5-Cog Battery for Detecting Cognitive Impairment and Dementia

Albert Einstein College of Medicine1,201 enrolled

Overview

Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings. The investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to overcome the technical, cultural and logistic barriers of current cognitive screens to improve dementia care in primary care patients with cognitive concerns.

Despite the availability of numerous cognitive assessment tools, cognitive impairment related to dementia is frequently under-diagnosed in primary care settings, and is a more prevalent problem among older African-Americans and Hispanics than among older whites. Missed detection delays treatment of reversible conditions as well as provision of support services and critical planning. To overcome the technical, cultural and logistic barriers of current cognitive screens and dementia care in primary care settings the investigators have developed a 5-minute cognitive screen (5-Cog) coupled with a decision tree to identify persons at high risk of developing dementia in multi-ethnic primary care populations. The 5-Cog includes the Picture based Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and a brief non-memory picture based test (Symbol Match). The cognitive assessment will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. It is coupled with a decision tree to guide clinicians through the follow up based on results of the 5-Cog. The primary objective is to test the ability of the 5-Cog and decision tree paradigm to improve dementia care in primary care patients with cognitive concerns. The investigators propose a single-blind, randomized clinical trial (RCT) in 1,200 older primary care patients with cognitive concerns who will be randomized to receive the 5-Cog (intervention group) or a 5-minute health literacy and grip assessment (active control group). Non-physicians will administer the intervention and control assessments in primary care sites and will provide results for both arms to the treating physician with a decision tree follow up guide based on the results of the assessments.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Conditions

Dementia Cognitive Impairment Mild Cognitive Impairment Neurocognitive Disorders

Interventions

5-CogOTHER

The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.

Health Literacy & Grip AssessmentOTHER

The health literacy and grip assessment will take approximately 5 minutes, and will test the patient's comprehension and pronunciation of health-related terms as well as strength in their dominant hand. The screen will sort out patients with 'low health literacy' and 'frail (low grip strength)' from those with normal health literacy and normal grip strength.

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 65 and older. 2. Presence of cognitive or memory concerns expressed by patient, caregiver, health care provider or other source who knows the patient. 3. Registered as patient at Montefiore Medical Center and have a primary care doctor appointment that day. 4. Able to hear and see well enough to complete intervention or control assessments. 5. English or Spanish speaking. Exclusion Criteria: 1. Prior diagnosis of dementia or MCI as ascertained by ICD-10 codes or the documentation of prescription for anti-dementia medications in EMR. Patients with a diagnosis containing any of the following terms will be excluded: 1. "Dementia" 2. "Mild Cognitive Impairment" 3. "Alzheimer's Disease" 4. "Creutzfeldt-Jakob Disease" 5. "Major Neurocognitive Disorder" 6. "Minor Neurocognitive Disorder" Patients with any of the following medications documented in their EMR will be excluded (generic = brand): 1. Donepezil = Aricept 2. Memantine = Namenda 3. Rivastigmine = Exelon 4. Galantamine = Razadyne 5. Donepezil and Memantine = Namzaric 2. Adults who are permanent residents of a nursing facility. 3. Patients who do not speak English or Spanish. 4. Patients who are not seeing a primary care physician at the clinic that day. 5. Patients who are blind or deaf or cannot hear loud voice even with hearing aids.

Locations (1)

Albert Einstein College of Medicine

The Bronx, New York, United States

Outcomes

Primary Outcomes

New Occurrence in Dementia Care-A Composite Endpoint Including New Cognitive Diagnoses, Laboratory Investigations Related to Cognitive Impairment, New Dementia Prescriptions, and Cognitive Related Referrals.

Dementia care is defined as the occurrence of any of the following endpoints following the screening visit. The endpoint is the number of participants who received 1 or more of the following orders: 1. Any new diagnosis of dementia (relevant International Classification of Diseases (ICD)-10 codes) or Mild Cognitive Impairment (MCI) documented in the EMR. 2. Tests ordered for reversible causes of cognitive impairment as recommended by the published guidelines of professional societies (i.e. thyroid function tests, B-12 level, Syphilis Panel, human immunodeficiency virus (HIV) test, computed tomography (CT) or Magnetic Resonance Imaging (MRI) scans) documented in the EMR. 3. Any new prescriptions for dementia medications (i.e. Donepezil, Aricept, Memantine, Namenda, Rivastigmine, Exelon, Galantamine, Razadyne, Donepezil, or Namzaric) documented in the EMR. 4. Referral for cognitive/dementia evaluation by specialists (i.e. Neurology, Geriatrics or Psychiatry) documented in the EMR.

Time frame: 90 days after the participant is randomized

Secondary Outcomes

New Occurrence of in Health Care Utilization

Utilization is defined in terms of emergency room visits and hospitalizations following the screening visit. The number of participants who went to the emergency room or had a hospitalization in the 6 months following the screening visit are presented in aggregate.

Time frame: 6 months after the participant is randomized

Data from ClinicalTrials.gov

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