Department of Internal Medicine - Section Geriatric Medicine, Erasmus MC, University Medical Rotterdam, P,O, Box 2040, 3000 CA Rotterdam, The Netherlands.
BMC Geriatr. 2011 Aug 21;11:48. doi: 10.1186/1471-2318-11-48.
Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall.
METHODS/DESIGN: A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D), costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis.
The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction.
The trial is registered in the Netherlands Trial Register (NTR1593).
在全球老龄化社会中，跌倒事件是一个日益严重的公共卫生问题。跌倒的一个主要危险因素是使用增加跌倒风险的药物。该研究的主要目的是比较包括减少增加跌倒风险的药物在内的结构化药物评估与“常规护理”对因跌倒而到急诊科就诊的老年人新跌倒次数的影响。
方法/设计：这是一项在荷兰医院进行的前瞻性、多中心、随机对照试验。邀请年龄≥65 岁因跌倒而到急诊科就诊的人参加这项试验。所有患者都在研究门诊接受全面老年评估。患者随机分为结构化药物评估组（包括减少增加跌倒风险的药物）和“常规护理”组。使用 3 个月一次的跌倒日历评估一年随访期间的跌倒次数、跌倒者和相关伤害。测量时间为 3 个月、6 个月、9 个月和 12 个月，包括功能结局、医疗保健消费、社会人口特征和临床信息。12 个月后进行第二次门诊就诊，评估干预组新药物治疗方案的依从性。主要结局是新跌倒的发生率。次要结局测量是药物停药的可能健康影响、健康相关生活质量（简短表格-12 和 EuroQol-5D）、成本和干预的成本效益。数据将采用意向治疗分析进行分析。
该试验的成功完成将为减少跌倒风险的药物在老年患者中的停药效果提供证据。
该试验在荷兰试验注册中心（NTR1593）注册。
