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临床试验/NCT03298386
NCT03298386已完成不适用

Elderly Appropriate Treatment in Primary Care (EAT)

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 3,032 人开始时间: 2017年8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
3,032
试验地点
2
主要终点
A composite criterion: - percentage of unplanned hospitalization - percentage of death regardless of cause, - percentage of emergency department visit - percentage of institutionalization

研究概览

简要总结

The general practitioner (GP) is confronted, for a part of his clientele, with the management of patients suffering from multimorbidity, leading most often to a polypharmacy. It has five major consequences: increasing the number of inappropriate treatments, increasing the risk of potentially dangerous drug interactions, increasing the risk of contraindications associated with several concomitant pathologies, decreasing adherence to treatments by patients and the increased cost of care. Drug misuse in the elderly is particularly common, due to the age-related physiological changes and physiological alterations, with the consequent increase in the risk of adverse events, particularly hospitalizations. Several tools have been proposed to decrease morbimortality in elderly patients with polypharmacy. The studies concluded that the STOPP/START tool was the most structured, sensitive and had the most appropriate use format for clinical practice. However, there are currently no ambulatory studies demonstrating the impact of prescription revision with STOPP/START on the morbimortality of persons aged 75 years and over. This study aims to assess the effectiveness of an intervention targeting GPs to decrease morbimortality in elderly patients with polypharmacy. Volunteer GPs will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. The intervention consists in systematic medication review by GP with STOPP/START. In both groups, patient morbimortality will be measured at the end of the study.

详细描述

STOPP/START criteria for potential inappropriate prescribing in older people recognise the dual nature of inappropriate prescribing by including a list of potentially inappropriate medications (STOPP criteria) and potential prescribing omissions (START criteria).

研究设计

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

入排标准

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

入选标准

  • Patient 75 years of age or older
  • With polypharmacy (≥ 5 medications)
  • Not institutionalized
  • Patient affiliated with the French health care system
  • Oral consent given to participate in the study
  • Patient who can be followed up 12 months
  • Patient visiting the GP for any reason

排除标准

  • Patient protected by law (under guardianship or curatorship)
  • Having an estimated life expectancy of less than 12 months
  • Participating in a therapeutic trial during the study period

研究组 & 干预措施

Intervention Group "STOPP/START"

Experimental

Training of General Practitioners with the tool STOPP/START Systematic medication review by GP with STOPP/START

干预措施: Systematic medication review with the STOPP/START tool (Other)

Control group

No Intervention

Patient's usual care by the general practitioner (who will not be trained in the STOPP/START tool)

结局指标

主要结局

A composite criterion: - percentage of unplanned hospitalization - percentage of death regardless of cause, - percentage of emergency department visit - percentage of institutionalization

时间窗: at 12 months

The primary outcome measure will be a composite criterion comprising unplanned hospitalization, death regardless of cause, emergency department visits and institutionalization after 12 months of follow-up. Unplanned hospitalization is defined as either hospitalization decided after a visit to the emergency department (whether the patient was sent by a doctor or not) or hospitalization decided on the same day by the general practitioner.

次要结局

  • Decrease in the number of drugs on the prescription (%)(at 12 months)
  • Percentage of unplanned hospitalization(at 12 months)
  • Percentage of recommendations followed(at 12 months)
  • Percentage of death regardless of cause(at 12 months)
  • Percentage of loss of autonomy(at 12 months)
  • Percentage of emergency department visits(at 12 months)
  • Percentage of institutionalization(at 12 months)
  • Percentage of falls(at 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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