Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease Study (D-PRESCRIBE-AD)

点击翻译按钮获取中文摘要

PROJECT SUMMARY/ABSTRACT Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing is a “morbidity multiplier,” increasing overall symptom burden, and adversely affecting health-related quality of life and function. Inappropriate prescribing of certain drug categories such as sedative/hypnotics, antipsychotics, highly anticholinergic agents, and certain oral hypoglycemic medications poses particular risks for older adults, and may be more prevalent among those with Alzheimer’s disease and Alzheimer’s disease-related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and associated polypharmacy. The Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer’s Disease Study (D-PRESCRIBE- AD) will test a health plan-based intervention leveraging the NIH Collaboratory's Distributed Research Network, which uses the Food and Drug Administration (FDA) Sentinel Initiative infrastructure. The overarching goal of our proposal is to develop, implement, and evaluate the effect of a patient/caregiver-centered, multifaceted educational intervention on inappropriate prescribing in patients with AD/ADRD. Our research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and lead to an improvement in medication safety for this vulnerable population. Our study population will include community-dwelling patients with AD/ADRD, identified based on a diagnosis of AD/ADRD or use of a medication for Alzheimer’s Disease, who have evidence of inappropriate prescribing. We will evaluate the effect of educational interventions designed to stimulate patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be health plan-based, conducted in two large, national health plans. The study design will be a prospective, cluster randomized, comparative effectiveness intervention trial with three arms: (1) a combined patient/caregiver and provider educational intervention; (2) a provider only educational intervention; and (3) usual care. A one-year R61 planning phase will precede a four-year R33 implementation phase. During the R33 phase we will sequentially implement two separate pragmatic trials, each enrolling over 11,000 patients, adapting the second trial based on the findings and experience gained in the first. The R33 aims are: (1) to assess the impact of the patient/caregiver educational intervention on inappropriate prescribing to AD/ADRD patients, employing a prospective, cluster randomized trial design with three arms; and (2) to create a plan for disseminating study findings to stakeholders who might implement the intervention or make decisions about its future use. The proposed study is feasible because our partners include two large, national health plans, we will leverage an existing FDA Sentinel infrastructure, and we have a strong, multidisciplinary research team.