Abstract
BackgroundMultiple national expert panels have identified early detection of Alzheimer’s disease and related dementias (ADRD) as a national priority. However, the United States Preventive Services Task Force (USPSTF) does not currently support screening for ADRD in primary care given that the risks and benefits are unknown. The USPSTF stresses the need for research examining the impact of ADRD screening on family caregiver outcomes.MethodsThe Caregiver Outcomes of Alzheimer’s Disease Screening (COADS) is a randomized controlled trial that will examine the potential benefits or harms of ADRD screening on family caregivers. It will also compare the effectiveness of two strategies for diagnostic evaluation and management after ADRD screening. COADS will enroll 1800 dyads who will be randomized into three groups (n = 600/group): the ‘Screening Only’ group will receive ADRD screening at baseline and disclosure of the screening results, with positive-screen participants receiving a list of local resources for diagnostic follow-up; the ‘Screening Plus’ group will receive ADRD screening at baseline coupled with disclosure of the screening results, with positive-screen participants referred to a dementia collaborative care program for diagnostic evaluation and potential care; and the control group will receive no screening. The COADS trial will measure the quality of life of the family member (the primary outcome) and family member mood, anxiety, preparedness and self-efficacy (the secondary outcomes) at baseline and at 6, 12, 18 and 24 months. Additionally, the trial will examine the congruence of depressive and anxiety symptoms between older adults and family members at 6, 12, 18 and 24 months and compare the effectiveness of two strategies for diagnostic evaluation and management after ADRD screening between the two groups randomized to screening (Screening Only versus Screening Plus).DiscussionWe hypothesize that caregivers in the screening arms will express higher levels of health-related quality of life, lower depressive and anxiety symptoms, and better preparation for caregiving with higher self-efficacy at 24 months. Results from this study will directly inform the National Plan to Address Alzheimer’s Disease, the USPSTF and other organizations regarding ADRD screening and early detection policies.Trial registrationClinicalTrials.gov, NCT03300180. Registered on 3 October.
Highlights
There are currently 5.4 million adults with Alzheimer’s disease and related dementias (ADRD) and 11 million informal caregivers in the USA [1], potentially rising to 13.8 and 27 million, respectively by 2050 [2, 3]
If the patient screens positive, the dyad will receive a list of local resources for follow-up diagnostic care and disclosure of positive screening results to the patient’s primary care physician; older adults in the second group will be screened for ADRD at baseline coupled with disclosure of the screening results and, if they screen positive, a referral to a dementia collaborative care program (the Aging Brain Care (ABC) Aging Brain Care Program (Program)) for diagnostic evaluation and subsequent care if ADRD is diagnosed
Discussion multiple national expert panels who represent a broad range of stakeholders, including the National Academy of Science, the National Plan to Address Alzheimer’s Disease, and the Affordable Care Act, through the Annual Wellness Visit (AWV), have identified early detection of ADRD as a national priority [12, 15], the United States Preventive Services Task Force (USPSTF) recommendations do not currently support screening for ADRD in primary care [12]
Summary
There are currently 5.4 million adults with Alzheimer’s disease and related dementias (ADRD) and 11 million informal caregivers in the USA [1], potentially rising to 13.8 and 27 million, respectively by 2050 [2, 3]. The National Academy of Science, the National Plan to Address Alzheimer’s Disease, and the Affordable Care Act (via the Medicare Annual Wellness Visit (AWV)) all identify earlier detection of ADRD as a core aim for improving the quality of care for older adults [13,14,15]. Of those patients with ADRD living in the community, 75% are cared for by family caregivers [16,17,18] and treated in primary care settings [19,20,21]. The USPSTF stresses the need for research examining the impact of ADRD screening on family caregiver outcomes
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