Clinical trial NCT05508607: Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention
Official title: Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: CDI
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 13319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our goal is to study the all adults admitted to any of the 22 Intermountain Healthcare network acute care hospitals who are classified as high risk for CDI by the risk classification tool. In this pre-post design study, we will identify two cohorts, the first representing a two-year cohort prior to implementation of the risk classification-enhanced AMS process and the second a post-implementation cohort representing one-year after implementation. These cohorts will be identified retrospectively.

Brief summary: To decrease CDI incidence by implementing an electronic health record-integrated CDI-risk classification tool for Clostridioides difficile infection (CDI) to focus a bundle of antimicrobial stewardship (AMS) CDI prevention recommendations on high-risk patients.

Detailed description: This study aims to use a pre/post implementation design to evaluate the use of a novel risk classification tool to improve existing methods of identifying patients eligible for routine antimicrobial stewardship (AMS) care processes targeting reduction of Clostridioides difficile infection (CDI). Antimicrobial stewardship is an established, evidence-based quality improvement program that is required by The Joint Commission and a condition of participation by the Centers for Medicare and Medicaid. AMS processes of care are evidence based, supported by published research demonstrating outcomes benefits, are recommended by national guidelines and are not investigational. Treatment decisions remain at the discretion of clinicians and patients

Eligibility criteria: Inclusion Criteria:

* adult acute care patients identified as high-CDI risk by the CDI risk classification tool. This sub-group represents approximately 6% of all acute care admissions

Exclusion Criteria:

* Behavioral health units
* Inpatient rehabilitation units
* Labor and Delivery units
* Same day surgery and observation units

Primary outcomes:
measure: Per-Admission Rate
timeFrame: 30 days after discharge
Secondary outcomes:
measure: Total Antibiotic Usage
timeFrame: through study completion, an average of 1 year
measure: High-Risk Antibiotic Usage
timeFrame: through study completion, an average of 1 year
measure: Proton Pump Inhibitor Therapy Administered
timeFrame: through study completion, an average of 1 year
measure: Total Variable Cost per Admission
timeFrame: through study completion, an average of 1 year
measure: Hospital Length of Stay
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
References: