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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

Tracking Information
First Submitted Date  ICMJE January 31, 2014
First Posted Date  ICMJE February 4, 2014
Last Update Posted Date September 11, 2018
Actual Study Start Date  ICMJE February 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2014)		 Number of CAUTIs [ Time Frame: One Year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2014)
  • Number of catheter days [ Time Frame: One year ]
  • Rate of catheter re-insertion [ Time Frame: One Year ]
  • Patient mortality due to CAUTI [ Time Frame: One year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of CAUTI Prevention Alert - A Randomized Control Trial
Official Title  ICMJE Effect of CAUTI Prevention Alert - A Randomized Control Trial
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Infection Due to Indwelling Urinary Catheter
Intervention  ICMJE Other: CAUTI Decision Support
Decision support used to prevent Catheter Associated Urinary Tract Infections
Study Arms  ICMJE
  • 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)
    Intervention: Other: CAUTI Decision Support
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2018)		 108
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2014)		 10830
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02054065
Other Study ID Numbers  ICMJE 12-06-225
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jason S Adelman, MD, MS Albert Einstein College of Medicine
PRS Account Montefiore Medical Center
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP