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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.


N/A
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating

Outcome Time Frame:

Maximum study duration is 9 days per patient

Safety Issue:

Yes

Principal Investigator

Marie Fallon

Investigator Role:

Study Director

Investigator Affiliation:

University of Edinburgh

Authority:

United Kingdom: Research Ethics Committee

Study ID:

06/MRE10/84

NCT ID:

NCT00595777

Start Date:

December 2007

Completion Date:

August 2012

Related Keywords:

  • Cancer
  • Institutional change
  • Improved pain management

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