Driving in Mild Dementia Decision Tool

Driving in Mild Dementia Decision Tool

Sponsors

Lead Sponsor: Sunnybrook Health Sciences Centre

Collaborator: Canadian Institutes of Health Research (CIHR)

Source Sunnybrook Health Sciences Centre
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 January 2014
Completion Date January 2016
Primary Completion Date January 2016
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: Driving in Mild Dementia Decision Tool

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
Location Countries

Canada

Verification Date

February 2016

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Driving in Mild Dementia Decision Tool

Type: Experimental

Description: Participants in this arm will be assessing patients using the Driving in Mild Dementia Decision Tool

Label: Control

Type: No Intervention

Description: Participants will assess patients using their usual care strategies.

Acronym DMD-DT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov