Smoking Cessation Messages for Pregnant Aboriginal and Torres Strait Islander Women: A Rapid Review of Peer-Reviewed Literature and Assessment of Research Translation of Media Content.

This review summarized literature about knowledge, attitudes, and beliefs of Aboriginal and Torres Strait Islander women from Australia who smoke during pregnancy, then examined the extent that existing health promotion materials and media messages aligned with evidence on smoking cessation for pregnant Aboriginal and Torres Strait Islander women. Knowledge, attitudes, and beliefs of pregnant Aboriginal women who smoke tobacco were identified in the literature. Health promotion campaigns were retrieved from a grey literature search with keywords and social and professional networks. Key themes from peer-reviewed papers were compared against the content of health promotion campaigns using the Aboriginal Social and Emotional Wellbeing Model, the Behavior Change Wheel and thematic analysis. Eleven empirical studies and 17 campaigns were included. Empirical studies highlighted women sought holistic care that incorporated nicotine replacement therapy, engaged with their family and community and the potential for education about smoking cessation to empower a woman. Health promotion campaigns had a strong focus on 'engagement with family and community', 'knowledge of risks of smoking,' 'giving up vs cutting down' and 'culture in language and arts'. There were similarities and variances in the key themes in the research evidence and promotion materials. Topics highly aligned included risks from smoking and quitting related issues.

Ngaa-bi-nya-nhumi-nya (to Test First): Piloting the Feasibility of Using the Growth and Empowerment Measure with Aboriginal Pregnant Women Who Smoke.

INTRODUCTION: Aboriginal pregnant women who smoke experience barriers to quitting, including challenges to social and emotional well-being, but these are infrequently quantified. Finding an appropriate measurement tool in this setting is crucial to increase knowledge for holistic smoking cessation interventions. AIMS: To pilot the Growth and Empowerment Measure (GEM) with a sample of pregnant Aboriginal women who smoke. METHODS: Aboriginal women participating in the step-wedge ICAN QUIT in Pregnancy pilot study completed the GEM comprised of 14-item Emotional Empowerment Scale (EES14), 12 Scenarios (12S), and K6 items at baseline, 4 weeks, and 12 weeks. Qualitative interviews with service staff were held at the end of the study to assess feasibility. RESULTS: 15 pregnant Aboriginal women took part between November 2016 and July 2017. At 12 weeks, n = 8/12 (67%) of women reported an increase in both the EES14 and 12S scores. Total 12S scores were significantly higher at 12 weeks (p = 0.0186). Total K6 had a nonsignificant trend for reduction (p = 0.0547). Staff reported that the length of the survey presents challenges in this setting. CONCLUSIONS: A shortened, modified GEM is recommended in this setting. We recommend the GEM to be tested in a larger study, powered to assess its associations with smoking behaviours.

Feasibility of Audio-Recording Consultations with Pregnant Australian Indigenous Women to Assess Use of Smoking Cessation Behaviour Change Techniques.

INTRODUCTION: Behavioural counselling is an effective method to improve smoking cessation during pregnancy. Audio recordings of consultations have been used previously to assess fidelity in specialized smoking cessation services, but not in primary care. AIMS: The study is aimed at assessing the feasibility of audio-recording smoking cessation counselling as part of an intervention in primary care settings and exploring the number and type of behaviour change techniques (BCTs) delivered. METHODS: This study was a nested feasibility study within a larger trial. Health providers (HPs) and pregnant women were asked to agree or decline audio recording their smoking-related consultations. Data collected included percentage providing consent, number of recordings performed, HP type, and date (pre/post intervention). Interviews were conducted to assess the trial procedures' acceptability. RESULTS: Two services provided seven recordings, all pre-intervention. Of the 22 recruited women, 14 consented to being audio recorded (64%) and five provided recordings; of the 23 recruited HPs, 16 agreed (69%), and two provided recordings. Qualitative data suggest that HPs found audio recording difficult to remember. HPs spent on average two minutes discussing smoking and used few BCTs. CONCLUSIONS: Audio recordings of smoking-related counselling were not feasible as planned. Future research will need to explore acceptable methods to assess BCT use in primary care.

The effectiveness of technology-based interventions for smoking cessation: An umbrella review and quality assessment of systematic reviews.

ISSUES: With the advancement and rapid increase in the public's interest in utilisation of Internet and mobile phones, technology-based interventions are being implemented across a range of health conditions to improve patient outcomes. The aim of this review was to summarise findings from systematic reviews that evaluated the effectiveness of technology-based smoking cessation interventions and to critically appraise their methodological qualities. APPROACH: An umbrella review was conducted using studies identified from a comprehensive literature search of six databases and grey literature. All included systematic reviews were checked for eligibility criteria and quality using the Assessment of Multiple Systematic Reviews tool. The level of evidence for each intervention category was assessed, citation matrices were generated and corrected covered area was calculated. KEY FINDINGS: Five systematic reviews with a total of 212 randomised controlled trials and 237 760 participants were included. Fourteen intervention approaches were identified and classified into three categories: stand-alone web-based; stand-alone mobile phone-based and multicomponent interventions. Incorporating web and/or mobile-based interventions with face-to-face approach improved the rate of smoking cessation. However, there was no consistent evidence regarding the effectiveness of stand-alone Internet or mobile-based interventions. IMPLICATIONS: Policymakers are recommended to develop strategies that enable health professionals to integrate these approaches with face-to-face smoking cessation support. Health professionals are recommended to be trained and equipped for online and mobile-based interventions. CONCLUSION: Adding technology-based intervention to face-to-face smoking cessation support improves smoking cessation. Further research is needed to evaluate stand-alone web-based and mobile phone-based interventions.

Evaluating level of adherence to nicotine replacement therapy and its impact on smoking cessation: a systematic review and meta-analysis.

BACKGROUND: Nicotine replacement therapy (NRT) has proven effect in assisting smoking cessation. However, its effectiveness varies across studies and population groups. This may be due to differences in the rate of adherence. Hence, this review aims to examine the level of adherence to NRT and to assess if the level of adherence to NRT affects success of smoking cessation. METHODS: A systematic review and meta-analysis was conducted using studies retrieved from five electronic databases (MEDLINE, Scopus, EMBASE, Web of science, and PsycINFO) and grey literature. Pooled analysis was conducted using Stata version 16 software. Methodological quality and risk of bias were assessed using the NIH Quality Assessment Tool. Analyses were done among those studies that used similar measurements to assess level of adherence and successful smoking cessation. Heterogeneity of studies was assessed using the Higgins' I2 statistical test. Funnel plots and Egger's regression asymmetry test were used to affirm presence of significant publication bias. RESULTS: A total of 7521 adult participants of 18 years old and above from 16 studies were included in the analysis. Level of adherence to NRT among participants of randomised controlled trials were found to be 61% (95% CI, 54-68%), p-value of < 0.001 and I2 = 85.5%. Whereas 26% of participants were adherent among participants of population-based studies with 95% CI, 20-32%, p-value of < 0.001 and I2 = 94.5%. Level of adherence was the lowest among pregnant women (22%) with 95% CI, 18-25%, p-value of 0.31 and I2 = 15.8%. Being adherent to NRT doubles the rate of successful quitting (OR = 2.17, 95% CI, 1.34-3.51), p-value of < 0.001 and I2 = 77.6%. CONCLUSIONS: This review highlights a low level of adherence to NRT among participants of population-based studies and pregnant women as compared to clinical trials. Moreover, the review illustrated a strong association between adherence and successful smoking cessation. Hence, it is recommended to implement and assess large scale interventions to improve adherence. Health programs and policies are recommended to integrate the issue of adherence to NRT as a core component of smoking cessation interventions. TRIAL REGISTRATION: PROSPERO registration number: CRD42020176749 . Registered on 28 April 2020.

Building an Indigenous-Led Evidence Base for Smoking Cessation Care among Aboriginal and Torres Strait Islander Women during Pregnancy and Beyond: Research Protocol for the Which Way? Project.

Strong and healthy futures for Aboriginal and Torres Strait Islander people requires engagement in meaningful decision making which is supported by evidence-based approaches. While a significant number of research publications state the research is co-designed, few describe the research process in relation to Indigenous ethical values. Improving the health and wellbeing of Aboriginal and Torres Strait Islander mothers and babies is crucial to the continuation of the oldest living culture in the world. Developing meaningful supports to empower Aboriginal and Torres Strait Islander mothers to quit smoking during pregnancy is paramount to addressing a range of health and wellbeing outcomes. Aboriginal and Torres Strait Islander women have called for non-pharmacological approaches to smoking cessation during pregnancy. We describe a culturally responsive research protocol that has been co-designed and is co-owned with urban and regional Aboriginal communities in New South Wales. The project has been developed in line with the AH&MRC's (Aboriginal Health & Medical Research Council) updated guidelines for ethical research with Aboriginal and Torres Strait Islander communities. Ethics approvals have been granted by AH&MRC #14541662 University of Newcastle HREC H-2020-0092 and the Local Health District ethics committee 2020/ETH02095. Results will be disseminated through peer reviewed articles, community reports, infographics, and online social media content.

Socioecological Mapping of Barriers and Enablers to Smoking Cessation in Indigenous Australian Women During Pregnancy and Postpartum: A Systematic Review.

BACKGROUND: With a high prevalence of smoking during pregnancy and limited Indigenous-specific evidence for treatment, we used socioecological mapping to identify multilevel barriers and enablers to smoking cessation related to Indigenous Australian pregnant and postpartum women. METHODS: Nine electronic databases were searched. Original studies except interventions and trials, published in English, up to February 29, 2020 were included. Studies were appraised using the QualSyst tool. Evidence was narratively synthesized. The review protocol was registered with PROSPERO (CRD42019135543). RESULTS: A total of 15 studies (10 quantitative, 5 qualitative) were included, covering 1306 women, 3 partners/family members, 234 health professionals (HP), and 2755 patient records. Complex and overlapping barriers were identified at individual, family, community, societal, and system levels. Socioeconomic disadvantages, inequality, and pervasive racism as legacies of colonization, combined with personal, family, and community circumstances intensified individual experiences of stress, which may be heightened during pregnancy. Inadequate smoking cessation care (SCC), inconsistent antitobacco messages, and ineffectual HP interventions underscore a need for service enhancement and further evidence to develop culturally relevant messages. High motivation of pregnant women to quit, resilience, and supports available in the family and community are strengths that warrant attention in future interventions. CONCLUSIONS: SCC without ameliorating the social disadvantages and the disparities in health determinants between Indigenous and non-Indigenous Australian women may limit the effectiveness of SCC. A comprehensive approach is required that includes policy changes for addressing external stressors the women experience, engagement of family and community, and better training of HP and provision of free pharmacotherapy. IMPLICATIONS: To systematically address barriers to smoking cessation at multiple levels, initiatives to ameliorate social disadvantages and discrepancies in social determinants of health between Indigenous and non-Indigenous Australians are required to be taken in tandem with SCC. Initiatives may include making relevant policy changes and allocating more resources for education, employment, housing, and community development. Enhancement of knowledge, skills, and confidence of HP regarding the provision of high-quality SCC for Indigenous women and their families is warranted. Future interventions may build on high motivation, resilience, and strengths of individual women, and incorporate support strategies engaging family and community.

Barriers and Facilitators of Adherence to Nicotine Replacement Therapy: A Systematic Review and Analysis Using the Capability, Opportunity, Motivation, and Behaviour (COM-B) Model.

BACKGROUND: Poor adherence to nicotine replacement therapy (NRT) is associated with low rates of smoking cessation. Hence, this study aims to identify and map patient-related factors associated with adherence to NRT using the capability, opportunity, motivation, and behaviour (COM-B) model. METHODS: A systematic review was conducted by searching five databases (MEDLINE, Scopus, EMBASE, CINAHL, and PsycINFO) and grey literature on 30 August 2020. Data were extracted, thematically analysed, and mapped to the COM-B model. The Joanna Briggs Institute (JBI) critical appraisal tool was utilised to assess the quality of studies. RESULTS: A total of 2929 citations were screened, and 26 articles with a total of 13,429 participants included. Thirty-one factors were identified and mapped to COM-B model: psychological capability (forgetfulness, education), physical capability (level of nicotine dependence, withdrawal symptoms), reflective motivation (perception about NRT and quitting), automatic motivation (alcohol use, stress, depression), physical opportunity (cost), and social opportunity (social support). The most prominent element associated with adherence was reflective motivation followed by physical capability and automatic motivation. CONCLUSIONS: Multiple personal, social, and environmental factors affect NRT adherence. Hence, it is recommended to implement a multifaceted behavioural intervention incorporating factors categorised under the COM-B model, which is the hub of the behaviour change wheel (BCW) to improve adherence and quitting.

Evaluating level of adherence to nicotine replacement therapy and its impact on smoking cessation: a protocol for systematic review and meta-analysis.

INTRODUCTION: Nicotine replacement therapy (NRT) has proven effective for smoking cessation in clinical trials, however it was found less effective in population-based studies, potentially due to inconsistent or incorrect use of NRT. The aim of this paper is to describe a systematic review protocol to evaluate level of adherence to NRT; the discrepancy of adherence to NRT in clinical and population-based studies and degree of association between level of adherence and success of smoking cessation. METHODS AND ANALYSIS: Literature search will use five databases (Medline, Scopus, Embase, CINAHL and PsycINFO). Studies will be appraised for methodological quality using National Institutes of Health Quality Assessment Tool. To reduce heterogeneity, we will analyse clinical trials and population-based studies separately; pooled analyses will be done among studies that used similar measurements. Heterogeneity of studies will be assessed by Higgins' I2 statistical test. When studies are adequately homogeneous, results will be pooled using random-effects model with proportion and ORs with 95% CIs and p values for each outcome. We will explain sources of heterogeneity by subgroup analysis or sensitivity analysis. Funnel plots and Egger's regression asymmetry test with p<0.05 will be used as a cut-off point to affirm presence of statistically significant publication bias. Statistical analyses will be carried out using Stata V.16 software. Only studies reporting a valid strategy to control for reverse causality will be included. DISCUSSION: This review will provide evidence to support the importance of adherence on rate of smoking cessation and level of adherence to NRT. The findings will be used to inform smoking cessation interventions, researchers and policymakers. ETHICS AND DISSEMINATION: As a systematic literature review, this protocol does not require ethics approval. Research outcomes will be presented at relevant conferences and findings will be published in a relevant peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42020176749.

Aboriginal Wingadhan Birrang (woman's journey) of smoking cessation during pregnancy as they participate in the ICAN QUIT in pregnancy pilot step-wedge trial.

BACKGROUND: Addressing smoking cessation during pregnancy among Aboriginal women is a national priority under the Closing the Gap campaign. There is a need to measure and report interventions to support Aboriginal women during pregnancy. AIM: To quantitatively assess women's smoking experiences over a 12 week ICAN QUIT in Pregnancy program. METHODS: Aboriginal women and/or women expecting an Aboriginal baby reported their smoking experiences through repeated cross-sectional survey at baseline, four weeks, and 12 weeks. Self-reported nicotine dependence measures (heaviness of smoking index, strength of urges and frequency of urges to smoke), intentions to quit smoking, quit attempts, use of nicotine replacement therapy were gathered as well as a carbon-monoxide measure at each time point. RESULTS: Expectant mothers (n=22) of Aboriginal babies participated from six Aboriginal Community Controlled Health Services between November 2016 and July 2017. At 12 weeks women reported (n=17) low heaviness of smoking index 1.21 with high strength of urges 2.64 and frequency of urges 3.00; 12/13 (92%) reported likely/very likely to quit smoking, made a mean 1.67 number of quit attempts, three women (13.6%) quit smoking (validated); 5/16 (31%) reported using nicotine replacement therapy. DISCUSSION: Participating women made multiple quit attempts demonstrating motivation to quit smoking. Smoking cessation interventions should be tailored to address high strength and frequency of nicotine dependence despite low consumption. CONCLUSION: Prolonged smoking cessation support is recommended to address physical, behavioural and psychological aspect of smoking. Cessation support should address previous quitting experiences to assess smoking dependence and tailoring of support. TRIAL REGISTRATION: Australian and New Zealand Clinicial Trials Registry (Ref #ACTRN12616001603404).

Ngu-ng-gi-la-nha (to exchange) knowledge. How is Aboriginal and Torres Strait Islander people's empowerment being upheld and reported in smoking cessation interventions during pregnancy: a systematic review.

Smoking during pregnancy is a national priority to improve Aboriginal health. Empowerment approaches underpin the priorities set by the government to improve Aboriginal health and wellbeing; however, empowerment is seldom evaluated within interventions for Aboriginal people. Literature was searched to April 2018 and data was extracted using an assessment tool with domains of individual and community empowerment in smoking cessation during pregnancy studies with Aboriginal women. Three interventions were found in published and grey literature. Elements of individual empowerment were embedded in all interventions. Interventions considered barriers for Aboriginal women to quit smoking and areas for capacity building. Interventions used health education resources. There was limited reporting of community empowerment domains. Aboriginal ethics and capacity building was the only criterium addressed by all studies. Interventions are incorporating individual empowerment, but seldom report community empowerment. The development of reporting guidelines or extensions of current guidelines would be beneficial to set a consistently high standard reporting across Aboriginal health interventions, similar to the work conducted to develop the extension of Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Equity (PRISMA-E) for health equity in systematic review reporting. Reporting empowerment domains would reflect the government priority of empowerment to improve Aboriginal health, as well as enhancing knowledge translation into practice.

Improving smoking cessation care in pregnancy at Aboriginal Medical Services: 'ICAN QUIT in Pregnancy' step-wedge cluster randomised study.

OBJECTIVES: This study aimed to examine the impact of the 'ICAN QUIT in Pregnancy' intervention on individual health providers (HPs) smoking cessation care (SCC) knowledge, attitudes and practices in general, and specifically regarding nicotine replacement therapy (NRT) prescription. DESIGN: Step-wedge clustered randomised controlled study. HPs answered a preintervention and 1-6 months postintervention survey. SETTING: Six Aboriginal Medical Services (AMSs) in three states of Australia. PARTICIPANTS: All HPs were invited to participate. Of 93 eligible, 50 consented (54%), 45 completed the presurvey (90%) and 20 the post (40%). INTERVENTION: Included three 1-hour webinar sessions, educational resource package and free oral NRT. OUTCOMES: HPs knowledge was measured using two composite scores-one from all 24 true/false statements, and one from 12 NRT-specific statements. Self-assessment of 22 attitudes to providing SCC were measured using a five-point Likert scale (Strongly disagree to Strongly agree). Two composite mean scores were calculated-one for 15 general SCC attitudes, and one for 7 NRT-specific attitudes. Self-reported provision of SCC components was measured on a five-point Likert scale (Never to Always). Feasibility outcomes, and data collected on the service and patient level are reported elsewhere. RESULTS: Mean knowledge composite scores improved from pre to post (78% vs 84% correct, difference 5.95, 95% CI 1.57 to 10.32). Mean NRT-specific knowledge composite score also improved (68% vs 79% correct, difference 9.9, 95% CI 3.66 to 16.14). Mean attitude composite score improved (3.65 (SD 0.4) to 3.87 (SD 0.4), difference 0.23, 95% CI 0.05 to 0.41). Mean NRT-specific attitudes composite score also improved (3.37 (SD 0.6) to 3.64 (SD 0.7), difference 0.36, 95% CI 0.13 to 0.6). Self-reported practices were unchanged, including prescribing NRT. CONCLUSIONS: A multicomponent culturally sensitive intervention in AMSs was feasible, and might improve HPs provision of SCC to pregnant Aboriginal women. Changes in NRT prescription rates may require additional intensive measures. TRIAL REGISTRATION NUMBER: ACTRN 12616001603404; Results.

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.

"Building strength in coming together": A mixed methods study using the arts to explore smoking with staff working in Indigenous tobacco control.

ISSUE ADDRESSED: Tobacco is a major risk factor contributing to Indigenous health disparities. Art may be a powerful and transformative tool to enable health providers to develop targeted messages for tobacco control. METHODS: Indigenous and non-Indigenous staff, working in Indigenous tobacco control, attended a 2-hour workshop, and were led through a process to create individual artworks. Participants completed surveys before and after the workshop. Scales compared understandings of how art can be used in tobacco control, and the likelihood of utilising arts in future programs. Three pairs of Indigenous and non-Indigenous researchers analysed the artworks, using the Four Frames (New South Wales Board of Studies), explored themes, and developed a model. RESULTS: Nineteen participants completed both surveys; 17 artworks were analysed. Pre- to post-workshop increases in "understanding" about the use of arts (P < 0.00001) for tobacco control, and "likelihood" of use of arts in the next 6 months (P < 0.006) were significant. Participants expressed personal and professional benefits from the workshop. Artworks demonstrated themes of optimism, the strength of family and culture, smoking as a barrier, resilience, recovery and urgency. CONCLUSIONS: The workshop increased the understanding and likelihood of using the arts for tobacco control. Artworks revealed contemporary challenges impacting on equity; health staff expressed optimism for being engaged in their work. SO WHAT?: The Framework Convention for Tobacco Control supports novel techniques to increase the reach and relevance of health messages for diverse populations. This study successfully demonstrated how a novel, positively framed art-based technique proved to be advantageous for health professionals, working in an area of Indigenous tobacco control, where behavioural change can be complex.

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.

Designing an implementation intervention with the Behaviour Change Wheel for health provider smoking cessation care for Australian Indigenous pregnant women.

BACKGROUND: Indigenous smoking rates are up to 80% among pregnant women: prevalence among pregnant Australian Indigenous women was 45% in 2014, contributing significantly to the health gap for Indigenous Australians. We aimed to develop an implementation intervention to improve smoking cessation care (SCC) for pregnant Indigenous smokers, an outcome to be achieved by training health providers at Aboriginal Medical Services (AMS) in a culturally competent approach, developed collaboratively with AMS. METHOD: The Behaviour Change Wheel (BCW), incorporating the COM-B model (capability, opportunity and motivation for behavioural interventions), provided a framework for the development of the Indigenous Counselling and Nicotine (ICAN) QUIT in Pregnancy implementation intervention at provider and patient levels. We identified evidence-practice gaps through (i) systematic literature reviews, (ii) a national survey of clinicians and (iii) a qualitative study of smoking and quitting with Aboriginal mothers. We followed the three stages recommended in Michie et al.'s "Behaviour Change Wheel" guide. RESULTS: Targets identified for health provider behaviour change included the following: capability (psychological capability, knowledge and skills) by training clinicians in pharmacotherapy to assist women to quit; motivation (optimism) by presenting evidence of effectiveness, and positive testimonials from patients and clinicians; and opportunity (environmental context and resources) by promoting a whole-of-service approach and structuring consultations using a flipchart and prompts. Education and training were selected as the main intervention functions. For health providers, the delivery mode was webinar, to accommodate time and location constraints, bringing the training to the services; for patients, face-to-face consultations were supported by a booklet embedded with videos to improve patients' capability, opportunity and motivation. CONCLUSIONS: The ICAN QUIT in Pregnancy was an intervention to train health providers at Aboriginal Medical Services in how to implement culturally competent evidence-based practice including counselling and nicotine replacement therapy for pregnant patients who smoke. The BCW aided in scientifically and systematically informing this targeted implementation intervention based on the identified gaps in SCC by health providers. Multiple factors impact at systemic, provider, community and individual levels. This process was therefore important for defining the design and intervention components, prior to a conducting a pilot feasibility trial, then leading on to a full clinical trial.

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).