Clinical trial NCT01735448: Improving Health for Aboriginal People Through Tobacco Related Research
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Dependence
Keywords: smoking cessation
tobacco
addiction
Aboriginal
youth
Indigenous
pharmacological
focus group
interview
Lead sponsor: The Queen Elizabeth Hospital
Sponsor class: OTHER
Collaborators: name: University of Adelaide
First posted: 2012-11-28
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who agree to be involved in the focus groups will be recruited via existing community contacts (e.g., Aboriginal elders, leaders of community groups and doctors who support the planned research) in urban Adelaide and regional Murray Bridge. We also intend on actively recruiting through clinic visits made by our visiting respiratory clinicians. Copies of the participant information sheet and consent form will be disseminated via local healthcare workers to seek focus group volunteers and via existing contacts in health and by word of mouth for one-on-one interview participants. Survey participants will be recruited as per above methods in addition to use of delegate lists and mail outs.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Male Smokers

* Willing to participate
* Identifies as an Aboriginal person
* Uses more than 10 cigarettes or cigarette equivalent per week
* Has lived in the relevant community for \>12 months

Female Smokers

* Willing to participate
* Identifies as an Aboriginal person
* Uses more than 10 cigarettes or cigarette equivalent per week
* Has lived in the relevant community for \>12 months

Male Non/Ex Smokers

* Willing to participate
* Identifies as an Aboriginal person
* Has not used tobacco for \>3 months
* Has lived in the relevant community for \>12 months

Female Non/Ex Smokers

* Willing to participate
* Identifies as an Aboriginal person
* Has not used tobacco for \>3 months
* Has lived in the relevant community for \>12 months

Healthcare worker

* Willing to participate
* Has provided healthcare to people from Aboriginal people for at least 25% of employment hours over the past 12 months, or
* Has provided healthcare to people from Aboriginal people for at least 5 years of their working career
* Is a qualified healthcare worker

GP's / Specialists

* Willing to participate
* Has provided clinical care to people from Aboriginal people over a 12 month period (at least one consult per week or equivalent)
* Is a qualified General Practitioner or,
* Is a qualified doctor specialising in one of the following disciplines: respiratory, vascular, neurology, oncology, cardiology

Key Stakeholders

* Willing to participate
* Currently working/has worked in Aboriginal health as a primary focus of the position, or
* Is a community Elder, or
* Is influential in Aboriginal health/communities

Exclusion Criteria:

* Cannot speak English
* Cannot sign a consent
* Does not have the intellectual capacity required to respond to questions

Primary outcomes:
measure: Determine the barriers and facilitators to pharmacological initiatives for tobacco cessation in Aboriginal populations
timeFrame: 18 months
Secondary outcomes:
measure: Determine the barriers and facilitators for tobacco prevention initiatives, particularly related to Aboriginal youth
timeFrame: 18 months
measure: Identify the barriers and facilitators for doctor visits by Aboriginal people
timeFrame: 18 months
measure: Identify barriers and facilitators to research initiatives in Aboriginal people and identify self-reported health priorities
timeFrame: 18 months
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: The Basil Hetzel Institute for Translational Health Research
state: South Australia
city: Adelaide
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Murray Bridge
country: Australia
facility: Murray Mallee Community Health Service; Aboriginal Primary Health Care Unit
state: South Australia
Study officials:
affiliation: University of Adelaide
name: Kristin V Carson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Queen Elizabeth Hospital
name: Brian J Smith, MBBS, PhD
role: STUDY_DIRECTOR
affiliation: University of South Australia
name: Adrian J Esterman, PhD,MSc,BSc
role: STUDY_DIRECTOR
affiliation: Concord Hospital
name: Matthew J Peters, MBBS, PhD
role: STUDY_DIRECTOR
References:
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: 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.