Clinical trial NCT00595777: Edinburgh Pain Assessment Tool (EPAT©) 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Institutional change
Improved pain management
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
First posted: 2008-01-16
Enrollment: 1928
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: The magnitude of change in pain scores at the 2 evaluation points measured by patient self-rating
timeFrame: Maximum study duration is 9 days per patient
Secondary outcomes:
measure: Magnitude of change in BPI scores over the 2 evaluation points (includes impact on function)
timeFrame: Maximum study duration is 9 days per patient
measure: Patient satisfaction with attention to pain
timeFrame: Maximum study duration is 9 days per patient
measure: Global distress
timeFrame: Maximum study duration is 9 days per patient
Other outcomes:
Locations:
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre
state: Middlesex
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: Sommerset
city: Belfast
country: United Kingdom
facility: Belfast City Hospital
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Hospital
city: Edinburgh
country: United Kingdom
facility: The Western General Hospital
city: Glasgow
country: United Kingdom
facility: Beaston Oncology Centre
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
city: Leeds
country: United Kingdom
facility: St. James's Hospital
city: Liverpool
country: United Kingdom
facility: Clatterbridge Centre for Oncology
city: London
country: United Kingdom
facility: The Royal Marsden Hospital
city: Manchester
country: United Kingdom
facility: The Christie
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: City Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Southampton
country: United Kingdom
facility: Southampton University Hospital
city: Sutton
country: United Kingdom
facility: The Royal Marsden Hospital
Study officials:
affiliation: University of Edinburgh
name: Marie Fallon
role: STUDY_DIRECTOR
affiliation: University of Edinburgh
name: Michael Sharpe
role: STUDY_DIRECTOR
affiliation: University of Edinburgh
name: Lesley Colvin
role: STUDY_DIRECTOR
affiliation: University of Edinburgh
name: Gordon Murray
role: STUDY_DIRECTOR
References:
citation: Fallon M, Walker J, Colvin L, Rodriguez A, Murray G, Sharpe M; Edinburgh Pain Assessment and Management Tool Study Group. Pain Management in Cancer Center Inpatients: A Cluster Randomized Trial to Evaluate a Systematic Integrated Approach-The Edinburgh Pain Assessment and Management Tool. J Clin Oncol. 2018 May 1;36(13):1284-1290. doi: 10.1200/JCO.2017.76.1825. Epub 2018 Mar 15.