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Multi-professional clinical medication reviews in care homes for the elderly: study protocol for a randomised controlled trial with cost effectiveness analysis

机译：老年人护理院中的多专业临床药物评论：具有成本效益分析的随机对照试验研究方案

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Background Evidence demonstrates that measures are needed to optimise therapy and improve administration of medicines in care homes for older people. The aim of this study is to determine the clinical and cost effectiveness of a novel model of multi-professional medication review. Methods A cluster randomised controlled trial design, involving thirty care homes. In line with current practice in medication reviews, recruitment and consent will be sought from general practitioners and care homes, rather than individual residents. Care homes will be segmented according to size and resident mix and allocated to the intervention arm (15 homes) or control arm (15 homes) sequentially using minimisation. Intervention homes will receive a multi-professional medication review at baseline and at 6 months, with follow-up at 12 months. Control homes will receive usual care (support they currently receive from the National Health Service), with data collection at baseline and 12 months. The novelty of the intervention is a review of medications by a multi-disciplinary team. Primary outcome measures are number of falls and potentially inappropriate prescribing. Secondary outcome measures include medication costs, health care resource use, hospitalisations and mortality. The null hypothesis proposes no difference in primary outcomes between intervention and control patients. The primary outcome variable (number of falls) will be analysed using a linear mixed model, with the intervention specified as a fixed effect and care homes included as a random effect. Analyses will be at the level of the care home. The economic evaluation will estimate the cost-effectiveness of the intervention compared to usual care from a National Health Service and personal social services perspective. The study is not measuring the impact of the intervention on professional working relationships, the medicines culture in care homes or the generic health-related quality of life of residents. Discussion This study will establish the effectiveness of a new model of multi-professional clinical medication reviews in care homes, using novel approaches to recruitment and consent. It is the first study to undertake an examination of direct patient outcomes, together with an economic analysis. Trial Registration ISRCTN: ISRCTN90761620
机译：背景证据表明，需要采取措施优化治疗并改善老年人护理院中的药物管理。这项研究的目的是确定一种新型的多专业药物审查模型的临床和成本效益。方法采用整群随机对照试验设计，涉及三十个疗养院。根据药物审查的当前做法，将寻求全科医生和疗养院的征募和同意，而不是个人居民。养老院将根据规模和居民组合进行细分，并使用最小化顺序分配给干预部门（15所房屋）或控制部门（15所房屋）。干预院将在基线和第6个月接受多专业药物审查，并在第12个月进行随访。对照之家将得到常规护理（他们目前从国家卫生局获得支持），并在基线和12个月时收集数据。干预的新颖性是一个多学科团队对药物的审查。主要结果指标是跌倒的次数和可能不适当的处方。次要结果指标包括药物费用，医疗资源使用，住院和死亡率。零假设表明干预和对照患者的主要结局无差异。主要结果变量（跌倒次数）将使用线性混合模型进行分析，其中干预措施指定为固定效应，而护理院则指定为随机效应。分析将在养老院进行。经济评估将从国家卫生服务和个人社会服务的角度评估与常规护理相比的干预措施的成本效益。该研究并未衡量干预措施对专业工作关系，疗养院中的药物文化或居民与健康相关的一般生活质量的影响。讨论本研究将使用新颖的招募和同意方法，建立护理院中多专业临床药物审查新模型的有效性。这是第一项对患者直接结果进行检查并进行经济分析的研究。试用注册ISRCTN：ISRCTN90761620

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