Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000603617
Ethics application status
Approved
Date submitted
24/05/2023
Date registered
2/06/2023
Date last updated
29/02/2024
Date data sharing statement initially provided
2/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Back pain fact sheets and decisions about future healthcare
Scientific title
Effect of back pain fact sheets on decisions about future healthcare in adults attending primary care
Secondary ID [1] 309731 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
low back pain 330122 0
Condition category
Condition code
Musculoskeletal 327003 327003 0 0
Other muscular and skeletal disorders
Public Health 327056 327056 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
JAMA Patient Page on low back pain. 1 page fact sheet delivered by GP or by SMS from GP practice. Content focuses on listing evidence-based treatment options. Freely available resource accessible at: https://jamanetwork.com/journals/jama/fullarticle/2782184

Participants can read the fact sheet at their own time and pace. GPs can open and discuss the fact sheet with their patient during the consult if they wish. Twenty-four hours after their consultation with the GP, HealthShare sends patients an SMS containing a link to the fact sheet on behalf of the GP. To monitor adherence participants will complete a study-specific questionnaire.

Participants can also access the fact sheet via an advertisement on social media (Facebook, Twitter, and Instagram). The advertisement will invite people with experience of back pain to view a fact sheet and complete a short survey.
Intervention code [1] 326171 0
Treatment: Other
Comparator / control treatment
Australian Commission for Healthcare Safety and Quality Information for Patients Fact Sheet (ACHSQ fact sheet), 1 page fact sheet delivered by GP or by SMS from GP practice. Content focuses on explaining how a person can self-manage back pain. Freely available resource accessible at: https://www.safetyandquality.gov.au/publications-and resources/resource-library/how-manage-your-low-back-pain-information-patients

Participants can read the fact sheet at their own time and pace. GPs can open and discuss the fact sheet with their patient during the consult if they wish. Twenty-four hours after their consultation with the GP, HealthShare sends patients an SMS containing a link to the fact sheet on behalf of the GP. To monitor adherence participants will complete a study-specific questionnaire.

Participants can also access the fact sheet via an advertisement on social media (Facebook, Twitter, and Instagram). The advertisement will invite people with experience of back pain to view a fact sheet and complete a short survey.
Control group
Active

Outcomes
Primary outcome [1] 334862 0
Preparation for decision-making, measured using the Preparation for Decision Making (PrepDM) scale.
Timepoint [1] 334862 0
Immediate (after reading fact sheet)
Secondary outcome [1] 422273 0
Management intentions assessed by study-specific questionnaire
Timepoint [1] 422273 0
Immediate (after reading fact sheet)
Secondary outcome [2] 422419 0
Reassurance assessed by study-specific questionnaire
Timepoint [2] 422419 0
Immediate (after reading fact sheet)
Secondary outcome [3] 422420 0
Acceptability assessed by study-specific questionnaire
Timepoint [3] 422420 0
Immediate (after reading fact sheet)
Secondary outcome [4] 422421 0
Fidelity assessed by study-specific questionnaire
Timepoint [4] 422421 0
Immediate (after reading fact sheet)

Eligibility
Key inclusion criteria
1. People 18 years or older
2. Visiting their GP for back pain
3. Receive a back pain fact sheet and choose to complete the online survey
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This study is quasi randomised. Participants are allocated to intervention and control groups via three methods. The first method is based on GP discretion as to which study fact sheet they provide to their patient. The comparison of outcomes for people allocated to fact sheet interventions via this method is therefore non-random. The second allocation method is random. Based on a computerised random number list, a GP software provider will allocate access to either the intervention or control fact sheet, for one month at a time for the duration of the trial. The comparison of outcomes for people allocated to interventions via this method is therefore based on a randomised computer generated sequence.

The third allocation method will be random. Participants via social media advertisement will be allocated to either intervention or control fact sheet randomly.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Our primary analysis will compare the PrepDM scores in people exposed to the JAMA fact sheet vs the ACHSQ fact sheet, immediately after they have read the sheet. Assuming a mean difference of 6 points on a 100-point scale (ie 60 points in JAMA fact sheet group, 54 points in ACHSQ group, SD of 26) with 90% power, we require a sample size of 790. To account for anticipated uneven group size we will increase the minimum sample size to 1000.

For the secondary outcomes of management intentions, reassurance, and acceptability, we compare means and proportions where applicable in the whole sample and generate 95% confidence intervals.

Subgroup analysis
We will compare the effects of the sheets on PrepDM scores in people with chronic pain vs acute pain, and in people with higher pain intensity vs lower pain intensity. We will also examine effects on healthcare intentions in people who received the fact sheet through GP-led approach vs patient-led approach, and people who had seen their GP in the past 4 weeks vs those who had not.

Data from patients receiving a fact sheet using random and non-random methods of allocation will be analysed separately in a sensitivity analysis.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/06/2023
Actual
2/06/2023
Date of last participant enrolment
Anticipated
7/06/2024
Actual
Date of last data collection
Anticipated
7/06/2024
Actual
Sample size
Target
1000
Accrual to date
474
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313921 0
University
Name [1] 313921 0
The University of Sydney, Faculty of Medicine and Health (Next Step Funding)
Country [1] 313921 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
NSW 2006
Australia
Country
Australia
Secondary sponsor category [1] 315781 0
None
Name [1] 315781 0
N/A
Address [1] 315781 0
N/A
Country [1] 315781 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313067 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 313067 0
Ethics committee country [1] 313067 0
Australia
Date submitted for ethics approval [1] 313067 0
Approval date [1] 313067 0
22/05/2023
Ethics approval number [1] 313067 0
2023/179

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

Contacts
Principal investigator
Name 126874 0
Dr Adrian Traeger
Address 126874 0
The University of Sydney
Level 10N, King George V Building, Royal Prince Alfred Hospital (C39)
PO Box M179, Missenden Road, NSW, 2050
Country 126874 0
Australia
Phone 126874 0
+61286276231
Fax 126874 0
Email 126874 0
[email protected]
Contact person for public queries
Name 126875 0
Adrian Traeger
Address 126875 0
The University of Sydney
Level 10N, King George V Building, Royal Prince Alfred Hospital (C39)
PO Box M179, Missenden Road, NSW, 2050
Country 126875 0
Australia
Phone 126875 0
+61286276231
Fax 126875 0
Email 126875 0
[email protected]
Contact person for scientific queries
Name 126876 0
Adrian Traeger
Address 126876 0
The University of Sydney
Level 10N, King George V Building, Royal Prince Alfred Hospital (C39)
PO Box M179, Missenden Road, NSW, 2050
Country 126876 0
Australia
Phone 126876 0
+61286276231
Fax 126876 0
Email 126876 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 will not be available


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.