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    Effectiveness of a New Service Delivery Model for Management of Knee Osteoarthritis in Primary Care: A Cluster Randomized Controlled Trial
    Hunter, DJJ ; Bowden, JLL ; Hinman, RSS ; Egerton, T ; Briggs, AMM ; Bunker, SJJ ; French, SDD ; Pirotta, M ; Shrestha, R ; Schofield, DJJ ; Schuck, K ; Zwar, NAA ; Silva, SSM ; Heller, GZZ ; Bennell, KLL ; PARTNER, ST (WILEY, 2023-06)
    OBJECTIVE: To evaluate the effectiveness and health costs of a new primary care service delivery model (the Optimising Primary Care Management of Knee Osteoarthritis [PARTNER] model) to improve health outcomes for patients with knee osteoarthritis (OA) compared to usual care. METHODS: This study was a 2-arm, cluster, superiority, randomized controlled trial with randomization at the general practice level, undertaken in Victoria and New South Wales, Australia. We aimed to recruit 44 practices and 572 patients age ≥45 years with knee pain for >3 months. Professional development opportunities on best practice OA care were provided to intervention group general practitioners (GPs). All recruited patients had an initial GP visit to confirm knee OA diagnosis. Control patients continued usual GP care, and intervention patients were referred to a centralized care support team (CST) for 12-months. Via telehealth, the CST provided OA education and an agreed OA action plan focused on muscle strengthening, physical activity, and weight management. Primary outcomes were patient self-reported change in knee pain (Numerical Rating Scale [range 0-10; higher score = worse]) and physical function (Knee Injury and Osteoarthritis Outcome Score activities of daily living subscale [range 0-100; higher score = better] at 12 months. Health care cost outcomes included costs of medical visits and prescription medications over the 12-month period. RESULTS: Recruitment targets were not reached. A total of 38 practices and 217 patients were recruited. The intervention improved pain by 0.8 of 10 points (95% confidence interval [95% CI] 0.2, 1.4) and function by 6.5 of 100 points (95% CI 2.3, 10.7), more than usual care at 12 months. Total costs of medical visits and prescriptions were $3,940 (Australian) for the intervention group versus $4,161 for usual care. This difference was not statistically significant. CONCLUSION: The PARTNER model improved knee pain and function more than usual GP care. The magnitude of improvement is unlikely to be clinically meaningful for pain but is uncertain for function.
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    Protocol for the process and feasibility evaluations of a new model of primary care service delivery for managing pain and function in patients with knee osteoarthritis (PARTNER) using a mixed methods approach
    Bowden, JL ; Egerton, T ; Hinman, RS ; Bennell, KL ; Briggs, AM ; Bunker, SJ ; Kasza, J ; French, SD ; Pirotta, M ; Schofield, DJ ; Zwar, NA ; Hunter, DJ (BMJ PUBLISHING GROUP, 2020-02)
    INTRODUCTION: This protocol outlines the rationale, design and methods for the process and feasibility evaluations of the primary care management on knee pain and function in patients with knee osteoarthritis (PARTNER) study. PARTNER is a randomised controlled trial to evaluate a new model of service delivery (the PARTNER model) against 'usual care'. PARTNER is designed to encourage greater uptake of key evidence-based non-surgical treatments for knee osteoarthritis (OA) in primary care. The intervention supports general practitioners (GPs) to gain an understanding of the best management options available through online professional development. Their patients receive telephone advice and support for OA management by a centralised, multidisciplinary 'Care Support Team'. We will conduct concurrent process and feasibility evaluations to understand the implementation of this new complex health intervention, identify issues for consideration when interpreting the effectiveness outcomes and develop recommendations for future implementation, cost effectiveness and scalability. METHODS AND ANALYSIS: The UK Medical Research Council Framework for undertaking a process evaluation of complex interventions and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) frameworks inform the design of these evaluations. We use a mixed-methods approach including analysis of survey data, administrative records, consultation records and semistructured interviews with GPs and their enrolled patients. The analysis will examine fidelity and dose of the intervention, observations of trial setup and implementation and the quality of the care provided. We will also examine details of 'usual care'. The semistructured interviews will be analysed using thematic and content analysis to draw out themes around implementation and acceptability of the model. ETHICS AND DISSEMINATION: The primary and substudy protocols have been approved by the Human Research Ethics Committee of The University of Sydney (2016/959 and 2019/503). Our findings will be disseminated to national and international partners and stakeholders, who will also assist with wider dissemination of our results across all levels of healthcare. Specific findings will be disseminated via peer-reviewed journals and conferences, and via training for healthcare professionals delivering OA management programmes. This evaluation is crucial to explaining the PARTNER study results, and will be used to determine the feasibility of rolling-out the intervention in an Australian healthcare context. TRIAL REGISTRATION NUMBER: ACTRN12617001595303; Pre-results.
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    Better Knee, Better Me™: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis - protocol for a randomized controlled trial
    Bennell, KL ; Keating, C ; Lawford, BJ ; Kimp, AJ ; Egerton, T ; Brown, C ; Kasza, J ; Spiers, L ; Proietto, J ; Sumithran, P ; Quicke, JG ; Hinman, RS ; Harris, A ; Briggs, AM ; Page, C ; Choong, PF ; Dowsey, MM ; Keefe, F ; Rini, C (BMC, 2020-03-12)
    BACKGROUND: Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese. METHODS: Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and < 41 kg/m2 and painful knee osteoarthritis. Recruitment is Australia-wide amongst Medibank private health insurance members. All three groups receive access to a bespoke website containing information about osteoarthritis and self-management. Participants in the Exercise group also receive six consultations with a physiotherapist via videoconferencing over 6 months, including prescription of a strengthening exercise and physical activity program, advice about management, and additional educational resources. The Exercise plus weight management group receive six consultations with a dietitian via videoconferencing over 6 months, which include a very low calorie ketogenic diet with meal replacements and resources to support behaviour change, in addition to the interventions of the Exercise group. Outcomes are measured at baseline, 6 and 12 months. Primary outcomes are self-reported knee pain and physical function at 6 months. Secondary outcomes include weight, physical activity levels, quality of life, global rating of change, satisfaction with care, knee surgery and/or appointments with an orthopaedic surgeon, and willingness to undergo surgery. Additional measures include adherence, adverse events, self-efficacy, and perceived usefulness of intervention components. Cost-effectiveness of each intervention will also be assessed. DISCUSSION: This pragmatic study will determine whether a scalable remotely-delivered service combining weight management with exercise is more effective than a service with exercise alone, and with both compared to an information-only control group. Findings will inform development and implementation of future remotely-delivered services for people with knee osteoarthritis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12618000930280 (01/06/2018).
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    Effectiveness of a new model of primary care management on knee pain and function in patients with knee osteoarthritis: Protocol for THE PARTNER STUDY
    Hunter, DJ ; Hinman, RS ; Bowden, JL ; Egerton, T ; Briggs, AM ; Bunker, SJ ; Kasza, J ; Forbes, AB ; French, SD ; Pirotta, M ; Schofield, DJ ; Zwar, NA ; Bennell, KL (BMC, 2018-04-30)
    BACKGROUND: To increase the uptake of key clinical recommendations for non-surgical management of knee osteoarthritis (OA) and improve patient outcomes, we developed a new model of service delivery (PARTNER model) and an intervention to implement the model in the Australian primary care setting. We will evaluate the effectiveness and cost-effectiveness of this model compared to usual general practice care. METHODS: We will conduct a mixed-methods study, including a two-arm, cluster randomised controlled trial, with quantitative, qualitative and economic evaluations. We will recruit 44 general practices and 572 patients with knee OA in urban and regional practices in Victoria and New South Wales. The interventions will target both general practitioners (GPs) and their patients at the practice level. Practices will be randomised at a 1:1 ratio. Patients will be recruited if they are aged ≥45 years and have experienced knee pain ≥4/10 on a numerical rating scale for more than three months. Outcomes are self-reported, patient-level validated measures with the primary outcomes being change in pain and function at 12 months. Secondary outcomes will be assessed at 6 and 12 months. The implementation intervention will support and provide education to intervention group GPs to deliver effective management for patients with knee OA using tailored online training and electronic medical record support. Participants with knee OA will have an initial GP visit to confirm their diagnosis and receive management according to GP intervention or control group allocation. As part of the intervention group GP management, participants with knee OA will be referred to a centralised multidisciplinary service: the PARTNER Care Support Team (CST). The CST will be trained in behaviour change support and evidence-based knee OA management. They will work with patients to develop a collaborative action plan focussed on key self-management behaviours, and communicate with the patients' GPs. Patients receiving care by intervention group GPs will receive tailored OA educational materials, a leg muscle strengthening program, and access to a weight-loss program as appropriate and agreed. GPs in the control group will receive no additional training and their patients will receive usual care. DISCUSSION: This project aims to address a major evidence-to-practice gap in primary care management of OA by evaluating a new service delivery model implemented with an intervention targeting GP practice behaviours to improve the health of people with knee OA. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12617001595303 , date of registration 1/12/2017.
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    Effectiveness of a new model of primary care management on knee pain and function in patients with knee osteoarthritis: Protocol for THE PARTNER STUDY (vol 19, 132, 2018)
    Hunter, DJ ; Hinman, RS ; Bowden, JL ; Egerton, T ; Briggs, AM ; Bunker, SJ ; Kasza, J ; Forbes, AB ; French, SD ; Pirotta, M ; Schofield, DJ ; Zwar, NA ; Bennell, KL (BMC, 2018-12-20)
    After the publication of this protocol [1], our collaborator Prima Health solutions advised us of their intent to withdraw from the study.