ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Pain

Condition category

Condition code

Anaesthesiology

Pain management

Public Health

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]

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]

Satisfaction with pain management. This will be collected using a 6 point ordinal scale (very dissatisfied - very satisfied)

Timepoint [1]

48 hours post discharge from the emergency department

Secondary outcome [1]

nil

Timepoint [1]

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?

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]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Hospital Emergency Department

Address [1]

Studley Rd, Heidelberg, Victoria, Australia 3084

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Hospital

Address

Studley Rd, Heidelberg, Victoria, Australia 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

Ethics committee address [1]

Studley Rd, Heidelberg, Victoria, Australia 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

18/12/2014

Ethics approval number [1]

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

Prof David Taylor

Address

Austin Hospital, Studley Rd, Heidelberg, Victoria 3084

Country

Australia

Phone

+61 3 9496 4711

Fax

[email protected]

Contact person for public queries

Name

David Taylor

Address

Austin Hospital, Studley Rd, Heidelberg, Victoria 3084

Country

Australia

Phone

+61 3 9496 4711

Fax

[email protected]

Contact person for scientific queries

Name

David Taylor

Address

Austin Hospital, Studley Rd, Heidelberg, Victoria 3084

Country

Australia

Phone

+61 3 9496 4711

Fax

[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

Source	Title	Year of Publication	DOI
Embase	The effect of provision of pain management advice on patient satisfaction with their pain management: A pilot, randomised, controlled trial (pain advice trial).	2016	https://dx.doi.org/10.1136/emermed-2015-205365

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically