Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000392167
Ethics application status
Approved
Date submitted
5/03/2019
Date registered
12/03/2019
Date last updated
12/03/2019
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Information leaflets regarding diagnostic imaging for low back pain
Scientific title
Effect of three types of information leaflets on intention to undergo diagnostic imaging for non-specific low back pain: a randomised controlled trial in patients and the general public
Secondary ID [1] 297604 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 311862 0
Condition category
Condition code
Musculoskeletal 310457 310457 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial includes community participants and patient participants.

Community participants will complete a survey (hosted by Qualtrics) on their computer. They will be asked to imagine that they have developed sudden, severe low back pain and have gone to their local emergency department. The scenario will state that before they have a consultation with the emergency department doctor, they pick-up a leaflet in the waiting room. At this point, the randomiser function in Qualitrics survey will randomly allocate each community participant to view one of the three leaflets on their computer screen. The leaflets contain information about low back pain and use of imaging, presented in different ways (see below for more detail). No time limit will be given to participants to read the leaflet, however, they will not be able to navigate back to the leaflet once they begin answering the outcome questionnaires.

Patient participants will also be given one of three leaflets to read but will base their answers on their own experience rather than receive the hypothetical scenario. After consenting to participate, a research assistant will give patient participants, who are waiting for their appointment at a back pain clinic, an iPad on which to read the leaflet. At this point, the randomiser function in Qualitrics survey will randomly allocate each patient participant to view one of the three leaflets on the iPad. The leaflets (identical to those provided to community participants) contain information about low back pain and use of imaging, presented in different ways (see below for more detail). No time limit will be given to participants to read the leaflet, however, they will not be able to navigate back to the leaflet once they begin answering the outcome questionnaires.

Types of intervention leaflets:

1. Fact Box leaflet
This leaflet contains "Fact Box" which contains balanced information on the benefits and harms of imaging for low back pain, presented side by side.

2. Nudge Leaflet
This leaflet contains information that is biased towards highlighting the harms of imaging for low back pain, more than any benefits.
Intervention code [1] 313839 0
Behaviour
Comparator / control treatment
Participants in the control group will be given a standard care leaflet, developed by Agency for Clinical Innovation, which is currently provided to patients who attend Emergency Departments in Australia.
Control group
Active

Outcomes
Primary outcome [1] 319327 0
The primary outcome will be the intention of participants to undergo diagnostic imaging for low back pain.
Participants will be asked: on a 10 point scale “Which describes your intention to have an imaging test to investigate your low back pain, (1=definitely will not, to 10=definitely will)."
Timepoint [1] 319327 0
Immediately after exposure to the leaflet.
Secondary outcome [1] 367770 0
Beliefs about the necessity of imaging for back pain--“Everyone who gets low back pain should have imaging” from Back Beliefs Questionnaire (yes/no).
Timepoint [1] 367770 0
Immediately after exposure to the leaflet. In patient participants we will also assess intention to undergo diagnostic imaging for low back pain at 6 months and 12 months.
Secondary outcome [2] 367797 0
Usefulness of the leaflet
We will ask participants items from the Decisional Conflict Scale – Low Literacy Format, namely the ‘Informed’ and ‘Uncertainty’ subscales (yes, no, unsure)
Timepoint [2] 367797 0
Immediately after reading the leaflet
Secondary outcome [3] 367798 0
Additional open-ended question in patient participants.

"Did your intention to have/not have imaging change after viewing the leaflet? Why? Is there any other information you would like to know about imaging before making the decision?"
Timepoint [3] 367798 0
After reading the leaflet
Secondary outcome [4] 367799 0
Knowledge (NB Although all participants will be asked these questions, some information will not have been covered by the Control leaflet. This will need to be considered when interpreting results e.g. only compare Knowledge results between the Fact Box leaflet vs the Nudge Leaflet).

1. Are people who undergo scanning more likely to feel better by 3 months than those who don’t? (Yes/No/Don't know)
2. Of 100 people with low back pain, about how many do you think benefit from having a back scan?
3. Of 100 people with low back pain, about how many do you think are harmed (eg, receive unnecessary surgery) by having a back scan?
4. Of 100 people with low back pain, about how many do you think get a false alarm (eg, ‘abnormal’ findings unrelated to the back pain) by having a back scan?
Timepoint [4] 367799 0
Before and after reading the leaflet
Secondary outcome [5] 367800 0
Additional outcomes for patient participants

Satisfaction with Decision scale

"Regarding your intention to have diagnostic imaging for your low back pain, please rate how you feel about the following statements (1= strongly agree, 2= agree, 3= neither agree nor disagree, 4 disagree, 5= strongly disagree)?"
Timepoint [5] 367800 0
Immediately after patient participants rate their intention to have a scan.
Secondary outcome [6] 367801 0
Pain intensity numerical rating scale (NRS):
Over the past week, how would you rate your pain intensity on 11-point scale (0= no pain to 10= worst pain imaginable)?
Timepoint [6] 367801 0
Before patient participants read the leaflet, and again at 6 months and 12 months
Secondary outcome [7] 367802 0
Worry about low back pain
1. How reassured do you feel that there is no serious condition causing your back pain (0= not reassured at all to 10= completely reassured)?
Timepoint [7] 367802 0
Before reading the leaflet, after reading the leaflet, at 6 months and 12 months in patient participants.
Secondary outcome [8] 367803 0
Harms

A potential harm of the intervention is an increase in illness-related worry. We will collect information on illness-related worry on a five point scale (0= no, 4= most of the time).

1. Do you worry about your health?
2. Are you worried you might get a serious illness in the future?
3. Does the thought of serious illness scare you?
Timepoint [8] 367803 0
Before reading the leaflet, after reading the leaflet, at 6 months and at 12 months.
Secondary outcome [9] 367804 0
We will also ask patient participants following:

Did you receive imaging (yes/no)? If yes, types of imaging received (X-ray, CT or MRI). (Multi-choice question)
Timepoint [9] 367804 0
At 6 months and 12 months follow up with patient participants.
Secondary outcome [10] 367805 0
Decision regret scale

"Regarding the decision you made about having/not having diagnostic imaging for your low back pain, please rate how you feel about the following statements ((1= strongly agree, 2= agree, 3= neither agree nor disagree, 4 disagree, 5= strongly disagree):"

1. It was the right decision
2. I regret the choice that was made
3. I would go for the same choice if I had to do it over again
4. The choice did me a lot of harm
5. The decision was a wise one
Timepoint [10] 367805 0
At 6 months and 12 months with patient participants.
Secondary outcome [11] 367872 0
Roland-Morris disability questionnaire (RDQ) (each positive answer= 1 point; scale from 0= no disability to 24= severe disability)
Timepoint [11] 367872 0
Before patient participants read the leaflet, and again at 6 months and 12 months
Secondary outcome [12] 368040 0
Intention of patient participants to undergo diagnostic imaging for low back pain.
Participants will be asked: on a 10 point scale “Which describes your intention to have an imaging test to investigate your low back pain, (1=definitely will not, to 10=definitely will)."
Timepoint [12] 368040 0
At 6 months and 12 months.
Secondary outcome [13] 368041 0
Worry about low back pain
2. Do you think your symptoms should be investigated more extensively (laboratory tests, X-rays etc. (yes/no)?
Timepoint [13] 368041 0
Before reading the leaflet, after reading the leaflet, at 6 months and 12 months in patient participants.
Secondary outcome [14] 368047 0
Other back pain related healthcare:

1. Number of visits to General Practitioner
We will measure this by asking how many times did you visit General Practitioner in last 6/12 months for your back pain? (Open text)
Timepoint [14] 368047 0
At 6 months and 12 months
Secondary outcome [15] 368048 0
Other back pain related healthcare:

2. Number of visits to specialist
We will measure this by asking how many times did you visit a specialist in last 6/12 months for your back pain? (Open text)
Timepoint [15] 368048 0
At 6 months and 12 months
Secondary outcome [16] 368049 0
Other back pain related healthcare:

3. Non-pharmacological therapies used
We will measure this by asking what types of non-pharmacological therapies did you use for your back pain? (Open text)
Timepoint [16] 368049 0
At 6 months and 12 months
Secondary outcome [17] 368050 0
Other back pain related healthcare:

4. Medications used
We will measure this by asking what medications did you use for your back pain? (Open text)
Timepoint [17] 368050 0
At 6 months and 12 months

Eligibility
Key inclusion criteria
Community participants: Community sample of people with or without a history of low back pain.

Patient participants: Patients with low back pain before seeing clinicians at a back pain clinic attached to a teaching hospital in Sydney, Australia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants who cannot speak English
Patients who have undergone imaging for the recent episode of low back pain

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
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will conduct the primary analysis on the community sample. We will conduct 3 independent samples t-tests to compare intention scores between participants allocated to the control leaflet group vs. Fact Box leaflet group, the control leaflet group vs. the Nudge leaflet group, and the Fact Box leaflet group vs. the Nudge leaflet group. To determine if health literacy or initial intention to scan moderates the effect of the intervention we will build two exploratory linear models: one that includes an intervention group*health literacy interaction term and another that includes intervention group*initial intention interaction term. Open-ended questions from patient sample will be analysed thematically using a Framework Analysis in NVivo. All other data from the patient sample will be analysed descriptively (i.e. no inferential statistics will be performed). Because the Control leaflet does not cover some of the Knowledge questions (e.g. number of people with age-related ‘abnormalities’, number of people who are worse off), we will interpret Knowledge results in the Control group with caution. However we plan to compare Knowledge statistically between Fact Box group vs Nudge group for hypothesis generation.

Sample size (based on the community sample)
If one of these interventions was superior to another by any margin we would be interested in detecting that effect. However, due to limited resources we can recruit a maxmimum of 400 community participants to this study. We have estimated that recruiting 360 community participants (120 per group) will allow us to detect a 1 point difference in mean intention to have an imaging test between any of the three trial arms (i.e., control vs Fact Box leaflet; control vs Nudge leaflet; Fact Box vs. Nudge Leaflet), assuming a standard deviation of 2.75 (based on previous work (42)) with 80% power and significance level of 0.05.
Recruitment of patient participants will contribute feasibility data. Because no inferential statistics will be performed on this sample, a minimal sample size is not required. However, to attain meaningful data regarding the acceptability of the leaflet, recruitment rates, and ease of survey completion, we will aim to recruit 50 patients from the RPA Back Pain clinic for the patient sample.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/03/2019
Actual
Date of last participant enrolment
Anticipated
11/06/2019
Actual
Date of last data collection
Anticipated
11/06/2020
Actual
Sample size
Target
410
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13296 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 25870 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 302149 0
Government body
Name [1] 302149 0
Wiser Healthcare NHMRC Program Grant
Country [1] 302149 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Sydney, NSW, 2006, Australia
Country
Australia
Secondary sponsor category [1] 301986 0
None
Name [1] 301986 0
Address [1] 301986 0
Country [1] 301986 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302831 0
Sydney Local Health District Ethics Review Committee (RPAH Zone) [HERC\EXCOR\19-01]
Ethics committee address [1] 302831 0
Ethics committee country [1] 302831 0
Australia
Date submitted for ethics approval [1] 302831 0
19/11/2018
Approval date [1] 302831 0
09/02/2019
Ethics approval number [1] 302831 0
HREC/18/RPAH/717

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

Contacts
Principal investigator
Name 91538 0
Ms Sweekriti Sharma
Address 91538 0
Level 10 North, King George V Building, Royal Prince Alfred Hospital,
Missenden Road, NSW, 2050
Country 91538 0
Australia
Phone 91538 0
+61 481174488
Fax 91538 0
Email 91538 0
[email protected]
Contact person for public queries
Name 91539 0
Sweekriti Sharma
Address 91539 0
Level 10 North, King George V Building, Royal Prince Alfred Hospital,
Missenden Road, NSW, 2050
Country 91539 0
Australia
Phone 91539 0
+61 481174488
Fax 91539 0
Email 91539 0
[email protected]
Contact person for scientific queries
Name 91540 0
Adrian Traeger
Address 91540 0
Level 10 North, King George V Building, Royal Prince Alfred Hospital,
Missenden Road, NSW, 2050
Country 91540 0
Australia
Phone 91540 0
+61 416122784
Fax 91540 0
Email 91540 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


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.