Training primary care providers to manage rheumatoid arthritis versus rheumatologist care

Comparative Effectiveness of Primary Care Providers Trained in Rheumatoid Arthritis Management Versus Rheumatologist Care: A Randomized Controlled Trial

This trial will test whether primary care doctors who completed a focused RA training program can safely manage stable adults with rheumatoid arthritis as well as their rheumatologist over one year.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: St. Lawrence Health System (Academic / other)
• Locations: 1 site (Potsdam, New York)
• Trial ID: NCT07034196 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial assigns stable RA patients to either a local primary care provider who completed a structured RA training program or to usual rheumatologist care at a regional clinic. Nine PCPs underwent lectures, case reviews, and a final exam before offering study care. Patients are followed for 12 months with regular medical exams, disease activity measures, and patient-reported outcomes to compare clinical status and experience. The goal is to determine whether trained PCPs can deliver guideline-concordant care and maintain patient outcomes in a rural health system.

Who should consider this trial

Good fit: Adults with a confirmed diagnosis of rheumatoid arthritis who meet the 2010 ACR/EULAR classification criteria and whose disease is considered appropriate for management in a stable-care pathway are ideal candidates.

Not a fit: Patients with highly active, complex, newly diagnosed RA, major comorbidities, or cases needing advanced rheumatologic procedures are unlikely to benefit from primary-care-only management in this model.

Why it matters

Potential benefit: If successful, this approach could expand local access to RA management, reduce travel and wait times, and free rheumatology appointments for more complex cases.

How similar studies have performed: Related shared-care and nurse-led models for stable RA and other chronic rheumatic conditions have shown acceptable outcomes in some settings, but randomized evidence comparing trained PCPs directly to rheumatologists is limited.

Eligibility criteria

Inclusion Criteria:

* 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.

The highest score achieved in a given domain is used for this calculation. These domains and their values are:

* Number and site of involved joints:

  * 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
  * Greater than 10 joints (including at least 1 small joint) = 5 points
* Serological abnormality (RF or ACPA)

  * Low positive (above the upper limit of normal) = 2 points
  * High positive (greater than three times the upper limit of normal) = 3 points
* Elevated acute phase response (ESR or CRP) above the upper limit of normal = 1 point
* Symptom duration at least six weeks = 1 point

  * Stable disease activity, defined as a RAPID-3 score of no higher than 4 over the past three months or no RA-related medication changes for at least six months prior to the informed consent date.
  * Primary residence in the North Country region of New York (Jefferson, Lewis, St. Lawrence, Clinton, Essex, Franklin, and Hamilton counties).
  * Established with the participating rheumatology clinic and a participating PCP (Note: For patients who are established in PCP clinics outside of the health system conducting this study, patients may see a participating PCP within their established clinic). To be considered an established patient, the participant should have had a visit within the year prior to the screening visit.
  * Willingness to participate in the study and provide informed consent.
  * Females of childbearing potential must agree to use highly effective birth control throughout duration of the study.

Exclusion Criteria:

* 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.
* Inability to adhere to the study protocol or follow-up requirements.
* Any comorbid condition that, in the opinion of the investigator, would make the subject unsuitable for participation in this study.

Where this trial is running

Potsdam, New York

• St. Lawrence Health — Potsdam, New York, United States (Recruiting)

Study contacts

• Principal investigator: Eyal Kedar, MD — St. Lawrence Health
• Study coordinator: McKailey Lyndaker

Conditions Rheumatoid Arthritis (RA