Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000300976
Ethics application status
Approved
Date submitted
26/02/2020
Date registered
5/03/2020
Date last updated
5/03/2020
Date data sharing statement initially provided
5/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Awareness campaign to improve care for low back pain
Scientific title
Scan your options, not your back: awareness campaign to reduce unnecessary imaging of low back pain in the Emergency Department (ED). A feasibility study
Secondary ID [1] 300646 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 316429 0
Condition category
Condition code
Musculoskeletal 314689 314689 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Name:
- Awareness Campaign

Details:
- A standing 55-inch LCD screen will be positioned in the Emergency Department waiting room of participating Hospitals.
- Between the hours of 6am and 10pm the waiting room screen will display the Awareness Campaign. Screen goes black between 10pm -6am.
- The Awareness Campaign includes 5 digital posters and a patient education leaflet. The posters and leaflets were designed specifically for this study.
- The posters address misconceptions about imaging for low back pain, and encourage the public to consider their options and ask questions of their doctor:
o Scan your options, not your back
o Back scans can cause harm
o Back scans can lead to unnecessary procedures
o Back scans rarely locate the source of low back pain
o Ask your doctor what the alternatives to imaging are
- Each poster is displayed on the screen for 10 seconds. Total Campaign run time = 50secs. The Campaign is continuously looped between 6am and 10pm. Participants can view the screen and/or take a patient education leaflet at their discretion. Although they will be positioned in highly visible locations of the waiting room, there is no obligation to view either the posters or the leaflet.
- The patient education leaflet describes the Awareness Campaign messages in more detail. The leaflet was designed specifically for this study.
- All Emergency Department staff will be notified of the campaign by their Head of Department. The Head of Department will circulate a copy of the patient education leaflet that will be made available during the intervention periods.
- During the intervention periods the patient education leaflets will be positioned in a rack adjacent to the screen and in the ED nursing and doctor’s stations
- The Awareness Campaign runs for one week at a time for a total of 3 weeks (ie 3x 1week "on" periods)
- During the "run-in" period (6 weeks prior to the first intervention 'A' period) the participants will be exposed to a usual ED waiting room (no LCD screen display or leaflets available). Imaging rates and patient satisfaction will be measured using routinely collected data.

Tailoring:
- The Intervention will not be individually tailored

Fidelity:
- Campaign display duration and unexpected disruptions can be monitored remotely
- We will audit the number of patient education leaflets given out
- We are conducting a qualitative study of 15 people in the waiting to determine: awareness, visibility, understanding, and views of the campaign
Intervention code [1] 316978 0
Behaviour
Comparator / control treatment
Name:
- Control Campaign

Details:
- Screen displays 4 digital posters with neutral messages about the participating hospital.
- No content on imaging or low back pain
- No content designed to improve patient satisfaction
- Posters displayed for the same period of time as Awareness Campaign intervention i.e. each poster on for 30 seconds, 2min run time, 6am-11pm, off from 11pm-6am, for a period of 4 weeks.
- During the Control periods, patient education leaflets that accompany the Awareness Campaign are removed from the rack adjacent to the screen and from the ED nursing and doctor’s stations

Tailoring
- None

Fidelity
- Campaign display duration and unexpected disruptions can be monitored remotely
Control group
Active

Outcomes
Primary outcome [1] 323016 0
Feasibility of a repeated time-series study using routinely collected ED data. Feasibility measured using composite of:
- recruitment rate (number of participants recruited in 12 weeks)
- collection of PROMS (patient satisfaction – Bureau of Health Information Emergency Department Patient Experience Survey Q64 & Q65) using waiting room kiosk
- collection of imaging data (% of low back pain presentations where imaging was provided)
Timepoint [1] 323016 0
Measured at baseline (6-week run-in period) and then weekly for 6-weeks.
Secondary outcome [1] 380534 0
Proportion of people who present with low back pain and receive at least one imaging test during the trial period. This outcome will be assessed using routinely collected radiology data linked to a participant's medical record. Imaging data for all patients with ED presenting problem of 'pain, back' in their medical record will be collected.
Timepoint [1] 380534 0
Measured at baseline (average of 6-week run-in period) and then weekly for 6-weeks.
Secondary outcome [2] 380582 0
Patient satisfaction measured using data from the Bureau of Health Information Emergency Department Patient Experience Survey Q64:

Q64 Overall how would you rate the care you received while in the ED?
Very good
Good
Neither good nor poor
Poor
Very poor
Timepoint [2] 380582 0
Measured at baseline (average of 6-week run-in period) and then weekly for 6-weeks
Secondary outcome [3] 380844 0
Patient satisfaction measured using data from the Bureau of Health Information Emergency Department Patient Experience Survey Q65:

Q65 If asked about your experience in the ED by friends and family, how would
you respond?

I would speak highly of the ED
I would neither speak highly nor be critical
I would be critical of the ED
Timepoint [3] 380844 0
Measured at baseline (average of 6-week run-in period) and then weekly for 6-weeks

Eligibility
Key inclusion criteria
Adult patients attending Emergency Department at a participating hospital with presenting problem of 'pain,back.' We will include all presentations with diagnostic codes related to low back pain with non-specific cause or those associated with neurological signs and symptoms (such as sciatica and lumbar spinal stenosis).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude presentations of low back pain where the person was diagnosed with serious pathology (such as fracture or cauda equine syndrome) or diagnosed with a problem beyond the spine (such as renal colic).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Feasibility study using ABAB or 'replicated time-series' design. Design includes 6-week run-in time, followed by one-week Intervention period ('A' period), followed by one-week control period ('B' period). The AB sequence is replicated another two times (ie, 3 x 'A' periods and 3x 'B' periods in total). This means there is 6-week run-in period plus 6-weeks of the the replicated time series. We will monitor outcomes (imaging rates, patient satisfaction) for 12 weeks in total:

Week Period
1 Run in
2 Run in
3 Run in
4 Run in
5 Run in
6 Run in
7 Intervention
8. Control
9 Intervention
10 Control
11 Intervention
12 Control
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size will be determined by the number of people presenting during the 12-week trial period. We will describe recruitment rate per site. If collection of routine data is feasible we will describe lumbar imaging rates (ie, the proportion of non-serious low back pain presentations who receive any lumbar imaging) and average patient satisfaction during the Intervention, Control, and run-in periods.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 15986 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 15987 0
Westmead Hospital - Westmead
Recruitment hospital [3] 15988 0
Prince of Wales Hospital - Randwick
Recruitment hospital [4] 15989 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 29481 0
2170 - Liverpool
Recruitment postcode(s) [2] 29482 0
2145 - Westmead
Recruitment postcode(s) [3] 29483 0
2031 - Randwick
Recruitment postcode(s) [4] 29484 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 305071 0
Government body
Name [1] 305071 0
National Health and Medical Research Council
Country [1] 305071 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 305439 0
None
Name [1] 305439 0
None
Address [1] 305439 0
N/A
Country [1] 305439 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305460 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 305460 0
Ethics committee country [1] 305460 0
Australia
Date submitted for ethics approval [1] 305460 0
25/06/2019
Approval date [1] 305460 0
16/07/2019
Ethics approval number [1] 305460 0
2019/ETH00281

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

Contacts
Principal investigator
Name 100454 0
Dr Adrian Traeger
Address 100454 0

The University of Sydney
Faculty of Medicine and Health, Sydney School of Public Health, Institute for Musculoskeletal Health

Level 10N, King George V Building, Royal Prince Alfred Hospital (C39) |
PO Box M179, Missenden Road, Camperdown | NSW | 2050
+61 2 8627 6231
Country 100454 0
Australia
Phone 100454 0
+61 2 8627 6231
Fax 100454 0
Email 100454 0
[email protected]
Contact person for public queries
Name 100455 0
Adrian Traeger
Address 100455 0

The University of Sydney
Faculty of Medicine and Health, Sydney School of Public Health, Institute for Musculoskeletal Health

Level 10N, King George V Building, Royal Prince Alfred Hospital (C39) |
PO Box M179, Missenden Road, Camperdown | NSW | 2050
+61 2 8627 6231
Country 100455 0
Australia
Phone 100455 0
+61 2 8627 6231
Fax 100455 0
Email 100455 0
[email protected]
Contact person for scientific queries
Name 100456 0
Adrian Traeger
Address 100456 0

The University of Sydney
Faculty of Medicine and Health, Sydney School of Public Health, Institute for Musculoskeletal Health

Level 10N, King George V Building, Royal Prince Alfred Hospital (C39) |
PO Box M179, Missenden Road, Camperdown | NSW | 2050
+61 2 8627 6231
Country 100456 0
Australia
Phone 100456 0
+61 2 8627 6231
Fax 100456 0
Email 100456 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
IPD plans not yet developed


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.