5-Cog Paradigm to Improve Detection of Cognitive Impairment in Primary Care: Pragmatic Clinical Trial
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Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. This problem is more prevalent in health disparities populations. We 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. We are presently conducting a simple randomized clinical trial to examine the clinical efficacy of the 5-Cog paradigm (5-Cog brief cognitive assessment paired with a clinical decision-making tool) to improve dementia care in 1,200 predominantly minority sample of older adults with cognitive concerns presenting to a primary care clinic in the Bronx. Interim analysis revealed that the 5-Cog paradigm resulted in an over 8-fold increase in new cognitive impairment diagnoses and over 3-fold increase in improved dementia care actions by primary care physicians compared to an active control arm. Following up on these very promising results, in this renewal, we 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. Study aims include: 1. 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 minority, socio-economically challenged, and rural underserved populations. 2. To measure, using mixed methods guided by the Consolidated Framework for Implementation Research, the mechanisms and the moderators of the implementation of the 5-Cog paradigm in the diverse primary care clinics. 3. To assess the cost effectiveness of the 5-Cog paradigm from a societal perspective. This proposed study, which is highly responsive to RFA-NS-22-009, focuses on scalable approaches to address the unmet need of early detection of incident cognitive impairment, including in populations that experience health disparities.
