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Clinical Decision Support to Reduce Catheter Associated Urinary Tract Infections

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06454500
Enrollment
79369
Registered
2024-06-12
Start date
2021-08-17
Completion date
2023-04-04
Last updated
2024-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheter-associated Urinary Tract Infection, Health Care Associated Infection

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.

Interventions

OTHERClinical decision support

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

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Urinary catheter dwell timeMeasured 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

MeasureTime frameDescription
Catheter Associate Urinary Tract Infection (CAUTI) rateThe 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.
CAUTI population rateThe 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.
CAUTI Free survivalThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026