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Completed

NCT Number: NCT04141891

Advancing Understanding of Transportation Options

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.

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Key information

Conditions

Diabetic Retinopathy Acute Coronary Syndrome Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Apnea Arthritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Diseases Brain Injuries Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Chemically-Induced Disorders Chronic Disease Chronic Obstructive Pulmonary Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Congestive Heart Failure Consciousness Disorders Craniocerebral Trauma Dementia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Diabetes Complications Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetic Angiopathies Disease Attributes Disorders of Excessive Somnolence Dizziness Dyssomnias Ear Diseases End Stage Renal Disease Endocrine System Diseases Eye Diseases Eye Diseases, Hereditary Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Foot--Abnormalities Genetic Diseases, Inborn Glaucoma Glucose Metabolism Disorders Heart Diseases Heart Failure Heart Valve Diseases Hypertrophic Obstructive Cardiomyopathy Hypotension Hypotension, Orthostatic Immune System Diseases Implantable Defibrillator User Insomnia Insulin Dependent Diabetes Mellitus Joint Diseases Kidney Diseases Kidney Failure, Chronic Labyrinth Diseases Lung Diseases Lung Diseases, Obstructive Macular Degeneration Male Urogenital Diseases Mental Disorders Metabolic Diseases Movement Disorders Multiple Sclerosis Musculoskeletal Diseases Myocardial Ischemia Narcolepsy Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Obstructive Sleep Apnea Ocular Hypertension Orthostatic Hypotension Orthostatic Intolerance Otorhinolaryngologic Diseases Parasomnias Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Presyncope Primary Dysautonomias Pulmonary Disease, Chronic Obstructive Renal Insufficiency Renal Insufficiency, Chronic Respiration Disorders Respiratory Tract Diseases Restless Legs Syndrome Retinal Degeneration Retinal Diseases Retinal Dystrophies Retinitis Pigmentosa Seizures Sensation Disorders Signs and Symptoms Sleep Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Spinal Cord Diseases Spinal Cord Injuries Stroke Substance Use Substance-Related Disorders Syncope Synucleinopathies Trauma, Nervous System Unconsciousness Urogenital Diseases Urologic Diseases Vascular Diseases Vertigo Vestibular Diseases Vision Disorders Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Diego, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Driving Decision Aid

Behavioral

Healthwise DDA

Other names: DDA

Older Drivers Website

Behavioral

National Institute on Aging (NIA) Older Drivers Website

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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).

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Decision Making Among Older Adults: the AUTO Study

Acronym: AUTO

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2019
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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