5-Cog 2.0: A Pragmatic Clinical Trial

Study 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.

Primary Outcome

The clinical effectiveness of the 5-Cog paradigm on new cognitive impairment detection will be examined by comparing the proportion of 'new Mild Cognitive Impairment (MCI) and dementia diagnoses' over 90-days in the 5-cog paradigm and the enhanced usual care group using generalized linear mixed effects models. For patients with a previous diagnosis of MCI in the electronic medical record, only a new diagnosis of dementia will be considered as an incident outcome.

Conditions Studied

Interventions

• OTHER Enhanced usual care
• OTHER 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)

Study Locations (2)