Effect of CAUTI Prevention Alert - A Randomized Control T... | NCT02054065

Studies
Effect of CAUTI Prevention Alert - A Randomized Control Trial

NCT02054065

Sponsor

Montefiore Medical Center

Status

Completed

Last Update Posted

Sep 11, 2018Actual

Enrollment

108Actual

Phase

Not Applicable

Conditions

Infection Due to Indwelling Urinary Catheter

Interventions

CAUTI Decision Support

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014Actual

Primary Completion Date

Jan 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Jan 31, 2014

First Submission Date that Met QC Criteria

Feb 3, 2014

First Posted Date

Feb 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2018

Last Update Posted Date

Sep 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

108Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CAUTI Decision Support	Other	Decision support used to prevent Catheter Associated Urinary Tract Infections	CAUTI Decision Support

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of CAUTIs		One Year

Secondary Outcomes

Measure	Description	Time Frame
Number of catheter days		One year
Rate of catheter re-insertion		One Year
Patient mortality due to CAUTI

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jason S Adelman, MD, MS	Albert Einstein College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Montefiore Medical Center		New York	New York	10467	United States

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided