Clinical trial NCT04852601: ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings
Official title: ToolBox Detect: Low Cost Detection of Cognitive Decline in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Dysfunction
Dementia
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: ACCESS Community Health Network
First posted: 2021-04-21
Enrollment: 41500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of detected impairment
timeFrame: Up to 3 years
Secondary outcomes:
measure: Rate of cognitive testing
timeFrame: Up to 3 years
measure: Rate of detected cases with mild impairment
timeFrame: Up to 3 years
measure: Rate of cognition-related referrals
timeFrame: Up to 3 years
measure: Caregiver involvement
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References: