The 5-Cog Paradigm to Improve Detection of Cognitive Impairment and Dementia: Clinical Trial Protocol

Abstract

Cognitive impairment related to dementia is under-diagnosed in primary care despite availability of numerous cognitive assessment tools; under-diagnosis is more prevalent for members of racial and ethnic minority groups. Clinical decision-support systems may improve rates of primary care providers responding to positive cognitive assessments with appropriate follow-up. The 5-Cog study is a randomized controlled trial in 1200 predominantly Black and Hispanic older adults from an urban underserved community who are presenting to primary care with cognitive concerns. The study will validate a novel 5-minute cognitive assessment coupled with an electronic medical record-embedded decision tree to overcome the barriers of current cognitive assessment paradigms in primary care and facilitate improved dementia care.

Plain Language Summary

Dementia is common, though under-recognized, in older adults (OAs). Primary care providers (PCPs) miss opportunities to help patients and their families manage the disease because of failure to, or delay to, make an appropriate diagnosis. Black and Hispanic OAs are more likely than White OAs to experience delayed diagnosis. Most available memory tests are too long for practical use by PCPs, and are ill suited to patients of diverse language, cultural and educational backgrounds. Studies have shown that even when patients test positive for dementia in primary care, PCPs often do not take follow-up action. Our improved memory test, the 5-Cog, is brief (5 min), not biased by language issues (uses pictures and symbols instead of words), and simple (doesn’t require expensive technology and complex staff training). The 5-Cog is paired with a clinical decision support tool, providing tailored recommendations directly into the patient’s medical record, and making it easier for PCPs to take appropriate action. This study will evaluate whether the 5-Cog paradigm results in improved dementia care.

Tweetable abstract

The 5-Cog study: validating a novel, simple, non literacy-biased, brief cognitive assessment paired with clinical decision support to improve, and reduce inequities in, dementia diagnosis and care.

Keywords:

• clinical trial protocol
• cognitive assessment
• cognitive impairment
• cognitive screening
• dementia
• dissemination and implementation science
• randomized controlled trial

Author contributions

J Verghese, J Zwerling, A Ehrlich, R Malik, EF Weiss, C Wang, KL Possin: study design, data analysis and interpretation and preparation of manuscript; R Chalmer, E Ayers, EF Weiss, A Ansari: data collection, analysis and interpretation and preparation of manuscript. Additionally, KL Possin, shared and allowed adaptation of a component of the Brain Health Assessment.

Acknowledgements

The authors gratefully acknowledge the study staff (C Veloz, C Nsubayi and D Rodriguez) for their assistance with data collection; and A Ansari, Montefiore Medical Group regional medical director, for his welcoming the study into a clinical site and assisting with logistical integration; the study participants for producing the data.

Financial & competing interests disclosure

This work is supported by a grant from National Institute of Neurological Disorders and Stroke of the National Institutes of Health under Award Numbers UG3NS105565 and UH3NS105565. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained institutional review board approval from Albert Einstein College of Medicine for the research described. In addition, they have obtained verbal and written informed consent from the patients for the inclusion of their medical and treatment history within this work. The 5-Cog study has been registered on www.clinicaltrials.gov – identifier: NCT03816644.