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Trial registered on ANZCTR


Registration number
ACTRN12619000991112
Ethics application status
Approved
Date submitted
3/07/2019
Date registered
11/07/2019
Date last updated
5/02/2021
Date data sharing statement initially provided
11/07/2019
Date results information initially provided
5/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of testing the effectiveness of a theory-informed implementation intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial
Scientific title
Feasibility of testing the effectiveness of a theory-informed implementation intervention consisting of general practitioner training to use a low back pain patient education and management booklet designed to reduce imaging for low back pain: a pilot cluster randomised controlled trial
Secondary ID [1] 297406 0
None
Universal Trial Number (UTN)
U1111-1228-5735
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 311566 0
Condition category
Condition code
Musculoskeletal 310197 310197 0 0
Other muscular and skeletal disorders
Public Health 312010 312010 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Low back pain education and management booklet

General practitioners in the intervention group will be provided with a 30 minute face-to-face individual training session with one of the research team. The researcher administering the training session will be a chiropractor with PhD qualification who was involved in the development of the intervention. The training session will include information on appropriate use of imaging for low back pain, an introduction to the low back pain booklet and why it was developed, and instruction on how the booklet is intended to be used in practice. Practitioners will also be provided with hardcopy and digital copies of the booklet, a digital version of the training presentation, an information sheet summarising the training information, and copies of recent guidelines regarding low back pain management and appropriate use of imaging. Practitioners will be given an opportunity to ask questions regarding the study or use of the booklet. Practitioners will be contacted fortnightly during the 4 month study period by phone and/or email as per practitioner preference to check if they have any questions related to delivering the intervention.

The development of the booklet has been published in BMC Health Services Research, including access to a PDF copy of the booklet, available at: https://bmchealthservres.biomedcentral.com/articles/10.1186/s12913-018-3526-7
The booklet has been designed to be used by practitioners during a low back pain consult to help educate patients about low back pain and why imaging is not usually necessary. Included in the booklet are:
1. A flow chart for practitioners to indicate to patients whether they need or don't need imaging.
2. Information about the nature of low back pain.
3. Information about imaging and why it is not usually helpful in the management of low back pain.
4. General advice for the management of low back pain.
5. A personalisable management plan for practitioners to provide specific management advice to the patient for their low back pain, including follow-up advice and warning symptoms to watch out for.
6. Further evidenced-based resources for patients to access for more information about low back pain.

General practitioners will be instructed to use the low back pain booklet during the four month study period in clinical consults with patients presenting with low back pain, who do not require imaging, as they deem appropriate. Practitioners can use the booklet to screen the patient, demonstrate to the patient why they do not require imaging, provide the patient with information about low back pain and why imaging is not usually useful, and provide the patient with a customised management plan. Practitioners can either provide the patient with the hard copy version, or print out or email the patient the digital version.

At the end of the study period practitioners will be asked to undertake a short 10-15 minute interview (either face to face or over the phone) with the same researcher who performed the training. Qualitative information on intervention adherence and fidelity will be collected by asking practitioners about their experiences in the study, how they used the booklet, and which patients they chose to use it with. To continue reminding practitioners to use the booklet and improve fidelity, practitioners will be contacted fortnightly during the 4 month study period by phone and/or email as per practitioner preference to check if they have any questions related to delivering the intervention.

Intervention code [1] 313655 0
Behaviour
Intervention code [2] 314947 0
Prevention
Comparator / control treatment
Control group practitioners will provide usual care throughout the four month study period. Usual care is defined as the care the practitioner would normally provide for patients with low back pain, including referral for imaging as they deem appropriate. No restrictions or changes to the practitioners usual care are being implemented as part of the study.
Control group
Active

Outcomes
Primary outcome [1] 319086 0
Calculation of the proportion of patients with low back pain who were referred for imaging.

Counts of the number of patient consults for low back pain will be collected from the practice management system using specific codes for low back pain.

Counts of the number of low back imaging referrals will be collected from Medicare audit data using specific item numbers for low back imaging.

Timepoint [1] 319086 0
Four month period post randomisation
Secondary outcome [1] 366945 0
Proportion of practices recruited from those practices approached
Timepoint [1] 366945 0
Randomisation
Secondary outcome [2] 366946 0
Proportion of general practitioners recruited per recruited clinic
Timepoint [2] 366946 0
Randomisation
Secondary outcome [3] 366947 0
Counts of low back presentations per general practitioner during the study period collected from the practice management system using specific codes for low back pain.
Timepoint [3] 366947 0
Four months after randomisation
Secondary outcome [4] 366948 0
Qualitative assessment of the ability to extract counts of low back pain presentations from practice management system and counts of low back imaging referral data from Medicare audit data.
Qualitative assessment of any limitations to retrieving data and any costs or troubleshooting that may impact a future large-scale effectiveness trial
Timepoint [4] 366948 0
Four months after randomisation
Secondary outcome [5] 366950 0
Qualitative assessment of GP experiences using the intervention (including booklet and training session) and using codes in practice management system. Qualitative data collected through semi-structured interviews
Timepoint [5] 366950 0
Four months after randomisation
Secondary outcome [6] 372341 0
Time-frame and costs required for practice and practitioner recruitment. Data will be collected on the time required to approach and recruit practices and practitioners and any associated costs incurred
Timepoint [6] 372341 0
Randomisation
Secondary outcome [7] 372343 0
GP demographics through written questionnaire including sex, age, years in practice, special interest in low back pain, beliefs about need for imaging for low back pain
Timepoint [7] 372343 0
Training session
Secondary outcome [8] 372344 0
Time-frame and costs required for data collection through the practice management system and Medicare audit.
Timepoint [8] 372344 0
4 months post randomisation

Eligibility
Key inclusion criteria
General practice inclusion:
- at least two general practitioners within the clinic
- see patients presenting with low back pain
- use practice management software to record patient consults, with the ability to search and extract data from the system (ie. Medical Director or Best Practice)

General practitioner inclusion:
- work at one of the included practices, for at least 10 hours per week
- see patients with low back pain
- provide consent to access Medicare Billing Schedule data
Minimum age
24 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None in addition to inclusion criteria

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)
Randomisation will be performed centrally after recruitment of all clinics, at the level of the clinic
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated list of random numbers
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
This is a pilot study to determine the feasibility of conducting a full-scale effectiveness clustered randomised controlled trial. As such, this study is not powered to assess the effectiveness outcomes. To assess the feasibility outcomes we aim to recruit 4 GP clinics (clusters) with a minimum of 2 participating GPs within each clinic.

The specific outcome measures and analysis are:
1. Feasibility of GP practice and practitioner recruitment
- Time and ability to recruit GP practices meeting inclusion criteria
• Number of practices approached to recruit the necessary number
• Time-frames and costs required for practice recruitment
- Ability to recruit GPs with sufficient demographic spread within participating practices
• Proportion of GPs recruited of total GPs in clinic
• Descriptive data of GP demographics and beliefs about the need for imaging for low back pain
- Time (weeks/months) needed for GPs to see adequate numbers of patients presenting
with low back pain
• Number of low back pain presentations per GP per month during the study period
2. Feasibility of data collection methods
- Ability to extract data on the number of low back pain presentations and imaging referrals
from the GP practice management systems
• Descriptive data of whether necessary data can be collected from the practice
management system
• Descriptive data on whether GPs were able to use codes for low back pain
presentations
- Ability to extract data on the number of imaging referrals from Medicare data for included
GPs
• Descriptive data of whether necessary data can be collected from medicare
- The costs and time-frames associated with collecting the data
• Descriptive data of associated costs and time-frames for both methods of data
collection
3. Feasibility of implementing the intervention in GP practice
- GP experiences using the digital compared to hardcopy booklet options
• Descriptive analysis of open-ended interview questions
- Appropriateness of training session
• Descriptive analysis of open-ended interview questions

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 25698 0
2109 - Macquarie University

Funding & Sponsors
Funding source category [1] 301976 0
Other Collaborative groups
Name [1] 301976 0
Australia and New Zealand Musculoskeletal Clinical Trials Network
Address [1] 301976 0
4 Drysdale St
Malvern
Vic
3144
Country [1] 301976 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Balaclava Rd
North Ryde
NSW
2109
Country
Australia
Secondary sponsor category [1] 301750 0
None
Name [1] 301750 0
Address [1] 301750 0
Country [1] 301750 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302655 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 302655 0
Balaclava Rd
North Ryde
NSW
2109
Ethics committee country [1] 302655 0
Australia
Date submitted for ethics approval [1] 302655 0
18/02/2019
Approval date [1] 302655 0
28/03/2019
Ethics approval number [1] 302655 0
5201949847695

Summary
Brief summary
Imaging is overused in the management of low back pain, resulting in high healthcare costs and poorer patient outcomes. Previous strategies to reduce imaging have been largely ineffective. In prior work our research team has developed an intervention to reduce non-indicated imaging for low back pain. Prior to future effectiveness testing of the intervention, it is important to assess the feasibility of using the intervention in clinical practice and conducting a large-scale randomised controlled trial (RCT). The overall aim of this study is to perform a pilot cluster RCT to determine the feasibility of a fully powered effectiveness study, and to assess the feasibility of implementing the developed intervention in clinical practice. This is critical to gain funding for future effectiveness testing using a large high-quality cluster RCT.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90950 0
Dr Hazel Jenkins
Address 90950 0
Rm 347, 17 Wally's Walk
Macquarie University
NSW
2109
Country 90950 0
Australia
Phone 90950 0
+61 298509383
Fax 90950 0
Email 90950 0
hazel.jenkins@mq.edu.au
Contact person for public queries
Name 90951 0
Dr Hazel Jenkins
Address 90951 0
Rm 347, 17 Wally's Walk
Macquarie University
NSW
2109
Country 90951 0
Australia
Phone 90951 0
+61 298509383
Fax 90951 0
Email 90951 0
hazel.jenkins@mq.edu.au
Contact person for scientific queries
Name 90952 0
Dr Hazel Jenkins
Address 90952 0
Rm 347, 17 Wally's Walk
Macquarie University
NSW
2109
Country 90952 0
Australia
Phone 90952 0
+61 298509383
Fax 90952 0
Email 90952 0
hazel.jenkins@mq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will not be collected as part of this study.
Individual practitioner data is being obtained through the Department of Human Services who do not provide approval for the data to be used for any other purposes other than the study described
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary