Johansen Jeanette Schultz, Havnes Kjerstin, Halvorsen Kjell H, Haustreis Stine, Skaue Lillann Wilsgård, Kamycheva Elena, Mathiesen Liv, Viktil Kirsten K, Granås Anne Gerd, Garcia Beate H
Department of Pharmacy, Faculty of Health Sciences, UiT-The Arctic University of Norway, Tromsø, Norway.
Hospital Pharmacy of North Norway Trust, Tromsø, Norway.
BMJ Open. 2018 Jan 23;8(1):e020106. doi: 10.1136/bmjopen-2017-020106.
Drug-related problems (DRPs) are common in the elderly, leading to suboptimal therapy, hospitalisations and increased mortality. The integrated medicines management (IMM) model is a multifactorial interdisciplinary methodology aiming to optimise individual medication therapy throughout the hospital stay. IMM has been shown to reduce readmissions and drug-related hospital readmissions. Using the IMM model as a template, we have designed an intervention aiming both to improve medication safety in hospitals, and communication across the secondary and primary care interface. This paper presents the study protocol to explore the effects of the intervention with regard to healthcare use, health-related quality of life (HRQoL) and medication appropriateness in elderly patients.
A total of 500 patients aged ≥70 years will be included and randomised to control (standard care) or intervention group (1:1). The intervention comprises five steps mainly performed by pharmacists: (1) medication reconciliation at admission, (2) medication review during hospital stay, (3) patient counselling about the use of medicines, (4) a comprehensible and patient-friendly medication list with explanations in discharge summary and (5) postdischarge phone calls to the primary care level. The primary outcome is the difference between intervention and control patients in the rate of emergency medical visits (acute readmissions and visits to emergency department) 12 months after discharge. Secondary outcomes include length of index hospital stay, time to first readmission, mortality, hip fractures, strokes, medication changes, HRQoL and medication appropriateness. Patient inclusion started in September 2016.
The trial was approved by the Norwegian Centre for Research Data and the Norwegian Data Protection Authority. We aim to publish the results in international peer-reviewed open access journals, at national and international conferences, and as part of two PhD theses.
NCT02816086.
药物相关问题（DRPs）在老年人中很常见，会导致治疗效果欠佳、住院治疗以及死亡率上升。综合药物管理（IMM）模式是一种多因素跨学科方法，旨在优化患者在整个住院期间的药物治疗。IMM已被证明可减少再入院率和与药物相关的医院再入院率。以IMM模式为模板，我们设计了一项干预措施，旨在提高医院的用药安全性以及改善二级和初级医疗保健机构之间的沟通。本文介绍了该研究方案，以探讨该干预措施对老年患者医疗保健使用情况、健康相关生活质量（HRQoL）和用药合理性的影响。
总共将纳入500名年龄≥70岁的患者，并将其随机分为对照组（标准护理）或干预组（1:1）。干预措施主要由药剂师执行，包括五个步骤：（1）入院时的用药核对，（2）住院期间的用药审查，（3）对患者进行用药咨询，（4）在出院小结中提供一份易懂且对患者友好的带有解释的用药清单，以及（5）出院后致电初级医疗保健机构。主要结局是出院12个月后干预组和对照组患者在紧急医疗就诊率（急性再入院和急诊就诊）方面的差异。次要结局包括首次住院时长、首次再入院时间、死亡率、髋部骨折、中风、用药变化、HRQoL和用药合理性。患者纳入工作于2016年9月开始。
该试验已获得挪威研究数据中心和挪威数据保护局的批准。我们旨在将研究结果发表在国际同行评审的开放获取期刊上、在国内和国际会议上发表，并作为两篇博士论文的一部分。
NCT02816086。
