Methods: The PARTNER model will be assessed using mixed methods, including a multicentre cluster randomised controlled trial, with aligned economic and qualitative evaluations. We will recruit 44 general practices and 572 patients with knee OA in urban and rural areas of NSW and Victoria, Australia. The intervention targets both general practitioners (GPs) and their patients, recruited from the GP's patient database. The general practices will be randomised, rather than individual patients, as the intervention involves changes at the general practice level. General practices will be randomised before patient recruitment at a 1:1 ratio, using opaque, sealed envelopes to allocate treatment. Patients will be recruited if they are aged 45 years or older, have knee pain 4/10 or above for more than three months and are a patient of a participating GP. Outcomes are patient-level validated measures, with the two primary outcome measures of change in self-reported pain and function at 12 months. A range of secondary outcome measures will be used including self-reported change in quality of life, weight, mood, sleep and knee symptoms at 6 and 12 months. The trial duration is expected to be 2.5 years. GPs in the intervention group will be offered training and support to facilitate non-surgical management for their patients. GPs will receive a self-audit/feedback activity, and undertake e-modules on evidence based OA diagnosis and treatment options, and access to a desktop IT support tool. Patients will be enrolled in the trial for 12 months. They will have an initial GP visit to confirm their diagnosis, discuss management options and referral to a centralised multidisciplinary service; the PARTNER Care Support Team (CST). The CST will provide remotely-delivered (phone, email), personalised advice and support to assist the person effectively self-manage their OA. The CST staff will be trained in behaviour change support and evidence-based knee OA management and will work with the person to develop a collaborative action plan focused on exercise, weight loss, pain management and other active self-management behaviours to address sleep, depression and work productivity. Patients will be provided with educational materials on OA and OA management, a physiotherapist developed leg strengthening program, and if relevant will have access to a weight-loss program. GPs in the control group will receive no additional training and their patients will receive their GP's usual care. The trial is funded by an Australian NHMRC Partnership grant (APP1115720) and our partner organisations.
Results: The trial will be prospectively registered with the ANZCTR prior to the trial commencing. We have performed extensive work to develop a new service delivery model underpinned by models of chronic care and behaviour change, and informed by broad stakeholder input. A mixed methods process evaluation will be undertaken to assess intervention fidelity, understand the process of implementation, identify contextual influences on scalability and sustainability, and to identify cost considerations for scaling up the intervention.
Conclusions: This project will fill a major evidence-to-practice gap in primary care management of OA by implementing and evaluating a new service delivery model to improve the health of people with knee OA, a major Australian public health burden.