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

Area of Science:

• Rheumatology
• Health Services Research
• Clinical Trial Methodology

Background:

• Biologic agents and Janus kinase (JAK) inhibitors offer expanded treatment options for rheumatic diseases.
• International guidelines advocate for shared decision-making (SDM) in treatment selection.
• Optimal patient engagement in treatment decisions for rheumatoid arthritis (RA) and ankylosing spondylitis (AS) is crucial.

Purpose of the Study:

• To evaluate if a structured SDM model improves patient perceptions of SDM compared to standard care.
• To assess the impact of decision aids and AI chatbots within the SDM model.
• To compare treatment selection processes for biologic agents and JAK inhibitors in RA and AS patients.

Main Methods:

• An open-label, multicentre, stratified cluster-randomised trial involving 300 RA or AS patients.
• Three arms: SDM Group I (Three-Talk Model + decision aids), SDM Group II (Three-Talk Model + decision aids + AI chatbot), and standard care.
• Primary outcome: Shared Decision-Making Questionnaire score; Secondary outcomes: Decisional Conflict Scale, Health Empowerment Scale, Leeds Satisfaction Questionnaire, EuroQol-5 Dimension.

Main Results:

• The study aims to provide evidence on the effectiveness of structured SDM.
• It will compare patient perceptions and outcomes across different SDM intervention groups and standard care.
• Data collection via iCReaT.

Conclusions:

• Structured SDM models, potentially enhanced by digital tools, may improve patient involvement in selecting advanced therapies for RA and AS.
• Findings could inform clinical practice and enhance patient outcomes in rheumatology.
• This research addresses the need for evidence-based SDM implementation in complex treatment scenarios.