<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/NCT01676532</url>
  </required_header>
  <id_info>
    <org_study_id>1000025631</org_study_id>
    <nct_id>NCT01676532</nct_id>
  </id_info>
  <brief_title>Feasibility Study on the Model School Pediatric Health Initiative Pilot Project</brief_title>
  <official_title>Feasibility Study on the Model School Pediatric Health Initiative Pilot Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cross sectional study to assess the feasibility of a school based&#xD;
      health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in&#xD;
      Toronto. The SBHC allows inner-city children who face barriers to accessing health care the&#xD;
      opportunity to receive health care in their school.The primary aim of this study is to&#xD;
      determine utilization of the SBHC. Establishing feasibility of the SBHC would support further&#xD;
      development and expansion of this program into other inner city schools.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A chart review of the first year of the SBHC was conducted. Feasibility metrics included the&#xD;
      number of children who enrolled at the SBHC. Efficacy metrics included the proportion of&#xD;
      enrolled children who enrolled at SBHC. Efficacy metrics included the proportion of enrolled&#xD;
      children who attended and received new diagnoses and treatment plans&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Enrolled Participants Who Attended SBHC</measure>
    <time_frame>1 year</time_frame>
    <description>The primary objectives are to determine utilization of the SBHC including:&#xD;
The number of students who are enrolled at the SBHC&#xD;
The number of enrolled students enrolled who attended the SBHC</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Students Attending SBHC With New Treatment Plans</measure>
    <time_frame>1 year</time_frame>
    <description>Proportion of children seen in the clinic with treatment plans</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Students Attending SBHC With New Diagnoses</measure>
    <time_frame>1 year</time_frame>
    <description>Number of students attending SBHC with new diagnoses</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Referrals Made of Students Attending SBHC</measure>
    <time_frame>1 year</time_frame>
    <description>Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)</measure>
    <time_frame>8 months</time_frame>
    <description>The number of students who enrolled in SBHC who were from the host school Sprucecourt</description>
  </other_outcome>
  <other_outcome>
    <measure>Sprucecourt Public School Vs Other Participating Schools</measure>
    <time_frame>8 months</time_frame>
    <description>To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Students Triaged From School Support Team Meetings</measure>
    <time_frame>1 year</time_frame>
    <description>The number of students triaged from SST meetings was not collected.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Students Referred to SBHC Who Attended SBHC</measure>
    <time_frame>8 months</time_frame>
    <description>This data was not collected.</description>
  </other_outcome>
  <other_outcome>
    <measure>Follow-up Appointments</measure>
    <time_frame>1 year</time_frame>
    <description>Attendance at follow-up appoints was not collected.</description>
  </other_outcome>
  <other_outcome>
    <measure>Absenteeism</measure>
    <time_frame>1 year</time_frame>
    <description>Outcome data comparing absenteeism in the school with the year preceding the SBHC was not collected</description>
  </other_outcome>
  <other_outcome>
    <measure>Ontario Health Insurance Plan (OHIP)Status</measure>
    <time_frame>1 year</time_frame>
    <description>OHIP status of students attending the clinic was not reported or collected</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">127</enrollment>
  <condition>School Board Health Centers</condition>
  <arm_group>
    <arm_group_label>Students attending SBHC</arm_group_label>
    <description>Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Students attending SBHC</intervention_name>
    <description>School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC</description>
    <arm_group_label>Students attending SBHC</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All students of Sprucecourt Public School as well as the fourteen surrounding inner city&#xD;
        public schools and their siblings. All children attending the on-site Parenting and Family&#xD;
        Literacy Centre.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All students at Sprucecourt Public School and the surrounding fourteen schools, as&#xD;
             well as their siblings (ages 0-12 years), who are enrolled at and have consent to&#xD;
             attend the SBHC&#xD;
&#xD;
          -  All infants and preschool aged children attending the on-site Parenting and Family&#xD;
             Literacy Centre who are enrolled at the SBHC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  N/A&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathon Maguire, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hospital for Sick Children</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <results_first_submitted>November 17, 2015</results_first_submitted>
  <results_first_submitted_qc>April 15, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 24, 2016</results_first_posted>
  <last_update_submitted>April 15, 2016</last_update_submitted>
  <last_update_submitted_qc>April 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 24, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>Jonathon Maguire</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>School Board Health Center</keyword>
  <keyword>Pediatrics</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Students Attending SBHC</title>
          <description>Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="127"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Students Attending SBHC</title>
          <description>Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.&#xD;
Students attending SBHC: School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="127"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>Retrospective chart review</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="127"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Enrolled Participants Who Attended SBHC</title>
        <description>The primary objectives are to determine utilization of the SBHC including:&#xD;
The number of students who are enrolled at the SBHC&#xD;
The number of enrolled students enrolled who attended the SBHC</description>
        <time_frame>1 year</time_frame>
        <population>379 students enrolled in the SBHC and 127 of those students attended SBHC. Existing data is based on 127 students who attended SBHC.</population>
        <group_list>
          <group group_id="O1">
            <title>Students Attending SBHC</title>
            <description>Students who were enrolled at the SBHC and then attended the SBHC</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Enrolled Participants Who Attended SBHC</title>
          <description>The primary objectives are to determine utilization of the SBHC including:&#xD;
The number of students who are enrolled at the SBHC&#xD;
The number of enrolled students enrolled who attended the SBHC</description>
          <population>379 students enrolled in the SBHC and 127 of those students attended SBHC. Existing data is based on 127 students who attended SBHC.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="379"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total number of students attending SBHC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of students not attending SBHC</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="252"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Students Attending SBHC With New Treatment Plans</title>
        <description>Proportion of children seen in the clinic with treatment plans</description>
        <time_frame>1 year</time_frame>
        <population>115 students out of 127 students attending SBHC had a new treatment plan.</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Students Attending SBHC With New Treatment Plans</title>
            <description>The total number of students who attended SBHC that had new treatment plans proposed</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Students Attending SBHC With New Treatment Plans</title>
          <description>Proportion of children seen in the clinic with treatment plans</description>
          <population>115 students out of 127 students attending SBHC had a new treatment plan.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of students with treatment plans</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="115"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of students with no treatment plans</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Students Attending SBHC With New Diagnoses</title>
        <description>Number of students attending SBHC with new diagnoses</description>
        <time_frame>1 year</time_frame>
        <population>120 of the 127 students who attended the SBHC had a new diagnosis. 94 received one new diagnosis and 26 children received more than one new diagnosis</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Students Attending SBHC With New Diagnoses</title>
            <description>Porportion of students attending SBHC with new diagnoses</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Students Attending SBHC With New Diagnoses</title>
          <description>Number of students attending SBHC with new diagnoses</description>
          <population>120 of the 127 students who attended the SBHC had a new diagnosis. 94 received one new diagnosis and 26 children received more than one new diagnosis</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of students attending SBHC_ new diagnosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Number of students attending SBHC with &gt;1 new diag</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No new diagnosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Referrals Made of Students Attending SBHC</title>
        <description>Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Number of Referrals Made for Students Attending SBHC</title>
            <description>Types and number of referrals made for students attending SBHC.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Referrals Made of Students Attending SBHC</title>
          <description>Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Number of students with no referrals</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students referred to family physician</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students referred to specialist</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students referred for psychological test</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students ref to community mental health</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students referred to dietician</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students referred to audiology testing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students referred to vision testing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)</title>
        <description>The number of students who enrolled in SBHC who were from the host school Sprucecourt</description>
        <time_frame>8 months</time_frame>
        <population>Total number of students who enrolled in SBHC. Outcome is the number of students from host school (sprucecourt) who enrolled in SBHC</population>
        <group_list>
          <group group_id="O1">
            <title>Number of Students From Sprucecourt Who Enrolled in SBHC</title>
            <description>From the total number of students who enrolled in the SBHC, the number of students from the host school (Sprucecourt) was calculated</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)</title>
          <description>The number of students who enrolled in SBHC who were from the host school Sprucecourt</description>
          <population>Total number of students who enrolled in SBHC. Outcome is the number of students from host school (sprucecourt) who enrolled in SBHC</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="379"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Sprucecourt Public School Vs Other Participating Schools</title>
        <description>To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools</description>
        <time_frame>8 months</time_frame>
        <population>total number of students who attended SBHC</population>
        <group_list>
          <group group_id="O1">
            <title>Sprucecourt Public School Vs Other Participating Schools</title>
            <description>The number of students from the host school of the SBHC and other participating schools</description>
          </group>
        </group_list>
        <measure>
          <title>Sprucecourt Public School Vs Other Participating Schools</title>
          <description>To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools</description>
          <population>total number of students who attended SBHC</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="127"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>number of students attending from Sprucecourt</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students attending from school cluster</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students attending from preschool age</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>number of students with unknown enrolment data</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Students Triaged From School Support Team Meetings</title>
        <description>The number of students triaged from SST meetings was not collected.</description>
        <time_frame>1 year</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Students Referred to SBHC Who Attended SBHC</title>
        <description>This data was not collected.</description>
        <time_frame>8 months</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Follow-up Appointments</title>
        <description>Attendance at follow-up appoints was not collected.</description>
        <time_frame>1 year</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Absenteeism</title>
        <description>Outcome data comparing absenteeism in the school with the year preceding the SBHC was not collected</description>
        <time_frame>1 year</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Ontario Health Insurance Plan (OHIP)Status</title>
        <description>OHIP status of students attending the clinic was not reported or collected</description>
        <time_frame>1 year</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>no adverse events were reported for students attending SBHC</desc>
      <group_list>
        <group group_id="E1">
          <title>Students Attending SBHC</title>
          <description>Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="127"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sloane Freeman</name_or_title>
      <organization>St.Michael's Hospital</organization>
      <phone>416-864-6060 ext 77042</phone>
      <email>freemansl@smh.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01676532
org study id: 1000025631
nct id: NCT01676532
lead sponsor: 
has dmc: No
This is a prospective cross sectional study to assess the feasibility of a school based
      health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in
      Toronto. The SBHC allows inner-city children who face barriers to accessing health care the
      opportunity to receive health care in their school.The primary aim of this study is to
      determine utilization of the SBHC. Establishing feasibility of the SBHC would support further
      development and expansion of this program into other inner city schools.
A chart review of the first year of the SBHC was conducted. Feasibility metrics included the
      number of children who enrolled at the SBHC. Efficacy metrics included the proportion of
      enrolled children who enrolled at SBHC. Efficacy metrics included the proportion of enrolled
      children who attended and received new diagnoses and treatment plans
observational model: Cohort
time perspective: Prospective
measure: Number of Enrolled Participants Who Attended SBHC
time frame: 1 year
description: The primary objectives are to determine utilization of the SBHC including:
The number of students who are enrolled at the SBHC
The number of enrolled students enrolled who attended the SBHC
measure: Number of Students Attending SBHC With New Treatment Plans
time frame: 1 year
description: Proportion of children seen in the clinic with treatment plans
measure: Number of Students Attending SBHC With New Diagnoses
time frame: 1 year
description: Number of students attending SBHC with new diagnoses
measure: Number of Referrals Made of Students Attending SBHC
time frame: 1 year
description: Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic
measure: Number of Students Enrolled in SBHC Who Were From the Host School (Sprucecourt)
time frame: 8 months
description: The number of students who enrolled in SBHC who were from the host school Sprucecourt
measure: Sprucecourt Public School Vs Other Participating Schools
time frame: 8 months
description: To compare the number of students who attend the SBHC from the host school (Sprucecourt Public School) with the number of students who attend the SBHC from the other participating schools
measure: Number of Students Triaged From School Support Team Meetings
time frame: 1 year
description: The number of students triaged from SST meetings was not collected.
measure: Number of Students Referred to SBHC Who Attended SBHC
time frame: 8 months
description: This data was not collected.
measure: Follow-up Appointments
time frame: 1 year
description: Attendance at follow-up appoints was not collected.
measure: Absenteeism
time frame: 1 year
description: Outcome data comparing absenteeism in the school with the year preceding the SBHC was not collected
measure: Ontario Health Insurance Plan (OHIP)Status
time frame: 1 year
description: OHIP status of students attending the clinic was not reported or collected
arm group label: Students attending SBHC
description: Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
intervention type: Other
intervention name: Students attending SBHC
description: School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC
arm group label: Students attending SBHC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jonathon Maguire, MD
role: Principal Investigator
affiliation: The Hospital for Sick Children
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: Jonathon Maguire
investigator title: Staff Physician
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 