Sluggett Janet K, Chen Esa Y H, Ilomäki Jenni, Corlis Megan, Hilmer Sarah N, Van Emden Jan, Ooi Choon Ean, Nguyen Kim-Huong, Comans Tracy, Hogan Michelle, Caporale Tessa, Edwards Susan, Quirke Lyntara, Patching Allan, Bell J Simon
Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, Victoria, 3052, Australia.
NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Hornsby, New South Wales, Australia.
Trials. 2018 Jan 12;19(1):37. doi: 10.1186/s13063-017-2417-2.
Complex medication regimens are highly prevalent in residential aged care facilities (RACFs). Strategies to reduce unnecessary complexity may be valuable because complex medication regimens can be burdensome for residents and are costly in terms of nursing time. The aim of this study is to investigate application of a structured process to simplify medication administration in RACFs.
SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) is a non-blinded, matched-pair, cluster randomised controlled trial of a single multidisciplinary intervention to simplify medication regimens. Trained study nurses will recruit English-speaking, permanent residents from eight South Australian RACFs. Medications taken by residents in the intervention arm will be assessed once using a structured tool (the Medication Regimen Simplification Guide for Residential Aged CarE) to identify opportunities to reduce medication regimen complexity (e.g. by administering medications at the same time, or through the use of longer-acting or combination formulations). Residents in the comparison group will receive routine care. Participants will be followed for up to 36 months after study entry. The primary outcome measure will be the total number of charted medication administration times at 4 months after study entry. Secondary outcome measures will include time spent administering medications, medication incidents, resident satisfaction, quality of life, falls, hospitalisation and mortality. Individual-level analyses that account for clustering will be undertaken to determine the impact of the intervention on the study outcomes.
Ethical approval has been obtained from the Monash University Human Research Ethics Committee and the aged care provider organisation. Research findings will be disseminated through conference presentations and peer-reviewed publications. SIMPLER will enable an improved understanding of the burden of medication use in RACFs and quantify the impact of regimen simplification on a range of outcomes important to residents and care providers.
Australian New Zealand Clinical Trials Registry, ACTRN12617001060336 . Retrospectively registered on 20 July 2017.
复杂的药物治疗方案在老年护理机构（RACFs）中极为普遍。减少不必要复杂性的策略可能很有价值，因为复杂的药物治疗方案会给居民带来负担，且在护理时间方面成本高昂。本研究的目的是调查一种结构化流程在简化RACFs药物管理中的应用。
长期护理居民药物简化（SIMPLER）是一项非盲、配对、整群随机对照试验，采用单一多学科干预措施简化药物治疗方案。经过培训的研究护士将从南澳大利亚的八个RACFs招募说英语的常住居民。干预组居民服用的药物将使用一种结构化工具（《老年护理机构药物治疗方案简化指南》）进行一次评估，以确定降低药物治疗方案复杂性的机会（例如通过同时给药，或使用长效或复方制剂）。对照组居民将接受常规护理。研究开始后，参与者将被随访长达36个月。主要结局指标将是研究开始后4个月记录的药物给药总次数。次要结局指标将包括给药时间、用药事件、居民满意度、生活质量、跌倒、住院和死亡率。将进行考虑聚类的个体水平分析，以确定干预对研究结局的影响。
已获得莫纳什大学人类研究伦理委员会和老年护理服务提供商组织的伦理批准。研究结果将通过会议报告和同行评审出版物进行传播。SIMPLER将有助于更好地理解RACFs中药物使用的负担，并量化方案简化对一系列对居民和护理提供者重要的结局的影响。
澳大利亚新西兰临床试验注册中心，ACTRN12617001060336。于2017年7月20日追溯注册。
