The Evaluation and Research on Antimicrobial Stewardship's Effect on Clostridium difficile (ERASE C. difficile) Project
Antimicrobial stewardship for reducing C. difficile offers a potentially promising path for facilities invested in and committed to the effort. Developing and implementing a successful ASP will involve structural, process, and cultural changes in your organization. To effect the changes needed in clinical practice, organizations require multiple adjustments in roles, responsibilities, workflow, decisionmaking, and communication.
Failure to assess your organization's readiness for the change at multiple levels can lead to unanticipated implementation challenges. Bringing about organizational change of any type is difficult. You will not want to move
ahead until you are confident of your organization's readiness. Even then, it will be important to balance the need to proceed thoughtfully with the need to move quickly enough to show progress and maintain momentum.
Consider the following questions as you evaluate your organization's readiness and identify action steps to prepare.
This toolkit assumes that your hospital already has an ASP or the foundation for an ASP from which to launch the ASP targeted to promote appropriate antibiotic use and potential C. difficile reduction. Implementing and maintaining an effective ASP requires a dedicated multidisciplinary team and ongoing communication and collaboration as well as ongoing monitoring of systems. Further, ongoing monitoring may necessitate course corrections.
Team membership will vary among organizations, but the core team should include an infectious disease physician, PharmD, clinical microbiologist, infection control representative, hospital epidemiologist, information technology (IT) representative, and senior administrator. Ideally, the team should be supported by an in-house lab and IT resources.
Before going further, you should review your facility's current ASP or, if necessary, take steps to develop a basic ASP from which to target C. difficile reduction. To develop an ASP, you can use the GNYHA ASP toolkit (PDF File; Plugin Software Help). Also remember that antimicrobial stewardship is intended to complement other antibiotic
prescribing practices and efforts to promote C. difficile prevention in your organization. You may also want to review the other prevention measures you have in place.
- Is there an active ASP in place? Who are its members and how does it operate?
- What other C. difficile prevention measures do you have in place?
Even if you have a strong stewardship foundation in place, you will need to assess your facility's stage of readiness for targeting an ASP to C. difficile reduction. Developing an ASP to work toward reducing C.
difficile will require a coordinated systems approach with readiness to change on many levels.
To stimulate your thinking in making the case for ASP for C. difficile reduction and considering your path forward, consider the following reasons to move forward with further developing ASPs. These were cited by facilities with newly established ASPs.
|Reasons To Develop ASPs for C. difficile Reduction
- Desire to decrease C. difficile.
- Desire to optimize antibiotic use, including decreased use of specific/targeted antibiotics and shortened length of antibiotic courses.
- Desire to strengthen interdisciplinary cooperation and relationships.
- Desire to increase back-end strategies and streamline audit and feedback.
- Desire to find best practices for stewardship.
- Desire to advocate for more resources to conduct stewardship activities.
- Desire to further develop existing program or refine current program.
- Desire to understand the differential effect or impact of stewardship versus infection control and environmental cleaning.
You will need to begin this process by addressing six questions about both readiness and support from various components of your organization. You will need to cycle back to the last five questions throughout your change process. Reviewing these questions will reinforce communication with colleagues and stakeholders and strengthen answers about the clinical case, business case, and resources needed as you gather data and experience.
- Do multiple disciplines understand why a structured ASP is needed? Is there an urgency to change?
- Do senior leaders and other key stakeholders support and provide guidance to planning and implementing an ASP?
- Do key stakeholders in multiple disciplines understand why a structured ASP is needed?
- Is there a clinical and business case for creating an ASP for reducing C. difficile? Do leadership and prescribers understand and support it?
- What kinds of resources are needed to develop an effective ASP?
- What barriers might we face and how might we deal with them?
This toolkit describes an individualized approach and tailoring of selected stewardship interventions based on the results of limited case-control studies and identified issues at each facility. As you begin to identify antibiotics to target, you will also need to look at prescribing practices that will be targeted for change. You will need to plan the strategies you will use with prescribers to appropriately limit the targeted antibiotics in use. The strategy will depend on a combination of known evidence-based promising practices and what will work in your organization. To address these issues, you should consider four questions, discussed in the following sections.
For many reasons, a targeted risk assessment offers a promising path for identifying antimicrobial stewardship interventions to reduce C. difficile. First, most ASPs have limited resources, time, and staff to have activities that affect all antimicrobial prescribing within their health care facility. Second, some traditional components of a stewardship program may have little impact on C. difficile rates. Third, while there may be less variability in practices for infection control and environmental cleaning so that bundled approaches have controlled outbreaks and prevented healthcare-associated infections, the same is unlikely to be true of antimicrobial prescribing. Finally, antibiotic type and use vary considerably at health care facilities throughout an area (formularies are large).
The institutional risk assessment approach offers a more sophisticated approach than a uniform bundle of interventions at each facility. The tools below provide a roadmap for performing an assessment and information for tallying antimicrobial use in your facility.
To identify antibiotics most associated with C. difficile cases that may be targets of stewardship interventions, an internal, time-limited, focused retrospective case-control study can be performed. There is no single perfect way to perform the case-control study. The best methods may vary by facility based on number of C. difficile cases, resources, personnel, availability of medical records and antibiotic use data, time, and interest. However, in selecting your method, there are common factors to consider, including:
- Timeframe and number of cases of C. difficile.
- Choice of controls.
- Data selection and collection.
- Data analysis, including resources for calculating odds ratios and p values.
As shown in the Institutional Risk Assessment Roadmap in Resource 2A, multiple approaches can be taken to reviewing the use of potential target antibiotics. You will need to choose the approach that best fits your organization. For example, you can conduct a formal medication review for several weeks or longer of prescribing patterns of the targeted antibiotic. For many facilities, this timeframe is unrealistic; a review of only a few days of prescribing patterns (potentially on random days) may suffice to begin to strategize interventions.
Details to review will include but not be limited to: number of patients given prescriptions/length of therapy; most common prescribers; most common wards or patients receiving target; reason for target drug prescribing (e.g., empiric therapy, directed therapy, prophylactic regimen); most common syndromes and diagnoses treated by the target drug; and appropriateness and potential for prescribing changes (choice, length, other options).
The target antibiotic from the case-control study and the medication review will start to guide your intervention decisions. Other factors will also need to be considered, including stewardship staffing and skill set; ability to affect a large enough burden of prescribing, IT, and other external resources; acceptability of activities to prescribers, stewardship team, pharmacy, administration, and other key players at your facility; and previous and current stewardship activities (what has and has not worked in the past, what will complement current activities). Examples of intervention strategies from other hospitals may help you identify the interventions most likely to fit your organization.
Once you determine what the interventions will be in terms of the factors described above, you need to develop strategies tailored to your organization for implementing the interventions. With leadership support, the C. difficile ASP team will need to guide, coordinate, and support the implementation efforts during the initial phases and as the ASP practices are rolled out across the hospital to intended populations and prescribers.
Because the interventions may involve changes in the way people work, you may have difficulty incorporating them into practice. Consider the following questions to determine the changes that will be needed:
- Whose help is needed to implement and sustain the interventions?
- Do we need to pilot test the new practices?
- How do we engage staff in an ASP to reduce C. difficile?
- How should we work with staff at the unit level? How can we help staff learn new practices?
At all points in this process you will need to monitor appropriate processes and outcomes of the stewardship efforts. The frequency that data are collected, compiled, and analyzed will vary by site. Perhaps your facility has internal committees or boards who require regular submission of data; perhaps your State has a reporting requirement (e.g., C. difficile is reportable in New York State).
It will be important to know the requirements at your facility so that you can make the proper preparations in terms of reporting mechanisms. In deciding how to monitor your intervention and outcomes, you should consider six questions. Some of the tools and resources from earlier sections will help you in this process.
Many facilities are already tracking patient cases and rates of C. difficile. If your facility (or State/local health department) does not have a formal system, it will be easier to use or adapt from CDC's NHSN system rather than creating your own definitions and surveillance. The following are questions to consider:
- Whom might we need help from?
- What is key information to be aware of?
- How should we track C. difficile cases?
- Is it important to know whether C. difficile cases are acquired in our facility or in the community?
- Are we mandated to report C. difficile? Are there Web resources to help with C. difficile surveillance?
One of the biggest challenges in antimicrobial stewardship in general and specifically in measuring the potential effect of an intervention is obtaining needed data on antibiotic volume for more than one patient at a time. Once the data are obtained, challenges arise in cleaning, aggregating, summarizing, and comparing the data in a meaningful way. It is beyond the scope of this toolkit to address every potential issue, but the following questions may be helpful in guiding your process:
- What are possible antibiotic data sources?
- What are some common antibiotic data cleaning and aggregation challenges?
- What are some antibiotic metrics we can consider using?
It is important to monitor the interventions for multiple reasons. First, you need to be able to verify that the interventions are occurring. Next, you need to look for early and tangible signs of success (antibiotic metrics may be slow to show effects). Finally, you need to identify barriers to success and ways to improve the intervention, assess whether additional interventions are needed, assess whether the interventions are sustainable, and determine whether the intervention could be an effective way to affect other outcomes, such as C. difficile and antibiotic resistance.
This last point is important, because many stewardship interventions have been successful in reducing targeted antibiotic use and cost but have fallen short in reducing more concrete outcomes such as C. difficile rates and antibiotic resistance. If these outcomes are not achieved, monitoring the intervention is important to distinguish whether the intervention did not work because the activities were not completed; the intervention could not affect prescribing practices, antibiotic use, or outcomes; or insufficient time has elapsed to affect C. difficile rates.
It is also important to ensure that your interventions do not have unintended consequences for your patients. Thus, looking at rates of reinstitution of broad antibiotic therapy, missed or delayed antibiotic doses, or readmission (especially for infection) should be part of ongoing surveillance. In addition, your interventions may have other positive outcomes (e.g., reduced length of stay for patients receiving the intervention) that you will need to monitor and track.
Further, your institution's infection control, isolation precautions, and environmental cleaning policies and practices should be monitored throughout your intervention as changes in these can also affect C. difficile rates. Finally, it is important to assess how the intervention affects your stewardship team and other prescribers. Qualitative data collection such as prescriber surveys, informal discussions, or focus groups may enrich your understanding of the ASP and activities at your facility.
It will be important to conduct a financial impact analysis at your facility to estimate the costs associated with running an ASP, including staffing, software, and equipment; estimate the cost savings from reduced antimicrobial use; and understand the potential reimbursement impact of reducing infections. In addition, you may want to estimate indirect savings, including savings on isolation equipment or estimated savings from meeting external quality measures, such as those from the Centers for Medicare & Medicaid Services.
You may choose to examine antibiotic purchasing data if those data are available, or you may need to use industry sources to estimate costs associated with antibiotic purchasing. Data from the hospital should be available as they are routinely compiled for internal hospital purposes or required external use (e.g., billing). In the current climate of competing demands, leadership is frequently interested in the ways patient safety initiatives translate into financial savings.
3.6. How do we assess the overall impact of our interventions? How do we decide which interventions have been the most successful (and which interventions were not) and why?
Factors to consider include:
- Ability to implement the intervention (cost, staffing, IT support, timeframe).
- Ability to potentially affect a large enough burden of target antibiotic and then reduce that antibiotic use (and not increase use of more worrisome antibiotic combinations).
- Acceptability to stewardship team (does not impede other needed stewardship activities).
- Acceptability to prescribers.
- Effect on surrogate/process measure, long-term outcomes (such as C. difficile if possible), and lack of negative consequences.
- Sustainability of the intervention.
Early in the process of developing your ASP aimed at reducing C. difficile, you will need to think ahead about sustaining the program once it is in place. Often, sustaining changes in clinical practice introduced through a new initiative is more difficult than implementing them initially. To maintain your ASP C. difficile reduction so that it thrives and continues to be useful, consider at least four questions; you may have others.
In considering the questions, reflect on the challenges you currently face and consider strategies for working on them in the future. The tools and processes introduced in earlier sections can be used in developing your sustainability plan.
- Will our current ASP staffing work on an ongoing basis?
- What is the plan for ongoing measurement and feedback?
- What ongoing organizational support will be needed to keep the new ASP practices in place?
- How do we keep the ASP efforts relevant and a continued focus?
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