Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention (PASTCDI)

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.

Study Overview

• Status: Completed
• Conditions: CDI
• Intervention / Treatment: Other: CDI-risk Classification Tool

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 Type: Observational
• Enrollment (Actual): 13319

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-Implementation
Post-Implementation	Other: CDI-risk Classification Tool; This tool will focus a bundle of antimicrobial stewardship (AMS) CDI prevention recommendations on high-risk patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 1051390

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No