Implementing whole blood TBI point-of-care testing in Level 1 trauma centers: protocol for emergency department implementation for TBI (EDI for TBI) hybrid type II effectiveness-implementation trial.

INTRODUCTION: Technological advances have enabled rapid screening for traumatic brain injury (TBI) at the point of care (POC), with devices approved by the United States Food and Drug Administration (FDA), in part to address throughput and resource allocation challenges in emergency departments (EDs). This point-of-care test quantifies the concentration of two biological markers of brain injury in whole blood after venipuncture. METHODS: The objective of this study is to identify determinants for routine use of POC whole blood TBI test and to evaluate its impact on clinical and health system outcomes across three academic Level 1 trauma centers with accompanying EDs from three distinct geographical regions of the United States. We will utilize an effectiveness-implementation hybrid type II approach for this study involving 280 patients with Glasgow Coma Scale (GCS) scores of 13-15 (i.e., "mild" TBI). RESULTS: Data will be collected (n = 140) using the POC whole blood TBI test, while simultaneously evaluating determinants of use to inform future widespread implementation efforts. An implementation blueprint will be developed and pilot tested at each site, while concurrently enrolling the final 140 patients with GCS 13-15. DISCUSSION: Our goal is to provide evidence that use of the POC whole blood TBI test can reliably and safely improve clinical practice in EDs by reducing rates of unnecessary radiation exposure, shortening time spent in the emergency department, and demonstrating the efficacy of an implementation blueprint that can facilitate uptake of this test at similar Level 1 trauma center emergency departments. CLINICAL TRIAL REGISTRATION: [ClinicalTrials.gov], identifier [NCT07373509].