Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000057987
Ethics application status
Approved
Date submitted
11/11/2019
Date registered
24/01/2020
Date last updated
3/04/2024
Date data sharing statement initially provided
24/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Occupational therapy driving assessment outcomes, life space, and on-road driving rehabilitation post acquired brain injury
Scientific title
Community access and participation following acquired brain injury: A mixed methods evaluation of the driving assessment process including outcomes, life space, and the efficacy of on-road driving remediation.
Secondary ID [1] 299781 0
Nil known
Universal Trial Number (UTN)
U1111-1243-3209
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
acquired brain injury 315147 0
Condition category
Condition code
Neurological 313463 313463 0 0
Other neurological disorders
Stroke 313464 313464 0 0
Haemorrhagic
Stroke 313465 313465 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effectiveness of rehabilitation following acquired brain injury (ABI) may be measured in terms of community participation and integration (Levack, Kayes, & Fadyl, 2010). Return to driving is an avenue through which integration and participation goals such as independent living, social engagement and return to work can be achieved (Norlander et al., 2016) and psychological morbidity such as loneliness, depression and diminished life satisfaction can be reduced (Griffen, Rapport, Coleman Bryer, & Scott, 2009). This project will explore the life space experience of people referred for occupational therapy driver assessment (OTDA) following ABI in ways not previously explored. The research project has three aims. Firstly, to investigate life space after acquiring a brain injury prior to and following comprehensive OTDA so as to explore whether this process may enhance, restrict, or have no impact on community access and community participation. Secondly, to investigate the efficacy of on-road driving rehabilitation following ABI not only in achieving medical fitness to drive but in maintaining that status at follow-up. Finally, the research aims to explore potential relationships between driving status, driving rehabilitation and psychosocial aspects of adjusting to life following ABI in terms of self awareness, driving self efficacy and depression. Knowledge gained will provide understanding as to how the process of OTDA, irrespective of outcome, may impact upon life space following ABI.

Following consent process, demographic data will be collected at point of recruitment and all participants will complete a life space travel diary over a two-week period to record the frequency, destination and purpose of travel outside the home to quantify and define the geographical space of activities undertaken and the Life Space Assessment tool. A semi-structured interview will be conducted at the conclusion of the data collection period for every third participant with a member of the research team either face-to-face or over the phone to capture qualitative aspects of life space. Interviews will be audio-recorded with consent and transcribed for analysis to elaborate, enhance, clarify and contextualise qualitative factors influencing community access from the participant perspective.

All participants will then receive a baseline comprehensive OTDA with the outcome of that assessment determining their pathway. Occupational Therapy driving assessments (OTDA) in Australia are undertaken by occupational therapists with advanced training and post-graduate qualifications in the field (Fields, Unsworth & Harreveld, 2018). OTDA consist of two main components: an off-road evaluation and an on-road driving assessment. The off-road review provides opportunity for the therapist to understand the participant’s current functioning across a range of domains identified as underpinning safe and effective driving. These include consideration to the individual’s past driving experience and anticipated future driving goals, medical status, visual, physical and cognitive function and behavioural aspects (Fields et al., 2018).

If indicated, the evaluation progresses to the implementation of an on-road assessment where functional analysis of the individual’s capacity to operate a vehicle, negotiate the driving environment and interact with other road users can occur. The session is completed on an open road route, in a dual control vehicle with the participant driving the vehicle, the driving instructor positioned in the front passenger seat with access to dual controls and the occupational therapist positioned in the rear passenger seat. It is the driving instructor’s role to provide directions to the participant and to ensure safe passage of the vehicle. The occupational therapist observes and records the person’s driving performance across a diverse range of road and traffic conditions (Unsworth, 2007; Mallon & Wood, 2004; 2018 Fields et al., 2018). Current evidence supports this comprehensive off- and on-road driving assessment process as the “gold standard” in evaluating medical fitness to drive (Paillat, Massonneau, Azouvi, & D’Apolito, 2015).

In the first pathway, the participants who are deemed fit to resume driving or not medically fit to resume driving, will be asked to repeat the life space measure at 6 month follow-up and will then exit the study.

In the second pathway, participants who are recommended to receive on-road driving rehabilitation will enter into an embedded randomised controlled trial that has had previous feasibility testing (Bassingthwaighte, Griffin, Fleming, & Gustafsson, 2019) and will be randomly assigned to an intervention or wait-list control group to receive the on-road driving rehabilitation.

For the intervention group, an individualised on-road driving remediation program devised by the driver trained occupational therapist and delivered by a qualified driving instructor experienced in working with people with medical conditions in a dual control car over a period of 4 to 8 weeks, at a frequency of 1-2 lessons/week for a duration of 50 minutes/session. The duration of the driving remediation program is determined by the occupational therapist conducting the initial OTDA and is related to the number and significance of driving skills/performance requiring address based upon clinical reasoning.
Following each driving lesson, the participant and driving instructor will independently complete a brief questionnaire concerning driving conditions encountered and perceived driving performance. The post-intervention OTDA will be completed within 2 weeks of completing the on-road driving remediation intervention.

The wait-list control group will receive no driving related remediation for a period of 6 weeks. This group will then complete a second OTDA prior to receiving on-road remediation program. All participants will complete a post intervention OTDA and a 6 month follow up OTDA and repeat measurement of life space.
Intervention code [1] 316036 0
Rehabilitation
Comparator / control treatment
No treatment regarding driving rehabilitation will be provided to the control group (wait-list control group). The wait-list control group will receive no driving related remediation for a period of 6 weeks. This group will then complete a second OTDA prior to receiving on-road remediation program. All participants will complete a post intervention OTDA and a 6 month follow up OTDA and repeat measurement of life space.
Control group
Active

Outcomes
Primary outcome [1] 321935 0
The primary outcome measure is life space trajectory pre- to post OTDA in terms of frequency of travel from home, maximum distance of travel from home, purpose of travel and need for assistance when accessing community.

Quantitative measurement of life space will occur through use of a travel diary completed by every participant. Every third participant will complete the Life Space Questionnaire- composite version (Baker et al, 2003), a nine item tool which defines how far a person travels from their room and includes use of equipment and/or assistance. These participants will also engage in a semi-structed interview with a member of the research team. Interviews will be audio-recorded with consent and transcribed for analysis to elaborate, enhance, clarify and contextualise qualitative factors influencing community access from the participant perspective.
Timepoint [1] 321935 0
Conducted pre- OTDA (at point between gaining consent to participate in study but before initial OTDA; aiming for completion 2-4 weeks pre-OTDA) and 6 months post OTDA
Secondary outcome [1] 376741 0
Medical fitness to drive as rated following on-road driving assessment at both post-intervention and six month follow-up assessments. The on-road driving assessment will utilise validated 15 km open road route conducted by a driver trained occupational therapist and driving instructor in a dual-controlled vehicle (Mallon & Wood, 2004).
Timepoint [1] 376741 0
The post-intervention OTDA will be completed within 2 weeks of completing the on-road driving remediation intervention. Follow-up assessment will be completed 6 months after post-intervention assessment.
Secondary outcome [2] 376940 0
Predictive measures such as age, gender, diagnosis, time since injury/onset. Data collection sheet to be completed by member of the research team to collate information extracted from medical record.
Timepoint [2] 376940 0
To be gathered after consent prior to completion of initial OTDA
Secondary outcome [3] 376941 0
Driving self efficacy as measured Adelaide Driving Self-Efficacy Scale (George, Clark & Crotty, 2007), A 12-item scale rating confidence with specific driving tasks such as negotiating roundabouts, responding to road signs, planning travel to new destinations and parking. Using a 10 point scale to rate individual tasks, a higher score represents greater confidence in one’s own capacity to complete the driving task.
Timepoint [3] 376941 0
At each off-road driving assessment point (Initial, pre-intervention, post-intervention and follow-up)
Secondary outcome [4] 376942 0
Depression status using Depression, Anxiety and Stress Scale (DASS-21), self measure of depression, anxiety and stress requiring the participant to rate the truth of 21 statements. Scored out of 21, a higher score indicates higher levels of depression, anxiety and stress symptomatology
Timepoint [4] 376942 0
At each off-road driving assessment point (initial, pre-intervention, post-intervention and follow-up)
Secondary outcome [5] 376943 0
Awareness, as measured using Patient Awareness Questionnaire, A 17 item questionnaire that measures levels of self-awareness of brain injury related impairments on a range of everyday functions. Rated on a 5-point scale where a score of 3 reflects performance comparable with pre-injury ability, a higher score represented a self-perception of improved performance and a lower score indicates a participant perceives that his or her performance is worse than pre-injury levels.
Timepoint [5] 376943 0
At each off-road driving assessment point (initial, pre-intervention, post-intervention and follow-up).
Secondary outcome [6] 376944 0
Patient perceptions and experiences of the driving remediation program driving remediation variables using a brief 2 question rating scale.
Timepoint [6] 376944 0
Completed by the participant at the end of each driving remediation lesson.
Secondary outcome [7] 376954 0
Driving Instructor perceptions of driving performance measured on a brief questionnaire designed specifically for this study.
Timepoint [7] 376954 0
Completed by driving instructor at the end of each driving session.
Secondary outcome [8] 376955 0
Driving performance measured using on-road assessment protocol and assessment route adapted from Queensland Health Driving Assessment Guidelines for Occupational Therapy Driving Assessors (2011)* and VicRoads Occupational Therapy Driving Test: Assessment Manual35, 36 and met Australian Competency Standards for Occupational Therapy Driver Assessors26 and Queensland road law requirements. To be completed by a specialist occupational therapist during on road assessment conducted with a qualified driving instructor in a vehicle fitted with dual controls. The therapist assesses the participants driving performance in a 50-minute test on a standardized route, using a standardized assessment proforma to evaluate the driver. The therapist will then recommend one of the following to the participant via report to the consumer’s referring doctor and general practitioner. a) The participant is medically fit to drive. (b) The participant would benefit from driving remediation. (c) The participant is not medically fit to drive.
Timepoint [8] 376955 0
Completed at every on-road driving assessment point.

Eligibility
Key inclusion criteria
Inclusion criteria for participants (a) aged between 18 years and 65 years inclusively; (b) medically stable; (c) holder of a current and valid provisional or open drivers licence; and (d) diagnosis of ABI.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals who (a) are learner drivers; and/or (b) have a previous neurological condition/incident will be excluded from the study so as to eliminate potential confounding effects.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After participating in a comprehensive OTDA and if deemed to require on-road driving remediation, participants will be allocated to either wait-listed control group or the intervention group via randomization achieved using a computerised random allocation generator. After being informed of the outcome of the initial OTDA by the therapist conducting the baseline assessment, the principal investigator will request random allocation from a second investigator not actively involved in the conduct of the trial. Randomization to be completed in subsets of 10 whereby for every 10 participants entering RCT, 5 participants will be allocated to the intervention group and 5 to the waitlist control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised random allocation generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
Intervention group receives intervention whilst wait-listed control group receive no driving related intervention. After waiting period, all members of the wait-list group will then receive the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A biostatistician was consulted to establish the sample size calculation and determine appropriate analysis strategies. A feasibility study was undertaken to ascertain the viability of progressing to a full randomised control trial. Using the McNemar test of equality of paired proportions, with a significance level of 5% and a power of 80%, a sample size of 37 patients was identified as being required to achieve statistical significance. Whilst a dropout rate of 25% was observed in the feasibility study, as the numbers were low (2 dropouts out of 8), a more conservative dropout rate of 50% the final estimate was used for the primary sample size estimation, inflating the target to 74 patients or 37 per group.

All data will be entered into SPSS for data analysis, including generation of descriptive statistics.

Life space data will be summarised and between group comparisons completed using ANOVA or non-parametric alternatives.

Analysis of within and between group changes across the three data points will be completed using Linear Mixed Modelling.

Regression analyses will be used where appropriate to explore relationships and predictors of outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/02/2020
Actual
8/04/2021
Date of last participant enrolment
Anticipated
25/08/2021
Actual
30/11/2022
Date of last data collection
Anticipated
23/02/2022
Actual
19/07/2023
Sample size
Target
74
Accrual to date
Final
51
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 15134 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 28428 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 304244 0
Other Collaborative groups
Name [1] 304244 0
The Hopkins Centre: Research for Rehabilitation and Resilience
Country [1] 304244 0
Australia
Primary sponsor type
Hospital
Name
MetroSouth Health
Address
199 Ipswich Rd
Woolloongabba Qld 4102
Country
Australia
Secondary sponsor category [1] 304486 0
None
Name [1] 304486 0
Address [1] 304486 0
Country [1] 304486 0
Other collaborator category [1] 281028 0
University
Name [1] 281028 0
Griffith University
Address [1] 281028 0
Griffith University
Nathan Campus
N55_2.31
Qld 4122
Country [1] 281028 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304702 0
MetroSouth Human Research Ethics Committee
Ethics committee address [1] 304702 0
Ethics committee country [1] 304702 0
Australia
Date submitted for ethics approval [1] 304702 0
13/11/2019
Approval date [1] 304702 0
20/12/2019
Ethics approval number [1] 304702 0
HREC/2019/QMS/57505

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

Contacts
Principal investigator
Name 97926 0
Ms Louise Bassingthwaighte
Address 97926 0
Occupational Therapy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba Queensland 4102
Country 97926 0
Australia
Phone 97926 0
+61 7 3176 5008
Fax 97926 0
+61 7 3176 3320
Email 97926 0
[email protected]
Contact person for public queries
Name 97927 0
Louise Bassingthwaighte
Address 97927 0
Occupational Therapy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba Queensland 4102
Country 97927 0
Australia
Phone 97927 0
+61 7 3176 5008
Fax 97927 0
+61 7 3176 3320
Email 97927 0
[email protected]
Contact person for scientific queries
Name 97928 0
Louise Bassingthwaighte
Address 97928 0
Occupational Therapy Department
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba Queensland 4102
Country 97928 0
Australia
Phone 97928 0
+61 7 3176 5008
Fax 97928 0
+61 7 3176 3320
Email 97928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results.
When will data be available (start and end dates)?
Following publication; no end date determined.
Available to whom?
Only researchers who provide a methodologically sound proposal at the discretion of research team.
Available for what types of analyses?
Only to achieve the aims in the approval proposal
How or where can data be obtained?
Access subject to approvals by principal investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5616Study protocol  [email protected]



Results publications and other study-related documents

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