Decision Making Among Older Adults: the AUTO Study

CompletedNot a drug-phase studyMS (type not specified)NCT04141891

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Driving Decision Aid

Compared with

  • Older Drivers Website

Results by group

Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)

Day 0 (Post-intervention)

GroupValueIntervalNumber analysed
Older Drivers Website15.2 units on a scale13.3 (Standard Deviation)148
Driving Decision Aid12.3 units on a scale12.9 (Standard Deviation)145

Older Drivers Website

15.2

Driving Decision Aid

12.3

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Older Drivers Website2673 (1.1%)4
Driving Decision Aid2624 (1.5%)5

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)

    Day 0 (Post-intervention)

Other measures (10)

  • Values Clarity Subscale Score at Day 0 (Post-intervention)

    Day 0 (Post-intervention)

  • Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention)

    Day 0 (Post-intervention)

    Safety
  • Decision Self Efficacy Score at Day 0 (Post-intervention)

    Day 0 (Post-intervention)

  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score

    6 months, 12 months, 18 months, 24 months

    Mood and sleepQuality of life (reported by participants)
  • Change in Ottawa Decision Regret Score

    12 months, 18 months, 24 months

    Quality of life (reported by participants)
  • Change in Life Space Score

    6 months, 12 months, 18 months, 24 months

    Walking and mobility
  • Change in Self-reported Driving Frequency

    6 months, 12 months, 18 months, 24 months

  • Change in Self-reported Situational Driving Avoidance

    6 months, 12 months, 18 months, 24 months

    Bladder, bowel and sexual function
  • Occurrence of Driving Cessation

    6 months, 12 months, 18 months, 24 months

  • Occurrence of Self-reported Crashes

    6 months, 12 months, 18 months, 24 months

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

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)

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Dec 2019

    2. Main results due

      Jun 2023

    3. Finished

      Dec 2023

    4. Results posted

      Feb 2025

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