Clinical Decision Support to Reduce Catheter Associated Urinary Tract Infections

Health Care Associated Infection Clinical Trial

Official title:

Randomized, Controlled Evaluations of the Effectiveness of Clinical Decision Support Systems (REEDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06454500
• Other study ID #: AAAU3416
• Status: Completed
• Phase: N/A
• Start date: August 17, 2021
• Est. completion date: April 4, 2023

Study information

• Verified date: June 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79369
• Est. completion date: April 4, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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"

Related Conditions & MeSH terms

• Catheter-associated Urinary Tract Infection
• Communicable Diseases
• Cross Infection
• Health Care Associated Infection
• Infections
• Urinary Tract Infections

Intervention

Other:
• Clinical decision support
A 48 hour expiration on orders placed for indwelling urinary catheters.

Locations

Country	Name	City	State
United States	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 Allen Hospital	New York	New York
United States	NewYork-Presbyterian Columbia University Irving Medical Center	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

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary catheter dwell time	The time between urinary catheter insertion and removal	Measured from time of catheter insertion until catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
Secondary	Catheter Associate Urinary Tract Infection (CAUTI) rate	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.	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.
Secondary	CAUTI population rate	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.	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.
Secondary	CAUTI Free survival	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.	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.