Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention

NCT05508607 | Completed

• 1 other identifier: 1051390
• Study Type: observational
• Target: 13,319
• Locations: 1 country
• Sites: 1

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.

Conditions

CDI

Outcome Measures

Primary Outcomes (1)

• Per-Admission Rate

  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

  30 days after discharge

Secondary Outcomes (5)

• Total Antibiotic Usage

  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

• Hospital Length of Stay

  through study completion, an average of 1 year

Study Arms (2)

Pre-Implementation

Post-Implementation

Other: CDI-risk Classification Tool

Interventions

CDI-risk Classification Tool OTHER

This tool will focus a bundle of antimicrobial stewardship (AMS) CDI prevention recommendations on high-risk patients.

Post-Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: August 19, 2022
• Study Start: May 1, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)