Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000918628
Ethics application status
Approved
Date submitted
10/08/2023
Date registered
28/08/2023
Date last updated
5/11/2024
Date data sharing statement initially provided
28/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
ConnecTBack Trial – Creating Team-Based care for a new primary care model for low back pain
Scientific title
The effectiveness and cost effectiveness of a model of care that integrates musculoskeletal clinicians within primary care teams for people with low back pain: A cluster randomised trial
Secondary ID [1] 309476 0
None
Universal Trial Number (UTN)
Trial acronym
ConnecTBack
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 329738 0
Condition category
Condition code
Public Health 326637 326637 0 0
Health service research
Musculoskeletal 328018 328018 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The trial intervention is an organisational-level team-based intervention that involves integrating a musculoskeletal (MSK) clinician (physiotherapist/chiropractor) within a primary care team for people with low back pain (LBP). Patients with LBP will first see their general practitioner (GP) and will then be provided with a rapid referral to see an onsite practice MSK clinician as soon as is convenient for the patient, aiming for within 48 hours. The team-based intervention will be administered at each participating practice over 12 months. Each participant will be followed for 12 months post-index presentation to GP.

Patients will see the MSK clinician, in person, for 2 visits (paid for by the study) over 1 week, and these visits will comprise:
1) Assessment: a comprehensive history and physical examination, including the use of the STarT Back tool for assessing the patient’s risk of persistent pain.
2) Individualised self-management intervention: MSK clinicians will provide support for patients to self-manage their LBP, including providing reassurance, education, and printed educational handouts as needed.
3) Health services navigation and team collaboration: the MSK clinician will keep the referring GP informed about the patient’s progress and refer the patient back to the GP as appropriate. The MSK clinician will refer to other healthcare clinicians as needed.
4) Providing additional MSK care to specific people as needed: determined by the STarT Back tool and the MSK clinician’s clinical judgement, some patients will be provided with additional treatment as required.

MSK clinicians will receive training on how to deliver the intervention. The MSK training will take place at least 2 weeks before the intervention commences. The training will take 2 days, and it will be delivered mostly in person with some online modules. The training will be delivered by members of the research team on site at Macquarie university, and online as required. Training modules will cover: the principles of engagement for the team-based model of care; clinical assessment; individualising self-management interventions; how to navigate health services and team collaboration; and, providing MSK treatment.

To ensure intervention fidelity, the study team will be in regular contact with MSK clinicians to discuss how the intervention is being delivered. Intervention fidelity will also be assessed as part of a process evaluation conducted by the study team.
Intervention code [1] 325899 0
Treatment: Other
Comparator / control treatment
Usual GP-led care will be provided in the comparison primary care sites. GPs in the comparison group are free to provide the care they would normally provide, for example giving advice, education, prescribing or recommending medication, and referral for imaging or other healthcare clinicians.
Control group
Active

Outcomes
Primary outcome [1] 334505 0
Self-reported low back pain (LBP) disability using the Roland Morris Disability Questionnaire (RMDQ). Disability and function are considered the most important outcomes for people with LBP.
Timepoint [1] 334505 0
Baseline, 2 weeks, 6 weeks, 3 months (primary timepoint), 6 months, 9 months and 12 months, post-index presentation to GP,
Secondary outcome [1] 420921 0
Pain Intensity (Numeric Pain Rating Scales, based on the Brief Pain Inventory)
Timepoint [1] 420921 0
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months, post-index presentation to GP,
Secondary outcome [2] 420922 0
Quality of Life, measured by the European Quality of Life five dimensions (EuroQol 5D) questionnaire
Timepoint [2] 420922 0
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months, post-index presentation to GP,
Secondary outcome [3] 420923 0
Global rating of change, self-reported
Timepoint [3] 420923 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months, post-index presentation to GP,
Secondary outcome [4] 420924 0
Patient satisfaction with care and treatment (a study-specific question)
Timepoint [4] 420924 0
2 weeks, 6 weeks, 3 months, 6months, 9 months and 12 months, post-index presentation to GP,
Secondary outcome [5] 420926 0
Adverse events, defined as any morbidity or events causing unwarranted distress to a participant that were potentially related to any trial-related intervention. These will patient-reported at every clinical and questionnaire contact.
Timepoint [5] 420926 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months, post-index presentation to GP, and at every clinical encounter
Secondary outcome [6] 422294 0
Economic outcomes will include direct health costs attributable to consumption of healthcare resources, measured using Medicare and Pharmaceutical Benefit data and patient self-report. Economic outcomes include: imaging received, healthcare clinicians used, medications consumed, and emergency department/hospital visits
Timepoint [6] 422294 0
Baseline, 3 months, 6 months, 9 months 12 months, post-index presentation to GP
Secondary outcome [7] 425713 0
Absenteeism and presenteeism measured by the Productivity Cost Questionnaire (iPCQ)
Timepoint [7] 425713 0
Baseline, 3 months, 6 months, 9 months 12 months, post-index presentation to GP
Secondary outcome [8] 441431 0
Pain Self-Efficacy Questionnaire (PSEQ)
Timepoint [8] 441431 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Secondary outcome [9] 441432 0
TAMPA Scale for Kinesiophobia
Timepoint [9] 441432 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Secondary outcome [10] 441433 0
TAMPA Scale for Kinesiophobia
Timepoint [10] 441433 0
2 weeks, 6 weeks, 3 months, 6 months, 9 months, 12 months.

Eligibility
Key inclusion criteria
Practice inclusion criteria: At least 1 GP from the practice is willing to participate; and the practice can accommodate a trial MSK clinician to coordinate patient treatment.

GP inclusion criteria: GP works in an eligible practice and the GP is willing for their practice to be randomised to the intervention or usual care arm.

Patient inclusion criteria: adults (18 years and older) with LBP (with or without associated leg pain) of any duration, who can read, write, and speak in English. LBP is defined as pain between the 12th rib and the buttock crease.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Practice exclusion criteria: The practice already has an integrated MSK clinician (physiotherapist or chiropractor) onsite.

GP exclusion criteria: working in a practice that already has a physiotherapist/chiropractor integrated into the team.

Patient exclusion criteria: known or suspected serious pathology as the cause of LBP (e.g. cancer, infection or fracture) or neurodegenerative disease, or inability to complete the scheduled follow-ups over 1-year. We have excluded non-English speaking patients due to the cost burden of employing interpreters at each of the 20 primary care sites.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by a statistician blinded to the site names using a concealed list of anonymised codes for each site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial is a parallel arm cluster randomised trial (CRT) with 20 primary care sites randomised 1:1 to either a new primary care model for LBP incorporating a team-based approach, or to usual GP-led care.

The sites will be allocated 1:1 using stratified permuted blocks. Two strata will be defined by whether the practice is in an urban, or regional/rural-remote location. Clusters will be stratified by geographic region using the Modified Monash Model (MMM) classification (urban, regional/rural-remote: MMM1, MMM2-5). A statistician independent of the trial team will computer-generate the allocation sequence. The statistician will be provided with practice identification codes and stratification information.
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
Detailed statistical methods will be pre-specified in a separate statistical analysis plan.

All analyses will be by intention-to-treat. Our primary outcome (RMDQ) with repeated measures at 0, 2-week, 6-weeks, 3-, 6-, 9-, and 12-months will be analysed using linear mixed-effects regression, estimated using restricted maximum likelihood (REML). The model will include fixed effects for time, group by time interaction (omitting the group main effect to ensure baseline differences are constrained to 0), factors used in the covariate constrained allocation procedure, and other pre-specified covariates associated with LBP-related disability. The correlation in repeated measures on the same participant will be modelled using a suitable covariance structure, identified using information criteria (AIC/BIC) and likelihood ratio tests. To account for clustering within practices, site will be modelled as a random effect. The intervention effect will be obtained as the adjusted least square mean difference between arms at 12-months together with 95% confidence intervals. Secondary comparisons will be obtained using least square mean differences at intermediate time points. The use of REML estimation under an assumption of missing at random allows the use of all available data without the need for multiple imputation. To examine the risk of bias due to missing data, we will compare characteristics of those remaining and those lost to follow-up to identify factors associated with attrition and adjust for any such factors as covariates. Secondary outcomes that are continuous will be analysed as described for the primary outcome, while secondary outcomes that are categorical will be analysed using generalised linear mixed effects modelling with binomial, Poisson, or negative binomial distribution. We will analyse results after completion of 12-month follow-up with no planned interim analyses.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/08/2023
Actual
6/03/2024
Date of last participant enrolment
Anticipated
6/01/2026
Actual
Date of last data collection
Anticipated
6/01/2027
Actual
Sample size
Target
1560
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 313673 0
Government body
Name [1] 313673 0
Department of Health and Aged Care - Medical Research Future Fund (MRFF)
Country [1] 313673 0
Australia
Primary sponsor type
University
Name
Macquarie University
Country
Australia
Secondary sponsor category [1] 315475 0
None
Name [1] 315475 0
Country [1] 315475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312838 0
Macquarie University Human Research Ethics Committee
Ethics committee address [1] 312838 0
Ethics committee country [1] 312838 0
Australia
Date submitted for ethics approval [1] 312838 0
Approval date [1] 312838 0
13/12/2021
Ethics approval number [1] 312838 0
Reference No:520211097035593

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 126094 0
Prof Simon French
Address 126094 0
Macquarie University, Faculty of Medicine, Health and Human Sciences Wallumattagal Campus, Level 2, 75 Talavera Road North Ryde, NSW 2109
Country 126094 0
Australia
Phone 126094 0
+61 2 9850 6383
Fax 126094 0
Email 126094 0
simon.french@mq.edu.au
Contact person for public queries
Name 126095 0
Simon French
Address 126095 0
Macquarie University, Faculty of Medicine, Health and Human Sciences Wallumattagal Campus, Level 2, 75 Talavera Road North Ryde, NSW 2109
Country 126095 0
Australia
Phone 126095 0
+61 2 9850 6383
Fax 126095 0
Email 126095 0
simon.french@mq.edu.au
Contact person for scientific queries
Name 126096 0
Simon French
Address 126096 0
Macquarie University, Faculty of Medicine, Health and Human Sciences Wallumattagal Campus, Level 2, 75 Talavera Road North Ryde, NSW 2109
Country 126096 0
Australia
Phone 126096 0
+61 2 9850 6383
Fax 126096 0
Email 126096 0
simon.french@mq.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers who provide a methodologically sound ethically-approved proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• De-identified data and statistical code will be made available on request soon after each report of the data has been published.

What types of analyses could be done with individual participant data?
• Only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
Different aspects of the data will be published separately, which will determine when those data are publicly available. Broadly, IPD will be available from July 2027 with no end date determined.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approval by the Principal Investigator (simon.french@mq.edu.au). A data-sharing agreement will require a commitment to using the data only for specified research purposes, to securing the data appropriately, and to destroying the data after a nominated period.

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Study protocol  simon.french@mq.edu.au To be made available in an open access journal or ... [More Details] Research protocol_ConnecTBackTrial_v1.8clean.pdf
Ethical approval  simon.french@mq.edu.au Study-related document.pdf
Statistical analysis plan    To be made available in an open access journal or ... [More Details]


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.