Protocol for the process evaluation of an intervention to improve antenatal smoking cessation support (MOHMQuit) in maternity services in New South Wales, Australia.

INTRODUCTION: Smoking cessation in pregnancy remains a public health priority. Our team used the Behaviour Change Wheel to develop the Midwives and Obstetricians Helping Mothers to Quit smoking (MOHMQuit) intervention with health system, leader (including managers and educators) and clinician components. MOHMQuit addresses a critical evidence to practice gap in the provision of smoking cessation support in antenatal care. It involves nine maternity services in New South Wales in a cluster randomised stepped-wedge controlled trial of effectiveness. This paper describes the design and rationale for the process evaluation of MOHMQuit. The process evaluation aims to assess to what extent and how MOHMQuit is being implemented (acceptability; adoption/uptake; appropriateness; feasibility; fidelity; penetration and sustainability), and the context in which it is implemented, in order to support further refinement of MOHMQuit throughout the trial, and aid understanding and interpretation of the results of the trial. METHODS AND ANALYSIS: The process evaluation is an integral part of the stepped-wedge trial. Its design is underpinned by implementation science frameworks and adopts a mixed methods approach. Quantitative evidence from participating leaders and clinicians in our study will be used to produce individual and site-level descriptive statistics. Qualitative evidence of leaders' perceptions about the implementation will be collected using semistructured interviews and will be analysed descriptively within-site and thematically across the dataset. The process evaluation will also use publicly available data and observations from the research team implementing MOHMQuit, for example, training logs. These data will be synthesised to provide site-level as well as individual-level implementation outcomes. ETHICS AND DISSEMINATION: The study received ethical approval from the Population Health Services Research Ethics Committee for NSW, Australia (Reference 2021/ETH00887). Results will be communicated via the study's steering committee and will also be published in peer-reviewed journals and presented at conferences. TRIAL REGISTRATION NUMBER: Australian New Zealand Trials Registry ACTRN12622000167763. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12622000167763.

The MOHMQuit (Midwives and Obstetricians Helping Mothers to Quit Smoking) Trial: protocol for a stepped-wedge implementation trial to improve best practice smoking cessation support in public antenatal care services.

BACKGROUND: Smoking during pregnancy is the most important preventable cause of adverse pregnancy outcomes, yet smoking cessation support (SCS) is inconsistently provided. The MOMHQUIT intervention was developed to address this evidence-practice gap, using the Behaviour Change Wheel method by mapping barriers to intervention strategies. MOHMQuit includes systems, leadership and clinician elements. This implementation trial will determine the effectiveness and cost-effectiveness of MOHMQuit in improving smoking cessation rates in pregnant women in public maternity care services in Australia; test the mechanisms of action of the intervention strategies; and examine implementation outcomes. METHODS: A stepped-wedge cluster-randomised design will be used. Implementation of MOHMQuit will include reinforcing leadership investment in SCS as a clinical priority, strengthening maternity care clinicians' knowledge, skills, confidence and attitudes towards the provision of SCS, and clinicians' documentation of guideline-recommended SCS provided during antenatal care. Approximately, 4000 women who report smoking during pregnancy will be recruited across nine sites. The intervention and its implementation will be evaluated using a mixed methods approach. The primary outcome will be 7-day point prevalence abstinence at the end of pregnancy, among pregnant smokers, verified by salivary cotinine testing. Continuous data collection from electronic medical records and telephone interviews with postpartum women will occur throughout 32 months of the trial to assess changes in cessation rates reported by women, and SCS documented by clinicians and reported by women. Data collection to assess changes in clinicians' knowledge, skills, confidence and attitudes will occur prior to and immediately after the intervention at each site, and again 6 months later. Questionnaires at 3 months following the intervention, and semi-structured interviews at 6 months with maternity service leaders will explore leaders' perceptions of acceptability, adoption, appropriateness, feasibility, adaptations and fidelity of delivery of the MOHMQuit intervention. Structural equation modelling will examine causal linkages between the strategies, mediators and outcomes. Cost-effectiveness analyses will also be undertaken. DISCUSSION: This study will provide evidence of the effectiveness of a multi-level implementation intervention to support policy decisions; and evidence regarding mechanisms of action of the intervention strategies (how the strategies effected outcomes) to support further theoretical developments in implementation science. TRIAL REGISTRATION: ACTRN12622000167763, registered February 2nd 2022.

Improving implementation of smoking cessation guidelines in pregnancy care: development of an intervention to address system, maternity service leader and clinician factors.

BACKGROUND: Smoking during pregnancy increases the risk of multiple serious adverse infant, child and maternal outcomes, yet nearly 10% of Australian women still smoke during pregnancy. Despite evidence-based guidelines that recommend routine and repeated smoking cessation support (SCS) for all pregnant women, the provision of recommended SCS remains poor. Guidance on developing complex interventions to improve health care recommends drawing on existing theories, reviewing evidence, undertaking primary data collection, attending to future real-world implementation and designing and refining interventions using iterative cycles with stakeholder input throughout. Here, we describe using the Behaviour Change Wheel (BCW) and the Theoretical Domains Framework to apply these principles in developing an intervention to improve the provision of SCS in Australian maternity services. METHODS: Working closely with key stakeholders in the New South Wales (NSW) health system, we applied the steps of the BCW method then undertook a small feasibility study in one service to further refine the intervention. Stakeholders were engaged in multiple ways-as a core research team member, through a project Advisory Group, targeted meetings with policymakers, a large workshop to review potential components and the feasibility study. RESULTS: Barriers to and enablers of providing SCS were identified in five of six components described in the BCW method (psychological capability, physical opportunity, social opportunity and reflective and automatic motivation). These were mapped to intervention types and we selected education, training, enablement, environmental restructuring, persuasion, incentivisation and modelling as suitable in our context. Through application of the APEASE criteria (Affordability, Practicability, Effectiveness, Acceptability, Side effects and Equity) in the stakeholder workshop, behaviour change techniques were selected and applied in developing the intervention which includes systems, clinician and leadership elements. The feasibility study confirmed the feasibility and acceptability of the midwifery component and the need to further strengthen the leadership component. CONCLUSIONS: Using the BCW method combined with strong stakeholder engagement from inception resulted in transparent development of the MOHMQuit intervention, which targets identified barriers to and enablers of the provision of SCS and is developed specifically for the context in which it will be implemented. The intervention is being trialled in eight public maternity services in NSW.

Improving Clinicians' Implementation of Guidelines to Help Women Stop Smoking in Pregnancy: Developing Evidence-Based Print and Video Materials.

Smoking in pregnancy remains a public health challenge. Our team developed a comprehensive intervention using the Behaviour Change Wheel to support clinicians' implementation of guidelines on supporting women to stop smoking in pregnancy. Integral to the intervention was a suite of evidence-based video and print materials. This paper describes the rationale and process for developing these materials. Comprehensive mixed methods research was undertaken to identify the key barriers and enablers for clinicians in implementing the guidelines. This research identified which behaviours required change, and which behaviour change techniques were best suited to effecting that change. Materials were developed based on this understanding, in a collaborative process with multiple stakeholders, and their feasibility and acceptability explored in a small trial. Materials developed included leadership, clinician and client resources. There are considerable advantages to systematically and collaboratively developing materials which are integral to a behaviour-change intervention even though it is resource intensive to do so.

Factors associated with provision of smoking cessation support to pregnant women - a cross-sectional survey of midwives in New South Wales, Australia.

BACKGROUND: Smoking is the most important preventable cause of adverse pregnancy outcomes, but provision of smoking cessation support (SCS) to pregnant women is poor. We examined the association between midwives' implementation of SCS (5As - Ask, Advise, Assess, Assist, Arrange follow-up) and reported barriers/enablers to implementation. METHODS: On-line anonymous survey of midwives providing antenatal care in New South Wales (NSW), Australia, assessing provision of the 5As and barriers/enablers to their implementation, using the Theoretical Domains Framework (TDF). Factor analyses identified constructs underlying the 5As; and barriers/enablers. Multivariate general linear models examined relationships between the barrier/enabler factors and the 5As factors. RESULTS: Of 750 midwives invited, 150 (20%) participated. Respondents more commonly reported Asking and Assessing than Advising, Assisting, or Arranging follow-up (e.g. 77% always Ask smoking status; 17% always Arrange follow-up). Three 5As factors were identified- 'Helping', 'Assessing quitting' and 'Assessing dependence'. Responses to barrier/enabler items showed greater knowledge, skills, intentions, and confidence with Assessment than Assisting; endorsement for SCS as a priority and part of midwives' professional role; and gaps in training and organisational support for SCS. Nine barrier/enabler factors were identified. Of these, the factors of 'Capability' (knowledge, skills, confidence); 'Work Environment' (service has resources, capacity, champions and values SCS) and 'Personal priority' (part of role and a priority) predicted 'Helping'. CONCLUSION: The TDF enabled systematic identification of barriers to providing SCS, and the multivariate models identified key contributors to poor implementation. Combined with qualitative data, these results have been mapped to intervention components to develop a comprehensive intervention to improve SCS.

Barriers and enablers to implementation of antenatal smoking cessation guidelines in general practice.

Smoking is a major preventable cause of adverse outcomes in pregnancy. Despite the existence of smoking cessation support guidelines, many pregnant smokers do not receive support in quitting. The aim of this study was to identify and understand the facilitators and barriers experienced by GPs in implementing the 5As of smoking cessation support with pregnant women. The results of this study may help in shaping interventions to support GPs in implementing the guidelines. This was a qualitative study using semi-structured interviews built around the Theoretical Domains Framework. Participants were 15 GPs, and thematic analysis was used to identify relevant themes. Perceived barriers to implementing guidelines included unfamiliarity with the 5As, uncertainty using nicotine replacement therapy, lack of time, and fears of damaging rapport. Perceived facilitators included high levels of knowledge and skills, patients' expectations and a recognition that smoking cessation was a fundamental and essential part of the GPs' role in antenatal care. Educating and training GPs regarding the 5As and NRT (nicotine replacement therapy) use in pregnancy may have a role in improving delivery of smoking cessation support. The strong overall commitment to provision of smoking cessation support among GPs may also have a role in developing interventions in the future.

Improving implementation of the smoking cessation guidelines with pregnant women: How to support clinicians?

OBJECTIVE: this study aimed to explore the enablers and barriers to implementation of the Australian smoking cessation in pregnancy guidelines. These guidelines direct clinicians to follow the 5As of cessation: Ask, Advise, Assess, Assist and Arrange follow-up. DESIGN: semi-structured interviews based on the Theoretical Domains Framework (TDF) elicited clinicians' views and experiences of implementing the guidelines. SETTING: antenatal care in the NSW public health system. PARTICIPANTS: 27 maternity service managers, obstetricians and midwives. FINDINGS: participants confirmed that implementation of the smoking cessation guidelines was sub-optimal. This was particularly the case with Assist and Arrange follow up at the initial visit, and with following any of the 5As at subsequent visits. Key barriers included systems which did not support implementation or monitoring, lack of knowledge, skills and training, perceived time restrictions, 'difficult conversations' and perceiving smoking as a social activity. Enablers included clinicians' knowledge of the harms of smoking in pregnancy, clinicians' skills in communicating with pregnant women, positive emotions, professional role and identity, the potential of training and of champions to influence practice, and systems that regulated behaviour. KEY CONCLUSIONS: these findings will contribute to the development of a multifaceted intervention to support clinicians in implementing the guidelines. IMPLICATIONS FOR PRACTICE: Building on existing strengths, antenatal care providers may be supported in implementing the guidelines by working with systems which remind and support implementation, the clear reframing of smoking as an addiction, knowledge and skills development and by realizing the potential of leadership to maximise the impact of reinforcement and social influence.

Smoke-free homes: what are the barriers, motivators and enablers? A qualitative systematic review and thematic synthesis.

OBJECTIVE: To thematically synthesise primary qualitative studies of the barriers, motivators and enablers of smoke-free homes (SFHs). DESIGN: Systematic review and thematic synthesis. DATA SOURCES: Searches of MEDLINE, EBM Reviews (Cochrane Database of Systematic Reviews), PsycINFO, Global Health, CINAHL, Web of Science, Informit and EMBASE, combining terms for families, households and vulnerable populations; SFH and secondhand smoke; and qualitative research, were supplemented by searches of PhD theses, key authors, specialist journals and reference lists. STUDY SELECTION: We included 22 articles, reporting on 18 studies, involving 646 participants. INCLUSION CRITERIA: peer-reviewed; English language; published from 1990 onwards (to week 3 of April 2014); used qualitative data collection methods; explored participants' perspectives of home smoking behaviours; and the barriers, motivators and enablers to initiating and/or maintaining a SFH. DATA EXTRACTION: 1 of 3 authors extracted data with checking by a second. DATA SYNTHESIS: A thematic synthesis was performed to develop 7 core analytic themes: (1) knowledge, awareness and risk perception; (2) agency and personal skills/attributes; (3) wider community norms and personal moral responsibilities; (4) social relationships and influence of others; (5) perceived benefits, preferences and priorities; (6) addiction and habit; (7) practicalities. CONCLUSIONS: This synthesis highlights the complexity faced by many households in having a SFH, the practical, social, cultural and personal issues that need to be addressed and balanced by households, and that while some of these are common across study settings, specific social and cultural factors play a critical role in shaping household smoking behaviours. The findings can inform policy and practice and the development of interventions aimed at increasing SFHs. TRIAL REGISTRATION NUMBER: CRD42014014115.

Children, smoking households and exposure to second-hand smoke in the home in rural Australia: analysis of a national cross-sectional survey.

OBJECTIVES: This paper aimed to explore the association between rurality and (1) household smoking status and (2) home second-hand smoke exposure, in households with children aged 0-14 years. DESIGN: Cross-sectional study. SETTING: Households across Australia. PARTICIPANTS: Households across the country were randomly selected to provide a nationally representative sample. Respondents were persons aged 12 years or older in each household who were next going to celebrate their birthday. PRIMARY OUTCOME MEASURES: Household smoking status and smoking inside the home. METHODOLOGY: The 2010 Australian National Drug Strategy Household survey data were analysed to explore the prevalence of household smoking and home second-hand smoke exposure in rural and urban households with children. Multivariable logistic regression was used to explore the association of rurality with household smoking and with home second-hand smoke exposure, controlling for potential confounders. RESULTS: Households with children were more likely to be smoking households (35.4%, 95% CI 34.2% to 36.5%) than households without children (32.1%, 95% CI 31.3% to 32.8%). Both household smoking (43.6% (95% CI 41.5% to 45.7%) vs 31.4% (95% CI 30.0% to 32.8%)) and home second-hand smoke exposure (8.0% (95% CI 6.8% to 9.1%) vs 5.2% (95% CI 4.5% to 5.8%)) were significantly more common for rural children. In multivariate analyses controlling for confounding factors, rurality remained associated with smoking households (OR 1.21, 95% CI 1.07 to 1.37), whereas it did not remain associated with children's home second-hand smoke exposure (OR 1.07, 95% CI 0.85 to 1.35). Larger household size, low socioeconomic status and being a single-parent household were the main drivers of home second-hand smoke exposure. CONCLUSIONS: The proportion of smoking households with children, and the number of children regularly exposed to second-hand smoke in their homes remain important public health concerns. Smoking cessation support and tobacco control policies might benefit from targeting larger and/or socioeconomically disadvantaged households including single-parent households.

The motivators and barriers to a smoke-free home among disadvantaged caregivers: identifying the positive levers for change.

INTRODUCTION: The aims of this study were to explore home smoking behaviors and the motivators and barriers to smoke-free homes among a group of disadvantaged caregivers for young children and to identify the positive levers that health care professionals can utilize when supporting smoking behavior change. METHODS: In-depth qualitative interviews were conducted between July and September 2009, with 22 disadvantaged smoking caregivers, accessing Children's Centre Services in Nottingham, UK. Interviews were audiorecorded and transcribed verbatim. Data were coded and analyzed thematically to identify emergent main and subthemes. RESULTS: Caregivers had some general understanding of the dangers of secondhand smoke (SHS), but their knowledge appeared incomplete and confused. All interviewees described rules around smoking in the home; however, these tended to be transient and fluid and unlikely to be effective. Caregivers were often living in difficult and complex circumstances and experienced significant barriers to creating a smoke-free home. The motivators for change were more strongly linked to house decor and smell than children's health, suggesting that visible evidence of the harm done by SHS to children might help promote smoke-free homes. CONCLUSIONS: Findings suggest that further tailored information on the effect of SHS is required, but to instigate caregiver behavior change, providing demonstrable evidence of the impact that their smoking is having on their children's health is more likely to be effective.