RecruitingACTRN12619000871145

Implementation of a novel pathway of care for common musculoskeletal conditions in primary care

Implementation of a novel clinical PAthway of CarE for common musculoskeletal conditions in primary care (PACE study): impact on physical and other health outcomes and costs

Sponsor

University of Sydney

Enrollment

716 participants

Start Date

Mar 20, 2020

Study Type

Interventional

Conditions

Whiplash Low Back Pain

Summary

Musculoskeletal conditions, low back pain, neck pain/whiplash and osteoarthritis of the knee are one of the highest contributors to years lost to disease. The PACE intervention aims to identify patients at risk of poor prognosis to improve their management in primary health care settings. Patients identified as low risk will receive minimal intervention (up to 3 sessions of guideline based care advice and exercises). Those identified as medium to high risk will be referred to a specialist musculoskeletal clinician who will undertake a more complex examination of individual physical, psychological and pain factors. The specialist clinician will then liaise with the patient and the primary health care practitioner to decide further care. We hypothesize that implementation of this novel musculoskeletal clinical care pathway will result in improved health outcomes and be more cost-effective. If successful PACE will be a useful addition to primary care musculoskeletal care management.. This study will include embedded observational studies that will evaluate patient perceptions, experience, health professional practice and inter-professional collaboration

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Back pain, neck pain, and knee osteoarthritis are among the most common reasons people see their GP or physiotherapist. Unfortunately, care quality varies widely, and people often receive treatments that are not based on the best evidence. The PACE pathway is a structured clinical approach that first identifies whether a patient is at low, medium, or high risk of a poor outcome — then matches the level of care to that risk. Low-risk patients receive simple, evidence-based advice and a few sessions of guided exercise. Higher-risk patients are referred to a musculoskeletal specialist who works with the patient and their GP to personalise their care. This implementation study will evaluate whether rolling out this pathway in primary care (general practice and physiotherapy) leads to better health outcomes and is more cost-effective than usual care. Patients with low back pain, neck pain or whiplash, or knee osteoarthritis who are seeking care within four weeks of symptom onset will be enrolled. Participants must be proficient in English and meet specific clinical criteria for each condition. People with suspected serious spinal pathology (such as cancer in the spine), fractures, severe depression, or those scheduled for knee replacement are excluded. This research could fundamentally reshape how musculoskeletal conditions are managed in Australian primary care, ensuring people get the right level of support from the start.

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Interventions

Participants will initially undergo baseline assessment of risk for poor outcome using the Short Form Orebro Musculoskeletal Pain Questionnaire (SF-OMSQ) where scores >50 will indicate high risk of ongoing pain and disability. Participants will also complete the Keele STarT MSK Tool for comparison but it is the scores on the SF-OMSQ that will be used for risk-stratification. At baseline, participants will complete baseline questionnaires that assess demographic factors, pain and disability and potential effect moderators including validated condition-specific disability measures (e.g., Oswestry Disability Questionnaire, Neck Disability Index, WOMAC). Participants will then be randomised to usual care or the clinical pathway of care (PACE). Clinical Pathway of Care (PACE). Participants randomised to PACE will receive matched care according to their risk of poor outcome. Low risk: Once a participant’s risk of recovery is identified, those with a good prognosis (low risk) should do well with minimal care delivered by the participant's primary health care professional (e.g., general practitioner, physiotherapist, chiropractor or osteopath). Those stratified to low risk will receive minimal intervention (between 1-4 sessions of guideline-based care consisting of advice and exercises). Participants will also be directed to the custom-designed online musculoskeletal e-hub resource (MY PAIN HUB) which will have links to existing evidence informed guideline-based resources developed by the research team. The research assistants will contact participants by phone (1 week and 4-6 weeks post randomisation) and encourage them to access this site for information, advice, exercise pages and to watch the videos. Information in MY PAIN HUB has been adapted from the most recent evidence-based guidelines for each condition. It is a one access portal bringing together all the resources to facilitate easy access and utilisation by primary health care professionals managing whiplash/neck pain, low back pain and or knee OA. In Australia, existing resources include the development and implementation of a website for whiplash (CI Rebbeck, CI Sterling, CI Cameron, AI Ritchie), for osteoarthritis (CI Simic, AI Bennell) and in the UK, low back pain (AI Foster). Each resource provides guideline-based information for first line care (such as provision of advice and simple exercises), recommendations on the appropriate use of musculoskeletal imaging, validated risk-stratification tools for clinicians, and recommendations on when referral for specialist care is required. Guideline based information for each condition is based on: Knee OA: RACGP Guidelines for the management of knee and hip osteoarthritis; https://www.racgp.org.au/download/Documents/Guidelines/Musculoskeletal/guideline-for-the-management-of-knee-and-hip-oa-2nd-edition.pdf Whiplash: State Insurance Regulatory Authority (SIRA) Whip Lash guidelines; https://www.sira.nsw.gov.au/resources-library/motor-accident-resources/publications/for-professionals/whiplash-resources/SIRA08104-Whiplash-Guidelines-1117-396479.pdf Neck Pain: National Institute for Health and Care Excellence (NICE) Neck Pain guidelines; https://www.evidence.nhs.uk/search?q=NICE%20guidelines%20on%20treatment%20of%20neck%20pain Back Pain: The Agency for Clinical Innovation (ACI) acute low back pain guidelines https://www.aci.health.nsw.gov.au/resources/musculoskeletal/management-of-people-with-acute-low-back-pain/albp-model www.mybackpain.org.au E-health educational videos /webinars for primary health care professionals for each condition will be developed by the CI and AI team according to relevant expertise. The e-Health implementation process for the low risk group will be advised by AI Shaw (e-health Professor) and AI Foster who have completed similar strategies in the UK. Health professionals will be able to access these resources as required through the MY PAIN HUB. Intervention for those at high risk. Participants at high risk of poor outcome will be referred to a specialist musculoskeletal clinician within 4 weeks of randomisation. Specialist Musculoskeletal Clinicians will be recruited by the chief investigators prior to study commencement. For the purposes of clarity in this study, a specialist is defined as a health care professional who have a higher degree or fellowship qualifications in musculoskeletal health or who have recognised expertise in the management of complex musculoskeletal conditions for example, those that have been independently appointed by workers’ compensation and motor vehicle injury insurance regulators to perform peer review, consultancy and dispute resolution services for complex musculoskeletal injuries and disorders). These specialist musculoskeletal clinicians most commonly are physiotherapists, but can also include psychologists, chiropractors and medical practitioners. Prior to the commencement of the trial, specialist musculoskeletal clinicians at each treatment site will be trained to implement the pathway of care in a 1-2-day advanced musculoskeletal workshop conducted by the CI’s. The content of each workshop will be developed by the CI and AI team who are currently world leaders in their relative areas. The specialist musculoskeletal clinician will conduct a thorough assessment based on an individual participant's presentation and include examination of factors known to be associated with poor outcome (e.g., physical, pain-related and psychological factors) and then make one of three decisions: 1. Shared care: The specialist musculoskeletal clinician liaises with the primary health care professional on best management. Example scenarios include when the participant has localised symptoms. 2. Specialist care: Up to 6 sessions of specialist-led care addressing the assessed impairments using a psychologically informed cognitive/ behavioural approach. This pathway will be chosen when the treating practitioner may be less confident in managing the participant's presentation or when presentation is more complex. 3. Referred care: For example, to a psychologist when scores on screening questionnaires for psychological factors (e.g., depression or post-traumatic stress) are above threshold levels, to a medical pain specialist when pain features are above threshold (e.g., clinical indication of pain sensitivity) or to an orthopaedic surgeon when advanced osteoarthritis is present. Specialist musculoskeletal clinicians will be given guidance during their training about when to make these decisions. Patient and health professional questionnaires and health professional interviews will be used to assess and monitor adherence to the intervention.