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Trial registered on ANZCTR
Registration number
ACTRN12622000589785
Ethics application status
Approved
Date submitted
29/03/2022
Date registered
21/04/2022
Date last updated
21/04/2022
Date data sharing statement initially provided
21/04/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
An Occupational Therapy Pathway for Mild Traumatic Brain Injury Emergency Department presentations across the lifespan
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Scientific title
The effect of an Occupational Therapy Pathway on Post-Concussion Symptoms for Mild Traumatic Brain Injury ED presentations across the lifespan: A Non-Contemporaneous Cohort Comparison Study
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Secondary ID [1]
306785
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Not applicable
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
mild traumatic brain injury
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persistent post concussive syndrome
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Condition category
Condition code
Physical Medicine / Rehabilitation
323158
323158
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0
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Occupational therapy
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Injuries and Accidents
323244
323244
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0
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Other injuries and accidents
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Neurological
323245
323245
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Occupational Therapy (OT) Referral Pathway (Cohort 2):
The OT referral pathway aims to provide specialist follow up for patients seen in ED for a head injury, outside of business hours and demonstrating characteristics most at risk of experiencing functional deterioration. This pathway is being implemented as routine care regardless of a patient's participation in the study.
Patients will be referred to their respective services by the ED treating team:
-Adults (over the age of 18yrs, OR no longer attending formal schooling due to lifestyle and behaviour factors)
-Paediatrics (5yo or school attending, and under the age of 18yrs).
Patients will be provided with written educational material about head injury by the ED team upon referral to the OT pathway.
The OT clinic provides telehealth counselling sessions aimed at education, symptom management and intervention based on patient goals and occupational engagement to promote client centred care and re-integration into community / productivity roles.
Initial assessment (which will take up to 30 minutes) will be completed over telephone by an Occupational Therapist and aims to obtain a detailed history, impact of symptoms on daily functioning including the administration of the Rivermead Post Concussion Symptom Questionnaire, WHODAS 2.0 and if clinically indicated a Vestibular Screening Tool.
Patients will be offered subsequent reviews as clinically indicated, focusing on their re-integration and patient specific goals. As such, the number of times of intervention and duration of intervention will vary depending on the patient's presentation and may range from a single 30 minute follow up phone call to several 30-60minute appointments over 3-6 months. (Nature, duration and attendance at each session will be recorded and monitored as part of the data collection process for this research). Sessions may be administered via telehealth, telephone or face to face as required. Face to face sessions will be conducted at the Gold Coast University Hospital, OT clinic rooms.
Intervention provided on the pathway is based on a local evidence-based clinical guideline and may include the following management:
- Normalising symptoms and expected outcomes
- Reassurance
- Gradual return to activities and life roles
- Strategies to manage symptoms;
- Sleep hygiene
- Relaxation and modification of environment
- Graded return to daily routine, activity and employment responsibilities or occupational roles
- Graded return to school and leisure activities
- Fatigue management
- Sensory modulation approach
- Relevant cognitive assessment and intervention
- Mental health and associated symptoms and referrals
- Visual disturbances associated referrals
- Vestibular and balance disturbances and associated referrals
Interventions are provided until symptoms resolve, or significant improvement has been reported, as identified in either goal achievement and/ or perceived symptoms within the Rivermead Post Concussion Symptom Questionnaire. Alternative indicators for referrals and discharge options will also be explored including referral to GP, community psychology or Vestibular Physiotherapy for ongoing management and care.
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Intervention code [1]
323238
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Rehabilitation
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Intervention code [2]
323359
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Treatment: Other
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Comparator / control treatment
Pre-implementation usual care (Cohort 1):
Prior to the implementation of this direct referral pathway- there was no formal referral process for follow up of these patients, or standardised treatment follow-up within the Hospital Health Service (GCUH and Robina Hospitals). Some patients were referred to Occupational Therapy on an ad hoc basis with no formal or coordinated treatment pathway. The time period this data will be collected will be approximately 4-5 months prior to the implementation of the pathway (being approximately March 2022 to July 2022).
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Control group
Historical
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Outcomes
Primary outcome [1]
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Representation to Emergency department associated with mild traumatic brain injury (TBI). This will be accessed from the patient's electronic medical record.
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Assessment method [1]
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Timepoint [1]
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4 weeks post initial presentation from ED (Primary end point) and 3 months post initial presentation from ED
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Primary outcome [2]
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Emergency department length of stay as determined by health service health analytics data derived from the patient's electronic medical record.
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Assessment method [2]
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Timepoint [2]
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At the time of discharge from ED
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Primary outcome [3]
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Number of post concussion symptoms (as measured by Rivermead Post Concussion Symptom Questionnaire)
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Assessment method [3]
330910
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Timepoint [3]
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-4 weeks post initial presentation from ED (Primary end point) and 3 months post initial presentation from ED- Cohort 1 and 2
- At the time of admission and time of discharge to the Occupational Therapy clinic for Cohort 2 only
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Secondary outcome [1]
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Number of multidisciplinary referrals made determined by accessing patient's electronic medical record and local health analytics data.
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Assessment method [1]
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Timepoint [1]
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4 weeks post initial presentation from ED and 3 months post initial presentation from ED
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Secondary outcome [2]
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Functional burden and disability as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS).
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Assessment method [2]
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Timepoint [2]
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4 weeks post initial presentation from ED and 3 months post initial presentation from ED
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Secondary outcome [3]
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Patient satisfaction with follow up provided, as measured by a tailored patient reported experience survey with 5 point Likert scale questions and free form question,
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Assessment method [3]
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Timepoint [3]
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4 weeks post initial presentation from ED and 3 months post initial presentation from ED
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Secondary outcome [4]
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Staff experience with OT intervention pathway as evaluated using focus groups
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Assessment method [4]
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Timepoint [4]
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Approximately 4-5 months OT intervention pathway implementation
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Secondary outcome [5]
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Health resource utilisation as measured by cost to the health service (i.e., health practitioner costs for direct and indirect patient time associated with OT intervention pathway and resource use as captured by treating OT and cost for length of stay, outpatient appointments, and representations as captured from the electronic medical records data) and cost to patient (i.e., loss of income from loss of work/need to care for child missing school as reported by patient).
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Assessment method [5]
408034
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Timepoint [5]
408034
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4 weeks post initial presentation from ED and 3 months post initial presentation from ED
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Secondary outcome [6]
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Number of days missed from work and/or study as assessed by tailored questionnaire collected over telephone
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Assessment method [6]
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Timepoint [6]
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4 weeks post initial presentation from ED and 3 months post initial presentation from ED
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Secondary outcome [7]
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Adherance to referring eligible patients to the OT intervention pathway, as measured retrospectively by an audit of eligible patient's electronic medical record.
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Assessment method [7]
408389
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Timepoint [7]
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On discharge from initial ED presentation (Cohort 1 only)
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Secondary outcome [8]
408390
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Description of the type of OT interventions provided as collected by treating Occupational Therapist completing treatment data collection form after each session.
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Assessment method [8]
408390
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Timepoint [8]
408390
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Throughout admission to OT clinic (Cohort 1 only)
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Eligibility
Key inclusion criteria
-ED presentation (Gold Coast University or Robina Hospital)
- Primary diagnosis of mild Traumatic Brain Injury (mTBI) and related diagnostic groups as coded by Gold Coast Hospital and Health Service Health Analytic Data including coded diagnostic groups of (Minor Head Injury, Head Injury, Concussion injury of cerebrum, Concussion with loss of consciousness, Concussion with no loss of consciousness, Concussion with less than 1-hour loss of consciousness, Repeated concussion).
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Minimum age
5
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Under five years of age
• Those receiving an inpatient admission for mTBI symptom management from ED
• Patients admitting to accessory sites constructed in periods of medical response (eg: Mobile ED services).
• Those residing in a Residential Aged Care Facility
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As this is a non-randomised trial this is not applicable.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As this is a non-randomised trial this is not applicable.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
This is a sequential explanatory mixed methods study involving a non-contemporaneous cohort comparison study with an embedded process evaluation and nested focus group.
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Between group comparisons between Cohort 1 and 2 at 4 weeks and 3 months-post injury will be made on all continuous data (i.e., client outcomes, service outcomes) using a linear regression model, and for proportion data (i.e., readmission rates), a logistic regression model will be undertaken. To compare within group differences from admission to discharge within the OT clinic for Cohort 2, a linear regression model will be undertaken between admission to the clinic and discharge from the clinic. We will include covariates in the model known to have a potential impact on outcomes (e.g., gender, age, paediatric vs adult, previous OT input). Where paediatric versus adult is found to have a significant interaction effect on outcomes, then a separate sub analyses will be undertaken.
To answer our research question regarding the incidence of patients with mTBI with Persistent Post Concussion syndrome sequalae, data will be described as number, and percentages with 95% confidence interval. To describe the Occupational Therapy interventions undertaken, descriptive statistics will be undertaken and average proportion of the types of intervention provided to Cohort 2 together with 95% confidence intervals will be reported. We will also continue to consult with Dr Ian Hughes, GCHHS Biostatistician for statistical advice for this study.
Measures of participant time from work, time from school, and time caring for a child/minor during recovery, as well as resource utilisation to administer the OT intervention will be used for an economic analysis.
Qualitative analyses:
Audio recordings for the focus group will be transcribed and inductively coded using qualitative content analyses in NVivo . This will involve meaning units being coded and grouped into related descriptive categories by a member of the research team and checked by a second team member, with any discrepancies discussed by a third member until a consensus is reached. The same approach will be used for open-ended responses for satisfaction questionnaire data.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
26/04/2022
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Actual
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Date of last participant enrolment
Anticipated
12/12/2022
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Actual
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Date of last data collection
Anticipated
14/03/2023
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Actual
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Sample size
Target
700
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
22055
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Gold Coast University Hospital - Southport
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Recruitment hospital [2]
22056
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Robina Hospital - Robina
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Recruitment postcode(s) [1]
37178
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4215 - Southport
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Recruitment postcode(s) [2]
37179
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4226 - Robina
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Funding & Sponsors
Funding source category [1]
311122
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Charities/Societies/Foundations
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Name [1]
311122
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Queensland Emergency Medical Foundation
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Address [1]
311122
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Suite 1B, Terraces, 19
Lang Parade,
Milton Qld 4064
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Country [1]
311122
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Australia
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Funding source category [2]
311126
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Government body
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Name [2]
311126
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Queensland Health Health Practitioner's Research Scheme
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Address [2]
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Allied Health Professional Office of Queensland
Health Practitioner Research
Level 1, 15 Butterfield Street
Herston Qld 4006
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Country [2]
311126
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Australia
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Primary sponsor type
Hospital
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Name
Gold Coast University Hospital
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Address
Gold Coast University Hospital
Office of Research Governance and Development
Level 2 E block
Gold Coast University Hospital
1 Hospital Boulevard
Southport, Qld 4216
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Country
Australia
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Secondary sponsor category [1]
312459
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None
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Name [1]
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None
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Address [1]
312459
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None
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Country [1]
312459
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310652
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Gold Coast Hospital and Health Service HREC
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Ethics committee address [1]
310652
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1 Hospital Boulevard
Gold Coast University Hospital
Southport, QLD 4216
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Ethics committee country [1]
310652
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Australia
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Date submitted for ethics approval [1]
310652
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27/04/2021
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Approval date [1]
310652
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06/08/2021
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Ethics approval number [1]
310652
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HREC/2021/QGC/75197
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Summary
Brief summary
Mild Traumatic Brain Injury (mTBI) is a significant burden to Queensland emergency departments (EDs) in adults and children. Between 2019-2020, there were over 1800 presentations of isolated mTBI to Gold Coast Hospital Health Service (GCHHS) EDs, presenting outside of usual business hours with 26% re-presented within the first 6 weeks of their initial presentation, many of which were related to the initial injury. Management pathways to support this population and reduce the high rate of re-presentations must therefore be prioritized. With this in mind, the Occupational Therapy (OT) Outpatient Service are implementing an innovative practice model involving specialist OT follow up for these patients to facilitate recovery and linking into appropriate specialty referrals where indicated to prevent ED representations.
The primary aim of this research is to evaluate the impact of this Occupational Therapy (OT) intervention pathway for patients presenting to ED with a mTBI outside of business hours compared to pre-implementation care. The study secondly aims to evaluate the process of implementing the pathway in relation to adherence, patient satisfaction, and staff experience. It is anticipated that the implementation of the OT pathway will lead to decreased ED readmission, enhanced clinical outcomes (including reduced functional burden and disability and days missed of work/school) and decreased ED length of stay for monitoring of symptoms.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Ms Lauren Heslop
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Address
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Occupational Therapy
GCUH Block D Clinical Services
Level 5
1 Hospital Boulevard
Gold Coast University Hospital
Southport, Qld 4215
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Country
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Australia
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Phone
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+61 0403380098
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mrs Alexandra Ballingall
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Address
118399
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Occupational Therapy
GCUH Block D Clinical Services
Level 5
1 Hospital Boulevard
Gold Coast University Hospital
Southport, Qld 4215
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Country
118399
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Australia
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Phone
118399
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+61 0756873353
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Fax
118399
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Email
118399
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[email protected]
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Contact person for scientific queries
Name
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Dr Rachel Wenke
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Address
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GCUH Block D Ground floor- Allied Health
Gold Coast University Hospital
1 Hospital Boulevard
Southport, Qld 4215
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Country
118400
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Australia
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Phone
118400
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+61 0403808931
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Fax
118400
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Email
118400
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
We do not have ethical clearance or patient consent for sharing individual participant data.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
15597
Ethical approval
383835-(Uploaded-05-04-2022-15-46-26)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF