Clinical trial NCT03848689: FQ Restriction for the Prevention of CDI
Official title: Fluoroquinolone Restriction Ofr the Prevention of C. Difficile Infection (CDI)_the FIRST Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clostridium Difficile
Clostridium Difficile Infection
C Difficile Colitis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2019-02-21
Enrollment: 5871
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is comprised of clinicians and patients at 12 ICUs in 5 acute care hospitals. Once initiated, the intervention will be applied to all patients admitted to the ICU and all healthcare workers involved in antibiotic prescribing in that ICU.

Brief summary: This study evaluates the effectiveness of a new intervention, fluoroquinolone (FQ) Preprescription Authorization (PPA) strategy, to reduce and prevent Clostridium difficile infection (CDI) in hospital intensive care units (ICUs). The investigators will model a successful FQ PPA strategy in several Wisconsin ICUs and compare whether the intervention has improved outcomes in reducing CDIs. An additional goal of the study is to evaluate environmental and work system factors using systems engineering models in order to determine the most successful way to implement these new strategies.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the incidence of healthcare facility-onset Clostridiodes difficile infection (HO-CDI) with intensive care unit (ICU)-onset before and after initiating FQ PPA intervention
timeFrame: 24 Months
measure: Change in the overall incidence of HO-CDI before and after initiating FQ PPA intervention
timeFrame: 24 months
measure: Change in incidence of healthcare-associated CDI (HA-CDI) before and after initiation of FQ PPA intervention
timeFrame: 24 Months
Secondary outcomes:
measure: Change in the usage of FQ from the time of participant hospital admission per 1000 patient-days.
timeFrame: 24 months
measure: Change in usage of non-FQ antibiotics per patient admission, and days of therapy per 1000 PD
timeFrame: 24 months
measure: Change in the number of patients per site showing Acute Kidney Injury (AKI) using the Kidney Disease Improving Global Outcomes (KDIGO) guideline definition.
timeFrame: 24 months
measure: Hospital Mortality Rate of Participants
timeFrame: 24 months
measure: Length of Participants's Hospital Stay
timeFrame: 24 months
measure: Number of Participants Readmitted within 30 Days
timeFrame: 24 months
measure: Number of Incidences of Hospital Acquired Infections
timeFrame: 24 months
measure: Baseline proportion of CDI due to NAP-1 in site ICUs and associated facilities.
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo-Arizona
state: Arizona
city: Moreno Valley
country: United States
facility: Riverside University Health System Medical Center
state: California
city: Rochester
country: United States
facility: Mayo-Rochester
state: Minnesota
city: Kansas City
country: United States
facility: St. Luke's Health System
state: Missouri
city: Galveston
country: United States
facility: University of Texas Medical Branch at Galveston
state: Texas
city: La Crosse
country: United States
facility: Gundersen Health Systems
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Nasia Safdar, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Safdar N, Parmasad V, Brown R, Carayon P, Lepak A, O'Horo JC, Schulz L. Decreasing ICU-associated Clostridioides difficile infection through fluoroquinolone restriction, the FIRST trial: a study protocol. BMJ Open. 2021 Jun 29;11(6):e046480. doi: 10.1136/bmjopen-2020-046480.