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

控制和阻止导致阿尔茨海默氏病药物不良反应的级联研究 (CASCADES-AD)

• 批准号: 9768599
• 负责人: JERRY H GURWITZ
• 金额: $ 81.67万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9768599
• 关键词: Address; Admission activity; Adverse drug effect; Adverse effects; Affect; Alzheimer' s Disease; Alzheimer' s disease risk; Anti-Cholinergics; Antihypertensive Agents; Antiparkinson Agents; Antipsychotic Agents; Calcium Channel Blockers; Caregivers; Caring; Cholinesterase Inhibitors; Clinical; Communication; Data; Decision Making; Dementia; Diagnostic Errors; Diuretics; Edema; Education; Educational Intervention; Elderly; Emergency department visit; Evaluation; Future; Goals; Gout; Health Personnel; Health system; Healthcare Systems; Hypertension; Interdisciplinary Study; Intervention; Intervention Trial; Medical; Morbidity - disease rate; Non-Steroidal Anti-Inflammatory Agents; Outpatients; Parkinsonian Disorders; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Play; Polypharmacy; Positioning Attribute; Prevalence; Prevention; Provider; Randomized; Research; Research Design; Research Infrastructure; Risk; Safety; Sentinel; Skilled Nursing Facilities; Symptoms; Testing; Thiazide Diuretics; United States Food and Drug Administration; United States National Institutes of Health; Urinary Incontinence; Visit; arm; base; collaboratory; comparative effectiveness; design; health care service utilization; health plan; health related quality of life; high risk; hospitalization rates; improved; mortality; multiple chronic conditions; pragmatic trial; primary outcome; prospective; randomized trial; secondary outcome; study population; success; treatment as usual; trial design

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.

项目概要/摘要 当医疗保健提供者将药物的副作用误解为新的副作用时，就会发生级联处方。 医疗状况，并开出第二种可能不必要的药物治疗来解决副作用。 级联处方是“发病率乘数”，增加了总体症状负担，并对健康产生不利影响 阿尔茨海默病患者的健康相关生活质量和功能的风险增加。 由于高水平的多重发病率和多重用药而导致的级联处方，以及挑战和 护理的复杂性通常以不以患者/护理人员为中心的方式提供。 停止导致阿尔茨海默氏病药物不良反应研究 (CASCADES-AD) 的级联将是一项 大型、务实的试验，旨在测试基于健康计划的干预措施，利用 NIH 合作实验室的分布式 研究网络，使用美国食品和药物管理局 (FDA) 哨兵计划基础设施。 总体目标是制定、实施和评估以患者/护理人员为中心和 医疗保健提供者对预防和逆转具有临床影响的高优先级疾病的教育干预 我们的研究对阿尔茨海默病和相关痴呆症 (ADRD) 患者进行级联治疗。 假设是，对患者/护理人员及其提供者进行处方级联教育可以 提高 ADRD 患者的用药安全性并降低药物相关发病率。 人口数量将达到 22,500 人，其中包括根据使用药物来确定的 ADRD 患者 阿尔茨海默氏病（例如，前一年内服用过胆碱酯酶抑制剂） 多药治疗（定义为> 5种不同药物的有效处方）。 患者/护理人员和提供者的教育干预措施（与常规护理相比），以预防或逆转疾病 处方级联，这将作为主要结果 该试验将以健康计划为基础，于 2019 年进行。 两项大型国家卫生计划将是前瞻性、随机、比较性的。 三组有效性干预试验：(1) 患者/护理人员和提供者教育相结合 干预；（2）仅提供者的教育干预；以及（3）我们研究的具体目标。 是： (1) 制定以患者/护理人员为中心的教育干预措施，交付给患者/护理人员 和提供者，针对 ADRD 患者的级联处方 (2) 评估该药物的影响； 对 ADRD 患者中优先级处方级联的预防和逆转进行干预 (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、护理人员、提供者和健康计划领导者；(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对其未来使用做出决定的利益相关者。 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 现有的 FDA Sentinel 基础设施，我们拥有强大的多学科研究团队。

项目成果

Prescribing cascades in persons with Alzheimer's disease: engaging patients, caregivers, and providers in a qualitative evaluation of print educational materials.

• DOI: 10.1177/2042098620968310
• 发表时间: 2020
• 期刊: Therapeutic advances in drug safety
• 影响因子: 4.4
• 作者: Bloomstone S;Anzuoni K;Cocoros N;Gurwitz JH;Haynes K;Nair VP;Platt R;Rochon PA;Singh S;Mazor KM
• 通讯作者: Mazor KM

Antidopaminergic-Antiparkinsonian Medication Prescribing Cascade in Persons with Alzheimer's Disease.

• DOI: 10.1111/jgs.17013
• 发表时间: 2021-05
• 期刊: Journal of the American Geriatrics Society
• 影响因子: 6.3
• 作者: Singh S;Cocoros NM;Haynes K;Nair VP;Harkins TP;Rochon PA;Platt R;Dashevsky I;Reynolds J;Mazor KM;Bloomstone S;Anzuoni K;Crawford SL;Gurwitz JH
• 通讯作者: Gurwitz JH