Implementation of shared decision making in rheumatoid arthritis: study protocol for RAiSeD (Rheumatoid Arthritis...

Area of Science:

• Rheumatology
• Health Services Research
• Clinical Trial Methodology

Background:

• Rheumatoid arthritis (RA) significantly impacts patient quality of life, leading to disability and increased mortality.
• Individualized treatment decisions are crucial for RA management, with shared decision-making (SDM) being a cornerstone of current guidelines.
• Suboptimal uptake of SDM necessitates interventions to improve its implementation in clinical practice.

Purpose of the Study:

• To evaluate the effectiveness of a multicomponent SDM intervention on rheumatoid arthritis (RA) disease activity.
• To explore the early implementation of this SDM intervention across diverse rheumatology settings.
• To assess the impact of SDM on RA patient knowledge and medication adherence.

Main Methods:

• A stepped-wedge, cluster-randomized trial design involving over 400 patients and 45 clinicians across three U.S. Veterans Health Administration rheumatology clinics.
• The intervention includes clinician training, patient activation tools (AskShareKnow), and point-of-care decision aids (RA Choice, medication summary).
• Mixed-methods evaluation including clinical outcomes (Clinical Disease Activity Index - CDAI), patient-reported measures of SDM, audio recordings of clinic visits, and stakeholder interviews.

Main Results:

• The primary outcome is the change in disease activity measured by CDAI.
• Secondary outcomes include patient knowledge of RA medications and medication adherence.
• Process evaluation will assess implementation fidelity and stakeholder experiences.

Conclusions:

• This is the first multi-site trial testing a comprehensive SDM intervention for veterans with RA.
• The study hypothesizes improved SDM uptake, leading to decreased RA disease activity and increased patient knowledge.
• Findings will guide broader implementation of SDM in rheumatology care to enhance patient outcomes.