A systematic review to determine the effect of strategies to sustain chronic disease prevention interventions in clinical and community settings: study protocol.

BACKGROUND: The primary purpose of this review is to synthesise the effect of strategies aiming to sustain the implementation of evidenced-based interventions (EBIs) targeting key health behaviours associated with chronic disease (i.e. physical inactivity, poor diet, harmful alcohol use, and tobacco smoking) in clinical and community settings. The field of implementation science is bereft of an evidence base of effective sustainment strategies, and as such, this review will provide important evidence to advance the field of sustainability research. METHODS: This systematic review protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) checklist. Methods will follow Cochrane gold-standard review methodology. The search will be undertaken across multiple databases, adapting filters previously developed by the research team, data screening and extraction will be performed in duplicate, strategies will be coded using an adapted sustainability-explicit taxonomy, and evidence will be synthesised using appropriate methods (i.e. meta-analytic following Cochrane or non-meta-analytic following SWiM guidelines). We will include any randomised controlled study that targets any staff or volunteers delivering interventions in clinical or community settings. Studies which report on any objective or subjective measure of the sustainment of a health prevention policy, practice, or programme within any of the eligible settings will be included. Article screening, data extraction, risk of bias, and quality assessment will be performed independently by two review authors. Risk of bias will be assessed using Version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). A random-effect meta-analysis will be conducted to estimate the pooled effect of sustainment strategies separately by setting (i.e. clinical and community). Sub-group analyses will be undertaken to explore possible causes of statistical heterogeneity and may include the following: time period, single or multi-strategy, type of setting, and type of intervention. Differences between sub-groups will be statistically compared. DISCUSSION/CONCLUSION: This will be the first systematic review to determine the effect of strategies designed to support sustainment on sustaining the implementation of EBIs in clinical and community settings. The findings of this review will directly inform the design of future sustainability-focused implementation trials. Further, these findings will inform the development of a sustainability practice guide for public health practitioners. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42022352333.

E-cigarette use in pregnancy in Australia: A cross-sectional survey of public antenatal clinic attendees.

INTRODUCTION: E-cigarette use has rapidly increased amongst young people in Australia, however the prevalence of use amongst pregnant people is not known. The aim of this study was to examine the prevalence of e-cigarette use and dual use of e-cigarettes and tobacco cigarettes, characteristics associated with use and reasons for use amongst a sample of pregnant Australian people attending public antenatal clinics. METHODS: A cross-sectional survey was conducted with 4024 pregnant people attending antenatal appointments, between July 2021 and December 2022, in one local health district in New South Wales, Australia. Main outcome measures were current use of e-cigarettes, dual use with tobacco cigarettes, participant characteristics associated with use and reasons for use. RESULTS: 1.24% of pregnant people used e-cigarettes, 34% of these were dual smokers. Being a current smoker (OR 39.49; 95% CI 9.99-156.21) or ex-smoker (OR 29.86; 95% CI 8.75-101.95) were associated with e-cigarette use. Quitting smoking was the most reported reason for use (52%). DISCUSSION AND CONCLUSIONS: This study is the first to report on the prevalence of e-cigarette use amongst pregnant people in Australia. We found that a small proportion of pregnant people use e-cigarettes and that many are dual users or ex-smokers. E-cigarette use and rates of dual use in pregnancy in Australia appear lower than internationally, however they are similarly being used as a smoking-cessation aid by many. As regulatory environments relating to e-cigarette access change in Australia, large-scale studies are required to continue to monitor e-cigarette use and dual use in pregnancy.

Effect of implementation strategies on the routine provision of antenatal care addressing smoking in pregnancy: study protocol for a non-randomised stepped-wedge cluster controlled trial.

INTRODUCTION: Globally, guideline-recommended antenatal care for smoking cessation is not routinely delivered by antenatal care providers. Implementation strategies have been shown to improve the delivery of clinical practices across a variety of clinical services but there is an absence of evidence in applying such strategies to support improvements to antenatal care for smoking cessation in pregnancy. This study aims to determine the effectiveness and cost effectiveness of implementation strategies in increasing the routine provision of recommended antenatal care for smoking cessation in public maternity services. METHODS AND ANALYSIS: A non-randomised stepped-wedge cluster-controlled trial will be conducted in maternity services across three health sectors in New South Wales, Australia. Implementation strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training and monitoring and feedback will be delivered sequentially to each sector over 4 months. Primary outcome measures will be the proportion of: (1) pregnant women who report receiving a carbon monoxide breath test; (2) smokers or recent quitters who report receiving quit/relapse advice; and (3) smokers who report offer of help to quit smoking (Quitline referral or nicotine replacement therapy). Outcomes will be measured via cross-sectional telephone surveys with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost effectiveness of the implementation intervention. Process measures including acceptability, adoption, fidelity and reach will be reported. ETHICS AND DISSEMINATION: Ethics approval was obtained through the Hunter New England Human Research Ethics Committee (16/11/16/4.07; 16/10/19/5.15) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health policy-makers and health services to inform best practice processes for effective guideline implementation. Findings will also be disseminated at scientific conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry-ACTRN12622001010785.

Evaluation of an implementation support package to increase community mental health clinicians' routine delivery of preventive care for multiple health behaviours: a non-randomised controlled trial.

BACKGROUND: People with a mental health condition are more likely to engage in risk behaviours compared to people without. Delivery of preventive care to improve such behaviours is recommended for community mental health services, but inadequately implemented. This study assessed the effectiveness of an implementation support package on clinicians' delivery of preventive care (assessment, advice, referral) for four risk behaviours (tobacco smoking, harmful alcohol consumption, physical inactivity, inadequate fruit and vegetable intake) compared to no implementation support. The participatory approach to developing the support package, and fidelity of the implementation strategies, are also described. METHODS: A non-randomised controlled trial was undertaken in 2019-2020 with two community mental health services (control and target) in one health district in New South Wales, Australia. A 4-month support package consisting of multiple implementation strategies was delivered to one site following a two-phase participatory design process. Five implementation strategies were proposed to service managers by researchers. After consultation with managers and clinicians, the final implementation support package included four strategies: training and education materials, enabling resources and prompts, client activation material, and audit and feedback. Client-reported receipt of the three elements of preventive care for the four risk behaviours was collected from a cross-sectional sample of clients who had recently attended the service at baseline (6 months) and follow-up (5 months). Logistic regression models examined change in receipt of preventive care to assess effectiveness. RESULTS: A total of 860 client surveys were completed (control baseline n = 168; target baseline n = 261; control follow-up n = 164; and target follow-up n = 267). Analyses revealed no significant differential changes in preventive care receipt between the target and control sites from baseline to follow-up, including across the four primary outcomes: assessed for all behaviours (OR = 1.19; 95% CI 0.55, 2.57; p = 0.65); advised for all relevant risk behaviours (OR = 1.18; 95% CI 0.39, 3.61; p = 0.77); referred for any relevant risk behaviour (OR = 0.80; 95% CI 0.40, 1.63; p = 0.55); and complete care (OR = 3.11; 95% CI 0.62, 15.63; p = 0.17). Fidelity of the implementation strategies was limited as one of the four strategies (audit and feedback) was not delivered, components of two strategies (enabling resources and prompts, and client activation material) were not delivered as intended, and one strategy (education and training) was delivered as intended although some components were offered late in the implementation period. CONCLUSIONS: The implementation support package was ineffective at increasing preventive care delivery. Further investigation is required to determine optimal participatory design methods to develop effective implementation strategies, including those that support delivery of care in community mental health settings within the ongoing context of uncertain environmental challenges. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ACTRN12619001379101.

Clustering of smoking, alcohol consumption and weight gain in pregnancy: prevalence, care preferences and associated factors.

BACKGROUND: Smoking, alcohol consumption and weight gain outside recommendations during pregnancy are preventable health risk factors associated with poorer health outcomes for mother and infant. Clustering of these risk factors further increases the risk and severity of outcomes. Limited research has explored the characteristics of pregnant women that are associated with clustering of these risks and women's preferences for receiving support. This paper aimed to determine: (i) the prevalence of clustered preventable risk factors; (ii) associations between maternal characteristics and presence of clustered risk factors; and (iii) women's preferences for receiving care for clustered risk factors. METHODS: A cross-sectional survey was undertaken with women who had recently given birth in public maternity services in New South Wales, Australia. Descriptive statistics were used to assess prevalence of clustered risk factors and care preferences. Associations between the presence of clustered risk factors and maternal characteristics were assessed using multiple regression analyses. RESULTS: Of the 514 women who completed the survey, 52% reported one preventable health risk factor and 10% and 2% reported two or three. For women with two or more risk factors, the most common combination was alcohol consumption and gestational weight gain outside of recommendations (50%, n = 30). One characteristic had an association with the presence of clustered risk factors. Most women (77%, n = 46) with clustered risk factors indicated they wanted support for these health risks. Preferences for support addressing some or all risk factors, and whether the support was sequential or simultaneous, were not associated with particular risk factor combinations. CONCLUSIONS: Around one in eight women reported clustered preventable risk factors during pregnancy, most of whom would like support to address these risks. There was only one association between maternal characteristics and clustered risk factors. This suggests a need for antenatal care that is women-centred and caters for a diverse profile of clustered risks and varied preferences for care.

An audit of the dissemination strategies and plan included in international food-based dietary guidelines.

OBJECTIVE: Food-based dietary guidelines (FBDG) are an important resource to improve population health; however, little is known about the types of strategies to disseminate them. This study sought to describe dissemination strategies and content of dissemination plans that were available for FBDG. DESIGN: A cross-sectional audit of FBDG with a published English-language version sourced from the United Nations FAO repository. We searched for publicly available dissemination strategies and any corresponding plans available in English language. Two authors extracted data on strategies, which were grouped according to the Model for Dissemination Research Framework (including source, audience, channel and message). For guidelines with a dissemination plan, we described goals, audience, strategies and expertise and resources according to the Canadian Institute for Health Research guidance. SETTING: FBDG from fifty-three countries mostly from high-income (n 28, 52·8 %), and upper-middle income (n 18, 34 %) areas were included. PARTICIPANTS: n/a. RESULTS: The source of guidelines was most frequently health departments (79·2 %). The message included quantities and types of foods, physical activity recommendations and 88·7 % included summarised versions of main messages. The most common channels were infographics and information booklets, and the main end-users were the public. For twelve countries (22·6 %), we were able to source an English-language dissemination plan, where none met all recommendations outlined by the Canadian Institute for Health Research. CONCLUSIONS: The public was the most frequently identified end-user and thus most dissemination strategies and plans focused on this group. Few FBDG had formal dissemination plans and of those there was limited detailed provided.

A systematic review to determine the effect of strategies to sustain chronic disease prevention interventions in clinical and community settings: study protocol.

Background: The primary purpose of this review is to synthesise the effect of strategies aiming to sustain the implementation of evidenced based interventions (EBIs) targeting key health behaviours associated with chronic disease (i.e., physical inactivity, poor diet, harmful alcohol use and tobacco smoking) in clinical and community settings. The field of implementation science is bereft of an evidence base of effective sustainment strategies, and as such this review will provide important evidence to advance the field of sustainability research. Methods: This systematic review protocol is reported in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis Protocol (PRISMA-P) checklist (Additional file 1). Methods will follow Cochrane gold-standard review methodology. The search will be undertaken across multiple databases, adapting filters previously developed by the research team; data screening and extraction will be performed in duplicate; strategies will be coded using an adapted sustainability-explicit taxonomy; evidence will be synthesised using appropriate methods (i.e. meta-analytic following Cochrane or non-meta-analytic following SWiM guidelines). We will include any randomised controlled study that targets any staff or volunteers delivering interventions in clinical or community settings. Studies which report on any objective or subjective measure of the sustainment of a health prevention policy, practice, or program within any of the eligible settings will be included. Article screening, data extraction, risk of bias and quality assessment will be performed independently by two review authors. Risk of bias will be assessed using Version 2 of the Cochrane risk-of-bias tool for randomised trials (RoB 2). A random effect meta-analysis will be conducted to estimate the pooled effect of sustainment strategies separately by setting (i.e. clinical and community). Sub-group analyses will be undertaken to explore possible causes of statistical heterogeneity and may include: time period, single or multi strategy, type of setting and type of intervention. Differences between sub-groups will be statistically compared. Discussion/Conclusion: This will be the first systematic review to determine the effect of strategies designed to support sustainment on sustaining the implementation of EBIs in clinical and community settings. The findings of this review will directly inform the design of future sustainability-focused implementation trials. Further, these findings will inform the development of a sustainability practice guide for public health practitioners. Registration: This review was prospectively registered with PROSPERO (registration ID: CRD42022352333).

Dissemination of public health research to prevent non-communicable diseases: a scoping review.

BACKGROUND: Dissemination is a critical element of the knowledge translation pathway, and a necessary step to ensure research evidence is adopted and implemented by key end users in order to improve health outcomes. However, evidence-based guidance to inform dissemination activities in research is limited. This scoping review aimed to identify and describe the scientific literature examining strategies to disseminate public health evidence related to the prevention of non-communicable diseases. METHODS: Medline, PsycInfo and EBSCO Search Ultimate were searched in May 2021 for studies published between January 2000 and the search date that reported on the dissemination of evidence to end users of public health evidence, within the context of the prevention of non-communicable diseases. Studies were synthesised according to the four components of Brownson and colleagues' Model for Dissemination of Research (source, message, channel and audience), as well as by study design. RESULTS: Of the 107 included studies, only 14% (n = 15) directly tested dissemination strategies using experimental designs. The remainder primarily reported on dissemination preferences of different populations, or outcomes such as awareness, knowledge and intentions to adopt following evidence dissemination. Evidence related to diet, physical activity and/or obesity prevention was the most disseminated topic. Researchers were the source of disseminated evidence in over half the studies, and study findings/knowledge summaries were more frequently disseminated as the message compared to guidelines or an evidence-based program/intervention. A broad range of dissemination channels were utilised, although peer-reviewed publications/conferences and presentations/workshops predominated. Practitioners were the most commonly reported target audience. CONCLUSIONS: There is a significant gap in the peer reviewed literature, with few experimental studies published that analyse and evaluate the effect of different sources, messages and target audiences on the determinants of uptake of public health evidence for prevention. Such studies are important as they can help inform and improve the effectiveness of current and future dissemination practices in public health contexts.

Study protocol for an economic evaluation and budget impact of implementation strategies to support routine provision of antenatal care for gestational weight gain: a stepped-wedge cluster trial.

BACKGROUND: Antenatal clinical practice guidelines recommend routine assessment of weight and provision of advice on recommended weight gain during pregnancy and referral to additional services when appropriate. However, there are barriers to clinicians adopting such best-practice guidelines. Effective, cost-effective, and affordable implementation strategies are needed to ensure the intended benefits of guidelines are realised. This paper describes the protocol for evaluating the efficiency and affordability of implementation strategies compared to the usual practice in public antenatal services. METHOD: The prospective trial-based economic evaluation will identify, measure, and value key resource and outcome impacts arising from the implementation strategies compared with usual practice. The evaluation will comprise of (i) costing, (ii) cost-consequence analyses, where a scorecard approach will be used to show the costs and benefits given the multiple primary outcomes included in the trial, and (iii) cost-effectiveness analysis, where the primary outcome will be incremental cost per percent increase in participants reporting receipt of antenatal care for gestational weight gain consistent with the guideline recommendations. Affordability will be evaluated using (iv) budget impact assessment and will estimate the financial implications of adoption and diffusion of this implementation strategy from the perspective of relevant fund-holders. DISCUSSION: Together with the findings from the effectiveness trial, the outcomes of this economic evaluation will inform future healthcare policy, investment allocation, and research regarding the implementation of antenatal care to support healthy gestational weight gain. TRIAL REGISTRATION: Trial Registration: Australian and New Zealand Clinical Trials Registry, ACTRN12621000054819 (22/01/2021) http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=380680&isReview=true .

Breastfeeding practices and associations with pregnancy, maternal and infant characteristics in Australia: a cross-sectional study.

BACKGROUND: Exclusive breastfeeding to six months of age is a major global public health priority. Several characteristics are known to be associated with early cessation of breastfeeding, however, limited evidence exists regarding whether women's reported reasons for cessation are associated with maternal, pregnancy and infant characteristics. The aims of this study were to: i) describe women's reported intention to breastfeed and their subsequent breastfeeding practices; ii) describe women's reported reasons for breastfeeding cessation prior to the infant being five months of age; and iii) examine associations between these factors and maternal, pregnancy and infant characteristics. METHODS: Telephone and online surveys were conducted between October 2019 and April 2020 with 536 women who had given birth in the previous eight to 21 weeks at four public maternity services in Australia. RESULTS: The majority of women intended to (94%), and did, initiate (95%) breastfeeding. At the time the survey was conducted, 57% of women were exclusively breastfeeding. Women who: had less than University level education, had a pre-pregnancy BMI in the overweight or obese category, and who smoked tobacco at the time of the survey had lower odds of exclusively breastfeeding. The most common self-reported reasons for breastfeeding cessation were breastfeeding challenges (47%) and low milk supply (40%). Women aged 26-35 years and 36 + years had greater odds of reporting breastfeeding cessation due to low milk supply (OR = 2.92, 95% CI: 1.11, 7.66; OR = 5.57, 95% CI: 1.70, 18.29) compared to women aged 18-25 years. While women who had completed a TAFE certificate or diploma had lower odds of reporting this as a reason for breastfeeding cessation (OR = 0.28; 95% CI: 0.11, 0.73) compared to women who had University level education. There were no other significant associations found between characteristics and reasons for ceasing breastfeeding. CONCLUSIONS: The most common reasons for breastfeeding cessation may be modifiable through the provision of breastfeeding support in the early postpartum period, with such support being tailored to women's age and level of education. Such support should aim to increase women's self-efficacy in breastfeeding, and be provided from the antenatal period and throughout the first six months postpartum.

Differential effectiveness of a practice change intervention to improve antenatal care addressing alcohol consumption during pregnancy: Exploratory subgroup analyses within a randomised stepped-wedge controlled trial.

OBJECTIVE: A practice change intervention demonstrated improvements in the provision of antenatal care addressing alcohol consumption. The aim of this study was to explore whether the effectiveness of the intervention differed between subgroups of pregnant women and types and location of maternity services. DESIGN AND SETTING: Post-hoc exploratory subgroup analyses of the outcomes from a randomised stepped-wedge controlled trial conducted with all public maternity services within three sectors of a local health district in Australia. MEASUREMENTS: Two outcomes (receipt of alcohol assessment and complete care) measured at two visit types (initial and subsequent) were included in analyses. Logistic regression models explored interactions between pre-post differences and subgroups of women (age, Aboriginal origin, education level, disadvantage, gravidity and alcohol consumption in pregnancy) and services (geographic remoteness, service and provider type/s) that have been reported to be associated with variation in guideline implementation. FINDINGS: Surveys from 5694 women were included in the analyses. For the initial visit, no significant differential intervention effects between subgroups of women or type/location of services were found for either outcome. For subsequent visits, the intervention effect differed significantly only between Aboriginal origin subgroups (Aboriginal OR: 1.95; 95% CI: 0.99-3.85; non-Aboriginal OR: 5.34; 95% CI: 4.17-6.83; p<0.01) and women's alcohol consumption in pregnancy subgroups (consumed alcohol OR: 1.28; 95% CI: 0.59-2.78; not consumed alcohol OR: 5.22; 95% CI: 4.11-6.65; p<0.001) for assessment of alcohol consumption. KEY CONCLUSIONS: These exploratory results suggest that the intervention may have had similar effects between different subgroups of women and types and location of services, with the exception of women who were non-Aboriginal and women who had not consumed alcohol, for whom the intervention was potentially more effective. IMPLICATIONS FOR PRACTICE: The practice change intervention could be implemented with different maternity service and provider types to effectively support improvements in antenatal care addressing alcohol consumption. These exploratory results provide further data for hypothesis generation regarding targeted areas for the testing of additional strategies that enable Aboriginal women to benefit equally from the intervention, and to ensure those women most in need of care, those consuming alcohol during pregnancy, have their care needs met.

Evaluation of measures of sustainability and sustainability determinants for use in community, public health, and clinical settings: a systematic review.

BACKGROUND: Sustainability is concerned with the long-term delivery and subsequent benefits of evidence-based interventions. To further this field, we require a strong understanding and thus measurement of sustainability and what impacts sustainability (i.e., sustainability determinants). This systematic review aimed to evaluate the quality and empirical application of measures of sustainability and sustainability determinants for use in clinical, public health, and community settings. METHODS: Seven electronic databases, reference lists of relevant reviews, online repositories of implementation measures, and the grey literature were searched. Publications were included if they reported on the development, psychometric evaluation, or empirical use of a multi-item, quantitative measure of sustainability, or sustainability determinants. Eligibility was not restricted by language or date. Eligibility screening and data extraction were conducted independently by two members of the research team. Content coverage of each measure was assessed by mapping measure items to relevant constructs of sustainability and sustainability determinants. The pragmatic and psychometric properties of included measures was assessed using the Psychometric and Pragmatic Evidence Rating Scale (PAPERS). The empirical use of each measure was descriptively analyzed. RESULTS: A total of 32,782 articles were screened from the database search, of which 37 were eligible. An additional 186 publications were identified from the grey literature search. The 223 included articles represented 28 individual measures, of which two assessed sustainability as an outcome, 25 covered sustainability determinants and one explicitly assessed both. The psychometric and pragmatic quality was variable, with PAPERS scores ranging from 14 to 35, out of a possible 56 points. The Provider Report of Sustainment Scale had the highest PAPERS score and measured sustainability as an outcome. The School-wide Universal Behaviour Sustainability Index-School Teams had the highest PAPERS score (score=29) of the measure of sustainability determinants. CONCLUSIONS: This review can be used to guide selection of the most psychometrically robust, pragmatic, and relevant measure of sustainability and sustainability determinants. It also highlights that future research is needed to improve the psychometric and pragmatic quality of current measures in this field. TRIAL REGISTRATION: This review was prospectively registered with Research Registry (reviewregistry1097), March 2021.

The effectiveness of implementation strategies in improving preconception and antenatal preventive care: a systematic review.

BACKGROUND: Clinical guideline recommendations for addressing modifiable risk factors are not routinely implemented into preconception and antenatal care. This review assessed the effectiveness of implementation strategies in improving health professional provision of preconception and antenatal care addressing tobacco smoking, weight management and alcohol consumption. METHODS: A systematic review of randomised and non-randomised studies with a parallel comparison group was conducted. Eligible studies used implementation strategy/ies targeted at health professionals to improve at least one element of preconception and/or antenatal care (smoking: ask, advise, assess, assist, arrange; weight/alcohol: assess, advise, refer) compared to usual practice/control or alternative strategies. Eligible studies were identified via CENTRAL, MEDLINE, EMBASE, Maternity and Infant Care, CINAHL and other sources. Random-effects meta-analyses were conducted where appropriate, with other findings summarised using the direction of effect. The certainty of the pooled evidence was assessed using the GRADE approach. RESULTS: Fourteen studies were included in the review. Thirteen were in the antenatal period and 12 tested multiple implementation strategies (median: three). Meta-analyses of RCTs found that implementation strategies compared to usual practice/control probably increase asking (OR: 2.52; 95% CI: 1.13, 5.59; 3 studies; moderate-certainty evidence) and advising (OR: 4.32; 95% CI: 3.06, 6.11; 4 studies; moderate-certainty evidence) about smoking and assessing weight gain (OR: 57.56; 95% CI: 41.78, 79.29; 2 studies; moderate-certainty evidence), and may increase assessing (OR: 2.55; 95% CI: 0.24, 27.06; 2 studies; low-certainty evidence), assisting (OR: 6.34; 95% CI: 1.51, 26.63; 3 studies; low-certainty evidence) and arranging support (OR: 3.55; 95% CI: 0.50, 25.34; 2 studies; low-certainty evidence) for smoking. The true effect of implementation strategies in increasing advice about weight gain (OR: 3.37; 95% CI: 2.34, 4.84; 2 non-randomised studies; very low-certainty evidence) and alcohol consumption (OR: 10.36; 95% CI: 2.37, 41.20; 2 non-randomised studies; very low-certainty evidence) is uncertain due to the quality of evidence to date. CONCLUSIONS: Review findings provide some evidence to support the effectiveness of implementation strategies in improving health professional delivery of antenatal care addressing smoking and weight management. Rigorous research is needed to build certainty in the evidence for improving alcohol and weight gain advice, and in preconception care. TRIAL REGISTRATION: PROSPERO-CRD42019131691.

Effectiveness of a practice change intervention in reducing alcohol consumption in pregnant women attending public maternity services.

BACKGROUND: The aim of this study was to examine the effect of a practice change intervention to support the implementation of guideline-recommended care for addressing alcohol use in pregnancy on self-reported alcohol use during pregnancy. METHODS: A randomized, stepped-wedge controlled trial in three clusters (sectors) within the Hunter New England Local Health District (NSW, Australia). We evaluated a practice change intervention that supported the introduction of a new model of care for reducing alcohol use in pregnancy, consistent with local and international guidelines, and implemented in random order across the sectors. Each week throughout the study period, pregnant women who attended any public antenatal services within the previous week, for a 27-28 or 35-36 week gestation visit, were randomly sampled and invited to participate in the survey. The intended intervention for all women was Brief advice (to abstain from alcohol and information about potential risks). Women identified as medium-risk alcohol consumers using the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) were to be offered referral to a phone coaching service, and women identified as high-risk were to be offered referral to a Drug and Alcohol Service. Rates of self-reported alcohol use (AUDIT-C risk level and special occasion drinking) were summarized and compared in groups of women pre-intervention and post-intervention using multivariable logistic regression. RESULTS: Surveys were completed by 1309 women at pre-intervention and 2540 at post-intervention. The majority of women did not drink during pregnancy (pre-intervention: 89.68%; post-intervention: 90.74%). There was no change in the proportion of women classified as No risk from drinking (AUDIT-C score = 0) or Some risk from drinking (AUDIT-C score ≥ 1) pre- or post-intervention (p = 0.08). However, a significant reduction in special occasion drinking was observed (pre-intervention: 11.59%; post-intervention: 8.43%; p < 0.001). CONCLUSIONS: Special occasion drinking was reduced following implementation of guideline-recommended care. Failure to change other patterns of alcohol use in pregnancy may reflect barriers to implementing the model of care in antenatal care settings and the need to address other social determinants of alcohol use. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (registration number: ACTRN12617000882325; date: 16 June 2017).

Iterative delivery of an implementation support package to increase and sustain the routine provision of antenatal care addressing alcohol consumption during pregnancy: study protocol for a stepped-wedge cluster trial.

INTRODUCTION: Antenatal care addressing alcohol consumption during pregnancy is not routinely delivered in maternity services. Although a number of implementation trials have reported significant increases in such care, the majority of women still did not receive all recommended care elements, and improvements dissipated over time. This study aims to assess the effectiveness of an iteratively developed and delivered implementation support package in: (1) increasing the proportion of pregnant women who receive antenatal care addressing alcohol consumption and (2) sustaining the rate of care over time. METHODS AND ANALYSIS: A stepped-wedge cluster trial will be conducted as a second phase of a previous trial. All public maternity services within three sectors of a local health district in Australia will receive an implementation support package that was developed based on an assessment of outcomes and learnings following the initial trial. The package will consist of evidence-based strategies to support increases in care provision (remind clinicians; facilitation; conduct educational meetings) and sustainment (develop a formal implementation blueprint; purposely re-examine the implementation; conduct ongoing training). Measurement of outcomes will occur via surveys with women who attend antenatal appointments each week. Primary outcomes will be the proportion of women who report being asked about alcohol consumption at subsequent antenatal appointments; and receiving complete care (advice and referral) relative to alcohol risk at initial and subsequent antenatal appointments. Economic and process evaluation measures will also be reported. ETHICS AND DISSEMINATION: Ethical approval was obtained through the Hunter New England (16/11/16/4.07, 16/10/19/5.15) and University of Newcastle Human Research Ethics Committees (H-2017-0032, H-2016-0422) and the Aboriginal Health and Medical Research Council (1236/16). Trial findings will be disseminated to health service decision makers to inform the feasibility of conducting additional cycles to further improve antenatal care addressing alcohol consumption as well as at scientific conferences and in peer-reviewed journals. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry (ACTRN12622000295741).

Written information and health professionals are the information sources about alcohol use in pregnancy most often used by pregnant women.

INTRODUCTION: Alcohol use in pregnancy remains common in Australia, despite national guidelines recommending that pregnant women abstain. The aims of this study were to investigate where pregnant women obtain information about alcohol use in pregnancy and the relationship between the information source used and women's demographic characteristics and alcohol use. METHODS: In this cross-sectional survey of pregnant women attending public maternity services in the Hunter New England region (New South Wales), women were asked, 'Where did you get information to help you make decisions about alcohol use during pregnancy?'. The number and types of information sources were analysed using descriptive statistics. Associations between women's information sources, and their demographic characteristics and alcohol use in pregnancy were assessed using chi-square tests and logistic regression. RESULTS: Of 4511 pregnant women surveyed, 80.1% used at least one type of information source (range 0-5). Written/electronic information (45.4%), health providers (37.6%) and family/friends (19.5%) were the sources most reported. Higher use of written/electronic information, antenatal health providers and family/friends was associated with first pregnancy, younger age and higher education. The type of information source used was associated with alcohol use in pregnancy. Women who reported alcohol use were more likely to receive information from written/electronic sources. Almost 20% of women (older, multiparous [>1 pregnancy] and more highly educated) obtained no information regarding alcohol use in pregnancy. DISCUSSION AND CONCLUSIONS: Antenatal providers should routinely provide information on alcohol use in pregnancy, including for women least likely to access available information.

Practice change intervention to improve antenatal care addressing alcohol consumption during pregnancy: a randomised stepped-wedge controlled trial.

BACKGROUND: Clinical guideline recommendations for addressing alcohol consumption during pregnancy are sub-optimally implemented and limited evidence exists to inform practice improvements. The aim of this study was to estimate the effectiveness of a practice change intervention in improving the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. METHODS: A randomised stepped-wedge controlled trial was undertaken with all public maternity services in three sectors (one urban, two regional/rural) of a single local health district in New South Wales, Australia. All antenatal care providers were subject to a seven-month multi-strategy intervention to support the introduction of a recommended model of care. For 35 months (July 2017 - May 2020) outcome data were collected from randomly selected women post an initial, 27-28 weeks and 35-36 weeks gestation antenatal visit. Logistic regression models assessed intervention effectiveness. RESULTS: Five thousand six hundred ninety-four interviews/online questionnaires were completed by pregnant women. The intervention was effective in increasing women's reported receipt of: assessment of alcohol consumption (OR: 2.63; 95% CI: 2.26-3.05; p < 0.001), advice not to consume alcohol during pregnancy and of potential risks (OR: 2.07; 95% CI: 1.78-2.41; p < 0.001), complete care relevant to alcohol risk level (advice and referral) (OR: 2.10; 95% CI: 1.80-2.44; p < 0.001) and all guideline elements relevant to alcohol risk level (assessment, advice and referral) (OR: 2.32; 95% CI: 1.94-2.76; p < 0.001). Greater intervention effects were found at the 27-28 and 35-36 weeks gestation visits compared with the initial antenatal visit. No differences by sector were found. Almost all women (98.8%) reported that the model of care was acceptable. CONCLUSIONS: The practice change intervention improved the provision of antenatal care addressing alcohol consumption during pregnancy in public maternity services. Future research could explore the characteristics of pregnant women and maternity services associated with intervention effectiveness as well as the sustainment of care practices over time to inform the need for, and development of, further tailored practice change support. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry (Registration number: ACTRN12617000882325; Registration date: 16/06/2017) https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372985&isReview=true.

Cost, cost-consequence and cost-effectiveness evaluation of a practice change intervention to increase routine provision of antenatal care addressing maternal alcohol consumption.

BACKGROUND: Implementation of antenatal clinical guideline recommendations for addressing maternal alcohol consumption is sub-optimal. There is a complete absence of evidence of the cost and cost-effectiveness of delivering practice change interventions addressing maternal alcohol consumption amongst women accessing maternity services. The study sought to determine the cost, cost-consequence and cost-effectiveness of developing and delivering a multi-strategy practice change intervention in three sectors of a health district in New South Wales, Australia. METHODS: The trial-based economic analyses compared the costs and outcomes of the intervention to usual care over the 35-month period of the stepped-wedge trial. A health service provider perspective was selected to focus on the cost of delivering the practice change intervention, rather than the cost of delivering antenatal care itself. All costs are reported in Australian dollars ($AUD, 2019). Univariate and probabilistic sensitivity analyses assessed the effect of variation in intervention effect and costs. RESULTS: The total cost of delivering the practice change intervention across all three sectors was $367,646, of which $40,871 (11%) were development costs and $326,774 (89%) were delivery costs. Labour costs comprised 70% of the total intervention delivery cost. A single practice change strategy, 'educational meetings and educational materials' contributed 65% of the delivery cost. Based on the trial's primary efficacy outcome, the incremental cost effectiveness ratio was calculated to be $32,570 (95% CI: $32,566-$36,340) per percent increase in receipt of guideline recommended care. Based on the number of women attending the maternity services during the trial period, the average incremental cost per woman who received all guideline elements was $591 (Range: $329 - $940) . The average cost of the intervention per eligible clinician was $993 (Range: $640-$1928). CONCLUSION: The intervention was more effective than usual care, at an increased cost. Healthcare funders' willingness to pay for this incremental effect is unknown. However, the strategic investment in systems change is expected to improve the efficiency of the practice change intervention over time. Given the positive trial findings, further research and monitoring is required to assess the sustainability of intervention effectiveness and whether economies of scale, or reduced costs of intervention delivery can be achieved without impact on outcomes. TRIAL REGISTRATION: The trial was prospectively registered with the Australian and New Zealand Clinical Trials Registry, No. ACTRN12617000882325 (date registered: 16/06/2017).

Predictors of alcohol use during pregnancy in Australian women.

INTRODUCTION: This paper aimed to document alcohol use during pregnancy and determine predictors of ongoing use, including knowledge and agreement with national alcohol guideline recommendations. METHODS: Pregnant women (n = 1179) attending public antenatal services in a Local Health District in NSW, Australia, were surveyed about their alcohol use before pregnancy and after pregnancy recognition, and awareness of, and agreement with, national alcohol guidelines and health-related statements. Respondent characteristics, drinking behaviour and predictors of ongoing drinking during pregnancy were assessed. RESULTS: Most women consumed alcohol before pregnancy (79.3%) but the majority (82.0%) stopped following pregnancy recognition. Half the ongoing drinkers only drank on special occasions. Most (63.6%) women were aware of the national guidelines: 78.1% knew the recommendation that consuming no alcohol in pregnancy is safest, 4.6% thought some alcohol was safe and 17.3% were unsure. Predictors [OR (95%CI)] of ongoing drinking were older age [1.11 (1.07, 1.15)]; medium [2.42 (1.46, 4.00)] or high-risk drinking pre-pregnancy [3.93 (2.35, 6.56)]; and agreement that: avoiding alcohol in pregnancy is safest [0.05 (0.006, 0.47)]; avoiding alcohol is important for baby's health [0.14 (0.06, 0.31)] and pregnancy is a good time to change alcohol use for mother's health [0.29 (0.13, 0.63)]. DISCUSSION AND CONCLUSIONS: Results emphasise the importance of asking about special occasion drinking, the link between pre-pregnancy drinking and ongoing drinking during pregnancy, and the need to understand why women disagree with the national guideline. To ensure guidelines have their intended benefit, interventions to promote behaviour change relating to alcohol consumption during pregnancy are warranted.