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Optimizing polypharmacy among elderly hospital patients with chronic diseases—study protocol of the cluster randomized controlled POLITE-RCT trial

机译:在老年慢性病患者中优化多药房—聚类随机对照POLITE-RCT试验的研究方案

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Background Treatment of patients with multimorbidity is challenging. A rational reduction of long-term drugs can lead to decreased mortality, less acute hospital treatment, and a reduction of costs. Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence. The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients. The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based, patient-centered medication review prior to the patient?s discharge from hospital. Methods The POLITE-RCT trial is a cluster randomized controlled trial. Two major secondary health care providers of Mecklenburg-Western Pomerania, Germany, take part in the study. Clusters are wards of both medical centers. All wards where patients with chronic diseases and multimorbidity are regularly treated will be included. Patients aged 65+ years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively. Cluster-randomization takes place after a six-month baseline data collection period. Patients of the control group receive care as usual. The independent two main primary outcomes are (1) health-related quality of life (EQ-5D) and (2) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group. The secondary outcomes are appropriateness of prescribed medication (PRISCUS list, Beers Criteria, MAI), patient satisfaction (TSQM), patient empowerment (PEF-FB-9), patient autonomy (IADL), falls, re-hospitalization, and death. The points of measurement are at admission to (T0) and discharge from hospital (T1) as well as 6 and 12 months after discharge from the hospital (T2 and T3). In 42 wards, 1,626 patients will be recruited. Discussion In case of positive evaluation, the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy. Trial registration Current Controlled Trials ISRCTN42003273 webcite
机译:背景技术对多发病患者的治疗具有挑战性。合理减少长期药物治疗可以降低死亡率,减少急症医院的治疗,并降低成本。药物治疗方案的简化也与更高水平的患者满意度和依从性有关。 POLITE-RCT试验将测试旨在减少多病态和慢性病患者长期服用处方药数量的干预措施的有效性。干预措施着重于初级和二级医疗保健之间的接口,包括在患者出院前以药剂师为基础,以患者为中心的用药审查。方法POLITE-RCT试验是一项集群随机对照试验。德国梅克伦堡-前波莫瑞州的两家主要二级医疗保健提供者都参与了这项研究。集群是两个医疗中心的病房。包括所有定期治疗患有慢性疾病和多发病的患者的病房。年龄在65岁以上且服用了五种或以上处方长期药物并且可能在参与医院住院至少5天的患者将被招募并连续纳入。在六个月的基准数据收集期之后进行集群随机化。对照组患者照常接受护理。独立的两个主要主要结局是(1)健康相关的生活质量(EQ-5D)和(2)干预组与对照组之间处方长期药物的数量差异。次要结果是处方药的适用性(PRISCUS清单,Beers Criteria,MAI),患者满意度(TSQM),患者赋权(PEF-FB-9),患者自主性(IADL),跌倒,再次住院和死亡。测量点在入院(T0)和出院(T1)以及出院后6个月和12个月(T2和T3)。在42个病房中,将招募1,626名患者。讨论在获得积极评价的情况下,拟议的研究将通过增强以患者为中心和患者自主性,为多药业的可持续减少提供证据。试用注册当前对照试验ISRCTN42003273网站

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