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临床试验/NCT02083835
NCT02083835招募中不适用

Improvement in Postoperative Pain Outcome

University of Jena2 个研究点 分布在 1 个国家目标入组 200,000 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200,000
试验地点
2
主要终点
Assessment of postoperative pain treatment

研究概览

简要总结

PAIN OUT is a multi-national, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported outcome data of postoperative pain.

详细描述

PAIN OUT offers a large registry as well as a system for benchmarking and feedback of outcome quality and decision support in acute pain conditions. It collects demographic, clinical and outcome data, using a validated assessment tool available in multiple languages.

The registry part of the project aims at performing population-based research. Furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care.

The benchmark part of the project provides the medical community with a unique, user-friendly system to improve treatment of patients with postoperative pain. A web-based information system, featuring two main functions, was developed:

  1. a feedback and benchmarking system which provides participating sites with continuously updating data and analyses about the quality of care they provide compared to other institutions and allows identification of best clinical practice.
  2. a knowledge library which provides clinicians with easily accessible and regularly updated summaries of evidence-based recommendations tailored to specific post-operative situations.

PAIN OUT is leading and overseeing sub-projects in Mexico, China, a number of European countries. Additional countries will join over time. The sub-projects are scheduled to take place over a period of two years. The design is an uncontrolled pre- post-study, in which approximately 10 hospitals from each country participate. The project consists of collecting data (processes and patient reported outcomes) at baseline from 1-3 wards in participating hospitals; analyzing of the findings, selecting and implementing measures for change in practice; carrying out another round of data collection; summerizing the findings and discussing options for further work.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • >= 18 years or >= 4 years for sub-project QUIPSI/PAIN OUTinfant
  • patient is post-op day 1
  • patient is at least 6 hours on the ward
  • patient has given consent

排除标准

  • patient cannot communicate
  • patient is cognitively impaired
  • patient is asleep
  • patient is too ill
  • patient does not want to fill in the questionnaire

研究组 & 干预措施

post-surgical patients

post-surgical patients > 18 years

pediatric patients post-op day 1

pediatric patients <18 years on post-op day 1 (sub-project QUIPSI - PAIN OUTinfant)

结局指标

主要结局

Assessment of postoperative pain treatment

时间窗: first postoperative day

次要结局

  • patients' perception of pain treatment outcome(first postoperative day)

研究者

发起方
University of Jena
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Winfried Meissner

apl. Prof. Dr. med. Winfried Meissner

University of Jena

研究点 (2)

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