Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001629123
Ethics application status
Approved
Date submitted
15/10/2019
Date registered
25/11/2019
Date last updated
6/12/2022
Date data sharing statement initially provided
25/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of different driver education types on safety outcomes for older adults.
Scientific title
The relative effectiveness of tailored lessons, workshops and feedback on older drivers’ on-road safety over two years.
Secondary ID [1] 299192 0
Nil known
Universal Trial Number (UTN)
U1111-1239-9659
Trial acronym
DBLT
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Driving safety and crash risk prevention in older drivers 314835 0
Condition category
Condition code
Injuries and Accidents 313173 313173 0 0
Other injuries and accidents
Public Health 313418 313418 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: Classroom Education (C);
* Intervention I: Feedback (F) plus C;
* Intervention II: Driving Lessons-Plus-Feedback (L+F) plus C.

Classroom Education (C)
* All participants receive Classroom Education, which is an online group-based road-rules refresher course, and a copy of the latest NSW Road Users Handbook. The Classroom Education will be run in a group setting by an accredited Driving Instructor (DI) and/or a driver trained Occupational Therapist (OT). Participants attend a single 1-hour session 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, general effects of ageing on driving safety, opportunity for questions and discussion. Participants complete a Process Evaluation Survey after the course, 3 months and 24 months later.

Feedback (F)
* Participants allocated to Interventions I and II will receive (in addition to the Classroom Education session) a 1-hour individual Feedback session over zoom with the Intervention OT, within one month of completing the Classroom Education session. 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. Participants will complete a process evaluation form after this session.

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 form after the end of the 12 weeks and at the end of their study involvement.

* Participants allocated to Intervention II will receive (in addition to the Classroom Education session, 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 Classroom Education session. (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 Feedback session 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 Feedback sessions), 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 form after each driving lesson, 12 weeks and 24 months later.

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 1-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 24-month period, assessing their driving frequency and whether or not they had any accidents. All participants will be followed up at 3, 12 and 24 months. At 3 months all participants will complete the 1-hour On-Road Driving Test, the Process Surveys and continue their monthly diaries. At 12 and 24 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, and continue their monthly driving diaries.


Adherence indicators
Classroom Education session: attendance.
NSW Road User Handbook: checklist of receiving it.
Feedback session: attendance, and process evaluation form.
Workbook: level of fortnightly completion and self-reported adherence, and process evaluation form.
Driving lessons: attendance and process evaluation form.
Intervention code [1] 315819 0
Prevention
Intervention code [2] 315820 0
Behaviour
Intervention code [3] 315874 0
Treatment: Other
Comparator / control treatment
Participants allocated to the active control group will receive Classroom Education, which will be an online group-based road-rules refresher course, and will also receive a copy of the latest NSW Road Users Handbook. As in the intervention groups, the Classroom Education will be run in a group online setting by an accredited DI and/or a driver trained OT. Participants attend a single 1-hour session following randomisation. The 1-hour session will include presentation of road-rules, vehicle safety, general effects of ageing on driving safety, and an opportunity for questions and discussion. Participants will complete process evaluation form shortly after the session.

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 form and follow-up in 12 weeks, and for the benefit of social interaction in the intervention. Participants will complete a process evaluation 12 weeks after the session.
Control group
Active

Outcomes
Primary outcome [1] 321691 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 each time point will be used as the primary outcome in analyses.
Timepoint [1] 321691 0
3 months, 12 months, and 24 months after the intervention has commenced (all three primary timepoints were included in power analysis)
Secondary outcome [1] 375912 0
The number of Self-Reported Traffic Incidents over a 24-month period adjusted for mileage will be collected in monthly driving diaries.
Timepoint [1] 375912 0
24 months after intervention commenced
Secondary outcome [2] 375913 0
The number of critical errors recorded during the On-Road Driving Assessment.
Timepoint [2] 375913 0
12 and 24 months after intervention commenced.
Secondary outcome [3] 375914 0
Changes in Quality in Life using the Health-related Quality of Life assessment (EuroQol-5D-5L).
Timepoint [3] 375914 0
12 and 24 months after intervention commenced.
Secondary outcome [4] 375915 0
Changes in driving self-efficacy as measured by the Driving Self-Efficacy Scale
Timepoint [4] 375915 0
12 and 24 months after intervention commenced.
Secondary outcome [5] 375916 0
Changes in social participation as measured by the Social Participation Questionnaire.
Timepoint [5] 375916 0
12 and 24 months after intervention commenced.
Secondary outcome [6] 375917 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] 375917 0
12 and 24 months after intervention commenced.
Secondary outcome [7] 376610 0
The number of hazard perception errors recorded during the On-Road Driving Assessment.
Timepoint [7] 376610 0
12 and 24 months after intervention commenced

Eligibility
Key inclusion criteria
1. Hold a current driver’s licence;
2. Be available for the duration of the intervention;
3. Drive a vehicle that has at least third-party insurance;
4. Have never taken an older driver refresher course; and
5. Have sufficient English language skills to complete the written questionnaires and follow verbal instructions.

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);
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; or
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 administering the treatment/s
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 384, with 128 participants in each of the three groups. Power analysis shows that a sample of 384 participants (128 per group), allowing for the expected rate of attrition of 4% at each follow-up, is required to achieve at least 90% power to detect a difference between the groups at each time point if the true difference between Feedback and Classroom Education, and between Driving Lessons-Plus-Feedback and Feedback is 0.5 SD.

The primary outcome of driver safety rating 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 will be reported for each of the 3 post-baseline time points (12 weeks, 12 months and 24 months), with the Benjamini-Hochberg procedure used to control the false discovery rate at 5% across all 9 comparisons.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Data collection has ceased early due to the study being impacted by a variety of factors including COVID-19 lockdowns, isolation periods, staff and participant illness, skilled staff shortage and severe wet weather conditions. These factors accumulated to impact the study timeline resulting in the team choosing to revise the design and consequently wrap up the current study.
Date of first participant enrolment
Anticipated
3/02/2020
Actual
15/02/2022
Date of last participant enrolment
Anticipated
2/10/2023
Actual
23/05/2022
Date of last data collection
Anticipated
24/12/2024
Actual
29/11/2022
Sample size
Target
384
Accrual to date
Final
102
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303733 0
Government body
Name [1] 303733 0
National Health & Medical Research Council (NHMRC) / Project Grant
Country [1] 303733 0
Australia
Primary sponsor type
University
Name
University of New South Wales (UNSW)
Address
University of New South Wales, Faculty of Science, Sydney NSW 2052 Australia

Country
Australia
Secondary sponsor category [1] 303849 0
Other
Name [1] 303849 0
Neuroscience Research Australia
Address [1] 303849 0
Margarete Ainsworth Building, Barker St, Randwick, NSW 2031
Country [1] 303849 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304257 0
The University of New South Wales Higher Research Ethics Review (HREC) Executive Committee
Ethics committee address [1] 304257 0
Ethics committee country [1] 304257 0
Australia
Date submitted for ethics approval [1] 304257 0
04/06/2019
Approval date [1] 304257 0
22/08/2019
Ethics approval number [1] 304257 0
HC190439

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

Contacts
Principal investigator
Name 96310 0
Prof Kaarin J. Anstey
Address 96310 0
Neuroscience Research Australia
Margarete Ainsworth Building, Barker St, Randwick, NSW 2031
UNSW, Faculty of Science, Rm 901 Matthews Building
Country 96310 0
Australia
Phone 96310 0
+61 2 9399 1019
Fax 96310 0
Email 96310 0
[email protected]
Contact person for public queries
Name 96311 0
Abigail Hansen
Address 96311 0
Neuroscience Research Australia
Margarete Ainsworth Building, Barker St, Randwick, NSW 2031
Country 96311 0
Australia
Phone 96311 0
+61 2 9399 1134
Fax 96311 0
Email 96311 0
[email protected]
Contact person for scientific queries
Name 96312 0
Kaarin J. Anstey
Address 96312 0
Neuroscience Research Australia
Margarete Ainsworth Building, Barker St, Randwick, NSW 2031
UNSW, Faculty of Science, Rm 901 Matthews Building
Country 96312 0
Australia
Phone 96312 0
+61 2 9399 1019
Fax 96312 0
Email 96312 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. See contact details above.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5568Study protocolAccess subject to approval by the Primary Investigator.  [email protected]



Results publications and other study-related documents

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