Brain Safe: Consumer Intervention to Reduce Exposure to Drugs Linked to Alzheimer's Disease

项目摘要/摘要 三分之一的美国老年人服用强效抗胆碱能药物，尽管服用了抗胆碱药物。 是老年人的禁忌，因为有大量证据表明使用抗胆碱类药物与 认知障碍、阿尔茨海默病和相关的痴呆。国家实体，包括国家 医学科学院呼吁研究减少老年人抗胆碱能暴露的干预措施， 作为阿尔茨海默病的危险因素，可以进行行为干预。 据我们所知，目前还没有直接针对抗胆碱类药物消费者的干预研究。在之前的工作中，我们 展示了减少老年人使用抗胆碱类药物的能力，方法是让老年医生 直接对消费者进行干预。虽然成功地将抗胆碱能使用者的比例减少了52%， 由医生或药剂师提供的这种干预措施和其他干预措施都很昂贵，而且不可扩展。 我们提议的研究测试了消费者干预的有效性，数字大脑安全移动应用程序，一种低成本的 由我们的跨学科专家团队设计的成本低廉、可扩展的移动应用程序，涉及药物安全、老化、 为老年人设计以用户为中心的技术。干预措施整合了个性化的 抗胆碱能风险计算器，有针对性的多媒体内容，以及帮助患者自我 与临床医生一起开始抗胆碱能停药。在一项对17名老年人进行的大脑安全可行性试验中 至少一种强大的抗胆碱能药物，100%的参与者报告说对药物治疗有更好的了解 安全性在使用Brain Safe后，94%的人报告计划与医生谈论他们的抗胆碱能风险， 88%的人这样做了(82%的病例得到了内科医生的确认)。对34名老年人进行的可用性测试显示 “优秀”可用性等级(系统可用性得分中位数=82.5)。 在这项拟议的研究中，计划进行一项随机对照试验，以初步测试大脑安全对 干预后12个月老年人的处方抗胆碱能暴露。其次，我们会 在12个月时测试大脑安全对认知功能和健康相关生活质量的影响。我们会 探讨脑安全在6个月时对这些初级和次级结局的早期影响。年纪较大的成年人 参与者将被随机接受大脑安全或注意力控制应用程序(WebMD健康评估) 已经12个月了。在为期42个月的时间里，将从大量患者中招募总共700名参与者 在Eskenazi Health和印第安纳大学Health接受初级医疗保健。将执行评估 在基线、6个月和12个月。我们将使用t检验和混合效应模型来检验假设，比较 12个月时接触强效抗胆碱药物的两种情况。试用版在主服务器上运行 通过配药记录评估12个月时抗胆碱能药物暴露的结果。 因为接触抗胆碱能药物是阿尔茨海默病和相关疾病的可改变的危险因素 对于痴呆症，迫切需要可扩展的干预措施，以减少老年人接触抗胆碱类药物。

PROJECT SUMMARY/ABSTRACT One in three older Americans is prescribed a strong anticholinergic medication, despite anticholinergics being contraindicated for older adults on the basis of considerable evidence linking use of anticholinergics with cognitive impairment, Alzheimer's disease, and related dementias. National entities including the National Academy of Medicine call for research on interventions to reduce anticholinergic exposure among older adults, as a risk factor for Alzheimer's disease that is amenable to behavioral intervention. We know of no intervention studies directly targeting consumers of anticholinergics. In prior work, we demonstrated the ability to reduce anticholinergics use by older adults by having a geriatrician deliver the intervention directly to consumers. While successful in reducing the proportion of anticholinergic users by 52%, this and other interventions delivered by a physician or pharmacist are expensive and not scalable. Our proposed study tests the efficacy of a consumer intervention, the digital Brain Safe mobile app, a low- cost, scalable mobile application designed by our interdisciplinary team of experts on medication safety, aging, and user-centered design of technology for older adults. The intervention integrates a personalized anticholinergic risk calculator, targeted multimedia content, and a conversation starter to help patients to self- initiate anticholinergic de-prescribing with a clinician. In a feasibility trial of Brain Safe with 17 older adults using at least one strong anticholinergic, 100% of participants reported feeling better informed about medication safety after using Brain Safe, 94% reported planning to speak to a physician about their anticholinergic risk, and 88% did so (confirmed by physician in 82% of cases). Usability testing with 34 older adults showed an “Excellent” usability grade (median System Usability Score = 82.5). In the proposed study, a randomized controlled trial is planned to primarily test the impact of Brain Safe on prescription anticholinergic exposure among older adults at 12 months after intervention. Secondarily, we will test the impact of Brain Safe on cognitive function and health-related quality of life at 12 months. We will explore early effects of Brain Safe on these primary and secondary outcomes at 6 months. Older adult participants will be randomized to receive Brain Safe or an attention control app (WebMD Health Assessment) for 12 months. A total of 700 participants will be enrolled over a 42-month period from a large pool of patients receiving primary healthcare at Eskenazi Health and Indiana University Health. Assessments will be performed at baseline, 6, and 12 months. We will use t tests and mixed effects models to test hypotheses comparing the two conditions on exposure to strong anticholinergics at 12 months. The trial is powered on the primary outcome of anticholinergic exposure at 12 months, assessed by dispensing records. Because anticholinergic drug exposure is a modifiable risk factor for Alzheimer's disease and related dementias, scalable interventions to reduce older adult exposure to anticholinergics are urgently needed.