Summary

This randomised controlled trial evaluates the effect of the SMART Choice (Knee) tool on patient willingness for surgery.

Abstract

Background

Approximately 1 in 5 patients feel unsatisfied after total knee arthroplasty (TKA). Prognostic tools may aid in the patient selection process and reduce the proportion of patients who experience unsatisfactory surgery. This study uses the prognostic tool, SMART Choice (Patient Prognostic Tool for Total Knee Arthroplasty) to predict patient improvement at 12 months after TKA. This tool has been developed using machine learning and traditional statistical methods. The tool aims to be used by the patient without clinician input and does not require clinical data such as X-ray findings or blood results. The objective of this study is to evaluate the SMART Choice tool on patient decision making, particularly willingness for surgery. We hypothesise that the use of the SMART Choice tool will influence willingness to undergo surgery, especially when used earlier in the patient TKA journey.

Methods

This is a multicentred, pragmatic, randomised controlled trial conducted from Melbourne, Australia. Participants will be recruited from the St. Vincent’s Hospital, Melbourne (SVHM) Orthopaedic Clinic, and the client base of HCF, Australia (private health insurance company). Patients over 45? years of age who have been diagnosed with knee osteoarthritis and considering TKA are eligible for participation. Participants will be randomised to either use the SMART Choice tool or treatment as usual. The SMART Choice tool provides users with a prediction for improvement or deterioration / no change after surgery based on utility score change calculated from the Veterans-RAND 12 (VR-12) survey. The primary outcome of the study is patient willingness for TKA surgery. The secondary outcomes include evaluating the optimal timing for tool use in the TKA pathway and using decision quality questionnaires to understand the patient experience when using the tool. Participants will be followed up for 6? months from the time of recruitment.

Preliminary Results
We expect 400 patients to be recruited to this study; 200 from the SVHM arm and 200 from the HCF arm. To date, 227 patients have been included in the study with recruitment ongoing. Based on current recruitment projections and follow up time, this study will conclude in January 2023 with full results available in February 2023.

Discussion

The SMART Choice tool has the potential to improve patient decision making for TKA. Although many prognostic tools have been developed for other areas of surgery, most are confined within academic bodies of work. Furthermore, the technical performance of a predictive model on a paper may not necessarily translate to performance in a clinical environment. After all, it is the effect a tool like the SMART Choice can have on patient decisions and outcomes that are most important. This study will be one of the first to evaluate the impact of a prognostic tool on patient decision making using a prospective clinical trial, an important step in transitioning the tool for use in clinical practice.

Trial Registration
Australia and New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12622000072718. Prospectively registered – 21 January 2022.

Additional Notes
The SMART Choice tool is available as a standalone tool (smartchoice.org.au) and as a study-centred website (URL withheld as study is ongoing). This study is related to abstract #21509 submitted to ISAKOS 2023.