Department of Integrative Medical Biology, Umeå University, Umeå, Sweden
Department of Integrative Medical Biology, Umeå University, Umeå, Sweden.
BMJ Open. 2020 Apr 27;10(4):e036650. doi: 10.1136/bmjopen-2019-036650.
Drug-related problems (DRPs) are a major cause of unplanned hospital admissions among elderly people, and transitions of care have been emphasised as a key area for improving patient safety. We have designed a complex clinical pharmacist intervention that targets people ≥75 years of age undergoing transitions of care from hospital to home and primary care. The main objective is to investigate if the intervention can reduce the risk of unplanned drug-related readmission within the first 180 days after the person is discharged from hospital.
This is a randomised, controlled, superiority trial with two parallel arms. A total of 700 people ≥75 years will be assigned to either intervention or routine care (control). The intervention, which aims to find and manage DRPs, is initiated within a week of the person being discharged from hospital and combines repeated medical chart reviews, phone interviews and in some cases medication reviews. People in both study arms may have been the subject of a medication review during their ward stay. As the primary outcome, we will measure time until unplanned drug-related readmission within 180 days of leaving hospital and use log rank tests and Cox proportional hazard models to analyse differences between the groups. Further investigations of subgroup effects and adjustments of the regression models will be based on heart failure and cognitive impairment as prognostic factors.
The study has been approved by the Regional Ethical Review Board in Umeå (registration numbers 2017-69-31M, 2018-83-32M and 2018-254-32M). We intend to publish the results with open access in international peer-reviewed journals and present our findings at international conferences. The trial is expected to result in more than one published article and form part of two PhD theses.
NCT03671629.
药物相关问题（DRPs）是导致老年人非计划性住院的主要原因，医疗护理交接被强调是提高患者安全的关键领域。我们设计了一项复杂的临床药师干预措施，针对的是从医院到家庭和初级保健过渡的 75 岁及以上人群。主要目的是调查该干预措施是否可以降低患者出院后 180 天内药物相关非计划性再入院的风险。
这是一项随机、对照、优效性试验，有两个平行组。共有 700 名 75 岁及以上的患者将被分配到干预组或常规护理（对照组）。干预措施旨在发现和管理药物相关问题，在患者出院后一周内启动，结合重复的病历审查、电话访谈，在某些情况下还进行药物审查。研究组和对照组的患者在住院期间都可能接受过药物审查。作为主要结局，我们将测量从出院到 180 天内药物相关非计划性再入院的时间，并使用对数秩检验和 Cox 比例风险模型分析组间差异。进一步对亚组效应和回归模型的调整将基于心力衰竭和认知障碍等预后因素进行调查。
该研究已获得于默奥地区伦理审查委员会的批准（注册号 2017-69-31M、2018-83-32M 和 2018-254-32M）。我们打算在国际同行评议期刊上公开获取研究结果，并在国际会议上展示我们的发现。该试验预计将产生一篇以上的文章，并作为两篇博士论文的一部分。
NCT03671629。
