Over 11 million Americans who are ?65 years have Diabetes (DM), a prototypic chronic disease requiring self- management. Up to 30% of older adults have co-occurring DM and Alzheimer's disease and related dementia (ADRD) and older people with DM may have as much as a two-fold risk of developing ADRD. Caregivers of patients with co-occurring DM-ADRD have many unmet needs, adversely affecting caregivers' ability to manage these conditions. Moreover, a lack evidence for what constitutes optimal DM management for these patients, particularly those of more advanced age (? 75 years), further compounds the challenge of managing this chronic and often comorbid disease from both the patient and medical provider perspective. With a lack of decisional guidance, primary care providers are currently ill equipped to direct care to achieve best outcomes. The goal of this research is to develop and test a quality improvement program for older patients with DM- ADRD, using a pragmatic randomized controlled trial (RCT) and mixed methods in a large, diverse healthcare system. This will feature consensus decisional guidance for the medical management of DM-ADRD patients, PCP workflow enhancements including use of a panel manager and the electronic health record (EHR) for decision support/feedback, and PCP collaborative learning. To conduct this study, ?Enhanced Quality In Primary care for Elders with Diabetes-ADRD? (EQUIPED-ADRD), we will use the R21/R33 mechanism. The R21 in the first year will develop key resources needed for the pragmatic trial, such as provider decisional guidance based on current evidence, trial design and evaluation methodology, appropriate healthcare system administrative / EHR support, and will test intervention feasibility. The R33 will implement the larger pragmatic trial in a large healthcare system through cluster randomization of the 12 largest primary care practice sites with ~60 providers and over 600 patients with diagnosed DM and ADRD. It will test hypotheses about whether care based on explicit standards for DM medical management for people with ADRD will: H1) Improve patient symptoms and quality of life while maintaining expected clinical outcomes; H2) decrease patient and caregiver management burden and improve care quality based on patient/caregiver preferences; H3) (secondary) decrease specialty, ED and hospital utilization. We will gather data from the EHR, Medicare and Medicaid insurance claims, caregiver surveys and qualitative interviews, and clinician interviews. If this clinical trial demonstrates that patients and family caregivers who receive this enhanced care quality program achieve established goals for diabetic care in addition to fewer dementia-related symptoms, less caregiver burden and stress, and fewer DM-related adverse events, potentially avoidable and costly utilization may also decrease. This best practice approach could then be widely disseminated to other clinical practices.
Dementia is a common problem for older patients with diabetes and for their caregivers (family and friends), who often lack the support and understanding to manage the myriad of problems that may be related to medical management of this chronic condition. The Enhancing Quality in Primary care for Elders with Diabetes and Dementia (EQUIPED-ADRD) study will use a one-year developmental phase to engage primary care providers to develop guidelines based on current evidence, and to use research data experts to develop logistical support for a quality improvement intervention in primary care. Then a 4-year pragmatic randomized controlled trial in 12 primary care clinics will evaluate whether guidelines and a quality improvement program featuring panel managers in intervention clinics will improve patient symptoms and quality of life, decrease patient and caregiver management burden and improve care quality based on patient/caregiver preferences, while decreasing acute care utilization.
