背景:综合用药和使用潜在的不适当药物在疗养院居民中很常见,并与负面结果相关。尽管已经提出了取消处方作为减少这些问题的一种方法,实施多学科综合用药审查和开药的最佳方式及其在特定高危人群中的实际影响,比如养老院的居民,还不清楚。这项多中心随机对照临床试验旨在评估多学科调解管理计划对药物使用和健康问题的影响。
方法:韩国22家养老院中符合目标标准的1,672名65岁以上的居民,例如使用≥10种药物,有资格参加。实验组将接受全面的用药审查,去处方,以及借助平台的多学科案例会议。结果将在基线测量,在干预结束时,以及干预结束后3、6、9和12个月。主要终点将是药物不良事件的发生率,潜在不适当药物/潜在不适当药物使用者/两种或两种以上中枢神经系统药物/中枢神经系统吸毒者的数量,谵妄,急诊部门的访问,住院治疗,和瀑布。次要终点将是服用的药物数量和多重用药用户。
结论:我们的试验设计是独特的,因为它旨在引入一个结构化的可操作的临床计划,专注于减少在大样本疗养院环境中的多重用药和潜在的不适当药物。
背景:道德批准是由卫生和福利部公共机构审查委员会(2022-1092-009)授予的。该研究还在临床研究信息服务处注册(标识符:KCT0008157,长期护理机构居民多学科药物管理计划的开发和评估状态:批准首次提交日期:2023/01/18注册日期:2023/02/03最后更新日期:2023/01/18(nih。走吧。kr)https://cris。nih.走吧。kr/),其中包括世界卫生组织试验注册数据集中的所有项目。
BACKGROUND: Polypharmacy and the use of potentially inappropriate medications are common among nursing home residents and are associated with negative outcomes. Although deprescribing has been proposed as a way to curtail these problems, the best way to implement multidisciplinary comprehensive medication review and deprescribing and its real impact in specific high-risk populations, such as nursing home residents, is still unclear. This multicenter randomized controlled clinical
trial aims to assess the effects of a multidisciplinary mediation management program on medication use and health problems.
METHODS: A total of 1,672 residents aged ≥ 65 years from 22 nursing homes in South Korea who meet the targeted criteria, such as the use of ≥ 10 medications, are eligible to participate. The experimental group will receive a comprehensive medication review, deprescription, and multidisciplinary case conference with the help of platform. Outcomes will be measured at baseline, at the end of the intervention, as well as at 3, 6, 9, and 12 months after the end of the intervention. The primary endpoints will be the rate of adverse drug events, number of potentially inappropriate medications/potentially inappropriate medication users/two or more central nervous system drug/ central nervous system drug users, delirium, emergency department visits, hospitalization, and falls. The secondary endpoint will be the number of medications taken and polypharmacy users.
CONCLUSIONS: Our
trial design is unique in that it aims to introduce a structured operationalized clinical program focused on reducing polypharmacy and potentially inappropriate medications in a nursing home setting with large samples.
BACKGROUND: Ethical approval was granted by the public institutional review board of the Ministry of Health and Welfare (2022-1092-009). The
study is also registered with the Clinical Research Information Service (Identifier: KCT0008157, Development and evaluation of a multidisciplinary medication management program in long-term care facility residents Status: Approved First Submitted Date: 2023/01/18 Registered Date: 2023/02/03 Last Updated Date: 2023/01/18 (nih.go.kr) https://cris.nih.go.kr/ ), which includes all items from the World Health Organization
Trial Registration Dataset.