Implementation of shared decision making in rheumatoid arthritis: study protocol for RAiSeD (Rheumatoid Arthritis Shared Decision Making) stepped wedge, cluster-randomized trial.

Background: Rheumatoid arthritis (RA) impacts quality of life causing disability and increased mortality. Treatment decisions are complex and require individualization. Shared decision making (SDM) is the first principle of RA treat-to-target guidelines, but uptake is suboptimal. We aim to evaluate the effectiveness of a multicomponent SDM intervention on RA disease activity and explore the early implementation of the intervention within three geographically diverse rheumatology services.

Methods: The RAiSeD trial uses a stepped-wedge, cluster-randomized trial design at three U.S. Veterans Health Administration rheumatology clinics, targeted to enroll more than 400 patients and over 45 clinicians. The multicomponent SDM intervention consists of three parts: (1) rheumatology clinician training and a pocket card on SDM and fostering choice awareness ("acknowledging when there is more than one sensible option available to address a patient's situation"), (2) RA patient activation using the AskShareKnow questions, and (3) a point-of-care decision aid (RA Choice) and medication summary guide. We will conduct a mixed-methods outcomes and process evaluation. Outcomes will be evaluated during a pre-intervention (usual care) and intervention period. The primary outcome is disease activity as measured by the validated Clinical Disease Activity Index (CDAI), with secondary outcomes of RA knowledge and medication adherence. SDM will be measured by two brief, validated patient-reported measures. A subgroup of clinic visits will be audio-recorded and clinicians' efforts to involve patients in SDM will be assessed. The implementation process will be evaluated using stakeholder interviews and field notes at each of the three sites.

Discussion: This study is the first multi-site trial of a multicomponent intervention to facilitate SDM among veterans with RA. We expect to improve uptake of SDM across geographically distinct rheumatology clinics and hypothesize that patients exposed to the interventions will have a greater decrease in disease activity and an increase in knowledge of RA medications compared to usual care. Insights gained from this study will inform broader dissemination and implementation of SDM across VA rheumatology clinics and beyond, with the goal of improving quality of care for all persons with RA.

Trial registration: ClinicalTrials.gov NCT05530694. Registered on September 7, 2022.