NCT07034196 | RECRUITING | Rheumatoid Arthritis (RA

Detailed Description:

Rheumatoid arthritis (RA) is a chronic autoimmune disorder characterized by joint inflammation, stiffness, and pain. If left untreated, RA can lead to irreversible joint damage and functional impairment. This disease has significant impact on the healthcare system of the United States because it requires specialized care, while also affection about 1.5 million individuals \[Pfizer, 2025\]. Within the United States, access to specialized care is not widespread, with large disparities between urban and rural areas. Rural areas have about 1/8th the specialists per 100,000 people when compared to urban areas \[NRHA\]. Access to timely and effective care is vital to maintain the quality of life of RA patients. St. Lawrence Health (SLH) is a rural health system in St. Lawrence County in northern New York. SLH not only serves its own county, but the four surrounding counties. Eyal Kedar, MD, is the sole rheumatologist of this expansive region, and manages a large RA patient load. If there were more access to RA management in our area, our rheumatology clinic would be more available for patients who need to see a rheumatologist for something other than RA. This trial will evaluate if trained primary care providers (PCPs) can give care that is meets the standards set by our rheumatology clinic. Nine PCPs in our area were selected and subjected to a structured training course involving regularly scheduled lectures, discussions, case studies and a final exam to test the knowledge obtained through these training sessions. The trial will consist of two arms, the intervention arm (Arm 1) and the active comparator (control) arm (Arm 2). In Arm 1, patients will be seeing their established PCP who has completed the RA training for their RA management. In Arm 2, patients will be meeting with our rheumatology clinic with either a rheumatologist or a rheumatology APP. Patients will be randomly assigned to one of these arms in a 1:1 ratio. Maximum enrollment of this trial is one hundred subjects, and PCPs will see a minimum of two subjects and a maximum of twenty. Over the course of the study, there will be monthly case review sessions with the rheumatology team, and ad hoc consultations outside of the monthly meeting as needed. The study will collect data at screening/baseline, 6 weeks, 12 weeks, 26 weeks, 40 weeks, and 52 weeks utilizing standard assessments of RA activity (MD\_HAQ, Evaluator Global assessment, Tender and Swollen Joint Count, DAS28 Calculation, CDAI Calculation, and SDAI Calculation, Glucocorticoid Exposure), patient-reported outcomes and medical records review. If the study shows PCP's that are properly trained can effectively manage stable RA patients, this could vastly improve chronic disease management in underserved areas like the northern country of New York State. This model would allow healthcare systems to better utilize workforce capacity, reduce burden on subspeciality care, and possibly lower cost associated with receiving treatment. Furthermore, the success could be applicable to other complex chronic diseases like lupus, chronic kidney disease, etc. This would serve as the blueprint for sustainable and scalable care that would meet the needs of patients in the rural areas without relying on telemedicine or other forms of treatment. For patients, especially those living in remote areas, the benefits of this study would be significant. If the model was to be successful, it would eliminate the need for long-distance driving to specialists, make it more affordable and easier to receive care in a timely manner. Patients would have the benefit of receiving care from their trusted PCP who are trained by the rheumatology department. This would allow for better disease control, a better quality of life, and possibly great satisfaction with the treatment given. Furthermore, this model will enhance overall health care in the northern country as by expanding the pool of providers that are able to manage complex diseases. This trial is a pioneering effort to more efficiently deal with chronic disease care in rural areas. By training PCPS to take a lead in RA management, this study may offer a possible solution to the subspecialty shortages that effect millions of rural residents. Thus, if this model proves to be successful, this will not only better the lives of RA patients in the rural areas but will pave the way for more efficient healthcare delivery methods across the world.