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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cognitive Dysfunction; Dementia
• Intervention / Treatment: Other: ToolboxDetect

Detailed Description

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. We will conduct a large-scale, primary care practice-randomized trial to implement and comprehensively evaluate ToolboxDetect as a standard of care with AWVs, linked to an EHR (Epic). Diverse, academic and community settings are included to optimize future dissemination efforts.

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.

• Study Type: Interventional
• Enrollment (Estimated): 41500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Individuals aged 65 and older will be considered.
2. Adults who may or may not have cognitive impairments.
3. Practices affiliated with Northwestern Medicine and Access Community Health Network.

Exclusion Criteria:

1. Severe, uncorrectable vision or hearing impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of detected impairment	This will be operationalized as either results of an any administered cognitive test suggesting impairment ('detected'), or having any relevant ICD 10 classification code recorded in a patient's record after the trial launch date and throughout follow-up observation period ('diagnosis').	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of cognitive testing	Extraction from the enterprise data warehouse (EDW) of elements used to document cognitive assessment	Up to 3 years
Rate of detected cases with mild impairment	Mild vs. other impairment rates will be compared across trial arms, operationalized by ICD code groupings.	Up to 3 years
Rate of cognition-related referrals	Extraction from the electronic data warehouse for whether or not a cognitive-related referral was made (medical or non-medical) following a "detected" cognitive screen	Up to 3 years
Caregiver involvement	Text search of clinic note from any follow-up visit post AWV, wellness visit mention of accompanying family member/caregiver; extraction from EDW to determine if proxy access to patient's MyChart portal has been shared.	Up to 3 years

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: ACCESS Community Health Network

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Actual): February 28, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Dementia
• Other Study ID Numbers: R01AG069762 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No