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

项目总结/摘要 处方级联发生时，医疗保健提供者误解了药物的副作用作为一个新的 医疗条件，并规定第二个，可能不必要的药物治疗，以解决副作用。 处方级联是“发病率倍增器”，增加了整体症状负担，并对 与健康相关的生活质量和功能。老年痴呆症患者的风险增加， 由于高水平的多药和多药，以及挑战和 护理的复杂性通常以非以患者/患者为中心的方式提供。控制和 停止级联导致阿尔茨海默病药物不良反应研究（CASCADES-AD）将是一项 一项大型、务实的试验，利用NIH合作实验室的分布式 研究网络，它使用食品和药物管理局（FDA）哨兵倡议基础设施。我们 总体目标是开发、实施和评估以患者/患者为中心的 医疗保健提供者对预防和逆转具有临床影响力的高优先级 阿尔茨海默病和相关痴呆症（ADRD）患者的处方级联。我们的研究 假设在患者/护理人员及其提供者之间进行关于处方级联的教育， 提高ADRD患者用药安全性，降低药物相关发病率。我们的研究 人口将达到22，500人，将包括根据药物使用确定的ADRD患者， 阿尔茨海默病（例如，胆碱酯酶抑制剂），其特征在于 多种药物（定义为不同药物的>5种有效处方）。我们将评估 患者/护理人员和提供者教育干预（与常规护理相比）， 处方级联，这将作为主要结局。该试验将基于健康计划， 两个大型的国家健康计划研究设计为前瞻性、随机、比较性 三组有效性干预试验：（1）患者/护理人员和提供者联合教育 干预;（2）仅提供教育干预;（3）常规护理。我们研究的具体目标 （1）制定以患者/护理人员为中心的教育干预措施，并将其提供给患者/护理人员 和供应商，针对ADRD患者的处方级联;（2）评估 干预ADRD患者中高优先级处方级联的预防和逆转;（3） 评估干预的可接受性、适当性和可行性，并结合以下观点： 患者、护理人员、提供者和健康计划负责人;（4）制定传播研究的计划 将调查结果提供给可能实施干预措施或决定其未来用途的利益攸关方。的 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卫生计划，我们将利用 我们有一个强大的、多学科的研究团队。

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.