SLENCT03240536
Choosing Tests Wisely in Rheumatology
A study testing Choosing Wisely form in people with SLE, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This is a randomized study intended to produce a reduction in ordering of inappropriate tests by general practitioners as determined by recommendations from the CRA's Choosing Wisely guidelines. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- SLE
- What is being tested?
- Choosing Wisely form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 638 participants
- Where
- 1 siteCanada
- Study dates
- 15 May 2018to 8 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ordering physicians who recently made a referral to the Rheumatology clinic at St. Joseph's Health Care.
Who cannot join
- N/A, all recent referrals will be included.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized study intended to produce a reduction in ordering of inappropriate tests by general practitioners as determined by recommendations from the CRA's Choosing Wisely guidelines. This reduction of inappropriate testing is expected in referrals to the rheumatologists randomized to the intervention group. This study will further explore which recommendations from the Canadian Rheumatology Association (CRA)/Canada Choosing Wisely campaign have the most impact on regional referring physicians to the Rheumatology clinic at St. Joseph's Hospital, London.
Read the detailed description
This a randomized study in that 6 rheumatologists (30 referrals each) will be randomized to one of two groups: intervention or control. Referring physicians to the intervention group will be faxed a brief Choosing Wisely form (intervention) based upon the recommendations of the Canadian Rheumatology Association's (CRA) Canada Choosing Wisely campaign, while referring physicians from the control group will not receive the form (non intervention). Analysis will be based upon the results of a three question survey faxed to all referring physicians at year one and at year two and on future referrals from the referring physicians to determine if there is a reduction in the group of ordering physicians that received the intervention (Choosing Wisely form).
- Conditions
- SLE
- Being tested
- Choosing Wisely form
- Keywords
- Rheumatology Referral, Choosing Wisely
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Choosing Wisely formOther
The investigators will fax a "Choosing Wisely form" to ordering physicians that will include information from the Canadian Rheumatology Association Canada Choosing Wisely Guidelines. Three points will be included with some additional explanation of why these are important.
The three guidelines included will be:
- Don't order an ANA as a screening test in patients without specific signs or symptoms of systemic lupus erythematous (SLE) or another connective tissue disorder (CTD).
- Don't routinely image patients with low back pain regardless of the duration of symptoms unless that are clinical reasons to suspect serious underlying pathology
- Don' routinely order a shoulder ultrasound as it is likely to indicate a tear in many people over the age of 50 years and will not change the initial management.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Ordering physicians who have referred to a rheumatologist in the St. Joseph's rheumatology clinic randomized to the intervention group will receive a brief Choosing Wisely form (for education of guidelines) faxed with the referral notice. At one and two years all ordering physicians will receive by fax a three question survey. Receives: Other: Choosing Wisely form |
| Control Group | No intervention | Ordering physicians who have referred to rheumatologists in the control group will not receive the Choosing Wisely form. At one and two years all ordering physicians will receive by fax a three question survey. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the change in the number of the total number of ANA tests, back CT's and shoulder ultrasounds in rheumatology referrals
-collecting the total number of ANA tests, back CT's and shoulder ultrasounds
Measured: Change from baseline number of tests at year one, year two
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start15 May 2018
- Primary completion8 Sep 2021
- Study completion8 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Study
- Masking
- None (open label)
- Enrolment
- 638 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03240536
- Sponsor's protocol ID
- 109363
- Status last verified
- Apr 2022
- First submitted
- 27 Jul 2017
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choosing Tests Wisely in Rheumatology
- ClinicalTrials.gov ID
- NCT03240536
- Acronym / sponsor ID
- 109363
- Conditions
- SLE
- Keywords
- Rheumatology Referral, Choosing Wisely
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 638 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2021 (actual)
- First posted
- 7 Aug 2017 (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.
This is a randomized study intended to produce a reduction in ordering of inappropriate tests by general practitioners as determined by recommendations from the CRA's Choosing Wisely guidelines. This reduction of inappropriate testing is expected in referrals to the rheumatologists randomized to the intervention group. This study will further explore which recommendations from the Canadian Rheumatology Association (CRA)/Canada Choosing Wisely campaign have the most impact on regional referring physicians to the Rheumatology clinic at St. Joseph's Hospital, London.
Detailed description
This a randomized study in that 6 rheumatologists (30 referrals each) will be randomized to one of two groups: intervention or control. Referring physicians to the intervention group will be faxed a brief Choosing Wisely form (intervention) based upon the recommendations of the Canadian Rheumatology Association's (CRA) Canada Choosing Wisely campaign, while referring physicians from the control group will not receive the form (non intervention). Analysis will be based upon the results of a three question survey faxed to all referring physicians at year one and at year two and on future referrals from the referring physicians to determine if there is a reduction in the group of ordering physicians that received the intervention (Choosing Wisely form).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Study
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Choosing Wisely formOrdering physicians who have referred to a rheumatologist in the St. Joseph's rheumatology clinic randomized to the intervention group will receive a brief Choosing Wisely form (for education of guidelines) faxed with the referral notice. At one and two years all ordering physicians will receive by fax a three question survey. |
| Control Group | No intervention | –Ordering physicians who have referred to rheumatologists in the control group will not receive the Choosing Wisely form. At one and two years all ordering physicians will receive by fax a three question survey. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ordering physicians who recently made a referral to the Rheumatology clinic at St. Joseph's Health Care.
Key exclusion criteria (1 listed)
- N/A, all recent referrals will be included.
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 |
|---|---|---|
| Choosing Wisely formThe investigators will fax a "Choosing Wisely form" to ordering physicians that will include information from the Canadian Rheumatology Association Canada Choosing Wisely Guidelines. Three points will be included with some additional explanation of why these are important. The three guidelines included will be: 1. Don't order an ANA as a screening test in patients without specific signs or symptoms of systemic lupus erythematous (SLE) or another connective tissue disorder (CTD). 2. Don't routinely image patients with low back pain regardless of the duration of symptoms unless that are clinical reasons to suspect serious underlying pathology 3. Don' routinely order a shoulder ultrasound as it is likely to indicate a tear in many people over the age of 50 years and will not change the initial management. | Other | Intervention Group |
Primary outcome
Assessing the change in the number of the total number of ANA tests, back CT's and shoulder ultrasounds in rheumatology referrals
Time frame: Change from baseline number of tests at year one, year two
-collecting the total number of ANA tests, back CT's and shoulder ultrasounds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Choosing Wisely form in people with SLE, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site 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 1 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: finished, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessing the change in the number of the total number of ANA tests, back CT's and shoulder ultrasounds in rheumatology referrals (time frame: Change from baseline number of tests at year one, year two). 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 26 Apr 2022.