JMIR Publications

ABSTRACT

Background:

The 5-Cog paradigm is a five-minute brief cognitive assessment coupled with a clinical decision support tool to improve clinicians’ early detection of cognitive impairment including dementia among their diverse older primary care patients [1,2]. The 5-Cog battery uses picture- and symbol-based assessments plus a questionnaire. It is low-cost; simple (can be successfully administered with minimal training); minimizes literacy bias (avoids heavily language-based tests); and is culturally fair. The decision support component of the paradigm helps nudge appropriate provider response to an abnormal 5-Cog battery [1,2].

Objective:

We propose to evaluate the effectiveness, implementation, and cost of the 5-Cog paradigm.

Methods:

We will enroll 6600 older patients with cognitive concerns from 22 primary care clinics in the Bronx, New York, and multiple rural and suburban locations in Indiana for this Type 1 Hybrid Implementation-Effectiveness Trial [3]. We will analyze effectiveness of the 5-Cog paradigm to increase the rate of new diagnoses of mild cognitive impairment syndrome (MCI) or dementia using a pragmatic, cluster-randomized clinical trial design. The secondary outcome is ordering of new tests, treatments, and referrals for cognitive indications within 90 days of the study visit. The 5-Cog’s decision support component will be deployed as an integrated electronic medical record (EMR) feature. We will analyze the 5-Cog’s implementation process, context, and outcomes through the Consolidated Framework for Implementation Research (CFIR) [4] using a mixed methods design (surveys and interviews). The study will also examine cost effectiveness from societal and payer (Medicare) perspectives by estimating cost per additional dementia diagnosis.

Results:

The study was funded by the National Institutes of Health (2U01NS105565) and the protocol was approved by the Institutional Review Board in September 2022, and enrollment was authorized by the Data Safety Monitoring Board (DSMB) in July 2023. A validation study was completed to select cut-scores for the 5-Cog battery. By October 2023, all 22 clinics were randomized. As of May 2024, seven clinics have completed onboarding processes, and 935 patients have been enrolled.

Conclusions:

Results of this study will facilitate rapid adaptation and dissemination of this effective, practical clinical tool across a diversity of primary care clinical settings. Clinical Trial: ClinicalTrials.gov NCT05515224