DMD-DT: Driving in Mild Dementia Decision Tool

Sponsor
Sunnybrook Health Sciences Centre (Other)
Overall Status
Completed
CT.gov ID
NCT02036099
Collaborator
Canadian Institutes of Health Research (CIHR) (Other)
69
1
2
24
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Driving in Mild Dementia Decision Tool
N/A

Detailed Description

as above

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Driving in Mild Dementia Decision Tool
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Jan 1, 2016
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Participants in this arm will assess patients using the Driving in Mild Dementia Decision Tool.

Other: Driving in Mild Dementia Decision Tool

No Intervention: Control

Participants in this arm will assess patients using their usual care strategies.

Outcome Measures

Primary Outcome Measures

  1. Number of patients reported to the Ontario Ministry of Transportation [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.

Secondary Outcome Measures

  1. 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)]

    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.

  2. Number of recommendations given for specialized on-road testing [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.

  3. Quality of Doctor-Patient Relationship [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sunnybrook Health Sciences Centre Toronto Ontario Canada M4N 3M5

Sponsors and Collaborators

  • Sunnybrook Health Sciences Centre
  • Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Mark J Rapoport, MD, Sunnybrook Health Sciences Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT02036099
Other Study ID Numbers:
  • KAL129896
First Posted:
Jan 14, 2014
Last Update Posted:
Feb 10, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Sunnybrook Health Sciences Centre
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2021