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临床试验/NCT02336113
NCT02336113Unknown不适用

Oslo Pharmacist Intervention Study - Effect on Readmissions

Oslo University Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2014年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
1
主要终点
Days outside hospital until an eventual first readmission

研究概览

简要总结

Earlier studies have shown that pharmacists detect and solve drug related problems (DRPs) when they are a part of the multidisciplinary treatment-team at hospital wards. However, in the Norwegian health care system, there is a lack of studies on the effect of pharmacist intervention on clinically relevant outcomes. Hospital readmissions has both clinical and economical negative effects, and time outside the hospital until an eventual readmission is considered as a clinical relevant outcome measure. The investigators are conducting a randomized controlled trial at an internal medicine ward at Oslo University Hospital. 400 acute admitted patients using minimum 4 regular drugs from minimum 2 drug groups will be enrolled in the study. Patients randomized to the Control group will receive standard care (without a pharmacist involved) and patients randomized to the Intervention group will receive a pharmacist in their treatment team during the hospital stay. The study hypothesis is that including a pharmacist in the multidisciplinary treatment team at a hospital ward, will improve the patients drug treatment, hence lead to an increased time outside the hospital until an eventual readmission.

The inclusion of patients was completed March 17th 2016 With 399 patients randomised. The last day of follow-up on readmission and mortality was December 31, 2017. The Application process for outcome data to the Norwegian Patient Registry and the Norwegian Cause of Death Registry started in June 2017 and lasted until May 2018. Huge workload at the Registers entails a very long processing time for outcome data. On May 25, 2018 the statistical analysis plan was finalized and signed, hereunder the analysis population defined and the endpoint analyses detailed. Outcome datafiles from patient registries was prepared for analysis May 29 to June 6, 2018. Blinded outcome analyses was conducted June 8, 2018.


The investigators have obtained approval for a protocol amendment to use the data from the study in further analyses togheter with data from 100 new patients admitted to the internal medicine ward. The hypothesis is that a set of patient characteristics can identify patients who are at high risk of drug-related readmissions and who would benefit most from the pharmaceutical intervention.The investigators aim to identify these patients by building a statistical model based on significant variables from the 399 patients collected in the randomised controlled trial. The statistical model will be validated using data from 100 new patients admitted to the internal medicine ward.

The inclusion of patients to this New sample was finalised July 6th 2018 (primary completion). Data on hospital readmissions and death will be collected from the Norwegian Patient Registry and the Norwegian Cause of Death Registry in June 2020.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •acute admitted patients using minimum 4 regular drugs from minimum 2 drug groups at admittance
  • •Norwegian personal identification number

排除标准

  • •terminally ill
  • •not able no communicate in Norwegian or English and an interpreter is not available
  • •patients isolated due to severe infections
  • •readmitted patients earlier included are not re-included

研究组 & 干预措施

Control group

No Intervention

Standard care during hospital stay, without pharmacist involved

Pharmacist intervention

Experimental

A pharmacist is included in the multidisciplinary treatment team during the hospital stay

干预措施: multidisciplinary treatment (Behavioral)

结局指标

主要结局

Days outside hospital until an eventual first readmission

时间窗: 12 months after hospital discharge

Calculated as the difference between the Control- and intervention group in the intention-to-treat population with data from The Norwegian Patient Register

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Morten Mowe

Associate professor, senior consultant

Oslo University Hospital

研究点 (1)

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