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Advancing Understanding of Transportation Options (AUTO)

Primary Purpose

Diabetic Retinopathy, Macular Degeneration, Glaucoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Driving Decision Aid
Older Drivers Website
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of California, San Diego
  • CU Anschutz Medical Center
  • Indiana University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Driving Decision Aid

Older Drivers Website

Arm Description

Web-based Driving Decision Aid

National Institute on Aging (NIA) Older Drivers website

Outcomes

Primary Outcome Measures

Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)
The DCS is a 16-item scale (with Likert scale response options) that has high reliability and test-retest correlation (Cronbach's alpha coefficients > 0.78). In prior work, the DCS has been shown to discriminate between known groups who make or delay decisions (effect size 0.4-0.8),53 with lower scores indicating low decision conflict (and greater likelihood of implementing a decision). Scores <25 (out of 100 total) are associated with implementing decisions; scores <25 represent positive outcomes. The measure will be assessed immediately following administration of control condition or intervention

Secondary Outcome Measures

Values Clarity Subscale Score at Day 0 (Post-intervention)
The "Values Clarity" subscale of the DCS will be used to examine specifically how much participants feel their decisions are in line with their values. Three DCS items are summed and multiplied by 8.33; scores range from 0 (extremely clear) to 100 (extremely unclear about personal values). Lower Values Clarity Subscale Scores are associated with positive outcomes. The measure will be assessed immediately following administration of control condition or intervention
Older adult driving safety knowledge scores as assessed by true/false questions at 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. The measure will be assessed immediately following administration of control condition or intervention
Decision Self Efficacy score at Day 0 (Post-intervention)
The Decision Self-Efficacy Scale will be used to assess decision self efficacy. Scores range from 0 (extremely low) to 100 (extremely high self-efficacy). Higher scores indicate better outcomes. The measure will be assessed immediately following administration of control condition or intervention
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression score
Change in depression will be measured using the PROMIS 4-item scale, with higher scores indicating higher depression. All PROMIS scores are analyzed as standardized T-scores (mean=50, standard deviation=10). Lower scores indicate better outcomes.
Change in Ottawa Decision Regret score
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.
Change in Life Space score
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 self-reported driving frequency
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.
Change in self-reported situational driving avoidance
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.
Occurrence of driving cessation
Driving cessation will be measured by asking participants which of the following driving cessation options best describes their driving behavior: no driving cessation, partial driving cessation, or complete driving cessation. 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.
Occurrence of self-reported crashes
Occurrence of self-reported crashes will be measured by ≥1 crash versus no crashes, where ≥1 crash is a negative outcome.

Full Information

First Posted
October 22, 2019
Last Updated
October 6, 2022
Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT04141891
Brief Title
Advancing Understanding of Transportation Options
Acronym
AUTO
Official Title
Decision Making Among Older Adults: the AUTO Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
August 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
530 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Driving Decision Aid
Arm Type
Experimental
Arm Description
Web-based Driving Decision Aid
Arm Title
Older Drivers Website
Arm Type
Active Comparator
Arm Description
National Institute on Aging (NIA) Older Drivers website
Intervention Type
Behavioral
Intervention Name(s)
Driving Decision Aid
Other Intervention Name(s)
DDA
Intervention Description
Healthwise DDA
Intervention Type
Behavioral
Intervention Name(s)
Older Drivers Website
Intervention Description
National Institute on Aging (NIA) Older Drivers Website
Primary Outcome Measure Information:
Title
Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)
Description
The DCS is a 16-item scale (with Likert scale response options) that has high reliability and test-retest correlation (Cronbach's alpha coefficients > 0.78). In prior work, the DCS has been shown to discriminate between known groups who make or delay decisions (effect size 0.4-0.8),53 with lower scores indicating low decision conflict (and greater likelihood of implementing a decision). Scores <25 (out of 100 total) are associated with implementing decisions; scores <25 represent positive outcomes. The measure will be assessed immediately following administration of control condition or intervention
Time Frame
Day 0 (Post-intervention)
Secondary Outcome Measure Information:
Title
Values Clarity Subscale Score at Day 0 (Post-intervention)
Description
The "Values Clarity" subscale of the DCS will be used to examine specifically how much participants feel their decisions are in line with their values. Three DCS items are summed and multiplied by 8.33; scores range from 0 (extremely clear) to 100 (extremely unclear about personal values). Lower Values Clarity Subscale Scores are associated with positive outcomes. The measure will be assessed immediately following administration of control condition or intervention
Time Frame
Day 0 (Post-intervention)
Title
Older adult driving safety knowledge scores as assessed by true/false questions at Day 0 (Post-intervention)
Description
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. The measure will be assessed immediately following administration of control condition or intervention
Time Frame
Day 0 (Post-intervention)
Title
Decision Self Efficacy score at Day 0 (Post-intervention)
Description
The Decision Self-Efficacy Scale will be used to assess decision self efficacy. Scores range from 0 (extremely low) to 100 (extremely high self-efficacy). Higher scores indicate better outcomes. The measure will be assessed immediately following administration of control condition or intervention
Time Frame
Day 0 (Post-intervention)
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) 4-item depression score
Description
Change in depression will be measured using the PROMIS 4-item scale, with higher scores indicating higher depression. All PROMIS scores are analyzed as standardized T-scores (mean=50, standard deviation=10). Lower scores indicate better outcomes.
Time Frame
6 months, 12 months, 18 months, 24 months
Title
Change in Ottawa Decision Regret score
Description
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.
Time Frame
6 months, 12 months, 18 months, 24 months
Title
Change in Life Space score
Description
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.
Time Frame
6 months, 12 months, 18 months, 24 months
Title
Change in self-reported driving frequency
Description
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.
Time Frame
6 months, 12 months, 18 months, 24 months
Title
Change in self-reported situational driving avoidance
Description
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.
Time Frame
6 months, 12 months, 18 months, 24 months
Title
Occurrence of driving cessation
Description
Driving cessation will be measured by asking participants which of the following driving cessation options best describes their driving behavior: no driving cessation, partial driving cessation, or complete driving cessation. 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.
Time Frame
6 months, 12 months, 18 months, 24 months
Title
Occurrence of self-reported crashes
Description
Occurrence of self-reported crashes will be measured by ≥1 crash versus no crashes, where ≥1 crash is a negative outcome.
Time Frame
6 months, 12 months, 18 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian E Betz, MD, MPH
Organizational Affiliation
University of Colorado - Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
CU Anschutz Medical Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35441700
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.
Results Reference
derived
PubMed Identifier
33934709
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.
Results Reference
derived

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Advancing Understanding of Transportation Options

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