompliance and the lack of demonstrated risk.
The Hospital for Sick Children quality review committee reviewed this project and provided approval and a waiver of research ethics board review.
Resources used and skills needed
Our multidisciplinary core QI team of 12 people included neonatal and surgical physicians, infectious disease specialists, and an antimicrobial stewardship pharmacist. Key stakeholders included all neonatal and surgical trainees, attending physicians, neonatal and surgical nurse practitioners, neonatal nurses, and policy administrators.
TABLE 1. REASONS FOR CONTINUATION OF ANTIBIOTICS
No additional costs or funding sources were necessary to implement and maintain this QI initiative.
The primary outcome measure was the percentage of eligible surgical patients in the NICU receiving prophylactic antibiotics for more than 24 hours postoperatively. The secondary outcome was the duration of postoperative antibiotic prophylaxis in hours. We included only those neonates who had low risk for postoperative infection who could be evaluated for adverse outcomes related to our intervention. Inclusion criteria were as follows:
- Gestational age of at least 35 weeks Congenital gastrointestinal (GI) conditions (that is, tracheoesophageal fistula/esophageal atresia, intestinal atresia, anorectal malformations, omphalocele, gastroschisis, malrotation)
- Operation considered clean or clean-contaminated
- Antibiotic duration as prescribed for prophylaxis and not for completion of sepsis protocol with risk factors or treatment of active infection
At the end of each month, three physicians reviewed all surgical cases admitted to the NICU for eligibility. Information was obtained from the patients’ electronic health record through review of progress notes, surgical case notes, and the medication administration record. Data were entered into the Research Electronic Data Capture (REDCap) database. The duration of antibiotics was calculated from the date and time of administration of the first dose to the start of the last dose during the postoperative period.
FIGURE 4. STATISTICAL PROCESS CONTROL P-CHART FOR OUTCOME MEASURE
Process measures were reasons for noncompliance, specifically the incidence of NICU team or surgical team preference, and the discussion of antibiotic duration during the postoperative huddle.
These measures were included to screen for contributing systems issues and to focus future interventions.
Balancing measures included the incidence of SSI among patients who had discontinuation of antibiotics within 24 hours postoperatively, and the number of patients restarted on antibiotics within one week of discontinuation. SSI was defined as localized erythema, swelling, pain, and/or purulent drainage at or near the surgical site, with or without a fever, occurring within 30 days of surgery.21
Outcome and process measures were evaluated on statistical process control charts. Signals, indicating special cause, were identified using standard control chart rules.22 Descriptive statistics were used to describe baseline data. To compare data from the baseline and postintervention periods, the chi-square test for proportions (proportion with discontinuation of antibiotics with 24 hours postoperatively) was used, and the Mann Whitney U test was used for non-normally distributed continuous variables (duration of antibiotics).
We evaluated 64 neonates who had clean or clean-contaminated congenital GI surgery over an 18-month period with 25 in the preintervention period (July 2018 to December 2018) and 39 in the postintervention period (February 2019 to December 2019). The proportion of neonates who received prophylactic antibiotics more than 24 hours postoperatively decreased from 56 percent (14/25) to 36 percent (14/39) in the pre- and postintervention periods, respectively (p = 0.114). The reasons for continuing antibiotics for more than 24 hours are summarized in Table 1.
The duration of prophylactic postoperative antibiotics decreased from a median of 41 (24, 48) hours to 18 (16, 41) hours in the pre- and postintervention periods, respectively (p = 0.01).
The proportion of cases with antibiotic duration of more than 24 hours by each month is shown in Figure 4.
There was overall improvement over time in the proportion of patients who received prophylactic postoperative antibiotics for more than 24 hours and the duration of postoperative antibiotics.
The overall proportion decreased after implementation, but there was major fluctuation in the proportions for each month.
The process measure, compliance with discussion of duration of antibiotics in the postoperative huddle for each month since implementation, is shown in Figure 5. During the full six-month period, antibiotic duration was discussed in 84 percent (80/95) of cases.
FIGURE 5. DISCUSSION OF ANTIBIOTIC DURATION DURING POSTOPERATIVE HUDDLE
For the balancing measures, no differences were noted in the pre- and postintervention periods. Two cases of SSI arose—one during the preintervention period in a patient who had Ladd’s procedure for malrotation and had stoppage of antibiotics 4.7 hours postoperatively, who developed SSI and wound dehiscence two days postoperatively; and the second case during the postintervention period in a patient who had anorectal malformation and had stoppage of antibiotics 37.5 hours postoperatively, who developed SSI four days postoperatively. Among patients who had antibiotics restarted within seven days of stopping prophylactic postoperative antibiotics, two were in the preintervention period—one for urinary tract infection (UTI) prophylaxis and one who was treated for possible culture-negative meningitis based on recurrent fever and head ultrasound abnormalities; and 10 in the postintervention phase (eight for UTI prophylaxis, one for polysplenia prophylaxis, and one for prophylaxis for chest tube insertion). In none of these cases were concerns raised regarding infection due to early discontinuation of postoperative prophylactic antibiotics.
In summary, we achieved our aim to decrease the proportion of neonates receiving prophylactic antibiotics for clean or clean-contaminated general surgery procedures beyond the 24-hour postoperative period, and the duration of antibiotic use in the postoperative period. This intervention had no adverse effects in terms of an increase in SSI or need to restart antibiotics within seven days of discontinuation.
At the project outset, we anticipated challenges in obtaining support for a standardized guideline from all members of the neonatology and surgery team. To overcome this challenge, we involved neonatology and surgical staff at the conceptualization stage and included leadership from both disciplines in our core quality team. We formally presented the literature on the negative effects of prolonged antibiotic administration, and the judicious use of antibiotics at other major children’s hospitals during joint surgery and neonatology rounds. All neonatologists and general surgeons had an opportunity to provide feedback on the draft guidelines prior to finalization. We ensured that the guidelines were clear and easy to understand, and disseminated them via multi-modal methods described previously.
Initially, we planned to target a reduction in the inappropriate initiation of antibiotics for all surgical patients but found that this was difficult to achieve. Our NICU is an out-born unit with no deliveries onsite. Patients transferred from referral sites frequently are already on antibiotics after a partial septic work-up before any contact with our site. Because surgery for congenital GI conditions often occurred within the first 24 hours of life, the continuation of antibiotics beyond 24 hours postoperatively may have been part of the preoperative plan given perinatal risk factors. Review of the cases started on antibiotics before transfer demonstrated that most cases did have an appropriate indication for starting antibiotics postnatally (for example, maternal risk factors for chorioamnionitis or late preterm delivery 35−37 weeks gestational age). As antibiotics were appropriately initiated, there was no indication for practice change to not initiate antibiotics; therefore, we abandoned this aim to decrease initiation of preoperative antibiotics.
We focused on practice changes to reduce overall unnecessary antimicrobial use. Although we did not measure specific cost savings, the overall reduction in antibiotic use without a significant increase in adverse outcomes is anticipated to reduce costs.
Tips for others
A crucial factor for success was the early engagement of key stakeholders at the conceptualization stage, including health care professionals from surgery, neonatology, infectious diseases, and pharmacy. We included hospital leaders from the surgical program and ASP into the core quality team, which was essential to ensuring staff buy-in, especially by the surgical group.
At our institution, a strong multidisciplinary relationship between surgery and neonatology was already in place, largely as a result of previous and ongoing QI projects. We built on the success of a previous collaborative project among surgeons and neonatologists that implemented a perioperative huddle. We used the checklist developed as part of the previous QI project to heighten awareness of our goal to reduce postoperative prophylactic antibiotic use. We also aligned our aims with hospital-wide priorities of antimicrobial stewardship and external collaborations, such as Choosing Wisely Canada, which ensured executive leadership buy-in.
The presentation of real-time local data, external standards, and the literature were key steps that increased the acceptability of the practice change. For real-time data, we used support from our information technology manager to minimize manual extraction of data.
In a busy, high-acuity NICU that has multiple frontline staff with frequent turnover, a fundamental strategy was to ensure that any interventions to promote compliance were incorporated into routine events and did not require a significant effort or time expenditure from any individual. We embedded reminders for antibiotic stewardship within processes that already existed in the culture of the NICU and selected events that required the leadership of permanent staff rather than temporary rotating staff such as residents and fellows. For instance, we capitalized on the preexisting postoperative huddles that had been established for all surgical procedures since 2017 and were led by NICU charge nurses.
During these huddles, a checklist was used 100 percent of the time, so it was a minor change to add an additional item to discuss the duration of postoperative antibiotics. We also used the twice-weekly ASP rounds established in 2012 within the NICU that were led by the hospital ASP team consisting of an infectious disease physician and pharmacist. All patients on antibiotics were routinely reviewed jointly with the NICU house staff and a surgical fellow or nurse practitioner. It was not overly onerous to add a question to these rounds regarding whether postoperative antibiotics could be discontinued.
In addition, we reviewed and presented preliminary results after each PDSA cycle to provide direct feedback and education to key stakeholders during neonatal-surgical multidisciplinary rounds. Embedding reminders and reinforcements helped to consolidate the change and facilitate sustainability of the interventions.
Frontline staff feedback indicated that the most helpful interventions included reminders to stimulate discussion among house staff about the duration and indication of postoperative antibiotics during the twice-weekly ASP rounds, and the prompt on the postoperative huddle checklist. Spot audits to track postoperative antibiotic use with feedback to frontline providers also would support sustainability.
We would like to acknowledge Rosanna Yankanah, NICU Research Manager, for assistance with REDCap database creation.
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