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Self-assessment Triage in Inflammatory Arthritis

Primary Purpose

Inflammatory Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-administered Triage
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammatory Arthritis focused on measuring New Referrals, Triage, Self-assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Raheem Kherani
  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Joint Count + Early Inflammatory Arthritis Detection Tool

Early Inflammatory Arthritis Detection Tool

Joint Count

Control

Arm Description

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.

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.

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.

Rheumatologist does not review any of the self-administered tools completed by the patient.

Outcomes

Primary Outcome Measures

Urgency Rating
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.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2018
Last Updated
July 8, 2021
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT04956380
Brief Title
Self-assessment Triage in Inflammatory Arthritis
Official Title
Self-assessment Triage in Inflammatory Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Arthritis
Keywords
New Referrals, Triage, Self-assessment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2x2 factorial randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Joint Count + Early Inflammatory Arthritis Detection Tool
Arm Type
Experimental
Arm Description
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.
Arm Title
Early Inflammatory Arthritis Detection Tool
Arm Type
Experimental
Arm Description
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.
Arm Title
Joint Count
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Rheumatologist does not review any of the self-administered tools completed by the patient.
Intervention Type
Other
Intervention Name(s)
Self-administered Triage
Intervention Description
Self-assessment including a self-administered patient joint count and a self-administered Early Inflammatory Arthritis Detection Tool
Primary Outcome Measure Information:
Title
Urgency Rating
Description
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.
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Dr. Raheem Kherani
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V7C 5L9
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Self-assessment Triage in Inflammatory Arthritis

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