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Electronic Triggers: Microhematuria Trigger

Primary Purpose

Hematuria

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Trigger Microhematuria Alert
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hematuria

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 35 years of age or older
  • 3+ RBC on Urinalysis
  • Urinalysis sent during an outpatient encounter
  • any of the following: 60 years of age or older; RBC > 25; current or prior tobacco use; Gross Hematuria

Exclusion Criteria:

  • Under 35 years of age
  • Cystoscopy within 1 year prior to Urinalysis
  • Nitrite positive AND Leukocyte Esterase positive
  • Nitrite positive AND >100 WBC
  • Leukocyte Esterase positive AND >100 WBC
  • Know GU cancer diagnosis
  • Urinalysis ordered by urology provider

Sites / Locations

  • NYU Langone

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

The group which will receive the InBasket message to notify users that a patient has clinically significant microscopic hematuria and makes recommendations for follow-up.

The group which will not receive the InBasket message to notify users that a patient has clinically significant microscopic hematuria. (Standard practice)

Outcomes

Primary Outcome Measures

Evaluation rate
Urology evaluation with cystoscopy and appropriate imaging

Secondary Outcome Measures

Full Information

First Posted
August 16, 2021
Last Updated
July 12, 2022
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05011253
Brief Title
Electronic Triggers: Microhematuria Trigger
Official Title
Electronic Trigger for Microhematuria
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
June 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The research team will evaluate the effectiveness of an InBasket Results message that prompts providers to place appropriate follow up orders.
Detailed Description
The research team will evaluate the effectiveness of an InBasket Results message that prompts providers to place appropriate follow up orders. The message will notify users that a patient has clinically significant microscopic hematuria and is at high risk for underlying malignancy and will include the official recommendations (imaging with a CT urogram, urology evaluation with cystoscopy).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematuria

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The group which will receive the InBasket message to notify users that a patient has clinically significant microscopic hematuria and makes recommendations for follow-up.
Arm Title
Control
Arm Type
No Intervention
Arm Description
The group which will not receive the InBasket message to notify users that a patient has clinically significant microscopic hematuria. (Standard practice)
Intervention Type
Other
Intervention Name(s)
Electronic Trigger Microhematuria Alert
Intervention Description
To evaluate the effectiveness of an InBasket Results message in prompting providers to place appropriate follow up orders. The message will notify users that a patient has clinically significant microscopic hematuria and is at high risk for underlying malignancy and will include the official recommendations (imaging with a CT urogram, urology evaluation with cystoscopy).
Primary Outcome Measure Information:
Title
Evaluation rate
Description
Urology evaluation with cystoscopy and appropriate imaging
Time Frame
180 days of alert

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 35 years of age or older 3+ RBC on Urinalysis Urinalysis sent during an outpatient encounter any of the following: 60 years of age or older; RBC > 25; current or prior tobacco use; Gross Hematuria Exclusion Criteria: Under 35 years of age Cystoscopy within 1 year prior to Urinalysis Nitrite positive AND Leukocyte Esterase positive Nitrite positive AND >100 WBC Leukocyte Esterase positive AND >100 WBC Know GU cancer diagnosis Urinalysis ordered by urology provider
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saul Blecker, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Electronic Triggers: Microhematuria Trigger

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