FQ Restriction for the Prevention of CDI

The objective of the proposed study is to evaluate the effectiveness and implementation of a
fluoroquinolone (FQ) Preprescription Authorization (PPA) as an antibiotic stewardship (AS)
strategy to target and prevent CDI, promote appropriate antibiotic use, and reduce the
transmission of resistant bacteria. This will contribute to the long-term goal of reducing
the burden of Clostridium difficile infection (CDI), which is an essential step in improving
the safety and quality of healthcare. FQ PPA is a particularly promising AS strategy to
reduce CDI. Although FQs are one of the most frequently utilized classes of antibiotics in
inpatient acute care facilities and are closely associated with risk for CDI, FQ usage has
not been the focus of control efforts in endemic settings in the US. The proposed study will
use an effectiveness-implementation hybrid type 2 design to simultaneously evaluate the
efficacy of an FQ PPA intervention to reduce CDI as well as the key considerations for
implementing such an intervention successfully. Intensive care units in acute care hospitals
throughout Wisconsin will participate in this stepped wedge cluster randomized controlled
trial. The specific aims for the proposed study are to: 1) determine the impact of a FQ PPA
on hospital-onset and healthcare-associated CDI rates and other clinical outcomes compared
with usual care; and 2) evaluate the implementation of FQ PPA using a systems engineering
approach. For aim 1, electronic health record data will be used to evaluate the impact of the
FQ PPA on hospital-onset and healthcare-associated CDI, as well as other important clinical
outcomes. For aim 2, surveys and interviews with healthcare providers will be used to
evaluate the contextual, implementation, and work system factors that contribute to
successful implementation of a FQ PPA intervention. In addition to addressing an urgent need
to identify effective AS strategies, this study will provide a framework to implement and
evaluate other interventions for healthcare-acquired infection (HAI) prevention. Regardless
of the results, the proposed study will generate data, tools and methods with widespread
applicability for AS initiatives in healthcare-associated infection prevention.

Inclusion Criteria:

- Medical-surgical intensive care unit with at least 10 beds

- Presence of existing antibiotic stewardship (AS) program with pharmacist and ID
physician support

- Electronic health record (EHR) vendor is Epic Systems Corporation

- Has ability to extract antibiotic usage data (days of therapy)

- Has ability to extract required outcomes data (CDI, mortality, length of ICU stay)

- Ability to extract or abstract data on indications for antibiotic use

- Adherence to best practices for infection control relevant to CDI

Exclusion Criteria:

- Medical-surgical intensive care units with a FQ restriction in place as part of their
usual care procedures will be excluded.