<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/NCT01664793</url>
  </required_header>
  <id_info>
    <org_study_id>1U01IP000321-01</org_study_id>
    <nct_id>NCT01664793</nct_id>
  </id_info>
  <brief_title>From Innovation to Solutions: Childhood Influenza Vaccination Planning</brief_title>
  <official_title>From Innovation to Solutions: Autodialers, Use of Early Autumn Physicals and Vaccination Assessment as a Vital Sign to Increase Childhood Influenza Vaccination in Diverse Settings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to increase childhood influenza vaccination rates using the FDA&#xD;
      licensed influenza vaccines according to national guidelines in a randomized cluster trial in&#xD;
      which primary care offices are randomized to intervention or control with the control group&#xD;
      receiving the intervention in the second year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will conduct a stratified, randomized cluster trial of 20 diverse primary&#xD;
      care practices to compare influenza vaccination rates in intervention and control sites.&#xD;
      Intervention sites will use a package of newly developed and evidence-based techniques that&#xD;
      will be tailored to their practice structure and culture, called the 4 Pillars Immunization&#xD;
      Toolkit, in addition to receiving donated vaccine for early season vaccination. Control&#xD;
      practices will not receive such assistance but will receive the intervention in the second&#xD;
      year.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2010</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Outcome</measure>
    <time_frame>3/1/2011-2/29/2012</time_frame>
    <description>Influenza vaccination rates in each arm at the end of year 1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effectiveness Score</measure>
    <time_frame>End of February 2012</time_frame>
    <description>Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87665</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Intervention Group Year 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group Year 1</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>4 Pillars Immunization Toolkit</intervention_name>
    <description>Pillar 1: Convenient Vaccination Services; Pillar 2: Patient notification about the importance of vaccination and availability of convenient services; Pillar 3: Enhanced Office Systems; Pillar 4: Motivation: Office immunization champion tracks progress towards a goal; Early delivery of donated vaccines for disadvantaged children, staff education, support of effort by research staff.</description>
    <arm_group_label>Intervention Group Year 1</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        For children: attendance at the selected health care center within the last year and age&#xD;
        &gt;/=6 months thru 18 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        For children: Severe egg allergy or allergy to influenza vaccine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Zimmerman, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh, School of Medicine, Department of Family Medicine and Clinical Epidemiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Chyongchiou Lin, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Pittsburgh</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Pittsburgh, School of Medicine, Deparment of Family Medicine and Clinical Epidemiology</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Nowalk MP, Lin CJ, Hannibal K, Reis EC, Gallik G, Moehling KK, Huang HH, Allred NJ, Wolfson DH, Zimmerman RK. Increasing childhood influenza vaccination: a cluster randomized trial. Am J Prev Med. 2014 Oct;47(4):435-43. doi: 10.1016/j.amepre.2014.07.003. Epub 2014 Aug 8.</citation>
    <PMID>25113138</PMID>
  </reference>
  <reference>
    <citation>Zimmerman RK, Nowalk MP, Lin CJ, Hannibal K, Moehling KK, Huang HH, Matambanadzo A, Troy J, Allred NJ, Gallik G, Reis EC. Cluster randomized trial of a toolkit and early vaccine delivery to improve childhood influenza vaccination rates in primary care. Vaccine. 2014 Jun 17;32(29):3656-63. doi: 10.1016/j.vaccine.2014.04.057. Epub 2014 Apr 29.</citation>
    <PMID>24793941</PMID>
  </reference>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <results_first_submitted>May 27, 2014</results_first_submitted>
  <results_first_submitted_qc>November 21, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 24, 2014</results_first_posted>
  <last_update_submitted>November 21, 2014</last_update_submitted>
  <last_update_submitted_qc>November 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 24, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Richard Zimmerman</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>influenza</keyword>
  <keyword>vaccination</keyword>
  <keyword>strategies</keyword>
  <keyword>children/adolescents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention Group</title>
          <description>Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the Intervention group; n=49,039.&#xD;
Intervention sites will use the 4 Pillars toolkit along with early season vaccine to promote increases in childhood influenza vaccination.</description>
        </group>
        <group group_id="P2">
          <title>Control Group</title>
          <description>Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the control group; n=38,626. They will receive the 4 Pillars Toolkit and early season vaccine in Year 2.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="49039"/>
                <participants group_id="P2" count="38626"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="49039"/>
                <participants group_id="P2" count="38626"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Children enrolled at family medicine practices and pediatric practices in the year preceding the intervention year for both intervention and control groups who were seen for a visit between 3/1/2010 and 2/28/2011.</population>
      <group_list>
        <group group_id="B1">
          <title>Intervention Group</title>
          <description>Children in 10 diverse pediatric and family medicine practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.</description>
        </group>
        <group group_id="B2">
          <title>Control Group</title>
          <description>Children in 10 diverse pediatric and family practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="43293"/>
            <count group_id="B2" value="38306"/>
            <count group_id="B3" value="81599"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>To be eligible, the practice must have had a patient population of children under 19 years old.</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.3" spread="4.8"/>
                    <measurement group_id="B2" value="7.1" spread="5.2"/>
                    <measurement group_id="B3" value="7.2" spread="5"/>
                  </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="21560"/>
                    <measurement group_id="B2" value="18540"/>
                    <measurement group_id="B3" value="40100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21733"/>
                    <measurement group_id="B2" value="19766"/>
                    <measurement group_id="B3" value="41499"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>children at sites</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43293"/>
                    <measurement group_id="B2" value="38306"/>
                    <measurement group_id="B3" value="81599"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Outcome</title>
        <description>Influenza vaccination rates in each arm at the end of year 1</description>
        <time_frame>3/1/2011-2/29/2012</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>Children seen in 10 diverse pediatric and family medicine practices between 3/1/2011 and 2/29/2012.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>Children with a visit between 3/1/2011 and 2/29/2012 in 10 diverse pediatric and family practices.</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Outcome</title>
          <description>Influenza vaccination rates in each arm at the end of year 1</description>
          <units>participants vaccinated out of all</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="49039"/>
                <count group_id="O2" value="38626"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26432"/>
                    <measurement group_id="O2" value="19352"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>Chi-squared</method>
            <method_desc>Chi-square tests for comparisons of between-arm changes in vaccination rates from pre to post intervention.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Effectiveness Score</title>
        <description>Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).</description>
        <time_frame>End of February 2012</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention Group</title>
            <description>2 respondents in each of 10 diverse pediatric and family medicine practices.</description>
          </group>
          <group group_id="O2">
            <title>Control Group</title>
            <description>This group did not rate effectiveness of the intervention.</description>
          </group>
        </group_list>
        <measure>
          <title>Effectiveness Score</title>
          <description>Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Intervention Group</title>
          <description>Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.</description>
        </group>
        <group group_id="E2">
          <title>Control Group</title>
          <description>Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.</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="26432"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19352"/>
              </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="26432"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19352"/>
              </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>
    <limitations_and_caveats>2 offices of 1 practice were randomized to each arm potentially causing carryover of the intervention.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Richard K. Zimmerman</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>412-383-2355</phone>
      <email>zimmer@pitt.edu</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/NCT01664793
org study id: 1U01IP000321-01
nct id: NCT01664793
lead sponsor: 
has dmc: No
The purpose of this study is to increase childhood influenza vaccination rates using the FDA
      licensed influenza vaccines according to national guidelines in a randomized cluster trial in
      which primary care offices are randomized to intervention or control with the control group
      receiving the intervention in the second year.
The investigators will conduct a stratified, randomized cluster trial of 20 diverse primary
      care practices to compare influenza vaccination rates in intervention and control sites.
      Intervention sites will use a package of newly developed and evidence-based techniques that
      will be tailored to their practice structure and culture, called the 4 Pillars Immunization
      Toolkit, in addition to receiving donated vaccine for early season vaccination. Control
      practices will not receive such assistance but will receive the intervention in the second
      year.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Primary Outcome
time frame: 3/1/2011-2/29/2012
description: Influenza vaccination rates in each arm at the end of year 1
measure: Effectiveness Score
time frame: End of February 2012
description: Two staff members from each site were surveyed as to usefulness/effectiveness of a list of strategies recommended in the toolkit to increase vaccination rates. Values (range = 1-100 with 1 being not at all effective and 100 being highly effective) were averaged and used as an effectiveness score for each strategy. The average value for each site was combined with all sites and averaged for each strategy. (actual range = 20.6-90.7).
arm group label: Intervention Group Year 1
arm group type: Experimental
description: The 4 Pillars Immunization Toolkit along with donated vaccines for early season vaccination, staff education and support.
arm group label: Control Group Year 1
arm group type: No Intervention
description: Control sites will not receive assistance with increasing influenza vaccination in Year 1, they will follow guidelines for usual care.
intervention type: Behavioral
intervention name: 4 Pillars Immunization Toolkit
description: Pillar 1: Convenient Vaccination Services; Pillar 2: Patient notification about the importance of vaccination and availability of convenient services; Pillar 3: Enhanced Office Systems; Pillar 4: Motivation: Office immunization champion tracks progress towards a goal; Early delivery of donated vaccines for disadvantaged children, staff education, support of effort by research staff.
arm group label: Intervention Group Year 1
criteria: 
gender: All
minimum age: 6 Months
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard Zimmerman, MD, MPH
role: Principal Investigator
affiliation: University of Pittsburgh, School of Medicine, Department of Family Medicine and Clinical Epidemiology
last name: Chyongchiou Lin, PhD
role: Study Director
affiliation: University of Pittsburgh
facility: 
country: United States
citation: Nowalk MP, Lin CJ, Hannibal K, Reis EC, Gallik G, Moehling KK, Huang HH, Allred NJ, Wolfson DH, Zimmerman RK. Increasing childhood influenza vaccination: a cluster randomized trial. Am J Prev Med. 2014 Oct;47(4):435-43. doi: 10.1016/j.amepre.2014.07.003. Epub 2014 Aug 8.
PMID: 25113138
citation: Zimmerman RK, Nowalk MP, Lin CJ, Hannibal K, Moehling KK, Huang HH, Matambanadzo A, Troy J, Allred NJ, Gallik G, Reis EC. Cluster randomized trial of a toolkit and early vaccine delivery to improve childhood influenza vaccination rates in primary care. Vaccine. 2014 Jun 17;32(29):3656-63. doi: 10.1016/j.vaccine.2014.04.057. Epub 2014 Apr 29.
PMID: 24793941
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Richard Zimmerman
investigator title: Professor
mesh term: Influenza, Human
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: 2 offices of 1 practice were randomized to each arm potentially causing carryover of the intervention.
point of contact: 