Abstract
BackgroundAlzheimer’s disease and related dementias (ADRD) impact a woman’s life expectancy and her ability to participate in medical decision-making about breast cancer screening, necessitating the involvement of family caregivers. Making decisions about mammography screening for women with ADRD is stressful. There are no data that suggest that breast cancer screening helps women with ADRD live longer or better. Decision aids may improve the quality of decision-making about mammography for ADRD patients and may inform family caregivers about the risks, benefits, and need for decision-making around mammography screening.Methods/designThe Decisions about Cancer Screening in Alzheimer’s Disease (DECAD) trial, a randomized controlled clinical trial, will enroll 426 dyads of older women with ADRD (≥75 years) and a family caregiver from clinics and primary-care practices in Indiana to test a novel, evidence-based decision aid. This decision aid includes information about the impact of ADRD on life expectancy, the benefit of mammograms, and the impact on the quality of life for older women with ADRD. Dyads will be randomized to receive the decision aid or active control information about home safety. This trial will examine the effect on the caregiver’s decisional conflict (primary outcome) and the caregiver’s decision-making self-efficacy (secondary outcome). A second follow-up at 15 months will include a brief, semi-structured interview with the caregiver regarding the patient’s experience with mammograms and decision-making about mammograms. At the same time, a review of the patient’s electronic medical record (EMR) will look at discussions about mammography with their primary-care physician and mammogram orders, receipt, results, and burden (e.g., additional diagnostic procedures due to false-positive results, identification of an abnormality on the screening exam but further work-up declined, and identification of a clinically unimportant cancer). A third follow-up at 24 months will extract EMR data on mammogram orders, occurrences, results, and the burden of mammograms.DiscussionWe hypothesize that caregivers who receive the decision aid will have lower levels of decisional conflict and higher levels of decision-making self-efficacy compared to the control group. We also hypothesize that the DECAD decision aid will reduce mammography use among older women with ADRD.Trial registrationClinical Trials Register, NCT03282097. Registered on 13 September 2017.
Highlights
Alzheimer’s disease and related dementias (ADRD) impact a woman’s life expectancy and her ability to participate in medical decision-making about breast cancer screening, necessitating the involvement of family caregivers
We hypothesize that the Decisions about Cancer Screening in Alzheimer’s Disease (DECAD) decision aid will reduce mammography use among older women with ADRD
We hypothesize that the DECAD decision aid will reduce mammography use among older women with ADRD within the follow-up period of 24 months
Summary
The benefits and harms of mammograms for older women are not known, as no randomized controlled trial has included women with ADRD who are ≥75 years [23, 37, 71]. The DECAD study is the only randomized controlled trial of a decision aid to support ADRD caregivers in deciding on cancer screening, which is a common decision in primary care. If the DECAD trial is successful, the results may inform the development of other decision aids for ADRD caregivers in primary-care settings, addressing other cancer screening tests, such as a colonoscopy, or other treatments of questionable value for patients with ADRD. The results from this study will inform other interventions that support ADRD caregivers’ decision-making around other types of medical care and treatment and that are tailored to match the ADRD patient’s life expectancy and goals of care Trial status This protocol was registered in ClinicalTrial.gov under identifier NCT03282097 on 13 September 2017 and the last update was made on 21 November 2017. Author details 1Indiana University School of Medicine, 1101 West 10th Street, Indianapolis, IN 46202, USA. 2Division of General Internal Medicine and Geriatrics, 1101 West 10th Street, Indianapolis, IN 46202, USA. 3Regenstrief Institute, Indiana University Center for Aging Research, 1101 West 10th Street, Indianapolis, IN 46202, USA. 4Sandra Eskenazi Center for Brain Care Innovation, 1101 West 10th Street, Indianapolis, IN 46202, USA. 5Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA 02215, USA. 6Center for Bioethics, 1101 West 10th Street, Indianapolis, IN 46202, USA. 7Department of Biostatistics, 410 W. 10th Street, Suite 3000, Indianapolis, IN 46202, USA
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