PASTCDI: Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention

• Sponsor: Intermountain Health Care, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT05508607
• Collaborator: (none)
• Enrollment: 13,319
• Location: 1
• Actual Duration (Months): 14
• Patients Per Site Per Month: 953.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CDI	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 Design

• Study Type: Observational
• Actual Enrollment: 13319 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Precision Antimicrobial STewardship for Clostridioides DIfficile Prevention
• Actual Study Start Date: May 1, 2021
• Actual Primary Completion Date: Jun 30, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. Total Antibiotic Usage [through study completion, an average of 1 year]

2. High-Risk Antibiotic Usage [through study completion, an average of 1 year]

3. Proton Pump Inhibitor Therapy Administered [through study completion, an average of 1 year]

4. Total Variable Cost per Admission [through study completion, an average of 1 year]

5. Hospital Length of Stay [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intermountain Medical Center	Salt Lake City	Utah	United States	84107

Sponsors and Collaborators

• Intermountain Health Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Intermountain Health Care, Inc.
• ClinicalTrials.gov Identifier: NCT05508607
• Other Study ID Numbers: 1051390
• First Posted: Aug 19, 2022
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 19, 2022