<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/NCT01728038</url>
  </required_header>
  <id_info>
    <org_study_id>CIN381902</org_study_id>
    <secondary_id>1K22CA163747</secondary_id>
    <nct_id>NCT01728038</nct_id>
  </id_info>
  <brief_title>Exploring a Cessation Intervention for Smokers</brief_title>
  <official_title>Exploring a Cessation Intervention for Low Income Smokers in an Emergency Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED)&#xD;
      annually. Up to 50% of these parental smokers are from low-income, racially/ethnically&#xD;
      diverse households in which a variety of tobacco-related disparities (TRD) exist for both the&#xD;
      parents and their children. The PED is an ideal setting in which to address these&#xD;
      disparities, which include differences in tobacco use, pediatric second hand smoke exposure&#xD;
      (SHSe), quit rates, access to cessation resources, and morbidity such as cancer. The team has&#xD;
      conducted the only two small-scale randomized control trials (RCTs) investigating the&#xD;
      efficacy of providing smoking cessation counseling to parents in the PED setting. This&#xD;
      previous research indicates that parental smokers who visit the PED are aware of the&#xD;
      pediatric effects of SHSe, motivated to quit, eager to receive cessation counseling in this&#xD;
      setting, and show trends towards quitting.&#xD;
&#xD;
      Parents with children who have a SHSe-related illness will have higher prolonged abstinence&#xD;
      and point prevalence cessation rates, higher motivation to quit, greater number of quit&#xD;
      attempts, and lower child SHSe compared to those parents who have a child with a&#xD;
      non-SHSe-related illness at baseline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The long-range goal of my research is to test PED-based cessation interventions that are&#xD;
      readily translated into practice in large, multi-center trials. However, before this can&#xD;
      occur, preliminary data are needed, including analyses of: (1) the types of cessation&#xD;
      intervention components that low-income parental smokers regard as essential to their&#xD;
      cessation success; (2) perceived organizational barriers to the sustainability of the&#xD;
      intervention after the study period ends which will impede translation into practice; (3)&#xD;
      factors associated with parental cessation outcomes such as the presence of an acute&#xD;
      SHSe-related chief complaint in the child; and (4) the effect size of the intervention. This&#xD;
      data will be used to develop a parental cessation intervention that is tailored to low-income&#xD;
      parents who are likely to quit. Data from the proposed project will be used in a RO1&#xD;
      application to test the efficacy of this cessation intervention in a large, multi-center&#xD;
      randomized trial.&#xD;
&#xD;
      The proposed developmental study will be conducted in three phases. During Phase I, the&#xD;
      investigators will conduct focused interviews of PED nurses, physicians, and hospital&#xD;
      administrators to explore barriers to intervention sustainability that will assist in future&#xD;
      intervention planning. During Phase II, The investigators will conduct a pilot prospective&#xD;
      trial to examine the effectiveness of this screening, brief intervention, and assisted&#xD;
      referral to treatment (SBIRT) intervention on parental smoking cessation. Equal numbers of&#xD;
      parental smokers who bring their child to the PED for either a SHSe-related illness or non&#xD;
      SHSe-related illness will be given a brief intervention using an adapted form of the Clinical&#xD;
      Practice Guidelines: Treating Tobacco Use and Dependence. Intervention components may include&#xD;
      brief cessation counseling using an &quot;Advise, Assess, and Assist&quot; approach; information on&#xD;
      SHSe in children; direct connection to the Quitline (QL) in the ED; and/or free&#xD;
      administration of nicotine replacement therapy (NRT). The Health Belief Model will be used to&#xD;
      explore whether factors unique to this setting (e.g., child's acute illness) moderate the&#xD;
      effect of the intervention on cessation outcomes. Outcomes will be assessed following the&#xD;
      intervention via phone, email, or text messaging, based on parental preference. In Phase III&#xD;
      we will explore the feasibility of a pilot study to collect, send, analyze, and store child&#xD;
      saliva samples in twenty five children whose parents consent to the study. The same PED-based&#xD;
      SBIRT cessation intervention will be given to these parental smokers as in Specific Aim 2,&#xD;
      however, only English-speaking parents and parents of children who are 0-5 years of age who&#xD;
      present to the PED with SHSe-related illnesses will be asked if they agree to have their&#xD;
      child participate in this baseline and then 1-month after baseline, saliva sample collection.&#xD;
      These saliva samples will be analyzed to assess child cotinine levels at baseline and again&#xD;
      at 1 month after the SBIRT cessation intervention. Leftover saliva will be stored and frozen&#xD;
      indefinitely for possible future research, if parents consent.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Parents who report that they have not smoked in the past seven (7) days, and their verbal response is verified by a carbon monoxide test.</measure>
    <time_frame>Approximately 2 years</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">230</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Cessation Counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Parental smokers will be given a brief cessation intervention consisting of counseling, nicotine replacement therapy and Quitline connection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cessation Counseling</intervention_name>
    <description>Parental Smokers will be given brief cessation counseling, nicotine replacement therapy and Quitline connection.</description>
    <arm_group_label>Cessation Counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Phase 1: Focused Interviews of Pediatric Emergency Department Practitioners will be&#xD;
        conducted to assess their perceived attitudes and barriers to implementing routine tobacco&#xD;
        screening and tobacco counseling in the pediatric emergency department.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospital personnel: PED medical director, Chief of Staff, Chairman of Pediatrics,&#xD;
             quality systems specialists, informational technology specialists, PED physicians, and&#xD;
             PED registered nurses.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-hospital personnel&#xD;
&#xD;
        Phase 2: Parental smokers who bring their children to the pediatric emergency department&#xD;
        will be given brief smoking cessation counseling which includes advice on quitting,&#xD;
        nicotine replacement therapy vouchers and direct Quitline connection.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent/Legal Guardian (18 years or older), who are tobacco users, accompanying a child&#xD;
             (0 to 18 years old) being treated in the PED with a non-urgent complaint/condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent/Legal Guardian who is only a tobacco chewer.&#xD;
&#xD;
          -  Parent/Legal Guardian who is enrolled in a smoking cessation program.&#xD;
&#xD;
          -  Parent/Legal Guardian who is using Nicotine Replacement Therapy (NRT) or other&#xD;
             cessation treatment.&#xD;
&#xD;
          -  Parent/Legal Guardian who is moving within 8 months after enrollment.&#xD;
&#xD;
        Phase 3: The same PED-based SBIRT cessation intervention will be given to these parental&#xD;
        smokers as in Phase 2. However, parents will also be asked if they agree to have their&#xD;
        child participate in saliva sample collection at baseline and at one month. Parents will&#xD;
        also be asked if their child's leftover saliva can be stored for future research.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent/Legal Guardian (18 years or older), who are tobacco users, accompanying a child&#xD;
             (0 to 5 years old) being treated in the PED with a non-urgent second hand smoke&#xD;
             exposure related complaint/condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent/Legal Guardian who is only a tobacco chewer.&#xD;
&#xD;
          -  Parent/Legal Guardian who is enrolled in a smoking cessation program.&#xD;
&#xD;
          -  Parent/Legal Guardian who is using Nicotine Replacement Therapy (NRT) or other&#xD;
             cessation treatment.&#xD;
&#xD;
          -  Parent/Legal Guardian who is moving within 8 months after enrollment&#xD;
&#xD;
          -  Parent/Legal Guardian who does not speak or read English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Esther M. Mahabee-Gittens, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Mahabee-Gittens EM, Stone L, Gordon JS. Pediatric emergency department is a promising venue for adult tobacco cessation interventions. Nicotine Tob Res. 2013 Oct;15(10):1792-3. doi: 10.1093/ntr/ntt069. Epub 2013 May 24. No abstract available.</citation>
    <PMID>23709612</PMID>
  </results_reference>
  <results_reference>
    <citation>Mahabee-Gittens EM, Khoury JC, Ho M, Stone L, Gordon JS. A smoking cessation intervention for low-income smokers in the ED. Am J Emerg Med. 2015 Aug;33(8):1056-61. doi: 10.1016/j.ajem.2015.04.058. Epub 2015 May 2.</citation>
    <PMID>25976268</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bronchiolitis</keyword>
  <keyword>Cough</keyword>
  <keyword>Ear Infection</keyword>
  <keyword>Respiratory Infection</keyword>
  <keyword>Wheezing</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01728038
org study id: CIN381902
secondary id: 1K22CA163747
nct id: NCT01728038
lead sponsor: 
collaborator: 
has dmc: Yes
An estimated 6.6 million parents who smoke visit pediatric emergency departments (PED)
      annually. Up to 50% of these parental smokers are from low-income, racially/ethnically
      diverse households in which a variety of tobacco-related disparities (TRD) exist for both the
      parents and their children. The PED is an ideal setting in which to address these
      disparities, which include differences in tobacco use, pediatric second hand smoke exposure
      (SHSe), quit rates, access to cessation resources, and morbidity such as cancer. The team has
      conducted the only two small-scale randomized control trials (RCTs) investigating the
      efficacy of providing smoking cessation counseling to parents in the PED setting. This
      previous research indicates that parental smokers who visit the PED are aware of the
      pediatric effects of SHSe, motivated to quit, eager to receive cessation counseling in this
      setting, and show trends towards quitting.

      Parents with children who have a SHSe-related illness will have higher prolonged abstinence
      and point prevalence cessation rates, higher motivation to quit, greater number of quit
      attempts, and lower child SHSe compared to those parents who have a child with a
      non-SHSe-related illness at baseline.
The long-range goal of my research is to test PED-based cessation interventions that are
      readily translated into practice in large, multi-center trials. However, before this can
      occur, preliminary data are needed, including analyses of: (1) the types of cessation
      intervention components that low-income parental smokers regard as essential to their
      cessation success; (2) perceived organizational barriers to the sustainability of the
      intervention after the study period ends which will impede translation into practice; (3)
      factors associated with parental cessation outcomes such as the presence of an acute
      SHSe-related chief complaint in the child; and (4) the effect size of the intervention. This
      data will be used to develop a parental cessation intervention that is tailored to low-income
      parents who are likely to quit. Data from the proposed project will be used in a RO1
      application to test the efficacy of this cessation intervention in a large, multi-center
      randomized trial.

      The proposed developmental study will be conducted in three phases. During Phase I, the
      investigators will conduct focused interviews of PED nurses, physicians, and hospital
      administrators to explore barriers to intervention sustainability that will assist in future
      intervention planning. During Phase II, The investigators will conduct a pilot prospective
      trial to examine the effectiveness of this screening, brief intervention, and assisted
      referral to treatment (SBIRT) intervention on parental smoking cessation. Equal numbers of
      parental smokers who bring their child to the PED for either a SHSe-related illness or non
      SHSe-related illness will be given a brief intervention using an adapted form of the Clinical
      Practice Guidelines: Treating Tobacco Use and Dependence. Intervention components may include
      brief cessation counseling using an "Advise, Assess, and Assist" approach; information on
      SHSe in children; direct connection to the Quitline (QL) in the ED; and/or free
      administration of nicotine replacement therapy (NRT). The Health Belief Model will be used to
      explore whether factors unique to this setting (e.g., child's acute illness) moderate the
      effect of the intervention on cessation outcomes. Outcomes will be assessed following the
      intervention via phone, email, or text messaging, based on parental preference. In Phase III
      we will explore the feasibility of a pilot study to collect, send, analyze, and store child
      saliva samples in twenty five children whose parents consent to the study. The same PED-based
      SBIRT cessation intervention will be given to these parental smokers as in Specific Aim 2,
      however, only English-speaking parents and parents of children who are 0-5 years of age who
      present to the PED with SHSe-related illnesses will be asked if they agree to have their
      child participate in this baseline and then 1-month after baseline, saliva sample collection.
      These saliva samples will be analyzed to assess child cotinine levels at baseline and again
      at 1 month after the SBIRT cessation intervention. Leftover saliva will be stored and frozen
      indefinitely for possible future research, if parents consent.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Parents who report that they have not smoked in the past seven (7) days, and their verbal response is verified by a carbon monoxide test.
time frame: Approximately 2 years
arm group label: Cessation Counseling
arm group type: Experimental
description: Parental smokers will be given a brief cessation intervention consisting of counseling, nicotine replacement therapy and Quitline connection.
intervention type: Behavioral
intervention name: Cessation Counseling
description: Parental Smokers will be given brief cessation counseling, nicotine replacement therapy and Quitline connection.
arm group label: Cessation Counseling
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Esther M. Mahabee-Gittens, MD, MS
role: Principal Investigator
affiliation: Professor
facility: 
country: United States
citation: Mahabee-Gittens EM, Stone L, Gordon JS. Pediatric emergency department is a promising venue for adult tobacco cessation interventions. Nicotine Tob Res. 2013 Oct;15(10):1792-3. doi: 10.1093/ntr/ntt069. Epub 2013 May 24. No abstract available.
PMID: 23709612
citation: Mahabee-Gittens EM, Khoury JC, Ho M, Stone L, Gordon JS. A smoking cessation intervention for low-income smokers in the ED. Am J Emerg Med. 2015 Aug;33(8):1056-61. doi: 10.1016/j.ajem.2015.04.058. Epub 2015 May 2.
PMID: 25976268
responsible party type: Sponsor