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Trial registered on ANZCTR


Registration number
ACTRN12618002013246
Ethics application status
Approved
Date submitted
11/12/2018
Date registered
14/12/2018
Date last updated
9/12/2019
Date data sharing statement initially provided
14/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Factors impacting on patient satisfaction with pain management in the Emergency Department
Scientific title
Factors impacting on patient satisfaction with pain management in the Emergency Department
Secondary ID [1] 296855 0
None
Universal Trial Number (UTN)
U1111-1225-3850
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain 310761 0
Condition category
Condition code
Emergency medicine 309451 309451 0 0
Other emergency care
Anaesthesiology 309474 309474 0 0
Pain management
Public Health 309475 309475 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients enrolled will be randomised to be consented for follow up either while they are in the emergency department or at the time of the follow up telephone call (48 hours post emergency department discharge). Those consented in the emergency department will have the study explained by a final year medical student. They will be given an information form and allowed to ask any questions. Verbal consent will be obtained and documented. Those not consented in the emergency department will not know of the study until they receive the follow up call. At that time, the student will give an explanation of the study, answer any questions and obtain verbal consent before proceeding. Neither patient group will be aware that they were randomised to consent in the ED or at follow up. Both techniques could be considered standards of care and knowledge of the randomisation has the potential to introduce response bias into the data - something that could compromise the study's findings. The approving ethics committee was happy with this approach.
The total time commitment for each participant is expected to be approximately 5 minutes (including explanation of the study and consent.
Intervention code [1] 313135 0
Other interventions
Comparator / control treatment
The control group will comprise those patients who are consented for follow up while they are in the emergency department. This is because this is the standard of care for most follow up studies.
Control group
Active

Outcomes
Primary outcome [1] 308406 0
The outcome will be the level of patient satisfaction with their pain management. This will be measured on using a 6 point ordinal scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied). We have used this tool on many occasions.
Timepoint [1] 308406 0
48 hours post discharge from the emergency department
Secondary outcome [1] 354882 0
We also aim to determine the variables associated with patient satisfaction with their pain management (i.e. the primary outcome).
These variables comprise a standard demographic variables and aspects of the participants' management in the emergency department, The former will be collected from the electronic medical record and the latter using a questionnaire specifically designed for this study.
Timepoint [1] 354882 0
48 hours post discharge from the emergency department
Secondary outcome [2] 354883 0
The outcome will be the level of patient satisfaction with their pain management. This will be measured on using a 6 point ordinal scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied). We will determine statistically which of a range of demographic and management variables are associated with patient satisfaction.
Timepoint [2] 354883 0
48 hours post discharge from the emergency department

Eligibility
Key inclusion criteria
• Age 18 years or more
• Moderate or severe pain (triage pain score 4 or more on a scale of 0-10)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Refusal to participate (in the ED or at follow up)
• Significant illness/pain rendering pain scoring inappropriate
• Inability to communicate a pain score (significant disability or cognitive impairment, 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)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
At no time will participants be aware that they were randomised to consent in the emergency department or at follow up. While all will provide consent at some stage, they will be blinded to the fact that they had been randomised. This feature of the study design is intentional and attempts to avoid the possibility of response bias.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size is based upon the important association between receipt of any analgesia and satisfaction with pain management. Approximately 48% of patients treated in the Austin ED are ‘very satisfied’ with their pain management [Emerg Med J 2016; 33: 453-457]. We expect that more patients who receive analgesia in the ED will be ‘very satisfied’ than patients who do not. We believe that a clinically significant difference in the proportions of patients who are ‘very satisfied’ will be 15% e.g. 50% versus 35%, respectively. Data from our previous pain studies indicate that approximately 80% of patients who present with a pain score of 4 or more (out of 10) receive analgesia in the ED. In order to demonstrate a statistically significant difference in the proportions who are very satisfied in the two patient subgroups (50% versus 35%), we need to enroll at least 516 and 129 patients who do/do not receive analgesia, respectively (ratio 4:1, alpha 0.05, 2-sided, power 0.85). To account for some uncertainty in this calculation, we will round up the sample sizes to 520 and 130, respectively (total sample size 650). This sample size will be adequate for a statistical comparison of the effect of the informed consent process (power >0.95).

The primary outcome (patients ‘very satisfied’ with their pain management) will be reported descriptively (n, %).

The differences in patient satisfaction between subgroups of patients (e.g. age groups) will be compared using the Chi square test (proportion in each subgroup that is ‘very satisfied’). Logistic regression will then be undertaken to further determine variables associated with patient satisfaction. The level of significance will be 0.05.

The differences in patient loss to follow up rates (patients consented in the ED versus those consented at follow up) will be compared using the Chi square. The level of significance will be 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/02/2019
Actual
5/02/2019
Date of last participant enrolment
Anticipated
10/05/2019
Actual
6/05/2019
Date of last data collection
Anticipated
16/05/2019
Actual
13/05/2019
Sample size
Target
650
Accrual to date
Final
655
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12703 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 25124 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301427 0
Hospital
Name [1] 301427 0
Austin Hospital
Country [1] 301427 0
Australia
Primary sponsor type
Hospital
Name
Austin Hospital
Address
Studley Road, Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 301106 0
None
Name [1] 301106 0
Address [1] 301106 0
Country [1] 301106 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302160 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302160 0
Austin Hospital, Studley Road, Heidelberg, VIC 3084
Ethics committee country [1] 302160 0
Australia
Date submitted for ethics approval [1] 302160 0
17/10/2018
Approval date [1] 302160 0
13/11/2018
Ethics approval number [1] 302160 0
HREC-44954-Austin-2018

Summary
Brief summary
Our experience with cold calling patients to obtain followup data on their satisfaction with pain management is that some patients were upset by the unexpected cold call. We hypothesized, therefore, that this upset may affect the way that patients respond to the subjective question of satisfaction. We undertook a clinical trial where patients were randomized to consent to participate either in the emergency department or at the start of the cold call. The purpose of the study was to determine if the timing and context of informed consent would confound (impact upon) subjective study endpoints.
Trial website
Trial related presentations / publications
Presented at the Australasian College for Emergency Medicine Annual Scientific Meeting in Hobart November 2019. (Best Paper session). Paper for publication is being prepared.
Public notes

Contacts
Principal investigator
Name 89334 0
Prof David Taylor
Address 89334 0
c/o Emergency Department, Austin Hospital, Studley Rd, Heidelberg, VIC 3084
Country 89334 0
Australia
Phone 89334 0
+61 3 9496 4711
Fax 89334 0
Email 89334 0
[email protected]
Contact person for public queries
Name 89335 0
David Taylor
Address 89335 0
c/o Emergency Department, Austin Hospital, Studley Rd, Heidelberg, VIC 3084
Country 89335 0
Australia
Phone 89335 0
+61 3 9496 4711
Fax 89335 0
Email 89335 0
[email protected]
Contact person for scientific queries
Name 89336 0
David Taylor
Address 89336 0
c/o Emergency Department, Austin Hospital, Studley Rd, Heidelberg, VIC 3084
Country 89336 0
Australia
Phone 89336 0
+61 3 9496 4711
Fax 89336 0
Email 89336 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data at the individual level in this trial is of no relevance. Furthermore, ethics approval has not been given for the release of individual data, only summary data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
701Study protocol    376569-(Uploaded-11-12-2018-17-40-42)-Study-related document.doc
702Informed consent form    376569-(Uploaded-11-12-2018-17-41-00)-Study-related document.docx
703Ethical approval    376569-(Uploaded-11-12-2018-17-41-21)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDiscordance between patient-reported and actual emergency department pain management.2021https://dx.doi.org/10.1111/1742-6723.13690
N.B. These documents automatically identified may not have been verified by the study sponsor.