跳至主要内容
临床试验/NCT02570945
NCT02570945已完成4 期

Randomized Controlled Trial of a Pharmacist-physician Intervention Model to Reduce High-risk Drug Use by Elderly Inpatients

Centre de recherche du Centre hospitalier universitaire de Sherbrooke0 个研究点目标入组 321 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
321
主要终点
Change rate in medication

研究概览

简要总结

The study population will consist of all elderly (65 and older) patients hospitalized at the Centre hospitalier universitaire de Sherbrooke. The patients who present a pharmacotherapeutic problem will be randomly allocated between intervention and control groups. Practically, the relevant data will be extracted from the Electronic Medical Record (EMR) on a daily basis and analysed by a Computerized Alert System (CAS) to identify pharmacotherapeutic problems. These problems will be analysed a pharmacist specialised in geriatrics to determine their clinical relevance and the modifications that can be made. Clinically relevant pharmacotherapeutic problems will be discussed by the pharmacist and treating physician to establish the changes needed to optimize drug therapy. A geriatrician will also be available to assist the pharmacist in his initial assessment for particularly complex cases. For control patients, a CAS analysis will be conducted to identify patients with a pharmacotherapeutic problem but there will not be a formal discussion amongst the health care providers (usual care) and the physicians of the control group will provide usual care to their patients. The investigators believe that it is ethical to provide usual care to the control group since the beneficial impact on patients outcomes of the investigators' intervention has not been demonstrated.

Pharmacotherapeutic problems were prioritized by the CHUS Elderly Adapted Care-medication committee and are based on the Beers criteria with an emphasis on drugs involved in the development of delirium. Selected pharmacotherapeutic problems are: 1) For patients 75 and older: i) taking a PIM; ii) concomitant use of 4 or more drugs from a list of drugs active at the CNS; iii) positive test for delirium with a PIM; 2) For patients 65 years and older: i) taking levodopa (Parkinson indicator) with a PIM; ii) taking cholinesterase inhibitor or memantine (indicators of dementia) with a PIM. The use of levodopa, a cholinesterase inhibitor or memantine are frailty indicators.

研究设计

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

入排标准

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

入选标准

  • Patients 65 and older admitted at the Centre hospitalier universitaire de Sherbrooke

排除标准

  • Patients admitted in psychiatry and intensive care
  • Patients seen only in the emergency room

结局指标

主要结局

Change rate in medication

时间窗: 48 hours

The main outcome was the change rate in medications, defined as the number of patient-days with a change in at least one medication out of the total number of patient-days with a pharmacist intervention with the treating physician.

次要结局

  • Clinical relevance of the Computerized Alert System alerts(1 day)
  • Number of falls(From randomisation to the end of the hospitalisation, an average of 12 days)
  • Death(From randomisation to the end of the hospitalisation, an average of 12 days)
  • Delirium(From randomisation to the end of the hospitalisation, an average of 12 days)
  • Readmission within 30 days of hospital discharge(30 days after hospital discharge)

研究者

发起方
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benoit Cossette

Principal investigator

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

相似试验