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| Sponsors and Collaborators: |
University of Edinburgh Cancer Research UK |
| Information provided by: | University of Edinburgh |
| ClinicalTrials.gov Identifier: | NCT00595777 |
Purpose
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.
| Condition | Intervention |
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Cancer |
Behavioral: EPAT© Educational Package |
| MedlinePlus related topics: | Cancer |
| ChemIDplus related topics: | BaseLine |
| Study Type: | Interventional |
| Study Design: | Health Services Research, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| 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. |
| Estimated Enrollment: | 1800 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1. Comparison: No Intervention
The centres allocated to the comparison group will continue to provide usual care only.
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2. Experimental: 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.
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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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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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Moira Ross | +44 (0)131 777 3546 | epat@ed.ac.uk |
| United Kingdom, Sommerset | |||||
| Bristol Haematology and Oncology Centre | Recruiting | ||||
| Bristol, Sommerset, United Kingdom, BS2 8ED | |||||
| Principal Investigator: Karen Forbes | |||||
| University of Edinburgh |
| Cancer Research UK |
| 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 |
More Information
| Responsible Party: | University of Edinburgh ( Professor Marie Fallon ) |
| Study ID Numbers: | 06/MRE10/84 |
| First Received: | January 7, 2008 |
| Last Updated: | January 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00595777 |
| Health Authority: | United Kingdom: Research Ethics Committee |
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