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Effect of CAUTI Prevention Alert - A Randomized Control Trial

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ClinicalTrials.gov Identifier: NCT02054065
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Study Description
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Brief Summary:

This study proposes to expand upon previous research by studying the effects of a urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs with a large, randomized controlled trial within a three-hospital academic medical center.

Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter days and decrease the number of catheter associated urinary tract infections (CAUTIs), but will not affect the catheter re-insertion rate.


Condition or disease Intervention/treatment Phase
Infection Due to Indwelling Urinary Catheter Other: CAUTI Decision Support Not Applicable

Detailed Description:

Primary Objectives

  • Specific Aim 1: Investigate the effect of a urinary-catheter removal alert on the rate of catheter associated urinary tract infections (CAUTIs).
  • Specific Aim 2: Investigate the effect of a urinary-catheter removal alert on the number of catheter days.
  • Specific Aim 3: Evaluate the effect of a urinary-catheter removal alert on the rate of catheter re-insertion.
  • Specific Aim 4: Evaluate the effect of a urinary-catheter removal alert on overall mortality in patients with indwelling catheters.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of CAUTI Prevention Alert - A Randomized Control Trial
Actual Study Start Date : February 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Normal care conditions, no computer-based physician alert.
Experimental: CAUTI Decision Support
Decision support aimed at preventing Catheter Associated Urinary Tract Infections (CAUTIs)
 Other: CAUTI Decision Support
Decision support used to prevent Catheter Associated Urinary Tract Infections


Outcome Measures
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Primary Outcome Measures :
  1. Number of CAUTIs [ Time Frame: One Year ]

Secondary Outcome Measures :
  1. Number of catheter days [ Time Frame: One year ]
  2. Rate of catheter re-insertion [ Time Frame: One Year ]
  3. Patient mortality due to CAUTI [ Time Frame: One year ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All admissions with an indwelling urinary catheter will be randomly assigned to intervention vs. control (usual care) conditions.

Exclusion Criteria:

  • Neonatal Intensive Care Unit and pediatric patients
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054065


Locations
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United States, New York
Montefiore Medical Center
New York, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Jason S Adelman, MD, MS Albert Einstein College of Medicine
More Information
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT02054065    
Other Study ID Numbers: 12-06-225
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Keywords provided by Montefiore Medical Center:
Urinary Catheter
urinary tract infection
Additional relevant MeSH terms:
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Infection