SpAMetrix IINCT01749618
Closing the Gap in Care in Seronegative Inflammatory Arthritis
A study testing Education and Feedback in people with SpA and PsA, run by Pope Research Corporation at 9 sites in Canada.
Trial summary
Rheumatologists treating patients with seronegative arthritis will be randomized to treat their patients to a target or to treat their patients under their usual standard of care. All physicians will perform an initial chart audit. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Education and Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesCanada
- Study dates
- Nov 2012to Nov 2016
- 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
- Canadian Rheumatologist
Who cannot join
None listed.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Dr. Vandana Ahluwalia
Brampton, Ontario
Dr. Sanjay Dixit
Burlington, Ontario, L7L 0B7
Dr Pauline Boulos
Hamilton, Ontario, L8N 1Y2
Dr. Nikhil Chopra
London, Ontario, N6B 2E8
Dr Angela Montgomery
Mississauga, Ontario, L5B 2P7
Credit Valley Rheumatology
Mississauga, Ontario, L5M 2V8
The Medical Centre
Peterborough, Ontario, K9J 7B3
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Dr. Arthur Karasik
Toronto, Ontario, M9C 5N2
About this study
Official title: Closing the Gap in Care in Seronegative Inflammatory Arthritis: From Identification to Implementation of Treating to Target: A Randomized Trial of Feedback, Education, and Behavioural Change
Rheumatologists treating patients with seronegative arthritis will be randomized to treat their patients to a target or to treat their patients under their usual standard of care. All physicians will perform an initial chart audit. Following the initial chart audit, all physicians in the treat-to-target group will receive accredited educational training. Six months after the initial chart audit, all physicians will perform a repeat audit to see if patients are assessed more systematically and treated to a target of low disease state.
- Being tested
- Education and Feedback
- Keywords
- Seronegative Inflammatory Arthritis, SpA, PsA, Randomized, Behavioural Change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and FeedbackBehavioural
Rheumatologists are rated on how systematically they assess their patients, and receive six sessions of university accredited education about systematic assessments of patients with seronegative arthritis.
| Study group | Role | What they receive |
|---|---|---|
| No education or feedback | No intervention | Rheumatologists randomized to this treatment arm receive no additional education or feedback about their systematic assessments of patients |
| Education and Feedback | Experimental | Rheumatologists randomized to receive education and feedback participate in six web conferences designed to improve their systematic assessments of their patients, and are given feedback about their performances Receives: Behavioral: Education and Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of Systematic Assessments
Physicians in the Education and Feedback arm are assessed via a needs assessment to identify the care gaps for their patients with inflammatory arthritis. After the education and feedback, they complete a second chart audit and their improvements in assessments is recorded.
Measured: November 2012 - November 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpAStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pope Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Academic Medical Organization of Southwestern Ontario, Abbott
- Responsible party
- Sponsor
- Investigators
- Janet E Pope, MD, MPH, FRCPC, Principal investigator, Pope Research Corp., St. Joseph's Health Care, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749618
- Sponsor's protocol ID
- Metrix II
- Acronym
- Metrix II
- Status last verified
- Apr 2017
- First submitted
- 6 Nov 2012
- Last updated
- 7 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closing the Gap in Care in Seronegative Inflammatory Arthritis: From Identification to Implementation of Treating to Target: A Randomized Trial of Feedback, Education, and Behavioural Change
- ClinicalTrials.gov ID
- NCT01749618
- Acronym / sponsor ID
- Metrix II / Metrix II
- Keywords
- Seronegative Inflammatory Arthritis, SpA, PsA, Randomized, Behavioural Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Pope Research CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Academic Medical Organization of Southwestern Ontario, Abbott
- Study start
- Nov 2012
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Dec 2012 (estimated)
- 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.
Rheumatologists treating patients with seronegative arthritis will be randomized to treat their patients to a target or to treat their patients under their usual standard of care. All physicians will perform an initial chart audit. Following the initial chart audit, all physicians in the treat-to-target group will receive accredited educational training. Six months after the initial chart audit, all physicians will perform a repeat audit to see if patients are assessed more systematically and treated to a target of low disease state.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No education or feedback | No intervention | –Rheumatologists randomized to this treatment arm receive no additional education or feedback about their systematic assessments of patients |
| Education and Feedback | Experimental | Behavioral: Education and FeedbackRheumatologists randomized to receive education and feedback participate in six web conferences designed to improve their systematic assessments of their patients, and are given feedback about their performances |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Canadian Rheumatologist
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Education and FeedbackRheumatologists are rated on how systematically they assess their patients, and receive six sessions of university accredited education about systematic assessments of patients with seronegative arthritis. | Behavioural | Education and Feedback |
Primary outcome
Improvement of Systematic Assessments
Time frame: November 2012 - November 2013
Physicians in the Education and Feedback arm are assessed via a needs assessment to identify the care gaps for their patients with inflammatory arthritis. After the education and feedback, they complete a second chart audit and their improvements in assessments is recorded.
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 7 Apr 2017.
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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.
Janet E Pope, MD, MPH, FRCPC principal investigator
Pope Research Corp., St. Joseph's Health Care, Western University
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Feedback in people with SpA and PsA, run by Pope Research Corporation at 9 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 0 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 7 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
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?
Improvement of Systematic Assessments (time frame: November 2012 - November 2013). 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 7 Apr 2017.