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.

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

Feasibility and acceptability of Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy multicomponent implementation intervention and study design for Australian Indigenous pregnant women: A pilot cluster randomised step-wedge trial

BACKGROUND: Many health providers (HPs) lack knowledge, confidence, optimism and skills in addressing smoking with pregnant women. This study aimed to explore the feasibility and acceptability of a) a co-designed multi-component intervention for HPs at Aboriginal Medical Services (AMSs) in culturally-targeted pregnancy-specific smoking cessation care and b) the study design. METHODS: Using a randomised step-wedge cluster design, the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy Trial was evaluated across six AMSs in three Australian states. HPs were provided educational resource packages including live interactive webinars, treatment manuals, patient resources, carbon monoxide (CO) meters, and oral Nicotine Replacement Therapy (NRT). Feasibility was assessed through recruitment and retention rates of both pregnant women (12-weeks) and HPs (end of study) as well as the potential to improve women's quit rates. Qualitative interviews with staff post-trial explored acceptability of the intervention and study, based on capability, opportunity and motivation from the Behaviour Change Wheel. RESULTS: Pregnant women (n = 22; 47% (95% CI: 32%, 63%) eligible) and HPs (n = 50; 54% (95% CI: 44%, 64%) eligible) were recruited over 6 months with retention rates of 77% (95% CI: 57%, 90%) and 40% (95% CI: 28%, 54%) respectively. Self-reported 12-week 7-day point-prevalence abstinence was 13.6% (n = 3) and validated abstinent with CO readings ≤6 ppm. Staff interviewed regarding intervention implementation highlighted the importance of provision and use of resources, including training materials, patient resources, CO meters and oral NRT. Resources helped increase capability and opportunity, restructure the environment, and provided social comparison and modelling. Staff were motivated by greater engagement with pregnant women and seeing the women's reductions in CO readings. Having the intervention at the AMSs improved organisational capacity to engage with pregnant women. Staff reported changes to their routine practice that were potentially sustainable. Recommendations for improvement to the implementation of the intervention and research included reducing training length and the tasks related to conducting the study. CONCLUSION: ICAN QUIT in Pregnancy was a pilot study with the ability to enrol Indigenous women. It was feasible to implement and acceptable to most staff of the AMSs in three states, with modifications recommended. Smoking in pregnancy is a key challenge for Indigenous health. The intervention needs to be evaluated through a methodologically rigorous fully-powered study to determine the efficacy of outcomes for women. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12616001603404. Registered 21 November 2016 - retrospectively registered, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371778

Feasibility and acceptability of Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy multicomponent implementation intervention and study design for Australian Indigenous pregnant women: a pilot cluster randomised step-wedge trial

BACKGROUND: Many health providers (HPs) lack knowledge, confidence, optimism and skills in addressing smoking with pregnant women. This study aimed to explore the feasibility and acceptability of a) a co-designed multi-component intervention for HPs at Aboriginal Medical Services (AMSs) in culturally-targeted pregnancy-specific smoking cessation care and b) the study design. METHODS: Using a randomised step-wedge cluster design, the Indigenous Counselling And Nicotine (ICAN) QUIT in Pregnancy Trial was evaluated across six AMSs in three Australian states. HPs were provided educational resource packages including live interactive webinars, treatment manuals, patient resources, carbon monoxide (CO) meters, and oral Nicotine Replacement Therapy (NRT). Feasibility was assessed through recruitment and retention rates of both pregnant women (12-weeks) and HPs (end of study) as well as the potential to improve women's quit rates. Qualitative interviews with staff post-trial explored acceptability of the intervention and study, based on capability, opportunity and motivation from the Behaviour Change Wheel. RESULTS: Pregnant women (n = 22; 47% (95% CI: 32%, 63%) eligible) and HPs (n = 50; 54% (95% CI: 44%, 64%) eligible) were recruited over 6 months with retention rates of 77% (95% CI: 57%, 90%) and 40% (95% CI: 28%, 54%) respectively. Self-reported 12-week 7-day point-prevalence abstinence was 13.6% (n = 3) and validated abstinent with CO readings ≤6 ppm. Staff interviewed regarding intervention implementation highlighted the importance of provision and use of resources, including training materials, patient resources, CO meters and oral NRT. Resources helped increase capability and opportunity, restructure the environment, and provided social comparison and modelling. Staff were motivated by greater engagement with pregnant women and seeing the women's reductions in CO readings. Having the intervention at the AMSs improved organisational capacity to engage with pregnant women. Staff reported changes to their routine practice that were potentially sustainable. Recommendations for improvement to the implementation of the intervention and research included reducing training length and the tasks related to conducting the study. CONCLUSION: ICAN QUIT in Pregnancy was a pilot study with the ability to enrol Indigenous women. It was feasible to implement and acceptable to most staff of the AMSs in three states, with modifications recommended. Smoking in pregnancy is a key challenge for Indigenous health. The intervention needs to be evaluated through a methodologically rigorous fully-powered study to determine the efficacy of outcomes for women. TRIAL REGISTRATION:Australian and New Zealand Clinical Trials Registry, ACTRN12616001603404. Registered 21 November 2016 - retrospectively registered, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371778.Gillian S.Gould, Michelle Bovill, Lauren Pollock, Billie Bonevski, Maree Gruppetta, Lou Atkins, Kristin Carson-Chahhoud, Katherine M.Boydell, Gabrielle R.Gribbin, Chris Oldmeadow, Alix Hall, I CAN QUIT in Pregnancy Pilot Group, Yael Bar-Zeev (Gillian S Gould ... Kristin Carson ... et al.

Assessing and Validating an Educational Resource Package for Health Professionals to Improve Smoking Cessation Care in Aboriginal and Torres Strait Islander Pregnant Women

Australian Aboriginal pregnant women have a high smoking prevalence (45%). Health professionals lack adequate educational resources to manage smoking. Resources need to be tailored to ensure saliency, cultural-sensitivity and account for diversity of Indigenous populations. As part of an intervention to improve health professionals’ smoking cessation care in Aboriginal pregnant women, a resource package was developed collaboratively with two Aboriginal Medical Services. The purpose of this study was to assess and validate this resource package. A multi-centred community-based participatory 4-step process (with three Aboriginal Medical Services from three Australian states), included: (1) Scientific review by an expert panel (2) ‘Suitability of Materials’ scoring by two Aboriginal Health Workers (3) Readability scores (4) Focus groups with health professionals. Content was analysed using six pre-determined themes (attraction, comprehension, self-efficacy, graphics and layout, cultural acceptability, and persuasion), with further inductive analysis for emerging themes. Suitability of Material scoring was adequate or superior. Average readability was grade 6.4 for patient resources (range 5.1–7.2), and 9.8 for health provider resources (range 8.5–10.6). Emergent themes included ‘Getting the message right’; ‘Engaging with family’; ‘Needing visual aids’; and ‘Requiring practicality under a tight timeframe’. Results were presented back to a Stakeholder and Consumer Aboriginal Advisory Panel and resources were adjusted accordingly. This process ensured materials used for the intervention were culturally responsive, evidence-based and useful. This novel formative evaluation protocol could be adapted for other Indigenous and culturally diverse interventions. The added value of this time-consuming and costly process is yet to be justified in research, and might impact the potential adaption by other projects

Assessing and validating an educational resource package for health professionals to improve smoking cessation care in Aboriginal and Torres Strait Islander pregnant women

Australian Aboriginal pregnant women have a high smoking prevalence (45%). Health professionals lack adequate educational resources to manage smoking. Resources need to be tailored to ensure saliency, cultural-sensitivity and account for diversity of Indigenous populations. As part of an intervention to improve health professionals’ smoking cessation care in Aboriginal pregnant women, a resource package was developed collaboratively with two Aboriginal Medical Services. The purpose of this study was to assess and validate this resource package. A multi-centred community-based participatory 4-step process (with three Aboriginal Medical Services from three Australian states), included: (1) Scientific review by an expert panel (2) ‘Suitability of Materials’ scoring by two Aboriginal Health Workers (3) Readability scores (4) Focus groups with health professionals. Content was analysed using six pre-determined themes (attraction, comprehension, self-efficacy, graphics and layout, cultural acceptability, and persuasion), with further inductive analysis for emerging themes. Suitability of Material scoring was adequate or superior. Average readability was grade 6.4 for patient resources (range 5.1-7.2), and 9.8 for health provider resources (range 8.5-10.6). Emergent themes included ‘Getting the message right’; ‘Engaging with family’; ‘Needing visual aids’; and ‘Requiring practicality under a tight timeframe’. Results were presented back to a Stakeholder and Consumer Aboriginal Advisory Panel and resources were adjusted accordingly. This process ensured materials used for the intervention were culturally responsive, evidence-based and useful. This novel formative evaluation protocol could be adapted for other Indigenous and culturally diverse interventions. The added value of this time-consuming and costly process is yet to be justified in research, and might impact the potential adaption by other projects

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

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 #: ACTRN12616001603404