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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
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
Secondary ID [1] 306785 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mild traumatic brain injury 325833 0
persistent post concussive syndrome 325834 0
Condition category
Condition code
Physical Medicine / Rehabilitation 323158 323158 0 0
Occupational therapy
Injuries and Accidents 323244 323244 0 0
Other injuries and accidents
Neurological 323245 323245 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.



Intervention code [1] 323238 0
Rehabilitation
Intervention code [2] 323359 0
Treatment: Other
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).
Control group
Historical

Outcomes
Primary outcome [1] 330907 0
Representation to Emergency department associated with mild traumatic brain injury (TBI). This will be accessed from the patient's electronic medical record.
Timepoint [1] 330907 0
4 weeks post initial presentation from ED (Primary end point) and 3 months post initial presentation from ED
Primary outcome [2] 330909 0
Emergency department length of stay as determined by health service health analytics data derived from the patient's electronic medical record.
Timepoint [2] 330909 0
At the time of discharge from ED
Primary outcome [3] 330910 0
Number of post concussion symptoms (as measured by Rivermead Post Concussion Symptom Questionnaire)
Timepoint [3] 330910 0
-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
Secondary outcome [1] 408030 0
Number of multidisciplinary referrals made determined by accessing patient's electronic medical record and local health analytics data.
Timepoint [1] 408030 0
4 weeks post initial presentation from ED and 3 months post initial presentation from ED
Secondary outcome [2] 408031 0
Functional burden and disability as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS).
Timepoint [2] 408031 0
4 weeks post initial presentation from ED and 3 months post initial presentation from ED
Secondary outcome [3] 408032 0
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,
Timepoint [3] 408032 0
4 weeks post initial presentation from ED and 3 months post initial presentation from ED
Secondary outcome [4] 408033 0
Staff experience with OT intervention pathway as evaluated using focus groups
Timepoint [4] 408033 0
Approximately 4-5 months OT intervention pathway implementation
Secondary outcome [5] 408034 0
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).
Timepoint [5] 408034 0
4 weeks post initial presentation from ED and 3 months post initial presentation from ED
Secondary outcome [6] 408035 0
Number of days missed from work and/or study as assessed by tailored questionnaire collected over telephone
Timepoint [6] 408035 0
4 weeks post initial presentation from ED and 3 months post initial presentation from ED
Secondary outcome [7] 408389 0
Adherance to referring eligible patients to the OT intervention pathway, as measured retrospectively by an audit of eligible patient's electronic medical record.
Timepoint [7] 408389 0
On discharge from initial ED presentation (Cohort 1 only)
Secondary outcome [8] 408390 0
Description of the type of OT interventions provided as collected by treating Occupational Therapist completing treatment data collection form after each session.
Timepoint [8] 408390 0
Throughout admission to OT clinic (Cohort 1 only)

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).
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
As this is a non-randomised trial this is not applicable.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
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.
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/04/2022
Actual
Date of last participant enrolment
Anticipated
12/12/2022
Actual
Date of last data collection
Anticipated
14/03/2023
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 22055 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 22056 0
Robina Hospital - Robina
Recruitment postcode(s) [1] 37178 0
4215 - Southport
Recruitment postcode(s) [2] 37179 0
4226 - Robina

Funding & Sponsors
Funding source category [1] 311122 0
Charities/Societies/Foundations
Name [1] 311122 0
Queensland Emergency Medical Foundation
Country [1] 311122 0
Australia
Funding source category [2] 311126 0
Government body
Name [2] 311126 0
Queensland Health Health Practitioner's Research Scheme
Country [2] 311126 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
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
Country
Australia
Secondary sponsor category [1] 312459 0
None
Name [1] 312459 0
None
Address [1] 312459 0
None
Country [1] 312459 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310652 0
Gold Coast Hospital and Health Service HREC
Ethics committee address [1] 310652 0
Ethics committee country [1] 310652 0
Australia
Date submitted for ethics approval [1] 310652 0
27/04/2021
Approval date [1] 310652 0
06/08/2021
Ethics approval number [1] 310652 0
HREC/2021/QGC/75197

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

Contacts
Principal investigator
Name 118398 0
Ms Lauren Heslop
Address 118398 0
Occupational Therapy
GCUH Block D Clinical Services
Level 5
1 Hospital Boulevard
Gold Coast University Hospital
Southport, Qld 4215
Country 118398 0
Australia
Phone 118398 0
+61 0403380098
Fax 118398 0
Email 118398 0
Lauren.Heslop@health.qld.gov.au
Contact person for public queries
Name 118399 0
Alexandra Ballingall
Address 118399 0
Occupational Therapy
GCUH Block D Clinical Services
Level 5
1 Hospital Boulevard
Gold Coast University Hospital
Southport, Qld 4215
Country 118399 0
Australia
Phone 118399 0
+61 0756873353
Fax 118399 0
Email 118399 0
aleksandra.ballingall@health.qld.gov.au
Contact person for scientific queries
Name 118400 0
Rachel Wenke
Address 118400 0
GCUH Block D Ground floor- Allied Health
Gold Coast University Hospital
1 Hospital Boulevard
Southport, Qld 4215
Country 118400 0
Australia
Phone 118400 0
+61 0403808931
Fax 118400 0
Email 118400 0
rachel.wenke@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical clearance or patient consent for sharing individual participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15597Ethical 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.