Caregivers' Reactions and Experience: Imaging Dementia - Evidence for Amyloid Scanning (CARE IDEAS)

September 23, 2016

Courtney Van Houtven (General Internal Medicine) and Duke-Margolis founding faculty member Don Taylor are partnering with Vincent Mor at Brown University to gather preliminary information on how diagnostic imaging in dementia affects caregiver experiences.

Alzheimer’s disease (AD) is the most prevalent cause of dementia, accounting for an estimated 60 to 80 percent of dementia cases. An estimated 5.3 million Americans had AD in 2015. This number will inexorably increase as baby boomers age and mortality reductions in advanced old age continue. Barring scientific innovations, the number of Americans with AD is expected to increase to over 7 million by 2025 and to 13.8 million by 2050. AD is a slowly progressive brain disease that begins with a clinically silent phase despite evidence of brain pathology. Next is a prodromal phase with mild cognitive symptoms (often labeled mild cognitive impairment -- MCI) but relatively unimpaired functional activity, and the final phase is significant clinical and functional impairment that progresses with increasing neuropathology. Researchers and advocates believe that early detection is critical to preventing, slowing, and arresting AD, particularly as effective treatments become available. However, to date, there has not been a validated AD biomarker diagnostic test that is reimbursed by the Centers for Medicare and Medicaid Services (CMS), making accurate early diagnosis difficult.

In 2013, the Centers for Medicare and Medicaid Services (CMS) established that amyloid PET scans would be covered under the CMS Coverage with Evidence policy, and the Imaging Dementia – Evidence for Amyloid Scanning (IDEAS) study was established. IDEAS is led by the Alzheimer’s Association and managed by the American College of Radiology Imaging Network (ACRIN). It represents a unique opportunity to integrate basic clinical science questions with social and behavioral science data on how patients and their care partners make decisions about, and cope with, the onset and progression of AD. The purpose of IDEAS is to examine how amyloid PET scans guide doctors in diagnosing MCI, AD, and other dementias early in disease progression, where the cause is ambiguous, thereby leading to significant changes in patient management. The recruitment of 18,488 Medicare beneficiaries began in March of 2016 in 159 recruitment centers across the country. As of June 2016, IDEAS is recruiting over 700 patients a month. Current recruitment and consenting processes ask patients whether they would be willing to be contacted about participating in supplemental studies that expand upon the rich clinical imaging and medical report data that are being collected under the main IDEAS study. Some 88% of patients recruited into IDEAS over the first several months have agreed to consider participating in supplemental studies. 

This proposed CARE IDEAS project has been approved by the IDEAS Executive Committee as an official “supplemental study” that will enhance and complement the core study by recruiting and interviewing 3500 patients and their care partners, such as spouses, children, or other family members supporting the patients as they traverse the diagnosis and treatment process. Ultimately, interview responses will be linked to PET scan results, clinical reports, and comprehensive Medicare Part A, B and D claims data about IDEAS patients and their care partners.  The purpose of the current study is to:

  1. Design telephone interviews to be administered to Medicare beneficiaries and their care partners, covering topics ranging from demographics, history of seeking diagnostic information about the source of their symptoms of dementia, health care decision making, advanced care planning, and health care preferences;
  2. Recruit 3500 patients, including oversampling minority patients, enrolled in the IDEAS study along with their care partners (spouses, children or others knowledgeable about the patient’s treatment) to participate in telephone interviews (7000 participants total);
  3. Obtain consent to access longitudinal Medicare health insurance claims information as well as other relevant financial data from CARE IDEAS study patients and their care partners who are eligible for Medicare;
  4. Create complete data files of patient and care partner interview responses in a form amenable for analysis.

The study offers a unique way of understanding the value patients and their care partners place on knowing their diagnosis and whether a definitive diagnosis alters patients’ and care partners’ pursuit of additional diagnostic “certainty”.  The ability of the CARE IDEAS study to build off of the IDEAS study, with its rich clinical and technological brain scan data, makes this unique opportunity to link psycho-social information with detailed clinical diagnostic information possible.

The study is funded by NIH grant 1 R56 AG05393401.