NCT00595777

Edinburgh Pain Assessment Tool (EPAT©) Study

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,928 (actual)
• Sponsor: University of Edinburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-12-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2008-01-16
• Last updated: 2012-09-26

Locations

19 sites across 1 country: United Kingdom