Edinburgh Pain Assessment Tool (EPAT©) Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: EPAT© Educational Package


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1. Comparison<br>The centres allocated to the comparison group will continue to provide usual care only. | |
| Experimental: 2. Experimental<br>The EPAT package consists of an educational programme, which deals with the common barriers to effective cancer pain control and the bedside pain tool. | Behavioral: EPAT© Educational Package<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Institutional change, Improved pain management