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临床试验/NCT01513265
NCT01513265已完成不适用

Rationalisation of Polypharmacy in the Elderly by the RASP Instrument (Rationalisation of Home Medication by an Adjusted STOPP-list in Older Patients): a Prospective, Clinical Trial.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2011年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
172
试验地点
1
主要终点
Number of actually stopped or adjusted drugs

研究概览

简要总结

The aim of this study is to determine whether a clinical pharmacist using the RASP list (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions) can optimise the drug use in elderly inpatients.

详细描述

Older persons take on average multiple drugs. As people age, there is an apparent increase in pharmacodynamic sensitivity to different making the patient more prone to experience side effects. Alterations in body composition and concomitant changes in pharmacokinetic parameters can also result in a higher risk for adverse drug events. All these factors make the older person, notwithstanding the heterogeneity of this population, more vulnerable for the negative consequences of polypharmacy.

Polypharmacy is a cause of negative clinical outcomes but it still remains unclear which intervention or set of interventions should be used to optimize the prescription of pharmacotherapy in the elderly patient. Therefore, the investigators developed the RASP (RASP = Rationalisation of home medication by an adjusted STOPP-list in older patients; STOPP = Screening Tool of Older Persons' potentially inappropriate Prescriptions), a list as tool to reduce polypharmacy adapted to Belgian national prescribing tendencies within geriatric wards. Content and reliability of the RASP have been validated and the investigators aim to further study the impact of the systematic implementation of this RASP on geriatric wards in a prospective cluster randomized controlled trial.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Care Provider)

入排标准

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

入选标准

  • •Signed informed consent by the patient or a caregiver if the patient is incompetent to sign
  • •Consecutive inclusion of all newly admitted patients to the wards coming from home or the emergency room department

排除标准

  • •Patients not admitted to the hospital from home or a nursing home
  • •Patients unable to communicate in Dutch
  • •Patients admitted for palliative care
  • •Patients who do not take any drugs at admission

研究组 & 干预措施

RASP

Active Comparator

干预措施: Pharmaceutical care plan, mostly based on the RASP (Other)

Control group

No Intervention

Subjects enrolled in this arm will undergo usual medical and pharmaceutical care with registration of drug use at admission and discharge without interference of RASP or clinical pharmacist.

结局指标

主要结局

Number of actually stopped or adjusted drugs

时间窗: Patients will be followed for the duration of hospital stay, an expected average of 14 days.

At hospital discharge the number of stopped or adjusted drugs will be determined. This variable will be compared between the two arms.

次要结局

  • Length of stay(Determined at discharge, on average after 14 days)
  • Number of potentially inappropriate drug prescriptions as defined by the RASP.(Patients will be followed for the duration of hospital stay, an expected average of 14 days.)
  • Number of falls post-discharge(Within 90 days post-discharge)
  • Actual drug use(Measured on 30 and 90 days post-discharge.)
  • Number of falls(Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge)
  • Incidence of delirium(Patients will be followed for the duration of hospital stay, an expected average of 14 days)
  • Number and category of drugs adjusted on recommendations of the clinical pharmacist independent of RASP(Patients will be followed for the duration of hospital stay, an expected average of 14 days.)
  • Mortality(Measured during hospitalisation, an expected average of 14 days and within 90 days after discharge.)
  • Quality of Life (EQ-5D-3L)(Patients will be followed for the duration of hospital stay, an expected average of 14 days.)
  • Rehospitalisation(Within 90 days post-discharge.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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