This is a pragmatic, open-label, multicenter, stepped-wedge, Type II hybrid effectiveness-implementation study. It is designed to evaluate both the comparative effectiveness and implementation feasibility of a biomarker-plus-clinical guidelines algorithm to reduce low-value brain computed tomography (CT) use in emergency department (ED) patients evaluated for suspected traumatic brain injury (TBI). The biomarkers are Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin Carboxy-terminal Hydrolase L1 (UCH-L1), two brain-injury proteins cleared by the FDA to support brain CT imaging decisions after trauma. All six participating EDs will contribute baseline data for the first 6 months under usual care (clinical guidelines only). Beginning in month 7, two sites will transition to implementing the biomarker-guided algorithm. At month 13, two additional sites will implement the biomarker-guided approach, and the final two sites will transition at month 19. By the end of the 24-month rollout period, all sites will have implemented the biomarker-guided pathway.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
3,000
Patients will be managed using an algorithm that integrates the Canadian CT Head Rule (CCHR) with i-STAT whole-blood GFAP and UCH-L1 testing. Patients who meet CCHR criteria for CT imaging and those whose CT imaging decision-making is not covered by CCHR (e.g., no loss of consciousness or amnesia) will receive i-STAT testing. Sites will be assigned to one of three implementation waves, with two sites transitioning to the Guidelines + Biomarkers phase every six months. Prior to their assigned transition, sites will continue to use guidelines alone. Once a site transitions to the Guidelines + Biomarkers phase, the integrated biomarker-guided algorithm will become the standard-of-care protocol at that site for eligible patients and will remain the standard of care for the remainder of the study.
During the baseline phase, sites will rely solely on established clinical guidelines to guide brain CT utilization in patients with suspected TBI. Specifically, providers will apply the Canadian CT Head Rule, a validated decision instrument that identifies patients at high risk for clinically important brain injury who require CT imaging. All sites will begin in this Guidelines-Only baseline phase and will continue using this approach until their assigned transition to the Guidelines + Biomarkers phase. Sites will transition in three waves, with two sites transitioning every six months.
UCLA-Olive View Medical Center
Sylmar, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
Henry Ford Macomb (HFM)
Clinton Township, Michigan, United States
Henry Ford Hospital (HFH)
Detroit, Michigan, United States
Adventist Health Portland (AHP)
Portland, Oregon, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
The proportion of eligible emergency department (ED) patients with suspected traumatic brain injury (TBI) who receive brain CT imaging.
Time frame: Initial Emergency Department Visit (approximately 24 hours)
Proportion of eligible ED patients with suspected TBI who receive brain CT imaging and have a clinically significant traumatic lesion.
Time frame: Initial Emergency Department Visit (approximately 24 hours)
Incidence of clinically significant missed traumatic intracranial injury diagnosed within 7 days of the index ED visit
Time frame: Within 7 days of the index/initial ED visit
Incidence of neurosurgical interventions within 7 days of the index ED visit, without a new traumatic event.
Time frame: Within 7 days of the index/initial ED visit
ED length of stay
This will be measured in minutes.
Time frame: Initial Emergency Department Visit (approximately 24 hours)
Initial and sustained provider adherence at 6 and 24 months post-implementation
Time frame: 6 and 24 months post-implementation
Provider acceptability and feedback
Providers will answer 17 questions regarding the implementation of the biomarker-guided algorithm and acceptability. Information from this will be summarized.
Time frame: During implementation phase (months 9-32)
Provider trust in biomarker-guided CT decision making as measured by the proportion of biomarker-negative patients who don't get a CT
Time frame: During implementation phase (months 9-32)
30-day ED revisits and hospitalizations
Time frame: 30 days following Initial Emergency Department Visit
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