Clinical trial NCT06454500: Clinical Decision Support to Reduce Catheter Associated Urinary Tract Infections
Official title: Randomized, Controlled Evaluations of the Effectiveness of Clinical Decision Support Systems (REEDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Associated Infection
Catheter-associated Urinary Tract Infection
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 79369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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"

Primary outcomes:
measure: Urinary catheter dwell time
timeFrame: Measured from time of catheter insertion until catheter removal or hospital discharge if the catheter was not removed, up to 250 days.
Secondary outcomes:
measure: Catheter Associate Urinary Tract Infection (CAUTI) rate
timeFrame: 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.
measure: CAUTI population rate
timeFrame: 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.
measure: CAUTI Free survival
timeFrame: 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.
Other outcomes:
Locations:
city: Bronxville
country: United States
facility: NewYork-Presbyterian Westchester
state: New York
city: Brooklyn
country: United States
facility: NewYork-Presbyterian Brooklyn Methodist Hospital
state: New York
city: Cortlandt Manor
country: United States
facility: NewYork-Presbyterian Hudson Valley Hospital
state: New York
city: Flushing
country: United States
facility: NewYork-Presbyterian Queens
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Columbia University Irving Medical Center
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Allen Hospital
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Lower Manhattan Hospital
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Weill Cornell Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Jason Adelman, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: