Edinburgh Pain Assessment Tool (EPAT©) Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||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.|
- The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating [ Time Frame: Maximum study duration is 9 days per patient ] [ Designated as safety issue: Yes ]
- Magnitude of change in BPI scores over the 2 evaluation points (includes impact on function) [ Time Frame: Maximum study duration is 9 days per patient ] [ Designated as safety issue: Yes ]
- Patient satisfaction with attention to pain [ Time Frame: Maximum study duration is 9 days per patient ] [ Designated as safety issue: Yes ]
- Global distress [ Time Frame: Maximum study duration is 9 days per patient ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2007|
|Study Completion Date:||August 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
No Intervention: 1. Comparison
The centres allocated to the comparison group will continue to provide usual care only.
Experimental: 2. Experimental
The EPAT package consists of an educational programme, which deals with the common barriers to effective cancer pain control and the bedside pain tool.
Behavioral: EPAT© Educational Package
The EPAT package consists of an education programme, which deals with the known common barriers to effective pain control and the bedside pain tool. The pain tool is uniquely incorporated into the vital signs chart to enable a systematic approach to cancer pain assessment and review. EPAT consists of 2 steps: step 1 is a colour-coded pain assessment on the bedside vital signs chart. Patients with moderate or severe pain on step 1 will progress to to step 2, which helps to identify the aetiology of the pain, screening for opioid side effects and is linked via flags to simple management plans. The intervention will be delivered to the clusters randomised to the intervention, after collection of baseline data (pre-intervention data) on 50 patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595777
|Mount Vernon Cancer Centre|
|Northwood, Middlesex, United Kingdom|
|Bristol Haematology and Oncology Centre|
|Bristol, Sommerset, United Kingdom, BS2 8ED|
|Belfast City Hospital|
|Belfast, United Kingdom|
|Queen Elizabeth Hospital|
|Birmingham, United Kingdom|
|Cambridge, United Kingdom|
|Cardiff, United Kingdom|
|The Western General Hospital|
|Edinburgh, United Kingdom|
|Beaston Oncology Centre|
|Glasgow, United Kingdom|
|Hull Royal Infirmary|
|Hull, United Kingdom|
|St. James's Hospital|
|Leeds, United Kingdom|
|Clatterbridge Centre for Oncology|
|Liverpool, United Kingdom|
|The Royal Marsden Hospital|
|London, United Kingdom|
|Manchester, United Kingdom|
|Newcastle, United Kingdom|
|Nottingham, United Kingdom|
|Oxford, United Kingdom|
|Plymouth, United Kingdom|
|Southampton University Hospital|
|Southampton, United Kingdom|
|The Royal Marsden Hospital|
|Sutton, United Kingdom|
|Study Director:||Marie Fallon||University of Edinburgh|
|Study Director:||Michael Sharpe||University of Edinburgh|
|Study Director:||Lesley Colvin||University of Edinburgh|
|Study Director:||Gordon Murray||University of Edinburgh|