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Conditions
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
Healthwise DDA
National Institute on Aging (NIA) Older Drivers Website
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Score | 6 months, 12 months, 18 months, 24 months | 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). |
| Change in Ottawa Decision Regret Score | 12 months, 18 months, 24 months | 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). |
| 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 Frequency | 6 months, 12 months, 18 months, 24 months | 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. |
| Change in Self-reported Situational Driving Avoidance | 6 months, 12 months, 18 months, 24 months | 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. |
| Occurrence of Driving Cessation | 6 months, 12 months, 18 months, 24 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. |
| Occurrence of Self-reported Crashes | 6 months, 12 months, 18 months, 24 months | Occurrence of self-reported crashes will be measured by ≥1 crash versus no crashes, where ≥1 crash is a negative outcome. |
| Change in Life Space Score | 6 months, 12 months, 18 months, 24 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 529 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month Follow-up (Drivers + SPs) | Death | 1 | 4 |
| 12 Month Follow-up (Drivers + SPs) | Missed interview | 9 | 20 |
| 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) | Death | 1 | 2 |
| 18 Month Follow-up (Drivers Only) | Missed interview | 12 | 14 |
| 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) | Death | 2 | 3 |
| 24 Month Follow-up (Drivers and SPs) | Missed interview | 22 | 18 |
| 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 |
| 6 Month Follow-up (Drivers Only) | Missed interview | 3 | 8 |
| 6 Month Follow-up (Drivers Only) | Withdrawal by Subject | 4 | 4 |
Baseline characteristics
| Characteristic | Total | Older Drivers Website | Driving Decision Aid |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 451 Participants | 226 Participants | 225 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 41 Participants | 36 Participants |
| Age, Continuous | 72.4 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 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 512 Participants | 256 Participants | 256 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 3 Participants | 1 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 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 15 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) White | 492 Participants | 246 Participants | 246 Participants |
| Region of Enrollment United States | 529 participants | 267 participants | 262 participants |
| Sex: Female, Male Female | 304 Participants | 148 Participants | 156 Participants |
| Sex: Female, Male Male | 225 Participants | 119 Participants | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 267 | 5 / 262 |
| other Total, other adverse events | 16 / 267 | 17 / 262 |
| serious Total, serious adverse events | 3 / 267 | 4 / 262 |
Outcome results
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Drivers Website | Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention) | 15.2 units on a scale | Standard Deviation 13.3 |
| Driving Decision Aid | Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention) | 12.3 units on a scale | Standard Deviation 12.9 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Older Drivers Website | Change in Life Space Score | 6 month change-score (6 month - baseline) | -1.97 units on a scale | Standard Deviation 20.77 |
| Older Drivers Website | Change in Life Space Score | 12 month change-score (12 month - baseline) | 2.68 units on a scale | Standard Deviation 19.12 |
| Older Drivers Website | Change in Life Space Score | 18 month change-score (18 month - baseline) | 1.93 units on a scale | Standard Deviation 21.08 |
| Older Drivers Website | Change in Life Space Score | 24 month change-score (24 month - baseline) | 1.61 units on a scale | Standard Deviation 21.95 |
| Driving Decision Aid | Change in Life Space Score | 24 month change-score (24 month - baseline) | -1.91 units on a scale | Standard Deviation 19.93 |
| Driving Decision Aid | Change in Life Space Score | 6 month change-score (6 month - baseline) | -3.10 units on a scale | Standard Deviation 20.09 |
| Driving Decision Aid | Change in Life Space Score | 18 month change-score (18 month - baseline) | -0.16 units on a scale | Standard Deviation 20.23 |
| Driving Decision Aid | Change in Life Space Score | 12 month change-score (12 month - baseline) | -2.44 units on a scale | Standard Deviation 19.15 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Older Drivers Website | Change in Ottawa Decision Regret Score | 12 month change-score (12 month - 6 month) | 3.24 units on a scale | Standard Deviation 15.61 |
| Older Drivers Website | Change in Ottawa Decision Regret Score | 18 month change-score (18 month - 6 month) | 2.39 units on a scale | Standard Deviation 15.55 |
| Older Drivers Website | Change in Ottawa Decision Regret Score | 24 month change-score (24 month - 6 month) | 1.71 units on a scale | Standard Deviation 15.13 |
| Driving Decision Aid | Change in Ottawa Decision Regret Score | 12 month change-score (12 month - 6 month) | -1.98 units on a scale | Standard Deviation 9.57 |
| Driving Decision Aid | Change in Ottawa Decision Regret Score | 18 month change-score (18 month - 6 month) | -1.57 units on a scale | Standard Deviation 10.59 |
| Driving Decision Aid | Change in Ottawa Decision Regret Score | 24 month change-score (24 month - 6 month) | 0.37 units on a scale | Standard Deviation 12.47 |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Older Drivers Website | 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 5.5 |
| Older Drivers Website | 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 |
| Older Drivers Website | 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 |
| Older Drivers Website | 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 |
| Driving Decision Aid | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score | 24 month follow-up (change from baseline) | 0.65 units on a scale | Standard Deviation 5.81 |
| Driving Decision Aid | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score | 6 month follow-up (change from baseline) | 0.04 units on a scale | Standard Deviation 5.42 |
| Driving Decision Aid | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score | 18 month follow-up (change from baseline) | -1.10 units on a scale | Standard Deviation 5.49 |
| Driving Decision Aid | Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score | 12 month follow-up (change from baseline) | 0.26 units on a scale | Standard Deviation 5.91 |
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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Older Drivers Website | Change in Self-reported Driving Frequency | Have reduced days/week driving at 6 months | 64 Participants |
| Older Drivers Website | Change in Self-reported Driving Frequency | days/week driving at 12 months | 44 Participants |
| Older Drivers Website | Change in Self-reported Driving Frequency | days/week driving at 18 months | 32 Participants |
| Older Drivers Website | Change in Self-reported Driving Frequency | days/week driving at 24 months | 23 Participants |
| Driving Decision Aid | Change in Self-reported Driving Frequency | days/week driving at 24 months | 29 Participants |
| Driving Decision Aid | Change in Self-reported Driving Frequency | Have reduced days/week driving at 6 months | 70 Participants |
| Driving Decision Aid | Change in Self-reported Driving Frequency | days/week driving at 18 months | 43 Participants |
| Driving Decision Aid | Change in Self-reported Driving Frequency | days/week driving at 12 months | 45 Participants |
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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Older Drivers Website | Change in Self-reported Situational Driving Avoidance | 6 month change-score (6 month - baseline) | -0.10 units on a scale | Standard Deviation 1.23 |
| Older Drivers Website | Change in Self-reported Situational Driving Avoidance | 12 month change-score (12 month - baseline) | -0.38 units on a scale | Standard Deviation 1.06 |
| Older Drivers Website | Change in Self-reported Situational Driving Avoidance | 18 month change-score (18 month - baseline) | -0.42 units on a scale | Standard Deviation 1.19 |
| Older Drivers Website | Change in Self-reported Situational Driving Avoidance | 24 month change-score (24 month - baseline) | -0.69 units on a scale | Standard Deviation 1.19 |
| Driving Decision Aid | Change in Self-reported Situational Driving Avoidance | 24 month change-score (24 month - baseline) | -0.67 units on a scale | Standard Deviation 1.16 |
| Driving Decision Aid | Change in Self-reported Situational Driving Avoidance | 6 month change-score (6 month - baseline) | -0.40 units on a scale | Standard Deviation 1.15 |
| Driving Decision Aid | Change in Self-reported Situational Driving Avoidance | 18 month change-score (18 month - baseline) | -0.53 units on a scale | Standard Deviation 1.27 |
| Driving Decision Aid | Change in Self-reported Situational Driving Avoidance | 12 month change-score (12 month - baseline) | -0.42 units on a scale | Standard Deviation 1.16 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Drivers Website | Decision Self Efficacy Score at Day 0 (Post-intervention) | 92.9 units on a scale | Standard Deviation 10.3 |
| Driving Decision Aid | Decision Self Efficacy Score at Day 0 (Post-intervention) | 93.2 units on a scale | Standard Deviation 9.4 |
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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Older Drivers Website | Occurrence of Driving Cessation | 6 month | 4 Participants |
| Older Drivers Website | Occurrence of Driving Cessation | 12 month | 2 Participants |
| Older Drivers Website | Occurrence of Driving Cessation | 18 month | 6 Participants |
| Older Drivers Website | Occurrence of Driving Cessation | 24 month | 11 Participants |
| Driving Decision Aid | Occurrence of Driving Cessation | 24 month | 3 Participants |
| Driving Decision Aid | Occurrence of Driving Cessation | 6 month | 1 Participants |
| Driving Decision Aid | Occurrence of Driving Cessation | 18 month | 5 Participants |
| Driving Decision Aid | Occurrence of Driving Cessation | 12 month | 2 Participants |
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).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Older Drivers Website | Occurrence of Self-reported Crashes | 6 month | 15 Participants |
| Older Drivers Website | Occurrence of Self-reported Crashes | 12 month | 10 Participants |
| Older Drivers Website | Occurrence of Self-reported Crashes | 18 month | 10 Participants |
| Older Drivers Website | Occurrence of Self-reported Crashes | 24 month | 12 Participants |
| Driving Decision Aid | Occurrence of Self-reported Crashes | 24 month | 13 Participants |
| Driving Decision Aid | Occurrence of Self-reported Crashes | 6 month | 9 Participants |
| Driving Decision Aid | Occurrence of Self-reported Crashes | 18 month | 12 Participants |
| Driving Decision Aid | Occurrence of Self-reported Crashes | 12 month | 10 Participants |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Drivers Website | 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 |
| Driving Decision Aid | Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention) | 88.9 percentage of correct questions | Standard Deviation 16.4 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Older Drivers Website | Values Clarity Subscale Score at Day 0 (Post-intervention) | 13.8 units on a scale | Standard Deviation 15.3 |
| Driving Decision Aid | Values Clarity Subscale Score at Day 0 (Post-intervention) | 12.8 units on a scale | Standard Deviation 15.4 |