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.
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating
Maximum study duration is 9 days per patient
Yes
Marie Fallon
Study Director
University of Edinburgh
United Kingdom: Research Ethics Committee
06/MRE10/84
NCT00595777
December 2007
August 2012
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