Implementation Research, TBI (Traumatic Brain Injury)
Conditions
Keywords
Concussion, Traumatic Brain Injury, CT scan, Blood Biomarker, i-STAT Alinity TBI Test
Brief summary
The objective of this study is to identify determinants for implementing the i-STAT Alinity whole blood traumatic brain injury (TBI) test for its Food and Drug Administration (FDA)-indicated use and to evaluate other potential outcomes with clinical implications. The main questions it aims to answer are: 1. Determine the number of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans. 2. What are the obstacles for using the i-STAT Alinity for its FDA-indicated use
Detailed description
Objective: The objective of this study is to utilize the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework to identify determinants for implementing the whole blood traumatic brain injury (TBI) test for its Food and Drug Administration (FDA)-indicated use and to evaluate other potential outcomes with clinical implications. Specific Aims: Aim 1) Evaluate the effectiveness of the whole blood iSTAT Alinity test in determining the need for a head computed tomography (CT) scan in approximately 140 patients with a Glasgow Coma Score (GCS) 13-15 in the emergency department (ED) (approximately 47 per site) while assessing two novel outcomes with significant clinical implications (i.e., reduction in ED length of stay and predictive utility for ED revisits for the same injury). Aim 2) Evaluate determinants for routine use of the whole blood iSTAT Alinity test by assessing acceptability, adoption, appropriateness and feasibility of the test at the organizational- and physician-level for each site and determine how these factors interplay with patient perspectives and knowledge to influence implementation of the test. Aim 3) Develop a site-specific implementation blueprint for use of the whole blood iSTAT Alinity test in determining the need for a head CT scan and pilot test the blueprint in approximately 140 patients with GCS 13-15 in the ED (approximately 47 per site).
Interventions
DEVICEi-STAT Alinity TBI test
The i-STAT TBI cartridge is a point-of-care test that measures the level of biomarkers associated with brain injury in whole blood to help assess patients with suspected mTBI within 24 hours after injury.
Sponsors
Shawn Eagle
United States Department of Defense
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 or older 2. Presenting to an enrolling ED with ED Arrival GCS of 13-15 following reported head blunt impact within 24 hours of injury 3. Meets Department of Defense (DoD) definition of mTBI: A traumatically induced physiological disruption of brain function as a result of an external force that is indicated by new onset or worsening of at least one of the following clinical signs immediately following the event: 1. Any alteration of mental status (e.g., feeling dazed, disoriented, or confused) 2. Any period of loss of or a decreased level of consciousness, observed or self-report (loss of consciousness 30 minutes or less, an alteration of consciousness up to 24 hours) 3. Any loss of memory for events immediately before or after the injury (post-traumatic amnesia up to 1-day post-injury)
Exclusion criteria
1. Treating emergency department provider does not think a head CT scan is needed 2. Inability to obtain results for iSTAT Alinity TBI test within 24 hours of injury 3. Treating emergency department attending physician is not willing to participate 4. Pre-existing neurologic condition 5. Contraindication or inability to complete blood draw 6. Significant polytrauma that, in the opinion of the principal investigators, could impact peripheral GFAP levels or require a full body scan 7. History of penetrating TBI 8. History of neurosurgical intervention for previous TBI 9. Penetrating TBI for current injury 10. Any history of brain surgery 11. Any history of brain tumor 12. Patients on psychiatric hold
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of CT scans completed | Up to 5 hours (from enrollment to CT scan completion) | Rate of CTs completed for ED patient participants with a non-elevated i-STAT Alinity whole blood TBI test result. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ED patient length of stay | Up to 5 hours (from arrival to discharge) | — |
| Patient return visit to ED | Up to two weeks | Return visit for same injury within 2 weeks of initial visit |
| Military Acute Concussion Evaluation-2 (MACE-2) | Visit 1 (ED visit) | MACE 2 is a 15-minute multimodal tool that assists providers in the assessment and diagnosis of concussion. It includes: 1. An unscored screening section collected by clinician interview 2. A cognitive exam with scores ranging 0-30; with higher scores representing better performance. A score of 25 or less is considered abnormal. 3. Normal/Abnormal ratings of neurological function, symptom report, and visual-ocular functioning A total score is not generated. |
| Neurobehavioral Symptom Inventory (NSI) | The NSI will be completed once during the patient's visit 1 (ED visit), and once at visit 2 (2-week remote follow-up) | The NSI is a 22-item scale of TBI symptoms which takes 2 minutes to complete. Total scores range from 0-88, with higher scores indicating more severe symptom burden. |
| Modified Rosenbaum Concussion Knowledge and Attitudes Survey (RoCKAS) | Visit 1 (ED visit) | This is a 13-item survey to evaluate existing knowledge of concussion, which takes 2 minutes to complete. All questions are true/false. Correct responses get one point, with total scores ranging 0-13; higher scores indicate greater knowledge. |
| Mobilizing Implementation of iPARIHS Facilitation Planning Tool (Mi-PARIHS) | Visit 1 (enrollment) and again at 39 months (study conclusion) | This is a 34-item survey to be filled out by ED providers to identify determinants for implementation of the I-STAT TBI test. Each item is rated with a 5-item likert-scale, rated -2 to +2, to identify barriers and facilitators/enablers for the i-STAT TBI test. Lower scores indicate more barriers. |
| Decisional Conflict Scale (DCS) | Visit 1 (enrollment) and again at 39 months (study conclusion) | The DCS is a 16-item survey about decision-making to be filled out by ED providers. It measures 5 dimensions of decision making, with factors related to feeling uncertain, uninformed, unclear about values, unsupported, or ineffective decision making. All items are scored on a Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). Total scores range from 16-80; a higher score indicates a higher level of decisional conflict. |
| Implementation Questionnaire | Visit 1 (enrollment) and again at 39 months (study conclusion) | This is a 4-item survey about the i-STAT TBI test implementation to be filled out by ED providers. All items are scored on a Likert scale ranging from 1 (completely disagree) to 5 (completely agree). Total scores range from 4-20; a higher score indicates a higher level of i-STAT TBI test implementation acceptance. |
Countries
United States
Contacts
CONTACTShawn Eagle, PhD
CONTACTKathryn Edelman, MS
PRINCIPAL_INVESTIGATORShawn Eagle, PhD
University of Pittsburgh
Outcome results
None listed