NCT05011253

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

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

August 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 6, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

July 14, 2022

Status Verified

July 1, 2022

Enrollment Period

2 months

First QC Date

August 16, 2021

Last Update Submit

July 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluation rate

    Urology evaluation with cystoscopy and appropriate imaging

    180 days of alert

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

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).

Intervention

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • + 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Hematuria

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Saul Blecker, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 18, 2021

Study Start

October 6, 2021

Primary Completion

December 6, 2021

Study Completion

June 6, 2022

Last Updated

July 14, 2022

Record last verified: 2022-07

Locations