Emergency Department Implementation of the i-STAT Alinity Traumatic Brain Injury Whole Blood Test (EDI)

Shawn Eagle

Status: Not yet enrolling

Conditions: Implementation Research; TBI (Traumatic Brain Injury)

Treatments: Device: i-STAT Alinity TBI test

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07373509

STUDY25010137

HT94252510275 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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 & working hypotheses:

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).

• The working hypotheses are that the rate of patients with non-elevated (i.e., below clinical cutoff) whole blood iSTAT Alinity tests who also receive CT scans will mirror the preliminary study results (21 percent), a reduction in ED length of stay will be observed (in comparison to also receiving a CT scan) of greater than 3 hours, and predictive utility for return ED visits from the same injury will be high (area under the curve greater than 0.80).

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.

• The working hypotheses are that organization-, physician-, and patient-level determinants will be identified and gaps in patient knowledge will be observed. A diverse Community Advisory Board (CAB) will be assembled to provide important context of how these varying perspectives impact the whole blood iSTAT Alinity test utilization. We will also obtain community knowledge and perspective on this test via the CAB.

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).

• The working hypothesis is that an implementation blueprint that targets identified determinants in Aim 2 will lead to a reduction in the rate of patients with negative whole blood iSTAT tests who also receive CT scan to 5 percent or less.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

340 participants in 2 patient groups

ED Providers

Description:

Treating providers in the emergency department

ED patients

Description:

Patients in the emergency department with GCS 13-15 with suspected TBI

Treatment:

Device: i-STAT Alinity TBI test