Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention

CDI Clinical Trial

— PASTCDI  

Official title:

Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05508607
• Other study ID #: 1051390
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13319
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CDI

Intervention

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

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total Antibiotic Usage		through study completion, an average of 1 year
Secondary	High-Risk Antibiotic Usage		through study completion, an average of 1 year
Secondary	Proton Pump Inhibitor Therapy Administered		through study completion, an average of 1 year
Secondary	Total Variable Cost per Admission		through study completion, an average of 1 year
Secondary	Hospital Length of Stay		through study completion, an average of 1 year