NCT03843619

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 18, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

3.1 years

First QC Date

January 22, 2019

Last Update Submit

February 14, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • To assess difference in disease activity progression using Clinical Disease Activity Index (CDAI) at both 12 and 24 months.

    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.

    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.

    One year enrollment period with two year follow-up period.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients referred to a rheumatologist for inflammatory arthritis.

You may qualify if:

  • First ever referral to a rheumatologist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

February 18, 2019

Study Start

February 28, 2019

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

February 18, 2019

Record last verified: 2019-02