Cognitive Impairment, Dementia, Mild Cognitive Impairment, Neurocognitive Disorders
Conditions
Keywords
Cognitive screening, Primary care, Dementia, Cognitive Impairment, Mild Cognitive Impairment
Brief summary
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
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.
Interventions
OTHER5-Cog
The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.
OTHERHealth Literacy & Grip Assessment
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.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 90 days after the participant is randomized | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New Occurrence of in Health Care Utilization | 6 months after the participant is randomized | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness | 6 months after the participant is randomized | Medicare payments for health care utilization will be valued. Costs will be divided into fixed and variable costs and by the screening and follow-up phases. Total costs will be estimated for health care utilization and reimbursement data captured by the EMR. |
| Change in Health Care Utilization | 12 months after the participant is randomized | Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 5-Cog 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.
5-Cog: The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'. | 599 |
| Health Literacy & Grip Assessment 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.
Health Literacy & Grip Assessment: 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. | 602 |
| Total | 1,201 |
Baseline characteristics
| Characteristic | 5-Cog | Health Literacy & Grip Assessment | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 599 Participants | 602 Participants | 1201 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 72.88 years STANDARD_DEVIATION 6.38 | 72.64 years STANDARD_DEVIATION 6.67 | 72.76 years STANDARD_DEVIATION 6.52 |
| Education years | 11.24 years STANDARD_DEVIATION 4.1 | 10.95 years STANDARD_DEVIATION 4.26 | 11.09 years STANDARD_DEVIATION 4.18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 323 Participants | 344 Participants | 667 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 275 Participants | 258 Participants | 533 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Language of test administration English | 339 Participants | 342 Participants | 681 Participants |
| Language of test administration Spanish | 260 Participants | 260 Participants | 520 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 13 Participants | 10 Participants | 23 Participants |
| Race (NIH/OMB) Black or African American | 305 Participants | 280 Participants | 585 Participants |
| Race (NIH/OMB) More than one race | 33 Participants | 28 Participants | 61 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 183 Participants | 220 Participants | 403 Participants |
| Race (NIH/OMB) White | 59 Participants | 59 Participants | 118 Participants |
| Region of Enrollment United States | 599 participants | 602 participants | 1201 participants |
| Sex: Female, Male Female | 431 Participants | 434 Participants | 865 Participants |
| Sex: Female, Male Male | 168 Participants | 168 Participants | 336 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 599 | 0 / 602 |
| other Total, other adverse events | 0 / 599 | 0 / 602 |
| serious Total, serious adverse events | 0 / 599 | 0 / 602 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5-Cog | 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. | 111 Participants |
| Health Literacy & Grip Assessment | 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. | 41 Participants |
Comparison: The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in dementia care outcomes between the intervention and control groups at 90 days post screening visit. Models are adjusted for age, sex, and years of education.95% CI: [2.32, 5.07]
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 5-Cog | New Occurrence of in Health Care Utilization | 106 Participants |
| Health Literacy & Grip Assessment | New Occurrence of in Health Care Utilization | 96 Participants |
Comparison: The estimate of odds ratio, its 95% confidence interval and p-value are obtained from logistic regression models which were used to examine the difference in participants who were hospitalized or visited an ER 6 months post screening visit.95% CI: [0.837, 1.534]
Other Pre-specified
Change in Health Care Utilization
Utilization is defined in terms of specialty visits, emergency room visits, and hospitalizations following the screening visit.
Time frame: 12 months after the participant is randomized
Other Pre-specified
Cost-effectiveness
Medicare payments for health care utilization will be valued. Costs will be divided into fixed and variable costs and by the screening and follow-up phases. Total costs will be estimated for health care utilization and reimbursement data captured by the EMR.
Time frame: 6 months after the participant is randomized
Other Pre-specified
Cost-effectiveness
Medicare payments for health care utilization will be valued. Costs will be divided into fixed and variable costs and by the screening and follow-up phases. Total costs will be estimated for health care utilization and reimbursement data captured by the EMR.
Time frame: 12 months after the participant is randomized