Protocol for DESCIDE-RD: Determining Effectiveness of Shared Decision Making in Drug Therapy Selection for Rheumatic...

The availability of biologic agents and Janus kinase (JAK) inhibitors has expanded therapeutic options for rheumatic diseases, and international guidelines now recommend shared decision-making (SDM) to guide treatment selection. This study will evaluate whether a structured SDM model enhances patients' perceptions of SDM when selecting biologic agents or JAK inhibitors for rheumatoid arthritis (RA) and ankylosing spondylitis (AS), compared to standard care. This open-label, multicentre, stratified cluster-randomised trial will enrol 300 patients with RA or AS. Participants will be assigned in a 1:1:1 ratio to one of three groups: SDM Group I, SDM Group II, or standard care. In the SDM groups, the Three-Talk Model (Team Talk, Option Talk, and Decision Talk) will be implemented. SDM Group I will receive decision aids during Option Talk, while SDM Group II will receive both decision aids and an artificial intelligence-based chatbot. In the standard care group, treatment recommendations will be made at the physician's discretion. The primary outcome will be the Shared Decision-Making Questionnaire score. Secondary outcomes will include changes in the Decisional Conflict Scale, the Health Empowerment Scale, the Leeds Satisfaction Questionnaire, and the EuroQol-5 Dimension. Data will be collected using iCReaT (http://icreat.kr). This study will provide evidence on the effectiveness of structured SDM in selecting biologic agents and JAK inhibitors for RA and AS, with potential implications for improving treatment decisions and patient outcomes. Trial Registration: Clinical Research Information Service Identifier: KCT0011310.