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Completed

NCT Number: NCT06454500

Clinical Decision Support to Reduce Catheter Associated Urinary Tract Infections

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.

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Key information

Conditions

Health Care Associated Infection Catheter-Associated Urinary Tract Infection Cross Infection Disease Attributes Iatrogenic Disease Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NewYork-Presbyterian Westchester, Bronxville, New York, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Clinical Decision Support

Other

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

Primary outcomes

  1. Urinary catheter dwell time

    Time frame: 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 outcomes

  1. Catheter Associate Urinary Tract Infection (CAUTI) rate

    Time frame: 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.

  2. CAUTI population rate

    Time frame: 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.

  3. CAUTI Free survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2024
Registry last updated
Jun 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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