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Advancing Understanding of Transportation Options

Decision Making Among Older Adults: the AUTO Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04141891
Acronym
AUTO
Enrollment
529
Registered
2019-10-28
Start date
2019-12-12
Completion date
2023-12-21
Last updated
2025-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome, Arthritis, Brain Injuries, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Dementia, Diabetic Retinopathy, Dizziness, End Stage Renal Disease, Foot--Abnormalities, Glaucoma, Hypertrophic Obstructive Cardiomyopathy, Implantable Defibrillator User, Insomnia, Insulin Dependent Diabetes Mellitus, Macular Degeneration, Multiple Sclerosis, Narcolepsy, Obstructive Sleep Apnea, Orthostatic Hypotension, Parkinson Disease, Presyncope, Restless Legs Syndrome, Retinitis Pigmentosa, Seizures, Sleep Apnea, Spinal Cord Injuries, Stroke, Substance Use, Syncope, Vertigo, Vision Disorders

Brief summary

This Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.

Detailed description

The investigators will use a multi-site, two-armed randomized controlled trial of older drivers (n=300; ≥70 years) from clinical settings, and one family member each (n=up to 300), with longitudinal follow-up. Study goals are to test how much the DDA improves outcomes and identify who benefits most from the DDA. Evaluation of the DDA's efficacy (Aim 1) and its relative effect in subgroups (Aim 2) corresponds to Stage II in the NIH Stage Model for Behavioral Intervention Development. Findings from Aims 1 & 2 could identify necessary refinements (Stage I) and inform future efficacy, effectiveness or implementation trials.

Interventions

BEHAVIORALDriving Decision Aid

Healthwise DDA

BEHAVIORALOlder Drivers Website

National Institute on Aging (NIA) Older Drivers Website

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Colorado, Denver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

for drivers: * 70 years or older * Fluent in English * At least one medical condition linked in driving cessation * Drive at least one time per week * Have a study partner\* (\*drivers interested in participating in the study without a study partner will be placed on a wait list; they may be contacted as a later date for enrollment once 200 driver-study partner dyads have been enrolled across all sites) * 5-minute MoCA score greater or equal to 21

Exclusion criteria

for drivers: * In legal custody or institutionalized * Significant cognitive impairment as measured by 5-minute Montreal Cognitive Assessment (MoCA) * Since the last time they had their license renewed, has had at least one major change to health, vision, or hearing that has seriously impaired driving (based on potential participant self-report) * Feels the Department of Motor Vehicles would have serious concerns about their driving (based on potential participant self-report) Inclusion Criteria for study partners: * 18 years or older * Fluent in English * Identified by Driver participant to contact for potential participation, i.e., part of a driver-study partner dyad * 5-minute MoCA score greater or equal to 21

Design outcomes

Primary

MeasureTime frameDescription
Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)Day 0 (Post-intervention)Decision conflict scale (DCS) is calculated from 16 items, with each item ranging from 0 (strongly agree) to 4 (strongly disagree). The total score is reported on a 0-100 scale by summing all responses, dividing by 16 and multiplying by 25. Higher scores represent greater levels of uncertainty in decision-making (higher decision conflict = worse outcome), and interventions often aim to reduce decision conflict (lower decision conflict = greater likelihood of implementing a decision = better outcome).

Secondary

MeasureTime frameDescription
Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention)Day 0 (Post-intervention)The following true/false questions will be used to examine participants' safe driving knowledge: 1) Older drivers pose a bigger risk to other drivers and pedestrians than younger drivers do; 2) Drivers aged 70 years and older are more likely to be hurt or killed if they are in a crash; 3) There is a milestone age when everyone should stop driving; 4) With age, a person needs more light to see well; 5) Getting lost on familiar roads is a sign that it might be time to stop driving. A higher number of correctly answered questions indicate better outcomes. Knowledge will be defined as the percentage of correct scores of the 5 questions (ranging from 0% \[worst outcome\] to 100% \[best outcome\]). The measure will be assessed in drivers immediately following administration of control condition or intervention.
Decision Self Efficacy Score at Day 0 (Post-intervention)Day 0 (Post-intervention)The Decision Self-Efficacy Scale will be used to assess decision self efficacy. Scores range from 0 (extremely low self-efficacy; worst outcome) to 100 (extremely high self-efficacy; best outcome). Higher scores indicate better outcomes. The measure will be assessed in drivers immediately following administration of control condition or intervention
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score6 months, 12 months, 18 months, 24 monthsDepression will be measured using the PROMIS Short Form 4-item scale (4a Adult v1.0), with higher PROMIS scores indicating higher depression. PROMIS scores are presented as standardized T-scores (mean=50, standard deviation=10). Lower PROMIS depression scores indicate better outcomes (lower depression). Change in depression is calculated as the PROMIS depression score at each time point (6, 12, 18, or 24 months) minus the score at baseline (pre-randomization). Since PROMIS scores at each time point can range from 41.0 to 79.4, change in depression PROMIS scores can range from -38.4 to +38.4. Change-scores \> 0 represent increases in depression (poor outcome), and changes \<= 0 represent maintained or decreased depression (better outcome).
Change in Ottawa Decision Regret Score12 months, 18 months, 24 monthsChange in decision regret will be measured by the Ottawa Decision Regret Scale. This validated measure correlates with decision satisfaction and conflict, and overall quality of life. Scored from 0-100, high scores represent higher regret. Lower scores indicate better outcomes. Decision regret was measured at 6, 12, 18, and 24 months, so change in decision regret can be calculated from 12 months (vs. 6 months), 18 months (vs. 6 months), and 24 months (vs 6 months). Since decision regret scores range from 0-100, change in decision regret scores range from -100 to + 100, with change-scores \<= 0 representing maintenance or decreases in decision regret (positive outcome) and change-scores \> 0 representing increased decision regret over time (negative outcome).
Values Clarity Subscale Score at Day 0 (Post-intervention)Day 0 (Post-intervention)For the values clarity subscale, three decision conflict scale (DCS) items (Likert scale responses from 0 \['strongly agree'\] to 4 \['strongly disagree'\]) are summed, divided by 3 and multiplied by 25; scores range from 0 (extremely clear) to 100 (extremely unclear about personal values); lower scores represent higher values clarity, which is a better outcome. Lower values clarity subscale scores are associated with positive outcomes. The measure will be assessed in drivers immediately following administration of control condition or intervention.
Change in Self-reported Driving Frequency6 months, 12 months, 18 months, 24 monthsSelf-reported driving frequency will be measured by number of days per week participants drive, with consideration of higher or lower frequency as a positive or negative outcome in the context of participant's intent to drive with lower or higher frequency. In the final study survey, this question was reworded, so participants were asked during the past 6 months, have you reduced the number of days per week you normally drive? with response options of yes, no, I don't know. Percentage of those who answered yes at each time point are reported.
Change in Self-reported Situational Driving Avoidance6 months, 12 months, 18 months, 24 monthsDriving avoidance in certain situations will be measured by asking participants about their avoidance of riskier driving situations, e.g., nighttime driving, with consideration of avoidance in certain situations as a positive or negative outcome in the context of participant's intent to avoid these situations. Avoidance of night driving was worded as: Using a scale from 1 to 7 where 1 is Not At All Comfortable and 7 is Completely Comfortable, how comfortable do you feel in the following situation?, and the situation presented was Driving at night?. Higher scores indicate greater comfort with driving at night, and lower scores represent less comfort. Therefore, change-scores can range from -6 to + 6, with change-scores \>= 0 indicate maintained or increased comfort with driving at night, and change-scores \< 0 indicate reduced comfort in driving at night.
Occurrence of Driving Cessation6 months, 12 months, 18 months, 24 monthsDriving cessation will be measured by asking participants whether they are currently driving; all participants were currently driving at study baseline. Consideration of driving cessation as a positive or negative outcome will be determined in the context of participant's intent to engage in driving cessation. This question was worded as Do you currently drive? with response options of yes and no. The numbers reported are those who said no, which represents driving cessation. The wording of this question was added to the study after an early DSMB meeting, so less data are available for it at earlier time points.
Occurrence of Self-reported Crashes6 months, 12 months, 18 months, 24 monthsOccurrence of self-reported crashes will be measured by ≥1 crash versus no crashes, where ≥1 crash is a negative outcome.
Change in Life Space Score6 months, 12 months, 18 months, 24 monthsLife space is a global measure of mobility and community engagement. The Life-Space Assessment instrument (UAB Study of Aging) is a validated tool assessing recent mobility and function. Composite scores range from 0 (bedbound) to 120 (travel out of town every day without assistance); scores of ≤60 are correlated with lower levels of social participation and higher mortality. Higher scores indicate better outcomes. Change in life space can be calculated at 6 months (vs baseline), 12 months (vs baseline), 18 months (vs baseline), and 24 months (vs baseline). Since life space scores range from 0-120, change-scores in life space can range from -120 to +120. Maintained or increased life space (change-scores \>= 0) are positive outcomes, and decreased life space (change-scores \< 0) are negative outcomes.

Countries

United States

Participant flow

Participants by arm

ArmCount
Older Drivers Website
National Institute on Aging (NIA) Older Drivers website Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
267
Driving Decision Aid
Web-based Driving Decision Aid Driving Decision Aid: Healthwise DDA
262
Total529

Withdrawals & dropouts

PeriodReasonFG000FG001
12 Month Follow-up (Drivers + SPs)Death14
12 Month Follow-up (Drivers + SPs)Missed interview920
12 Month Follow-up (Drivers + SPs)Withdrawal by Subject118
12 Month Follow-up (Drivers + SPs)Withdrawn by team02
18 Month Follow-up (Drivers Only)Death12
18 Month Follow-up (Drivers Only)Missed interview1214
18 Month Follow-up (Drivers Only)Withdrawal by Subject13
18 Month Follow-up (Drivers Only)Withdrawn by team for health issues/hospitalization01
24 Month Follow-up (Drivers and SPs)Death23
24 Month Follow-up (Drivers and SPs)Missed interview2218
24 Month Follow-up (Drivers and SPs)Withdrawal by Subject56
24 Month Follow-up (Drivers and SPs)Withdrawn by team due to health issues20
6 Month Follow-up (Drivers Only)Missed interview38
6 Month Follow-up (Drivers Only)Withdrawal by Subject44

Baseline characteristics

CharacteristicTotalOlder Drivers WebsiteDriving Decision Aid
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
451 Participants226 Participants225 Participants
Age, Categorical
Between 18 and 65 years
77 Participants41 Participants36 Participants
Age, Continuous72.4 years
STANDARD_DEVIATION 11.3
71.1 years
STANDARD_DEVIATION 11.9
73.1 years
STANDARD_DEVIATION 10.6
Ethnicity (NIH/OMB)
Hispanic or Latino
13 Participants8 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
512 Participants256 Participants256 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants3 Participants1 Participants
Pre-randomization decision conflict scale (DCS) score)17.9 units on a scale
STANDARD_DEVIATION 12.4
18.5 units on a scale
STANDARD_DEVIATION 12.4
17.3 units on a scale
STANDARD_DEVIATION 12.5
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
6 Participants3 Participants3 Participants
Race (NIH/OMB)
Black or African American
14 Participants8 Participants6 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants1 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
15 Participants9 Participants6 Participants
Race (NIH/OMB)
White
492 Participants246 Participants246 Participants
Region of Enrollment
United States
529 participants267 participants262 participants
Sex: Female, Male
Female
304 Participants148 Participants156 Participants
Sex: Female, Male
Male
225 Participants119 Participants106 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
4 / 2675 / 262
other
Total, other adverse events
16 / 26717 / 262
serious
Total, serious adverse events
3 / 2674 / 262

Outcome results

Primary

Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)

Decision conflict scale (DCS) is calculated from 16 items, with each item ranging from 0 (strongly agree) to 4 (strongly disagree). The total score is reported on a 0-100 scale by summing all responses, dividing by 16 and multiplying by 25. Higher scores represent greater levels of uncertainty in decision-making (higher decision conflict = worse outcome), and interventions often aim to reduce decision conflict (lower decision conflict = greater likelihood of implementing a decision = better outcome).

Time frame: Day 0 (Post-intervention)

Population: Drivers post-randomization at baseline visit. Missing N = 8 participants' outcomes (N = 3 control, N = 5 DDA) because they did not respond to one or more questions required to calculate this outcome.

ArmMeasureValue (MEAN)Dispersion
Older Drivers WebsiteDecisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)15.2 units on a scaleStandard Deviation 13.3
Driving Decision AidDecisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)12.3 units on a scaleStandard Deviation 12.9
Secondary

Change in Life Space Score

Life space is a global measure of mobility and community engagement. The Life-Space Assessment instrument (UAB Study of Aging) is a validated tool assessing recent mobility and function. Composite scores range from 0 (bedbound) to 120 (travel out of town every day without assistance); scores of ≤60 are correlated with lower levels of social participation and higher mortality. Higher scores indicate better outcomes. Change in life space can be calculated at 6 months (vs baseline), 12 months (vs baseline), 18 months (vs baseline), and 24 months (vs baseline). Since life space scores range from 0-120, change-scores in life space can range from -120 to +120. Maintained or increased life space (change-scores \>= 0) are positive outcomes, and decreased life space (change-scores \< 0) are negative outcomes.

Time frame: 6 months, 12 months, 18 months, 24 months

Population: Drivers who have at least one life space change-score that can be calculated (required to have baseline life space score and data at at least one follow-up). Missing N = 19 participants' outcomes (N = 11 control, N = 8 DDA) because: (i) they withdrew between baseline and 6 month FU (N = 8 total, N = 4 control, N = 4 DDA) or (ii) they did not respond to one or more questions required to calculate this outcome at baseline and/or follow-up visits (N = 11 total, N = 7 control, N = 4 DDA).

ArmMeasureGroupValue (MEAN)Dispersion
Older Drivers WebsiteChange in Life Space Score6 month change-score (6 month - baseline)-1.97 units on a scaleStandard Deviation 20.77
Older Drivers WebsiteChange in Life Space Score12 month change-score (12 month - baseline)2.68 units on a scaleStandard Deviation 19.12
Older Drivers WebsiteChange in Life Space Score18 month change-score (18 month - baseline)1.93 units on a scaleStandard Deviation 21.08
Older Drivers WebsiteChange in Life Space Score24 month change-score (24 month - baseline)1.61 units on a scaleStandard Deviation 21.95
Driving Decision AidChange in Life Space Score24 month change-score (24 month - baseline)-1.91 units on a scaleStandard Deviation 19.93
Driving Decision AidChange in Life Space Score6 month change-score (6 month - baseline)-3.10 units on a scaleStandard Deviation 20.09
Driving Decision AidChange in Life Space Score18 month change-score (18 month - baseline)-0.16 units on a scaleStandard Deviation 20.23
Driving Decision AidChange in Life Space Score12 month change-score (12 month - baseline)-2.44 units on a scaleStandard Deviation 19.15
Secondary

Change in Ottawa Decision Regret Score

Change in decision regret will be measured by the Ottawa Decision Regret Scale. This validated measure correlates with decision satisfaction and conflict, and overall quality of life. Scored from 0-100, high scores represent higher regret. Lower scores indicate better outcomes. Decision regret was measured at 6, 12, 18, and 24 months, so change in decision regret can be calculated from 12 months (vs. 6 months), 18 months (vs. 6 months), and 24 months (vs 6 months). Since decision regret scores range from 0-100, change in decision regret scores range from -100 to + 100, with change-scores \<= 0 representing maintenance or decreases in decision regret (positive outcome) and change-scores \> 0 representing increased decision regret over time (negative outcome).

Time frame: 12 months, 18 months, 24 months

Population: Drivers who had 1+ change-score(s) that could be calculated for decision regret (had to have 6 month decision regret and at least one subsequent follow-up). Missing N = 53 participants' outcomes (N = 20 control, N = 33 DDA) because: (i) they withdrew from the study between baseline and 12 months (N = 15; N = 8 control, N = 7 DDA) or (ii) they did not respond question(s) required to calculate this outcome at 6 month and/or subsequent follow-up visits (N = 38 total, N = 12 control, N = 26 DDA).

ArmMeasureGroupValue (MEAN)Dispersion
Older Drivers WebsiteChange in Ottawa Decision Regret Score12 month change-score (12 month - 6 month)3.24 units on a scaleStandard Deviation 15.61
Older Drivers WebsiteChange in Ottawa Decision Regret Score18 month change-score (18 month - 6 month)2.39 units on a scaleStandard Deviation 15.55
Older Drivers WebsiteChange in Ottawa Decision Regret Score24 month change-score (24 month - 6 month)1.71 units on a scaleStandard Deviation 15.13
Driving Decision AidChange in Ottawa Decision Regret Score12 month change-score (12 month - 6 month)-1.98 units on a scaleStandard Deviation 9.57
Driving Decision AidChange in Ottawa Decision Regret Score18 month change-score (18 month - 6 month)-1.57 units on a scaleStandard Deviation 10.59
Driving Decision AidChange in Ottawa Decision Regret Score24 month change-score (24 month - 6 month)0.37 units on a scaleStandard Deviation 12.47
Secondary

Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score

Depression will be measured using the PROMIS Short Form 4-item scale (4a Adult v1.0), with higher PROMIS scores indicating higher depression. PROMIS scores are presented as standardized T-scores (mean=50, standard deviation=10). Lower PROMIS depression scores indicate better outcomes (lower depression). Change in depression is calculated as the PROMIS depression score at each time point (6, 12, 18, or 24 months) minus the score at baseline (pre-randomization). Since PROMIS scores at each time point can range from 41.0 to 79.4, change in depression PROMIS scores can range from -38.4 to +38.4. Change-scores \> 0 represent increases in depression (poor outcome), and changes \<= 0 represent maintained or decreased depression (better outcome).

Time frame: 6 months, 12 months, 18 months, 24 months

Population: Drivers with any depression change-scores that could be calculated (had to have baseline depression and data at at least one follow-up). Missing N = 12 participants' outcomes (N = 7 control, N = 5 DDA) either of for two reasons: (i) they withdrew from the study between baseline and 6 month follow-up (N = 8 total; N = 4 control, N = 4 DDA) or (ii) they did not respond to one or more questions needed to calculate this outcome at baseline and/or follow-up (N = 4 total; N = 3 control, N = 1 DDA).

ArmMeasureGroupValue (MEAN)Dispersion
Older Drivers WebsiteChange in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score6 month follow-up (change from baseline)0.56 units on a scaleStandard Deviation 5.5
Older Drivers WebsiteChange in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score12 month follow-up (change from baseline)1.32 units on a scaleStandard Deviation 4.58
Older Drivers WebsiteChange in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score18 month follow-up (change from baseline)1.46 units on a scaleStandard Deviation 5.05
Older Drivers WebsiteChange in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score24 month follow-up (change from baseline)1.20 units on a scaleStandard Deviation 5.31
Driving Decision AidChange in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score24 month follow-up (change from baseline)0.65 units on a scaleStandard Deviation 5.81
Driving Decision AidChange in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score6 month follow-up (change from baseline)0.04 units on a scaleStandard Deviation 5.42
Driving Decision AidChange in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score18 month follow-up (change from baseline)-1.10 units on a scaleStandard Deviation 5.49
Driving Decision AidChange in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score12 month follow-up (change from baseline)0.26 units on a scaleStandard Deviation 5.91
Secondary

Change in Self-reported Driving Frequency

Self-reported driving frequency will be measured by number of days per week participants drive, with consideration of higher or lower frequency as a positive or negative outcome in the context of participant's intent to drive with lower or higher frequency. In the final study survey, this question was reworded, so participants were asked during the past 6 months, have you reduced the number of days per week you normally drive? with response options of yes, no, I don't know. Percentage of those who answered yes at each time point are reported.

Time frame: 6 months, 12 months, 18 months, 24 months

Population: Drivers with a driving frequency response at at least one time point (6 months, 12 months, 18 months, and/or 24 months). Missing N = 11 participants' outcomes (N = 6 control, N = 5 DDA) because they (i) withdrew from the study between baseline and 6 month follow-up (N = 8 total, N = 4 control, N = 4 DDA) or (ii) did not respond to this question at any follow-up visits (N = 3 total, N = 2 control, N = 1 DDA).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Older Drivers WebsiteChange in Self-reported Driving FrequencyHave reduced days/week driving at 6 months64 Participants
Older Drivers WebsiteChange in Self-reported Driving Frequencydays/week driving at 12 months44 Participants
Older Drivers WebsiteChange in Self-reported Driving Frequencydays/week driving at 18 months32 Participants
Older Drivers WebsiteChange in Self-reported Driving Frequencydays/week driving at 24 months23 Participants
Driving Decision AidChange in Self-reported Driving Frequencydays/week driving at 24 months29 Participants
Driving Decision AidChange in Self-reported Driving FrequencyHave reduced days/week driving at 6 months70 Participants
Driving Decision AidChange in Self-reported Driving Frequencydays/week driving at 18 months43 Participants
Driving Decision AidChange in Self-reported Driving Frequencydays/week driving at 12 months45 Participants
Secondary

Change in Self-reported Situational Driving Avoidance

Driving avoidance in certain situations will be measured by asking participants about their avoidance of riskier driving situations, e.g., nighttime driving, with consideration of avoidance in certain situations as a positive or negative outcome in the context of participant's intent to avoid these situations. Avoidance of night driving was worded as: Using a scale from 1 to 7 where 1 is Not At All Comfortable and 7 is Completely Comfortable, how comfortable do you feel in the following situation?, and the situation presented was Driving at night?. Higher scores indicate greater comfort with driving at night, and lower scores represent less comfort. Therefore, change-scores can range from -6 to + 6, with change-scores \>= 0 indicate maintained or increased comfort with driving at night, and change-scores \< 0 indicate reduced comfort in driving at night.

Time frame: 6 months, 12 months, 18 months, 24 months

Population: Drivers with any situational driving avoidance change-scores that could be calculated (had to have baseline and data at at least one follow-up). Missing N = 11 participants' outcomes (N = 6 control, N = 5 DDA) for two reasons: (i) they withdrew from the study between baseline and 6 month follow-up (N = 8 total; N = 4 control, N = 4 DDA) or (ii) they did not respond to one or more questions needed to calculate this outcome at baseline and/or follow-up (N = 3 total, N = 2 control, N = 1 DDA).

ArmMeasureGroupValue (MEAN)Dispersion
Older Drivers WebsiteChange in Self-reported Situational Driving Avoidance6 month change-score (6 month - baseline)-0.10 units on a scaleStandard Deviation 1.23
Older Drivers WebsiteChange in Self-reported Situational Driving Avoidance12 month change-score (12 month - baseline)-0.38 units on a scaleStandard Deviation 1.06
Older Drivers WebsiteChange in Self-reported Situational Driving Avoidance18 month change-score (18 month - baseline)-0.42 units on a scaleStandard Deviation 1.19
Older Drivers WebsiteChange in Self-reported Situational Driving Avoidance24 month change-score (24 month - baseline)-0.69 units on a scaleStandard Deviation 1.19
Driving Decision AidChange in Self-reported Situational Driving Avoidance24 month change-score (24 month - baseline)-0.67 units on a scaleStandard Deviation 1.16
Driving Decision AidChange in Self-reported Situational Driving Avoidance6 month change-score (6 month - baseline)-0.40 units on a scaleStandard Deviation 1.15
Driving Decision AidChange in Self-reported Situational Driving Avoidance18 month change-score (18 month - baseline)-0.53 units on a scaleStandard Deviation 1.27
Driving Decision AidChange in Self-reported Situational Driving Avoidance12 month change-score (12 month - baseline)-0.42 units on a scaleStandard Deviation 1.16
Secondary

Decision Self Efficacy Score at Day 0 (Post-intervention)

The Decision Self-Efficacy Scale will be used to assess decision self efficacy. Scores range from 0 (extremely low self-efficacy; worst outcome) to 100 (extremely high self-efficacy; best outcome). Higher scores indicate better outcomes. The measure will be assessed in drivers immediately following administration of control condition or intervention

Time frame: Day 0 (Post-intervention)

Population: Drivers post-randomization. Missing N = 3 participants' outcomes (N = 1 control, N = 2 DDA) because they did not respond to one or more questions required to calculate this outcome.

ArmMeasureValue (MEAN)Dispersion
Older Drivers WebsiteDecision Self Efficacy Score at Day 0 (Post-intervention)92.9 units on a scaleStandard Deviation 10.3
Driving Decision AidDecision Self Efficacy Score at Day 0 (Post-intervention)93.2 units on a scaleStandard Deviation 9.4
Secondary

Occurrence of Driving Cessation

Driving cessation will be measured by asking participants whether they are currently driving; all participants were currently driving at study baseline. Consideration of driving cessation as a positive or negative outcome will be determined in the context of participant's intent to engage in driving cessation. This question was worded as Do you currently drive? with response options of yes and no. The numbers reported are those who said no, which represents driving cessation. The wording of this question was added to the study after an early DSMB meeting, so less data are available for it at earlier time points.

Time frame: 6 months, 12 months, 18 months, 24 months

Population: Drivers with 1 or more time points of data on driving cessation. Missing N = 21 participants' outcomes (N = 8 control, N = 13 DDA) for two reasons: (i) they withdrew from the study between baseline and 6 month (N = 8 total; N = 4 control, N = 4 DDA) or (ii) they did not respond to this question follow-up (N = 13 total, N = 4 control, N = 9 DDA). This question was inadvertently not added to data collection until the 6 month follow-up period, which is why sample sizes were smaller at 6 months.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Older Drivers WebsiteOccurrence of Driving Cessation6 month4 Participants
Older Drivers WebsiteOccurrence of Driving Cessation12 month2 Participants
Older Drivers WebsiteOccurrence of Driving Cessation18 month6 Participants
Older Drivers WebsiteOccurrence of Driving Cessation24 month11 Participants
Driving Decision AidOccurrence of Driving Cessation24 month3 Participants
Driving Decision AidOccurrence of Driving Cessation6 month1 Participants
Driving Decision AidOccurrence of Driving Cessation18 month5 Participants
Driving Decision AidOccurrence of Driving Cessation12 month2 Participants
Secondary

Occurrence of Self-reported Crashes

Occurrence of self-reported crashes will be measured by ≥1 crash versus no crashes, where ≥1 crash is a negative outcome.

Time frame: 6 months, 12 months, 18 months, 24 months

Population: Drivers with 1 or more time points of data on self-reported crashes. Missing N = 10 participants' outcomes (N = 6 control, N = 4 DDA) for two reasons: (i) they withdrew from the study between baseline and 6 month follow-up (N = 8 total; N = 4 control, N = 4 DDA) or (ii) they did not respond to this question follow-up (N = 2 total, N = 2 control, N = 0 DDA).

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Older Drivers WebsiteOccurrence of Self-reported Crashes6 month15 Participants
Older Drivers WebsiteOccurrence of Self-reported Crashes12 month10 Participants
Older Drivers WebsiteOccurrence of Self-reported Crashes18 month10 Participants
Older Drivers WebsiteOccurrence of Self-reported Crashes24 month12 Participants
Driving Decision AidOccurrence of Self-reported Crashes24 month13 Participants
Driving Decision AidOccurrence of Self-reported Crashes6 month9 Participants
Driving Decision AidOccurrence of Self-reported Crashes18 month12 Participants
Driving Decision AidOccurrence of Self-reported Crashes12 month10 Participants
Secondary

Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention)

The following true/false questions will be used to examine participants' safe driving knowledge: 1) Older drivers pose a bigger risk to other drivers and pedestrians than younger drivers do; 2) Drivers aged 70 years and older are more likely to be hurt or killed if they are in a crash; 3) There is a milestone age when everyone should stop driving; 4) With age, a person needs more light to see well; 5) Getting lost on familiar roads is a sign that it might be time to stop driving. A higher number of correctly answered questions indicate better outcomes. Knowledge will be defined as the percentage of correct scores of the 5 questions (ranging from 0% \[worst outcome\] to 100% \[best outcome\]). The measure will be assessed in drivers immediately following administration of control condition or intervention.

Time frame: Day 0 (Post-intervention)

Population: Drivers at post-randomization. Missing N = 7 participants' outcomes (N = 5 control, N = 2 DDA) because they did not respond to one or more questions required to calculate this outcome.

ArmMeasureValue (MEAN)Dispersion
Older Drivers WebsiteOlder Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention)79.9 percentage of correct questionsStandard Deviation 18.4
Driving Decision AidOlder Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention)88.9 percentage of correct questionsStandard Deviation 16.4
Secondary

Values Clarity Subscale Score at Day 0 (Post-intervention)

For the values clarity subscale, three decision conflict scale (DCS) items (Likert scale responses from 0 \['strongly agree'\] to 4 \['strongly disagree'\]) are summed, divided by 3 and multiplied by 25; scores range from 0 (extremely clear) to 100 (extremely unclear about personal values); lower scores represent higher values clarity, which is a better outcome. Lower values clarity subscale scores are associated with positive outcomes. The measure will be assessed in drivers immediately following administration of control condition or intervention.

Time frame: Day 0 (Post-intervention)

Population: Drivers at post-intervention. Missing N = 3 participants' outcomes (N = 2 control, N = 1 DDA) because they did not respond to one or more questions required to calculate this outcome.

ArmMeasureValue (MEAN)Dispersion
Older Drivers WebsiteValues Clarity Subscale Score at Day 0 (Post-intervention)13.8 units on a scaleStandard Deviation 15.3
Driving Decision AidValues Clarity Subscale Score at Day 0 (Post-intervention)12.8 units on a scaleStandard Deviation 15.4

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026