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| ID | Type | Description | Link |
|---|---|---|---|
| CRS-2024-001-257 | Other Grant/Funding Number | Abbott Point of Care |
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| Name | Class |
|---|---|
| Abbott Point of Care | INDUSTRY |
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According to the Centers for Disease Control and Prevention, approximately 200,000 hospitalizations occurred in 2020 related to Traumatic Brain Injury (TBI), which does not include many TBIs treated only in emergency departments, urgent care, primary care, or that are not evaluated by a clinician. Head CT is a critical component of care for severe TBI, however in mild TBI there is practice variation with a wider risk to benefit estimation for obtaining head CT imaging. Potential disadvantages of head CT include longer Emergency Department (ED) length of stay (LOS), higher costs, and diagnostic radiation exposure. The i-STAT TBI test is a panel of in vitro diagnostic immunoassays for the quantitative measurements of glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in whole blood and a semi-quantitative interpretation of test results derived from these measurements, using the i-STAT Alinity instrument. This biomarker test is cleared for use in adults with mild TBI (Glasgow Coma Scale 13-15) within 24 hours of injury, to aid in determining the need for head CT imaging. Currently, CT head imaging for adults with suspected mild TBI is obtained based on clinicians' usual practice patterns and beliefs about patient expectations. Prior research has demonstrated the blood TBI test may reduce unnecessary CT scans by up to 40%, however the impact on head CT ordering has not yet been studied prospectively. It is important to understand the extent to which a negative TBI biomarker result empowers a clinician to cancel a previously ordered head CT. Given that adult patients with mild TBI often present to EDs, which have access to CT scanners, this is a key setting to assess real-world impact of the i-STAT TBI test on CT head utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Notification Arm (Abbott iSTAT TBI test) | Experimental | The ED clinicians caring for the enrolled patient, along with the patient, receive the TBI blood test result with just-in-time education on the TBI test to aid in clinical decision making. |
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| Non-Notification Arm (Control) | No Intervention | Clinicians and enrolled patients do not receive the TBI blood test result. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-STAT TBI Test | Device | The Abbott i-STAT TBI test result is shared with the enrolled patient and treating clinicians. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Head CT scans canceled | Number of head CTs canceled in patients not on anticoagulants as measurement of percentage of reduction in the number of canceled head CTs out of total head CTs ordered (total number and percentage) | Within 24 hours of Traumatic Brain Injury |
| Measure | Description | Time Frame |
|---|---|---|
| Subset of Number of Head CT scans completed | If the i-STAT TBI test results had been strictly adhered to by clinicians, subset of negative i-STAT TBI test results, Potential reduction in the number of completed head CTs (canceled) out of total head CTs ordered (total number and percentage) | Within 24 hours of Traumatic Brain Injury |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mitali Pradhan, MS, CCRP | Contact | 201-423-3585 | Mitali.Pradhan@mountsinai.org | |
| Jonathan Schimmel, MD | Contact | jonathan.schimmel@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Shameeke Taylor, MD, MPH, MSCR | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Morningside | Recruiting | New York | New York | 10025 | United States |
There is no plan to share IPD at this time.
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Multisite randomized controlled clinical trial
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Patient is randomized to the intervention or control arm after consent is obtained. There is no masking for the treatment arm assignment. In the non-notification arm (control arm) participants and care providers will not learn the results of the i-STAT TBI test.
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| ED Length of Stay |
Length of stay for the Emergency Department patient encounter |
| Day 1 after patient ED care visit has ended |
| Number of cancellations of head CT scan order in patients on anticoagulants | Number of cancellations in head CTs in patients on anticoagulation | Day 1 after patient ED care visit has ended |
| Patient Satisfaction Scale | Assessment of patient satisfaction with care during ED visit. Full scale from 1 (worst care possible) to 10 (best care possible) | At 14 days after ED visit |
| Number of head CT scans completed | Number of head CT scans completed for patients within 14 days after index ED visit | At 14 days after ED visit |
| Stress of Uncertainty Scale (SUS) | Clinicians vary in their use of diagnostic testing and treatments, and stress of uncertainty may be one explanation for this variation. The stress of uncertainty scale measures clinician tolerance of uncertainty during patient care. SUS scores range from 15-90 with a higher score indicating greater fear of uncertainty. | Day 1 during patient ED care visit |
| Malpractice Fear Scale (MFS) Scores | Malpractice Fear Scale (MFS) scores. MFS scores range from 6 to 36 with a higher score indicating greater fear of malpractice. | Day 1 during patient ED care visit |
| Whole blood concentrations of GFAP (glial fibrillary acidic protein) | Whole blood concentrations for GFAP on the iSTAT device. Biomarker for use with mild TBI within 24 hours of injury to aid in determining the need for head CT imaging. | Day 1 during patient ED care visit |
| Whole blood concentrations of UCH-L1 (ubiquitin C-terminal hydrolase L1) | Whole blood concentrations for UCH-L1 on the iSTAT device. Biomarker for use with mild TBI within 24 hours of injury to aid in determining the need for head CT imaging. | Day 1 during patient ED care visit |
| Mount Sinai Hospital | Recruiting | New York | New York | 10029 | United States |
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| Mount Sinai West | Recruiting | New York | New York | 10029 | United States |
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| D020196 |
| Trauma, Nervous System |
| D014947 | Wounds and Injuries |