多学科干预措施提高养老院居民用药安全性：一项整群随机对照试验（HIOPP-3-iTBX 研究）方案。
Multidisciplinary intervention to improve medication safety in nursing home residents: protocol of a cluster randomised controlled trial (HIOPP-3-iTBX study).
机构信息
Institute for General Practice, Hannover Medical School, Carl-Neuberg-Straße 1, 30625, Hannover, Germany.
Philipp Klee Institute for Clinical Pharmacology, University of Witten/Herdecke, Heusnerstraße 40, 42283, Wuppertal, Germany.
出版信息
BMC Geriatr. 2019 Jan 25;19(1):24. doi: 10.1186/s12877-019-1027-0.
BACKGROUND
Medication safety is an important health issue for nursing home residents (NHR). They usually experience polypharmacy and often take potentially inappropriate medications (PIM) and antipsychotics. This, coupled with a frail health state, makes NHR particularly vulnerable to adverse drug events (ADE). The value of systematic medication reviews and interprofessional co-operation for improving medication quality in NHR has been recognized. Yet the evidence of a positive effect on NHR' health and wellbeing is inconclusive at this stage. This study investigates the effects of pharmacists' medication reviews linked with measures to strengthen interprofessional co-operation on NHR' medication quality, health status and health care use.
METHODS
Pragmatic cluster randomised controlled trial in nursing homes in four regions of Germany. A total of 760 NHR will be recruited. Inclusion: NHR aged 65 years and over with an estimated life expectancy of at least six months. Intervention with four elements: i) introduction of a pharmacist's medication review combined with a communication pathway to the prescribing general practitioners (GPs) and nursing home staff, ii) facilitation of change in the interprofessional cooperation, iii) educational training and iv) a "toolbox" to facilitate implementation in daily practice.
ANALYSIS
primary outcome - proportion of residents receiving PIM and ≥ 2 antipsychotics at six months follow-up. Secondary outcomes - cognitive function, falls, quality of life, medical emergency contacts, hospital admissions, and health care costs.
DISCUSSION
The trial assesses the effects of a structured interprofessional medication management for NHR in Germany. It follows the participatory action research approach and closely involves the three professional groups (nursing staff, GPs, pharmacists) engaged in the medication management. A handbook based on the experiences of the trial in nursing homes will be produced for a rollout into routine practice in Germany.
TRIAL REGISTRATION
Registered in the German register of clinical studies (DRKS, study ID DRKS00013588 , primary register) and in the WHO International Clinical Trials Registry Platform (secondary register), both on 25th January 2018.
背景
药物安全是养老院居民（NHR）的一个重要健康问题。他们通常同时服用多种药物，并且经常服用潜在不适当的药物（PIM）和抗精神病药物。再加上脆弱的健康状况，使得 NHR 特别容易受到药物不良事件（ADE）的影响。系统药物审查和跨专业合作对于提高 NHR 药物质量的价值已经得到认可。然而，在现阶段，关于这对 NHR 健康和福祉的积极影响的证据尚无定论。本研究调查了与加强跨专业合作措施相关的药师药物审查对 NHR 药物质量、健康状况和医疗保健使用的影响。
方法
在德国四个地区的养老院进行实用的集群随机对照试验。共招募 760 名 NHR。纳入标准：年龄在 65 岁及以上，预计至少有六个月的预期寿命。干预措施有四个要素：i）引入药师药物审查，结合与开处方的全科医生（GP）和养老院工作人员的沟通途径，ii）促进跨专业合作的改变，iii）教育和培训，以及 iv）“工具箱”，以促进在日常实践中的实施。
分析
主要结果 - 接受 PIM 和≥2 种抗精神病药物的居民比例在 6 个月随访时。次要结果 - 认知功能、跌倒、生活质量、医疗紧急联系人、住院和医疗保健费用。
讨论
该试验评估了德国结构化的跨专业药物管理对 NHR 的影响。它遵循参与式行动研究方法，并密切涉及参与药物管理的三个专业群体（护理人员、GP、药剂师）。将根据试验在养老院的经验编写一本手册，以在德国常规实践中推广。
试验注册
于 2018 年 1 月 25 日在德国临床研究注册处（DRKS，研究 ID DRKS00013588，主要注册处）和世界卫生组织国际临床试验注册平台（二级注册处）注册。
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