Inflammatory ArthritisNCT04956380
Self-assessment Triage in Inflammatory Arthritis
A study testing Self-administered Triage in people with Inflammatory Arthritis, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis
- What is being tested?
- Self-administered Triage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 2 sitesCanada
- Study dates
- 31 Oct 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- new patient referral
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Dr. Raheem Kherani
Richmond, British Columbia, V7C 5L9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
About this study
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.
- Conditions
- Inflammatory Arthritis
- Being tested
- Self-administered Triage
- Keywords
- New Referrals, Triage, Self-assessment
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered TriageOther
Self-assessment including a self-administered patient joint count and a self-administered Early Inflammatory Arthritis Detection Tool
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Self-administered Triage |
| Control | No intervention | Rheumatologist does not review any of the self-administered tools completed by the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start31 Oct 2017
- Primary completion31 Oct 2018
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia
- Responsible party
- Principal investigator, Dr. Mary Bell, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956380
- Sponsor's protocol ID
- 261-2017
- Status last verified
- Jul 2021
- First submitted
- 11 Apr 2018
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be faxed from Richmond Site to Toronto Site for entry and analysis.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-assessment Triage in Inflammatory Arthritis
- ClinicalTrials.gov ID
- NCT04956380
- Acronym / sponsor ID
- 261-2017
- Conditions
- Inflammatory Arthritis
- Keywords
- New Referrals, Triage, Self-assessment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- University of British Columbia
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 factorial randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Joint Count + Early Inflammatory Arthritis Detection Tool | Experimental | Other: Self-administered TriageRheumatologist 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. |
| Early Inflammatory Arthritis Detection Tool | Experimental | Other: Self-administered TriageRheumatologist 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. |
| Joint Count | Experimental | Other: Self-administered TriageRheumatologist 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. |
| Control | No intervention | –Rheumatologist does not review any of the self-administered tools completed by the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- new patient referral
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered TriageSelf-assessment including a self-administered patient joint count and a self-administered Early Inflammatory Arthritis Detection Tool | Other | Early Inflammatory Arthritis Detection Tool, Joint Count, Joint Count + Early Inflammatory Arthritis Detection Tool |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Individual participant dataSharing planned: Yes. De-identified data will be faxed from Richmond Site to Toronto Site for entry and analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-administered Triage in people with Inflammatory Arthritis, run by Sunnybrook Health Sciences Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urgency Rating (time frame: 1 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021.