About the FIRST Trial

The FIRST trial is a 5-year study funded by the Agency for Healthcare Research and Quality. The study period is August 1, 2018 to May 31, 2023. For the study, 12 intensive care units  will implement a fluoroquinolone pre-prescription authorization intervention. This intervention will restrict the use of fluoroquinolones by requiring providers to obtain authorization before prescribing fluoroquinolones from an infectious disease physician. The main goals of the study are to:

  1. Determine how the fluoroquinolone pre-prescription authorization policy affects antibiotic usage, C. difficile infection rates, and other clinical outcomes.
  2. Evaluate the fluoroquinolone pre-prescription authorization policy implementation process.

For the study, each intensive care unit will have a 12-month intervention period in which the University of Wisconsin-Madison study team will support and evaluate the implementation of the fluoroquinolone pre-prescription authorization intervention. At the end of the 12-month intervention period, clinical data collection related to the study will end and the University of Wisconsin-Madison study team will assess the implementation process using surveys and interviews of site staff. If the intensive care unit chooses to continue the intervention beyond the intervention period, the University of Wisconsin-Madison study team will assist site staff with planning how to sustain the intervention without study team support.

The initiation of the fluoroquinolone pre-prescription authorization policy at each of the 12 intensive care units will be staggered across the five-year study period. The timing of each intensive care unit’s intervention period will be determined by site readiness to begin (completion of preparatory activities) and University of Wisconsin-Madison study team capacity to onboard. The University of Wisconsin-Madison study team will assist sites with preparatory activities prior to the initiation of their fluoroquinolone pre-prescription authorization intervention. This process is expected to take 3-6 months.

Overview of the FIRST trial

The FIRST Trial is comprised of three study stages, (1) the pre-intervention phase, (2) the intervention, and (3) quality assurance to assess and ensure compliance with the intervention. The study schema (below) outlines the key activities involved in each phase.

Schema depicting pre-intervention, intervention, and quality assurance activities

Figure: FIRST Trial Study Schema (FQ=fluoroquinolone, EHR = electronic health record, ID = infectious diseases)

The Pre-Intervention stage (left column) depicts activities required to prepare for the intervention, which includes both the modifications to the electronic medical record that are needed to implement the fluoroquinolone pre-prescription authorization and the training for the prescribers and pharmacists on the unit. The Intervention stage (middle column) walks through the steps of the fluoroquinolone pre-prescription authorization from the perspective of a prescriber, which “starts” when a provider decides to order a fluoroquinolone and “ends” when either an alternative antibiotic is prescribed or a fluoroquinolone is appropriately prescribed following the fluoroquinolone pre-prescription authorization protocol. Finally, the Quality Assurance stage will occur simultaneously with the intervention stage to monitor for fluoroquinolone pre-prescription authorization adherence by prescribers and provide necessary follow-up and feedback to prescribers when the fluoroquinolone pre-prescription authorization is not followed.

Scientific RationaleMedical tools around clinician taking notes on clipboard

The University of Wisconsin-Madison conducted a mixed-methods pilot study to examine the feasibility and effectiveness of a fluoroquinolone pre-prescription authorization intervention from July 2016 through January 2017 at UW Health. The reduction in fluoroquinolone usage and notable decrease in the incidence of C. difficile infection led the hospital to continue the intervention after the study period ended.

The FIRST Trial aims to repeat the implementation of the fluoroquinolone pre-prescription authorization at other sites to assess the efficacy and implementation of the fluoroquinolone pre-prescription authorization to reduce C. difficile infections. Results from this multi-site trial will guide future antibiotic stewardship programs aiming to reduce C. difficile infection incidence and will provide essential tools and guidance for healthcare systems seeking to implement the fluoroquinolone pre-prescription authorization.

To learn more about the scientific rationale for the fluoroquinolone pre-prescription authorization intervention, click here.

Site Recruitment

We are actively recruiting sites to participate in the FIRST Trial. If you are interested in learning more or whether your institution’s intensive care unit could participate, click here. Already participating and need help finding something? Click here.