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临床试验/NCT02036099
NCT02036099已完成不适用

Driving in Mild Dementia Decision Tool

Sunnybrook Health Sciences Centre2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
2
主要终点
Number of patients reported to the Ontario Ministry of Transportation

研究概览

简要总结

Based on the literature on dementia and driving, and on knowledge tools available to date including one from our current work, a Driving in Mild Dementia Decision Tool (DMD-DT) will be adapted and tailored to guide physicians in their decisions to report a driver with mild dementia to the provincial licensing agency. The DMD-DT intervention will include a) an algorithm-based computerized clinical decision support system (CCDSS) for facilitating driving assessment and physicians' reporting to provincial transportation authorities, b) an individualized educational package for patients and caregivers about dementia and driving and driving cessation, and c) a modified reporting form to provincial driving regulatory authorities. Months 1 to 6: The DMD-DT will be tailored and adapted to practice with the input of the co-investigators and knowledge-users who represent the perspectives of physicians, patients and their caregivers, as well as transportation authorities. Pilot testing will be done, and input from focus groups of knowledge-users will refine the intervention. Physicians will be recruited to participate in a clinical trial of the DMD-DT. Months 7-18: A parallel-group cluster randomized controlled trial (RCT) will be conducted to compare the effects of the DMD-DT to a legislation reminder on recommendations for reporting to the licensing agency. The effects of the DMD-DT on the doctor-patient relationship will be further explored in focus groups and interviews with physicians. Months 19-24: The knowledge obtained from the study will be used to generalize and sustain use of the intervention beyond Ontario, Canada, and to disseminate the information to knowledge-users. The primary outcome measure is the filing of a report to the Ministry of Transportation of Ontario, indicating that the physician has a concern about the patient's health condition (i.e. mild dementia). The primary outcome of the study is the difference in reporting between the DMD-DT and control arms. Since the current reporting rate is low, approximately 13%, from a public health point of view, the primary outcome expected is that physicians in the DMD-DT group will report more patients with mild dementia than those in the control group.

详细描述

as above

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • family physicians and specialist physicians (geriatricians, geriatric psychiatrists, cognitive neurologists) practicing in Ontario, Canada, who assess and treat patients with mild dementia
  • must speak English and have computer access at the point of delivery of care

排除标准

  • family physicians must see at least 10 new patients per year with mild dementia, and specialist physicians must see at least 12 new patients per year with mild dementia
  • participants must not have participated in, attended a continuing medical education (CME) event about, or read about our "Dementia and Driving in Ontario" study (2010-2012)

结局指标

主要结局

Number of patients reported to the Ontario Ministry of Transportation

时间窗: When participants have completed 500 patient assessments (expected to take approximately 12 months)

The primary outcome of this study is the number of patients reported to the Ontario Ministry of Transportation by study participants. A "report" indicates that the participant believes his/her patient may be unsafe to continue driving due to mild cognitive impairment or mild dementia. The difference in the number of reports filed between the intervention and control group participants will be assessed.

次要结局

  • The number of "false positives", i.e. number of patients reported to the Ontario Ministry of Transportation as potentially being unsafe drivers who are deemed by expert consensus to be safe drivers.(When participants have completed 500 patient assessments (expected to take approximately 12 months))
  • Number of recommendations given for specialized on-road testing(When participants have completed 500 patient assessments (expected to take approximately 12 months))
  • Quality of Doctor-Patient Relationship(When participants have completed 500 patient assessments (expected to take approximately 12 months))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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