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临床试验/NCT05488834
NCT05488834已完成不适用

Nurse-led Pain Management in Adult ICU; A Randomised Stepped-Wedge Hybrid Effectiveness Trial

King Abdulaziz Medical City1 个研究点 分布在 1 个国家目标入组 880 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
880
试验地点
1
主要终点
Number of documented pain assessments per 24-hour period

研究概览

简要总结

This project is about implementing a pain scale, the Critical Care Pain Observation Tool (CPOT), in ICU settings at King Abdullah Medical City to evaluate its impact on nurse pain assessment and management.

Pain is considered as a significant problem in ICU and the literature shows that 50% of patients in ICU suffer moderate to severe pain and up to 70% of patients experience undetected pain while in ICU. The CPOT is an evidence-based intervention to assess pain among non-verbal patients in ICU settings. A stepped-Wedge Randomised trial will be used to implement the CPOT in 8 ICU in King Abduullah Medical City. Patient chart audits and a survey of ICU nurses will be conducted post implementation.

详细描述

This project is about implementing a pain scale, Critical Care Pain Observation Tool (CPOT), in 8 adult ICUs in King Abdullah Medical City to evaluate the impact on nurse pain assessment and management.

The literature shows that pain is perceived to be one of the most concerning issues in ICU and that 50% of patients in the ICU suffer moderate to severe pain. In addition, 70% of patients have undetected pain while admitted to ICU. Evidence-based guidelines suggest that CPOT is the most reliable and efficient pain scale tool for non-verbal patients in ICUs, and it is recommended in countries such as the USA, Canada, Australia and New Zealand. The literature suggests that CPOT has a positive impact on frequency of pain assessment.

A Stepped-Wedge Randomised trial will be used to implement the CPOT and at the same time assess the effectiveness of CPOT on pain assessment frequency and management. Patient charts will be audited, and a survey of nurses will be undertaken post CPOT implementation to assess the CPOT acceptability, appropriateness and feasibility.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Supportive Care
盲法
None

盲法说明

A stepped-wedge cluster randomised trial will be used to roll-out the implementation of CPOT (intervention) in a random sequence across groups. When the study starts, all groups will not be exposed to the intervention (control group). The groups are randomised and switched to the intervention at a predetermined moment. At the beginning of the trial, every two ICUs will be clustered in one group, so four groups will be formed. The study will be conducted over six months. In the first month (month 1), all groups will be in the control period, and then at month 2, the intervention will be implemented to the first group over one month, while the other three groups are in the control arm.

入排标准

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

入选标准

  • Patient's who are 18 years and above
  • Patients must be discharged from ICU
  • Exclusion criteria:
  • Patient's who are on muscle relaxants
  • Nurses survey
  • Inclusion criteria
  • Working in ICU
  • Understand English language

排除标准

  • 未提供

结局指标

主要结局

Number of documented pain assessments per 24-hour period

时间窗: 6 months

How many times pain is documented and reassessed then charted in the medical file for a non-verbal patient over a 24 hour period.

次要结局

  • Level of sedation and analgesia(6 months)
  • Length of intubation (LOI)(6 months)
  • Appropriateness(6 months)
  • ICU stay(6 months)
  • Acceptability(6 months)
  • Feasibility in nursing practice(6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Majid Alotni

PhD student

Newcastle University

研究点 (1)

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