Edinburgh Pain Assessment Tool (EPAT©) Study

University of Edinburgh

Status: Completed

Conditions: Cancer

Treatments: Behavioral: EPAT© Educational Package

Study type: Interventional

Funder types: Other

Identifiers

NCT00595777

06/MRE10/84

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,928 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,928 participants in 2 patient groups

1. Comparison

No Intervention group

Description:

The centres allocated to the comparison group will continue to provide usual care only.

2. Experimental

Experimental group

Description:

The EPAT package consists of an educational programme, which deals with the common barriers to effective cancer pain control and the bedside pain tool.

Treatment:

Behavioral: EPAT© Educational Package