<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/NCT02997735</url>
  </required_header>
  <id_info>
    <org_study_id>16-012868</org_study_id>
    <nct_id>NCT02997735</nct_id>
  </id_info>
  <brief_title>Parent eReferral to Tobacco Quitline</brief_title>
  <official_title>Parent eReferral to Tobacco Quitline in Primary Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pennsylvania Department of Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital of Philadelphia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Secondhand smoke (SHS) exposure is a significant public health problem in that it both harms&#xD;
      children and is widely prevalent, affecting more than 40% of US children. Tobacco cessation&#xD;
      quitlines are effective in helping smokers quit, but few smokers make use of their services.&#xD;
      Electronic health record-based systems that automate referral of interested parents to&#xD;
      quitlines through pediatric settings may increase the proportion of smokers who successfully&#xD;
      enroll in treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized controlled study of electronic quitline referral compared to standard&#xD;
      practice. Parent enrollment in the quitline will be reported to the study team by the state&#xD;
      tobacco quitline, managed by the Pennsylvania Department of Health.&#xD;
&#xD;
      This is a single site study at one large outpatient pediatric practice. Eligible study&#xD;
      participants are parents/caregivers (hereafter referred to as &quot;parents&quot;), 18 years of age or&#xD;
      older, who are present for the child's healthcare (both well-child and acute) visit, who&#xD;
      smoke, and who are interested in receiving treatment through the tobacco quitline.&#xD;
&#xD;
      The intervention is electronic referral to the tobacco quitline for parent smokers. The&#xD;
      referral process will be embedded in a tobacco treatment clinical decision support (CDS)&#xD;
      tool, created to help pediatricians provide counseling and treatment to parent smokers. The&#xD;
      primary outcome of interest is smoker enrollment in the quitline, defined as the proportion&#xD;
      of parent smokers identified in the clinic that enroll in quitline treatment compared across&#xD;
      the intervention (electronic referral) and control (standard practice) approaches. Secondary&#xD;
      outcomes include patient and parent demographic and behavioral factors associated with&#xD;
      successful enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 11, 2017</start_date>
  <completion_date type="Actual">August 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Parent Smokers Who Enrolled in Quitline</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Proportion of parent smokers identified in clinic that enroll in quitline treatment compared across the intervention (electronic referral) and control (standard of practice) approaches. Primary analysis wibased on an intent to treat approach and includes all subjects randomized at their referral visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Calls With the Quitline</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Total number of parent contacts with the quitline post-enrollment, compared between intervention and control and reported by the PA Quitline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Parents Who Quit Smoking</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Self-reported parent quit rates post-enrollment, compared between the intervention and control and reported by the PA Quitline</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Characteristics Associated With Successful Quitline Enrollment, Study Arm</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. The Odds Ratios (ORs) from multivariable logistic regression model of characteristics associated with successful quitline enrollment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characteristics Associated With Successful Quitline Enrollment, Patient Age</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characteristics Associated With Successful Quitline Enrollment, Parent Age</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
  </other_outcome>
  <other_outcome>
    <measure>Characteristics Associated With Successful Quitline Enrollment, Quit Stage</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">484</enrollment>
  <condition>Secondhand Smoke</condition>
  <arm_group>
    <arm_group_label>Electronic Quitline Referral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The electronic quitline referral will be embedded within the Tobacco Treatment CDS tool, a CDS system previously developed to help pediatricians provide smoking cessation counseling and treatment to parents who smoke, modeled off the CEASE intervention, an evidence-based approach for implementing smoking cessation treatment of parents in the pediatric setting. The parental tobacco treatment CDS tool prompts the pediatric clinician to ask the parent about smoking status and assess interest in quitting (at all well-child and acute visits), links to an electronic nicotine replacement therapy prescription for parents interested in quitting, and guides appropriate documentation. Electronic referral to the quitline will be made by clicking an automated link embedded in the tool that will send the parent smokers' names and telephone numbers (entered by the clinician) directly to the Pennsylvania (PA) Free Quitline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Practice</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All procedures implemented in the standard referral approach will be identical to those in the electronic referral approach with the exception of providing the telephone number for the Quitline to the parent (rather than electronic referral). The clinician workflow will be nearly the same, in that the clinician will use the link embedded in the tobacco treatment CDS tool to add the quitline to the patient's discharge paperwork (rather than automatically refer to the quitline).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Quitline Delivered Treatment</intervention_name>
    <description>The PA Free quitline is funded by the Pennsylvania Department of Health and staffed by trained cessation counselors available 24 hours a day, 7 days a week. Counseling is available in English and Spanish and can be provided in at least 15 additional languages through a third party. All smokers who enroll in smoking cessation treatment will receive counseling and support consistent with accepted clinical practice guidelines. This treatment includes as many as 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between calls. The timing of counseling calls will be relapse sensitive and include a call 1-2 days after the quit date, another telephone call a week after the first call, and additional calls generally occurring at 2-3-week intervals thereafter.</description>
    <arm_group_label>Electronic Quitline Referral</arm_group_label>
    <arm_group_label>Standard of Practice</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Parent/caregiver who presents for their child's healthcare (both well-child and acute)&#xD;
             visit&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Interested in being referred to the tobacco quitline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Parent/caregiver who smokes but is not present during their child's healthcare visit&#xD;
&#xD;
          -  Not interested in referral to the tobacco quitline&#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>
  <overall_official>
    <last_name>Alexander Fiks, MD, MSCE</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>May 8, 2019</results_first_submitted>
  <results_first_submitted_qc>October 3, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">October 28, 2019</results_first_posted>
  <last_update_submitted>October 3, 2019</last_update_submitted>
  <last_update_submitted_qc>October 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Secondhand Smoke</keyword>
  <keyword>Nicotine Replacement Therapy</keyword>
  <keyword>Clinical Decision Support</keyword>
  <keyword>Tobacco quitline</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 11, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/35/NCT02997735/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>eReferral</title>
          <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="233"/>
                <participants group_id="P2" count="251"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="233"/>
                <participants group_id="P2" count="251"/>
              </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>Rows may not add up to total owing to either not reported or missing data.</population>
      <group_list>
        <group group_id="B1">
          <title>eReferral</title>
          <description>Pediatricians screened for tobacco use; parent smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Pediatricians screened for tobacco use; parent smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</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="233"/>
            <count group_id="B2" value="251"/>
            <count group_id="B3" value="484"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <description>Parent Age</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>18-24</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>25-34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="122"/>
                    <measurement group_id="B3" value="229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>35-49</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="169"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 or greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <description>Child Sex</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="103"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="221"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="130"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="263"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <description>Child Ethnicity</description>
          <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="20"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="213"/>
                    <measurement group_id="B2" value="240"/>
                    <measurement group_id="B3" value="453"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <description>Child Race</description>
          <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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="213"/>
                    <measurement group_id="B2" value="225"/>
                    <measurement group_id="B3" value="438"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Child age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt;1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>13 or older</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Insurance status (child)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Private</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medicaid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="197"/>
                    <measurement group_id="B2" value="219"/>
                    <measurement group_id="B3" value="416"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Self-pay</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Asthma diagnosis (child)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No asthma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="168"/>
                    <measurement group_id="B2" value="176"/>
                    <measurement group_id="B3" value="344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="140"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarettes smoked per day (Parent)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>&lt; 10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="138"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="303"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 or greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="175"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Quit stage (Parent)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>30 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="124"/>
                    <measurement group_id="B2" value="133"/>
                    <measurement group_id="B3" value="257"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Over 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Available</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Parent Smokers Who Enrolled in Quitline</title>
        <description>Proportion of parent smokers identified in clinic that enroll in quitline treatment compared across the intervention (electronic referral) and control (standard of practice) approaches. Primary analysis wibased on an intent to treat approach and includes all subjects randomized at their referral visit.</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eReferral</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Parent Smokers Who Enrolled in Quitline</title>
          <description>Proportion of parent smokers identified in clinic that enroll in quitline treatment compared across the intervention (electronic referral) and control (standard of practice) approaches. Primary analysis wibased on an intent to treat approach and includes all subjects randomized at their referral visit.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="233"/>
                <count group_id="O2" value="251"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Not Enrolled</title>
                  <measurement_list>
                    <measurement group_id="O1" value="209"/>
                    <measurement group_id="O2" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Enrolled</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Calls With the Quitline</title>
        <description>Total number of parent contacts with the quitline post-enrollment, compared between intervention and control and reported by the PA Quitline</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eReferral</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Calls With the Quitline</title>
          <description>Total number of parent contacts with the quitline post-enrollment, compared between intervention and control and reported by the PA Quitline</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="233"/>
                <count group_id="O2" value="251"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No calls</title>
                  <measurement_list>
                    <measurement group_id="O1" value="209"/>
                    <measurement group_id="O2" value="245"/>
                  </measurement_list>
                </category>
                <category>
                  <title>One call (enrollment only)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Two calls</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Three or more calls</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Parents Who Quit Smoking</title>
        <description>Self-reported parent quit rates post-enrollment, compared between the intervention and control and reported by the PA Quitline</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eReferral</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Parents Who Quit Smoking</title>
          <description>Self-reported parent quit rates post-enrollment, compared between the intervention and control and reported by the PA Quitline</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="233"/>
                <count group_id="O2" value="251"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characteristics Associated With Successful Quitline Enrollment, Study Arm</title>
        <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. The Odds Ratios (ORs) from multivariable logistic regression model of characteristics associated with successful quitline enrollment.</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eReferral</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
          </group>
        </group_list>
        <measure>
          <title>Characteristics Associated With Successful Quitline Enrollment, Study Arm</title>
          <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. The Odds Ratios (ORs) from multivariable logistic regression model of characteristics associated with successful quitline enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="233"/>
                <count group_id="O2" value="251"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="5"/>
                  </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</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>7.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.81</ci_lower_limit>
            <ci_upper_limit>27.90</ci_upper_limit>
            <estimate_desc>ORs from multivariable logistic regression model of characteristics associated with successful quitline enrollment.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characteristics Associated With Successful Quitline Enrollment, Patient Age</title>
        <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eReferral</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
          </group>
        </group_list>
        <measure>
          <title>Characteristics Associated With Successful Quitline Enrollment, Patient Age</title>
          <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="233"/>
                <count group_id="O2" value="249"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1-5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6-12</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>13 or older</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="29"/>
                  </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</non_inferiority_type>
            <p_value>0.15</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.48</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.13</ci_lower_limit>
            <ci_upper_limit>1.72</ci_upper_limit>
            <estimate_desc>1-5 years Row (&lt;1 Ref)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.61</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.18</ci_lower_limit>
            <ci_upper_limit>2.12</ci_upper_limit>
            <estimate_desc>6-12 years Row (&lt;1 Ref)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.82</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.49</ci_lower_limit>
            <ci_upper_limit>6.94</ci_upper_limit>
            <estimate_desc>13 or Older Row (&lt;1 Ref)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characteristics Associated With Successful Quitline Enrollment, Parent Age</title>
        <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eReferral</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
          </group>
        </group_list>
        <measure>
          <title>Characteristics Associated With Successful Quitline Enrollment, Parent Age</title>
          <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="232"/>
                <count group_id="O2" value="248"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>18-34</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127"/>
                    <measurement group_id="O2" value="145"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>35-49</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 or older</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="21"/>
                  </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</non_inferiority_type>
            <p_value>0.028</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.92</ci_lower_limit>
            <ci_upper_limit>6.50</ci_upper_limit>
            <estimate_desc>35-49 years Row (18-34 Ref)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.46</ci_lower_limit>
            <ci_upper_limit>17.32</ci_upper_limit>
            <estimate_desc>50 or older Row (18-34 Ref)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)</title>
        <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eReferral</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
          </group>
        </group_list>
        <measure>
          <title>Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)</title>
          <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="233"/>
                <count group_id="O2" value="250"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>No asthma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthma</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="74"/>
                  </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</non_inferiority_type>
            <p_value>0.85</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>1.10</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.40</ci_lower_limit>
            <ci_upper_limit>2.80</ci_upper_limit>
            <estimate_desc>Asthma Row (No asthma Ref)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day</title>
        <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eReferral</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
          </group>
        </group_list>
        <measure>
          <title>Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day</title>
          <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="231"/>
                <count group_id="O2" value="247"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>&lt;10</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="138"/>
                    <measurement group_id="O2" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>10 or more</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="82"/>
                  </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</non_inferiority_type>
            <p_value>0.086</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>6.50</ci_upper_limit>
            <estimate_desc>10 or more cigarettes Row (&lt;10 cigarettes Ref)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Characteristics Associated With Successful Quitline Enrollment, Quit Stage</title>
        <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>eReferral</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
          </group>
        </group_list>
        <measure>
          <title>Characteristics Associated With Successful Quitline Enrollment, Quit Stage</title>
          <description>Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="230"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>30 days</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="124"/>
                    <measurement group_id="O2" value="133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Less than 6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 or more months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="41"/>
                  </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</non_inferiority_type>
            <p_value>0.35</p_value>
            <method>Chi-squared</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>1.27</ci_upper_limit>
            <estimate_desc>Less than 6 months Row (30 days Ref)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>0.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.15</ci_lower_limit>
            <ci_upper_limit>2.21</ci_upper_limit>
            <other_analysis_desc>6 or more months Row (30 days Ref)</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>eReferral</title>
          <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours).</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (&quot;warm handoff&quot;) involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
              </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="233"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="251"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Brian Jenssen, MD MSHP</name_or_title>
      <organization>Children's Hospital of Philadelphia</organization>
      <phone>215-554-4390</phone>
      <email>JenssenB@email.chop.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/NCT02997735
org study id: 16-012868
nct id: NCT02997735
lead sponsor: 
collaborator: 
has dmc: No
Secondhand smoke (SHS) exposure is a significant public health problem in that it both harms
      children and is widely prevalent, affecting more than 40% of US children. Tobacco cessation
      quitlines are effective in helping smokers quit, but few smokers make use of their services.
      Electronic health record-based systems that automate referral of interested parents to
      quitlines through pediatric settings may increase the proportion of smokers who successfully
      enroll in treatment.
This is a randomized controlled study of electronic quitline referral compared to standard
      practice. Parent enrollment in the quitline will be reported to the study team by the state
      tobacco quitline, managed by the Pennsylvania Department of Health.

      This is a single site study at one large outpatient pediatric practice. Eligible study
      participants are parents/caregivers (hereafter referred to as "parents"), 18 years of age or
      older, who are present for the child's healthcare (both well-child and acute) visit, who
      smoke, and who are interested in receiving treatment through the tobacco quitline.

      The intervention is electronic referral to the tobacco quitline for parent smokers. The
      referral process will be embedded in a tobacco treatment clinical decision support (CDS)
      tool, created to help pediatricians provide counseling and treatment to parent smokers. The
      primary outcome of interest is smoker enrollment in the quitline, defined as the proportion
      of parent smokers identified in the clinic that enroll in quitline treatment compared across
      the intervention (electronic referral) and control (standard practice) approaches. Secondary
      outcomes include patient and parent demographic and behavioral factors associated with
      successful enrollment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: Number of Parent Smokers Who Enrolled in Quitline
time frame: Through study completion, up to 1 year
description: Proportion of parent smokers identified in clinic that enroll in quitline treatment compared across the intervention (electronic referral) and control (standard of practice) approaches. Primary analysis wibased on an intent to treat approach and includes all subjects randomized at their referral visit.
measure: Number of Calls With the Quitline
time frame: Through study completion, up to 1 year
description: Total number of parent contacts with the quitline post-enrollment, compared between intervention and control and reported by the PA Quitline
measure: Number of Parents Who Quit Smoking
time frame: Through study completion, up to 1 year
description: Self-reported parent quit rates post-enrollment, compared between the intervention and control and reported by the PA Quitline
measure: Characteristics Associated With Successful Quitline Enrollment, Study Arm
time frame: Through study completion, up to 1 year
description: Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment. The Odds Ratios (ORs) from multivariable logistic regression model of characteristics associated with successful quitline enrollment.
measure: Characteristics Associated With Successful Quitline Enrollment, Patient Age
time frame: Through study completion, up to 1 year
description: Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
measure: Characteristics Associated With Successful Quitline Enrollment, Parent Age
time frame: Through study completion, up to 1 year
description: Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
measure: Characteristics Associated With Successful Quitline Enrollment, Asthma Diagnosis (Child)
time frame: Through study completion, up to 1 year
description: Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
measure: Characteristics Associated With Successful Quitline Enrollment, Cigarettes Smoked Per Day
time frame: Through study completion, up to 1 year
description: Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
measure: Characteristics Associated With Successful Quitline Enrollment, Quit Stage
time frame: Through study completion, up to 1 year
description: Multivariable logistic regression was used to assess demographic and behavioral factors which independently associated with successful enrollment.
arm group label: Electronic Quitline Referral
arm group type: Experimental
description: The electronic quitline referral will be embedded within the Tobacco Treatment CDS tool, a CDS system previously developed to help pediatricians provide smoking cessation counseling and treatment to parents who smoke, modeled off the CEASE intervention, an evidence-based approach for implementing smoking cessation treatment of parents in the pediatric setting. The parental tobacco treatment CDS tool prompts the pediatric clinician to ask the parent about smoking status and assess interest in quitting (at all well-child and acute visits), links to an electronic nicotine replacement therapy prescription for parents interested in quitting, and guides appropriate documentation. Electronic referral to the quitline will be made by clicking an automated link embedded in the tool that will send the parent smokers' names and telephone numbers (entered by the clinician) directly to the Pennsylvania (PA) Free Quitline.
arm group label: Standard of Practice
arm group type: Other
description: All procedures implemented in the standard referral approach will be identical to those in the electronic referral approach with the exception of providing the telephone number for the Quitline to the parent (rather than electronic referral). The clinician workflow will be nearly the same, in that the clinician will use the link embedded in the tobacco treatment CDS tool to add the quitline to the patient's discharge paperwork (rather than automatically refer to the quitline).
intervention type: Behavioral
intervention name: Quitline Delivered Treatment
description: The PA Free quitline is funded by the Pennsylvania Department of Health and staffed by trained cessation counselors available 24 hours a day, 7 days a week. Counseling is available in English and Spanish and can be provided in at least 15 additional languages through a third party. All smokers who enroll in smoking cessation treatment will receive counseling and support consistent with accepted clinical practice guidelines. This treatment includes as many as 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between calls. The timing of counseling calls will be relapse sensitive and include a call 1-2 days after the quit date, another telephone call a week after the first call, and additional calls generally occurring at 2-3-week intervals thereafter.
arm group label: Electronic Quitline Referral
arm group label: Standard of Practice
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alexander Fiks, MD, MSCE
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 