- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04956380
Self-assessment Triage in Inflammatory Arthritis
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Richmond, British Columbia, Canada, V7C 5L9
- Dr. Raheem Kherani
-
-
Ontario
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Toronto, Ontario, Canada, M4N3M5
- SunnyBrook Health Sciences Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 261-2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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