Reducing Duration of Postoperative Prophylactic Antibiotic Usage in Neonatal Surgical Patients

General Information

Institution Name: The Hospital for Sick Children

Primary Author Name and Title: Ashley Blagdon, MD, FRCPC (Neonatologist)

Co-Authors and Titles: Niki Oikonomopoulou, MD (Neonatal Fellow); Brian C. Gulack, MD, MHS (Surgical Fellow); Annie Fecteau MD (Pediatric Surgeon); Michelle Science, MD (Infectious Disease Specialist); Kathryn Timberlake, PhD (Antimicrobial Stewardship Pharmacist); Carlos Zozoya, MD (Neonatal Fellow); Adrianne Bischoff, MD (Neonatal Fellow); Liran Tamir-Hostovsky, MD (Neonatal Fellow); Mohammed Abu Helwa, MD (Neonatal Fellow); Marta Garcia, MD (Neonatal Fellow); and Kyong-Soon Lee, MD (Neonatologist)

Name of the Case Study: Reducing Duration of Postoperative Prophylactic Antibiotic Usage in Neonatal Surgical Patients

What Was Done?

Global Problem Addressed

Neonates undergoing surgical procedures are commonly exposed to antibiotics due to concerns regarding significant morbidity and mortality from infection. "Clean" and "clean-contaminated" operative wounds have a low risk of infection; 1 to 5 percent and 5 to 15 percent, respectively.¹ There is substantial variation among hospitals in Canada and the United States 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 are extrapolations from adult data and not applicable for patients less than one year of age.^7-9 Currently there are no consensus guidelines for postoperative antibiotic use in neonates; notably there is no evidence to support the prolonged use of antibiotics in the immediate postoperative period. Inappropriate antibiotic use in this vulnerable population has well-recognized 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 those having contaminated surgeries, is warranted.

Identification of Local Problem

A preliminary review of antibiotic utilization practices in the Neonatal Intensive Care Unit (NICU) at The Hospital for Sick Children in Toronto, ON, demonstrated that the preferred duration of prophylactic antibiotics during the immediate postoperative period varies greatly among surgeons, ranging from 24 hours up to seven days. This wide variation in practice provided a key 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 greater than 24 hours. The median (interquartile range [IQR]) duration of antibiotics during this baseline period was 41 (24, 48) hours.

How Was the Quality Improvement (QI) Activity Put in Place?

Context of the QI Activity

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 per year, among which approximately 350 have a primary admission diagnosis of a surgical condition. There are 10 to 20 surgical procedures per month. 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 was among the organizations’ own 2017 Choosing Wisely Canada list of five things physicians and patients should question.^13,14

Planning and Development Process

We recruited a multidisciplinary team of neonatal and surgical physicians, infectious disease specialists, and an antimicrobial stewardship pharmacist. Problem characterization through fishbone analysis (Figure 1) and process mapping (Figure 2) revealed that creating a clear, evidence-based guideline with consistent definitions would likely be most effective. The acceptance and implementation of a new practice guideline amongst a large group of practitioners in both the neonatal and surgical teams was anticipated to be challenging. Hence, we identified and engaged key stakeholders including nursing, physicians, pharmacists, and policy administrators through education sessions and regular team rounds led by our neonatology and surgical QI team leads. All stakeholders were provided with 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 success with 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 version 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 surgical conditions who underwent ‘clean’ or ‘clean-contaminated’ procedures, and the guideline recommended the discontinuation of prophylactic antibiotics at or before 24 hours postoperatively (Appendix A). The definitions of wound classifications including ‘clean’ and ‘clean-contaminated’ were derived from the Center for Disease Control.¹

Description of the Quality Improvement Activity

After reaching consensus on the guideline, our project leads presented education sessions to key stakeholders that included individuals across varying levels of training and focus and involved residents, fellows, and attending physicians as well as bedside nurses and nurse practitioners.

We implemented the guideline on 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 included education sessions during NICU team and research rounds, during which we highlighted the presence of, and rationale for, the guideline; as well as discussion during NICU antimicrobial stewardship program (ASP) rounds that occurred twice every week. We further promoted the guideline through email communication 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 earlier in October 2017 as part of a Children’s Hospitals Neonatal Consortium QI collaborative; whose earlier work 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 non-compliance 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

Staff

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.

Costs and Funding Sources

There were no additional costs or funding sources necessary to implement and maintain this QI initiative.

What Were the Results?

Overall Results

The primary outcome measure was the percentage of eligible surgical patients in the NICU receiving prophylactic antibiotics for greater 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 true adverse outcomes related to our intervention. Inclusion criteria were as follows:

1. Gestational age greater than or equal to 35 weeks (no weight restriction)
2. Congenital gastrointestinal (GI) conditions (i.e., tracheoesophageal fistula/ esophageal atresia (TEF/EA), intestinal atresia, anorectal malformations, omphalocele, gastroschisis, malrotation)
3. Surgery considered ‘clean’ or ‘clean-contaminated’ per Appendix A
4. 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, all surgical cases admitted to the NICU were reviewed for eligibility by three physicians (AB, NO and KSL). Information was obtained from the patients’ electronic medical 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.

Process measures were reasons for non-compliance, 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

Analysis

Outcome and process measures were evaluated on statistical process control (SPC) charts. Signals, indicating special cause, were identified by using standard control chart rules.22 Descriptive statistics were used to describe baseline data. To compare data from the baseline and post-intervention periods, the chi-square test was used for proportions (proportion with discontinuation of antibiotics with 24 hours postoperatively), and the Mann Whitney U test was used for non-normally distributed continuous variables (duration of antibiotics).

Results

We evaluated a total of 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, 6 months) and 39 in the postintervention period (February 2019 to December 2019, 11 months). The proportion of neonates who received prophylactic antibiotics >24 hours postoperatively decreased from 56 percent (14/25) to 36 percent (14/39) in the pre and postintervention periods respectively (p=0.114). Among these patients who continued antibiotics for >24 hours, the reasons are summarized in the table below.

The duration of prophylactic postoperative antibiotics decreased from median (IQR) 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 >24 hours by each month is shown in the p chart in Figure 3.

There was overall improvement over time in the proportion of patients who received prophylactic postoperative antibiotics >24 hours, and the duration of postoperative antibiotics. While the overall proportion decreased after implementation, 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 4. During the full six-month period, antibiotic duration was discussed in 84 percent (80/95) of cases.

For the balancing measures, there were no differences in the pre and postintervention periods. There were two cases of SSI, one during the preintervention period in a patient who had Ladd’s procedure for malrotation and had stoppage of antibiotics 4.7 hours postoperatively and 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, there were two in the preintervention period (one for urinary tract infection [UTI] prophylaxis and a second patient 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). None of these cases who had a restart of antibiotics had concerns regarding infection after discontinuation of postoperative prophylactic antibiotics.

In summary, we achieved our aim to decrease the proportion of neonates receiving prophylaxis antibiotics for ‘clean’ or ‘clean-contaminated’ general surgical procedures beyond the 24-hour postoperative period, and also the duration of antibiotic use in the postoperative period. There were no adverse effects of this intervention in terms of an increase in SSI or need to restart antibiotics within seven days of discontinuation.

Setbacks

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 the guidelines were clear and easy to understand, and disseminated them via multi-modal methods including lectures, emails, and screensavers on NICU computers.

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 outborn unit with no deliveries onsite, and patients are transferred from referral sites frequently already on antibiotics after a partial septic work-up, prior to any contact with our site. Since 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 due to perinatal risk factors. Review of the cases started on antibiotics prior to transfer demonstrated that the majority of cases did have an appropriate indication for starting antibiotics postnatally (e.g., maternal risk factors for chorioamnionitis or late preterm delivery between 35 and 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.

Cost Savings

We focused on practice changes to reduce overall unnecessary antimicrobial utilization. While 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 due to reduced medication use, and potentially a shorter duration of intravenous line use and reduced length of stay.

Tips for Others

Getting Started

A crucial factor for success was the early engagement of key stakeholders at the conceptualization stage, including healthcare providers from surgery, neonatology, infectious diseases, and pharmacy. We included hospital leaders from the surgical program and ASP into the core neonatology 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 existence, largely in part due to previous and ongoing QI projects. We built on the success of a prior collaborative project among surgeons and neonatologists that implemented a perioperative huddle. We utilized the existing checklist, which was part of a previous QI project, to heighten awareness of our goal to reduce postoperative prophylactic antibiotics 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 utilized support from our information technology manager to minimize the amount of manual extraction of data.

How to Sustain the Activity

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 and it was not a major change to add an additional item to discuss the duration of postoperative antibiotics. We also utilized 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. Additionally, 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 facilitated sustainability of the interventions.

From frontline staff feedback, 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. Thus, these two interventions are the most important to maintain. Spot audits to track postoperative antibiotic use with feedback to frontline providers would also support sustainability.

Acknowledgments

We would like to acknowledge Rosanna Yankanah, NICU Research Manager, for assistance with REDCap database creation.

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