Driving in Mild Dementia Decision Tool
Driving in Mild Dementia Decision Tool
Sponsors
Lead Sponsor
Collaborators
Source
Sunnybrook Health Sciences Centre
Oversight Info
Has Dmc
No
Brief Summary
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.
Overall Status
Completed
Start Date
2014-01-01
Completion Date
2016-01-01
Primary Completion Date
2016-01-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Number of patients reported to the Ontario Ministry of Transportation |
When participants have completed 500 patient assessments (expected to take approximately 12 months) |
Secondary Outcome
Measure |
Time Frame |
|
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) |
Enrollment
68
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
Study participants will be screening patients for fitness to drive using our DMD-DT, instead of using their usual care strategies.
Arm Group Label
Driving in Mild Dementia Decision Tool
Eligibility
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Gender
All
Minimum Age
N/A
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
|
Mark J Rapoport, MD |
Principal Investigator |
Sunnybrook Health Sciences Centre |
Location
Facility |
|
Sunnybrook Health Sciences Centre Toronto Ontario M4N 3M5 Canada |
Location Countries
Country
Canada
Verification Date
2016-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Driving in Mild Dementia Decision Tool
Arm Group Type
Experimental
Description
Participants in this arm will be assessing patients using the Driving in Mild Dementia Decision Tool
Arm Group Label
Control
Arm Group Type
No Intervention
Description
Participants will assess patients using their usual care strategies.
Firstreceived Results Date
N/A
Acronym
DMD-DT
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
January 3, 2014
Study First Submitted Qc
January 13, 2014
Study First Posted
January 14, 2014
Last Update Submitted
February 9, 2016
Last Update Submitted Qc
February 9, 2016
Last Update Posted
February 10, 2016
Pending Results
Submitted
April 30, 2019
Returned
July 11, 2019
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.