Clinical Decision Support to Reduce Catheter Associated Urinary Tract Infections

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

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.

Study Overview

• Status: Completed
• Conditions: Health Care Associated Infection; Catheter-associated Urinary Tract Infection
• Intervention / Treatment: Other: Clinical decision support

• Study Type: Interventional
• Enrollment (Actual): 79369
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronxville, New York, United States, 10708
      • NewYork-Presbyterian Westchester
    • Brooklyn, New York, United States, 11215
      • NewYork-Presbyterian Brooklyn Methodist Hospital
    • Cortlandt Manor, New York, United States, 10567
      • NewYork-Presbyterian Hudson Valley Hospital
    • Flushing, New York, United States, 11355
      • NewYork-Presbyterian Queens
    • New York, New York, United States, 10032
      • NewYork-Presbyterian Columbia University Irving Medical Center
    • New York, New York, United States, 10065
      • NewYork-Presbyterian Weill Cornell Medical Center
    • New York, New York, United States, 10034
      • NewYork-Presbyterian Allen Hospital
    • New York, New York, United States, 10038
      • NewYork-Presbyterian Lower Manhattan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stop Orders; 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; A 48 hour expiration on orders placed for indwelling urinary catheters.
No Intervention: Continuous Orders; For participants in this arm, no clinical decision support or alerts were displayed to care team clinicians and the urinary catheter order was continuous.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Jason Adelman, MD, MS, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Actual): April 4, 2023
• Study Completion (Actual): April 4, 2023

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 6, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Iatrogenic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Communicable Diseases; Urinary Tract Infections; Cross Infection
• Other Study ID Numbers: AAAU3416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No