Reducing Risk of Dementia through De-prescribing (R2D2)

通过取消处方降低痴呆症风险 (R2D2)

• 批准号: 10605238
• 负责人: Noll L. Campbell
• 金额: $ 63.64万
• 依托单位: PURDUE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-05-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10605238
• 关键词: Acute; Adverse event; Age; Alzheimer' s Disease; Alzheimer' s disease related dementia; Alzheimer' 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; Educational Intervention; Elderly; Enrollment; Epidemiology; Exclusion; Exposure to; Gender; Genetic; Geriatrics; Health; Health Care Costs; Healthcare Systems; Hospitalization; Human; Impaired cognition; Information Systems; Institute of Medicine (U.S.); Intervention; Measures; Memory; Mental Depression; Modeling; Monitor; Morbidity - disease rate; Multi-Institutional Clinical Trial; Outcome; Outcome Measure; Pain; Participant; Pathology; Patient Monitoring; Patient Outcomes Assessments; Patient Self-Report; Pharmaceutical Preparations; Pharmacists; Physicians; Population; Prevalence; Primary Care; Protocols documentation; Quality of life; Race; Randomized; Randomized, Controlled Trials; Risk; Risk Reduction; 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; care costs; cognitive testing; comorbidity; dementia risk; design; disability; efficacy evaluation; 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 patient; primary care setting; primary outcome; processing speed; randomized trial; response; risk minimization; safety outcomes; treatment as usual

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.

项目总结/摘要 美国老年医学会和医疗保险和医疗补助服务中心都已经确定了 抗胆碱能药物作为不适当的药物在老年人中，由于其不良认知作用， 阿尔茨海默病和相关痴呆症（ADRD）的风险增加。每年，多达30%的老年人 美国人至少使用其中一种药物，超过50%的人使用至少一种强效抗胆碱能药物。 五年尽管意识到这些不利的认知影响， 在过去的二十年里一些研究已经确定了这些药物的使用者中ADRD的风险较高， 然而，目前尚不清楚在当前使用者中停止这些药物是否会导致急性和持续性 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 药师驱动的取消处方方案对改善初级保健老年人认知的有效性 目前正在服用抗胆碱能药物我们将把干预重点放在高风险的初级保健患者身上。 由于当前的认知主诉或那些在认知上至少犯了一个错误而导致认知下降的风险 筛查工具，同时排除痴呆症患者。该设计将是一项随机分组试验， 医生将污染风险降至最低。受试者将随机接受常规治疗（UC）或活性药物治疗。 干预组（ACT），将接受基于药剂师的取消处方干预， 以前的工作。R2D2研究将招募344名老年人，以确定干预对认知的影响 基线后6、12、18和24个月。该试验将监测干预抑郁症的安全性， 焦虑、疼痛、失眠和生活质量。我们假设ACT组在以下方面的得分更高： 认知评估，安全性指标无变化，生活质量评分改善 常规护理 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 在ADRD高风险的老年人中可逆，为进一步的工作测试时间提供支持， 衰退或痴呆作为主要结局。延迟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成本产生重大影响。