Clinical Trials Directory

Trials / Completed

CompletedNCT02036099

Driving in Mild Dementia Decision Tool

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
69 (actual)
Sponsor
Sunnybrook Health Sciences Centre · Academic / Other
Sex
All
Age
Healthy volunteers
Accepted

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.

Detailed description

as above

Conditions

Interventions

TypeNameDescription
OTHERDriving in Mild Dementia Decision Tool

Timeline

Start date
2014-01-01
Primary completion
2016-01-01
Completion
2016-01-01
First posted
2014-01-14
Last updated
2021-02-10

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02036099. Inclusion in this directory is not an endorsement.