跳至主要内容
临床试验/NCT02691754
NCT02691754已完成不适用

A Cluster Randomised Trial to Measure the Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription

Azienda USL Reggio Emilia - IRCCS0 个研究点目标入组 16 人开始时间: 2012年11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
发起方
入组人数
16
主要终点
Consumption of NSAID

研究概览

简要总结

Paracetamol is recommended as first line treatment for pain control in osteoarthritis, but it is not included in list of drugs than can be prescribed in charge of National Health System by General Practitioners. The hypothesis is that removing this economical barrier the investigators can decrease the prescription of NSAID and of the Proton Pump Inhibitors (PPI), often given for gastric bleeding prophylaxis in NSAID chronic users. As secondary outcome, opioids use was also monitored to see.

Aim of the study is to test if allowing prescription of free paracetamol decreases the prescription of NSAID in osteoarthritic patients.

详细描述

The trial was conducted in two primary care units of the province of Reggio Emilia. The units have about 34.000 inhabitants. In this units 16 General Practitioners are active, the average beneficiaries per General Practitioner are 1500, about one fourth over 65 years old.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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
否

入选标准

  • •Patients with osteoarthritis assisted by a General Practitioners working in Reggio Emilia Province who agreed to participate in the study
  • •Exclusion critera:

排除标准

  • 未提供

研究组 & 干预措施

free paracetamol

Experimental

the General Practitioners can prescribe paracetamol for free (covered by NHS). Patients can receive monthly dose at the local hospital

干预措施: free paracetamol (Other)

standard drug prescription

No Intervention

Paracetamol is not included in the list of drugs than can be prescribed in charge of National Health System by General Practitioners.

The General Practitioners can prescribe other drugs or recommend paracetamol payed by the patient (out of pocket) at the chemistry.

结局指标

主要结局

Consumption of NSAID

时间窗: one year

Difference in defined daily dose (DDD) per patient between the control and the intervention

次要结局

  • Consumption of PPI(one year)
  • Consumption of opioids(one year)

研究者

发起方
Azienda USL Reggio Emilia - IRCCS
申办方类型
Other Gov
责任方
Sponsor

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