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临床试验/NCT03412903
NCT03412903已完成不适用

The Pharmacist in the Acute Geriatric Inpatient Treatment Team - Impact on Re-hospitalization and Trans-sectoral Communication

Prof. Dr. med. Cornelius Bollheimer1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2018年1月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
154
试验地点
1
主要终点
Drug related re-hospitalization

研究概览

简要总结

This trial investigates the effects of a comprehensive pharmaceutical assessment in an acute care geriatric hospital on the number of hospital readmissions and patient's days spent at home.

详细描述

Drug-related problems are common in elderly patients. These problems can not only be regarded from a medical or economical point of view (i.e. hospitalization, drug related deaths, longer hospital stays and increased healthcare costs) but also from a patient centered perspective: Drug therapy may not be sufficiently explained by health care practitioners, patients might suffer from side effects, the number of different medications could be too large and their intake schedule too difficult, all of this leading to a reduced adherence. In addition, medication histories are rarely accurate in older patients and doctor's letters do not always meet the requirements of a complex drug therapy. At the transition from inpatient to outpatient treatment this can lead to a significant loss of information and subsequently cause patient harm.

In Germany, clinical, ward-based pharmacists are not yet established in contrast to other countries (i.e. Great Britain, Canada and Australia). However, the implementation of a clinical pharmacist may particularly address the problems described above. The present study therefore describes the implementation of a comprehensive pharmaceutical assessment in an acute care geriatric hospital.

The above mentioned pharmaceutical assessment consists of the following steps:

First, the pharmacist will obtain the patient's medication history following the protocol of "best possible medication history" (WHO). Furthermore, he will ascertain the patient's adherence to his/her drug regime. With the information obtained, he will then carry out a thorough medication review (regarding interactions, contraindications, suitability for the elderly, dosage regimes, etc.) in order to develop a suggestion for the best possible drug regime, which is discussed with the treating physician. In addition, he will also observe possible side effects and provide information on the background and significance of every single drug to the patient and/or his/her care-giver. Furthermore, the handling of difficult devices (i.e. insulin pens, inhalators and transdermal therapeutic systems) will be individually explained. Finally, the pharmacist will prepare a distinctive paragraph in the medical discharge report in which he explains the changes in the medication regime during the inpatient period to the general practitioner and will also elaborate possible interactions and problems concerning the patient's medication (pharmaceutical council).

The main outcome to be evaluated will be the number of hospital readmissions and drug related hospital readmissions within six months after discharge (recorded at one, three and six months). The secondary outcome will be the days spent at home (also recorded at one, three and six months), time to readmission, changes in medication within six months and the acceptance of the supposed medication regime by the general practitioner (GP).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Geriatric complex treatment (Operation and procedure code (German: "Operationen- und Prozedurenschlüssel", OPS) 8-550)
  • In-patient stay for at least 7 days
  • Written informed consent of the patient or the legal representative
  • Existing concomitant drug therapy at the time of the inpatient admission

排除标准

  • Patients, that were already included in the study beforehand
  • Patients classified as terminally ill by the medical staff
  • Patients, that are incapable to give their informed consent and who do not have a legal representative

结局指标

主要结局

Drug related re-hospitalization

时间窗: 6 months

Number of re-hospitalizations with causal relation to one or more medicinal products, to examine the potential effect of an advising pharmacist

次要结局

  • Period of time until the potential re-hospitalization into the inpatient sector(6 months)
  • Evaluation of the clinical relevance of the medicinal products, which were not assessed by the doctors(6 months)
  • Days spent at home(6 months)
  • Completeness of the pharmaceutical anamnesis in the course of the inpatient admission(6 months)
  • Overall re-hospitalization(6 months)
  • Acceptance of the recommended medication plan by the further treating primary care physicians(6 months)
  • Time required for the pharmacists support(6 months)

研究者

发起方
Prof. Dr. med. Cornelius Bollheimer
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Prof. Dr. med. Cornelius Bollheimer

Univ.-Prof. Dr. med., Klinikdirektor

RWTH Aachen University

研究点 (1)

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