Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1928 participants
INTERVENTIONAL
2007-12-31
2012-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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1. Comparison
The centres allocated to the comparison group will continue to provide usual care only.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Cancer Research UK
OTHER
University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Marie Fallon
Role: STUDY_DIRECTOR
University of Edinburgh
Michael Sharpe
Role: STUDY_DIRECTOR
University of Edinburgh
Lesley Colvin
Role: STUDY_DIRECTOR
University of Edinburgh
Gordon Murray
Role: STUDY_DIRECTOR
University of Edinburgh
Locations
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Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, Sommerset, United Kingdom
Belfast City Hospital
Belfast, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Velindre Hospital
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
The Christie
Manchester, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
City Hospital
Nottingham, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Southampton University Hospital
Southampton, , United Kingdom
The Royal Marsden Hospital
Sutton, , United Kingdom
Countries
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References
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Fallon M, Walker J, Colvin L, Rodriguez A, Murray G, Sharpe M; Edinburgh Pain Assessment and Management Tool Study Group. Pain Management in Cancer Center Inpatients: A Cluster Randomized Trial to Evaluate a Systematic Integrated Approach-The Edinburgh Pain Assessment and Management Tool. J Clin Oncol. 2018 May 1;36(13):1284-1290. doi: 10.1200/JCO.2017.76.1825. Epub 2018 Mar 15.
Other Identifiers
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06/MRE10/84
Identifier Type: -
Identifier Source: org_study_id