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.

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 .

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.

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).

A randomised controlled trial of an implementation strategy delivered at scale to increase outdoor free play opportunities in early childhood education and care (ECEC) services: a study protocol for the get outside get active (GOGA) trial.

BACKGROUND: Increased outdoor play time in young children is associated with many health and developmental benefits. This study aims to evaluate the impact of a multi-strategy implementation strategy delivered at scale, to increase opportunities for outdoor free play in Early Childhood Education and Care (ECEC) services. METHODS: The study will employ a parallel-group randomised controlled trial design. One hundred ECEC services in the Hunter New England region of New South Wales, Australia, will be recruited and randomised to receive either a 6-month implementation strategy or usual care. The trial will seek to increase the implementation of an indoor-outdoor routine (whereby children are allowed to move freely between indoor and outdoor spaces during periods of free play), to increase their opportunity to engage in outdoor free play. Development of the strategy was informed by the Behaviour Change Wheel to address determinants identified in the Theoretical Domains Framework. ECEC services allocated to the control group will receive 'usual' implementation support delivered as part of state-wide obesity prevention programs. The primary trial outcome is the mean minutes/day (calculated across 5 consecutive days) of outdoor free play opportunities provided in ECEC services measured at baseline, 6-months (primary end point) and 18-months post baseline. Analyses will be performed using an intention-to-treat approach with ECEC services as the unit of analysis, using a linear mixed effects regression model to assess between-group differences. A sensitivity analysis will be undertaken, adjusting for service characteristics that appear imbalanced between groups at baseline, and a subgroup analysis examining potential intervention effect among services with the lowest baseline outdoor free play opportunities. DISCUSSION: Identifying effective strategies to support the implementation of indoor-outdoor routines in the ECEC setting at scale is essential to improve child population health. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ( ACTRN12621000987864 ). Prospectively registered 27th July 2021, ANZCTR - Registration.

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).

Effectiveness of referral to a population-level telephone coaching service for improving health risk behaviours in people with a mental health condition: study protocol for a randomised controlled trial.

BACKGROUND: People with a mental health condition have a shorter life expectancy than the general population. This is largely attributable to higher rates of chronic disease and a higher prevalence of modifiable health risk behaviours including tobacco smoking, alcohol consumption, poor nutrition, and physical inactivity. Telephone support services offer a viable option to provide support to reduce these health risk behaviours at a population-level; however, whilst there is some research pertaining to Quitlines, there is limited other research investigating whether telephone services may offer effective support for people with a mental health condition. This protocol describes a randomised controlled trial that aims to evaluate the referral of people with a mental health condition to a population-level telephone coaching service to increase physical activity, healthy eating, or weight management, and increase attempts to do so. METHODS: A parallel-group randomised controlled trial will be conducted recruiting participants with a mental health condition through community mental health services and advertisement on social media. Participants will be randomly assigned to receive either a health information pack only (control) or a health information pack and a proactive referral to a free, government-funded telephone coaching service, the NSW Get Healthy Coaching and Information Service® (intervention), which offers up to 13 telephone coaching calls with a University Qualified Health Coach to assist with client-identified goals relating to physical activity, healthy eating, weight management, or alcohol reduction. Data will be collected via telephone surveys at baseline and 6 months post-recruitment. Primary outcomes are as follows: (1) minutes of moderate to vigorous physical activity per week, (2) serves of fruit consumed per day, (3) serves of vegetables consumed per day, and (4) a composite measure assessing attempts to change at least one health risk behaviour (any attempts to change physical activity, fruit consumption, vegetable consumption, or other parts of nutrition). Secondary outcomes include weight and body mass index. DISCUSSION: This study is the first to evaluate the effectiveness of referral to a population-level telephone support service for reducing health risk behaviours relating to physical activity, healthy eating, and weight in people with a mental health condition. Results will inform future policy and practice regarding the delivery of telephone-based behaviour change coaching services and the management of physical health for this population to reduce health inequity and the burden of chronic disease. TRIAL REGISTRATION: The Australian New Zealand Clinical Trials Registry ACTRN12620000351910 . Retrospectively registered on 12 March 2020.

Scale-up of the Physical Activity 4 Everyone (PA4E1) intervention in secondary schools: 24-month implementation and cost outcomes from a cluster randomised controlled trial.

BACKGROUND: Physical Activity 4 Everyone (PA4E1) is an evidence-based program effective at increasing adolescent physical activity (PA) and improving weight status. This study aimed to determine a) the effectiveness of an adapted implementation intervention to scale-up PA4E1 at 24-month follow-up, b) fidelity and reach, and c) the cost and cost-effectiveness of the implementation support intervention. METHODS: A cluster randomised controlled trial using a type III hybrid implementation-effectiveness design in 49 lower socio-economic secondary schools, randomised to a program (n = 24) or control group (n = 25). An adapted implementation intervention consisting of seven strategies was developed to support schools to implement PA4E1 over 24-months. The primary outcome was the proportion of schools implementing at least four of the 7 PA practices, assessed via computer assisted telephone interviews (CATI) with Head Physical Education Teachers. Secondary outcomes included the mean number of PA practices implemented, fidelity and reach, cost and cost-effectiveness. Logistic regression models assessed program effects. RESULTS: At baseline, no schools implemented four of the 7 PA practices. At 24-months, significantly more schools in the program group (16/23, 69.6%) implemented at least four of the 7 PA practices than the control group (0/25, 0%) (p < 0.001). At 24-months, program schools were implementing an average of 3.6 more practices than control schools (4.1 (1.7) vs. 0.5 (0.8), respectively) (P < 0.001). Fidelity and reach of the implementation intervention were high (> 75%). The total cost of the program was $415,112 AUD (2018) ($17,296 per school; $117.30 per student). CONCLUSIONS: The adapted implementation intervention provides policy makers and researchers with an effective and potentially cost-effective model for scaling-up the delivery of PA4E1 in secondary schools. Further assessment of sustainability is warranted. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000681358 prospectively registered 12th May 2017.

An implementation intervention to increase the routine provision of antenatal care addressing gestational weight gain: study protocol for a stepped-wedge cluster trial.

BACKGROUND: Weight gain during pregnancy that is outside of recommended levels is associated with a range of adverse outcomes for the mother and child, including gestational diabetes, pre-eclampsia, preterm birth, and obesity. Internationally, 60-80% of pregnant women report gaining weight outside of recommended levels. While guideline recommendations and RCT evidence support the provision of antenatal care that supports healthy gestational weight gain, less than 10% of health professionals routinely weigh pregnant women; discuss weight gain, diet, and physical activity; and provide a referral for additional support. This study aims to determine the effectiveness of an implementation intervention in increasing the provision of recommended gestational weight gain care by maternity services. METHODS: A stepped-wedge controlled trial, with a staggered implementation intervention, will be conducted across maternity services in three health sectors in New South Wales, Australia. The implementation intervention will consist of evidence-based, locally-tailored strategies including guidelines and procedures, reminders and prompts, leadership support, champions, training, and monitoring and feedback. Primary outcome measures will be the proportion of women who report receiving (i) assessment of gestational weight gain; (ii) advice on gestational weight gain, dietary intake, and physical activity; and (iii) offer of referral to a telephone coaching service or local dietetics service. Measurement of outcomes will occur via telephone interviews with a random sample of women who attend antenatal appointments each week. Economic analyses will be undertaken to assess the cost, cost-consequence, cost-effectiveness, and budget impact of the implementation intervention. Receipt of all care elements, acceptance of referral, weight gain during pregnancy, diet quality, and physical activity will be measured as secondary outcomes. Process measures including acceptability, adoption, fidelity, and reach will be reported. DISCUSSION: This will be the first controlled trial to evaluate the effectiveness of a implementation intervention in improving antenatal care that addresses gestational weight gain. The findings will inform decision-making by maternity services and policy agencies and, if the intervention is demonstrated to be effective, could be applied at scale to benefit the health of women and children across Australia and internationally. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12621000054819 . Registered on 22 January 2021.

Self-reported suboptimal sleep and receipt of sleep assessment and treatment among persons with and without a mental health condition in Australia: a cross sectional study.

BACKGROUND: Poor sleep and poor mental health go hand in hand and, together, can have an adverse impact on physical health. Given the already disproportionate physical health inequities experienced by people with a mental health condition worldwide, the need to consider and optimise sleep has been highlighted as a means of improving both physical and mental health status. Sleep recommendations recently developed by the United States' National Sleep Foundation incorporate a range of sleep parameters and enable the identification of 'suboptimal' sleep. Among community-dwelling persons with and without a 12-month mental health condition in Australia, this study reports: [1] the prevalence of 'suboptimal' sleep and [2] rates of sleep assessment by a health care clinician/service and receipt of and desire for sleep treatment. METHODS: A descriptive study (N = 1265) was undertaken using self-report data derived from a cross-sectional telephone survey of Australian adults, undertaken in 2017. RESULTS: Fifteen per cent (n = 184) of participants identified as having a mental health condition in the past 12 months. Across most (7 of 8) sleep parameters, the prevalence of suboptimal sleep was higher among people with a mental health condition, compared to those without (all p < 0.05). The highest prevalence of suboptimal sleep for both groups was seen on measures of sleep duration (36-39% and 17-20% for people with and without a mental health condition, respectively). In terms of sleep assessment and treatment, people with a mental health condition were significantly more likely to: desire treatment (37% versus 16%), have been assessed (38% versus 12%) and have received treatment (30% versus 7%). CONCLUSIONS: The prevalence of suboptimal sleep among persons with a mental health condition in Australia is significantly higher than those without such a condition, and rates of assessment and treatment are low for both groups, but higher for people with a mental health condition. Population health interventions, including those delivered as part of routine health care, addressing suboptimal sleep are needed.

Improving Assessment, Diagnosis, and Management of Urinary Incontinence and Lower Urinary Tract Symptoms on Acute and Rehabilitation Wards That Admit Adult Patients: Protocol for a Before-and-After Implementation Study.

BACKGROUND: Urinary incontinence (UI) and lower urinary tract symptoms (LUTS) are commonly experienced by adult patients in hospitals (inpatients). Although peak bodies recommend that health services have systems for optimal UI and LUTS care, they are often not delivered. For example, results from the 2017 Australian National Stroke Audit Acute Services indicated that of the one-third of acute stroke inpatients with UI, only 18% received a management plan. In the 2018 Australian National Stroke Audit Rehabilitation Services, half of the 41% of patients with UI received a management plan. There is little reporting of effective inpatient interventions to systematically deliver optimal UI/LUTS care. OBJECTIVE: This study aims to determine whether our UI/LUTS practice-change package is feasible and effective for delivering optimal UI/LUTS care in an inpatient setting. The package includes our intervention that has been synthesized from the best-available evidence on UI/LUTS care and a theoretically informed implementation strategy targeting identified barriers and enablers. The package is targeted at clinicians working in the participating wards. METHODS: This is a pragmatic, real-world, before- and after-implementation study conducted at 12 hospitals (15 wards: 7/15, 47% metropolitan, 8/15, 53% regional) in Australia. Data will be collected at 3 time points: before implementation (T0), immediately after the 6-month implementation period (T1), and again after a 6-month maintenance period (T2). We will undertake medical record audits to determine any change in the proportion of inpatients receiving optimal UI/LUTS care, including assessment, diagnosis, and management plans. Potential economic implications (cost and consequences) for hospitals implementing our intervention will be determined. RESULTS: This study was approved by the Hunter New England Human Research Ethics Committee (HNEHREC Reference No. 18/10/17/4.02). Preimplementation data collection (T0) was completed in March 2020. As of November 2020, 87% (13/15) wards have completed implementation and are undertaking postimplementation data collection (T1). CONCLUSIONS: Our practice-change package is designed to reduce the current inpatient UI/LUTS evidence-based practice gap, such as those identified through national stroke audits. This study has been designed to provide clinicians, managers, and policy makers with the evidence needed to assess the potential benefit of further wide-scale implementation of our practice-change package. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/22902.

Economic evaluation of a web-based menu planning intervention to improve childcare service adherence with dietary guidelines.

BACKGROUND: Despite the known benefits of healthy eating in childhood, few Australian childcare services provide food that is consistent with dietary guidelines. The effectiveness of a web-based menu planning intervention to increase childcare service provision of healthy foods and decrease provision of discretionary foods in long day-care services in Australia was assessed in a randomised controlled trial. Here we consider the costs, consequences, cost-effectiveness and budget impact of the intervention using data collected within the trial. METHODS: The prospective trial-based economic evaluation involved 54 childcare services across New South Wales (NSW), Australia. Services were randomised to a 12-month intervention or usual care. The intervention involved access to a web-based menu planning and decision support tool and online resources. Effectiveness measures included mean number of food groups, overall menu and individual food group compliance with dietary guidelines, and mean servings of food groups at 12 months. Costs (reported in $AUD, 2017/18) were evaluated from both health sector and societal perspectives. The direct cost to support uptake of the intervention was calculated, as were costs to each childcare service. The incremental cost of the intervention was calculated as the net difference in the cost to undertake menu planning and review plus the direct cost of the intervention. Incremental cost-effectiveness ratios (ICERs) including uncertainty intervals were estimated for differences in costs and effects between intervention and control groups. A relative value index was calculated to determine overall value for money. RESULTS: Over the 12 months of the trial, we calculated a difference in cost between usual practice and intervention groups of - $482 (95% UI - $859, - $56). While the measured increase in menu and food group compliance within the trial did not reach statistical significance, there were significant improvements in mean servings of fruit and discretionary food, represented in the cost-consequence analysis. The calculated relative value index of 1.1 suggests that the intervention returns acceptable value for money for the outcomes generated. CONCLUSION: Compared to usual practice, web-based programmes may offer an efficient and sustainable alternative for childcare services to improve the provision of healthy foods to children in their care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616000974404.

5-Year Follow-Up of a Telephone Intervention to Increase Fruit and Vegetable Consumption in Preschoolers: The 'Healthy Habits' Cluster Randomised Trial.

Little is known about the long-term impact of telephone-based interventions to improve child diet. This trial aimed to assess the long-term effectiveness (after 5 years) of a telephone-based parent intervention in increasing children's fruit and vegetable consumption. Parents of 3-5 year olds were recruited from 30 Australian preschools to participate in a cluster randomised controlled trial. Intervention parents received four, weekly, 30-min support calls aimed at modifying the home food environment. Control parents received printed materials. Consumption was assessed using the Fruit and Vegetable subscale of the Children's Dietary Questionnaire (F&V-CDQ) (children) and daily servings of fruit and vegetables (children and parents) via parent telephone interview. Of the 394 parents who completed baseline, 57% (99 intervention, 127 control) completed follow-up. After 5-years, higher intervention F&V-CDQ scores, bordering on significance, were found in complete-case (+1.1, p = 0.06) and sensitivity analyses (+1.1, p = 0.06). There was no difference in parent or child consumption of daily fruit servings. Complete-case analysis indicated significantly higher consumption of child vegetable servings (+0.5 servings; p = 0.02), which was not significant in sensitivity analysis (+0.5 servings; p = 0.10). This telephone-based parent intervention targeting the family food environment may yield promising improvements in child fruit and vegetable consumption over a 5-year period.

Protocol for an economic evaluation and budget impact assessment of a randomised, stepped-wedge controlled trial for practice change support to increase routine provision of antenatal care for maternal alcohol consumption.

BACKGROUND: Antenatal clinical practice guidelines recommend routine assessment of women's alcohol consumption during pregnancy. The delivery of advice and referral when necessary are also recommended. However, evidence suggests there are barriers to the uptake of best-care guidelines. Effective, cost-effective and affordable implementation strategies are needed to ensure the intended benefits of guidelines are realised through addressing identified barriers. This paper describes the protocol for evaluating the efficiency and affordability of a practice change intervention compared to the usual practice in an implementation trial. METHODS: The effectiveness of the intervention will be evaluated in a stepped-wedge randomised controlled implementation trial, conducted in an Australian setting. An economic evaluation will be conducted alongside the trial to assess intervention efficiency. A budget impact assessment will be conducted to assess affordability. The prospective trial-based economic evaluation will identify, measure and value key resource and outcome impacts arising from the multi-strategy practice change intervention compared with usual practice. The evaluation will comprise (i) 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 (ii) cost-effectiveness analyses, where the primary outcome will be incremental cost per percent increase in participants reporting receipt of antenatal care for maternal alcohol consumption consistent with the guideline recommendations. Intervention affordability will be evaluated using budget impact assessment and will estimate the financial implications of adoption and diffusion of this implementation strategy from the perspective of relevant fundholders. Results will be extrapolated to estimate the cost and cost-effectiveness of rolling out the model of care. DISCUSSION: Uptake of clinical guidelines requires practice change support. It is hypothesized that the implementation strategy, if found to be effective, will also be cost-effective, affordable and scalable. This protocol describes the economic evaluation that will address these hypotheses. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry, ACTRN12617000882325. Registered on 16 June 2017.

An economic evaluation of a specialist preventive care clinician in a community mental health service: a randomised controlled trial.

BACKGROUND: Clinical practice guidelines and policies direct community mental health services to provide preventive care to address chronic disease risks, however, such care is infrequently provided in routine consultations. An alternative model of care is to appoint a clinician to the dedicated role of offering and providing preventive care in an additional consultation: the 'specialist clinician' model. Economic evaluations of models of care are needed to determine the cost of adhering to guidelines and policies, and to inform pragmatic service delivery decisions. This study is an economic evaluation of the specialist clinician model; designed to achieve policy concordant preventive care delivery. METHODS: A retrospective analysis of the incremental costs, cost-effectiveness, and budget impact of a 'specialist preventive care clinician' (an occupational therapist) was conducted in a randomised controlled trial, where participants were randomised to receive usual care; or usual care plus the offer of an additional preventive care consultation with the specialist clinician. The study outcome was client acceptance of referrals to two free telephone-based chronic disease prevention services. This is a key care delivery outcome mandated by the local health district policy of the service. The base case analysis assumed the mental health service cost perspective. A budget impact analysis determined the annual budget required to implement the model of care for all clients of the community mental health service over 5 years. RESULTS: There was a significantly greater increase from baseline to follow-up in the proportion of intervention participants accepting referrals to both telephone services, compared to usual care. The incremental cost-effectiveness ratio was $347 per additional acceptance of a referral (CI: $263-$494). The annual budget required to implement the model of care for all prospective clients was projected to be $711,446 over 5-years; resulting in 2616 accepted referrals. CONCLUSIONS: The evaluation provides key information regarding the costs for the mental health service to adhere to policy targets, indicating the model of care involved a low per client cost whilst increasing key preventive care delivery outcomes. Additional modelling is required to further explore its economic benefits. TRIAL REGISTRATION: ACTRN12616001519448. Registered 3 November 2016, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371709.

Protocol for a mixed methods process evaluation of a hybrid implementation-effectiveness trial of a scaled-up whole-school physical activity program for adolescents: Physical Activity 4 Everyone (PA4E1).

BACKGROUND: Physical Activity 4 Everyone (PA4E1) is a physical activity program for secondary schools located in low-socioeconomic areas. Over a 24-month period, schools in the program arm of a cluster randomised controlled trial (n = up to 38 schools) will receive a multi-component implementation support strategy to embed the seven school physical activity practices of the PA4E1 program. This article describes the process evaluation of the PA4E1 hybrid implementation-effectiveness trial. The process evaluation aims to describe the fidelity and reach of the implementation support strategies using quantitative data; and to describe the acceptability, appropriateness and feasibility of the implementation support strategies and physical activity practices to school stakeholders using mixed methods. METHODS: Quantitative and qualitative data will be collected from participants (Physical Education teachers, in-School Champions, students) in the program arm. Data collection will involve semi-structured interviews, focus groups, a fidelity monitoring log, a fidelity checklist, surveys, and routinely collected administrative and website data. Quantitative data will be analysed descriptively and qualitative data will be analysed thematically within and across data sets. Triangulation between data sources will be used to synthesise findings regarding the implementation and potential mechanisms of impact of PA4E1 on school physical activity practice adoption, with respect to context. DISCUSSION: Results of the process evaluation will facilitate the interpretation of the findings of the trial outcomes. It will comprehensively describe what was actually implemented and identify the potential contribution of the various components of the implementation support strategy to the school physical activity practice adoption outcomes. Findings will inform future improvement and scale-up of PA4E1 and approaches to implementing secondary school-based physical activity programs more broadly. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12617000681358 registered 12 May 2017.

Alcohol and fast food sponsorship in sporting clubs with junior teams participating in the 'Good Sports' program: a cross-sectional study.

OBJECTIVE: To examine: alcohol and fast food sponsorship of junior community sporting clubs; the association between sponsorship and club characteristics; and parent and club representative attitudes toward sponsorship. METHODS: A cross-sectional telephone survey of representatives from junior community football clubs across New South Wales and Victoria, Australia, and parents/carers of junior club members. Participants were from junior teams with Level 3 accreditation in the 'Good Sports' program. RESULTS: A total of 79 club representatives and 297 parents completed the survey. Half of participating clubs (49%) were sponsored by the alcohol industry and one-quarter (27%) were sponsored by the fast food industry. In multivariate analyses, the odds of alcohol sponsorship among rugby league clubs was 7.4 (95%CI: 1.8-31.0, p=<0.006) that of AFL clubs, and clubs located in regional areas were more likely than those in major cities to receive fast food industry sponsorship (OR= 9.1; 95%CI: 1.0-84.0, p=0.05). The majority (78-81%) of club representatives and parents were supportive of restrictions to prohibit certain alcohol sponsorship practices, but a minority (42%) were supportive of restrictions to prohibit certain fast food sponsorship practices. CONCLUSIONS: Large proportions of community sports clubs with junior members are sponsored by the alcohol industry and the fast food industry. There is greater acceptability for prohibiting sponsorship from the alcohol industry than the fast food industry. Implications for public health: Health promotion efforts should focus on reducing alcohol industry and fast food industry sponsorship of junior sports clubs.

Barriers to the implementation of clinical guidelines for maternal alcohol consumption in antenatal services: A survey using the theoretical domains framework.

ISSUE ADDRESSED: The aim of this study was to assess potential barriers to the implementation of clinical guideline recommendations regarding maternal alcohol consumption by antenatal clinicians and managers. METHODS: Cross-sectional surveys of antenatal clinicians and managers employed in a New South Wales Local Health District were undertaken. Survey items were developed based on 11 domains of the Theoretical Domains Framework. Consistent with previous studies, a cut point of less than 4 was applied to mean values of survey items (range: 1-5) to identify domains representing barriers to the implementation. RESULTS: Thirty-three antenatal clinicians and eight managers completed the surveys. For clinicians, the domains with the lowest mean values included "environmental context and resources" (ie, complexity of appointments and availability of supporting systems) (mean: 3.13, SD: 0.93); "social influences" (ie, expectations of others that alcohol will be addressed) (mean: 3.33, SD: 0.68); "beliefs about capabilities" (ie, confidence in providing guideline recommendations) (mean: 3.51, SD: 0.67); and "behavioural regulation" (ie, planning and responding to feedback) (mean: 3.53, SD: 0.64). For managers, "emotion regulation" (ie, stress in managing change) (mean: 2.13, SD: 0.64) and "environmental context and resources" (ie, complexities of managing change) (mean: 3.13, SD: 0.83) were the lowest scoring domains. CONCLUSIONS: The antenatal service environment and availability of resources appear to be primary barriers to both clinicians and managers implementing guidelines for maternal alcohol consumption. SO WHAT?: In the development of interventions to support the delivery of clinical guideline recommendations addressing alcohol consumption during pregnancy, a broad range of potential barriers at both the clinician and manager levels need to be considered and targeted by effective implementation strategies.