ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

U1111-1225-3850

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pain

Condition category

Condition code

Emergency medicine

Other emergency care

Anaesthesiology

Pain management

Public Health

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]

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]

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]

48 hours post discharge from the emergency department

Secondary outcome [1]

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]

48 hours post discharge from the emergency department

Secondary outcome [2]

Timepoint [2]

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?

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]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Hospital

Address [1]

Studley Road, Heidelberg, VIC 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Hospital

Address

Studley Road, Heidelberg, VIC 3084

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Austin Hospital, Studley Road, Heidelberg, VIC 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/10/2018

Approval date [1]

13/11/2018

Ethics approval number [1]

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

Prof David Taylor

Address

c/o Emergency Department, Austin Hospital, Studley Rd, Heidelberg, VIC 3084

Country

Australia

Phone

+61 3 9496 4711

Fax

David.Taylor@austin.org.au

Contact person for public queries

Name

David Taylor

Address

c/o Emergency Department, Austin Hospital, Studley Rd, Heidelberg, VIC 3084

Country

Australia

Phone

+61 3 9496 4711

Fax

David.Taylor@austin.org.au

Contact person for scientific queries

Name

David Taylor

Address

c/o Emergency Department, Austin Hospital, Studley Rd, Heidelberg, VIC 3084

Country

Australia

Phone

+61 3 9496 4711

Fax

David.Taylor@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	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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