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The Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy Pilot Study protocol: a feasibility step-wedge cluster randomised trial to improve health providers' management of smoking during pregnancy
  1. Yael Bar-Zeev1,
  2. Billie Bonevski1,
  3. Michelle Bovill1,
  4. Maree Gruppetta1,
  5. Chris Oldmeadow2,
  6. Kerrin Palazzi2,
  7. Lou Atkins3,
  8. Jennifer Reath4,
  9. Gillian S Gould1
  10. ICAN QUIT in Pregnancy Pilot Group
  1. 1 The University of Newcastle, Newcastle, New South Wales, Australia
  2. 2 Hunter Medical Research Institute, Newcastle, New South Wales, Australia
  3. 3 Centre for Behaviour Change, University College London, London, UK
  4. 4 Western Sydney University, Penrith, New South Wales, Australia
  1. Correspondence to Dr Yael Bar-Zeev; yael.barzeev{at}uon.edu.au

Abstract

Introduction Indigenous women have the highest smoking prevalence during pregnancy (47%) in Australia. Health professionals report lack of knowledge, skills and confidence to effectively manage smoking among pregnant women in general. We developed a behaviour change intervention aimed to improve health professionals’ management of smoking in Indigenous pregnant women—the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy. This intervention includes webinar training for health professionals, an educational resources package for health professionals and pregnant women, free oral nicotine replacement therapy (NRT) for pregnant women, and audit and feedback on health professionals' performance.

The aim of this study is to test the feasibility and acceptability of the ICAN QUIT in Pregnancy intervention to improve health professionals' provision of evidence-based culturally responsive smoking cessation care to Australian Indigenous pregnant smokers.

Methods and analysis This protocol describes the design of a step-wedge cluster randomised pilot study. Six Aboriginal Medical Services (AMSs) are randomised into three clusters. Clusters receive the intervention staggered by 1 month. Health professionals report on their knowledge and skills pretraining and post-training and at the end of the study. Pregnant women are recruited and followed up for 3 months. The primary outcome is the recruitment rate of pregnant women. Secondary outcomes include feasibility of recruitment and follow-up of participating women, and webinar training of health professionals, measured using a designated log; and measures of effectiveness outcomes, including quit rates and NRT prescription rates.

Ethics and dissemination In accordance with the Aboriginal Health and Medical Research Council guidelines, this study has been developed in collaboration with a Stakeholder and Consumer Aboriginal Advisory Panel (SCAAP). The SCAAP provides cultural consultation, advice and direction to ensure that implementation is acceptable and respectful to the Aboriginal communities involved. Results will be disseminated to AMSs, Aboriginal communities and national Aboriginal bodies.

Registration details This protocol (version 4, 14 October 2016) is registered with the Australian and New Zealand Clinical Trials Registry (Ref #: ACTRN 12616001603404).

  • step wedge randomized controlled trial
  • smoking cessation
  • indigenous
  • pregnancy

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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Footnotes

  • Contributors YBZ wrote the manuscript and contributed to the design of the study. GG contributed to writing the manuscript, and designed and oversees the study. CO and KP advised on the study design, and statistical analysis. MB contributed to the design of the study and with MG advised on Aboriginal community consultations and adherence to ethical guidelines to research with Aboriginal communities. BB and JR advised on methodology and implementation of the research. LA advised on the design of the intervention using the Theoretical Domains Framework and Behavior Change Wheel. All authors critically reviewed the manuscript.

  • Competing interests None declared.

  • Patient consent Obtained.

  • Ethics approval University of Newcastle Human Research Ethics Committee (HREC) (REF #H-2015-0438). Aboriginal Health & Medical Research Council (AH&MRC) HREC (REF #1140/15). South Australia Aboriginal HREC (REF #04-16-652. Far North Queensland HREC (REF #16/QCH/34 – 1040). Note: The interviews at the end of the study were not included in the original ethics application and have recently been submitted as an amendment

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement This is a protocol manuscript therefore there is no additional unpublished data currently from this study.

  • Collaborators Complete list of authors of the ICAN QUIT in Pregnancy pilot group is detailed in the acknowledgements.

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