In Trials
BACKGROUND : Osteoarthritis (OA) affects 20% of the adult Danish population, and the financial burden to society amounts to DKK 4.6 billion annually. Research suggests that up to 75% of surgical patients could have postponed an operation and managed with physical training. ERVIN.2 is an artificial intelligence (AI)-based clinical support system that addresses this problem by enhancing patient involvement in decisions concerning surgical knee and hip replacement. However, the clinical outcomes and cost-effectiveness of using such a system are scantily documented.
OBJECTIVE : The primary objective is to investigate whether the usual care is non-inferior to ERVIN.2 supported care. The second objective is to determine if ERVIN.2 enhances clinical decision support and whether ERVIN.2 supported care is cost-effective.
METHODS : This study used a single-centre, non-inferiority, randomised controlled in a two-arm parallel-group design. The study will be reported in compliance with CONSORT guidelines. The control group receives the usual care. As an add-on, the intervention group have access to baseline scores and predicted Oxford hip/knee scores and HRQoL for both the surgical and the non-surgical trajectory. A cost-utility analysis will be conducted alongside the trial using a hospital perspective, a 1-year time horizon and effects estimated using EQ-5D-3L. Results will be presented as cost per QALY gain.
DISCUSSION : This study will bring knowledge about whether ERVIN.2 enhances clinical decision support, clinical effects, and cost-effectiveness of the AI system. The study design will not allow for the blinding of surgeons.
TRIAL REGISTRATION : ClinicalTrials.gov NCT04332055 . Registered on 2 April 2020.
Kastrup Nanna, Bjerregaard Helene H, Laursen Mogens, Valentin Jan B, Johnsen Søren P, Jensen Cathrine E
2023-Jan-12
Artificial intelligence, Clinical decision support system, Cost-effectiveness, Machine learning, Osteoarthritis, Patient-reported outcomes, Randomised controlled trial, Total hip replacement, Total knee replacement
