In response to a strategic call from the National Institute on Aging (NIA) for low-cost cognitive screening methods, an interdisciplinary team of Cleveland Clinic researchers is embarking on a research project to develop a simple, time-efficient screening program for use in primary care settings. The researchers —from the health system’s Neurological Institute and Lerner Research Institute along with Cleveland Clinic Community Care — just received a $2.6 million grant from the NIA in support of the project.
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An unmet need
“Clinicians are facing an aging population, and with that comes an increased incidence of dementia,” says neuropsychologist Darlene Floden, PhD, who led the effort to obtain the grant. “Yet there is no feasible way to screen this population on a large scale. While tests like the Montreal Cognitive Assessment (MoCA) and the Mini-Cog are the current standard for screening, they take time and skill for a clinician to administer, and there often isn’t enough time for them in a typical appointment. Additionally, considerable user error has been documented with paper-and-pencil tests, as up to one-third of such tests are administered or scored incorrectly.”
Dr. Floden adds that primary care physicians may not be sure who to screen for cognitive deficits. “If a patient or family member complains of a cognitive issue or a physician detects one during a visit, a screening test is clearly worth doing,” she says. “But most patients won’t bring up the subject themselves, and it’s not always easy for a physician to discern cognitive issues during a routine visit.”
Moreover, many primary care physicians feel there aren’t many treatment options if cognitive decline is identified. “A few available medications might be helpful, depending on the etiology, but there’s not much that can be done for many causes of cognitive decline,” Dr. Floden observes.
She reports that her team’s research project will roll out over five years and involve two phases:
- Phase one will last two years and focus on developing and validating two low-cost, low-effort tools for screening.
- Phase two will last three years and consist of a phase IV pragmatic implementation trial of the tools.
First phase: Validation of two screening tools
In the first phase, the researchers will focus on developing and validating a risk calculator that estimates patients’ likelihood of experiencing cognitive declines over the next five years. “We’re developing this tool with Michael Kattan, PhD, Chair of the Department of Quantitative Health Sciences in our Lerner Research Institute, who is a risk prediction expert,” Dr. Floden explains. The tool uses information from the medical record, such as health status indicators, demographics and socioeconomic status, to predict who is at high risk for developing cognitive deficits.
The team also will test the longitudinal utility of the Brief Assessment of Cognitive Health (BACH), a patient-administered tool that Dr. Floden developed with Robyn Busch, PhD. “The BACH is completely automated with auditory instructions and can be completed in the waiting room,” says Dr. Floden. “It requires no time or special expertise on the part of the physician.”
It takes about 15 minutes to complete the BACH, which consists of a complex memory test, a formal depression screen and a medical history form. Unlike the MoCA, the BACH also screens for several reversible causes of cognitive decline that offer avenues for treatment — depression, sleep disruption and stress — in addition to detecting cognitive problems. Moreover, the BACH is incorporated into the Epic electronic medical record platform used by Cleveland Clinic, so its results are automatically recorded in patients’ medical records for providers to act upon.
“We will be comparing the BACH to the MoCA and to formal neuropsychological testing, and we expect that BACH will be more sensitive to cognitive change over time than the MoCA,” Dr. Floden observes.
Second phase: Implementation trial
For the project’s last three years, an implementation trial will be conducted to gauge the uptake and utility of the risk calculator and BACH in six primary care practices affiliated with Cleveland Clinic. “The approach will be modified during the course of this trial as we learn how these tools change physician behavior and patient treatment,” Dr. Floden says. “We will learn what works and what doesn’t and adapt as we go.”
Findings will be rolled out over the course of the five years of the trial. In addition, Drs. Floden and Busch plan to soon launch a web-based version of the BACH that people can complete at home. “Ultimately, if these tools are validated and physicians find them useful, we hope to offer them to other large medical systems, insurers and others,” Dr. Floden says.
A team effort
“It takes a lot of people to design these types of practical interventions, and it requires the perspectives of diverse providers who deal with these concerns in their practices,” Dr. Floden says. In addition to Drs. Busch and Kattan, she acknowledges the following Cleveland Clinic collaborators on the project:
- Robert Fox, MD, Vice Chair for Research in the Neurological Institute
- Kamini Krishnan, PhD, a neuropsychologist in the Lou Ruvo Center for Brain Health
- Anita Misra-Hebert, MD, Director of the Healthcare Delivery and Implementation Science Center
- Elizabeth Pfoh, PhD, and Michael Rothberg, MD, MPH, of the Center for Value-Based Care Research
- Saket Saxena, MD, of the Center for Geriatric Medicine