NCT02054065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

September 11, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

January 31, 2014

Last Update Submit

September 7, 2018

Conditions

Infection Due to Indwelling Urinary Catheter

Keywords

Urinary Catheterurinary tract infection

Outcome Measures

Primary Outcomes (1)

  • Number of CAUTIs

    One Year

Secondary Outcomes (3)

  • Number of catheter days

    One year

  • Rate of catheter re-insertion

    One Year

  • Patient mortality due to CAUTI

    One year

Study Arms (2)

Control

NO INTERVENTION

Normal care conditions, no computer-based physician alert.

CAUTI Decision Support

EXPERIMENTAL

Decision support aimed at preventing Catheter Associated Urinary Tract Infections (CAUTIs)

Other: CAUTI Decision Support

Interventions

CAUTI Decision SupportOTHER

Decision support used to prevent Catheter Associated Urinary Tract Infections

CAUTI Decision Support

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Neonatal Intensive Care Unit and pediatric patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

New York, New York, 10467, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Jason S Adelman, MD, MS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2014

First Posted

February 4, 2014

Study Start

February 1, 2014

Primary Completion

January 1, 2015

Study Completion

June 1, 2015

Last Updated

September 11, 2018

Record last verified: 2018-09

Locations

US(1)