Does the Institutionalisation of Pain Assessment Using the EPAT© Package Reduce the Pain in Cancer In-patients More Than Usual Care; a Cluster Randomised Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,928
- 试验地点
- 20
- 主要终点
- The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating
研究概览
简要总结
To determine if the institutionalisation of a regular systematic approach to the assessment of pain in inpatient cancer units using the Edinburgh Pain Assessment Tool (EPAT©) leads to better control of pain than that achieved by usual care.
详细描述
Background and relevance to cancer - Pain associated with cancer has a severe negative impact on quality of life and can also limit a patient's ability to tolerate potentially life-saving tumoricidal treatment. Unfortunately in practice only half of cancer patients receive adequate pain control. A fundamental reason for this is inadequate assessment of pain. The institutionalisation of pain assessment as a 5th vital sign on the bedside chart combined with training and guidance in pain management (EPAT) is a potentially effective solution.
We have already evaluated the feasibility and efficacy of EPAT in a randomised trial of 150 oncology inpatients and found that by Day 4 after admission 90% reported adequate pain control compared to only 52% of those who received usual care.
Aims - We now want to evaluate the effectiveness and cost-effectiveness of EPAT in practice and ask: Does it reduce cancer pain more that usual care? Are there adverse effects? Is it cost effective?
Outline plan - A UK-wide cluster randomised controlled trial of 18 inpatient cancer centres of which half will use the EPAT package and half usual care. The trial outcomes are clinically significant improvement, adverse effects such as opiate toxicity and cost effectiveness.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and consent to complete a Brief Pain Inventory score
- •Aged over 18 years
- •Have a pain score equal to or greater than 4 out of 10 at first assessment point (within 24 hours of admission) and pain is cancer related
- •Are expected to be available for pain assessment at 3 days after admission
排除标准
- •Do not consent to take part in the study or who are too ill to take part, including those with severe mental health problems
- •Do not have cancer-related pain
- •Are under 18 years of age
- •Have a pain score of less than 4
- •Are not expected to be available for pain assessment at 3 days after admission
结局指标
主要结局
The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating
时间窗: Maximum study duration is 9 days per patient
次要结局
- Magnitude of change in BPI scores over the 2 evaluation points (includes impact on function)(Maximum study duration is 9 days per patient)
- Patient satisfaction with attention to pain(Maximum study duration is 9 days per patient)
- Global distress(Maximum study duration is 9 days per patient)