Driving in Mild Dementia Decision Tool (DMD-DT)
|ClinicalTrials.gov Identifier: NCT02036099|
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : February 10, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dementia||Other: Driving in Mild Dementia Decision Tool||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Driving in Mild Dementia Decision Tool|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Driving in Mild Dementia Decision Tool
Participants in this arm will be assessing patients using the Driving in Mild Dementia Decision Tool
Other: Driving in Mild Dementia Decision Tool
Study participants will be screening patients for fitness to drive using our DMD-DT, instead of using their usual care strategies.
No Intervention: Control
Participants will assess patients using their usual care strategies.
- Number of patients reported to the Ontario Ministry of Transportation [ Time Frame: 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.
- 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. [ Time Frame: When participants have completed 500 patient assessments (expected to take approximately 12 months) ]Although the primary aim of the study from a public health point of view is to increase reporting of patients with mild dementia to transportation authorities who are unsafe to drive according to best-evidence, it is important to ensure that physician reporting does not unfairly punish those who are deemed not to be at significant potential risk. Hence, a secondary outcome measure will examine the number of false positive reports, or the number of patients reported when expert consensus indicates they should NOT be reported.
- Number of recommendations given for specialized on-road testing [ Time Frame: When participants have completed 500 patient assessments (expected to take approximately 12 months) ]International guidelines suggest that when physicians are uncertain about the driving safety of their patients, specialized on-road testing should be strongly considered. Such testing, while expensive, has substantially more face validity than in-office testing. A secondary outcome measure for this study is therefore the number of recommendations made by participants for specialized on-road testing for the patients assessed in the study.
- Quality of Doctor-Patient Relationship [ Time Frame: When participants have completed 500 patient assessments (expected to take approximately 12 months) ]Many physicians avoid discussing issues related to driving with their patients who have mild dementia and their caregivers or family members, because it can have a negative effect on the doctor-patient relationship. The impact of the Driving in Mild Dementia Decision Tool on the doctor-patient relationship will be examined in two ways: first, by comparing responses between intervention and control group participants on four 5-point Likert-type questions following each patient encounter; and second, by analyzing transcripts from focus groups with participants following completion of the trial.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036099
|Sunnybrook Health Sciences Centre|
|Toronto, Ontario, Canada, M4N 3M5|
|Principal Investigator:||Mark J Rapoport, MD||Sunnybrook Health Sciences Centre|