Electronic Triggers: Microhematuria Trigger

Electronic Trigger for Microhematuria

The research team will evaluate the effectiveness of an InBasket Results message that prompts providers to place appropriate follow up orders.

Study Overview

• Status: Completed
• Conditions: Hematuria
• Intervention / Treatment: Other: Electronic Trigger Microhematuria Alert

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).

• Study Type: Interventional
• Enrollment (Actual): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: Electronic Trigger Microhematuria Alert; 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).
No Intervention: Control; The group which will not receive the InBasket message to notify users that a patient has clinically significant microscopic hematuria. (Standard practice)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation rate	Urology evaluation with cystoscopy and appropriate imaging	180 days of alert

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Saul Blecker, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2021
• Primary Completion (Actual): December 6, 2021
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 14, 2022
• Last Update Submitted That Met QC Criteria: July 12, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Hemorrhage; Urination Disorders; Hematuria
• Other Study ID Numbers: QI-MH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No