Edinburgh Pain Assessment Tool (EPAT©) Study

Cancer Clinical Trial

— EPAT©  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595777
• Other study ID #: 06/MRE10/84
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: September 25, 2012
• Start date: December 2007
• Est. completion date: August 2012

Study information

• Verified date: September 2012
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1928
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	Sommerset
United Kingdom	Addenbrookes Hospital	Cambridge
United Kingdom	Velindre Hospital	Cardiff
United Kingdom	The Western General Hospital	Edinburgh
United Kingdom	Beaston Oncology Centre	Glasgow
United Kingdom	Hull Royal Infirmary	Hull
United Kingdom	St. James's Hospital	Leeds
United Kingdom	Clatterbridge Centre for Oncology	Liverpool
United Kingdom	The Royal Marsden Hospital	London
United Kingdom	The Christie	Manchester
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Mount Vernon Cancer Centre	Northwood	Middlesex
United Kingdom	City Hospital	Nottingham
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Southampton University Hospital	Southampton
United Kingdom	The Royal Marsden Hospital	Sutton

Sponsors (2)

Lead Sponsor	Collaborator
University of Edinburgh	Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Magnitude of change in BPI scores over the 2 evaluation points (includes impact on function)		Maximum study duration is 9 days per patient	Yes
Secondary	Patient satisfaction with attention to pain		Maximum study duration is 9 days per patient	Yes
Secondary	Global distress		Maximum study duration is 9 days per patient	Yes