Colorado Antibiotic Stewardship Collaborative – Neonatal Early Onset Sepsis

CASC-NEOS

Abbreviation

Antibiotic Stewardship for Neonatal Early Onset Sepsis

There is no question that antibiotics can save the lives of infants affected by early onset sepsis (EOS). However, a growing body of research shows antibiotics are being overprescribed for infants without true sepsis who don’t need such aggressive treatment. Furthermore, studies have shown that there are inexplicable, dramatic differences between hospitals in the frequency of antibiotic utilization in newborns (Schulman 2015). Many hospitals have successfully reduced neonatal antibiotic utilization without evidence for increased complications, using quality improvement methodology.

Potential risks for newborns exposed to antibiotics:

  • Higher incidence of allergies and asthma
  • Problems developing healthy intestinal bacteria
  • Increased likelihood of childhood obesity
  • Creation of treatment-resistant bacteria
  • Increased risk of necrotizing enterocolitis in premature neonates

The Centers for Disease Control and Prevention (CDC) estimates that antibiotic-resistant microbes cause > 2.8 million infections, resulting in over 35,000 deaths each year in the United States.

What can your hospital do? 

Simple, straightforward steps can make a big difference in your center’s antibiotic utilization rate (AUR) and create better outcomes for infants in your care. A 2018 American Academy of Pediatrics (AAP) Clinical Report proposed evidence-based approaches to sepsis risk assessment in newborns. The multivariate risk assessment approach endorsed in the Clinical Report has been shown to reduce exposure to antibiotics by almost 50% in some settings, without demonstrated adverse effects such as missed cases of sepsis (Puopolo 2018).

Some recommendations from the AAP and CDC include:

  • Carefully weigh risks and benefits of administering antibiotics in low-risk infants
  • Use a method (such as the Sepsis Risk Calculator) to risk-stratify newborns
  • Stop antibiotics when infection is not confirmed by appropriate cultures
  • In cases of true sepsis, prescribe antibiotics specific to the cultured bacteria
  • Create a guideline that promotes a consistent, evidence-based approach to evaluation and treatment of EOS

Our Approach: Antibiotic Stewardship Toolkit

The Colorado Antibiotic Stewardship Collaborative developed this toolkit of resources to be used by hospitals that would like to implement their own Neonatal Early Onset Sepsis quality improvement initiatives. The toolkit is designed to support teams through a self-directed quality improvement project. 

Guidance in this toolkit is specific to care of neonates age 0-7 days who were born ≥35 weeks gestation.

To get started, we recommend that you:

  • Review the 2018 American Academy of Pediatrics (AAP) Clinical Report
  • Determine which interventions are most relevant in your specific setting 
  • Utilize the resources in the Neonatal Antibiotic Stewardship Toolkit (sidebar) to begin your Neonatal Early Onset Sepsis antibiotic stewardship improvement journey.

Resources to guide you are included throughout this toolkit. However, you may contact info@cpcqc.org if you have any questions or require additional support.

About the Colorado Antibiotic Stewardship Collaborative – Neonatal Early Onset Sepsis (CASC-NEOS)

In 2015, the CDC and the Vermont Oxford Network (VON) launched a collaborative QI platform for antibiotic stewardship in newborns (Choosing Antibiotics Wisely). CPCQC formed CASC, a statewide collaborative that included 17 Colorado hospitals, to participate in this initiative. When the Choosing Antibiotics Wisely initiative ended, many CASC hospitals continued their work to reduce unnecessary antibiotic exposure in Colorado’s hospitalized newborns through CASC-NEOS. 

The CASC-NEOS Steering Committee developed this toolkit to share best practices and lessons learned through implementation of similar interventions at their hospitals. We would like to thank the Steering Committee members for their contributions to this toolkit and overall commitment to antibiotic stewardship. The list below includes Steering Committee members and the hospitals they worked with to implement neonatal antibiotic stewardship interventions:

  • Dr. Bobbi Chambers-Hawk (Neonatologist), Banner Health North Colorado Medical Center
  • Tracy Heaberlin (Neonatal Nurse Practitioner), Banner Health North Colorado Medical Center
  • Dr. Jeff Homann (Pharmacist), UCHealth Poudre Valley Hospital, UCHealth Greeley, UCHealth Medical Center of the Rockies
  • Dr. Mary R Laird (Neonatologist), Children’s Hospital Colorado, Colorado Springs, UCHealth Memorial Hospitals, and Parkview Medical Center
  • Carri Montgomery (RN, BSN, MSOL), Director of Women’s and Newborn Center, Platte Valley Medical Center
  • Melda Musick (Neonatal Nurse Practitioner), Children’s Hospital Colorado and  Platte Valley Medical Center
  • Scott Sveum (Pharmacist), CASC-NEOS Vice-Chair, Saint Joseph Hospital SCL Health
  • Dr. Pamela Zachar (Neonatologist), CASC-NEOS Chair

Implementing the Sepsis Risk Calculator (SRC)

Background and Resources

Background information from the 2018 AAP Clinical Report:

The Sepsis Risk Calculator (also known as the Kaiser Neonatal Sepsis Calculator and the Early Onset Sepsis Calculator) is a multivariate risk assessment tool that involves synthesis of established risk factors and the newborn clinical condition to estimate each infant’s specific risk of Early Onset Sepsis (EOS). This calculator was developed using information from over 600,000 newborn infants and has subsequently been validated in many sites throughout the world. It has been validated for use in infants delivered at 34 0/7 weeks gestational age or older (although this toolkit is intended for infants 35 0/7 weeks gestational age or older).

The calculator allows input of objective data including gestational age, the highest maternal intrapartum temperature, maternal GBS colonization status, the duration of rupture of membranes, and the type and duration of intrapartum antibiotic therapies. The calculator also includes information about the evolving newborn clinical condition during the first 2 to 4 hours after birth.

The advantages of this multivariate approach include:

  • It provides information about an infant’s individual risk 
  • It includes only objective data and not a clinical diagnosis of maternal chorioamnionitis 
  • It results in relatively few well-appearing newborn infants being treated empirically with antibiotic agents

Potential challenges include:

  • Implementation of the calculator requires workflow changes and staff education
  • Many infants will require closer monitoring off antibiotics to avoid missing cases of EOS

Resources:

References:

  • Puopolo KM, Benitz WE, Zaoutis TE; Committee on Fetus and Newborn; Committee on Infectious Diseases. Management of Neonates Born at ≥35 0/7 Weeks’ Gestation With Suspected or Proven Early-Onset Bacterial Sepsis. Pediatrics. 2018;142(6):e20182894. doi:10.1542/peds.2018-2894
  • Good PI, Hooven TA. Evaluating Newborns at Risk for Early Onset Sepsis. Pediatric Clinics of North America 66 (2019) 321–331. https://doi.org/10.1016/j.pcl.2018.12.003 
  • Achten NB, Klingenberg C, et al. Association of Use of the Neonatal Early-Onset Sepsis Calculator with Reduction in Antibiotic Therapy and Safety: A Systematic Review and Meta-analysis. JAMA Pediatrics 2019 Sep 3;173(11):1032-1040. doi: 10.1001/ jamapediatrics.2019.2825.
  • Deshmukh M, Mehta S, Patole S. Sepsis calculator for neonatal early onset sepsis – a systematic review and meta-analysis., Journal of Maternal-Fetal and Neonatal Medicine 2019 Aug 11;1-9. doi: 10.1080/14767058.2019.1649650.

Implementation Guidance 

Several CASC Steering Committee members implemented the SRC at their own hospital sites, and have developed numerous resources with suggestions for how others might implement the same practices.

  • SRC Implementation Tips from Platte Valley Medical Center
    This resource offers suggestions for SRC documentation, team communication, and nurse education during implementation. Sample report sheets are also included. 

    • [quote at side?]“Approximately six months after standardizing antibiotic treatment course durations, we knew if we adopted the SRC it would continue to improve consistency of practice within the pediatric groups.

      The proposal to adopt the SRC was presented to the Pediatric Clinical Section. It was approved and implementation was initiated. We found it standardized risk assessment and treatments. We were no longer treating babies who were clinically well with low risk factors. In addition, it decreased the number of CBC and blood cultures that were drawn. The AUR decreased, stabilized, and has remained within our set goals. The providers were grateful for standardization of practice overall improving newborn care.” – Carri Montgomery, Director Women’s and Newborn Services, Platte Valley Medical Center

Data Collection

Quick links to data collection resources are included here. For more information about data collection for Quality Improvement, go to “Creating a Neonatal Antibiotic Stewardship QI Team.”

Implementing other neonatal antibiotic stewardship best practices

Background and References

There are a number of neonatal antibiotic stewardship best practices that have been endorsed by the 2018 AAP Clinical Report in order to safely reduce the unnecessary use of antibiotics in neonates. These include:

  • Birth centers should consider the development of locally tailored, documented guidelines for EOS risk assessment and clinical management
  • Diagnosing infection with use of a properly collected blood or CSF culture, rather than ancillary tests, surface cultures, or improperly collected cultures
  • Using appropriate doses of ampicillin and gentamicin for empiric treatment of suspected sepsis in most infants, other than critically-ill infants
  • Standardizing the duration of empiric antibiotic therapy to 36-48 hours with negative blood and CSF cultures, unless there is clear evidence of site-specific infection

EOS Guideline Resources

The Sample Guideline linked below is an example of a comprehensive EOS guideline developed by Dr. Mary R Laird (neonatologist, Children’s Hospital Colorado). This example is meant to be used as a template for centers to begin creating their own EOS management guideline.

  • Sample Antibiotic Stewardship and Early Onset Sepsis Risk Calculator Guideline
  • Neonatal Blood Culture Collection
    • General Recommendations for Optimizing Blood Cultures
    • The Life of a Blood Culture (PQCNC)
    • When empiric antibiotics are recommended by the SRC, draw a blood culture, and utilize ampicillin and gentamicin. Refer to up to date published print or online references for neonatal dosing. Example references include Lexicomp, Harriet Lane Handbook, and Neofax (online versions are typically accessed through hospital licenses or personal paid subscriptions). Additionally, as of the writing of this toolkit, these publications included the most recent guidelines for dosing:
  • Reference for neonatal dosing: Puopolo KM, Lynfield R, and Cummings JJ, Committee on Fetus and Newborn; Committee on Infectious Diseases. Management of Infants at Risk for Group B Streptococcal Disease. Pediatrics August 2019, 144 (2) e20191881; DOI: https://doi.org/10.1542/peds.2019-1881
  • Reference for intrapartum antibiotic dosing: Committee on Obstetric Practice. Committee Opinion #712. Intrapartum Management of Intraamniotic Infection, Obstetrics and Gynecology, 2017 Aug;130(2):e95-e101. doi:10.1097/AOG.0000000000002236
  • References 
    • Puopolo KM, Lynfield R, and Cummings JJ, Committee on Fetus and Newborn; Committee on Infectious Diseases. Management of Infants at Risk for Group B Streptococcal Disease. Pediatrics August 2019, 144 (2) e20191881; DOI: https://doi.org/10.1542/peds.2019-1881
    • Puopolo KM, Benitz WE, Zaoutis TE; Committee on Fetus and Newborn; Committee on Infectious Diseases. Management of Neonates Born at ≥35 0/7 Weeks’ Gestation With Suspected or Proven Early-Onset Bacterial Sepsis. Pediatrics. 2018;142(6):e20182894. doi:10.1542/peds.2018-2894
    • Good PI, Hooven TA. Evaluating Newborns at Risk for Early Onset Sepsis. Pediatric Clinics of North America 66 (2019) 321–331. https://doi.org/10.1016/j.pcl.2018.12.003 
    • Ramasethu J and Kawakita T.  Antibiotic Stewardship in Perinatal and Neonatal Care.  Seminars in Fetal & Neonatal Medicine.  2017;22(5):278-283. PMID: 28735809. doi:10.1016/j.siny.2017.07.001

Implementation Guidance

Several CASC Steering Committee members implemented some of these suggested best practices at their own hospital sites, and have developed numerous resources with suggestions for how others might implement the same practices.

  • Standardizing antibiotic courses to 48 hours or less with a negative blood culture:
  • Jeff Homann, pharmacy: A multidisciplinary team (providers, pharmacy, nursing) agreed to a change in practice so that antibiotics would automatically be discontinued if blood cultures were negative at 36 hours. Next, Automatic Stop Orders were implemented via the Electronic Health Record. Now, if a provider wanted to continue a course of antibiotics beyond 48 hours, he or she needed to write an order to continue them, rather than remembering to discontinue the order. This was a big change in the mindset/workflow of the team and contributed to a culture of limiting antibiotic use when appropriate. 

We implemented a couple of feedback loops to let providers know how well they were complying with these new guidelines. First, the pharmacy compiles and shares the AUR run chart on a monthly basis. This information is posted on the unit and is a standing agenda item at our monthly quality meeting. On a more specific level, pharmacy privately informed each respective neonatologist of their antibiotic prescribing percentage relative to their peers. Luckily, we only did this once as it was relatively labor intensive and our AUR was improving independently of the specific feedback.

  • Carri Montgomery, nurse management: To begin with, we audited individual providers to determine the number of days of antibiotics typically prescribed. We wanted to confirm their average antibiotic order practices to determine inconsistencies. The ordering patterns were 2, 3, 4, 5, 6, or 7 days or a variance thereof.  Ordering of antibiotics was inconsistent. 

Through our work with the CASC group, we became familiar with the evidence for clearly defined antibiotic ordering best practices. We took this information to the Special Care Nursery provider work group. This group updated the policy to reflect standards of care based on this evidence. We standardized ordering practices to 36-48 hours with a negative blood culture and a clinically improved patient. The group decided if the baby did not clinically improve after 48 hours even with a negative blood culture the standard ordering practice would be seven days of antibiotic treatment. 

The proposal for standardized durations of antibiotic prescription was presented to the Pediatric Clinical Section. The policy was approved and adopted. The data reflected standardization of ordering practice and decrease in AUR. Once implemented, we followed up with individual providers as needed to remind them when their prescribing practices did not meet the agreed-upon guidelines.

Data Collection

Quick links to data collection resources are included here. For more information about data collection for Quality Improvement, go to “Creating a Neonatal Antibiotic Stewardship QI Team.”

Creating a neonatal antibiotic stewardship quality improvement team

Background and Resources

Any of the toolkit elements can be implemented as a stand-alone measure in your center. However, for hospitals that would like to create a sustainable culture change around antibiotic stewardship, it will be valuable to implement these measures as part of a more global quality improvement effort. 

The Centers for Disease Control and Prevention outlines seven Core Elements of Hospital Antibiotic Stewardship Programs:

Source: The Core Elements of Hospital Antibiotic Stewardship Programs, 2019

This work will start with the assembly of a multidisciplinary team that includes representatives from each stakeholder group involved with the delivery of antibiotics to neonates in your hospital. It will also be important to set a regular meeting schedule that should be at least monthly and possibly more frequent at the outset.

 Team members might include: 

  • Senior Leaders (CNO, CMO, CEO)
  • Providers (MD, NP/PA)
  • Pharmacists
  • L&D Nursing Staff
  • Nursery Nursing Staff
  • Nurse Managers
  • EMR IT Staff
  • Lab/Microbiology Technician(s)
  • Families 

Implementation Guidance

Several CASC Steering Committee members established a Quality Improvement Team at their own hospitals, and have developed numerous resources with suggestions for how others might implement the same practices.

Still not sure how to get started? The Pediatric Infectious Diseases Society’s How To Guide: Starting an (ASP) is a great resource for setting up your own Antibiotic Stewardship Program. In addition to the resources included in this toolkit, you may wish to visit the Perinatal Quality Collaborative of North Carolina and Illinois Perinatal Quality Collaborative antibiotic stewardship web pages to learn about other AS QI program models. 

Data collection

Why should my QI team collect data?

Strategic data collection is essential for ensuring your quality improvements are making a difference. Your data can be used to target key areas of improvement, and to communicate your successes to your administration or other stakeholders. Your data will also help you make sure that your interventions are having the intended effect and leading to improvement.

Suggested approach

? Partner with the pharmacy department, which may have an easy way to collect the measures you want to track. Many hospital pharmacies already collect this data. 

? Establish a baseline from the past 6-12 months to gauge your current AUR

  • Because of normal variations, it’s most accurate to have a longer baseline (10-12 months), especially if you have a low delivery volume. 
  • Sometimes even just preparing to do a QI project results in changes. It might be best to set your “year” of baseline data to end 1-2 months pre-intervention. 

? Track your hospital’s AUR on an Annotated Run Chart each month

  • Annotations show which interventions had the biggest impact on your AUR
  • Keep tracking this data after you’ve seen a change, until you are confident you have sustained improvement (up to a year after you reach your goal)

? Conduct case reviews for all infants with a positive blood culture in the first seven days of life to ensure procedural changes do not inadvertently increase risks.

Data collection resources

This sample run chart shows the importance of building improvements into hospital systems to sustain success. 

Family enagement resources

Parents and families can be valuable partners in improving care in your newborn nursery or NICU.  Parents can offer insights that might not be obvious to other team members because of their unique role within the healthcare team.  Parents may also have questions about the risks and benefits of antibiotic use in their infant.  We encourage you to include parents in your quality improvement work, and also to provide educational materials that will help parents to make informed decisions in partnership with the healthcare team.

Implementation Guidance

The Perinatal Quality Collaborative of North Carolina has some excellent resources to involve families in antibiotic stewardship:

For a more robust overview, visit PQCNC’s Patient Family Engagement Resources page where you will find general guidance for establishing a Family Advisor Program. 

Quality Improvement Tools & MOC Part IV Credit

Background

For pediatricians seeking ABP MOC Part IV credit for maintenance of board certification, this project has undergone pre-approval through the ABP.  The deadline to receive credit is December 31, 2022.  There is no associated cost to individual physicians who apply for credit as part of a CASC neonatal antibiotic stewardship quality improvement project.

In order to receive this credit, each physician/site must follow the steps of a data-driven quality-improvement project with the following elements:

  • QI Project Requirements:
    • It sought to improve a known gap in quality, not acquire new knowledge.
    • It had quantified goals within a specific time frame.
    • Measures were used to track the progress of this QI project.
    • At least three points of de-identified aggregate data were gathered over time.
    • The physician(s) applying participated in this QI project’s planning, execution, data review,
      implementation of changes, and team meetings.
    • The physician(s) applying for credit must submit the following information to CASC upon completion of the project (info@cpcqc.org):
      • Aim Statement:  A GAP you want to improve, by HOW MUCH, and by WHEN 
      • Measures:  
        • Elements tracked through this project
        • Goals for each
        • How often each measure was tracked
      • Data:  Graphic displaying AT LEAST three points of data over time (Pre, Post, Sustain OR Baseline, Improvement 1, Improvement 2)
      • Attestation that the physician seeking credit was intellectually engaged in planning and executing the project, helped to implement the project’s interventions (the changes designed to improve care), reviewed data in keeping with the project’s measurement plan, and collaborated actively by attending team meetings.

Implementation Guidance

The toolkit section entitled “Creating a neonatal antibiotic stewardship quality improvement team” will be helpful in designing a project that meets the ABP requirements outlined above. 

CPCQC implements quality improvement initiatives following the Institute for Healthcare Improvement’s (IHI) Model for Improvement. This model is built on three simple questions:

  1. What are we trying to accomplish? 
  2. How will we know when a change is an improvement?
  3. What change can we make that will result in improvement? 

Once they have answered these questions, improvement teams:

  1. Plan a change
  2. Implement (Do) the change on a small scale
  3. Study the outcome of the change 
  4. Act on the results
    1. If the change was effective: spread beyond the small test
    2. If the change was not effective: revise the plan and repeat the cycle

This process is commonly referred to as a PDSA Cycle (Plan-Do-Study-Act Cycle), and helps QI teams break down seemingly insurmountable challenges into small, manageable tests of change. 

This toolkit provides specific tests of change for your team to implement. For more detailed guidance on how to conduct quality improvement work, visit IHI’s How to Improve page.

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