Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000580875
Ethics application status
Approved
Date submitted
25/05/2012
Date registered
29/05/2012
Date last updated
20/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Best practice pain management in the emergency department: a cluster-randomised, controlled, clinical intervention trial
Scientific title
The administration to emergency department patients of an adequate analgesia intervention or standard care and its effects on patient satisfaction with their pain management.
Secondary ID [1] 280558 0
NIL
Universal Trial Number (UTN)
Trial acronym
The TARGET Pain trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 286557 0
Condition category
Condition code
Other 286825 286825 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
Public Health 286851 286851 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention will be the introduction of an 'adequate analgesia' target into clinical practice for a period of 6 months. In this study, 'adequate analgesia' is defined as that providing a decrease in the patient's triage pain score of at least 2 points and to a level that is less than 4 points (scale 0-10). Emergency Department staff will use this definition as a target to guide the management of their patient's pain. Any treatment used (including drug, dose, mode of administration, etc.) will be at the discretion of the treating clinician.
Intervention code [1] 284940 0
Treatment: Other
Comparator / control treatment
The participating emergency departments will be randomised to a cluster that will introduce the study intervention and a cluster that does not. The cluster that does not introduce the intervention will provide patients with standard pain management. Standard pain management will serve as the control. Standard pain management is any treatment used (including drug, dose, mode of administration, etc.) at the discretion of the treating clinician.
Control group
Active

Outcomes
Primary outcome [1] 287190 0
Patient satisfaction with their pain management in the Emergency Department. This will be assessed using a 6 point ordinal scale (very unsatisfied, unsatisfied, slightly unsatisfied, slightly satisfied, satisfied, very satisfied)
Timepoint [1] 287190 0
48 hours post-discharge from the Emergency Department
Secondary outcome [1] 297584 0
Sustainability of the intervention. This will be assessed by measuring patient satifaction (ordinal scale) six months after the intervention is introduced.
Timepoint [1] 297584 0
6 months post-intervention
Secondary outcome [2] 297585 0
Proportions of patients who receive any analgesia/opioids/parenteral analgesia
Timepoint [2] 297585 0
At discharge from the emergency department
Secondary outcome [3] 297586 0
Proportion of patients meeting the clinical target (pain decreased by at least 2 and to a level of less than 4) using a 10 point numerical rating scale.
Timepoint [3] 297586 0
At discharge from the emergency department

Eligibility
Key inclusion criteria
-age 18 years or more
-moderate/severe pain (triage pain score of at least 4)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-suspected cardiac chest pain (pain is treated differently)
-triage category 1 (often treated differently)
-inability to communicate a pain score (dementia, delirium, significant illness, poor English)
-patients being treated by a study investigator (to avoid a Hawthorne affect)
-inability to follow up (eg. no telephone)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The participating emergency departments will be randomised to an intervention cluster or a control cluster. Randomisation will be undertaken at the central administration site using computer generated numbers. Each site will then be advised by mail of their allocation and management will be 'open' (not blinded). For the first 3 months, the emergency departments will provide pain management for their patients that is consistent with their allocation. That is, either striving for the 'adequate analgesia' target or standard pain management. Individual patients will not be randomised.

At the end of 3 months, the emergency departments that were providing standard care will introduce the study intervention for the next 3 months. The original interventioncluster will continue with the study intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation will be used to randomise the emergency departments
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The first 3 months of the study, patients will receive the type of pain management to which their emergency department has been allocated. They will either receive intervention or standard management. In the second 3 months all patients will receive intervention management.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2012
Actual
3/06/2013
Date of last participant enrolment
Anticipated
1/03/2014
Actual
30/03/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
1317
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5337 0
3220
Recruitment postcode(s) [2] 5338 0
4215
Recruitment postcode(s) [3] 5339 0
6231
Recruitment postcode(s) [4] 5340 0
4814
Recruitment postcode(s) [5] 5341 0
4101
Recruitment postcode(s) [6] 5342 0
4102
Recruitment postcode(s) [7] 5343 0
6001
Recruitment postcode(s) [8] 5344 0
6992

Funding & Sponsors
Funding source category [1] 285322 0
Charities/Societies/Foundations
Name [1] 285322 0
Australasian College for Emergency Medicine Research Foundation
Country [1] 285322 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian College for Emergency Medicine Clinical Trials Group
Address
Australasian College for Emergency Medicine
Westcott Street
West Melbourne
Victoria 3003
Country
Australia
Secondary sponsor category [1] 284189 0
None
Name [1] 284189 0
Address [1] 284189 0
Country [1] 284189 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287340 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 287340 0
Ethics committee country [1] 287340 0
Australia
Date submitted for ethics approval [1] 287340 0
10/06/2012
Approval date [1] 287340 0
10/10/2012
Ethics approval number [1] 287340 0
HREC/12/Austin/58

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34226 0
Prof David Taylor
Address 34226 0
Emergency Department, Austin Hospital, Heidelberg, Victoria, Australia 3084
Country 34226 0
Australia
Phone 34226 0
+61 3 9496 4711
Fax 34226 0
Email 34226 0
[email protected]
Contact person for public queries
Name 17473 0
Professor David Taylor
Address 17473 0
Emergency Department
Austin Hospital
Studley Rd
Heidelberg
Victoria 3084
Country 17473 0
Australia
Phone 17473 0
+61 3 9496 4711
Fax 17473 0
+61 3 9496 3380
Email 17473 0
[email protected]
Contact person for scientific queries
Name 8401 0
Professor David Taylor
Address 8401 0
Emergency Department
Austin Hospital
Studley Rd
Heidelberg
Victoria 3084
Country 8401 0
Australia
Phone 8401 0
+61 3 9496 4711
Fax 8401 0
+61 3 9496 3380
Email 8401 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.