| STUDY PERIOD | |||||||
---|---|---|---|---|---|---|---|---|
Enrollment | Allocation | Post-allocation | Close-out | |||||
TIMEPOINT (months) | -t | t0 | t0 | t0 | t6 mo | t12 mo | t18 mo | t24 mo |
ENROLLMENT | ||||||||
 Eligibility screen | XD,SP |  |  |  |  |  |  |  |
 Informed consent |  | XD,SP |  |  |  |  |  |  |
 Randomization |  |  | XD,SP |  |  |  |  |  |
INTERVENTIONS | ||||||||
 Driving decision aid |  |  | XD,SP |  |  |  |  |  |
 Control website |  |  | XD,SP |  |  |  |  |  |
ASSESSMENTS | ||||||||
Immediate outcomes | ||||||||
 Decision Conflict Scale |  | XD,SP |  | XD,SP | XD | XD,SP | XD | XD,SP |
 Knowledge questionnaire |  | XD |  | XD,SP | XD | XD,SP | XD | XD,SP |
 Values concordance (DCS Values Clarity subscale) |  | XD,SP |  | XD,SP | XD | XD,SP | XD | XD,SP |
 Decision Self-Efficacy scale |  | XD |  | XD,SP | XD | XD,SP | XD | XD,SP |
Longitudinal outcomes | ||||||||
 PROMIS Depression |  | XD |  |  | XD | XD | XD | XD |
 Ottawa Decision Regret Scale |  |  |  |  | XD | XD,SP | XD | XD,SP |
 Life-Space Assessment |  | XD |  |  | XD | XD | XD | XD |
 Driving behaviors |  | XD |  |  | XD | XD,SP* | XD | XD,SP* |
Subgroups | ||||||||
 Cognitive screening (5-min MoCA) | XD,SP |  |  |  | XD | XD,SP | XD | XD,SP |
 Cognitive function (BTACT, OTMT) |  | XD |  |  |  |  |  |  |
 Beck Cognitive Insight Scale |  | XD |  |  |  |  |  | XD |
 Decisional capacity (SPACED) |  | XD |  |  |  |  |  | XD |
 Attitudes about driving (ARMT) |  | XD |  |  | XD | XD | XD | XD |
 Driving behaviors |  | XD,SP |  |  | XD | XD,SP* | XD | XD,SP* |
Other covariates | ||||||||
 Demographics |  | XD,SP |  |  | XD | XD,SP | XD | XD,SP |
 Physical health |  | XD |  |  | XD | XD | XD | XD |
 Mental health |  | XD |  |  | XD | XD | XD | XD |
 Personality (TIPI) |  | XD |  |  |  |  |  |  |
 Driving education |  | XD,SP |  |  | XD | XD,SP | XD | XD,SP |
 Family questionnaire |  | XSP |  |  |  | XSP |  | XSP |
 Major life events |  |  |  |  | XD | XD,SP* | XD | XD,SP* |
 COVID-19 related health |  |  |  | XD,SP | XD | XD,SP | XD | XD,SP |