5-Cog 2.0: A Pragmatic Clinical Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorAlbert Einstein College of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
65 years and older
Presence of cognitive concerns
English or Spanish speaking.
Able to see and hear well enough to complete assessments.
Disqualifiers
Prior diagnosis of dementia (documented in the electronic medical record or reported by physicians).
Permanent nursing facility residents.
Trial design
Design model
Parallel
Treatments tested in this trial
5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)
Other interventionA 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 5-Cog battery includes the Picture Memory Impairment Screen, Motoric Cognitive Risk Syndrome diagnosis, and Symbol Match. The simple, \<5-minute cognitive assessment will reliably identify older persons with cognitive impairment in primary care settings, and flag them for further evaluation.
Enhanced usual care
Other interventionA 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 groups
6,600 Participants
are divided into 2 treatment groupsGroup A: 5-Cog Paradigm (5-Cog battery coupled with clinical decision tool)Experimental treatment 1 intervention
Group B: Enhanced usual careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
New cognitive impairment diagnoses in the 90-day period following presentation of cognitive concern to the primary care physician (PCP).
The clinical effectiveness of the 5-Cog paradigm on new cognitive impairment detection will be examined by comparing the proportion of 'new Mild Cognitive Impairment (MCI) and dementia diagnoses' over 90-days in the 5-cog paradigm and the enhanced usual care group using generalized linear mixed effects models. For patients with a previous diagnosis of MCI in the electronic medical record, only a new diagnosis of dementia will be considered as an incident outcome.
Time frame
Up to 90 daysSecondary outcomes
1
Improved dementia care in the 90-day period following presentation of cognitive concern to the primary care provider (PCP).
The clinical effectiveness of the 5-Cog paradigm on improved dementia care will be examined by comparing the proportion of documentation of improved dementia care in the 5-cog paradigm and the enhanced usual care group using generalized linear mixed effects models. Improved dementia care is defined as 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.
Time frame
Up to 90 daysSponsors and contacts
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Albert Einstein College of Medicine
Lead sponsor
Indiana University
Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Northwestern University
Collaborator
Stony Brook University
Collaborator
Source ClinicalTrials.gov