Rheumatoid arthritis (RA) is a complex autoimmune disease where the immune system attacks healthy joint tissue; causing pain, swelling, and stiffness of the joints. This disease effects lots of people in the US and can lead to major joint damage if not properly treated. In rural areas like northern NY, these are underserved areas for RA patients, thus many patients struggle to get the appropriate care. This model is testing whether primary care providers (PCP) can safely and effectively provide stable RA patients with the proper treatment rather than send them to a specialist. PCPs were trained through classes, case reviews, and a final exam. Patients will be randomly assigned to either see a trained PCP or their normal rheumatologist at the rheumatology clinic. This study will examine how patients are doing over a year using medical exams and patient feedback. If this model proves to be successful, it will make RA treatment easier and more affordable for patients.
Fulfillment of the 2010 ACR/EULAR classification criteria for rheumatoid arthritis Using these criteria, a classification as "definite RA" is based upon the presence of synovitis in at least one joint, the absence of an alternative diagnosis that better explains the synovitis, and the achievement of a total score of at least 6 (of a possible 10) from the individual scores in four domains.
2 to 10 large joints (from among shoulders, elbows, hips, knees, and ankles) = 1 point
1 to 3 small joints (from among the MCP joints, PIP joints, second through fifth MTP joints, thumb IP joints, and wrists) = 2 points
4 to 10 small joints = 3 points
Changes in RA treatment within the six months prior to screening.
History of interstitial lung disease or any manifestation of rheumatoid vasculitis including cutaneous rheumatoid vasculitis, vasculitic neuropathy, RA-associated episcleritis, scleritis or keratitis)
Cognitive impairment or inability to complete study assessments.
Pregnancy, breastfeeding, or plans to become pregnant during the study period.
Parallel
Primary Care Treatment in lieu of Rheumatologist
Other interventionRA patients will be randomized to receive their RA care via their established PCP who completed a structured training course in RA and who has monthly case review/consultation sessions with the rheumatology team in this study
Change in Disease Activity Score (DAS-28)
The primary efficacy endpoint is the change in Disease Activity Score (DAS-28) response at 6 and 12 month intervals relative to baseline. It will be evaluated for non-inferiority of the treatment effect. The treatment difference between the Primary Care group and the Rheumatology group may be presented with point estimate and 95% CI.
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