Edinburgh Pain Assessment Tool (EPAT©) Study
EPAT©
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.
1 other identifier
interventional
1,928
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Dec 2007
Longer than P75 for not_applicable cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 7, 2008
CompletedFirst Posted
Study publicly available on registry
January 16, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedSeptember 26, 2012
September 1, 2012
4.7 years
January 7, 2008
September 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
1. Comparison
NO INTERVENTIONThe centres allocated to the comparison group will continue to provide usual care only.
2. Experimental
EXPERIMENTALThe EPAT package consists of an educational programme, which deals with the common barriers to effective cancer pain control and the bedside pain tool.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Edinburghlead
- Cancer Research UKcollaborator
Study Sites (19)
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, Sommerset, BS2 8ED, 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
Related Publications (1)
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.
PMID: 29543567DERIVED
MeSH Terms
Conditions
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2008
First Posted
January 16, 2008
Study Start
December 1, 2007
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
September 26, 2012
Record last verified: 2012-09