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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
Date results information initially provided
9/12/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Factors impacting on patient satisfaction with pain management in the Emergency Department
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Scientific title
Factors impacting on patient satisfaction with pain management in the Emergency Department
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Secondary ID [1]
296855
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None
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Universal Trial Number (UTN)
U1111-1225-3850
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pain
310761
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Condition category
Condition code
Emergency medicine
309451
309451
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0
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Other emergency care
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Anaesthesiology
309474
309474
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0
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Pain management
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Public Health
309475
309475
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
313135
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Other interventions
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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.
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Assessment method [1]
308406
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Timepoint [1]
308406
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48 hours post discharge from the emergency department
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Secondary outcome [1]
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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.
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Assessment method [1]
354882
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Timepoint [1]
354882
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48 hours post discharge from the emergency department
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Secondary outcome [2]
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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.
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Assessment method [2]
354883
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Timepoint [2]
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48 hours post discharge from the emergency department
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
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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)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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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.
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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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.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
11/02/2019
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Actual
5/02/2019
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Date of last participant enrolment
Anticipated
10/05/2019
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Actual
6/05/2019
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Date of last data collection
Anticipated
16/05/2019
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Actual
13/05/2019
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Sample size
Target
650
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Accrual to date
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Final
655
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
12703
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
25124
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
301427
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Hospital
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Name [1]
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Austin Hospital
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Address [1]
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Studley Road, Heidelberg, VIC 3084
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Country [1]
301427
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Australia
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Primary sponsor type
Hospital
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Name
Austin Hospital
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Address
Studley Road, Heidelberg, VIC 3084
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Country
Australia
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Secondary sponsor category [1]
301106
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None
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Name [1]
301106
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Address [1]
301106
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Country [1]
301106
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302160
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
302160
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Austin Hospital, Studley Road, Heidelberg, VIC 3084
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Ethics committee country [1]
302160
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Australia
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Date submitted for ethics approval [1]
302160
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17/10/2018
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Approval date [1]
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13/11/2018
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Ethics approval number [1]
302160
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HREC-44954-Austin-2018
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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.
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Trial website
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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.
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Public notes
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Contacts
Principal investigator
Name
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Prof David Taylor
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Address
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c/o Emergency Department, Austin Hospital, Studley Rd, Heidelberg, VIC 3084
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Country
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Australia
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Phone
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+61 3 9496 4711
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof David Taylor
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Address
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c/o Emergency Department, Austin Hospital, Studley Rd, Heidelberg, VIC 3084
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Country
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Australia
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Phone
89335
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+61 3 9496 4711
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Fax
89335
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Email
89335
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[email protected]
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Contact person for scientific queries
Name
89336
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Prof David Taylor
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Address
89336
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c/o Emergency Department, Austin Hospital, Studley Rd, Heidelberg, VIC 3084
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Country
89336
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Australia
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Phone
89336
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+61 3 9496 4711
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Fax
89336
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Email
89336
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
701
Study protocol
376569-(Uploaded-11-12-2018-17-40-42)-Study-related document.doc
702
Informed consent form
376569-(Uploaded-11-12-2018-17-41-00)-Study-related document.docx
703
Ethical 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
Source
Title
Year of Publication
DOI
Embase
Discordance between patient-reported and actual emergency department pain management.
2021
https://dx.doi.org/10.1111/1742-6723.13690
N.B. These documents automatically identified may not have been verified by the study sponsor.
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