Edinburgh Pain Assessment Tool (EPAT©) Study
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | January 7, 2008 | ||||||||||||||||
| Last Updated Date | September 25, 2012 | ||||||||||||||||
| Start Date ICMJE | December 2007 | ||||||||||||||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00595777 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Edinburgh Pain Assessment Tool (EPAT©) Study | ||||||||||||||||
| Official Title ICMJE | 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. | ||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Cancer | ||||||||||||||||
| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 1928 | ||||||||||||||||
| Completion Date | August 2012 | ||||||||||||||||
| Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | United Kingdom | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00595777 | ||||||||||||||||
| Other Study ID Numbers ICMJE | 06/MRE10/84 | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| Responsible Party | University of Edinburgh | ||||||||||||||||
| Study Sponsor ICMJE | University of Edinburgh | ||||||||||||||||
| Collaborators ICMJE | Cancer Research UK | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Edinburgh | ||||||||||||||||
| Verification Date | September 2012 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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