5-Cog Battery for Detecting Cognitive Impairment and Dementia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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5-Cog Battery to Improve Detection of Cognitive Impairment and Dementia

Conditions
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Dementia, Cognitive Impairment, Mild Cognitive Impairment, Neurocognitive Disorders

Intervention / Treatment
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* Other: 5-Cog
* Other: Health Literacy & Grip Assessment


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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 5-Cog<br>The 5-Cog coupled with a decision tree is a simple, 5-minute procedure that will identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. The 5-Cog includes the Picture Memory Impairment Screen (PMIS), Motoric Cognitive Risk syndrome (MCR), and the Symbol Match test. The 5-Cog will be given after randomization and before the patients sees the physician. The 5-Cog will sort patients with 'cognitive impairment' from those with 'no cognitive impairment'. After completing the 5-Cog, the non-physician tester will send a message through the Electronic medical record (EMR) system to provide the physician with the 5-Cog results and guide the them through the follow-up based on the results. | Other: 5-Cog<br>* The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.<br>|
| Active Comparator: Health Literacy & Grip Assessment<br>The 5 minute assessment includes the Short Assessment of Health Literacy (SAHL) and a grip assessment measured using a handgrip dynamometer. After completing the SAHL and grip assessment, the non-physician tester will send a message through the EMR to provide the physician with the results from the assessments and guide the them through the follow-up based on the results. | Other: Health Literacy & Grip Assessment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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. Any new diagnosis of dementia (relevant International Classification of Diseases (ICD)-10 codes) or Mild Cognitive Impairment (MCI) documented in the EMR. 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. Any new prescriptions for dementia medications (i.e. Donepezil, Aricept, Memantine, Namenda, Rivastigmine, Exelon, Galantamine, Razadyne, Donepezil, or Namzaric) documented in the EMR. Referral for cognitive/dementia evaluation by specialists (i.e. Neurology, Geriatrics or Psychiatry) documented in the EMR. | 90 days after the participant is randomized | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in health care utilization | Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit. | 6 months after the participant is randomized | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive screening, Primary care, Dementia, Cognitive Impairment, Mild Cognitive Impairment