Advancing Understanding of Transportation Options (AUTO)

January 31, 2025 updated by: University of Colorado, Denver

Decision Making Among Older Adults: the AUTO Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

529

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego
    • Colorado
      • Aurora, Colorado, United States, 80045
        • CU Anschutz Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Exclusion Criteria for study partners:

  • In legal custody or institutionalized
  • Significant cognitive impairment as measured by 5-minute Montreal Cognitive Assessment (MoCA)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Driving Decision Aid
Web-based Driving Decision Aid
Behavioral: Driving Decision Aid
Healthwise DDA
Other Names:
  • DDA
Active Comparator: Older Drivers Website
National Institute on Aging (NIA) Older Drivers website
Behavioral: Older Drivers Website
National Institute on Aging (NIA) Older Drivers Website

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)
Time Frame: 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).
Day 0 (Post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Values Clarity Subscale Score at Day 0 (Post-intervention)
Time Frame: 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.
Day 0 (Post-intervention)
Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention)
Time Frame: 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.
Day 0 (Post-intervention)
Decision Self Efficacy Score at Day 0 (Post-intervention)
Time Frame: 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
Day 0 (Post-intervention)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score
Time Frame: 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).
6 months, 12 months, 18 months, 24 months
Change in Ottawa Decision Regret Score
Time Frame: 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).
12 months, 18 months, 24 months
Change in Life Space Score
Time Frame: 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.
6 months, 12 months, 18 months, 24 months
Change in Self-reported Driving Frequency
Time Frame: 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.
6 months, 12 months, 18 months, 24 months
Change in Self-reported Situational Driving Avoidance
Time Frame: 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.
6 months, 12 months, 18 months, 24 months
Occurrence of Driving Cessation
Time Frame: 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.
6 months, 12 months, 18 months, 24 months
Occurrence of Self-reported Crashes
Time Frame: 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.
6 months, 12 months, 18 months, 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Marian E Betz, MD, MPH, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Actual)

June 23, 2023

Study Completion (Actual)

December 21, 2023

Study Registration Dates

First Submitted

October 22, 2019

First Submitted That Met QC Criteria

October 24, 2019

First Posted (Actual)

October 28, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-0059
  • R01AG059613 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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