Reducing Risk of Dementia through De-prescribing (R2D2)

通过取消处方降低痴呆症风险 (R2D2)

基本信息

批准号：
10392349
负责人：
Noll L. Campbell
金额：
$ 64.27万
依托单位：
PURDUE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-05-01 至 2024-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10392349
关键词：
Acute Adverse event Age Alzheimer&apos s Disease Alzheimer&apos s disease related dementia Alzheimer&apos s disease risk American Anti-Cholinergics Anxiety Awareness Brain Caring Cessation of life Characteristics Cholinergic Receptors Clinical Cluster randomized trial Cognition Cognitive Complement Delirium Dementia Disease Educational Intervention Elderly Enrollment Epidemiology Exposure to Gender Genetic Geriatrics Health Health Care Costs Healthcare Systems Hospitalization Human Impaired cognition Information Systems Institute of Medicine (U.S.)Intervention Measurement Measures Memory Mental Depression Modeling Monitor Morbidity - disease rate Multi-Institutional Clinical Trial Outcome Pain Participant Pathology Patient Care Patient Monitoring Patient Outcomes Assessments Patient Self-Report Pharmaceutical Preparations Pharmacists Physicians Population Prevalence Primary Health Care Protocols documentation Quality of life Race Randomized Randomized Controlled Trials Risk Safety Screening procedure Severity of illness Sleeplessness Societies Target Populations Testing Time United States Centers for Medicare and Medicaid Services United States National Institutes of Health Work aging population apolipoprotein E-4 base care costs cognitive testing comorbidity dementia risk design disability executive function experience follow-up group intervention health care service utilization health record high risk improved indexing information processing medical specialties mortality mouse model non-demented patient safety primary care setting primary outcome processing speed randomized trial response risk minimization safety outcomes treatment as usual

项目摘要

PROJECT SUMMARY/ABSTRACT Both the American Geriatrics Society and the Center for Medicare and Medicaid Services have identified anticholinergics as inappropriate medications in older adults due to their adverse cognitive effects causing an increased risk of Alzheimer's disease and related dementias (ADRD). Every year, as many as 30% of older Americans use at least one of these medications, and more than 50% use at least one strong anticholinergic in five years. Despite awareness of these adverse cognitive effects, there has been no decline in prevalence over the last two decades. Several studies have identified higher risks of ADRD among users of these medications, however it is unknown whether stopping these medications in current users results in acute and sustained improvements in cognition. We propose a new trial called “Reducing Risk of Dementia through De-prescribing (R2D2)” to determine the efficacy of a pharmacist-driven de-prescribing protocol to improve cognition among primary care older adults currently using an anticholinergic medication. We will focus the intervention on primary care patients at high risk of cognitive decline due to current cognitive complaints or those making at least one error on a cognitive screening tool, while excluding those with dementia. The design will be a cluster randomized trial, randomizing physicians to minimize risk of contamination. Participants will be randomized to usual care (UC) or an active intervention group (ACT) that will receive a pharmacist-based de-prescribing intervention modeled after our prior work. The R2D2 study will enroll 344 older adults to determine the impact of the intervention on cognition at 6, 12, 18, and 24 months after baseline. The trial will monitor the safety of the intervention on depression, anxiety, pain, insomnia, and quality of life. We hypothesize that the ACT group will have better scores on cognitive assessments, no change in safety measures, and improvement in quality of life scores compared to usual care. If our hypothesis holds, this study would prove that the adverse cognitive effects of anticholinergics are reversible in older adults at high risk of ADRD, providing support for further work testing time to cognitive decline or dementia as a primary outcome. Interventions delaying the onset of cognitive impairment and dementia will have a significant impact on both the quality and costs of care of the aging population.

项目概要/摘要美国老年医学会和医疗保险和医疗补助服务中心均已确定抗胆碱能药物对老年人来说是不合适的药物，因为它们会产生不良的认知影响，导致每年，多达 30% 的老年人患阿尔茨海默病和相关痴呆症 (ADRD) 的风险增加。美国人至少使用其中一种药物，并且超过 50% 的人至少使用一种强效抗胆碱能药物五年来，尽管人们意识到这些不利的认知影响，但患病率并没有下降。过去二十年中，多项研究发现这些药物的使用者患 ADRD 的风险较高，然而，目前尚不清楚当前使用者停止使用这些药物是否会导致急性和持续性的认知能力的提高。我们提出了一项名为“通过取消处方降低痴呆症风险 (R2D2)”的新试验，以确定药剂师驱动的取消处方方案对改善初级保健老年人认知的功效目前正在使用抗胆碱能药物，我们将重点针对高初级保健患者进行干预。由于当前的认知抱怨或在认知上至少犯了一个错误而导致认知能力下降的风险筛查工具，同时排除痴呆症患者。该设计将是一项整群随机试验，随机化。医生将参与者随机分配至常规护理 (UC) 或积极护理组。干预组（ACT）将接受基于药剂师的取消处方干预，该干预以我们的模型为模型 R2D2 研究将招募 344 名老年人来确定干预措施对认知的影响。该试验将在基线后 6、12、18 和 24 个月监测抑郁干预的安全性。我们发现 ACT 组在焦虑、疼痛、失眠和生活质量方面得分更高。与相比，认知评估、安全措施没有变化以及生活质量评分有所改善平时的护理。如果我们的假设成立，这项研究将证明抗胆碱能药物的不良认知作用是对于 ADRD 高风险老年人来说是可逆的，为进一步的工作测试时间提供认知认知支持将衰退或痴呆作为主要结局，并采取延缓认知障碍发作的干预措施。痴呆症将对老年人口的护理质量和费用产生重大影响。