Edinburgh Pain Assessment Tool (EPAT©) Study
- Conditions
- Cancer
- Interventions
- Behavioral: EPAT© Educational Package
- Registration Number
- NCT00595777
- Lead Sponsor
- University of Edinburgh
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1928
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2. Experimental EPAT© Educational Package The EPAT package consists of an educational programme, which deals with the common barriers to effective cancer pain control and the bedside pain tool.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (18)
City Hospital
🇬🇧Nottingham, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Southampton University Hospital
🇬🇧Southampton, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Mount Vernon Cancer Centre
🇬🇧Northwood, Middlesex, United Kingdom
Belfast City Hospital
🇬🇧Belfast, United Kingdom
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
The Western General Hospital
🇬🇧Edinburgh, United Kingdom
St. James's Hospital
🇬🇧Leeds, United Kingdom
Churchill Hospital
🇬🇧Oxford, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Liverpool, United Kingdom
The Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Freeman Hospital
🇬🇧Newcastle, United Kingdom
The Christie
🇬🇧Manchester, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, Sommerset, United Kingdom
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
Beaston Oncology Centre
🇬🇧Glasgow, United Kingdom
Velindre Hospital
🇬🇧Cardiff, United Kingdom