ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings
NCT ID: NCT04852601
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
41500 participants
INTERVENTIONAL
2022-08-25
2026-05-31
Brief Summary
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Detailed Description
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ToolboxDetect is an iPad-based, self-administered assessment that leverages two well validated measures from the NIH Toolbox Cognition Battery: Dimensional Change Card Sorting (for executive function) and the Picture Sequence Memory (for episodic memory). It takes approximately 7-8 minutes to administer, and for practices randomized to the ToolboxDetect arm, this will be used as the practice standard to fulfill the requirement for cognitive testing as part of the Medicare Annual Wellness Visit (AWV).
The aims of our investigation are to:
1. Evaluate the effectiveness of ToolboxDetect, compared to enhanced usual care, to promote timely detection of cognitive decline and its care management.
2. Disseminate and implement ToolboxDetect among a large Federally Qualified Health Center Network and assess its feasibility and acceptability for use;
3. Investigate the fidelity of ToolboxDetect, and identify any patient, caregiver, healthcare provider and/or system barriers to its optimal, sustained implementation;
4. Determine costs associated with implementing ToolboxDetect from a primary care perspective.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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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.
ToolboxDetect
The clinician or staff member will identify the patient by either scanning a barcode or entering his/her name, age and medical record number on an administrative screen (allowing for proper routing of test results). After completing the test, a 'submit' button will automatically generate a secure HL7 message, sharing 1) a binary classification of the results ('impaired cognition' or 'normal function'), 2) the quantitative ToolboxDetect score, and 3) brief clinical decision support to rule out any reversible causes. These results will be linked to a discrete, queriable, Epic SmartData element. As patients undergo multiple AWVs over time, ToolboxDetect quantitative scores will be displayed in Epic Synopsis Activity, a graphical display that can visualize trend data (e.g. patient vitals) and calculate a percentage change from the prior year. This will allow a clinician to establish a patient's own baseline (instead of using normative data only) for reference.
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.
No interventions assigned to this group
Interventions
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ToolboxDetect
The clinician or staff member will identify the patient by either scanning a barcode or entering his/her name, age and medical record number on an administrative screen (allowing for proper routing of test results). After completing the test, a 'submit' button will automatically generate a secure HL7 message, sharing 1) a binary classification of the results ('impaired cognition' or 'normal function'), 2) the quantitative ToolboxDetect score, and 3) brief clinical decision support to rule out any reversible causes. These results will be linked to a discrete, queriable, Epic SmartData element. As patients undergo multiple AWVs over time, ToolboxDetect quantitative scores will be displayed in Epic Synopsis Activity, a graphical display that can visualize trend data (e.g. patient vitals) and calculate a percentage change from the prior year. This will allow a clinician to establish a patient's own baseline (instead of using normative data only) for reference.
Eligibility Criteria
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Inclusion Criteria
2. Adults who may or may not have cognitive impairments.
3. Practices affiliated with Northwestern Medicine and Access Community Health Network.
Exclusion Criteria
65 Years
ALL
No
Sponsors
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ACCESS Community Health Network
OTHER
Northwestern University
OTHER
Responsible Party
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Michael S. Wolf
Professor
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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