Scientific Title:

Point of care testing in emergency departments after mild traumatic brain injury (POCkET)

Chief Investigator:

Chief investigator; Dr Virginia Newcombe, University of Cambridge and CUH

Funder:

Investigator led study funded by Abbott diagnostics

Sponsor:

Cambridge University Hospitals Trust and University of Cambridge

Health Condition or Problem Studied:

Patients who present to Emergency Departments (EDs) with mild traumatic brain injury (mTBI) defined as Glasgow Coma Score >12.

Study Design:

Non-interventional Mixed methods research – convergent, parallel mixed-methods approach

Observational Cohort Study (POCkET-Cohort):

Observational cohort study of 400 patients with mTBI who present to an ED. Patients will be recruited as soon as possible after arrival to an ED. Clinical data and blood sampling will be performed as per the protocol. Follow-up will occur at ~2 weeks, ~3 months and ~6 months. Blood sampling will include use of the i-STAT TBI assay using the i-STAT Alinity (Abbott).

Qualitative study (POCkET-Qualitative):

Workshop and interviews of staff members investigating current mTBI provision both planned and as performed.

Process mapping supplemented by operational data and health services data from clinical cohort.

Modelling of current service provision and comparison to potential biomarker and clinical decision support tool (CDST) implementation pathways.

Target Sample Size:

POCkET-cohort: 400 patients with mTBI

POCkET-qualitative:

Health care professionals:

• Recruitment of 10-15 participants in each workshop from across the ED professions including doctors, nursing and healthcare assistant staff, laboratory employees, operational management, clerks and porters
• Aim is to purposively sample seeded by initial workshops and background literature.
• Plan for two workshops at each of the participating sites
• Supplemented by key informant interviews – up to 8 at each site.

Status:

In set-up

Contact details:

Study queries: pocket.study@uea.ac.uk​

Public and scientific queries: pocket@medschl.cam.ac.uk​

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