None listed
Conditions
Brief summary
Our hypothesis is that a team-based approach to care in a general medical practice setting will have better outcomes than usual general practitioner (GP) led care for people with low back pain. The overall aim is to determine whether, for people with low back pain, a team-based approach in general medical practice that includes a musculoskeletal (MSK) clinician is more effective than usual GP-led care. Specific aims are to: 1) Understand the impact on disability (primary outcome at 3 months), pain intensity, quality of life, global rating of change, patient satisfaction, and adverse events. 2) Understand the impact on health system and societal outcomes, including healthcare access, GP workload, emergency department visits, diagnostic imaging, opioid medications used, and missed work. 3) Determine the cost-effectiveness of the planned approach.
Interventions
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
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.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
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.
Outcome results
None listed