HematuriaNCT05011253
Electronic Triggers: Microhematuria Trigger
A study testing Electronic Trigger Microhematuria Alert in people with Hematuria, run by NYU Langone Health at 1 site in United States.
Trial summary
The research team will evaluate the effectiveness of an InBasket Results message that prompts providers to place appropriate follow up orders. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Hematuria
- What is being tested?
- Electronic Trigger Microhematuria Alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2021to 6 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Hematuria
- Being tested
- Electronic Trigger Microhematuria Alert
- Medical subject headings
- Hematuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Trigger Microhematuria AlertOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation rate
Urology evaluation with cystoscopy and appropriate imaging
Measured: 180 days of alert
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start6 Oct 2021
- Primary completion6 Dec 2021
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saul Blecker, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011253
- Sponsor's protocol ID
- QI-MH
- Status last verified
- Jul 2022
- First submitted
- 16 Aug 2021
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Trigger for Microhematuria
- ClinicalTrials.gov ID
- NCT05011253
- Acronym / sponsor ID
- QI-MH
- Conditions
- Hematuria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 6 Dec 2021 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Electronic Trigger Microhematuria AlertThe group which will receive the InBasket message to notify users that a patient has clinically significant microscopic hematuria and makes recommendations for follow-up. |
| 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) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Trigger Microhematuria AlertTo 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). | Other | Intervention |
Primary outcome
Evaluation rate
Time frame: 180 days of alert
Urology evaluation with cystoscopy and appropriate imaging
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
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Hematuria - Cause Not Known
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saul Blecker, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Trigger Microhematuria Alert in people with Hematuria, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation rate (time frame: 180 days of alert). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.