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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
450
The Abbott i-STAT TBI test result is shared with the enrolled patient and treating clinicians.
Mount Sinai Morningside
New York, New York, United States
RECRUITINGMount Sinai Hospital
New York, New York, United States
RECRUITINGMount Sinai West
New York, New York, United States
RECRUITINGNumber 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)
Time frame: Within 24 hours of Traumatic Brain Injury
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)
Time frame: Within 24 hours of Traumatic Brain Injury
ED Length of Stay
Length of stay for the Emergency Department patient encounter
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 during patient ED care visit
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