<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03240536</url>
  </required_header>
  <id_info>
    <org_study_id>109363</org_study_id>
    <nct_id>NCT03240536</nct_id>
  </id_info>
  <brief_title>Choosing Tests Wisely in Rheumatology</brief_title>
  <official_title>Choosing Tests Wisely in Rheumatology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized study intended to produce a reduction in ordering of inappropriate tests&#xD;
      by general practitioners as determined by recommendations from the CRA's Choosing Wisely&#xD;
      guidelines. This reduction of inappropriate testing is expected in referrals to the&#xD;
      rheumatologists randomized to the intervention group. This study will further explore which&#xD;
      recommendations from the Canadian Rheumatology Association (CRA)/Canada Choosing Wisely&#xD;
      campaign have the most impact on regional referring physicians to the Rheumatology clinic at&#xD;
      St. Joseph's Hospital, London.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This a randomized study in that 6 rheumatologists (30 referrals each) will be randomized to&#xD;
      one of two groups: intervention or control. Referring physicians to the intervention group&#xD;
      will be faxed a brief Choosing Wisely form (intervention) based upon the recommendations of&#xD;
      the Canadian Rheumatology Association's (CRA) Canada Choosing Wisely campaign, while&#xD;
      referring physicians from the control group will not receive the form (non intervention).&#xD;
      Analysis will be based upon the results of a three question survey faxed to all referring&#xD;
      physicians at year one and at year two and on future referrals from the referring physicians&#xD;
      to determine if there is a reduction in the group of ordering physicians that received the&#xD;
      intervention (Choosing Wisely form).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2018</start_date>
  <completion_date type="Actual">September 8, 2021</completion_date>
  <primary_completion_date type="Actual">September 8, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomized Study</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <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</measure>
    <time_frame>Change from baseline number of tests at year one, year two</time_frame>
    <description>-collecting the total number of ANA tests, back CT's and shoulder ultrasounds</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">638</enrollment>
  <condition>SLE</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Choosing Wisely form</intervention_name>
    <description>The investigators will fax a &quot;Choosing Wisely form&quot; 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.&#xD;
The three guidelines included will be:&#xD;
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).&#xD;
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&#xD;
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.</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ordering physicians who recently made a referral to the Rheumatology clinic at St.&#xD;
             Joseph's Health Care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A, all recent referrals will be included.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. Joseph's Health Care London</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A4V2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>August 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatology Referral</keyword>
  <keyword>Choosing Wisely</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03240536
org study id: 109363
nct id: NCT03240536
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized Study
primary purpose: Health Services Research
masking: None (Open Label)
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
description: -collecting the total number of ANA tests, back CT's and shoulder ultrasounds
arm group label: Intervention Group
arm group type: Experimental
description: 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.
arm group label: Control Group
arm group type: No Intervention
description: 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.
intervention type: Other
intervention name: Choosing Wisely form
description: 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.
arm group label: Intervention Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No