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Open Access Study protocol

Implementing evidence-based recommended practices for the management of patients with mild traumatic brain injuries in Australian emergency care departments: study protocol for a cluster randomised controlled trial

Marije Bosch12*, Joanne E McKenzie3, Duncan Mortimer4, Emma J Tavender12, Jill J Francis5, Sue E Brennan3, Jonathan C Knott67, Jennie L Ponsford289, Andrew Pearce1011, Denise A O’Connor3, Jeremy M Grimshaw1213, Jeffrey V Rosenfeld1142, Russell L Gruen1152, Sally E Green3 and on behalf of the NET Program

Author Affiliations

1 Department of Surgery, Central Clinical School, Monash University, Melbourne, Australia

2 National Trauma Research Institute, The Alfred & Monash University, Melbourne, Australia

3 School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

4 Centre for Health Economics, Monash University, Melbourne, Australia

5 School of Health Sciences, City University London, London, UK

6 Melbourne Medical School, The University of Melbourne, Melbourne, Australia

7 Department of Emergency Medicine, Royal Melbourne Hospital, Melbourne, Australia

8 Monash-Epworth Rehabilitation Research Centre, Epworth Hospital, Melbourne, Australia

9 School of Psychology and Psychiatry, Monash University, Melbourne, Australia

10 MedSTAR Emergency Medical Retrieval Service, Adelaide, South Australia

11 Royal Adelaide Hospital Emergency Department, Adelaide, Australia

12 Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada

13 Department of Medicine, University of Ottawa, Ottawa, ON, Canada

14 Department of Neurosurgery, The Alfred Hospital, Melbourne, Australia

15 Department of Trauma, The Alfred Hospital, Melbourne, Australia

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Trials 2014, 15:281  doi:10.1186/1745-6215-15-281

Published: 11 July 2014

Abstract

Background

Mild head injuries commonly present to emergency departments. The challenges facing clinicians in emergency departments include identifying which patients have traumatic brain injury, and which patients can safely be sent home. Traumatic brain injuries may exist with subtle symptoms or signs, but can still lead to adverse outcomes. Despite the existence of several high quality clinical practice guidelines, internationally and in Australia, research shows inconsistent implementation of these recommendations. The aim of this trial is to test the effectiveness of a targeted, theory- and evidence-informed implementation intervention to increase the uptake of three key clinical recommendations regarding the emergency department management of adult patients (18 years of age or older) who present following mild head injuries (concussion), compared with passive dissemination of these recommendations. The primary objective is to establish whether the intervention is effective in increasing the percentage of patients for which appropriate post-traumatic amnesia screening is performed.

Methods/design

The design of this study is a cluster randomised trial. We aim to include 34 Australian 24-hour emergency departments, which will be randomised to an intervention or control group. Control group departments will receive a copy of the most recent Australian evidence-based clinical practice guideline on the acute management of patients with mild head injuries. The intervention group will receive an implementation intervention based on an analysis of influencing factors, which include local stakeholder meetings, identification of nursing and medical opinion leaders in each site, a train-the-trainer day and standardised education and interactive workshops delivered by the opinion leaders during a 3 month period of time. Clinical practice outcomes will be collected retrospectively from medical records by independent chart auditors over the 2 month period following intervention delivery (patient level outcomes). In consenting hospitals, eligible patients will be recruited for a follow-up telephone interview conducted by trained researchers. A cost-effectiveness analysis and process evaluation using mixed-methods will be conducted. Sample size calculations are based on including 30 patients on average per department. Outcome assessors will be blinded to group allocation.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12612001286831 (date registered 12 December 2012).

Keywords:
Mild traumatic brain injury; Cluster trial; Emergency department