Clinical Decision Support to Reduce Catheter Associated Urinary Tract Infections

Not Applicable

Completed

• Conditions: Catheter-associated Urinary Tract Infection; Health Care Associated Infection

• Registration Number: NCT06454500
• Lead Sponsor: Columbia University

Brief Summary

The goal of this randomized controlled trial is to compare the effects of a clinical decision support tool consisting of a 48-hour stop order for indwelling urinary catheters versus no clinical decision support in hospitalized patients with indwelling urinary catheters. The main questions it aims to answer are:

- Does the presence of an automated stop order integrated as part of a clinical decision support tool reduce dwell time of urinary catheters and the rate of catheter associated urinary tract infections?

Participants who have indwelling urinary catheters ordered will be randomized to either have these orders automatically expire after 48 hours unless an action is taken or have orders without expiration. Researchers will compare the urinary catheter dwell time and the rate of catheter associated urinary tract infections between the two groups.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-17
• Primary Completion: 2023-04-04
• Study Completion: 2023-04-04
• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-06
• Study First Posted: 2024-06-12
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79369

Inclusion Criteria

• Admitted to hospital
• At least 18 years old
• Has order placed for indwelling urinary catheter

Exclusion Criteria

• Indication for urinary catheter labeled as either "Chronic" or "Placed by urology"

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Urinary catheter dwell time	Measured from time of catheter insertion until catheter removal or hospital discharge if the catheter was not removed, up to 250 days.	The time between urinary catheter insertion and removal

Secondary Outcome Measures

Name	Time	Method
Catheter Associate Urinary Tract Infection (CAUTI) rate	The development of a CAUTI was assessed from time of catheter insertion until either catheter removal or hospital discharge if the catheter was not removed, up to 250 days.	The number of CAUTI's per 1000 catheter days. CAUTIs were defined according to NHSN (National Healthcare Safety Network) criteria as a urinary tract infection where an indwelling urinary catheter (IUC) was in place for more than two consecutive days in an inpatient location on the date of event or the day before, with day of device placement being Day 1. All positive urine cultures are reviewed by members of Infection Prevention and Control to determine if they meet the defined criteria for CAUTI. Events verified as CAUTIs are then recorded in the hospital data registry. The hospital data registry was used to determine CAUTI events in this study.
CAUTI Free survival	The development of a CAUTI was assessed from time of catheter insertion until either catheter removal or hospital discharge if the catheter was not removed, up to 250 days.	The time a catheter "survived" before developing a CAUTI CAUTIs were defined according to NHSN (National Healthcare Safety Network) criteria as a urinary tract infection where an indwelling urinary catheter (IUC) was in place for more than two consecutive days in an inpatient location on the date of event or the day before, with day of device placement being Day 1. All positive urine cultures are reviewed by members of Infection Prevention and Control to determine if they meet the defined criteria for CAUTI. Events verified as CAUTIs are then recorded in the hospital data registry. The hospital data registry was used to determine CAUTI events in this study.
CAUTI population rate	The development of a CAUTI was assessed from time of catheter insertion until either catheter removal or hospital discharge if the catheter was not removed, up to 250 days.	The number of CAUTI's per 10000 hospital days CAUTIs were defined according to NHSN (National Healthcare Safety Network) criteria as a urinary tract infection where an indwelling urinary catheter (IUC) was in place for more than two consecutive days in an inpatient location on the date of event or the day before, with day of device placement being Day 1. All positive urine cultures are reviewed by members of Infection Prevention and Control to determine if they meet the defined criteria for CAUTI. Events verified as CAUTIs are then recorded in the hospital data registry. The hospital data registry was used to determine CAUTI events in this study.

Trial Locations

Locations (8)

NewYork-Presbyterian Westchester; 🇺🇸 Bronxville, New York, United States

NewYork-Presbyterian Brooklyn Methodist Hospital; 🇺🇸 Brooklyn, New York, United States

NewYork-Presbyterian Hudson Valley Hospital; 🇺🇸 Cortlandt Manor, New York, United States

NewYork-Presbyterian Queens; 🇺🇸 Flushing, New York, United States

NewYork-Presbyterian Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States

NewYork-Presbyterian Allen Hospital; 🇺🇸 New York, New York, United States

NewYork-Presbyterian Lower Manhattan Hospital; 🇺🇸 New York, New York, United States

NewYork-Presbyterian Weill Cornell Medical Center; 🇺🇸 New York, New York, United States