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Table 2 Overall study flow for older drivers (D) and study partners (SP), following SPIRIT template of recommended content for the schedule of enrollment, interventions, and assessments (Chan et al. 2013)

From: The Advancing Understanding of Transportation Options (AUTO) study: design and methods of a multi-center study of decision aid for older drivers

 

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

  1. *Questions about older driver, as answered by study partner