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

Electronic and Lab Pre-screening of New Rheumatology Patients

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Inflammatory Arthritis

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients referred to a rheumatologist for inflammatory arthritis.

Description

Inclusion Criteria:

• First ever referral to a rheumatologist.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Non-E-referral; Patients who are referred in the traditional manner between two separate organizations.
E-referral; Patients who are referred in an automated manner between two separate organizations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Arthritis Northwest PLLC
• Collaborators: Bristol-Myers Squibb; Discus Analytics LLC

Study record dates

Study Major Dates

• Study Start (Anticipated): February 28, 2019
• Primary Completion (Anticipated): March 31, 2022
• Study Completion (Anticipated): March 31, 2022

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): February 18, 2019
• Last Update Submitted That Met QC Criteria: February 14, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: R-17015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No