Self-assessment Triage in Inflammatory Arthritis

July 8, 2021 updated by: Dr. Mary Bell, Sunnybrook Health Sciences Centre

There are benefits to early, intensive treatment of IA. But getting to treatment depends on timeline and accurate case identification. The longest delays occur in persons self-identifying the need to see care for IA, recognition of these cases by primary care providers (PCPs), and appropriate, timely referral to rheumatology. Current methods of improving time to referral and consultation are effective, but costly and unsustainable, so there is need to look for alternatives. One solutions may be the use of patient self-administered tools.

In this study, we will test whether the use of validated, self-administered patient questionnaires (self-assessment) can advance the urgency rating of referrals for people with inflammatory arthritis (IA). If urgency ratings can be advanced then self-assessment may have the potential to reduce wait times to see a rheumatologist.

In Canada, one in every hundred people has IA and hundreds of new patients are diagnosed each year. Wait times to see a rheumatologist are long, so anything that has the potential to reduce these wait times would have a significant impact.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • Richmond, British Columbia, Canada, V7C 5L9
        • Dr. Raheem Kherani
    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • SunnyBrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • new patient referral

Exclusion Criteria:

  • under 18 years of age
  • confirmed diagnosis of inflammatory condition
  • seen/managed by another rheumatologist within the last five years
  • unable to speak English
  • on disease modifying antirheumatic drugs.
  • referrals from the Emergency Department

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Joint Count + Early Inflammatory Arthritis Detection Tool
Rheumatologist reviews both the self-administered tender joint count (out of 68 joints on a homunculus) and self-administered Early Inflammatory Arthritis Detection Tool that were completed by the patient. Rheumatologist then uses the information provided in these tools by the patient to determine whether they should advance the urgency rating of the case.
Self-assessment including a self-administered patient joint count and a self-administered Early Inflammatory Arthritis Detection Tool
Experimental: Early Inflammatory Arthritis Detection Tool
Rheumatologist reviews both the self-administered Early Inflammatory Arthritis Detection Tool that was completed by the patient. Rheumatologist then uses the information provided in this tool by the patient to determine whether they should advance the urgency rating of the case.
Self-assessment including a self-administered patient joint count and a self-administered Early Inflammatory Arthritis Detection Tool
Experimental: Joint Count
Rheumatologist reviews both the self-administered Patient Tender Joint Count that was completed by the patient. Rheumatologist then uses the information provided in this tool by the patient to determine whether they should advance the urgency rating of the case.
Self-assessment including a self-administered patient joint count and a self-administered Early Inflammatory Arthritis Detection Tool
No Intervention: Control
Rheumatologist does not review any of the self-administered tools completed by the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urgency Rating
Time Frame: 1 Day

When a rheumatologist receives a new referral, he/she gives it an "urgency rating", which indicates how soon the patient needs to be seen based on information they have about the patient in the referral letter. Urgency rating has four levels: 1) urgent, schedule patient within 4 weeks, 2) urgent, schedule patient in 4 to 6 weeks, 3) urgent, schedule patient in 6 to 12 weeks, 4) non-urgent, schedule patient after 12 weeks. These were developed by the Canadian Rheumatology Association. Please note that these are NOT time points, but ratings used to describe how soon a patient should be seen.

Urgency rating will be recorded by the rheumatologist after three different cases: 1) After the rheumatologist receives the patient's referral letter, 2) after the patient arrives for their first appointment and completes a self-assessment in the waiting area, and 3) after the rheumatologist completes their first physical assessment of the patient.

1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2017

Primary Completion (Actual)

October 31, 2018

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

April 11, 2018

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 9, 2021

Study Record Updates

Last Update Posted (Actual)

July 9, 2021

Last Update Submitted That Met QC Criteria

July 8, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 261-2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be faxed from Richmond Site to Toronto Site for entry and analysis.

IPD Sharing Time Frame

Data is currently being collected and faxed. Data will remain available for 10 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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