Driving in Mild Dementia Decision Tool

NCT ID: NCT02036099

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

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.

Detailed Description

as above

Conditions

Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Driving in Mild Dementia Decision Tool

Intervention Type: OTHER

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Driving in Mild Dementia Decision Tool

Intervention Type: OTHER

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark J Rapoport, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

References

Rapoport MJ, Zucchero Sarracini C, Kiss A, Lee L, Byszewski A, Seitz DP, Vrkljan B, Molnar F, Herrmann N, Tang-Wai DF, Frank C, Henry B, Pimlott N, Masellis M, Naglie G. Computer-Based Driving in Dementia Decision Tool With Mail Support: Cluster Randomized Controlled Trial. J Med Internet Res. 2018 May 25;20(5):e194. doi: 10.2196/jmir.9126.

Reference Type: DERIVED

PMID: 29802093 (View on PubMed)

Other Identifiers

KAL129896

Identifier Type: -

Identifier Source: org_study_id