Purpose:
The purpose of this funding opportunity announcement (FOA) is to invite pragmatic clinical trial applications to test paradigms designed to address the unmet need to detect cognitive impairment, including dementia, in large and diverse populations seen in primary care across the United States when a patient, relative, or care provider indicates concern. Applications must propose pragmatic clinical trials to test paradigms to detect cognitive impairment, including dementia, with adequate power in up to 3 populations including at least two specified populations that experience health disparities. Clinical paradigms proposed for pragmatic clinical trials should have rigorous supporting preliminary data and utilize tools that are simple to use, standardized, integrated into the electronic medical record (EMR) workflow, and ideally take five minutes or less to administer in a primary care clinical setting. Paradigms must provide standardized and implementable turnkey guidance via the EMR to the care provider for follow-up based on results of either “no objective cognitive impairment detected” or “cognitive impairment possible or detected”.
Background:
arly detection of incident cognitive impairment, including dementia, is a recognized healthcare priority in the United States and is a highest level priority among the ADRD Summit 2019 milestones in the National Plan to Address Alzheimer’s Disease. For example, detecting cognitive impairment is a required component of the Medicare Annual Wellness Visit. Assessment tools, as well as signs and symptoms of cognitive impairment and dementia, are made available by the NIA, the Department of Veterans Affairs, the Alzheimer’s Association and others. However, and despite the existence of cognitive assessment tools that are widely accessible, cognitive impairment, even when dementia is present, continues to be under-recognized and under-diagnosed in primary care and other everyday clinical settings. The likely result, when cognitive complaints and other warning signs are evident but not pursued in primary care, is increased disease burden due to delayed or obviated treatment including of reversible conditions, delayed recognition of iatrogenic causes such as anti-cholinergic agents and polypharmacy, delayed use of appropriate medical and support services, and forestalled critical planning. The purpose of this FOA is to invite pragmatic clinical trial applications to test paradigms, i.e. clinical methodologies, for detecting incident cognitive impairment, including dementia, when a patient, relative, or care provider indicates concern. The major goal of this program is to address this unmet need, including in populations that experience health disparities, by focusing on pragmatic applied approaches that not only are applicable to but also are appealing for uptake in everyday care settings for large and varied adult populations in the United States. This initiative addresses health equity by mandating that barriers specific to populations that experience heath disparities in the United States be identified and addressed. This is because there is evidence that missed detection of cognitive impairment, including dementia, is even more prevalent among older African Americans, Hispanics and other populations that experience health disparities than among older whites.
One reason for the under-detection of cognitive impairment, including dementia, in primary care is that the existing detection tools have not been tested and standardized into rapid, EMR-compatible, billing-compatible, and user-friendly paradigms that are suitable for primary care and other everyday clinical practice settings. Moreover, a challenge specific for health equity is the need for paradigms, including associated tools, that are appropriate for the population being assessed. For example, few paradigms have been designed around factors that impact health equity of detecting such as low literacy, or stigma associated with cognitive impairment including dementia diagnoses. Taken together, these and other factors represent a barrier to rigorously assessing and addressing the public health importance and impact of cognitive impairment, including dementia, in older adults.
RFA-NS-17-012, the predecessor to this funding announcement, began to address this applied research gap by establishing DetectCID. DetectCID was the first NIH-funded consortium specifically tasked with developing practical paradigms designed to detect cognitive impairment including dementia in primary care and, critically, to provide concrete turnkey guidance for follow-up. During the first funding period of awards under RFA-NS-17-012 funded projects performed this applied research, both individually and in collaboration, to develop and perform the initial validation of paradigms designed to address the unmet need to detect cognitive impairment, including dementia, in large & diverse U.S. populations seen in everyday clinical settings, including in health disparities populations, when a patient, relative, or care provider indicates concern. The clinical paradigms developed and studied utilize tools that are simple to use, standardized, ideally take < 5 minutes to administer in primary care, and provide turnkey follow-up recommendations. Consortium sites at different locations in the United States performed initial development of several paradigms, consistent with the significant challenge at hand, and with the reality of diverse needs across the country that vary across local settings. These paradigms underwent site-specific validation studies as well as cross-site feasibility studies. A critical next step for paradigms supported by sufficient preliminary data, both from DetectCID and also from other research programs, is the opportunity to perform optimally powered pragmatic clinical trials that further and rigorously test their suitability for everyday care settings.
This Funding Opportunity Announcement will support pragmatic clinical trials for testing paradigms for detecting cognitive impairment, including dementia, in primary care and other everyday care settings. This activity will include both testing in the general population as well as in at least two populations that experience health disparities.
Paradigms should use tools that are simple to implement in large populations, can be standardized and validated, and ideally take five minutes or less (but not longer than 10 minutes) to administer in a primary care clinical setting. Paradigms proposed must be supported by rigorous preliminary data that justifies proceeding to a pragmatic clinical trial.
As the overall goal of this initiative is to support the “real world” assessment of paradigms and tools used to detect cognitive impairment, a strategy for implementation into everyday clinical settings must be included as part of proposed paradigms, with assessment of implementation cost, identification of the areas that are challenging for implementation, and with implementation measures, such as for adoption, fidelity, penetration, and sustainability, considered. Trials may be conducted across single or multiple health care systems. Results from the pragmatic trials supported by this FOA should inform policymakers, payers, doctors and patients in the primary care setting. More information about the approach to and conduct of pragmatic trials conducted within real-life healthcare system settings may be found at, “The NIH Collaboratory: Living Textbook of Pragmatic Clinical Trials.” Projects funded under this FOA will participate in Consortium meetings that will ensure and continue collaborative learnings to facilitate successful implementation of these goals.
Key Dates:
URL for more information:
https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-22-009.html
Filed Under: Funding Opportunities