跳至主要内容
临床试验/NCT00784381
NCT00784381已完成不适用

Impact of a Counselling System Coupled With a Computer Prescribing System to Optimize the Use of the Drugs for Old Subjects Having Renal Function Impairment

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Comparison of the changes from baseline of proportions [patients with inappropriate target drug prescribing/patients with creatinine clearance<60 ml/mn] between control and intervention groups

研究概览

简要总结

To evaluate the quality of orders for target drugs in old patients with impaired renal function, hospitalized or living in long stay units, and to improve these practices by means of a counselling system coupled to a computer prescribing system

详细描述

Context: The incidence of drug side effects increases with patient age, and the frail old subjects hospitalized in geriatric units are particularly exposed to this risk. Optimizing drug prescription is an important issue to prevent the side effects. Among the various possible actions, it is important to pay attention to impaired renal function which requires careful dose adjustment for drugs eliminated by renal way.

Objective: To evaluate the quality of orders for target drugs in old patients with impaired renal function, hospitalized or living in long stay units, and to improve these practices by means of counselling system coupled to a computer prescribing system. The computer prescribing system allow (a) to detect in real-time the order of drugs contraindicated in case of renal failure or prescribed in excessive amount taking into account the creatinine clearance (ClCr), and (b) to counsel the physician in these situations.

Participants: A coordinating centre (team of geriatrics 1, hospital Charles Foix, Ivry-sur-Seine, France), and 12 hospital investigator centres (hospital services of geriatrics working already in network, including the co-ordinating centre), and the department of Biostatistics (hospital Pitié-Salpétrière, Paris)

Type of study: Intervention study, cluster randomised, open, parallel.

General design: The investigator centres will be equipped with the electronic prescribing system (EPS) developed for the project. For each patient, the software requires the seizure of weight and plasma creatinine and calculates ClCr using Cockcroft formula, from which the result is accessible to the physician. After a phase of training of the EPS, the quality of the orders given to old subjects having renal failure (defined by ClCr<60 ml/mn) will be studied for 3 months under natural conditions of prescribing, without use of the counselling system (sequence A). After this phase, the counselling system will be activated for 6 months (sequence B) in 6 investigatory centres chosen by a cluster randomisation process. The centres were paired by the numbers of orders during the sequence A. For each pair, the centres were allocated to either intervention or control group by a randomisation table.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • geriatrics hospital units or nursing homes
  • using the same electronic prescribing system called ORDOCLIC
  • agreeing to participate in the study

排除标准

  • 未提供

结局指标

主要结局

Comparison of the changes from baseline of proportions [patients with inappropriate target drug prescribing/patients with creatinine clearance<60 ml/mn] between control and intervention groups

时间窗: 6 months

次要结局

  • Time-related improvement of target drug prescribing in intervention units(9 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验