Design: Nested feasibility study within a larger intervention trial – The Indigenous Counselling and Nicotine (ICAN) Quit in Pregnancy.(13-15) The ICAN Quit in Pregnancy trial aimed to test the feasibility of an intervention to improve HPs smoking cessation care with pregnant Aboriginal and Torres Strait Islander women who smoke in partnership with Aboriginal Medical Services.[13-15] As part of the ICAN Quit in Pregnancy trial, both HPs and pregnant women were recruited and followed (November 2016 to September 2017). HPs were asked to complete a pre and post intervention survey. Pregnant women were asked to complete surveys and undergo breath carbon monoxide measurements (for smoking status biochemical validation) at baseline, 4-week and 12-week follow-up visits. A full description of the ICAN Quit in Pregnancy trial methodology and results has been previously published, including adherence to the CONSORT guidelines. (13-15)
Aboriginal Advisory Panel: The ICAN Quit in Pregnancy trial was developed collaboratively with two Aboriginal Medical Services.(16) A Stakeholder and Consumer Aboriginal Advisory Panel guided the development and implementation of this study to ensure Aboriginal community ownership and cultural sensitivity; At least one member from each Aboriginal Medical Service was invited to participate on this panel.[16] Full details can be found elsewhere.[13, 14] The Aboriginal Advisory Panel also guided the development of the nested study.
Setting: Six Aboriginal Medical Services – one urban and five regional - in three Australian states (New South Wales, Queensland and South Australia).
Procedure: HPs and pregnant women recruited to the ICAN Quit in Pregnancy trial were asked, as part of the consent process, to agree or decline an additional option of audio-recording the part of their consultations relating to smoking cessation. Defining the audio-recording as an additional option was deemed necessary and more appropriate by the Stakeholder and Consumer Aboriginal Advisory Panel as it was felt that audio-recordings might be perceived as more intrusive by Aboriginal women and might deter them from consenting to the ICAN Quit in Pregnancy trial. A staff member from each service was trained as a research facilitator, and provided with two audio-recorders. Taking into consideration that pregnant women discuss multiple pregnancy and non-pregnancy related issues during their visits to the Aboriginal Medical Service, the Stakeholder and Consumer Aboriginal Advisory Panel found it to be unacceptable to record the entire session in order to extract only the smoking related counselling.
Therefore, staff were instructed to record only the content regarding smoking during any visit of the recruited pregnant woman, if both HP and the woman had consented to recordings. This was done to encourage pregnant women’s consent to the recording and protect privacy for other issues. All content was de-identified regarding to the women and HPs. Research facilitators were requested to record a mix of initial and follow-up consultations (ie, pre-quit attempt, and post-quit attempt up to the 4-week visit) with at least three pregnant women (expected recruitment for the ICAN Quit in Pregnancy trial was 10 eligible consenting women per service)[13], for a total of nine audio-recordings per service.
Participants: HPs were eligible if they consulted with pregnant women either for pregnancy confirmation, antenatal care and/or routine care. Pregnant women were eligible if they were ≤ 28 weeks gestation; Aboriginal and/or Torres Strait Islander or expectant mothers of Aboriginal and/or Torres Strait Islander babies; aged ≥16 years old; and smoked tobacco at any level of consumption. Participating women received up to $60 AUD as reimbursement for their time for ICAN QUIT in Pregnancy trial related visits; Women or HPs did not receive additional reimbursement for audio-recording consultations.
Qualitative Interviews: At the end of the ICAN Quit in Pregnancy trial, semi-structured interviews were conducted with staff from the services (including managers, research facilitator and HPs) to assess the acceptability of the study and intervention. No direct questions regarding feasibility and acceptability of audio-recording smoking cessation related consultations were included; However, a general question was included regarding what study procedures worked well and/or what were the more challenging aspects.
Analysis:
Feasibility measures: were collected by the research facilitator, including proportion consenting to audio-recording; number of recordings performed, profession of HP (general practitioner/midwife/nurse/Aboriginal Health Worker) performing the consultation, and date (pre/post intervention).
Qualitative interviews
Interviews at the end of the ICAN Quit in Pregnancy trial were audio-recorded and transcribed. Data relevant to the feasibility and acceptability of audio-recording smoking cessation related consultations was extracted.
Behaviour change techniques: Recordings were transcribed by a professional service and coded independently by two certified BCTs coders (YBZ and ES). Patients’ responses to the HP were not coded. Coding was based on the Michie et al 2010 taxonomy of smoking cessation BCTs v1.[7, 10] Initial inter-rater agreement levels (% positive agreement) was 48% (calculated by identifying the proportion of all BCTs within a transcript that were recognized by both coders). Discrepancies were resolved through discussion, until agreement reached 100%.
Ethics
The study was approved by the following ethics committees: 1) University of Newcastle Human Research Ethics Committee (HREC) (Reference H-2015-0438); 2) Aboriginal Health & Medical Research Council HREC (Reference #1140/15); 3) South Australia Aboriginal Health HREC (Reference #04-16-652); and 4) Far North Queensland HREC (Reference #16/QCH/34 – 1040). All participants provided and signed an informed consent to participating in the study.