Edinburgh Pain Assessment Tool (EPAT©) Study

This study has been completed.
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University of Edinburgh
ClinicalTrials.gov Identifier:
NCT00595777
First received: January 7, 2008
Last updated: September 25, 2012
Last verified: September 2012
  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
Cancer
Behavioral: EPAT© Educational Package

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

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

Primary Outcome Measures:
  • The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating [ Time Frame: Maximum study duration is 9 days per patient ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Magnitude of change in BPI scores over the 2 evaluation points (includes impact on function) [ Time Frame: Maximum study duration is 9 days per patient ] [ Designated as safety issue: Yes ]
  • Patient satisfaction with attention to pain [ Time Frame: Maximum study duration is 9 days per patient ] [ Designated as safety issue: Yes ]
  • Global distress [ Time Frame: Maximum study duration is 9 days per patient ] [ Designated as safety issue: Yes ]

Enrollment: 1928
Study Start Date: December 2007
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1. Comparison
The centres allocated to the comparison group will continue to provide usual care only.
Experimental: 2. 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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595777

Locations
United Kingdom
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, Sommerset, United Kingdom, BS2 8ED
Belfast City Hospital
Belfast, United Kingdom
Queen Elizabeth Hospital
Birmingham, 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
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, United Kingdom
Sponsors and Collaborators
University of Edinburgh
Cancer Research UK
Investigators
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

No publications provided

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT00595777     History of Changes
Other Study ID Numbers: 06/MRE10/84
Study First Received: January 7, 2008
Last Updated: September 25, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Edinburgh:
Institutional change
Improved pain management

ClinicalTrials.gov processed this record on July 29, 2014