Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000097549
Ethics application status
Approved
Date submitted
14/01/2015
Date registered
4/02/2015
Date last updated
20/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Patient satisfaction with their pain management: The effect of provision of pain management advice
Scientific title
Emergency department provision of pain advice compared to standard care: effects on patient satisfaction
Secondary ID [1] 285971 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 293910 0
Condition category
Condition code
Anaesthesiology 294214 294214 0 0
Pain management
Public Health 294308 294308 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In one arm (control arm), patients will receive standard care. In the second arm, patients will receive standard care and will be told, by emergency department staff or the investigators, that 'pain management is important and that the patient should tell the staff if they have pain'.
Intervention code [1] 290949 0
Treatment: Other
Comparator / control treatment
Patients in the first arm of the study will receive standard emergency department care. This will comprise the recording of a pain score at triage and as necessary thereafter. Anagesia will be administered as considered appropriate by the emergency department staff.
Control group
Active

Outcomes
Primary outcome [1] 294001 0
Satisfaction with pain management. This will be collected using a 6 point ordinal scale (very dissatisfied - very satisfied)
Timepoint [1] 294001 0
48 hours post discharge from the emergency department
Secondary outcome [1] 312334 0
nil
Timepoint [1] 312334 0
na

Eligibility
Key inclusion criteria
Presentation to the emergency department for treatment
Age 18 years or more
Moderate or 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
Refusal to participate (by patient at follow up)
Triage category 1 (logistically difficult to obtain pain scores)
Significant illness/pain rendering pain scoring inappropriate
Inability to communicate a pain score (significant disability, severe illness, poor English)
Inability to follow up the patient (e.g. 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)
Patients meeting the study entrance criteria will be identified by a research assistant when they are moved to an emergency department cubicle. Patients will be allocated to the next consecutive study envelope wich will contain a note indicating which study arm the patient has been randomised to. Patients will not be told about the study (and their enrolemnt) until th efollow up phone call at 48 hours.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised random number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparison of proportions of patients who are very satisfied with their pain mangement.
In our recent study, 26% of patients who did not receive advice regarding pain management were very satisfied with their management. We expect that 40% of patient who do receive this advice will be very satisfied. The sample size is based upon this difference (level of significance 0.05, 2 sided, ratio number of patients in each group 1:1, power 0.8)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/02/2015
Actual
4/03/2015
Date of last participant enrolment
Anticipated
Actual
29/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
470
Accrual to date
Final
411
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3331 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 9110 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 290557 0
Hospital
Name [1] 290557 0
Austin Hospital Emergency Department
Country [1] 290557 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Studley Rd, Heidelberg, Victoria, Australia 3084
Country
Australia
Secondary sponsor category [1] 289249 0
None
Name [1] 289249 0
Address [1] 289249 0
Country [1] 289249 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292201 0
Austin Health
Ethics committee address [1] 292201 0
Studley Rd, Heidelberg, Victoria, Australia 3084
Ethics committee country [1] 292201 0
Australia
Date submitted for ethics approval [1] 292201 0
Approval date [1] 292201 0
18/12/2014
Ethics approval number [1] 292201 0
LNRSSA/14/Austin/562

Summary
Brief summary
Many variables impact upon a patient's satisfaction with the way their pain is managed in the Emergency Department (ED). These include the length of time before they receive analgesia, the nature of the analgesia, ancillary means of managing pain (e.g. ice packs), staff courtesy etc. In three studies, we have observed that a high level of patient satisfaction with their pain management is associated with the provision of ‘pain advice’ i.e. being told by the ED staff that ‘pain management is important and that the patient should tell the staff if they have pain’. Providing pain advice (as above) should be part of the routine management of patients with pain. However, this does not always happen and standard care may be sup-optimal. In this study, we will randomize patients into two groups: 1) standard care, 2) standard care plus provision of pain advice (as above). We hypothesize that the provision of pain advice will result in increased patient satisfaction measured ~48 hours after discharge from the ED. If demonstrated, this will be powerful evidence that will inform the development of best-practice pain management guidelines. This is a low risk study. All patients will receive at least standard care. The intervention arm will receive a component of care that should be provided as part of standard care but is often not provided.
Trial website
nil
Trial related presentations / publications
The results are yet to be published
Public notes

Contacts
Principal investigator
Name 54046 0
Prof David Taylor
Address 54046 0
Austin Hospital, Studley Rd, Heidelberg, Victoria 3084
Country 54046 0
Australia
Phone 54046 0
+61 3 9496 4711
Fax 54046 0
Email 54046 0
David.Taylor@austin.org.au
Contact person for public queries
Name 54047 0
Prof David Taylor
Address 54047 0
Austin Hospital, Studley Rd, Heidelberg, Victoria 3084
Country 54047 0
Australia
Phone 54047 0
+61 3 9496 4711
Fax 54047 0
Email 54047 0
David.Taylor@austin.org.au
Contact person for scientific queries
Name 54048 0
Prof David Taylor
Address 54048 0
Austin Hospital, Studley Rd, Heidelberg, Victoria 3084
Country 54048 0
Australia
Phone 54048 0
+61 3 9496 4711
Fax 54048 0
Email 54048 0
David.Taylor@austin.org.au

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
SourceTitleYear of PublicationDOI
EmbaseThe effect of provision of pain management advice on patient satisfaction with their pain management: A pilot, randomised, controlled trial (pain advice trial).2016https://dx.doi.org/10.1136/emermed-2015-205365
N.B. These documents automatically identified may not have been verified by the study sponsor.