Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000667213
Ethics application status
Approved
Date submitted
19/04/2018
Date registered
24/04/2018
Date last updated
4/06/2019
Date data sharing statement initially provided
4/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Personalised advice and instructions for pain relief following discharge from ED (PAIN study)
Scientific title
Effectiveness of personalised advice and instructions for pain relief following discharge from ED (PAIN study)
Secondary ID [1] 294663 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute pain 307518 0
Condition category
Condition code
Emergency medicine 306595 306595 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pain has been suggested to be the "fifth vital sign", of obvious importance to the patient. Many patients who present to Emergency Departments are discharged home with pain, and need to take analgesia after discharge. This study aims to understand whether personalised advice provided to patients improves their compliance with medications, pain scores and understanding following discharge.

The PAIN study will be run as a prospective randomised controlled trial at the Sir Charles Gairdner Hospital Emergency Department. This is a pilot study. All patients who present with pain will be assessed for suitability, and if satisfying the inclusion and exclusion criteria, will be invited to participate in the study. This will involve randomisation to the control group who will receive the usual pain relief instructions or the intervention group who will receive customised pain relief instructions as a print out and via their mobile phone.

The instructions are created via a web/mobile application and combine small sections of advice in simple, readable text with accompanying pictograms. These instructions are customised for each patient based on the pain relief advice given to them at discharge by their treating doctor. The content of the print out of the instructions is viewable by text message (in the exact same format) on the patient's phone at discharge.

All patients will be followed up at 5 days with an online questionnaire.
Intervention code [1] 300962 0
Behaviour
Comparator / control treatment
The PAIN study will be run as a prospective randomised controlled trial at the Sir Charles Gairdner Hospital Emergency Department. This is a pilot study. All patients who present with pain will be assessed for suitability, and if satisfying the inclusion and exclusion criteria, will be invited to participate in the study.

This will involve randomisation to the control group who will receive the usual pain relief instructions or the intervention group who will receive customised pain relief instructions as a print out and via their mobile phone.

Usual pain relief instructions will be verbal pain relief advice, printed hand outs and/or typed/handwritten instructions usually given by the treating doctor/nursing staff.

All patients will be followed up at 5 days with an online questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 305593 0
Difference in change of score on numerical rating pain scale at 5 days after ED visit with the use of customised paper/mobile discharge instructions compared to usual discharge instructions for analgesia
Timepoint [1] 305593 0
5 days post discharge
Primary outcome [2] 305635 0
Difference in change of intensity of pain on Patient Global Impression of Change scale at 5 days after ED visit with the use of customised paper/mobile discharge instructions compared to usual discharge instructions for analgesia
Timepoint [2] 305635 0
5 days post discharge
Secondary outcome [1] 345848 0
Level of satisfaction as assessed on follow-up patient survey designed specifically for this study at 5 days after ED visit with the use of customised paper/mobile accessible discharge instructions compared to usual discharge instructions for analgesia
Timepoint [1] 345848 0
5 days post discharge
Secondary outcome [2] 345947 0
Level of compliance with analgesia as assessed on follow-up patient survey designed specifically for this study at 5 days after ED visit with the use of customised paper/mobile accessible discharge instructions compared to usual discharge instructions for analgesia.
Timepoint [2] 345947 0
5 days after discharge
Secondary outcome [3] 345948 0
Level of recall as assessed on follow-up patient survey designed specifically for this study at 5 days after ED visit with the use of customised paper/mobile accessible discharge instructions compared to usual discharge instructions
Timepoint [3] 345948 0
5 days after discharge
Secondary outcome [4] 345949 0
Number of associated unscheduled follow ups as assessed on follow-up patient survey designed specifically for this study at 5 days after ED visit with the use of customised paper/mobile accessible discharge instructions compared to usual discharge instructions
Timepoint [4] 345949 0
5 days post discharge

Eligibility
Key inclusion criteria
• acute musculoskeletal complaints not requiring admissions (strains, sprains, extremity fractures not requiring operative management, gouty arthritis) or
• visceral complaints not requiring admission (abdominal pain, renal colic, gynaecological pain with negative pregnancy test, or biliary colic).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• need for admission or observation
• unwilling or unable to comply with follow up
• non-English speaking
• a prisoner
• fracture requiring surgery
• chronic pain syndrome
• clinical suspicion of drug-seeking behaviour

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
12/04/2018
Date of last participant enrolment
Anticipated
26/04/2018
Actual
25/04/2018
Date of last data collection
Anticipated
2/05/2018
Actual
30/04/2018
Sample size
Target
80
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 10764 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 22492 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 299270 0
Charities/Societies/Foundations
Name [1] 299270 0
The Myer Foundation
Country [1] 299270 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 298546 0
None
Name [1] 298546 0
Address [1] 298546 0
Country [1] 298546 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300185 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 300185 0
Ethics committee country [1] 300185 0
Australia
Date submitted for ethics approval [1] 300185 0
04/09/2017
Approval date [1] 300185 0
17/03/2018
Ethics approval number [1] 300185 0
RGS0000000589

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82834 0
Dr Matthew Anstey
Address 82834 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
Country 82834 0
Australia
Phone 82834 0
+61 8 6457 3333
Fax 82834 0
Email 82834 0
[email protected]
Contact person for public queries
Name 82835 0
Matthew Anstey
Address 82835 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
Country 82835 0
Australia
Phone 82835 0
+61 8 6457 3333
Fax 82835 0
Email 82835 0
[email protected]
Contact person for scientific queries
Name 82836 0
Matthew Anstey
Address 82836 0
Sir Charles Gairdner Hospital, Hospital Ave, Nedlands WA 6009
Country 82836 0
Australia
Phone 82836 0
+61 8 6457 3333
Fax 82836 0
Email 82836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual participant data collected during the trial.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Case by case basis at the discretion of the Principal Investigator.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access subject to approvals by Principal Investigator and requirement to sign data access agreement.


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
No additional documents have been identified.