Controlling And Stopping Cascades leading to Adverse Drug Effects Study in Alzheimer's Disease (CASCADES-AD)

项目摘要/摘要 当医疗保健提供者将一种药物的副作用误解为一种新的药物时，就会发生开处方的级联反应 并开出第二种可能不必要的药物疗法来解决副作用。 开出连锁药方是“发病率倍增因素”，增加了整体症状负担，并对 与健康相关的生活质量和功能。阿尔茨海默病患者患阿尔茨海默病的风险增加 由于高水平的多发病和多药制而导致的级联开药，以及挑战和 复杂的护理通常以不以患者/照顾者为中心的方式提供。控制和控制 在阿尔茨海默病中停止级联反应导致药物不良反应的研究(CASCADS-AD)将是一项 利用美国国立卫生研究院合作实验室的分布测试基于健康计划的干预措施的大型务实试验 研究网络，它使用食品和药物管理局(FDA)哨兵倡议的基础设施。我们的 总体目标是制定、实施和评估以患者/照顾者为中心的 医疗保健提供者对预防和逆转临床有效、高优先级的教育干预 在阿尔茨海默病和相关痴呆(ADRD)患者中开出级联处方。我们的研究 假设是关于在患者/照顾者和他们的提供者中开出级联处方的教育可以 提高ADRD患者的用药安全性，降低用药相关发病率。我们的研究 人口将达到22,500人，其中将包括根据药物使用情况确定的ADRD患者 阿尔茨海默病(例如，前一年的胆碱酯酶抑制剂)，其特征是 多药联用(定义为针对不同药剂的有效处方)。我们将评估这些措施的效果 患者/护理者和提供者的教育干预(与通常的护理相比)预防或逆转 开出连锁药方，这将是主要结果。该试验将以健康计划为基础，在 两个大型的国家健康计划。研究设计将采用前瞻性、随机性、可比性 三个方面的有效性干预试验：(1)患者/照顾者和提供者相结合的教育 干预；(2)仅提供教育干预；以及(3)常规护理。我们研究的具体目标是什么 是：(1)开发以患者/照顾者为中心的教育干预，提供给患者/照顾者 和提供者，目标是ADRD患者的处方级联；(2)评估 预防和逆转ADRD患者高优先级处方级联的干预；(3) 评估干预措施的可接受性、适当性和可行性，纳入以下观点 患者、护理者、提供者和健康计划领导者；以及(4)创建传播研究的计划 向可能实施干预或就其未来使用做出决定的利益相关者提供调查结果。这个 拟议的研究是可行的，因为我们的合作伙伴包括两个大型的国家健康计划，我们将利用 现有的FDA哨兵基础设施，我们拥有一支强大的多学科研究团队。

PROJECT SUMMARY/ABSTRACT Prescribing cascades occur when a healthcare provider misinterprets the side effect of a drug as a new medical condition and prescribes a second, potentially unnecessary drug therapy to address the side effect. Prescribing cascades are “morbidity multipliers,” increasing overall symptom burden, and adversely affecting health-related quality of life and function. Patients with Alzheimer's disease are at an increased risk for prescribing cascades due to high levels of multimorbidity and polypharmacy, and the challenges and complexities of care often delivered in a manner that is not patient/caregiver-centric. The Controlling And Stopping Cascades leading to Adverse Drug Effects Study in Alzheimer's Disease (CASCADES-AD) will be a large, pragmatic trial to 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. Our overarching goal is to develop, implement, and evaluate the effect of a patient/caregiver-centered and healthcare provider educational intervention on the prevention and reversal of clinically impactful, high-priority prescribing cascades among patients with Alzheimer's disease and related dementia (ADRD). Our research hypothesis is that education on prescribing cascades among patients/caregivers and their providers can improve medication safety and reduce medication-related morbidity in patients with ADRD. Our study population, which will number 22,500, will include ADRD patients identified based on use of a medication for Alzheimer's Disease (e.g., a cholinesterase inhibitor within the prior year) who are characterized as having polypharmacy (defined as >5 active prescriptions for different agents). We will evaluate the effect of patient/caregiver and provider educational interventions (versus usual care) on the prevention or reversal of a prescribing cascade, which will serve as the primary outcome. The trial will be health plan-based, conducted in two large, national health plans. The study design will be a prospective, 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. The specific aims for our study are: (1) to develop a patient/caregiver-centered educational intervention, to be delivered to patients/caregivers and providers, targeting prescribing cascades among patients with ADRD; (2) to assess the impact of the intervention on the prevention and reversal of high-priority prescribing cascades among ADRD patients; (3) to evaluate the acceptability, appropriateness, and feasibility of the intervention, incorporating the perspectives of patients, caregivers, providers, and health plan leaders; and (4) 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.