Training primary care providers to manage rheumatoid arthritis versus rheumatologist care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Principal investigator: Eyal Kedar, MD — St. Lawrence Health
• Study coordinator: McKailey Lyndaker
• Email: mckailey.lyndaker@rochesterregional.org
• Phone: 315-261-6352

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.