The Indiana University Cognitive Health Outcomes Investigation of the Comparative Effectiveness of dementia screening (CHOICE) study: study protocol for a randomized controlled trial

BACKGROUND: Dementia affects over 4 million people in the US and is frequently unrecognized and underdiagnosed in primary care. Routine dementia screening in primary care is not recommended by the US Preventive Services Task Force due to lack of empirical data on the benefits and harms of screening. This trial seeks to fill this gap and contribute information about the benefits, harms, and costs of routine screening for dementia in primary care. METHODS/DESIGN: Single-blinded, parallel, randomized controlled clinical trial with 1:1 allocation. A total of 4,000 individuals aged ≥65 years without a diagnosis of dementia, cognitive impairment, or serious mental illness receiving care at primary care practices within two cities in Indiana. Subjects will be randomized to either i) screening for dementia using the Memory Impairment Screen Telephone version or ii) no screening for dementia. Subjects who screen positive for dementia will be referred to the local Aging Brain Care program that delivers an evidence-based collaborative care model for dementia and depression. Research assistants will administer the 15-item Health Utility Index, Patient Health Questionnaire, Generalized Anxiety Disorder Scale, and Medical Outcomes Study at baseline, 1, 6, and 12 months. Information about advanced care planning will be collected at baseline and 12 months. All enrollees’ medical records will be reviewed to collect data on health care utilization and costs. DISCUSSION: We have two primary hypotheses; first, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will have a higher health-related quality of life as measured by the Health Utility Index at 12 months post-screening. Second, in comparison to non-screened subjects, those who are screened and referred to a dementia collaborative care program will not have higher depression or anxiety at one month post-screening as measured by the Patient Health Questionnaire and Generalized Anxiety Disorder Scale scales. Our secondary hypothesis is that screened subjects will have an Incremental Cost-Effectiveness Ratio below the maximum acceptable threshold of $60,000 per quality adjusted life year saved at 12 months. TRIAL REGISTRATION: Ongoing; registered on September 19, 2012. ClinicalTrials.gov Identifier: 2012 NCT01699503.