Clinical trial NCT04141891: Advancing Understanding of Transportation Options
Official title: Decision Making Among Older Adults: the AUTO Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Retinopathy
Macular Degeneration
Glaucoma
Retinitis Pigmentosa
Vision Disorders
Acute Coronary Syndrome
Implantable Defibrillator User
Congestive Heart Failure
Hypertrophic Obstructive Cardiomyopathy
Orthostatic Hypotension
Syncope
Presyncope
Narcolepsy
Dementia
Multiple Sclerosis
Parkinson Disease
Brain Injuries
Spinal Cord Injuries
Stroke
Vertigo
Dizziness
Seizures
Substance Use
Insulin Dependent Diabetes Mellitus
Arthritis
Foot--Abnormalities
Chronic Obstructive Pulmonary Disease
Obstructive Sleep Apnea
End Stage Renal Disease
Sleep Apnea
Insomnia
Restless Legs Syndrome
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-10-28
Enrollment: 529
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Eligibility 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)

Primary outcomes:
measure: Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)
timeFrame: Day 0 (Post-intervention)
Secondary outcomes:
measure: Values Clarity Subscale Score at Day 0 (Post-intervention)
timeFrame: Day 0 (Post-intervention)
measure: Older Adult Driving Safety Knowledge Scores as Assessed by True/False Questions at Day 0 (Post-intervention)
timeFrame: Day 0 (Post-intervention)
measure: Decision Self Efficacy Score at Day 0 (Post-intervention)
timeFrame: Day 0 (Post-intervention)
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item Depression Score
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Change in Ottawa Decision Regret Score
timeFrame: 12 months, 18 months, 24 months
measure: Change in Life Space Score
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Change in Self-reported Driving Frequency
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Change in Self-reported Situational Driving Avoidance
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Occurrence of Driving Cessation
timeFrame: 6 months, 12 months, 18 months, 24 months
measure: Occurrence of Self-reported Crashes
timeFrame: 6 months, 12 months, 18 months, 24 months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Aurora
country: United States
facility: CU Anschutz Medical Center
state: Colorado
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: University of Colorado, Denver
name: Marian E Betz, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Betz ME, Hill LL, Fowler NR, DiGuiseppi C, Han SD, Johnson RL, Meador L, Omeragic F, Peterson RA, Matlock DD. "Is it time to stop driving?": A randomized clinical trial of an online decision aid for older drivers. J Am Geriatr Soc. 2022 Jul;70(7):1987-1996. doi: 10.1111/jgs.17791. Epub 2022 Apr 20.
citation: Betz ME, Omeragic F, Meador L, DiGuiseppi CG, Fowler NR, Han SD, Hill L, Johnson RL, Knoepke CE, Matlock DD, Moran R; AUTO Research Team. The Advancing Understanding of Transportation Options (AUTO) study: design and methods of a multi-center study of decision aid for older drivers. Inj Epidemiol. 2021 May 3;8(1):23. doi: 10.1186/s40621-021-00310-4.