Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001515785
Ethics application status
Approved
Date submitted
30/11/2022
Date registered
6/12/2022
Date last updated
6/07/2024
Date data sharing statement initially provided
6/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of online education, feedback and lessons to improve older driver safety.
Scientific title
The relative effectiveness of tailored lessons, workshops and feedback on older drivers’ on-road safety over 12 months.
Secondary ID [1] 308469 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Driving safety and crash risk prevention in older drivers 328277 0
Condition category
Condition code
Injuries and Accidents 325317 325317 0 0
Other injuries and accidents
Public Health 325318 325318 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised control trial involving two intervention arms and an active control group. The three arms will include the following conditions:
* Control: Road Rules Refresher Workshop (C);
* Intervention I: Feedback (F) plus C;
* Intervention II: Driving Lessons-Plus-Feedback (L+F) plus C.

Road Rules Refresher Workshop (C)
* All participants receive Road Rules Refresher Workshop, which is an online road-rules refresher course, and a copy of the latest NSW Road Users Handbook. The Workshop is pre-recorded by an accredited Driving Instructor (DI) and a link is sent to the participants who can complete the Workshop online. Participants are asked to complete the single 1-hour Workshop following randomisation and prior to undertaking any other interventions (for those allocated to Intervention I or II). The 1-hour session will include presentation of road-rules, vehicle safety, and general effects of ageing on driving safety. Participants will complete a Process Evaluation Survey 3 months and 12 months after randomisation.

Feedback (F)
* Participants allocated to Interventions I and II will receive (in addition to the Road Rules Refresher Workshop) a 1-hour individual Feedback session over zoom with the Intervention Occupational Therapist (OT), within one month of completing the Road Rules Refresher Workshop. This will include (1) discussion of the participants’ driving performance on the Baseline On-Road Assessment, (2) viewing the video clips of errors from the Baseline On-Road Assessment, (3) identifying behaviours/habits to change in order to improve safety, and (4) developing a written goal directed plan for implementing the behaviour changes. An example behaviour/habit that may be identified for change is a need to conduct a head-check prior to indication and lane change.

Following the session, participants will then use a workbook (custom developed for the study) for 10-30 minutes per fortnight over a period of 12 weeks to document fortnightly progress on their behaviour change goals, opportunities and barriers to practice, and self-evaluations. Participants will also complete a Process Evaluation Survey 3 months and 12 months after randomisation.

* Participants allocated to Intervention II will receive (in addition to the Road Rules Refresher Workshop, as well as Feedback session + 12-week workbook) two individual 1-hour driving lessons conducted by an accredited DI, within one month of completing the Road Rules Refresher Workshop. (1) Lesson 1 will be conducted in a dual-brake vehicle and includes on-road driving practice of the behaviour/habit changes identified in the Baseline assessment using routes within or near the participants’ usual driving range and environment, (2) Lesson 2 will be conducted in the participants’ own vehicle and involve the Intervention-DI providing guided on-road training and review of specific skills (identified in the Baseline assessment), using routes within or near the participants’ usual driving range, and then further application of those refreshed skills in unfamiliar areas. Lessons will be approximately 7 days apart. Participants will complete a Process Evaluation Survey 3 months and 12 months after randomisation.

To note, the Process Evaluation surveys allow us to monitor deliver of interventions, and participant acceptability and adherence.

All participants will complete baseline assessments, completing an online General Health and Driving Questionnaire, a 2-hour Lab Assessment (testing vision, cognitive functioning and off road driving skills), and a 1-hour On-Road Driving Test. Once enrolled, participants are asked to complete a monthly driving diary for the 12-month period, assessing their driving frequency and whether or not they had any accidents. All participants will be followed up at 3 and 12. At 3 months all participants will complete the 1-hour On-Road Driving Test, the Process Surveys and continue their monthly diaries. At 12 months, the participants will complete the 1-hour On-Road Driving Test, the 1-hour Lab Assessments, a follow-up General Health and Driving Questionnaire.


Adherence indicators
Road Rules Refresher Workshop: completion of video
NSW Road User Handbook: checklist of receiving it.
Feedback session: attendance, process evaluation survey
Workbook: level of fortnightly completion and self-reported adherence, and process evaluation survey
Driving lessons: attendance and process evaluation survey
Intervention code [1] 324907 0
Prevention
Intervention code [2] 324908 0
Behaviour
Intervention code [3] 324909 0
Treatment: Other
Comparator / control treatment
Participants allocated to the active control group will receive a Road Rules Refresher Workshop, which will be an online pre-recorded course,. Participants will also receive a copy of the latest NSW Road Users Handbook. As in the intervention groups, the Road Rules Refresher Workshop is delivered by an accredited DI. Participants complete the single 1-hour session following randomisation. The 1-hour session will include presentation of road-rules, vehicle safety and general effects of ageing on driving safety.

Following the workshop, participants in the Control group will receive a phone call from the Trial Manager for a general chat about participation experiences, a reminder about the Process Evaluation Survey and follow-up assessments at 12 weeks, and for the benefit of social interaction in the intervention. Participants will complete a Process Evaluation Survey after the interventions are complete (3 months post-randomisation).
Control group
Active

Outcomes
Primary outcome [1] 333184 0
Driver Safety Rating (DSR) score based on a 60-minute On-Road Driving Assessment on a standard urban route, conducted by an OT using standard scoring protocol (Anstey et al 2018: https://doi.org/10.1016/j.aap.2018.02.016). The On-Road Driving Assessment will be conducted in a dual-brake vehicle with a Driving Instructor and an Occupational Therapist on urban roads in non-peak traffic. The change in DSR at one time point will be used as the primary outcome in analyses.
Timepoint [1] 333184 0
3 months after intervention commenced
Secondary outcome [1] 416085 0
Driver Safety Rating (DSR) score based on a 60-minute On-Road Driving Assessment on a standard urban route, conducted by an OT using standard scoring protocol (Anstey et al 2018: https://doi.org/10.1016/j.aap.2018.02.016). The On-Road Driving Assessment will be conducted in a dual-brake vehicle with a Driving Instructor and an Occupational Therapist on urban roads in non-peak traffic. The change in DSR at one time point will be used as the secondary outcome in analyses.
Timepoint [1] 416085 0
12 months after intervention commenced
Secondary outcome [2] 416087 0
The number of critical errors recorded during the On-Road Driving Assessment.
Timepoint [2] 416087 0
12 months after intervention commenced
Secondary outcome [3] 416089 0
Changes in Quality in Life using the Health-related Quality of Life assessment (EuroQol-5D-5L).
Timepoint [3] 416089 0
12 months after intervention commenced
Secondary outcome [4] 416090 0
Changes in driving self-efficacy as measured by the Driving Self-Efficacy Scale
Timepoint [4] 416090 0
12 months after intervention commenced.
Secondary outcome [5] 416091 0
Changes in social participation as measured by the Social Participation Questionnaire.
Timepoint [5] 416091 0
12 months after intervention commenced
Secondary outcome [6] 416092 0
Cost effectiveness of Interventions in reducing self-reported traffic incidents will be assessed through the incremental cost-effectiveness ratio for the improvement in driver safety. Intervention costs determined from the project financial records, including staff time associated with data collection, driving lessons and off-road feedback. Costs associated with self-reported crashes will use NRMA Motoring Services. Cost of Road Crashes 2017 ( https://www.mynrma.com.au/-/media/documents/reports-and-subs/nrma-cost-of-crashes-report-2017.pdf)
Timepoint [6] 416092 0
12 months after intervention commenced
Secondary outcome [7] 416335 0
The number of Self-Reported Traffic Incidents over a 12-month period adjusted for mileage will be collected in monthly driving diaries.
Timepoint [7] 416335 0
12 months after intervention commenced

Eligibility
Key inclusion criteria
1. Hold a current driver’s licence and willing to provide the driver’s licence number, expiry date and conditions to the research team.
2. Be available for the duration of the intervention
3. Drive a vehicle that has at least third-party insurance and willing to show the certificate for verification
4. Have not completed an older driver refresher course in the last 5 years, and
5. Have sufficient English language skills to complete the written questionnaires and follow verbal instructions.
6. Lives in Sydney metropolitan area.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Significant cognitive impairment (likely to impact participation) (MoCA <23)
2. Other serious mental or physical health conditions that would prevent full participation in the study or require medications that impair driving ability (e.g., major stroke, current cancer treatment, antipsychotic medication, narcotic pain medication, significant visual field loss)
3. Vision impairment, and
4. High scores on the baseline ORT DSR (>8/10) occurring in 10% of our previous studies.
5. Very low scores on the baseline ORT DSR (<3/10) occurring in 5% of our previous studies.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who was “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified block randomisation with randomly selected block size (3/6/9), completed by the study statistician. Randomisation will be undertaken in a 1:1:1 ratio across the three groups, stratified by age group (65-74 years; 75+ years) and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The intended sample size is 198, with 66 participants in each of the three groups. The power analysis shows that a sample of 198 participants (66 per group), allowing for the expected rate of attrition, is required to achieve at least 80% power to detect a difference between the groups at one time point, if the true difference between Feedback and Road Rules Refresher Workshop, and between Driving Lessons-Plus-Feedback and Feedback is 0.5 SD.

The primary outcome of driver safety rating (DSR scale, range 0-10) will be analysed in a linear mixed effects model with random intercepts, fixed effects of intervention (included on an intention-to-treat basis) and time, and their interaction. All pairwise comparisons between the 3 intervention groups at each of the 2 post-baseline time points (3 months and 12 months) will be performed, with 3 months as the primary endpoint and 12month as the secondary endpoint. Benjamini-Hochberg procedure will be used to control the false discovery rate at 5% across all 6 comparisons.

The study is powered for the primary outcome measure.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
30/01/2023
Actual
15/02/2023
Date of last participant enrolment
Anticipated
22/12/2023
Actual
28/09/2023
Date of last data collection
Anticipated
22/12/2024
Actual
Sample size
Target
198
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 312711 0
Government body
Name [1] 312711 0
National Health & Medical Research Council (NHMRC) / Project Grant
Country [1] 312711 0
Australia
Primary sponsor type
Other
Name
Neuroscience Research Australia
Address
Margarete Ainsworth Building, Barker St, Randwick, NSW 2031
Country
Australia
Secondary sponsor category [1] 314330 0
University
Name [1] 314330 0
University of New South Wales (UNSW)
Address [1] 314330 0
University of New South Wales, Faculty of Science, Sydney NSW 2052 Australia
Country [1] 314330 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312012 0
The University of New South Wales Higher Research Ethics Review (HREC) Executive Committee
Ethics committee address [1] 312012 0
Ethics committee country [1] 312012 0
Australia
Date submitted for ethics approval [1] 312012 0
08/11/2022
Approval date [1] 312012 0
10/11/2022
Ethics approval number [1] 312012 0
HC190439

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

Contacts
Principal investigator
Name 123170 0
Prof Kaarin J. Anstey
Address 123170 0
Neuroscience Research Australia Margarete Ainsworth Building, Barker St, Randwick, NSW 2031 UNSW, Faculty of Science, Rm 901 Matthews Building
Country 123170 0
Australia
Phone 123170 0
+61 2 9399 1019
Fax 123170 0
Email 123170 0
[email protected]
Contact person for public queries
Name 123171 0
Ranmalee Eramudugolla
Address 123171 0
Neuroscience Research Australia Margarete Ainsworth Building, Barker St, Randwick, NSW 2031
Country 123171 0
Australia
Phone 123171 0
+61 2 9065 2887
Fax 123171 0
Email 123171 0
[email protected]
Contact person for scientific queries
Name 123172 0
Kaarin J. Anstey
Address 123172 0
Neuroscience Research Australia Margarete Ainsworth Building, Barker St, Randwick, NSW 2031 UNSW, Faculty of Science, Rm 901 Matthews Building
Country 123172 0
Australia
Phone 123172 0
+61 2 9399 1019
Fax 123172 0
Email 123172 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?
All individual participant data collected during the trial, after de-identification, and upon approval by Primary Investigator.
When will data be available (start and end dates)?
Available after publication of results with no end date.
Available to whom?
Case-by-case basis at the discretion of the Primary Investigator.
Available for what types of analyses?
Only to achieve the aims in the research proposal approved by the Primary Investigator.
How or where can data be obtained?
Access subject to approval by the Primary Investigator. Please email your request to [email protected].


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17680Study protocol  [email protected] Access subject to approval by the Primary Investig... [More Details]



Results publications and other study-related documents

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