FQ Restriction for the Prevention of CDI

Clostridium Difficile Infection Clinical Trial

— FIRST  

Official title:

Fluoroquinolone Restriction Ofr the Prevention of C. Difficile Infection (CDI)_the FIRST Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03848689
• Other study ID #: 2018-0852
• Secondary ID: 1R01HS026226-01A
• Status: Enrolling by invitation
• Start date: May 1, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 11000
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• C Difficile Colitis
• Clostridium Difficile
• Clostridium Difficile Infection
• Clostridium Infections
• Infections

Intervention

Other:
• fluoroquinolone preprescription authorization
Requires authorization from Infection Control consult prior to prescribing fluoroquinolone
• Control
Does not require authorization from Infection Control prior to prescribing fluoroquinolone

Locations

Country	Name	City	State
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	St. Luke's Health System	Kansas City	Missouri
United States	Gundersen Health Systems	La Crosse	Wisconsin
United States	University of Wisconsin Hospital & Clinics	Madison	Wisconsin
United States	Riverside University Health System Medical Center	Moreno Valley	California
United States	Mayo-Arizona	Phoenix	Arizona
United States	Mayo-Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effectiveness of fluoroquinolone (FQ) Pre-prescription Authorization (PPA) intervention to reduce HO-CDI with ICU-onset will be assessed by comparing changes in incidence over pre- and post-intervention periods.	24 Months
Primary	Change in the overall incidence of HO-CDI before and after initiating FQ PPA intervention	Effectiveness of FQ PPA intervention to reduce HO-CDI will be assessed by calculating changes in incidence over pre- and post-FQ PPA intervention periods.	24 months
Primary	Change in incidence of healthcare-associated CDI (HA-CDI) before and after initiation of FQ PPA intervention	Effectiveness of FQ PPA intervention to reduce HA-CDI will be assessed by calculating changes in incidence over pre- and post-FQ PPA intervention periods.	24 Months
Secondary	Change in the usage of FQ from the time of participant hospital admission per 1000 patient-days.	To confirm fidelity of implementation of FQ PPA intervention, the change in the usage of FQ and other antibiotics in days of therapy per 1000 patient-days will be measured.	24 months
Secondary	Change in usage of non-FQ antibiotics per patient admission, and days of therapy per 1000 PD	To confirm fidelity of implementation of FQ PPA intervention, the change in the usage of antibiotics other than FQ in days of therapy per 1000 patient-days will be measured.	24 months
Secondary	Change in the number of patients per site showing Acute Kidney Injury (AKI) using the Kidney Disease Improving Global Outcomes (KDIGO) guideline definition.	The potential of this intervention to increase usage of alternative antibiotics with a negative clinical outcomes such as AKI, as compared with usual care, will be measured by assessing change in incidence of AKI, defined as: Increase in serum creatinine by = 0.3 mg/dl within 48 hours, or increase in serum creatinine to =1.5 times baseline or urine volume <0.5 mg/kg/hour for 6 hours.	24 months
Secondary	Hospital Mortality Rate of Participants	Hospital mortality	24 months
Secondary	Length of Participants's Hospital Stay	The impact of FQ PPA on negative clinical outcomes as compared with usual care by the length of hospital stay	24 months
Secondary	Number of Participants Readmitted within 30 Days	The impact of FQ PPA intervention compared with usual care as it impacts the number of patients readmitted within 30 days.	24 months
Secondary	Number of Incidences of Hospital Acquired Infections	The impact of FQ PPA on negative clinical outcomes as compared with usual care by the incidence of other, non-CDI hospital acquired infections.	24 months
Secondary	Baseline proportion of CDI due to NAP-1 in site ICUs and associated facilities.	This would reflect whether the FQ PPA intervention was impacted by the prevalence of the strain of CDI most susceptible to FQ antibiotics.	24 months