Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals in Knee Osteoarthritis (CONNACT): Study Protocol for an Effectiveness-Implementation Hybrid Randomized Control Trial

Abstract

<jats:title>Abstract</jats:title> <jats:p><jats:bold>Background</jats:bold>: Knee Osteoarthritis (OA) is a leading cause of global disability, with most patients not receiving optimal non-surgical treatment resulting in significant morbidity and cost to the healthcare system, The <jats:bold>Collaborative Model of Care between Orthopaedics and Allied Healthcare Professionals (CONNACT) </jats:bold>Model of Care (MoC) was developed by<jats:bold> </jats:bold>optimizing evidence-based non-surgical treatments to deliver value-based care for people with knee OA. The primary aim of this study is to determine the clinical effectiveness of the CONNACT MoC compared to usual care. The secondary aims are: a) To determine the cost-effectiveness and b) To develop an evaluation and implementation framework to inform large scale implementation for this MoC. <jats:bold>Design</jats:bold>: A Type 1 Effectiveness-Implementation Hybrid Trial using an explanatory sequential mixed-method approach. <jats:bold>Methodology</jats:bold>: The study consists of 3 components. The first component is the pragmatic, parallel-arm, single-blinded randomized control trial. Inclusion criteria are patients with knee OA based on the National Institute of Health and Care Excellence (NICE) criteria with radiographic severity of greater than Kellgren-Lawrence 1, and Knee Injury and OA Outcome Score (KOOS<jats:sub>4</jats:sub>) of equal or less than 75. Exclusion criteria include other forms of arthritis, history of previous knee arthroplasty or wheelchair-bound patient. The intervention arm will undergo the CONNACT MoC while the usual care arm will be referred to the physiotherapist where the number and content of sessions are at the patient’s and physiotherapist’s discretion. The CONNACT MoC is a community-based, multidisciplinary 12-week program that uniquely uses an individualized approach based on a triaging criterion to tailor the treatment to each patient in line with the “<jats:italic>right care</jats:italic>, delivered at the <jats:italic>right time</jats:italic>, by the <jats:italic>right team</jats:italic>, in the <jats:italic>right place</jats:italic>, with the <jats:italic>right resources</jats:italic>” philosophy coupled with a strong emphasis on patient activation and self-management strategies to promote long term sustainable behavioural change. KOOS<jats:sub>4</jats:sub> is the primary outcome measure. Secondary outcomes include KOOS individual subscales, quality of life scoring, functional performance, global, diet and psychological related outcomes. The second component is an economic evaluation of the cost-effectiveness of the CONNACT MoC using a societal perspective. The third component is an implementation and evaluation framework using process evaluation under the RE-AIM framework using a mixed-method approach. <jats:bold>Discussion</jats:bold>: A rapidly aging global population has resulted in an OA epidemic that is currently being poorly managed on a global scale. CONNACT MoC is a complex intervention that has been developed to meet this growing need. In line with the MRC guidance for developing and evaluating complex interventions, a pilot feasibility study was completed and a comprehensive approach including an RCT, economic evaluation and process evaluation is described in this study protocol. Results from this study will help clinicians, healthcare administrators and policymakers guide the sustainable and effective implementation of the CONNACT MoC for knee OA and serve as a basis for similar multidisciplinary MoC for chronic degenerative musculoskeletal conditions to be developed.<jats:bold>Trial Registration</jats:bold>: Clinicaltrials.gov Identifier: NCT03809975. Registered January 18 2019. https://clinicaltrials.gov/ct2/show/NCT03809975</jats:p>