Trial Outcomes & Findings for Advancing Understanding of Transportation Options (NCT NCT04141891)
NCT ID: NCT04141891
Last Updated: 2025-02-21
Results Overview
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).
COMPLETED
NA
529 participants
Day 0 (Post-intervention)
2025-02-21
Participant Flow
Participant milestones
| Measure |
Older Drivers Website
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Baseline Enrollment (Drivers + SPs)
STARTED
|
267
|
262
|
|
Baseline Enrollment (Drivers + SPs)
COMPLETED
|
267
|
262
|
|
Baseline Enrollment (Drivers + SPs)
NOT COMPLETED
|
0
|
0
|
|
6 Month Follow-up (Drivers Only)
STARTED
|
151
|
150
|
|
6 Month Follow-up (Drivers Only)
COMPLETED
|
144
|
138
|
|
6 Month Follow-up (Drivers Only)
NOT COMPLETED
|
7
|
12
|
|
12 Month Follow-up (Drivers + SPs)
STARTED
|
263
|
258
|
|
12 Month Follow-up (Drivers + SPs)
COMPLETED
|
242
|
224
|
|
12 Month Follow-up (Drivers + SPs)
NOT COMPLETED
|
21
|
34
|
|
18 Month Follow-up (Drivers Only)
STARTED
|
143
|
143
|
|
18 Month Follow-up (Drivers Only)
COMPLETED
|
129
|
123
|
|
18 Month Follow-up (Drivers Only)
NOT COMPLETED
|
14
|
20
|
|
24 Month Follow-up (Drivers and SPs)
STARTED
|
249
|
238
|
|
24 Month Follow-up (Drivers and SPs)
COMPLETED
|
218
|
211
|
|
24 Month Follow-up (Drivers and SPs)
NOT COMPLETED
|
31
|
27
|
Reasons for withdrawal
| Measure |
Older Drivers Website
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
6 Month Follow-up (Drivers Only)
Missed interview
|
3
|
8
|
|
6 Month Follow-up (Drivers Only)
Withdrawal by Subject
|
4
|
4
|
|
12 Month Follow-up (Drivers + SPs)
Missed interview
|
9
|
20
|
|
12 Month Follow-up (Drivers + SPs)
Death
|
1
|
4
|
|
12 Month Follow-up (Drivers + SPs)
Withdrawal by Subject
|
11
|
8
|
|
12 Month Follow-up (Drivers + SPs)
Withdrawn by team
|
0
|
2
|
|
18 Month Follow-up (Drivers Only)
Missed interview
|
12
|
14
|
|
18 Month Follow-up (Drivers Only)
Death
|
1
|
2
|
|
18 Month Follow-up (Drivers Only)
Withdrawal by Subject
|
1
|
3
|
|
18 Month Follow-up (Drivers Only)
Withdrawn by team for health issues/hospitalization
|
0
|
1
|
|
24 Month Follow-up (Drivers and SPs)
Missed interview
|
22
|
18
|
|
24 Month Follow-up (Drivers and SPs)
Death
|
2
|
3
|
|
24 Month Follow-up (Drivers and SPs)
Withdrawal by Subject
|
5
|
6
|
|
24 Month Follow-up (Drivers and SPs)
Withdrawn by team due to health issues
|
2
|
0
|
Baseline Characteristics
N = 1 participant refused to share their age with the study team.
Baseline characteristics by cohort
| Measure |
Older Drivers Website
n=267 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=262 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
Total
n=529 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=267 Participants • N = 1 participant refused to share their age with the study team.
|
0 Participants
n=261 Participants • N = 1 participant refused to share their age with the study team.
|
0 Participants
n=528 Participants • N = 1 participant refused to share their age with the study team.
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=267 Participants • N = 1 participant refused to share their age with the study team.
|
36 Participants
n=261 Participants • N = 1 participant refused to share their age with the study team.
|
77 Participants
n=528 Participants • N = 1 participant refused to share their age with the study team.
|
|
Age, Categorical
>=65 years
|
226 Participants
n=267 Participants • N = 1 participant refused to share their age with the study team.
|
225 Participants
n=261 Participants • N = 1 participant refused to share their age with the study team.
|
451 Participants
n=528 Participants • N = 1 participant refused to share their age with the study team.
|
|
Age, Continuous
|
71.1 years
STANDARD_DEVIATION 11.9 • n=267 Participants • N = 1 participant refused to share their age with the study team.
|
73.1 years
STANDARD_DEVIATION 10.6 • n=261 Participants • N = 1 participant refused to share their age with the study team.
|
72.4 years
STANDARD_DEVIATION 11.3 • n=528 Participants • N = 1 participant refused to share their age with the study team.
|
|
Sex: Female, Male
Female
|
148 Participants
n=267 Participants
|
156 Participants
n=262 Participants
|
304 Participants
n=529 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=267 Participants
|
106 Participants
n=262 Participants
|
225 Participants
n=529 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=267 Participants
|
5 Participants
n=262 Participants
|
13 Participants
n=529 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
256 Participants
n=267 Participants
|
256 Participants
n=262 Participants
|
512 Participants
n=529 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=267 Participants
|
1 Participants
n=262 Participants
|
4 Participants
n=529 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=267 Participants
|
0 Participants
n=262 Participants
|
0 Participants
n=529 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=267 Participants
|
3 Participants
n=262 Participants
|
6 Participants
n=529 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=267 Participants
|
1 Participants
n=262 Participants
|
2 Participants
n=529 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=267 Participants
|
6 Participants
n=262 Participants
|
14 Participants
n=529 Participants
|
|
Race (NIH/OMB)
White
|
246 Participants
n=267 Participants
|
246 Participants
n=262 Participants
|
492 Participants
n=529 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=267 Participants
|
0 Participants
n=262 Participants
|
0 Participants
n=529 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=267 Participants
|
6 Participants
n=262 Participants
|
15 Participants
n=529 Participants
|
|
Region of Enrollment
United States
|
267 participants
n=267 Participants
|
262 participants
n=262 Participants
|
529 participants
n=529 Participants
|
|
Pre-randomization decision conflict scale (DCS) score)
|
18.5 units on a scale
STANDARD_DEVIATION 12.4 • n=267 Participants
|
17.3 units on a scale
STANDARD_DEVIATION 12.5 • n=262 Participants
|
17.9 units on a scale
STANDARD_DEVIATION 12.4 • n=529 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Older Drivers Website
n=148 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=145 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)
|
15.2 units on a scale
Standard Deviation 13.3
|
12.3 units on a scale
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Older Drivers Website
n=149 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=149 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Values Clarity Subscale Score at Day 0 (Post-intervention)
|
13.8 units on a scale
Standard Deviation 15.3
|
12.8 units on a scale
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Older Drivers Website
n=146 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=148 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention)
|
79.9 percentage of correct questions
Standard Deviation 18.4
|
88.9 percentage of correct questions
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: 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.
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
Outcome measures
| Measure |
Older Drivers Website
n=150 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=149 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Decision Self Efficacy Score at Day 0 (Post-intervention)
|
92.9 units on a scale
Standard Deviation 10.3
|
93.2 units on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 monthsPopulation: 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).
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).
Outcome measures
| Measure |
Older Drivers Website
n=144 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=145 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score
6 month follow-up (change from baseline)
|
0.56 units on a scale
Standard Deviation 5.50
|
0.04 units on a scale
Standard Deviation 5.42
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score
12 month follow-up (change from baseline)
|
1.32 units on a scale
Standard Deviation 4.58
|
0.26 units on a scale
Standard Deviation 5.91
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score
18 month follow-up (change from baseline)
|
1.46 units on a scale
Standard Deviation 5.05
|
-1.10 units on a scale
Standard Deviation 5.49
|
|
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score
24 month follow-up (change from baseline)
|
1.20 units on a scale
Standard Deviation 5.31
|
0.65 units on a scale
Standard Deviation 5.81
|
SECONDARY outcome
Timeframe: 12 months, 18 months, 24 monthsPopulation: 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).
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).
Outcome measures
| Measure |
Older Drivers Website
n=131 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=117 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Change in Ottawa Decision Regret Score
12 month change-score (12 month - 6 month)
|
3.24 units on a scale
Standard Deviation 15.61
|
-1.98 units on a scale
Standard Deviation 9.57
|
|
Change in Ottawa Decision Regret Score
18 month change-score (18 month - 6 month)
|
2.39 units on a scale
Standard Deviation 15.55
|
-1.57 units on a scale
Standard Deviation 10.59
|
|
Change in Ottawa Decision Regret Score
24 month change-score (24 month - 6 month)
|
1.71 units on a scale
Standard Deviation 15.13
|
0.37 units on a scale
Standard Deviation 12.47
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Older Drivers Website
n=140 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=142 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Change in Life Space Score
6 month change-score (6 month - baseline)
|
-1.97 units on a scale
Standard Deviation 20.77
|
-3.10 units on a scale
Standard Deviation 20.09
|
|
Change in Life Space Score
12 month change-score (12 month - baseline)
|
2.68 units on a scale
Standard Deviation 19.12
|
-2.44 units on a scale
Standard Deviation 19.15
|
|
Change in Life Space Score
18 month change-score (18 month - baseline)
|
1.93 units on a scale
Standard Deviation 21.08
|
-0.16 units on a scale
Standard Deviation 20.23
|
|
Change in Life Space Score
24 month change-score (24 month - baseline)
|
1.61 units on a scale
Standard Deviation 21.95
|
-1.91 units on a scale
Standard Deviation 19.93
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Older Drivers Website
n=145 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=145 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Change in Self-reported Driving Frequency
Have reduced days/week driving at 6 months
|
64 Participants
|
70 Participants
|
|
Change in Self-reported Driving Frequency
days/week driving at 12 months
|
44 Participants
|
45 Participants
|
|
Change in Self-reported Driving Frequency
days/week driving at 24 months
|
23 Participants
|
29 Participants
|
|
Change in Self-reported Driving Frequency
days/week driving at 18 months
|
32 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 monthsPopulation: 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).
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.
Outcome measures
| Measure |
Older Drivers Website
n=145 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=145 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Change in Self-reported Situational Driving Avoidance
6 month change-score (6 month - baseline)
|
-0.10 units on a scale
Standard Deviation 1.23
|
-0.40 units on a scale
Standard Deviation 1.15
|
|
Change in Self-reported Situational Driving Avoidance
18 month change-score (18 month - baseline)
|
-0.42 units on a scale
Standard Deviation 1.19
|
-0.53 units on a scale
Standard Deviation 1.27
|
|
Change in Self-reported Situational Driving Avoidance
12 month change-score (12 month - baseline)
|
-0.38 units on a scale
Standard Deviation 1.06
|
-0.42 units on a scale
Standard Deviation 1.16
|
|
Change in Self-reported Situational Driving Avoidance
24 month change-score (24 month - baseline)
|
-0.69 units on a scale
Standard Deviation 1.19
|
-0.67 units on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Older Drivers Website
n=143 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=137 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Occurrence of Driving Cessation
6 month
|
4 Participants
|
1 Participants
|
|
Occurrence of Driving Cessation
12 month
|
2 Participants
|
2 Participants
|
|
Occurrence of Driving Cessation
18 month
|
6 Participants
|
5 Participants
|
|
Occurrence of Driving Cessation
24 month
|
11 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6 months, 12 months, 18 months, 24 monthsPopulation: 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).
Occurrence of self-reported crashes will be measured by ≥1 crash versus no crashes, where ≥1 crash is a negative outcome.
Outcome measures
| Measure |
Older Drivers Website
n=145 Participants
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=146 Participants
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Occurrence of Self-reported Crashes
12 month
|
10 Participants
|
10 Participants
|
|
Occurrence of Self-reported Crashes
18 month
|
10 Participants
|
12 Participants
|
|
Occurrence of Self-reported Crashes
24 month
|
12 Participants
|
13 Participants
|
|
Occurrence of Self-reported Crashes
6 month
|
15 Participants
|
9 Participants
|
Adverse Events
Older Drivers Website
Driving Decision Aid
Serious adverse events
| Measure |
Older Drivers Website
n=267 participants at risk
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=262 participants at risk
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Injury, poisoning and procedural complications
Motor vehicle accident as driver
|
0.00%
0/151 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
|
0.00%
0/150 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
|
|
Injury, poisoning and procedural complications
Inpatient hospitalization
|
1.1%
3/267 • Number of events 3 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
|
1.5%
4/262 • Number of events 4 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
|
|
Injury, poisoning and procedural complications
Emergency department (ED) visit
|
0.00%
0/267 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
|
0.00%
0/262 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
|
Other adverse events
| Measure |
Older Drivers Website
n=267 participants at risk
National Institute on Aging (NIA) Older Drivers website
Older Drivers Website: National Institute on Aging (NIA) Older Drivers Website
|
Driving Decision Aid
n=262 participants at risk
Web-based Driving Decision Aid
Driving Decision Aid: Healthwise DDA
|
|---|---|---|
|
Social circumstances
Distress during any assessment
|
0.00%
0/267 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
|
0.38%
1/262 • Number of events 1 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
|
|
Injury, poisoning and procedural complications
Motor vehicle accident as driver
|
10.6%
16/151 • Number of events 16 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
|
10.7%
16/150 • Number of events 18 • 2 years of study from enrollment to follow-up (baseline, 6 month, 12 month, 18 month, 24 month visits)
Possible adverse events: distress during any assessment (driver or study partner), self-reported motor vehicle accident as driver (drivers only) Possible serious adverse events: DMV report of motor vehicle accident (drivers only), inpatient hospitalization (any reason; drivers or study partners); ED visit (any reason; drivers or study partners); death (all causes; driver or study partner)
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place