NCT04956380

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
207

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

October 31, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

July 9, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 9, 2021

Status Verified

July 1, 2021

Enrollment Period

1 year

First QC Date

April 11, 2018

Last Update Submit

July 8, 2021

Conditions

Keywords

New ReferralsTriageSelf-assessment

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 Day

Study Arms (4)

Joint Count + Early Inflammatory Arthritis Detection Tool

EXPERIMENTAL

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.

Other: Self-administered Triage

Early Inflammatory Arthritis Detection Tool

EXPERIMENTAL

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.

Other: Self-administered Triage

Joint Count

EXPERIMENTAL

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.

Other: Self-administered Triage

Control

NO INTERVENTION

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

Interventions

Self-assessment including a self-administered patient joint count and a self-administered Early Inflammatory Arthritis Detection Tool

Early Inflammatory Arthritis Detection ToolJoint CountJoint Count + Early Inflammatory Arthritis Detection Tool

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • new patient referral

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. Raheem Kherani

Richmond, British Columbia, V7C 5L9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Model Details: 2x2 factorial randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rheumatologist

Study Record Dates

First Submitted

April 11, 2018

First Posted

July 9, 2021

Study Start

October 31, 2017

Primary Completion

October 31, 2018

Study Completion

December 31, 2021

Last Updated

July 9, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data is currently being collected and faxed. Data will remain available for 10 years.

Locations