Decision Making Among Older Adults: the AUTO Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 529
- 试验地点
- 3
- 主要终点
- Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Driving Decision Aid
Web-based Driving Decision Aid
干预措施: Driving Decision Aid (Behavioral)
Older Drivers Website
National Institute on Aging (NIA) Older Drivers website
干预措施: Older Drivers Website (Behavioral)
结局指标
主要结局
Decisional Conflict Scale (DCS) Scores at Day 0 (Post-intervention)
时间窗: 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).
次要结局
- 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))
- 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)
- Change in Ottawa Decision Regret Score(12 months, 18 months, 24 months)
- Change in Self-reported Driving Frequency(6 months, 12 months, 18 months, 24 months)
- Change in Life Space Score(6 months, 12 months, 18 months, 24 months)
- Change in Self-reported Situational Driving Avoidance(6 months, 12 months, 18 months, 24 months)
- 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)