<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/NCT01735448</url>
  </required_header>
  <id_info>
    <org_study_id>04-12-472</org_study_id>
    <secondary_id>AHREC 04-12-472</secondary_id>
    <nct_id>NCT01735448</nct_id>
  </id_info>
  <brief_title>Improving Health for Aboriginal People Through Tobacco Related Research</brief_title>
  <official_title>Advancing the Understanding of Barriers and Facilitators for Tobacco Prevention, Cessation Treatments, Doctor Visits for Related Illnesses and Health Research for Aboriginal Australians</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Queen Elizabeth Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Adelaide</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Queen Elizabeth Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To identify barriers and facilitators in the uptake of smoking cessation&#xD;
      pharmacotherapies, tobacco prevention, doctor visits, smoking amongst youth, community held&#xD;
      health priorities and barriers to research in Aboriginal Australians from the perspectives&#xD;
      of:&#xD;
&#xD;
        -  Aboriginal smokers and ex/non-smokers&#xD;
&#xD;
        -  Aboriginal Healthcare workers&#xD;
&#xD;
        -  Consultants/general practitioners, and&#xD;
&#xD;
        -  Key stakeholders in Aboriginal health&#xD;
&#xD;
      Focus groups, one-on-one interviews and surveys will be conducted to provide information at&#xD;
      the 'grass-roots' level including examinations into perceived differences in locally held&#xD;
      beliefs, attitudes, knowledge, traditional practices and the cultural and social constructs,&#xD;
      to assist implementation of future tobacco cessation/prevention interventions and treatment&#xD;
      of smoking related illnesses. This information can be used to improve the health of&#xD;
      Aboriginal people by identifying inadequacies in current practices and highlighting what&#xD;
      these are through the eyes of community members, healthcare workers, consultants/general&#xD;
      practitioners and key stakeholders. We also intend on examining any facilitators that are&#xD;
      identified as positive and working aspects of current initiatives e.g. community&#xD;
      infrastructure, in an effort to not 'reinvent the wheel' and acknowledge what is working.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      We will identify barriers and facilitators for the implementation of smoking cessation&#xD;
      pharmacotherapies, tobacco prevention, doctor visits, youth and smoking, community held&#xD;
      health priorities and barriers to research through:&#xD;
&#xD;
        1. Multiple focus groups held within 2 communities with Aboriginal smokers and&#xD;
           ex/non-smokers, and&#xD;
&#xD;
        2. Focus groups with healthcare workers serving these communities, and&#xD;
&#xD;
        3. Qualitative one-on-one interviews with key stakeholders in Aboriginal communities&#xD;
&#xD;
        4. Qualitative one-on-one interviews with specialists/doctors working with Aboriginal&#xD;
           patients&#xD;
&#xD;
        5. Surveys with all participants mentioned above&#xD;
&#xD;
        6. Surveys with specialist groups including members of tobacco related special interest&#xD;
           groups of the Thoracic Society of Australia and New Zealand (TSANZ)&#xD;
&#xD;
      Smoking cessation is one of the most important ways to improve the prognosis of patients with&#xD;
      respiratory diseases. Despite being over represented in the burden of smoking related&#xD;
      morbidity and mortality, very little methodologically rigorous research has been conducted to&#xD;
      evaluate and/or enhance the uptake of smoking cessation pharmacotherapies and smoking&#xD;
      prevention for Aboriginal Australians, as evident in our two recent (2012) Cochrane&#xD;
      meta-analyses and through extensive consultation over the past two years with Aboriginal&#xD;
      Elders, key stakeholders, researchers and experts throughout Australia. Moreover, many of the&#xD;
      healthcare workers and some doctors on the frontline are reporting that they do not believe&#xD;
      they have the skills or ability to offer smoking cessation/prevention initiatives to these&#xD;
      patients, and perhaps more importantly, admit to the attitude of 'even if I did, it's not&#xD;
      going to work, so why bother'.&#xD;
&#xD;
      In light of this gap in knowledge, our project relates specifically to understanding and&#xD;
      improving the lung health of Aboriginal Australians, the cohort with the greatest burden of&#xD;
      disease and lowest life expectancy, through qualitative analyses. A total of 10 focus groups,&#xD;
      30 one-on-one interviews and approximately 120 surveys (unless data saturation is reached&#xD;
      sooner) will be carried out in collaboration with Aboriginal community involvement. The&#xD;
      information obtained from these will provide an overall picture of the barriers and enablers&#xD;
      from the perspectives of the various individuals involved, being:&#xD;
&#xD;
        -  Aboriginal participants from urban, regional and rural cohorts (8 focus groups plus&#xD;
           surveys)&#xD;
&#xD;
        -  Aboriginal healthcare workers from urban, regional and rural cohorts (2 focus groups&#xD;
           plus surveys)&#xD;
&#xD;
        -  Respiratory consultants who see Aboriginal patients (10 one-on-one interviews plus&#xD;
           surveys)&#xD;
&#xD;
        -  Key stakeholders in Aboriginal health including Aboriginal liaison officers, Aboriginal&#xD;
           health councils, Elders &amp; influential figures in communities (10 one-on-one interviews&#xD;
           plus surveys)&#xD;
&#xD;
        -  Medical Consultants who see Aboriginal patients (2 one-on-one interviews plus surveys&#xD;
           from each of the following disciplines: General Practitioners, cardiology, neurology,&#xD;
           oncology and vascular; total of 10, or until data saturation)&#xD;
&#xD;
      Triangulation will occur at multiple levels to improve credibility and dependability&#xD;
      including: data collection (focus groups, interviews and surveys), investigators (minimum&#xD;
      five investigators involved throughout various aspects of the study), data sources (multiple&#xD;
      locations, communities and venues), analysis methods (Grounded theory and Triandis model of&#xD;
      behavioural change).&#xD;
&#xD;
      In addition a detailed audit trail will be kept and all focus groups and interviews will&#xD;
      undergo feedback (confirmation of accuracy and interpretation) by participants.&#xD;
      Quasi-statistics will also be employed as part of the analysis methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">April 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the barriers and facilitators to pharmacological initiatives for tobacco cessation in Aboriginal populations</measure>
    <time_frame>18 months</time_frame>
    <description>Qualitative analysis (focus groups, one-on-one interviews and surveys). The use of pharmacotherapies for smoking cessation significantly improves the probability of successful abstinence. Identification of the barriers and facilitators for tobacco cessation pharmacotherapies will be determined through these qualitative discussions and mixed method approaches</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the barriers and facilitators for tobacco prevention initiatives, particularly related to Aboriginal youth</measure>
    <time_frame>18 months</time_frame>
    <description>Qualitative analysis (focus groups, one-on-one interviews and surveys). The use of tobacco prevention initiatives significantly improves the probability of lower tobacco prevalence long-term. Identification of the barriers and facilitators for tobacco prevention initiatives will be determined through these qualitative discussions and mixed method approaches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify the barriers and facilitators for doctor visits by Aboriginal people</measure>
    <time_frame>18 months</time_frame>
    <description>Qualitative analysis (focus groups, one-on-one interviews and surveys). Regular doctor visits by Aboriginal people can significantly reduce the progression of chronic illnesses, improve quality of life and reduce health care costs. Identification of the barriers and facilitators for these doctor visits, particularly with Respiratory physicians, will be determined through these qualitative discussions and mixed method approaches</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Identify barriers and facilitators to research initiatives in Aboriginal people and identify self-reported health priorities</measure>
    <time_frame>18 months</time_frame>
    <description>Qualitative analysis (focus groups, one-on-one interviews and surveys). Research in Aboriginal populations are often lengthy and in many cases fail to achieve their objectives, often due to inappropriate methodology or a lack of consultation with Aboriginal Elders or key stakeholders research initiatives particularly related to tobacco and chronic illnesses will be determined through these qualitative discussions and mixed method approaches. In addition, we aim to identify health priorities identified by participants within the focus groups, one-on-one interviews and surveys that can be targeted for future research initiatives.</description>
  </secondary_outcome>
  <number_of_groups>13</number_of_groups>
  <enrollment type="Actual">16</enrollment>
  <condition>Tobacco Dependence</condition>
  <arm_group>
    <arm_group_label>Aboriginal smoker, male, Adelaide</arm_group_label>
    <description>Focus group: Aboriginal smoker, male from Adelaide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aboriginal smoker, female, Adelaide</arm_group_label>
    <description>Focus group: Aboriginal smoker, female, from Adelaide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aboriginal ex/non-smoker, male, Adelaide</arm_group_label>
    <description>Focus group: Aboriginal ex/non-smoker, male, from Adelaide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aboriginal ex/non-smoker, female, Adelaide</arm_group_label>
    <description>Focus group: Aboriginal ex/non-smoker, female, from Adelaide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthcare workers, Adelaide</arm_group_label>
    <description>Focus group: Healthcare workers who are based in Adelaide and work with Aboriginal patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthcare workers, Murray Bridge</arm_group_label>
    <description>Focus group: Healthcare workers who are based in Murray Bridge and work with Aboriginal patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aboriginal smoker, male, Murray Bridge</arm_group_label>
    <description>Focus group: Aboriginal smoker, male, from Murray Bridge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aboriginal smoker, female, Murray Bridge</arm_group_label>
    <description>Focus group: Aboriginal smoker, female, from Murray Bridge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aboriginal ex/non-smoker, male, Murray Bridge</arm_group_label>
    <description>Focus group: Aboriginal ex/non-smoker, male, from Murray Bridge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Aboriginal ex/non-smoker, female, Murray Bridge</arm_group_label>
    <description>Focus group: Aboriginal ex/non-smoker, female, from Murray Bridge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Key community stakeholders</arm_group_label>
    <description>One-on-one interviews with 10 key Aboriginal community stakeholders</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Respiratory physicians</arm_group_label>
    <description>One-on-one interviews with 10 Respiratory physicians</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Consultants and General Practitioners</arm_group_label>
    <description>One-on-one interviews with 10 consultants and/or GP's</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Focus group</intervention_name>
    <description>Initially, ten focus groups with an average sample size of 5-7 participants each will be performed in two communities within South Australia, one being Adelaide and the other Murray Bridge, this includes focus groups held with healthcare workers.&#xD;
The proposed focus groups will be conducted by experienced mediators who have undertaken Aboriginal cultural awareness training and have experience in qualitative research methods. Both mediators have also been involved in all aspects of project development and consultation with Aboriginal Elders and key stakeholders since its conception.&#xD;
We will be using topic guides (reviewed by Aboriginal Elders and researchers) that will be semi-structured with open-ended questions designed to encourage group discussion around smoking cessation and the use of pharmacotherapies in particular, in addition to other objectives identified during the consultation phase of this research.</description>
    <arm_group_label>Aboriginal ex/non-smoker, female, Adelaide</arm_group_label>
    <arm_group_label>Aboriginal ex/non-smoker, female, Murray Bridge</arm_group_label>
    <arm_group_label>Aboriginal ex/non-smoker, male, Adelaide</arm_group_label>
    <arm_group_label>Aboriginal ex/non-smoker, male, Murray Bridge</arm_group_label>
    <arm_group_label>Aboriginal smoker, female, Adelaide</arm_group_label>
    <arm_group_label>Aboriginal smoker, female, Murray Bridge</arm_group_label>
    <arm_group_label>Aboriginal smoker, male, Adelaide</arm_group_label>
    <arm_group_label>Aboriginal smoker, male, Murray Bridge</arm_group_label>
    <arm_group_label>Healthcare workers, Adelaide</arm_group_label>
    <arm_group_label>Healthcare workers, Murray Bridge</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>One-on-one interviews</intervention_name>
    <description>One-on- one interviews will be held with both medical clinicians and key stakeholders and will be conducted by existing TQEH (The Queen Elizabeth Hospital), Clinical Practice Unit employees, experienced in qualitative research. Informed consent will be required and the interview will be audio taped to allow analysis of the qualitative data. All interviews will remain anonymous, unless the interviewee prefers to be named. In this case, they will be named in the acknowledgement section of all publications and presentations. Moderator guides have been developed and reviewed in the same process undergone by the focus group moderator guides</description>
    <arm_group_label>Consultants and General Practitioners</arm_group_label>
    <arm_group_label>Key community stakeholders</arm_group_label>
    <arm_group_label>Respiratory physicians</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>A four page survey will be administered to all focus group and interview participants in addition to select cohorts including tobacco related special interest groups of the Thoracic Society of Australia and New Zealand (TSANZ). The survey will include demographic data, smoking history and current smoking status (questions related to smoking for current tobacco users include the Fagerstrom test for nicotine dependence, multiple Likert scales for cravings, motivation to quit, confidence etc.) and Likert scales examining perceptions, attitudes and knowledge about tobacco use, cessation, prevention, health and research in the Aboriginal setting.</description>
    <arm_group_label>Aboriginal ex/non-smoker, female, Adelaide</arm_group_label>
    <arm_group_label>Aboriginal ex/non-smoker, female, Murray Bridge</arm_group_label>
    <arm_group_label>Aboriginal ex/non-smoker, male, Adelaide</arm_group_label>
    <arm_group_label>Aboriginal ex/non-smoker, male, Murray Bridge</arm_group_label>
    <arm_group_label>Aboriginal smoker, female, Adelaide</arm_group_label>
    <arm_group_label>Aboriginal smoker, female, Murray Bridge</arm_group_label>
    <arm_group_label>Aboriginal smoker, male, Adelaide</arm_group_label>
    <arm_group_label>Aboriginal smoker, male, Murray Bridge</arm_group_label>
    <arm_group_label>Consultants and General Practitioners</arm_group_label>
    <arm_group_label>Healthcare workers, Adelaide</arm_group_label>
    <arm_group_label>Healthcare workers, Murray Bridge</arm_group_label>
    <arm_group_label>Key community stakeholders</arm_group_label>
    <arm_group_label>Respiratory physicians</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants who agree to be involved in the focus groups will be recruited via existing&#xD;
        community contacts (e.g., Aboriginal elders, leaders of community groups and doctors who&#xD;
        support the planned research) in urban Adelaide and regional Murray Bridge. We also intend&#xD;
        on actively recruiting through clinic visits made by our visiting respiratory clinicians.&#xD;
        Copies of the participant information sheet and consent form will be disseminated via local&#xD;
        healthcare workers to seek focus group volunteers and via existing contacts in health and&#xD;
        by word of mouth for one-on-one interview participants. Survey participants will be&#xD;
        recruited as per above methods in addition to use of delegate lists and mail outs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male Smokers&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
          -  Identifies as an Aboriginal person&#xD;
&#xD;
          -  Uses more than 10 cigarettes or cigarette equivalent per week&#xD;
&#xD;
          -  Has lived in the relevant community for &gt;12 months&#xD;
&#xD;
        Female Smokers&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
          -  Identifies as an Aboriginal person&#xD;
&#xD;
          -  Uses more than 10 cigarettes or cigarette equivalent per week&#xD;
&#xD;
          -  Has lived in the relevant community for &gt;12 months&#xD;
&#xD;
        Male Non/Ex Smokers&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
          -  Identifies as an Aboriginal person&#xD;
&#xD;
          -  Has not used tobacco for &gt;3 months&#xD;
&#xD;
          -  Has lived in the relevant community for &gt;12 months&#xD;
&#xD;
        Female Non/Ex Smokers&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
          -  Identifies as an Aboriginal person&#xD;
&#xD;
          -  Has not used tobacco for &gt;3 months&#xD;
&#xD;
          -  Has lived in the relevant community for &gt;12 months&#xD;
&#xD;
        Healthcare worker&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
          -  Has provided healthcare to people from Aboriginal people for at least 25% of&#xD;
             employment hours over the past 12 months, or&#xD;
&#xD;
          -  Has provided healthcare to people from Aboriginal people for at least 5 years of their&#xD;
             working career&#xD;
&#xD;
          -  Is a qualified healthcare worker&#xD;
&#xD;
        GP's / Specialists&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
          -  Has provided clinical care to people from Aboriginal people over a 12 month period (at&#xD;
             least one consult per week or equivalent)&#xD;
&#xD;
          -  Is a qualified General Practitioner or,&#xD;
&#xD;
          -  Is a qualified doctor specialising in one of the following disciplines: respiratory,&#xD;
             vascular, neurology, oncology, cardiology&#xD;
&#xD;
        Key Stakeholders&#xD;
&#xD;
          -  Willing to participate&#xD;
&#xD;
          -  Currently working/has worked in Aboriginal health as a primary focus of the position,&#xD;
             or&#xD;
&#xD;
          -  Is a community Elder, or&#xD;
&#xD;
          -  Is influential in Aboriginal health/communities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot speak English&#xD;
&#xD;
          -  Cannot sign a consent&#xD;
&#xD;
          -  Does not have the intellectual capacity required to respond to questions&#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>Kristin V Carson, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Adelaide</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Brian J Smith, MBBS, PhD</last_name>
    <role>Study Director</role>
    <affiliation>The Queen Elizabeth Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adrian J Esterman, PhD,MSc,BSc</last_name>
    <role>Study Director</role>
    <affiliation>University of South Australia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew J Peters, MBBS, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Concord Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Basil Hetzel Institute for Translational Health Research</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Queen Elizabeth Hospital</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5011</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Murray Mallee Community Health Service; Aboriginal Primary Health Care Unit</name>
      <address>
        <city>Murray Bridge</city>
        <state>South Australia</state>
        <zip>5253</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <reference>
    <citation>Carson KV, Brinn MP, Labiszewski NA, Peters M, Chang AB, Veale A, Esterman AJ, Smith BJ. Interventions for tobacco use prevention in Indigenous youth. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD009325. doi: 10.1002/14651858.CD009325.pub2.</citation>
    <PMID>22895988</PMID>
  </reference>
  <reference>
    <citation>Carson KV, Brinn MP, Peters M, Veale A, Esterman AJ, Smith BJ. Interventions for smoking cessation in Indigenous populations. Cochrane Database Syst Rev. 2012 Jan 18;1:CD009046. doi: 10.1002/14651858.CD009046.pub2.</citation>
    <PMID>22258998</PMID>
  </reference>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 23, 2012</study_first_submitted>
  <study_first_submitted_qc>November 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>April 6, 2017</last_update_submitted>
  <last_update_submitted_qc>April 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Queen Elizabeth Hospital</investigator_affiliation>
    <investigator_full_name>Kristin Carson</investigator_full_name>
    <investigator_title>Senior Scientist</investigator_title>
  </responsible_party>
  <keyword>smoking cessation</keyword>
  <keyword>tobacco</keyword>
  <keyword>addiction</keyword>
  <keyword>Aboriginal</keyword>
  <keyword>youth</keyword>
  <keyword>Indigenous</keyword>
  <keyword>pharmacological</keyword>
  <keyword>focus group</keyword>
  <keyword>interview</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Available on request</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01735448
org study id: 04-12-472
secondary id: AHREC 04-12-472
nct id: NCT01735448
lead sponsor: 
collaborator: 
has dmc: Yes
Aim: To identify barriers and facilitators in the uptake of smoking cessation
      pharmacotherapies, tobacco prevention, doctor visits, smoking amongst youth, community held
      health priorities and barriers to research in Aboriginal Australians from the perspectives
      of:

        -  Aboriginal smokers and ex/non-smokers

        -  Aboriginal Healthcare workers

        -  Consultants/general practitioners, and

        -  Key stakeholders in Aboriginal health

      Focus groups, one-on-one interviews and surveys will be conducted to provide information at
      the 'grass-roots' level including examinations into perceived differences in locally held
      beliefs, attitudes, knowledge, traditional practices and the cultural and social constructs,
      to assist implementation of future tobacco cessation/prevention interventions and treatment
      of smoking related illnesses. This information can be used to improve the health of
      Aboriginal people by identifying inadequacies in current practices and highlighting what
      these are through the eyes of community members, healthcare workers, consultants/general
      practitioners and key stakeholders. We also intend on examining any facilitators that are
      identified as positive and working aspects of current initiatives e.g. community
      infrastructure, in an effort to not 'reinvent the wheel' and acknowledge what is working.
We will identify barriers and facilitators for the implementation of smoking cessation
      pharmacotherapies, tobacco prevention, doctor visits, youth and smoking, community held
      health priorities and barriers to research through:

        1. Multiple focus groups held within 2 communities with Aboriginal smokers and
           ex/non-smokers, and

        2. Focus groups with healthcare workers serving these communities, and

        3. Qualitative one-on-one interviews with key stakeholders in Aboriginal communities

        4. Qualitative one-on-one interviews with specialists/doctors working with Aboriginal
           patients

        5. Surveys with all participants mentioned above

        6. Surveys with specialist groups including members of tobacco related special interest
           groups of the Thoracic Society of Australia and New Zealand (TSANZ)

      Smoking cessation is one of the most important ways to improve the prognosis of patients with
      respiratory diseases. Despite being over represented in the burden of smoking related
      morbidity and mortality, very little methodologically rigorous research has been conducted to
      evaluate and/or enhance the uptake of smoking cessation pharmacotherapies and smoking
      prevention for Aboriginal Australians, as evident in our two recent (2012) Cochrane
      meta-analyses and through extensive consultation over the past two years with Aboriginal
      Elders, key stakeholders, researchers and experts throughout Australia. Moreover, many of the
      healthcare workers and some doctors on the frontline are reporting that they do not believe
      they have the skills or ability to offer smoking cessation/prevention initiatives to these
      patients, and perhaps more importantly, admit to the attitude of 'even if I did, it's not
      going to work, so why bother'.

      In light of this gap in knowledge, our project relates specifically to understanding and
      improving the lung health of Aboriginal Australians, the cohort with the greatest burden of
      disease and lowest life expectancy, through qualitative analyses. A total of 10 focus groups,
      30 one-on-one interviews and approximately 120 surveys (unless data saturation is reached
      sooner) will be carried out in collaboration with Aboriginal community involvement. The
      information obtained from these will provide an overall picture of the barriers and enablers
      from the perspectives of the various individuals involved, being:

        -  Aboriginal participants from urban, regional and rural cohorts (8 focus groups plus
           surveys)

        -  Aboriginal healthcare workers from urban, regional and rural cohorts (2 focus groups
           plus surveys)

        -  Respiratory consultants who see Aboriginal patients (10 one-on-one interviews plus
           surveys)

        -  Key stakeholders in Aboriginal health including Aboriginal liaison officers, Aboriginal
           health councils, Elders & influential figures in communities (10 one-on-one interviews
           plus surveys)

        -  Medical Consultants who see Aboriginal patients (2 one-on-one interviews plus surveys
           from each of the following disciplines: General Practitioners, cardiology, neurology,
           oncology and vascular; total of 10, or until data saturation)

      Triangulation will occur at multiple levels to improve credibility and dependability
      including: data collection (focus groups, interviews and surveys), investigators (minimum
      five investigators involved throughout various aspects of the study), data sources (multiple
      locations, communities and venues), analysis methods (Grounded theory and Triandis model of
      behavioural change).

      In addition a detailed audit trail will be kept and all focus groups and interviews will
      undergo feedback (confirmation of accuracy and interpretation) by participants.
      Quasi-statistics will also be employed as part of the analysis methods.
observational model: Cohort
time perspective: Prospective
measure: Determine the barriers and facilitators to pharmacological initiatives for tobacco cessation in Aboriginal populations
time frame: 18 months
description: Qualitative analysis (focus groups, one-on-one interviews and surveys). The use of pharmacotherapies for smoking cessation significantly improves the probability of successful abstinence. Identification of the barriers and facilitators for tobacco cessation pharmacotherapies will be determined through these qualitative discussions and mixed method approaches
measure: Determine the barriers and facilitators for tobacco prevention initiatives, particularly related to Aboriginal youth
time frame: 18 months
description: Qualitative analysis (focus groups, one-on-one interviews and surveys). The use of tobacco prevention initiatives significantly improves the probability of lower tobacco prevalence long-term. Identification of the barriers and facilitators for tobacco prevention initiatives will be determined through these qualitative discussions and mixed method approaches
measure: Identify the barriers and facilitators for doctor visits by Aboriginal people
time frame: 18 months
description: Qualitative analysis (focus groups, one-on-one interviews and surveys). Regular doctor visits by Aboriginal people can significantly reduce the progression of chronic illnesses, improve quality of life and reduce health care costs. Identification of the barriers and facilitators for these doctor visits, particularly with Respiratory physicians, will be determined through these qualitative discussions and mixed method approaches
measure: Identify barriers and facilitators to research initiatives in Aboriginal people and identify self-reported health priorities
time frame: 18 months
description: Qualitative analysis (focus groups, one-on-one interviews and surveys). Research in Aboriginal populations are often lengthy and in many cases fail to achieve their objectives, often due to inappropriate methodology or a lack of consultation with Aboriginal Elders or key stakeholders research initiatives particularly related to tobacco and chronic illnesses will be determined through these qualitative discussions and mixed method approaches. In addition, we aim to identify health priorities identified by participants within the focus groups, one-on-one interviews and surveys that can be targeted for future research initiatives.
arm group label: Aboriginal smoker, male, Adelaide
description: Focus group: Aboriginal smoker, male from Adelaide
arm group label: Aboriginal smoker, female, Adelaide
description: Focus group: Aboriginal smoker, female, from Adelaide
arm group label: Aboriginal ex/non-smoker, male, Adelaide
description: Focus group: Aboriginal ex/non-smoker, male, from Adelaide
arm group label: Aboriginal ex/non-smoker, female, Adelaide
description: Focus group: Aboriginal ex/non-smoker, female, from Adelaide
arm group label: Healthcare workers, Adelaide
description: Focus group: Healthcare workers who are based in Adelaide and work with Aboriginal patients
arm group label: Healthcare workers, Murray Bridge
description: Focus group: Healthcare workers who are based in Murray Bridge and work with Aboriginal patients
arm group label: Aboriginal smoker, male, Murray Bridge
description: Focus group: Aboriginal smoker, male, from Murray Bridge
arm group label: Aboriginal smoker, female, Murray Bridge
description: Focus group: Aboriginal smoker, female, from Murray Bridge
arm group label: Aboriginal ex/non-smoker, male, Murray Bridge
description: Focus group: Aboriginal ex/non-smoker, male, from Murray Bridge
arm group label: Aboriginal ex/non-smoker, female, Murray Bridge
description: Focus group: Aboriginal ex/non-smoker, female, from Murray Bridge
arm group label: Key community stakeholders
description: One-on-one interviews with 10 key Aboriginal community stakeholders
arm group label: Respiratory physicians
description: One-on-one interviews with 10 Respiratory physicians
arm group label: Consultants and General Practitioners
description: One-on-one interviews with 10 consultants and/or GP's
intervention type: Other
intervention name: Focus group
description: Initially, ten focus groups with an average sample size of 5-7 participants each will be performed in two communities within South Australia, one being Adelaide and the other Murray Bridge, this includes focus groups held with healthcare workers.
The proposed focus groups will be conducted by experienced mediators who have undertaken Aboriginal cultural awareness training and have experience in qualitative research methods. Both mediators have also been involved in all aspects of project development and consultation with Aboriginal Elders and key stakeholders since its conception.
We will be using topic guides (reviewed by Aboriginal Elders and researchers) that will be semi-structured with open-ended questions designed to encourage group discussion around smoking cessation and the use of pharmacotherapies in particular, in addition to other objectives identified during the consultation phase of this research.
arm group label: Aboriginal ex/non-smoker, female, Adelaide
arm group label: Aboriginal ex/non-smoker, female, Murray Bridge
arm group label: Aboriginal ex/non-smoker, male, Adelaide
arm group label: Aboriginal ex/non-smoker, male, Murray Bridge
arm group label: Aboriginal smoker, female, Adelaide
arm group label: Aboriginal smoker, female, Murray Bridge
arm group label: Aboriginal smoker, male, Adelaide
arm group label: Aboriginal smoker, male, Murray Bridge
arm group label: Healthcare workers, Adelaide
arm group label: Healthcare workers, Murray Bridge
intervention type: Other
intervention name: One-on-one interviews
description: One-on- one interviews will be held with both medical clinicians and key stakeholders and will be conducted by existing TQEH (The Queen Elizabeth Hospital), Clinical Practice Unit employees, experienced in qualitative research. Informed consent will be required and the interview will be audio taped to allow analysis of the qualitative data. All interviews will remain anonymous, unless the interviewee prefers to be named. In this case, they will be named in the acknowledgement section of all publications and presentations. Moderator guides have been developed and reviewed in the same process undergone by the focus group moderator guides
arm group label: Consultants and General Practitioners
arm group label: Key community stakeholders
arm group label: Respiratory physicians
intervention type: Other
intervention name: Survey
description: A four page survey will be administered to all focus group and interview participants in addition to select cohorts including tobacco related special interest groups of the Thoracic Society of Australia and New Zealand (TSANZ). The survey will include demographic data, smoking history and current smoking status (questions related to smoking for current tobacco users include the Fagerstrom test for nicotine dependence, multiple Likert scales for cravings, motivation to quit, confidence etc.) and Likert scales examining perceptions, attitudes and knowledge about tobacco use, cessation, prevention, health and research in the Aboriginal setting.
arm group label: Aboriginal ex/non-smoker, female, Adelaide
arm group label: Aboriginal ex/non-smoker, female, Murray Bridge
arm group label: Aboriginal ex/non-smoker, male, Adelaide
arm group label: Aboriginal ex/non-smoker, male, Murray Bridge
arm group label: Aboriginal smoker, female, Adelaide
arm group label: Aboriginal smoker, female, Murray Bridge
arm group label: Aboriginal smoker, male, Adelaide
arm group label: Aboriginal smoker, male, Murray Bridge
arm group label: Consultants and General Practitioners
arm group label: Healthcare workers, Adelaide
arm group label: Healthcare workers, Murray Bridge
arm group label: Key community stakeholders
arm group label: Respiratory physicians
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kristin V Carson, PhD
role: Principal Investigator
affiliation: University of Adelaide
last name: Brian J Smith, MBBS, PhD
role: Study Director
affiliation: The Queen Elizabeth Hospital
last name: Adrian J Esterman, PhD,MSc,BSc
role: Study Director
affiliation: University of South Australia
last name: Matthew J Peters, MBBS, PhD
role: Study Director
affiliation: Concord Hospital
facility: 
facility: 
facility: 
country: Australia
citation: Carson KV, Brinn MP, Labiszewski NA, Peters M, Chang AB, Veale A, Esterman AJ, Smith BJ. Interventions for tobacco use prevention in Indigenous youth. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD009325. doi: 10.1002/14651858.CD009325.pub2.
PMID: 22895988
citation: Carson KV, Brinn MP, Peters M, Veale A, Esterman AJ, Smith BJ. Interventions for smoking cessation in Indigenous populations. Cochrane Database Syst Rev. 2012 Jan 18;1:CD009046. doi: 10.1002/14651858.CD009046.pub2.
PMID: 22258998
responsible party type: Principal Investigator
investigator affiliation: The Queen Elizabeth Hospital
investigator full name: Kristin Carson
investigator title: Senior Scientist
mesh term: Tobacco Use Disorder
sharing ipd: Yes
ipd description: Available on request