5-Cog 2.0: A Pragmatic Clinical Trial

Albert Einstein College of Medicine

Status: Enrolling

Conditions: Cognitive Impairment; Dementia

Treatments: Other: Enhanced usual care; Other: 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05515224

2022-14144

2U01NS105565-07 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Cognitive impairment related to dementia is frequently under-diagnosed in primary care settings despite the increasing rates of patient cognitive complaints and the availability of numerous cognitive assessment tools. Missed detection delays treatment of reversible conditions as well as provision of support services and critical planning. This problem is more prevalent among older African-Americans and Hispanics than older whites, and more common in rural than urban 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 are conducting a simple randomized clinical trial to examine the clinical efficacy of the 5-Cog paradigm (5-Cog brief cognitive assessment paired with a clinical decision-making tool) to improve dementia care in 1,200 predominantly minority sample of older adults with cognitive concerns presenting to a primary care clinic in the Bronx. Interim analysis revealed that the 5-Cog paradigm resulted in an over 8-fold increase in new cognitive impairment diagnoses and over 3-fold increase in improved dementia care actions by primary care physicians compared to an active control arm. Following up on these very promising results, 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 aim of the pragmatic cluster-randomized trial is to test the clinical effectiveness of the 5-Cog paradigm in increasing cognitive impairment detection and improving dementia care - ascertained via electronic medical record. Randomization will be at the clinic level, and select 22 primary care practices; 6 in Bronx and 18 in urban and rural Indiana. 300 participants per practice will be enrolled for a total of 6,600 older patients with cognitive concerns. Results will also be examined in NIH designated health disparity populations including underserved minority and socio-economically challenged populations.

Outcomes are new cognitive impairment diagnoses (primary) and improved dementia care (secondary) in the 90-day period following presentation of cognitive concern to the primary care physician.

New cognitive impairment diagnoses (primary): New diagnosis of dementia or Mild Cognitive Impairment by primary care physicians. For patients with a previous diagnosis of Mild Cognitive Impairment in electronic medical record, only a new diagnosis of dementia will be considered as an incident outcome. Improved dementia care (secondary): Any of the following: 1. Tests ordered for reversible causes of cognitive impairment as per published guidelines. 2. New cognitive enhancing medication prescriptions or deprescribing anti-cholinergic. 3. Referral for cognitive/dementia evaluation by specialists (Neurology, Geriatrics, Psychiatry). 4. Referral to social worker or community-based organizations.

Implementation issues and cost-effectiveness of the 5-Cog paradigm will also be examined.

This proposed study focuses on scalable approaches to address the unmet need of early detection of incident cognitive impairment, including in populations that experience health disparities.

Enrollment: 6,600 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 65 years and older
2. Presence of cognitive concerns

Exclusion criteria

1. Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians).
2. Permanent nursing facility residents.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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6,600 participants in 2 patient groups

5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)

Experimental group

Description:

A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. If cognitive concerns are endorsed the 5-Cog battery will be conducted. The simple, <5-minute cognitive assessment will reliably identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation. Depending on whether the 5-Cog results are normal or abnormal on any one of the 3 tests, appropriate clinical decision support tools are provided to the primary care physicians in electronic medical record. The primary care physicians are not instructed to follow 5-Cog suggestions verbatim but use their clinical judgment.

Treatment:

Other: 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)

Enhanced usual care

Active Comparator group

Description:

Educational sessions for primary care physicians and clinic staff regarding cognitive detection and medical billing will be conducted. A cognitive concern screening will be conducted with patients aged 65 and older prior to their appointment with their primary care physician. The results will be provided to primary care physicians.

Treatment:

Other: Enhanced usual care