ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Our study objective is to widely implement and evaluate a user-centered, scalable, electronic health record (EHR)-linked strategy for the routine detection of cognitive decline among diverse primary care settings. This strategy, called ToolboxDetect, will provide an efficient and sensitive cognitive screen that can be easily implemented in everyday clinical settings, and is responsive to patient, family, and caregiver concerns for potential symptoms of cognitive decline (CD) and cognitive impairment (CI).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
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• Individuals aged 65 and older will be considered.

• Adults who may or may not have cognitive impairments.

• Practices affiliated with Northwestern Medicine and Access Community Health Network.

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Contact Information
Primary
Michael S Wolf, PhD MPH
mswolf@northwestern.edu
312-503-5592
Backup
Julia N Yoshino Benavente, MPH
julia.benavente@northwestern.edu
312-503-5585
Time Frame
Start Date: 2022-08-25
Estimated Completion Date: 2026-05
Participants
Target number of participants: 41500
Treatments
Experimental: ToolboxDetect Strategy
All practices randomized to the intervention arm will implement the ToolboxDetect battery as the standard of care routine cognitive assessment to fulfill the Medicare Annual Wellness Visit (AWV) requirement. The 7-8 minute ToolboxDetect battery contains self-administered versions of the NIH ToolBox Picture Sequence Memory Test (PSM) and the NIH ToolBox Dimensional Change Card Sorting (DCCS). PSM measures episodic memory and DCCS tests executive functioning.~The validated ToolboxDetect application will be imparted either as an application on an iPad or on a PC desktop/laptop computer commonly found in a clinical exam room for EHR access.
No_intervention: Enhanced Usual Care
At Northwestern Medicine, cognitive assessments included in Annual Wellness Visits or other routine or sick/problem-based visits vary by practice and also by clinician. However, the choice of test was limited to either a Mini-Cog©, Montreal Cognitive Assessment (MoCA), or Mini Mental Status Exam (MMSE).~While we will not make any explicit recommendations to these practices with regard to their use of a cognitive assessment, we will ensure that 1) any chosen test is linked to an Epic SmartData element, which will allow the clinician to record the results of the test as discrete data (which can then be queried), and that 2) providers receive a compiled list of local medical and non-medical referrals for any detected cases of CI. The Alzheimer's Association recommendations for early detection efforts among primary care practices will also be provided to each clinic's medical leadership.
Related Therapeutic Areas
Sponsors
Leads: Northwestern University
Collaborators: ACCESS Community Health Network

This content was sourced from clinicaltrials.gov