Electronic Triggers: Microhematuria Trigger

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT05011253

Collaborator

(none)

2,000

Enrollment

Location

Arms

Actual Duration (Months)

250.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hematuria	Other: Electronic Trigger Microhematuria Alert	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

2000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Screening

Official Title:

Electronic Trigger for Microhematuria

Actual Study Start Date :

Oct 6, 2021

Actual Primary Completion Date :

Dec 6, 2021

Actual Study Completion Date :

Jun 6, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Evaluation rate [180 days of alert]
Urology evaluation with cystoscopy and appropriate imaging

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

Principal Investigator: Saul Blecker, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT05011253

Other Study ID Numbers:

QI-MH

First Posted:

Aug 18, 2021

Last Update Posted:

Jul 14, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hematuria

Study Results

No Results Posted as of Jul 14, 2022