5-Cog Paradigm to Improve Detection of Cognitive Impairment in Primary Care: Pragmatic Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. This problem is more prevalent in health disparities populations. The investigators developed the 5-Cog brief cognitive assessment that is simple to use, standardized, takes \<5 minutes, does not require informants, and accounts for major technical, cultural, and logistical barriers of current assessments. The investigators propose a hybrid Type 1 effectiveness-implementation design in real-world settings to adapt and test the effectiveness of the 5-Cog paradigm to increase detection of cognitive impairment care in older adults presenting with cognitive concerns. The study aim is to evaluate, using a pragmatic cluster-randomized trial design, the effectiveness of the 5-Cog paradigm to increase 'incident cognitive impairment' detection (new MCI and dementia diagnoses) relative to enhanced usual care in 6,600 older patients presenting with cognitive concerns in 22 primary care clinics in Bronx and Indiana. As diagnosis without action will not improve patient care, 'improved dementia care' will be examined as a secondary outcome. Results will also be examined in NIH designated health disparity populations including underserved minority and socio-economically challenged populations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• 65 years and older

• Presence of cognitive concerns

• English or Spanish speaking.

• Able to see and hear well enough to complete assessments.

Locations
United States
Indiana
Indiana University
RECRUITING
Bloomington
New York
Albert Einstein College of Medicine
RECRUITING
The Bronx
Contact Information
Primary
Emmeline Ayers, MPH
emmeline.ayers@einsteinmed.edu
718-430-3835
Backup
Erica Weiss, PhD
EWEISS@montefiore.org
Time Frame
Start Date: 2023-08-18
Estimated Completion Date: 2027-11
Participants
Target number of participants: 6600
Treatments
Experimental: 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)
A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. If cognitive concerns are endorsed the 5-Cog battery will be conducted. The simple, \<5-minute cognitive assessment will reliably identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. Depending on whether the 5-Cog results are normal or abnormal on any one of the 3 tests, appropriate clinical decision support tools are provided to the primary care physicians in electronic medical record. The primary care physicians are not instructed to follow 5-Cog suggestions verbatim but use their clinical judgment.
Active_comparator: Enhanced usual care
Educational sessions for primary care physicians and clinic staff regarding cognitive detection and medical billing will be conducted. A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. The results will be provided to primary care physicians.
Related Therapeutic Areas
Sponsors
Collaborators: Indiana University, Northwestern University, National Institute of Neurological Disorders and Stroke (NINDS)
Leads: Albert Einstein College of Medicine

This content was sourced from clinicaltrials.gov