Electronic and Lab Pre-screening of New Rheumatology Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Electronic and Lab Pre-screening of New Rheumatology Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03843619
• Other study ID #: R-17015
• Status: Not yet recruiting
• Start date: February 28, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: February 2019
• Source: Arthritis Northwest PLLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

By forming the foundation of a delivery system that integrates primary care (PC) and rheumatology, this initiative strives to strengthen the roles of both primary care and rheumatology practices as they co-manage patients in a quality care delivery system. Importantly, it strives to fill an unmet need, the rapid evaluation by Primary Care providers; the appropriate and timely referral of inflammatory disease patients to a rheumatologist; and the implementation of early aggressive therapy in the management of patients with rheumatoid arthritis (RA) with tight control. Given the call for improved quality, value, and demonstration of results[1], this initiative uses the tenets of National Center for Quality Assurance's Patient Centered Specialty Program[1] (PCSP) and it successfully masters and streamlines coordination of care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First ever referral to a rheumatologist.

Exclusion Criteria:

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammatory Arthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Arthritis Northwest PLLC	Bristol-Myers Squibb, Discus Analytics LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To increase referral efficiencies through an electronic system to decrease the timeline prior	Mean and median time (in days) to the first rheumatology visit from PCP referral for both cohorts	One year enrollment period
Secondary	To assess difference in disease activity progression using Clinical Disease Activity Index (CDAI) at both 12 and 24 months.	The change in CDAI score from baseline at 1 and 2 years. CDAI uses a scale of 0 - 60 where scores less than 2.8 are considered "remission", 2.9 - 10.0 are "low" disease activity, 10.1 - 22.0 are "moderate" disease activity, and 22.1 or higher are "high" disease activity.	One year enrollment period with two year follow-up period.
Secondary	To assess difference in disease activity progression using Routine Assessment of Patient Index Data (RAPID3) at both 12 and 24 months.	The change in RAPID3 score from baseline at 1 and 2 years. RAPID3 uses a scale of 0 - 30 where scores less than 3.1 are considered "remission", 3.1 - 6.0 are "low" disease activity, 6.1 - 12.0 are "moderate" disease activity, and 12.1 or higher are "high" disease activity.	One year enrollment period with two year follow-up period.
Secondary	To assess radiographic progression using sharp scores in the electronically referred cohorts versus the traditional cohort.	The change in sharp scores from baseline at 1 and 2 years.	One year enrollment period with two year follow-up period.