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Edinburgh Pain Assessment Tool (EPAT©) Study

This study is currently recruiting participants.
Verified by University of Edinburgh, January 2008

Sponsors and Collaborators: University of Edinburgh
Cancer Research UK
Information provided by: University of Edinburgh
ClinicalTrials.gov Identifier: NCT00595777
  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

MedlinePlus related topics:   Cancer   

ChemIDplus related topics:   BaseLine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Health Services Research, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment:   1800
Study Start Date:   December 2007
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1. Comparison: No Intervention
The centres allocated to the comparison group will continue to provide usual care only.
2. Experimental: 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

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

Contacts
Contact: Moira Ross     +44 (0)131 777 3546     epat@ed.ac.uk    

Locations
United Kingdom, Sommerset
Bristol Haematology and Oncology Centre     Recruiting
      Bristol, Sommerset, United Kingdom, BS2 8ED
      Principal Investigator: Karen Forbes            

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


Responsible Party:   University of Edinburgh ( Professor Marie Fallon )
Study ID Numbers:   06/MRE10/84
First Received:   January 7, 2008
Last Updated:   January 15, 2008
ClinicalTrials.gov Identifier:   NCT00595777
Health Authority:   United Kingdom: Research Ethics Committee

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

Study placed in the following topic categories:
Pain

ClinicalTrials.gov processed this record on October 15, 2008




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