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CompletedNCT05508607PASTCDIUpdated Aug 19, 2022

Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention

An observational study in CDI, sponsored by Intermountain Health Care, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-19.

Sponsored by Intermountain Health Care, Inc. · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
13,319
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • CDI
03

In context

Lead sponsor

Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Behavioral health units
  • Inpatient rehabilitation units
  • Labor and Delivery units
  • Same day surgery and observation units
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
13,319 participants (actual)
Patient registry
No

Groups and cohorts

  • Pre-Implementation
  • Post-Implementation

    Other: CDI-risk Classification Tool

Interventions

  • OtherCDI-risk Classification Tool

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

06

What researchers measure

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

    Time frame: 30 days after discharge

Secondary outcomes

  1. Total Antibiotic Usage

    Time frame: through study completion, an average of 1 year

  2. High-Risk Antibiotic Usage

    Time frame: through study completion, an average of 1 year

  3. Proton Pump Inhibitor Therapy Administered

    Time frame: through study completion, an average of 1 year

  4. Total Variable Cost per Admission

    Time frame: through study completion, an average of 1 year

  5. Hospital Length of Stay

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Intermountain Medical Center
    Salt Lake City, Utah 84107, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05508607
Lead sponsor
Intermountain Health Care, Inc.
Responsible party
Sponsor
First posted
Aug 19, 2022
Start date
May 1, 2021
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Last update
Aug 19, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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