Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001286831
Ethics application status
Approved
Date submitted
4/12/2012
Date registered
12/12/2012
Date last updated
11/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Management of patients with mild head injury in Australian Emergency Departments: The Neurotrauma Evidence Translation (NET) Trial
Scientific title
Testing the effectiveness of a targeted implementation intervention compared with passive dissemination on the uptake of key evidence-based recommended practices in the emergency department management of mild head injury in Australia: A cluster randomised trial
Secondary ID [1] 281624 0
Nil
Universal Trial Number (UTN)
Trial acronym
NET Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild head injury 287908 0
Condition category
Condition code
Injuries and Accidents 288285 288285 0 0
Other injuries and accidents
Public Health 288286 288286 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Emergency departments (EDs) randomised to the intervention arm will receive a targeted, theory and evidence-informed implementation intervention designed to increase the uptake of key evidence-based recommended practices in the management of mild head injured patients.

The intervention will involve local stakeholder meetings, identification of nursing and medical clinical opinion leaders in each site; a train-the-trainer day; materials to increase the visibility of tools; and a non-specific reminder to optimise data collection and standardised education and interactive workshops delivered by the clinical leaders over a 3 month period of time.
Intervention code [1] 286157 0
Behaviour
Comparator / control treatment
Passive clinical practice guideline dissemination: Participating EDs randomised to the control group will receive a link to the electronic copy of Institute of Trauma and Injury Management’s (ITIM) ‘Initial Management of Closed Head Injury in Adults (2nd ed.)’ clinical practice guideline.
Control group
Active

Outcomes
Primary outcome [1] 288461 0
Management outcome:
- Appropriate post-traumatic amnesia (PTA) screening (using a validated tool, such as A-WPTAS, until perfect score received)
Timepoint [1] 288461 0
2 month period post-intervention
Secondary outcome [1] 300315 0
Management outcome:
- At least one complete administration of PTA screening, using a validated tool such as A-WPTAS
Timepoint [1] 300315 0
2 month period post-intervention
Secondary outcome [2] 300316 0
Management outcome:
- CT scan (in subgroup where clinical indication for CT is recorded in notes)
Timepoint [2] 300316 0
2 month period post-intervention
Secondary outcome [3] 300317 0
Management outcome:
- Provision of patient information upon discharge from the ED
Timepoint [3] 300317 0
2 month period post-intervention
Secondary outcome [4] 300318 0
Management outcome:
- Safe discharge (based on 'Appropriate PTA screening' and 'Provision of patient information upon discharge')
Timepoint [4] 300318 0
2 month period post-intervention
Secondary outcome [5] 300319 0
Management outcome:
- Safe discharge (based on 'Appropriate PTA screening', 'CT scan' and 'Provision of patient information upon discharge')
Timepoint [5] 300319 0
2 month period post-intervention
Secondary outcome [6] 300321 0
Predictors of management outcomes (Clinician self-report at baseline and endpoint) such as:
(a) Cognitions in relation to mTBI-related team climate (e.g. participative safety, support for innovation, vision, task orientation) (Team Climate Inventory, 12-item short version)
(b) Intention to adhere to recommended practices for PTA, CT and patient information upon discharge from the ED (1-item generalised intention measure)
(c) Other cognitions such as knowledge and beliefs about capabilities (for PTA only) (Survey items designed for this study)
Timepoint [6] 300321 0
Baseline and endpoint (2 month post-intervention)
Secondary outcome [7] 300322 0
Patient outcomes (self-report for a subgroup of patients):
(a) Anxiety (Relevant questions from the Hospital Anxiety and Depression Scale (HADS))
(b) Post-concussive symptoms (13-item Rivermead)
(c) Return to normal activities, including work (2-item Survey designed for this study)
(d) Health-related quality of life (SF12)
Timepoint [7] 300322 0
3-5 month post-discharge
Secondary outcome [8] 300323 0
Healthcare utilisation and costs (self-report for a subgroup of patients):
(a) representation to ED
(b) Healthcare visits in relation to mTBI
(c) mTBI related medication use
Timepoint [8] 300323 0
3-5 month post-discharge
Secondary outcome [9] 300324 0
Healthcare utilisation and costs (extraction from medical record):
(a) Medical and surgical services received, including CT scan
(b) Representation to ED
Timepoint [9] 300324 0
2 month period post-intervention
Secondary outcome [10] 300325 0
Healthcare utilisation and costs (data abstraction surveys):
(a) Direct costs of delivering the intervention (intervention group only)
Timepoint [10] 300325 0
Upon delivery of the intervention
Secondary outcome [11] 309870 0
Management outcome: - Memory assessment using questions in clinical assessment
Timepoint [11] 309870 0
2 month period post-intervention

Eligibility
Key inclusion criteria
Hospitals: 24 hour (private or public) emergency departments will be eligible for inclusion in the trial.

Clinician Cohort: Clinicians (both medical and nursing staff member) who have an appointment with the ED and currently engaged in clinical practice will be eligible for inclusion.

Patient Cohort: Patient participants will be eligible for inclusion if they are at least 18 years old, present to the ED within 24 hours after the traumatic event with potential acute brain injury and who have a GCS score of 14 or 15 at presentation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hospitals will be excluded if they * are either non 24-hour EDs or specialised hospital (e.g. women’s or children) and therefore do not routinely treat adult patients with TBI; * do not have a CT scanner on site; or if there is a significant risk of bias (e.g. risk of contamination due to two EDs having the same ED director or senior influential clinicians working across sites). EDs that participated in the pilot of the intervention will be ineligible for inclusion in the trial.

Clinician cohort: Academic staff (not currently engaged in the treatment of patients), students/interns, and -for nurses-, bank or agency nurses will be excluded.

Patient cohort: penetrating injuries, non-traumatic traumatic brain injury such as caused by stroke.

For the patients who participate in the follow-up (NET-Plus), additional exclusion criteria are: patients not consenting to participate in the follow-up study, and reasons (e.g. non-English speakers) for the patient not being able to answer the questions conducted over the phone

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will take place through inclusion of a random component and allocation of batches of EDs by a statistician independent of the trial. The statistician will be provided with a file containing only ED codes and the minimisation factors (thus no identifying information). For each batch of EDs, the statistician will randomise the order of EDs before using the minimisation algorithm to allocate the EDs to intervention and control groups.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
EDs will be allocated to the intervention and control groups using the method of minimisation proposed by Pocock and Simon (Biometrics 1975, 31:103-115). Minimisation has been shown through statistical simulation studies to outperform stratified allocation methods for maintaining baseline balance in prognostic factors. In addition, the method allows for balancing across a greater number of prognostic factors. The minimisation factors will include: the existence of a protocol for mTBI (consistent with our recommendation for appropriate PTA assessment); size (annual presentation rate 2012); rurality; and type of participation (NET or NET-Plus). Minimisation is essentially a deterministic method and therefore, use of this method can increase the risk of selection bias (Berger. Contemp Clin Trials 2010, 31:406). We plan to reduce the risk of selection bias through inclusion of a random component and allocation of batches of EDs by a statistician independent of the trial. The statistician will be provided with a file containing only ED codes and the minimisation factors (thus no identifying information). For each batch of EDs, the statistician will randomise the order of EDs before using the minimisation algorithm to allocate the EDs to intervention and control groups.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised trial (EDs unit of randomisation)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
The primary outcome in the NET trial is appropriate PTA screening. In the calculation of sample size for this outcome, adjustment needs to be made for the clustered nature of the design. The variance inflation factor, or design effect, used to achieve this is a function of the average cluster size, variation in cluster size, and the intra-cluster correlation (ICC).

The assumed ICC was calculated from two sources reporting ICCs from various datasets.Thirty three ICC estimates for process measures in secondary care were available, and the median ICC was 0.18. The variation in cluster size was incorporated into the sample size calculation through an estimate of the coefficient of variation (CV; 0.47), calculated from annual attendance at EDs across 170 hospitals in Australia (2009).

There were no studies providing estimates of rates of compliance for our primary outcome in adult populations. We therefore undertook a retrospective audit of two Australian metropolitan EDs. The estimated rates of appropriate PTA screening were 0% in one hospital, and 31% for a second (which had an mTBI protocol in place). We expected that hospitals without a protocol for mTBI would be more interested in participating in the trial, and therefore calculated our sample size based on a control group rate of 10%. We wish to detect an absolute increase in the rate of appropriate PTA screening of at least 20%. Based on the mentioned assumptions, we will require 15 EDs per intervention group. A total of 30 EDs will provide 900 patient participants for whom ED staff management will be assessed. Allowing for 10% attrition in EDs, we plan to initially recruit 17 EDs per intervention group.

Effectiveness analysis:
The effectiveness of the intervention on management outcomes, predictors of management outcomes, and patient outcomes will be estimated with marginal modelling using generalised estimating equations (GEEs). These models will appropriately account for correlation of responses of individuals within EDs.

Models will include adjustment for minimisation factors and pre-specified potential confounding variables. All pre-specified confounders will be included in the models even when no baseline imbalance exists. In addition, for continuous outcomes which are collected at both baseline and follow-up we will include the baseline measure of the outcome in the model.

Estimates of intervention effect from these models with binary outcomes will yield odds ratios. To aid interpretability, we plan to also provide estimates of risk differences. Estimates of risk differences will be computed from marginal probabilities estimated from the fitted logistic models.
All tests will be two-sided and carried out at the 5% level of significance. A full statistical analysis plan will be developed and written prior to undertaking any data analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/01/2013
Actual
30/10/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 286431 0
Government body
Name [1] 286431 0
Victorian Transport Accident Commission (TAC)
Country [1] 286431 0
Australia
Primary sponsor type
Other
Name
National Trauma Research Institute
Address
Level 4, 89 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 285216 0
None
Name [1] 285216 0
Address [1] 285216 0
Country [1] 285216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288510 0
Alfred Health Human Ethics Committee
Ethics committee address [1] 288510 0
Ethics committee country [1] 288510 0
Australia
Date submitted for ethics approval [1] 288510 0
Approval date [1] 288510 0
16/10/2012
Ethics approval number [1] 288510 0
398/12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35013 0
Prof Russell Gruen
Address 35013 0
National Trauma Research Institute (NTRI)
Level 4, Burnet Tower
89 Commercial Road
Melbourne VIC 3004
Country 35013 0
Australia
Phone 35013 0
+61 3 90762561
Fax 35013 0
Email 35013 0
nettrial@monash.edu
Contact person for public queries
Name 18260 0
Dr Marije Bosch or Ms Marisa Chau
Address 18260 0
Central Clinical School, Level 6, The Alfred Centre, 99 Commercial Rd, Melbourne 3004 VIC
Country 18260 0
Australia
Phone 18260 0
+61 3 9903 0062
Fax 18260 0
+61 3 9903 0556
Email 18260 0
nettrial@monash.edu
Contact person for scientific queries
Name 9188 0
Marije Bosch
Address 9188 0
Central Clinical School, Level 6, The Alfred Centre, 99 Commercial Rd, Melbourne 3004 VIC
Country 9188 0
Australia
Phone 9188 0
+61 3 9903 0062
Fax 9188 0
+61 3 9903 0556
Email 9188 0
nettrial@monash.edu

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEconomic evaluation of the NET intervention versus guideline dissemination for management of mild head injury in hospital emergency departments.2018https://dx.doi.org/10.1186/s13012-018-0834-6
EmbaseEvaluation of a targeted, theory-informed implementation intervention designed to increase uptake of emergency management recommendations regarding adult patients with mild traumatic brain injury: results of the NET cluster randomised trial.2019https://dx.doi.org/10.1186/s13012-018-0841-7
N.B. These documents automatically identified may not have been verified by the study sponsor.