Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention

Completed

• Conditions: CDI

• Registration Number: NCT05508607
• Lead Sponsor: Intermountain Health Care, Inc.

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

Study Timeline

• Study First Submitted: 2020-05-27
• Study Start: 2021-05-01
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-17
• Last Update Submitted: 2022-08-17
• Study First Posted: 2022-08-19
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13319

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Per-Admission Rate	30 days after discharge	per-admission rate of hospital-associated CDI, defined as: positive toxin B by enzyme-linked immunoassay or polymerase chain reaction test at least 72 hours after admission

Secondary Outcome Measures

Name	Time	Method
Hospital Length of Stay	through study completion, an average of 1 year
High-Risk Antibiotic Usage	through study completion, an average of 1 year
Proton Pump Inhibitor Therapy Administered	through study completion, an average of 1 year
Total Variable Cost per Admission	through study completion, an average of 1 year
Total Antibiotic Usage	through study completion, an average of 1 year

Trial Locations

Locations (1)

Intermountain Medical Center; 🇺🇸 Salt Lake City, Utah, United States