Clinical Decision Support to Reduce Catheter Associated Urinary Tract Infections

NCT06454500 | Completed

• 1 other identifier: AAAU3416
• Study Type: interventional
• Target: 79,369
• Locations: 1 country
• Sites: 8

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.

Conditions

Health Care Associated Infection; Catheter-associated Urinary Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Stop Orders

EXPERIMENTAL

For participants in this arm, a clinical decision support tool consisting of stop orders and an expiring alert that was displayed to care team clinicians.

Other: Clinical decision support

Continuous Orders

NO INTERVENTION

For participants in this arm, no clinical decision support or alerts were displayed to care team clinicians and the urinary catheter order was continuous.

Interventions

Clinical decision support OTHER

A 48 hour expiration on orders placed for indwelling urinary catheters.

Stop Orders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (8)

NewYork-Presbyterian Westchester

Bronxville, New York, 10708, United States

Location

NewYork-Presbyterian Brooklyn Methodist Hospital

Brooklyn, New York, 11215, United States

Location

NewYork-Presbyterian Hudson Valley Hospital

Cortlandt Manor, New York, 10567, United States

Location

NewYork-Presbyterian Queens

Flushing, New York, 11355, United States

Location

NewYork-Presbyterian Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

NewYork-Presbyterian Allen Hospital

New York, New York, 10034, United States

Location

NewYork-Presbyterian Lower Manhattan Hospital

New York, New York, 10038, United States

Location

NewYork-Presbyterian Weill Cornell Medical Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason Adelman, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: August 17, 2021
• Primary Completion: April 4, 2023
• Study Completion: April 4, 2023
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)