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.

Antenatal care addressing gestational weight gain (GWG): a cross sectional study of pregnant women's reported receipt and acceptability of recommended GWG care and associated characteristics.

BACKGROUND: The Australian Clinical Practice Guidelines for Pregnancy Care recommend that during the first and subsequent antenatal visits all pregnant women are weighed; advised of recommended gestational weight gain (GWG), dietary intake and physical activity; and offered referrals for additional support if needed. The extent to which these recommendations are implemented and women's acceptability of recommended care is unknown. This study examines women's reported receipt and acceptability of guideline care for GWG, and characteristics associated with receipt of such care and its acceptability. METHODS: From September 2018 to February 2019 a telephone survey was undertaken with women who had recently had a baby and received antenatal care from five public maternity services within a health district in Australia. Women self-reported their demographic characteristics, and receipt and acceptability of recommended GWG care. Receipt and acceptability of such care, and their association with the characteristics of women and the maternity service they attended, were examined using descriptive statistics and multivariable logistic regression analyses. RESULTS: Of 514 women, 13.1% (95%CI:10.3-16.5) reported that they received an assessment of weight at both their first and a subsequent antenatal visit, and less than one third (30.0%; 95%CI:26.0-33.9) received advice on their recommended GWG range, dietary intake and physical activity. Just 6.6% (95%CI:4.8-9.1) of women reported receiving all assessment and advice components of recommended antenatal care, and 9.9% (95%CI:7.6-12.8) of women reported being referred for extra support. Women who were younger (OR = 1.13;95%CI:1.05-1.21), identifying as Aboriginal and Torres Strait Islander (OR = 24.54;95%CI:4.98-120.94), had a higher pre-pregnancy BMI (OR = 1.13;95%CI:1.05-1.21), were experiencing their first pregnancy (OR = 3.36;95%CI:1.27-8.86), and lived in a least disadvantaged area (compared to mid-disadvantaged area (OR = 18.5;95%CI:2.6-130.5) and most disadvantaged area (OR = 13.1;95%CI:2.09-82.4)) were more likely to receive recommended assessment and advice. Most Aboriginal (92%) and non-Aboriginal (93%) women agreed that recommended GWG care is acceptable. CONCLUSION: Most women perceive antenatal care for GWG as recommended by the Clinical Practice Guidelines as acceptable, but did not receive it. When provided, such care is not delivered consistently to all women regardless of their characteristics or those of the maternity service they attend. There is a need for service-wide practice change to increase routine GWG care in pregnancy for all women.

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.

A cluster randomised controlled trial to assess the effectiveness of a multi-strategy sustainability intervention on teachers' sustained implementation of classroom physical activity breaks (energisers): study protocol.

BACKGROUND: Governments internationally have invested hugely in the implementation and scale-up of school-based physical activity interventions, but have little evidence of how to best sustain these interventions once active implementation support ceases. This study will assess the effectiveness of a multi-strategy sustainability intervention on classroom teachers' sustainment of energisers (short 3-5 min physical activity breaks during class-time) scheduled across the school day from baseline to 12 and 24-month follow-up. METHODS: A cluster randomised controlled trial will be conducted in 50 primary schools within the Hunter New England, Illawarra Shoalhaven, Murrumbidgee and Northern New South Wales (NSW) Local Health Districts of NSW Australia. Schools will be randomly allocated to receive either usual support or the multi-strategy sustainability intervention that includes: centralised technical assistance from a trained project officer; formal commitment and mandated change obtained from school principals; training in-school champions; reminders for teachers; educational materials provided to teachers; capturing and sharing local knowledge; and engagement of parents, carers and the wider school community. The primary trial outcome will be measured via a teacher logbook to determine the between-group difference in the change in mean minutes of energisers scheduled across the school day at 12 and 24-month follow-up compared to baseline. Analyses will be performed using an intention to treat framework. Linear mixed models will be used to assess intervention effects on the primary outcome at both follow-up periods. DISCUSSION: This study will be one of the first randomised controlled trials to examine the impact of a multi-strategy sustainability intervention to support schools' sustainment of a physical activity intervention. The proposed research will generate new evidence needed for the partnering organisations to protect their considerable investments to date in physical activity promotion in this setting and will provide seminal evidence for the field globally. TRIAL REGISTRATION: ACTRN12620000372987 version 1 registered 17th March 2020. Version 3 (current version) updated 4th August 2023.

Evaluating the scaling up of an effective implementation intervention (PACE) to increase the delivery of a mandatory physical activity policy in primary schools.

BACKGROUND: Physically Active Children in Education (PACE) is an effective implementation intervention for increasing the number of minutes classroom teachers schedule physical activity each week. To date, evaluations of PACE have included a smaller number of schools from only one region in New South Wales Australia. If PACE is to have population-wide benefits we must be able to deliver this support to a larger number of schools across multiple regions. This study aimed to evaluate the scale-up of PACE. METHODS: An uncontrolled before and after study, with 100 schools from three regions was conducted. Participating schools received PACE for approximately 12 months. We assessed the following outcomes: delivery of the evidence-based intervention (EBI) (i.e. minutes of physical activity scheduled by classroom teachers per week); delivery of the implementation strategies (i.e. reach, dose delivered, adherence and indicators of sustainability); and key determinants of implementation (i.e. acceptability of strategies and cost). Data were collected via project officer records, and principal and teacher surveys. Linear mixed models were used to assess EBI delivery by evaluating the difference in the mean minutes teachers scheduled physical activity per week from baseline to follow-up. Descriptive data were used to assess delivery of the implementation strategies and their perceived acceptability (i.e. PACE). A prospective, trial-based economic evaluation was used to assess cost. RESULTS: Delivery of the EBI was successful: teachers increas their average minutes of total physical activity scheduled across the school week by 26.8 min (95% CI: 21.2, 32.4, p < 0.001) after receiving PACE. Indicators for delivery of implementation strategies were high: 90% of consenting schools received all strategies and components (reach); 100% of strategies were delivered by the provider (dose); >50% of schools adhered to the majority of strategies (11 of the 14 components); and acceptability was > 50% agreement for all strategies. The incremental cost per additional minute of physical activity scheduled per week was $27 per school (Uncertainty Interval $24, $31). CONCLUSIONS: PACE can be successfully delivered across multiple regions and to a large number of schools. Given the ongoing and scalable benefits of PACE, it is important that we continue to extend and improve this program while considering ways to reduce the associated cost.

Improving Practice for Urinary Continence Care on Adult Acute Medical and Rehabilitation Wards: A Multi-Site, Co-Created Implementation Study.

Many adult inpatients experience urinary continence issues; however, we lack evidence on effective interventions for inpatient continence care. We conducted a before and after implementation study. We implemented our guideline-based intervention using strategies targeting identified barriers and evaluated the impact on urinary continence care provided by inpatient clinicians. Fifteen wards (acute = 3, rehabilitation = 7, acute and rehabilitation = 5) at 12 hospitals (metropolitan = 4, regional = 8) participated. We screened 2298 consecutive adult medical records for evidence of urinary continence symptoms over three 3-month periods: before implementation (T0: n = 849), after the 6-month implementation period (T1: n = 740), and after a 6-month maintenance period (T2: n = 709). The records of symptomatic inpatients were audited for continence assessment, diagnosis, and management plans. All wards contributed data at T0, and 11/15 wards contributed at T1 and T2 (dropouts due to COVID-19). Approximately 26% of stroke, 33% acute medical, and 50% of rehabilitation inpatients were symptomatic. The proportions of symptomatic patients (T0: n = 283, T1: n = 241, T2: n = 256) receiving recommended care were: assessment T0 = 38%, T1 = 63%, T2 = 68%; diagnosis T0 = 30%, T1 = 70%, T2 = 71%; management plan T0 = 7%, T1 = 24%, T2 = 24%. Overall, there were 4-fold increased odds for receiving assessments and management plans and 6-fold greater odds for diagnosis. These improvements were sustained at T2. This intervention has improved inpatient continence care.

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.

Describing the evidence-base for research engagement by health care providers and health care organisations: a scoping review.

BACKGROUND: Having a research-engaged health and medical workforce is associated with improvements in clinical outcomes for patients. As such, there has been significant government investment internationally to support health care organisations and services to increase staff engagement with research. OBJECTIVES: This scoping review sought to provide an overview of the literature describing strategies employed to increase research engagement by health care providers and organisations, and to undertake a qualitative analysis to generate a list of research engagement strategies. METHODS: A scoping review using systematic search strategies was undertaken to locate peer-review publications and grey literature related to research engagement by health care providers and organisations. Research engagement was defined as a 'deliberate set of intellectual and practical activities undertaken by health care staff and organisations to conduct research'. A database search of electronic records was performed with no limit on publication date. Publications were included regardless of study type (excluding systematic reviews) and categorised as either databased (presenting data or new analysis of existing data) and non-databased (no new data or analyses). Databased publications were further classified according to study type, study design and setting. A qualitative synthesis using a Framework Approach was undertaken with all studies that described a strategy to improve research engagement. RESULTS: A total of 152 publications were included in this study with 54% categorised as non-databased. Of the databased articles, the majority (72%) were descriptive studies describing prevalence of correlates of research engagement, 17 (25%) described intervention studies where only two were controlled studies. The following research engagement strategies were identified: i) dual skilled team/staff, ii) resources or physical infrastructure, iii) incentives, iv) leadership support of research, v) education/training, vi) networks, vii) forming partnerships or collaborations and viii) overall leadership structure of entity. CONCLUSIONS: The literature on research engagement is primarily opinion-based and descriptive in nature. To provide the evidence needed to inform strategies, this needs to progress beyond descriptive to more rigorous well-designed intervention research.

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.

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).

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.

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).

Intention to change multiple health risk behaviors and predictors of behavior change in vocational education students.

Objective: No studies have examined vocational education students' intention to change multiple health risk behaviors and whether baseline characteristics predict behavior change. Participants: Paticipants were vocational education students in New South Wales, Australia. Methods: Students in the no-intervention control arm of a cluster randomized controlled trial completed an online survey at baseline and 6 months later. Results: Of 450 participants (83.3%) who reported multiple health risk behaviors at baseline, one-third (33.1%) intended to change at least two risk behaviors within 6 months. Participants experiencing symptoms of anxiety [OR = 7.43, 95% CIs 1.26-43.87; p = 0.03] and who intended to change three to four risk behaviors [OR = 23.30, 95% CIs 4.01-135.40; p = 0.001] rather than one behavior had significantly greater odds of changing at least one behavior in 6 months. Conclusions: Interventions could support vocational education students to change behaviors they wish to as well as motivate them to address other risk behaviors.

Management of Acute Coronary Syndromes in Patients in Rural Australia: The MORACS Randomized Clinical Trial.

Importance: Treatment of ST-segment elevation myocardial infarction (STEMI) in rural settings involves thrombolysis followed by transfer to a percutaneous coronary intervention-capable hospital. The first step is accurate diagnosis via electrocardiography (ECG), but one-third of all STEMI incidents go unrecognized and hence untreated. Objective: To reduce missed diagnoses of STEMI. Design, Setting, and Participants: This cluster randomized clinical trial included 29 hospital emergency departments (EDs) in rural Australia with no emergency medicine specialists, which were randomized to usual care vs automatically triggered diagnostic support from the tertiary referral hospital (management of rural acute coronary syndromes [MORACS] intervention). Patients presenting with symptoms compatible with acute coronary syndromes (ACS) were eligible for inclusion. The study was conducted from December 2018 to April 2020. Data were analyzed in August 2021. Intervention: Triage of a patient with symptoms compatible with ACS triggered an automated notification to the tertiary hospital coronary care unit. The ECG and point-of-care troponin results were reviewed remotely and a phone call was made to the treating physician in the rural hospital to assist with diagnosis and initiation of treatment. Main Outcomes and Measures: The proportion of patients with missed STEMI diagnoses. Results: A total of 6249 patients were included in the study (mean [SD] age, 63.6 [12.2] years; 48% female). Of 7474 ED presentations with suspected ACS, STEMI accounted for 77 (2.0%) in usual care hospitals and 46 (1.3%) in MORACS hospitals. Missed diagnosis of STEMI occurred in 27 of 77 presentations (35%) in usual care hospitals and 0 of 46 (0%) in MORACS hospitals (P < .001). Of eligible patients, 48 of 75 (64%) in the usual care group and 36 of 36 (100%) in the MORACS group received primary reperfusion (P < .001). In the usual care group, 12-month mortality was 10.3% (n = 8) vs 6.5% (n = 3) in the MORACS group (relative risk, 0.64; 95% CI, 0.18-2.23). Patients with missed STEMI diagnoses had a mortality of 25.9% (n = 7) compared with 2.0% (n = 1) for those with accurately diagnosed STEMI (relative risk, 13.2; 95% CI, 1.71-102.00; P = .001). Overall, there were 6 patients who did not have STEMI as a final diagnosis; 5 had takotsubo cardiomyopathy and 1 had pericarditis. There was no difference between groups in the rate of alternative final diagnosis. Conclusion and Relevance: The findings indicate that MORACS diagnostic support service reduced the proportion of missed STEMI and improved the rates of primary reperfusion therapy. Accurate diagnosis of STEMI was associated with lower mortality. Trial Registration: anzctr.org.au Identifier: ACTRN12619000533190.

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.

The effect of zinc supplementation on glucose homeostasis: a randomised double-blind placebo-controlled trial.

AIMS: The burden and health costs of Type 2 Diabetes Mellitus continue to increase globally and prevention strategies in at-risk people need to be explored. Previous work, in both animal models and humans, supports the role of zinc in improving glucose homeostasis. We, therefore, aimed to test the effectiveness of zinc supplementation on glycaemic control in pre-diabetic adults. METHODS: We conducted a randomized, double-blind, placebo-controlled trial across 10 General Practitioner (GP) practices in NSW, Australia. The trial is known as Zinc in Preventing the Progression of pre-Diabetes (ZIPPeD)Study. Pre-diabetic (haemoglobin A1c [HbA1c] 5.7-6.4%, 39-46 mmol/mol) men and women (N = 98) were all assigned to a free state government telephone health coaching service (New South Wales Get Healthy Information and Coaching Service) and then randomised to either daily 30 mg zinc gluconate or placebo. Blood tests were collected at baseline, 1, 6 and 12 months for the primary outcomes (HbA1c, fasting blood glucose (FBG)); secondary outcomes included Homeostasis Model Assessment 2 (HOMA 2) parameters, lipids, body weight, height, waist circumference, blood pressure and pulse. RESULTS: The baseline-adjusted mean group difference at 6 months, expressed as treatment-placebo, (95% CI) was -0.02 (-0.14, 0.11, p = 0.78) for HbA1c and 0.17 (-0.07, 0.42; p = 0.17) for FBG, neither of which were statistically significant. There were also no significant differences between groups in any of the secondary outcomes. Zinc was well tolerated, and compliance was high (88%). CONCLUSION: We believe our results are consistent with other Western clinical trial studies and do not support the use of supplemental zinc in populations with a Western diet. There may still be a role for supplemental zinc in the developing world where diets may be zinc deficient. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12618001120268. Registered on 6 July 2018.

Understanding the sustainment of population health programmes from a whole-of-system approach.

BACKGROUND: Population health prevention programmes are needed to reduce the prevalence of chronic diseases. Nevertheless, sustaining programmes at a population level is challenging. Population health is highly influenced by social, economic and political environments and is vulnerable to these system-level changes. The aim of this research was to examine the factors and mechanisms contributing to the sustainment of population prevention programmes taking a systems thinking approach. METHODS: We conducted a qualitative study through interviews with population health experts working within Australian government and non-government agencies experienced in sustaining public health programs at the local, state or national level (n = 13). We used a deductive thematic approach, grounded in systems thinking to analyse data. RESULTS: We identified four key barriers affecting program sustainment: 1) short term political and funding cycles; 2) competing interests; 3) silo thinking within health service delivery; and 4) the fit of a program to population needs. To overcome these barriers various approaches have centred on the importance of long-range planning and resourcing, flexible program design and management, leadership and partnerships, evidence generation, and system support structures. CONCLUSION: This study provides key insights for overcoming challenges to the sustainment of population health programmes amidst complex system-wide changes.