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临床试验/NCT03736577
NCT03736577已完成不适用

Psychotropic Drug Use in the Elderly Living in Nursing Homes - Associations With Clinical Symptoms and the Influence of a Structured Drug Review

Ostfold Hospital Trust2 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2018年11月12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
224
试验地点
2
主要终点
Change in Quality of Life: QUALID

研究概览

简要总结

The overall aim of this study is to explore if a structured drug review will change clinical symptoms and the psychotropic drugs prescription rate in the elderly living in nursing homes (participants of the study). The study will examine how training of nursing home physicians on reviewing prescription lists using the Norwegian general practice criteria - Nursing homes (NorGeP-NH) will influence the participants' clinical symptoms such as cognition, depression, anxiety and their quality of life. Secondary, we will analyse how a structured drug review will influence further psychotropic drug prescribing rates in nursing homes.

The hypothesis for this study are:

  1. Training of nursing home physicians on doing a systematic drug review will decrease the participants' clinical symptoms and improve their Quality of Life.
  2. A systematic drug review will decrease the psychotropic drug prescription rates compared to before the drug review.

详细描述

Norwegian national guidelines recommend a very cautious use of psychotropic drugs in the elderly, especially for treating dementia-related symptoms. These drugs should be used at a very low dosage and for as short a time as possible. Despite these strict guidelines, patients with and without dementia living in nursing homes still receive a high amount of psychotropic drugs. Thus, there should be a higher focus on lowering the use of psychotropic medications in nursing homes. A reduction of prescription of potential harmful and inappropriate drugs for the elderly may improve the clinical symptoms of the patients, reduce the interaction between drugs and the side-effects, and thereby improving the quality of life of the patients.

In 2018 the Norwegian Institute of Public Health updated a report about the general health in the Norwegian elderly population. This report shows that prescription rates for the majority of drugs in the population above 65 years of age have increased in the past 11 years. Unfortunately, Norway does not have a prescription registry for patients living in nursing homes and according to the same report the drug use and the increase of prescription rates in nursing homes is underestimated. During the last years Norwegian authorities, media and user organizations have shown a particular interest in this subject, showing how clinical practice still differs from national and international guidelines, and focusing on the severity of polypharmacy in the elderly living in institutions, particularly concerning patients with dementia receiving psychotropic drugs.

As a result of missing data concerning the real use and increase of drug prescriptions in nursing homes, our study will keep exploring the psychotropic drug use in the elderly population living in Norwegian nursing homes, and it will increase the knowledge about risk factors associated to higher prescription rates. The effect of structured reviews with NorGeP is understudied, and the proposed randomized controlled trial could therefore add valuable knowledge to the field, by exploring how specific training for health personnel working in nursing homes will affect drug prescription in the future.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • The participant is living in a participating nursing home
  • Expected stay for more than 12 weeks

排除标准

  • Severe somatic or psychiatric disease where the participant is too debilitated or not able to cooperate, or where the examination or assessment would cause a too big psychological and physical burden (i.e. severe psychotic state)

结局指标

主要结局

Change in Quality of Life: QUALID

时间窗: 12 weeks

Quality of Life in Late-Stage Dementia (QUALID) - Reporting the QoL of the patients on a scale from 11-55 where lower score indicates better QoL

次要结局

  • Anxiety(12 weeks)
  • Number of drugs prescribed(12 weeks)
  • Neuropsychiatric symptoms - agitation(12 weeks)
  • Neuropsychiatric symptoms - affective symptoms(12 weeks)
  • Activity of daily living(12 weeks)
  • Depression(12 weeks)
  • Cognition(12 weeks)
  • Physical health(Participants will be assessed at baseline, after 8 weeks and 12 weeks)

研究者

发起方
Ostfold Hospital Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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